Could This Device Help Save Covid-19 Patients Before the ICU? – Houstonia Magazine

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ONE OF THE MOST DIFFICULT ASPECTS OF LIFE IN A COVID-19 world is the uncertainty. Not only are we facing an unseen opponent that we barely understand, but none of us know, should we contract the virus, whether well be part of the group that barely registers any symptoms or if well rapidly end up in a drug-induced haze on a ventilator in the ICU. More troubling still, neither do the doctors treating us.

What if there were a way to find out? OncologistDr. Cassian Yee of MD Anderson thinks the key to unlocking this mystery may very well be pumping inside our veins.

For more than 25 years Yee has been studying the use of T-cells, a type of white blood cell called lymphocytes, in his cancer research. They are like soldiers that are trained by the bodys immune system, he says. They go to sites of disease, the battlefield, and coordinate an attack on the enemy, the virus or cancer cell. When their job is completed, they return to the barracks and keep vigilant for any further attacks.

After reading reports that noted lower levels of T-cells in patientswith severe cases ofCovid-19, specificallythose who experiencedrespiratory failure, theoncologist realized thatdeveloping a test to quicklydetermine a patients T-cellcount could go a long waytoward helping medical personnel predict which patients are more prone to experiencing the viruss most deadly symptoms, long before doctors have to get machines to start breathing for them.

Technically this kind of lab test already exists, says Yee; its just not fast or easily available (were talking expensive and bulky equipment and results that take about half a day to process), especially when time is of the essence and equipment is in short supply. So Yee teamed up withKevin McHugh andPeter Lillehoj of Rice University to create a point-of-care device that would allow medical personnel to conduct these tests quickly and cheaply, key factors that could make this item crucial for both Texas Medical Center hospitals and underserved clinics on the front lines of the outbreak.

Using a small amount of blood, the teams point-of-care device will separate the different kinds of blood cells in the sample, count the lymphocytes, and spit out a quantifiable numberideally in about 15 minutes or less. Doctors will then use this number to determine whether a Covid-19 patient is more likely to suffer poor oxygenation. If doctors know beforehand that certain patients have low T-cell numbers and are thus more prone to experiencing the symptoms, including lung deterioration, that have been shown to be fatal in some, they could start more aggressively treating those patients long before they have to be put on ventilators. Its a bit like, Can this patient go home and safely recuperate, or should they stay in the hospital because they might need the ICU? explains McHugh, who specializes in bioengineering.

There are other potential uses for this device as well. While Yee and his team dont expect their point-of-care prototype device to be ready until January 2021 at the earliest, that hasnt stopped them from considering the technologys uses beyond the current coronavirus pandemic.

Wed love to be able to eventually move this into other viral diseases, such as HIV, Yee says. Perhaps even when patients are undergoing some type of treatment for their cancer.

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Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine

Safety Concern With Fingolimod to Ocrelizumab Switch in MS – Medscape

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A new study suggeststhe need for caution in switching from fingolimod to a B celldepleting anti-CD20 treatment such as ocrelizumab for patients with multiple sclerosis (MS).

Italian researchers report an increased risk for prolonged reductions in T-cell counts, in addition to depletion of B cells, among patients who make this switch. Such depletion could increase the risk for infection, a particular concern in the current COVID era.

The study showed that among patients who had been taking ocrelizumab, those who were switched from fingolimod had a greater risk for lymphocytopenia throughout the 12 months of follow-up compared with patients who were switched from other therapies or who had not taken other therapies.

The results were presented by Doriana Landi, MD, at the recent 8th Joint European Committee for Treatment and Research in Multiple SclerosisAmericas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

Landi is a postdoctoral researcher and clinical neurologist at the Multiple Sclerosis Clinical and Research Unit, Fondazione Policlinico Tor Vergatal, Rome, Italy.

"It has been thought that ocrelizumab and similar drugs just deplete CD20 B cells. But there is now evidence that the CD20 is also expressed on certain T-cell subtypes, and levels of these cells are also reduced by anti-CD20 drugs," she explained.

"It may be just a small effect, but we wanted to look at this with regard to starting ocrelizumab after other treatments, particularly fingolimod, which itself is associated with pronounced lymphocytopenia," she said.

This was an observational study of patients starting therapy with ocrelizumab. The patients were divided into three groups: those who had switched from fingolimod; those who had switched from other treatments (dimethyl fumarate, interferon-beta, glatiramer acetate, natalizumab, teriflunomide); and patients who were treatment naive.

Lymphocyte subtype counts (CD3+, CD4+, CD8+ and CD20+) were taken at baseline and every 6 months after treatment with ocrelizumab was initiated.

A sample of 135 patients was analyzed (37 had switched from fingolimod, 64 had switched from other drugs, and 34 were treatment naive). Median time between washout was 73 days for fingolimod and 68 days for other treatments.

Results showed that at baseline, in comparison with treatment-naive patients, those who had switched from fingolimod experienced a significant decrease in CD3+ (1204 vs 1735 cells/mm3; P = .0003), CD4+ (551 vs 997 cells/mm3; P < .0001), CD8+ (430 vs 537 cells/mm3; P = .027), and CD20+ (88 vs 191 cells/mm3; P = .021) lymphocytes.

After 6 months, the proportion of patients with CD3, CD4, and CD8 lymphocytopenia (below laboratory reference values) was significantly higher among patients who had switched from fingolimod compared to patients who had switched from other treatments or who had not taken other treatments.

At 12 months, there was a trend toward greater CD4 and CD8 lymphocytopenia compared to the other two groups. Data at 18 and 24 months have not been confirmed, owing to the limited number of available values.

There was no difference in B-cell counts among the three groups.

"We found that ocrelizumab had a small effect on reducing T cells which was similar in the three groups of patients, but patients who had previously received fingolimod were more likely to have low T-cell counts at baseline and to be lymphocytopenic at 6 months and at 12 months after ocrelizumab," Landi told Medscape Medical News.

"So the T cells don't recover on ocrelizumab, and some patients have a risk of double immunosuppression (low levels of both T and B cells)," she added. "This is relevant, as it may increase the risk of opportunistic infections."

After correcting for baseline values, the effect of ocrelizumab appeared similar in all three groups. There was a small percentage reduction in certain T cells.

"If the patients had a reasonable cell count at baseline, that probably isn't too much of an issue; they will likely stay in normal levels. But if they start with a low lymphocyte count, then even a small reduction with ocrelizumab may put them into double immunosuppression," Landi noted.

"We don't know how long this double lymphocytopenia will last. We need to follow patients longer. So far in our study, the mean follow-up is 12 months," she said.

The researchers are also monitoring infection risk but have not as yet analyzed the data.

Landi explained that fingolimod is a popular drug, but if MS is still active while a patient is taking the drug or if safety concerns arise, then treatment would normally be switched to a different therapy, and ocrelizumab is becoming one of the more commonly used options.

"In the clinical trials with ocrelizumab, few patients had been pretreated with fingolimod, so we don't have good data on that," she said.

She recommends that clinicians evaluate T-cell substrates when making this switch. "It would be a good idea to wait a bit after fingolimod discontinuation to let lymphocytes recover, but this has to be balanced by concerns over efficacy. If we wait too long, then the relapse rate may start to increase. Several studies are ongoing to evaluate this at present."

Landi points out that the risk for double immunosuppression could be more of a problem in the current COVID crisis, insofar as both T cells and B cells are involved with antiviral responses.

"We know that COVID causes a reduction in T cells even in healthy people. If patients already have a low peripheral T-cell count and they then contract COVID, this could be a problem. We need to evaluate B- and T-cell counts in patients with worse COVID outcomes to understand this better," Landi commented.

"We believe clinicians should be aware of this issue when switching from fingolimod to ocrelizumab and that this could represent an additional risk regarding COVID, so we need to be cautious."

She suggested that during the COVID-19 pandemic, it may be better for patients for whom fingolimod is being discontinued and who have very low lymphocyte counts to be switched to drugs that do not induce lymphocytopenia.

Commenting for Medscape Medical News, Robert J. Fox, MD, said: "This study is important because we have little evidence to guide how we change patients from one therapy to another."

Although in this study there was a prolonged reduction of lymphocytes in patients who were switched to ocrelizumab from fingolimod compared to other MS therapies, "it doesn't address what clinicians really want to know: are there safety concerns?" Fox, who is a staff neurologist at the Mellen Center for Multiple Sclersois, Cleveland Clinic, Cleveland, Ohio, added.

"We know that lymphocyte reduction isn't related to risk of infection with either fingolimod or dimethyl fumarate, so we still don't know if patients transitioning from other MS therapies to ocrelizumab are at higher risk of infections," Fox said.

"This study suggests a mechanism if there is an increased risk, but it's putting the cart before the horse. Is there an increased risk in the first place? At this point, I haven't seen data to suggest that there is."

Landi reports consultancies for Sanofi-Genzyme, Merck-Serono, Teva, Biogen, and Roche. Fox has disclosed no relevant financial relationships.

8th Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020: Session FC02.03, presented September 13, 2020.

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – Yahoo Finance

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Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

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Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - Yahoo Finance

Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study – Yahoo Finance

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Delivery of Investigational Endotracheal Ultraviolet-A Light Catheter Devices Enables Near-Term Initiation of Planned Clinical Studies in Severely Ill COVID-19 Patients

ENGLEWOOD, CO / ACCESSWIRE / August 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the delivery of Healight investigational devices. The delivery of these pilot scale Healight devices, designed and developed by Sterling Medical Devices ("Sterling"), enables the initiation of COVID-19 investigational clinical studies, which are expected to begin in the near-term.

Since Aytu signed a master services agreement with Sterling in April for Healight, the Company, Sterling, and its collaborators have sourced Healight device components and finalized design of the investigational devices for use in upcoming clinical studies.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "A significant amount of work has gone into the development of the Healight investigational device, and we thank all of our collaborators for their efforts. We are looking forward to taking the next steps and advancing Healight as quickly as possible. As the COVID-19 pandemic continues, the investigation and development of novel potential therapies remains a high priority for numerous companies, and Aytu is proud to be part of this important effort. If Healight demonstrates safety and effectiveness in upcoming, planned studies, we are hopeful it can become an important tool in the COVID-19 fight."

The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU). Beyond the initial pursuit of a potential SARS-CoV-2 ICU indication, additional experimental studies of mixed infection suggest broader potential clinical applications for the technology across a range of viral and bacterial pathogens. This may include nosocomial bacteria implicated in ventilator-associated pneumonia (VAP).

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, compliance, and global regulatory submissions. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory registrations, clearances, and/or approvals of Class I, II, and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21 CFR Part 820 and Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, manufacturing, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/601817/Aytu-BioScience-Announces-Manufacture-and-Delivery-of-HealightTM-Devices-for-Use-in-COVID-19-Clinical-Study

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Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study - Yahoo Finance

Is Testosterone Therapy Safe for Women? – HealthCentral.com

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The hormone testosterone (called T for short in medical circles) has long been associated with the male physique, athleticism, and a heightened sex drive. But now, theres an idea making the internet search rounds that testosterone therapy may be the secret sauce to revamping a womans shuttered sex drive.

Even health-conscious celebrities have gotten in on the hype. In 2011, Jane Fonda told The Sunday Telegraph that she started taking the hormone in her 70s to boost her sex drive. But before you run to your doctor to ask for a prescription, you should know that testosterone therapy is a controversial approach that is not FDA-regulated for women at this time. Despite its mythical reputation, this hormone isnt a cure-all for sexual dysfunction, and it could even be dangerous for your health if not taken carefully. Let us explain.

Testosterone may be known as a male hormone, but womens bodies naturally produce it, too. Its one of many hormones that work together to control our mood, metabolism, sexual desire, bone and muscle growth, and reproductive system. As you age, your hormone levels change, with one of the biggest shifts occurring during menopause when your menstrual cycle stops for good. Menopause causes your estrogen and progesterone levels to decrease, but interestingly, it is not associated with a sudden decrease in testosterone, according to the North American Menopause Society.

That said, there is evidence that testosterone decreases throughout your life. Testosterone drops with age more than with menopause, says Margaret Wierman, M.D., professor at the University of Colorado Anschutz Medical Campus in Aurora, CO and former Vice President of Clinical Sciences at the Endocrine Society. This may explain why testosterone pills, gels, and patches are sometimes touted by drug marketing campaigns (and celebs) as a sex drive booster for older men and women whose testosterone is naturally lower than it used to be.

The problem with this approach, according to Chrisandra Shufelt, M.D., associate director of the Barbra Streisand Womens Heart Center at the Cedars-Sinai Smidt Heart Institute in Los Angeles, CA, is that testosterone is not necessarily the miracle drug you may be reading about on the internet. If you search online, it seems like testosterone could be the panacea of all hormones, relieving everything from fatigue to weight gain to depression, Dr. Shufelt says. But interestingly, she notes, there is no scientifically proven list of symptoms directly correlated to low T in women. Everyones hormone levels are naturally different, and what looks low on a testosterone test for one woman may be a perfectly normal T level for another.

To some extent, yesbut its not the end all, be all. Dr. Wierman explains that there are many different causes of sexual dysfunction (the term for when youre no longer craving or enjoying sex). There are mechanical hardware causes, there are relationship causes, there are mood causes, she says. There are rarely hormonal causes, and [in those cases] it's usually estrogen deficiency that is causing abnormalities.

Testosterone products are supplemental versions of the hormone that people take to increase their existing T levels. They come as a patch, gel, pill, tablet, or injection. Prescription testosterone products are FDA-approved for men whose bodies cannot produce adequate testosterone, due to genetic conditions like Klinefelter syndrome or damage from infection or chemotherapy. Testosterone products are notwe repeat, not!approved for people whose testosterone is decreasing with age.

Nevertheless, this hasnt stopped people from taking T (and doctors from prescribing T) for reasons other than it is officially intended. This practice has become so widespread, in fact, that the FDA issued a safety announcement in March 2015 urging doctors not to prescribe testosterone to anyone other than men with testosterone-lowering medical conditions. The statement noted that testosterone therapy could possibly increase your risk of cardiovascular problems or stroke.

For women, the risks of testosterone therapy are even less clear. What we know about safety and what has been studied in women is the short-term effects, up to two years, Dr. Shufelt says. Longer effects are not known, and we do not know the effects in women who have risk factors for heart disease and breast cancer. She stresses that longer-term studies will be necessary to determine whether low-dose testosterone therapy has detrimental effects on a womans body.

When testosterone is taken in excess quantities, Dr. Shufelt explains, it can lead to some pretty severe medical issues for women. Too much testosterone in women can result in deepening of voice, hair loss, acne, anger, and negative changes to the cholesterol panel, she says. Dr. Wierman remembers seeing a perimenopausal patient who had been given testosterone pellets at an anti-aging clinic. The high levels of T caused an increase in bad cholesterol, increase in blood pressure, excessive body hair growth, and loss of scalp hair.

In September 2019, the Endocrine Society, International Menopause Society, European Menopause and Andropause Society, and others got together to publish a global consensus statement on the safety and efficacy of testosterone therapy for women. Dr. Wierman, one of the principal authors, explains the major takeaway: testosterone therapy has only proven to be useful for one specific subset of womenpost-menopausal women with hypoactive sexual desire disorder.

Hypoactive sexual desire disorder (HSDD) is characterized by an absence of sexual desire, to an extent that it causes emotional distress and relationship problems for a couple. HSDD can be caused by a variety of factors, from medication use and chronic health conditions, to chemical imbalances and hormone deficiencies. It is diagnosed by a healthcare provider using a questionnaire and treated with anything from counseling to hormone replacement therapy, depending on the situation.

Dr. Wierman says that for post-menopausal women with HSDD, controlled studies showed that getting high physiologic doses [of testosterone] increased satisfying sexual relations by one per month, with some other potentially good effects on sexual function, such as arousal and ability to orgasm. The consensus statement specified that these doses should mimic not exceed natural levels of testosterone in premenopausal women. The statement authors urged that more research be done on testosterone therapy for women, and that testosterone products for HSDD should be created specifically with women in mind.

If youre curious about testosterone therapy and wondering if you fit into the subset of women who may benefit, Dr. Wierman suggests talking to your regular womens healthcare provider. I think that most providers, whether theyre gynecologists or endocrinologists or primary care doctors who specialize in menopausal women, can discuss the issues related to testosterone pros and cons, she says.

But before you walk away with a prescription, keep in mind that your low sex drive may not have to do with your hormones. The first thing when someone has abnormalities in their sexual function is to discuss all the different other causes of it, and try to be a detective, Dr. Wierman says. If she is having painful intercourse, maybe it's local vaginal estrogen she needs. If theres stress in the relationship, maybe therapy is what they need. Testosterone therapy is one option to increase libido, but its certainly not a foolproof key to amazing sex. And unless youre a postmenopausal woman with HSDD, you probably want to steer clear.

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Is Testosterone Therapy Safe for Women? - HealthCentral.com

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – BioSpace

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Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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Low Testosterone: Symptoms, Diagnosis & Treatment …

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What is Testosterone?

Testosterone is the male sex hormone that is made in the testicles. Testosterone hormone levels are important to normal male sexual development and functions.

During puberty (in the teen years), testosterone helps boys develop male features like body and facial hair, deeper voice, and muscle strength. Men need testosterone to make sperm. Testosterone levels generally decrease with age, so older men tend to have low blood testosterone levels.

Some men have low testosterone levels. This is called testosterone deficiency (TD) or often referred to as Low Testosterone (Low-T).

The American Urology Association (AUA) identifies low blood testosterone (Low-T) as less than 300 nanograms per deciliter (ng/dL) on two tests obtained in the morning. Several symptoms or conditions may accompany TD:

You may benefit from testosterone therapy (TT) if you have TD and bothersome symptoms (described above). In some cases, TT is strongly recommended, such as with certain conditions you are born with (i.e. Klinefelter syndrome) or if the testicles are removed or lost due to surgery, trauma, infection, or other similar issues. The FDA has approved TT as a replacement for men with low T due to disorders of the testicles, pituitary gland, or brain which result in low T.

Although the use of TT in men with declining T levels due to aging or other conditions is not specifically approved by the FDA, it is commonly prescribed for these conditions "off-label." Speak with your physician to determine if you may benefit from TT, including which type of treatment is most appropriate.

TT may help you but it is also linked to certain (potentially harmful) side effects. (See discussion of these side effects below.) Some of these side effects are definitely linked to TT, while others remain debatable. One area of ongoing debate is whether TT may increase the risk for heart disease or stroke in certain men.

Based on data from a few clinical studies, the Federal Drug Administration (FDA) required that testosterone drug labels should state that there is a risk for heart disease and stroke for some men using testosterone products. All men should be checked for heart disease and stroke before, and periodically while on, TT. The AUA however, on careful review of evidence-based peer review literature, has stated that at the current time, it is not clear if TT increases or decreases the risk for cardiovascular events, such as cardiovascular disease or strokes.

It is hard to know how many men among us have low T, although data suggest that overall about 2.1% (about 2 men in every 100) may have low T. As few as 1% of younger men may have low T, while as many as 50% of men over 80 years old may have low T. People who study the condition often use different cut-off points for the numbers, so you may hear different numbers being stated.

Low T is more common in men who have diabetes or who are overweight. In one research study, 30% of overweight men had low T, compared to only 6.4% of those with normal weight. The same study found diabetes to be a risk factor for low T. In another study, 24.5% of men with diabetes had low T, compared to 12.6% of those without diabetes.

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Low Testosterone: Symptoms, Diagnosis & Treatment ...

Maybe its low testosterone? – The Durango Herald

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As we age, we tend to see dips in testosterone.

This isnt ideal as testosterone is a key hormone in keeping both men AND women at optimal health with high energy, supple skin, good muscle mass and the ability to build it, strong sex drive, and the ability to cope with stress (a big one for the times we are currently in).

So, how do we keep our testosterone levels at their peak as we age?

Drop excess body fat, especially the stuff around the belly. You can better bet that if you are sporting a beer belly or just seem to carry your fat in your midsection that your testosterone is lower than it should be. In men, this belly fat actually secretes hormones (aromatase) that help to convert the testosterone you do make into estrogen. Those low T and higher estrogen levels help the body continue to easily gain more fat that sticks primarily to your belly, chest, and throat area. For men, dropping this fat will allow for the most significant improvements in your testosterone levels than all of the other following suggestions.Move, but watch how you do it. The body doesnt like chronic cardio. By this I mean long stints on the bike, endurance runs by the river, or tedious bouts on the elliptical or rowing machine. This drags on the body, just like it does on the joints, and the body responds with a drop in testosterone among other things. What the body loves hormonally, is explosive resistance training and some high-intensity interval training. A few days a week, lift something heavy, not so heavy that youll injure yourself, but heavy enough that it overloads your muscles a bit. To get the most bang for your buck, make sure to work the bigger muscles groups (think legs) and body parts that carry a high density of androgen receptor sites (shoulders and chest). Dead lifts (avoid if you have low back pain) and squats are some of the best testosterone producing movements out there.

The days when you arent lifting, do some HIIT. Though HIIT might not sound appealing, the great thing about it is that the sessions are short and sweet. Lets use the stationary bike as an example. Warm up for 5 minutes, increase resistance or speed for 45 seconds so that you are breathing hard, then rest easy for 90 seconds. Repeat this on/off cycle about 10 to 12 times if you can and cool down. The entire HIIT session should only take about 20 to 25 minutes. And as always, consult your doctor before starting any new exercise routine.

Make sure you arent deficient in vitamins and minerals. Eat a whole-foods, nutrient-dense diet, dont skimp on dietary fats, and get plenty of vitamin D by spending time in the sun. You might also consider supplementing with boron, iodine, selenium, magnesium, and a B vitamin complex. If you do supplement, ask your doctor before taking any new supplements.Manage your stress and cultivate meaningful relationships. This might not seem like a big deal, but it is. High stress and lack of companionship decrease testosterone. Think self-care practices such as prayer/intention setting, time in nature, meditation, journaling or practicing gratitude a combination would be best! Building connection through relationships definitely takes effort but its worth it and your body will thank you.Prioritize sleep. This is a big one! The majority of daily testosterone secretions occur during sleep. Poor sleep (because of restlessness, not enough hours or sleep apnea, for instance) is associated with reduced testosterone in both men and women. A study published in the Journal of the American Medical Association found that one week of short sleep (5 hours per night) reduces testosterone production by 10% to 15%.There you have it! Five steps to start taking your health (and your hormones) into your own hands. Make the decision to take control of your body and say NO to low energy, poor mood, and suboptimal living.

Ashley Lucas holds a Ph.D. in sports nutrition and chronic disease and is a licensed, registered dietitian. She is the founder and owner of Ph.D. Weight Loss and Nutrition, offering in-office and at-home/virtual weight management and wellness services in the Four Corners. To contact her, visit http://www.myphdweightloss.com or call 764-4133.

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Maybe its low testosterone? - The Durango Herald

Low Testosterone (Low T): Causes, Symptoms, Diagnosis …

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What is low testosterone (male hypogonadism)?

Low testosterone (male hypogonadism) is a condition in which the testes (testicles, the male reproductive glands) do not produce enough testosterone (a male sex hormone).

In men, testosterone helps maintain and develop:

Low testosterone affects almost 40% of men aged 45 and older. It is difficult to define normal testosterone levels, because levels vary throughout the day and are affected by body mass index (BMI), nutrition, alcohol consumption, certain medications, age and illness.

As a man ages, the amount of testosterone in his body gradually drops. This natural decline starts after age 30 and continues (about 1% per year) throughout his life.

There are many other potential causes of low testosterone, including the following:

Symptoms of low testosterone depend on the age of person, and include the following:

Other changes that occur with low testosterone include:

Last reviewed by a Cleveland Clinic medical professional on 04/10/2018.

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Low Testosterone (Low T): Causes, Symptoms, Diagnosis ...

Hormone therapy no cure-all for ‘low T’ in ageing men – Health24

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__________________________________________________________________________________________

Testosterone therapy ads promise to help ageing men recapture their vitality, decrease body fat and enhance libido. But hormone treatments while medically necessary for some men aren't meant to be a fountain of youth, and experts warn more research is needed to determine if such therapy could boost heart disease risks.

Testosterone levels naturally decline in most men as they age. This decline is generally mild, and symptoms often are non-specific, such as low energy, reduced muscle mass and reduced vigour. Roughly 20% of men over the age of 60 have experienced a drop in testosterone levels, though this gradual decline can begin as early as the mid-30s.

While that can be frustrating, experts say it's not a clinical indication of a need for testosterone therapy, nor is there any evidence that therapy is effective for treating those symptoms. The Food and Drug Administration (FDA) has limited approval of testosterone therapy to the treatment of organic hypogonadism, a dramatic drop in testosterone caused by disease or injury of the hypothalamus, pituitary gland or the testes.

"If testosterone therapy is used appropriately in men with organic hypogonadism, then there is no controversy," said Dr Shehzad Basaria, associate director of Men's Health: Aging and Metabolism at Brigham and Women's Hospital in Boston. The condition causes specific symptoms such as decreased sexual desire, breast enlargement, testicular atrophy and hot flashes.

Potentially harmful use

But "in middle-aged and ageing men who have a slightly lower testosterone level and non-specific symptoms due to ageing or obesity, testosterone therapy is not indicated. Similarly, testosterone is not a rejuvenation drug," said Basaria, an associate professor of medicine at Harvard Medical School. "The majority of patients seen in our clinics have symptoms such as fatigue, weight gain, muscle loss or feeling sad. These symptoms are common and non-specific, and testosterone therapy is generally not indicated in such clinical scenarios."

Over the past two decades, intense direct-to-consumer marketing of hormone therapy for ageing men, much of it via television ads, has more than doubled its off-label use. It's a trend experts warn is medically unwarranted and potentially harmful.

The American College of Physicians, which issued new guidelines in January, recommends against prescribing testosterone therapy to boost energy, vitality or physical function, but supports its use for men experiencing sexual dysfunction. The recommendation calls for discussing potential benefits and risks with the patient and discontinuing treatment after one year if there is no improvement.

"I think one of the biggest concerns about testosterone therapy is whether it is really needed," said Dr Robert Eckel, professor of medicine and an endocrinologist at the University of Colorado School of Medicine in Aurora, Colorado. "Erectile dysfunction is a common problem as men age, but there can be other reasons for this, such as vascular disease or nerve damage, which is more common in patients with diabetes. It is not necessarily an indication for treatment with testosterone therapy. The patient must be properly evaluated."

Higher cardiovascular risk

The FDA warns against prescribing testosterone therapy for age-related hormonal decreases or anything other than a medical diagnosis of hypogonadism. Since 2015, it has required testosterone product labels to warn of a possible increased risk of heart attacks and stroke.

But research about that association so far is unclear, Basaria said.

"Some studies have reported higher cardiovascular risk with testosterone use but there are an equal number of studies showing that it does not increase cardiovascular risk," he said. "This discrepancy exists because no study published to date has been powered to assess cardiovascular events as the primary outcome."

Eckel, president of medicine and science for the American Diabetes Association and a past president of the American Heart Association, agreed. "The cardiovascular disease outcome story is not convincing one way or another. I think to make a strong statement here would be a mistake."

Image credit: iStock

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Strain engineering of the magnetic multipole moments and anomalous Hall effect in pyrochlore iridate thin films – Science Advances

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INTRODUCTION

The anomalous Hall effect (AHE) is a fundamental transport phenomenon that has been universally observed in time-reversal symmetry broken systems. AHE can arise from two different forms of mechanism (1): extrinsic mechanism, such as skew scattering or side jump due to magnetic impurities, and intrinsic mechanism originating from Berry curvature in momentum space. Since the fundamental topological properties of electronic wave functions are encoded in the Berry curvature, AHE is considered as a powerful tool for probing the topological properties of materials (2, 3). In addition to its fundamental interest, AHE can be applied for memory devices (4).

Conventionally, AHE has been observed mostly in itinerant ferromagnets. Its magnitude is known to be proportional to the magnetization (5), which is a measure of broken time-reversal symmetry. Recently, a large AHE has been unexpectedly found in noncollinear antiferromagnets, such as Mn3X (X = Sn, Ge) (68) and GdPtBi (9), which do not exhibit spontaneous magnetization. This unconventional response indicates that ferromagnetism is not a necessary condition for AHE and suggests a possible alternative origin of AHE. A recent theory proposed that higher-rank magnetic multipole (cluster multipole) moments formed from spin clusters in antiferromagnet can induce a nonzero AHE, beyond the conventional dipoles of ferromagnets (10). Subsequently, the anomalous Nernst (11) and magneto-optical Kerr effects (12) in Mn3Sn have also been attributed to its cluster octupoles. However, since antiferromagnets are not easily coupled to both magnetic and electric fields (13), it is very difficult to manipulate the higher-rank cluster multipoles. This imposes substantial limitations on controlled experiments on the cluster multipoles and associated AHE.

Here, we demonstrate that the strain can generate the AHE by inducing the higher-rank cluster multipoles, by using antiferromagnetic Nd2Ir2O7 (NIO) thin film. Further investigation reveals that biaxial strain on the pyrochlore lattice can modulate the spin structure and induce certain magnetic octupoles. The induced cluster octupoles can generate the net Berry curvature effect hidden in the bulk, leading to a finite AHE. We expect that our method could be widely applied to other spin-orbitcoupled topological magnets (10) and antiferromagnetic spintronics (4, 14).

The NIO belongs to the pyrochlore iridates family, R2Ir2O7 (R, rare-earth ions). The members of the family are geometrically frustrated magnets with complex lattice structures. As shown in Fig. 1A, R2Ir2O7 is composed of linked tetrahedrons with R and Ir at each vertex. In R2Ir2O7, strong electron correlations and large spin-orbit coupling of Ir d electrons result in unique antiferromagnetic spin structures, called all-in-all-out (AIAO) ordering (15, 16). As shown in the circle in Fig. 1B, the spins in one tetrahedron point inward and those in the neighboring tetrahedron point outward. The Nel temperatures of the Ir and Nd sublattices of bulk NIO are TNIr ~ 30 K (15) and TNNd ~ 15 K (17), respectively. This AIAO ordering breaks the time-reversal symmetry, allowing a nonzero Berry curvature distribution and generating correlated topological phases (18, 19) such as a Weyl semimetal.

(A) Pyrochlore lattice structure. Yellow (red) circles depict Nd (Ir) ions. Note that oxygen ions are not shown. (B) Schematic diagram of epitaxial NIO thin film on the yttria-stabilized zirconia (YSZ) substrate with biaxial strain along [111]. The deformed pyrochlore lattice is schematically displayed in the circle. The blue arrow at each site denotes the spin direction in the AIAO antiferromagnetic configuration. (C) The spin arrangement of a tetrahedron in the undistorted (i.e., bulk) AIAO configuration. According to the cluster magnetic multipole theory, the AIAO magnetic ordering can be represented as an A2-octupole. (D) Schematic diagram of the strained magnetic ground state. Biaxial strain along the [111] direction will distort the AIAO configuration, which can be represented as the superposition of a cluster dipole (M), an A2-octupole, and a T1-octupole (). M represents a ferromagnetic ordering, while represents an antiferromagnetic ordering other than AIAO. On the basis of symmetry analyses (see section S1 and table S1), we demonstrated that only the T1-octupole can induce the AHE without magnetization.

However, since AIAO ordering preserves the cubic crystalline symmetry, the net Berry curvature effect vanishes when we integrate over the Brillouin zone (BZ). Unless the cubic crystalline symmetry is broken, AHE cannot be observed in this system. To break the cubic symmetry, a magnetic field was applied to pressured NIO single crystals (19) and Pr-doped bulk samples (20, 21). However, the spin structures modulated by the magnetic field are fragile and easily return once the magnetic field is turned off. Thus, a stable method to break the cubic symmetry is highly desirable; here, we choose a strain engineering approach and investigate the associated AHE.

As shown in Fig. 1B, the biaxial strain elongates the unit tetrahedra along the [111] direction. This will naturally break the cubic symmetry of the system. Since the deformation modulates magnetic anisotropy (22), the Ir spin directions should be changed. To systematically describe the change of spin direction, we adopted the cluster multipole theory. Since the conduction electrons come from Ir d orbitals, we considered Ir sublattice only (16). In the cubic pyrochlore lattice, all spin ordering patterns can be classified into five different irreducible representations, carrying 12 distinct cluster multipoles (18). Among them, certain cluster multipoles that break the cubic symmetry are responsible for the AHE (see section S1).

In a bulk NIO, the AIAO ordering corresponds to a higher-rank magnetic multipole called the A2-octupole (Fig. 1C). Since the A2-octupole preserves the cubic symmetry, it cannot generate AHE. However, in a strained NIO (s-NIO), the AIAO spin structure becomes modulated under the strain. The resulting spin configuration is denoted by strained AIAO (s-AIAO), composed of a superposition of three kinds of cluster multipoles, namely, a dipole, an A2-octupole, and a T1-octupole (Fig. 1D). Note that the dipole is just the ferromagnetic ordering, while the T1-octupole is an antiferromagnetic ordering other than AIAO. Only the T1-octupole can induce the AHE without magnetization since it breaks the cubic symmetry as the dipole does.

To investigate the strain-induced magnetic multipole and associated AHE, we prepared two kinds of NIO thin films on the yttria-stabilized zirconia (YSZ) substrates: relaxed and fully strained films. The biaxial strain can arise from the lattice mismatch between the R2Ir2O7 film and the YSZ substrate (see Fig. 1B) (23, 24). Since the lattice parameter of YSZ is smaller than those of NIO bulk, the NIO film should be compressively strained. We estimated the strain (=2aYSZaNIOaNIO) to be 0.96%, where aNIO and aYSZ are lattice constants of bulk NIO (10.38 ) and YSZ (5.14 ), respectively.

Despite the substantial past efforts (2527), the in situ growth of high-quality R2Ir2O7 thin film is notoriously difficult. Under the proper crystalline growth conditions for pyrochlore oxides (28), the corresponding R2Ir2O7 phase becomes extremely unstable because of the formation of a gaseous IrO3 phase (29). To avoid this instability, many studies have used the solid-phase epitaxy (SPE) (25, 27) method, which involves the initial growth of amorphous R2Ir2O7 films at a lower temperature (T) followed by ex situ thermal annealing in a sealed tube. Although SPE can provide a method for the growth of single-phase R2Ir2O7 films, it usually produces relaxed films (25, 26). Therefore, we developed a previously unknown in situ film growth method, i.e., repeated rapid high-temperature synthesis epitaxy (RRHSE; see section S2 and Materials and Methods) (30).

The RRHSE method made us successfully grow the fully s-NIO films on YSZ (111) substrates. Figure 2A shows an x-ray diffraction -2 scan. The NIO (lll) and YSZ (lll) (l: integer) peaks can be seen, indicating epitaxial growth of NIO single phase. Particularly, the satellite peaks near the NIO (222) peaks are observed, which is commonly called thickness fringes. These interference peaks indicate the high quality of a sharp interface between film and substrate. Figure 2B shows x-ray reciprocal space mapping around the NIO (662) and YSZ (331) Bragg peaks of a 9-nm-thick NIO film. The lattice parameter of the (662)-plane, d(662), of bulk NIO is 1.19 , and the d(331) of YSZ is 1.18 . Note that the NIO (662) Bragg peak has the same Qx value as the YSZ (331) peak, demonstrating that our film becomes fully strained (~1% compressive strain) by the substrate.

(A) X-ray diffraction -2 scans of an epitaxial NIO film grown on a YSZ (111) substrate. The scans reveal that the NIO film was grown coherently with the YSZ substrate. (B) Reciprocal space mapping around the YSZ (331) and NIO (662) diffraction peaks. The Qx values of both peaks are the same, indicating that the film is under ~1% strain. (C) Scanning transmission electron microscopy image with the zone axis parallel to [1-10]; a clear interface between the film and the substrate can be seen. The distinctly colored circles indicate the pyrochlore structural ordering of the Nd and Ir ions. Images of selected areas in (C) were fast Fouriertransformed for (D) the NIO thin film, and (E) the YSZ substrate. The three vertical dotted lines between (D) and (E) are plotted without changing the scale. These lines indicate that the in-plane lattice constants of NIO and YSZ are the same, providing further direct evidence for the fully s-NIO thin film.

Figure 2C shows a scanning transmission electron microscopy image that indicates the high quality of our film. The NIO pyrochlore phase is formed with few structural defects or disordered structures. Figure 2 (D and E) shows fast Fourier transform patterns from the selected areas in the film and substrate, respectively, marked in Fig. 2C. As demonstrated by the red dotted lines, the as-grown NIO film has the same inverse lattice constant as the YSZ substrate, which also confirms that our film is fully strained.

We compared these fully s-NIO films grown by RRHSE with the relaxed NIO (r-NIO) films grown by the SPE (see section S3). The resistivity (T) curve of a 9-nm-thick s-NIO film exhibits a semimetallic behavior at most T. As shown in Fig. 3A, the s-NIO film has (T) an order of magnitude smaller than that of the r-NIO film. The (T) curve of an 80-nm-thick r-NIO film exhibits a metal-insulator transition around ~30 K (black dashed line in Fig. 3A), in agreement with its bulk counterpart (17, 31). The strong upturn of the r-NIO film is due to its insulating nature below TNIr ~ 30 K (17, 31). The (T) curve of the r-NIO film follows the Arrhenius plot (not shown here) in the low T region, indicating a bandgap opening. In contrast, the (T) curve of the s-NIO film has a positive slope for most T (orange line in Fig. 3A), suggesting that the film should be in a semimetallic state. Converting the resistivity into conductivity, the s-NIO film has xx ~ 1600 ohms1 cm1 at 2 K. The tiny upturn below ~30 K might arise from disorder effects.

(A) Orange solid (black dashed) line indicates the resistivity, xx, of the fully s(r)-NIO film, prepared by the RRHSE (SPE) method. xx reveals that the electronic structure of NIO could be changed under strain. The calculated band structure of the (B) bulk and (C) 1% biaxial s-NIO is shown. The insulator-to-semimetal transition can explain the large change in xx in (A). (D) Measured AHC xyA of fully s-NIO (circle) and r-NIO (dashed line) films. Note that the xyA of s-NIO is an order of magnitude larger than that of r-NIO. Orange circles and dashed arrows depict H-field sweep results between 9 and 9 T; antihysteresis-like behavior can be seen. (E) Corresponding Berry curvature calculation results along the high-symmetry lines in (B) and (C). Although the Berry curvature of the bulk seems larger, the net contribution of xy(k) becomes zero (i.e., hidden), resulting in xyA = 0 under cubic symmetry. On the other hand, the summation of the Berry curvature for the s-NIO could emerge because of the broken cubic symmetry. (F) Schematic of the BZ for the pyrochlore structure.

To understand the corresponding electronic structure changes, we performed mean-field calculations using the Hubbard model (see section S4). The previous study shows that the most valence and conduction bands near the Fermi energy come mainly from Ir 5d electrons (16). Our calculated electronic structure of the bulk (the r-NIO film in our case) explains its insulating nature. The energy gap opens with a value of about 13 meV (Fig. 3B), which agrees well with the bulk value (32). Under 1% compressive strain, the valence and conduction bands move, which slightly increases the direct gap at most k regions. However, some valence and conduction bands become crossed with Fermi level; thus, small electron and hole pockets develop near L1,2,3,4 (Fig. 3C), creating a semimetallic state. These model calculations can explain why the s-NIO film has a much smaller (T) than the r-NIO film.

Besides, the s-NIO film shows a much larger anomalous Hall conductivity (AHC) compared to the r-NIO film. Figure 3D shows the magnetic field (H)dependent AHC xyA(H) at 2 K, obtained after subtracting the ordinary Hall contribution from the total Hall conductivity (see Materials and Methods). The xyA curves of s- and r-NIO films are displayed by the circles and the dashed line, respectively. The xyA(H=9T) values of the s- and r-NIO films are 2.4 and 0.2 ohms1 cm1, respectively. The spontaneous Hall conductivity (SHC) xyA(H=0) of the s-NIO films is 1.04 ohms1 cm1, which is much larger than that of the r-NIO film. Note that the small AHC and SHC in the r-NIO film might be induced by the net magnetization of AIAO domain walls (33). However, the large AHC and SHC in the s-NIO suggest that the net Berry curvature effect can be modulated by the strain.

To cross-check, we compared our magnetotransport property values with those of ferromagnets. For example, (Ga, Mn)As (34) and CuCr2Se4xBrx (35) typically exhibit SHC with xyA(H = 0 T) ~ 1 to 10 ohms1 cm1 and xx(H = 0 T) ~ 1000 ohms1 cm1. These ferromagnets follow a scaling relationship xyAxx1.6 that implies the intrinsic nature of the AHE (5). Since xyA and xx values for the s-NIO film also fall on the same scaling curve (see section S5), we confirmed the enhanced AHC and SHC of our fully s-NIO film as the net Berry curvature effect.

Accordingly, we calculated the Berry curvature effect on AHC from the band structure obtained from the mean-field calculations mentioned above (see section S4). AHC can be obtained by integrating the Berry curvature xy(k) throughout the whole BZ (5):xyA=e2BZd3k(2)3nf(n(k))[111](k)(1)where f(n(k)) is the Fermi-Dirac distribution function and is the chemical potential. Figure 3E shows the Berry curvature [111](k) of NIO along its high-symmetry lines with H = 0. Sizable [111](k) at the L1,2,3,4 points in the BZ (Fig. 3F) exists for both the r- and s-NIO systems. The Berry curvature at each high-symmetry point for the r-NIO is somewhat larger than that for the 1% s-NIO. However, for the cubic r-NIO, xyA vanishes since the integration of [111](k) over the BZ cancels out. Generally, when twofold rotation symmetries C2 about the x, y, or z axis exist, (k) is canceled by (C2k). In the r-NIO, all three C2 exist, so the net (k) contribution becomes hidden (9). In contrast, for the trigonal s-NIO, the breaking of all C2 symmetries draw out a finite net (k) contribution. Thus, the biaxial strain can promote the net Berry curvature effect originally hidden in the bulk, generating the large AHE in the s-NIO films.

Another notable feature of s-NIO film is that its xyA(H) curve shows an intriguing antihysteresis-like behavior, displayed in Fig. 3D. When we sweep the H-field from 9 to +9 T, a sign change occurs at an H value of about 1 T (circles in Fig. 3D). Similar behavior is also observed when we reverse the H-field sweep from +9 to 9 T. This H-dependent sign change of the AHC differs from a typical hysteretic response of most ferroic materials, where the sign change occurs during the domain switch to the opposite direction. Although a similar antihysteresis-like behavior has been also reported in an earlier Hall conductivity study of an NIO single crystal under hydrostatic high pressure (21), its origin has not fully investigated yet.

To understand our antihysteresis-like xyA(H) curve, we used a phenomenological model (see section S6). The model is composed of two tangent hyperbolic functions; one is hysteretic (blue line) and the other is nonhysteretic (green line) (see Fig. 4A). Since the experimental data (orange circles) agree with the sum of two tangent hyperbolic functions (black solid line), the antihysteretic curve can be explained by the two different origins of xyA. To obtain further insight, we measured T-dependent xyA(H) curves of s-NIO film below 40 K. As shown in Fig. 4B, xyA does not exist at 40 K, when the system is in a paramagnetic phase. As T decreases, xyA starts to emerge at ~30 K and becomes stronger thereafter. In 15 K < T < 30 K, xyA exhibits no hysteretic behavior. However, as T decreases further below 15 K, xyA starts to show the antihysteresis-like behavior. Figure 4B shows that all T-dependent xyA curves are well matched with the sum of the nonhysteretic and hysteretic hyperbolic functions. Note that the bulk NIO has TNNd ~ 15 K and TNIr ~ 30 K (17), suggesting that the hysteretic and nonhysteretic responses are developed because of the magnetic orderings of Nd and Ir spins, respectively.

(A) AHC xyA at T = 3 K. The orange circles are the measured values. The blue (green) line indicates a fitting curve for the Nd (Ir) spin contribution, i.e., xyNd (xyIr), obtained from the phenomenological model (see main text). The black line is the sum of xyNd and xyIr. AOAI, all-out-all-in. (B) T-dependent xyA. The orange circles (black solid lines) depict the experimental results (fitting curves). Near T ~ TNIr (~ 30 K), AHC starts to emerge, which indicates the Ir spin ordering effect. Below T ~ TNNd (~ 15 K), AHC starts to exhibit hysteretic behavior, indicating that Nd spin ordering plays an important role via the f-d exchange interaction. (C) T-dependent contributions of Ir and Nd spins to AHC, i.e.,xyIr (H = 9 T) (green circles) and xyNd (H = 9 T) (blue circles). The red squares indicate the SHC values, i.e., AHC without magnetic field |xyA(H = 0 T)|. Note that SHC develops below TNNd ~ 15 K.

Figure 4C summarizes the results of the AHC fitting at H = 9 T with the TNNd and TNIr values, marked as the dotted lines. Note that, most transport in NIO occurs by Ir d electrons near the Fermi level. This carrier transport can be affected by the spin ordering at the Ir and Nd sublattices. In Fig. 4C, the nonhysteretic component (green circles) starts to emerge below TNIr, so it can be attributed to the Ir spin ordering, and we denote the nonhysteretic as xyIr. On the other hand, the hysteretic component (blue circles) starts to emerge below TNNd, so it can be attributed to the Nd spin ordering, and we denote the hysteretic as xyNd. The nonhysteretic contribution of Ir is due to the absence of the Ir-AIAO domain switch by the smallness of Ir-AIAO coupling to the field. Meanwhile, the hysteretic contribution of Nd is due to the presence of the Ir-AIAO domain switch through f-d exchange with either Nd-3O1I or Nd-3I1O, which can be formed by large Nd moments under a [111] magnetic field (see section S6). This hysteretic behavior of xyNd leads to the finite SHC at zero field xyA(H=0T) displayed as the red squares in Fig. 4C. Note that the SHC emerges below TNNd.

To reveal the relation of AHE and cluster multipoles under strain, we should compare M and xyA values (see Fig. 1D). The H-dependent M and xyA hysteresis curves at 3 K are displayed in Fig. 5A, and associated xyIr and xyNd curves are shown in Fig. 5B. Figure 5A demonstrates that the conventional understanding of the SHC (5), i.e., xyA(H=0T) M (0 T), does not hold for the s-NIO film. Although the s-NIO film has a large SHC signal (orange circles) shown in Fig. 5A, it has no spontaneous M at 3 K with H = 0 (purple squares) within the measurement error ( 0.01 B/NdIrO3.5). As shown in Fig. 1D, the biaxial deformation of pyrochlore lattice can generate three kinds of multipoles, i.e., a dipole, an A2-octupole, and a T1-octupole. The dipole is crossed out because of the zero magnetization of our data, and the A2-octupole is crossed out because of its zero contribution to AHC. Therefore, the strain-induced T1-octupole should play important roles in generating the AHC without magnetization.

(A) The M/H curve (purple squares) of s-NIO film at 3 K, overlaid with the experimental AHC (orange circles). Note that M = 0 but xyA0 without H. The nonzero value of xyA at H = 0 and M = 0 indicates an alternative origin of the AHE. (B) The AHC of s-NIO film at 3 K. The orange circles are experimental data. The green line is the contribution of Ir spins, i.e., xyIr, based on our model calculation (see Fig. 4A). The blue solid and dashed lines are the contributions of Nd spins, i.e., xyNd, during decreasing and increasing h-sweeps, respectively. Calculated magnetic multipoles in NIO under the effective Zeeman energy, h, (C) without and (D) with 1% strain are shown. The green and blue circles indicate dipole M and T1-octupole , respectively. The strain-induced becomes the origin of the SHC in our s-NIO film.

To elucidate how T1-octupole emerges under the strain, we calculated the spin structure from the spin model. Since both Nd and Ir spins play important roles, we included the Heisenberg, Dzyaloshinskii-Moriya, anisotropic spin-exchange interactions between Ir spins (36), the f-d exchange interaction between the Ir and Nd spins (17), and the Zeeman energy for both the Ir and Nd spins (for details, see section S7). On the basis of the calculated spin structure, we obtained the cluster multipoles (table S1 in section S1). Figure 5C shows the calculated dipole (M, green circles) and T1-octupole (, blue circles) as a function of the effective Zeeman energy h in the r-NIO. According to our calculation, r-NIO does not have a finite M or value for the Ir sublattice at h = 0. The zero values of M and can explain the negligible SHC of the r-NIO film (see Fig. 3D). Figure 5D shows the calculated M and of s-NIO, which are finite even for h = 0. Particularly, the hysteresis curve of looks similar to the xyNd curve in Fig. 5B. Therefore, we conclude that the large spontaneous that generate AHE can be induced by the strain in the s-NIO film.

Fully s-NIO films were in situ grown on insulating YSZ substrates using the RRHSE method. This film growth method is a modified form of pulsed laser deposition, based on repeated short-term thermal annealing processes using an infrared laser. RRHSE consists of two key steps in one thermal cycle. During the first step, amorphous stoichiometric NIO and IrO2 layers were deposited by a KrF excimer laser ( = 248 nm, 5 Hz) at T ~ 600C with PO2 ~ 50 mtorr. The additional IrO2 layer was deposited to compensate for the Ir loss that would unavoidably occur later during the synthesis process. During the second step, the pyrochlore phase is formed by rapidly raising T to 800C (up to ~400C min1). We must expose the sample to the high T for a period that is sufficiently long to synthesize the pyrochlore phase but short enough to minimize the formation of IrO3. Last, we repeated these deposition and thermal synthesis processes until the desired film thickness was obtained. During the growth, the reflection high-energy electron diffraction pattern was monitored and the intensity of the oscillation was recorded. After growth, NIO films were characterized by an x-ray diffractometer (Bruker Corp.) and an atomic-resolution high-angle annular dark-field scanning transmission electron microscope (JEM-ARM200F; JEOL) equipped with an energy-dispersive x-ray spectrometer.

Magnetotransport properties were measured via a standard four-point probe method using a commercial physical property measurement system (PPMS, Quantum Design), which has a base T of 2 K and a maximum magnetic field of 9 T. During the measurements, the current was applied along the [1-10] direction, and H was applied along the [111] direction. Magnetization data were obtained using a commercial superconducting quantum interference device magnetometer (MPMS, Quantum Design) with the magnetic field applied normal to the film.

The AHC value xyA can be obtained from the resistivity values, namely, xyA(H)=xyA(H)xx(H)2+xyA(H)2 where xyA is anomalous Hall resistivity and xx is longitudinal resistivity. To exclude the longitudinal contribution from the raw Hall resistivity data xyr, we used the antisymmetrization procedure (8, 9, 13). We separated the positive and negative field sweep branches and then antisymmetrized xy using xy+(H)=xyr+(H)xyr(H)2 and xy(H)=xyr(H)xyr+(H)2 . Note that xyr+(H) and xyr(H) denote positive field sweep (+9 T to 9 T) and negative field sweep (9 T to +9 T) branches, respectively. From xy+(H) and xy(H), we took out the linear part (ordinary Hall resistivity) to determine xyA.

We developed the Hubbard model for the s-NIO thin film under the magnetic field and acquired the ground state and electronic structure by the self-consistent mean-field method. We adopted 24 24 24 and 32 32 32 k-point mesh and found that the results are consistent. We calculated the AHC by integrating the Berry curvature, adopting a 48 48 48 k-point mesh of the entire BZ. Details of the calculation are provided in section S4.

We developed the spin model including Heisenberg exchange, Dzyaloshinskii-Moriya interaction, anisotropic exchange, the f-d exchange between Nd and Ir electrons, and the Zeeman effect by applying second-order perturbation theory to the Hubbard model and referring to previous works. We calculated the ground state by the iterative minimization method, which repeatedly aligns spins to the effective field direction until each spin is fixed. Details of the calculation are provided in section S7.

Acknowledgments: We acknowledge the invaluable comments and suggestions from D. Lee, S. H. Chang, T. H. Kim, and C. H. Sohn. Funding: This work was supported by the Research Center Program of the Institute for Basic Science in Korea (grants no. IBS-R009-D1 and no. IBS-R009-G1). T.O. and B.-J.Y. acknowledge the support by the Institute for Basic Science in Korea (Grant No. IBS-R009-D1), Basic Science Research Program through the National Research Foundation of Korea (NRF) (Grant No. 0426-20200003), and the U.S. Army Research Office under Grant Number W911NF-18-1-0137. STEM measurement was supported by the National Center for Inter-University Research Facilities (NCIRF) at Seoul National University in Korea. Author contributions: W.J.K., T.O., B.-J.Y., and T.W.N. conceived the original idea. W.J.K. and T.W.N designed the experiments. T.O. performed the tight-binding model calculations and spin model calculations under the supervision of B.-J.Y. J.M. performed the STEM measurements under the supervision of M.K., W.J.K., J.Song, and E.K.K. grew and characterized the structure of the samples. W.J.K., J.Song, Y.L., Z.Y., and Y.K. performed the magnetotransport measurements. W.J.K., T.O., J.Song, B.-J.Y., and T.W.N. analyzed the results and wrote the manuscript with contribution from all authors. All authors participated in the discussion during the manuscript preparation. Competing interests: The authors declare that they have no competing interests. Data and materials availability: All data needed to evaluate the conclusions in the paper are present in the paper and/or the Supplementary Materials. Additional data related to this paper may be requested from the authors.

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Strain engineering of the magnetic multipole moments and anomalous Hall effect in pyrochlore iridate thin films - Science Advances

Signs of Low Testosterone in Men Under 30

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When you think of declining levels of testosterone, you might think of middle-aged or older men. But men under 30 can also experience low testosterone, or low T.

According to the Mayo Clinic, testosterone levels tend to peak in men during adolescence and early adulthood. Those levels typically decline by about 1 percent each year, starting around age 30. But in some cases, you may experience declining testosterone at a younger age.

Low T is a medical condition where your body doesnt produce enough of the hormone testosterone. Both men and women produce testosterone, but its called the male hormone because men produce a lot more of it. Its critical for many male characteristics, including the maturation of male sex organs, sperm development, muscle mass development, voice deepening, and hair growth. Low T can cause a variety of symptoms, including erectile dysfunction, infertility, muscle mass loss, fat gain, and balding.

If you think you might be experiencing low T, make an appointment with your doctor. In some cases, it is caused by unhealthy lifestyle habits that you can change. In other cases, it is caused by an underlying medical condition that requires treatment. Your doctor can help you identify the cause of your symptoms and learn how to manage them.

Some advertisements for testosterone replacement products may lead you to believe that simply feeling tired or cranky is a sign of low T. In reality, symptoms tend to be more involved than that. Regardless of your age, low T symptoms can include:

Many of these symptoms can also be caused by other medical conditions or lifestyle factors. If youre experiencing them, make an appointment with your doctor. They can help you identify the underlying cause and recommend a treatment plan.

Low T is less common among men under 30, but it can still occur. Contributing factors include:

Some cases of low T may be linked to other medical conditions, such as:

If you suspect that you might have low T, make an appointment with your doctor. They can use a simple blood test to determine your testosterone level.

If your doctor finds that your testosterone level is lower than normal, they may order additional tests or do an exam to investigate why. Your treatment plan will depend on your diagnosis and medical history. Your doctor may recommend lifestyle changes or testosterone replacement therapy.

You should always talk to your doctor before taking new medications, including testosterone replacement therapy and supplements. According to research published in PLOSOne, testosterone therapy may increase your risk of heart attack, particularly if you already have heart disease. Your doctor can help you understand the potential benefits and risks of different treatment options.

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Signs of Low Testosterone in Men Under 30

Aytu BioScience Announces Distribution Partnership with Apollo Med Innovations to Expand Distribution of COVID-19 IgG/IgM Rapid Test in United States…

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Apollo Med Innovations Introduces Novel Research-Based Testing Approach to Offer COVID-19 Antibody Testing to Nationwide Network of Over 1,000 Medical Clinics and Recently Launched Mobile Testing Platform

ENGLEWOOD, CO / ACCESSWIRE / July 10, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs announced today that the Company has signed a distribution agreement with Apollo Med Innovations, Inc. ("Apollo") to distribute the COVID-19 IgG/IgM Rapid Test Cassette to Apollo's network of over 1,000 practices across the United States. This distribution relationship expands the Company's coverage of clinician and professional customers to a large network of medical clinics, clinical laboratories, and wellness centers. Apollo is also engaged with a growing number of employers and municipalities in offering their COVID-19 testing services. Through Apollo's introduction of innovative research-based COVID-19 testing protocols and their offering of comprehensive laboratory support services, this distribution relationship significantly expands the Company's COVID-19 potential user base.

Through this relationship between the Company and Apollo, Apollo has begun to introduce the COVID-19 IgG/IgM Rapid Test Cassette as part of a comprehensive support program for professional medical organizations, integrated wellness centers, employers, and municipalities. In addition to offering the COVID-19 IgG/IgM rapid antibody test Aytu distributes to their client practices, Apollo has partnered with clinical laboratories to offer an expanded menu of testing. Apollo is also offering consultation services to enable client-specific implementation of COVID testing research protocols along with a variety of environmental safety products such as ultraviolet light sanitation products.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are pleased to be partnering with Apollo in this innovative approach to offering testing services to an expanded base of clinicians, laboratories, employers, and municipalities around the country. Through the introduction of comprehensive research protocols and outside laboratory consultants, Apollo is positioning itself as a leader in combating the spread of COVID-19. We are proud that Apollo has chosen to partner with Aytu in making this COVID-19 IgG/IgM rapid antibody test an important part of their testing and consulting service offerings, and the program is now underway."

"Partnering with Aytu BioScience to bring this much needed COVID-19 testing to partners and communities across the country is the right thing to do at this time and provides peace of mind to individuals and families working each day for the greater good of their community," said Randy Wright, Chief Executive Officer, Apollo Med Innovations. "Our recently announced mobile corporate testing offering is designed to bring much needed help to essential workers and companies by providing clinical testing on-site to keep employers and employees safe as well as keep these critical companies open safely. If you would like to initiate a similar effort in your company or community, please visit our website at http://www.apollomedinnovations.com or contact us at 844-698-4782."

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid-phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About Apollo Med Innovations, Inc.

Apollo Med Innovations, Inc. is a leading distributor of cutting-edge aesthetic products to the medical spa and aesthetic industries. Apollo was founded to support physicians in choosing the right aesthetic products, services and devices to meet a patient's needs and to add new revenue streams to their practice. During this COVID crisis, Apollo has added COVID-19 rapid diagnostic testing with mobile clinical support and UVC sanitization lighting to its robust line-up of products and services. Our mission is to provide our customers with world-class products coupled with world-class training led by its esteemed Doctor Advisory Council and superior customer support. Apollo follows that support with a dedicated practice management team, unparalleled warranties and marketing support through their partnership with Social Strategy1. For more information on Apollo Med Innovations, please visit the company website at http://www.apollomedinnovations.com.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, the effectiveness of the COVID-19 Rapid Test, market acceptance of the National Cancer Institute's testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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Aytu BioScience Announces Distribution Partnership with Apollo Med Innovations to Expand Distribution of COVID-19 IgG/IgM Rapid Test in United States...

Does Low Testosterone Cause Night Sweats?

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Night sweats is a term for sweating during the night to the point that it soaks your pajamas or sheets. Hot flashes and night sweats are often linked to hormonal imbalances among women, especially during menopause. But men can experience hot flashes and night sweats too.

Night sweats in men are sometimes linked to low levels of testosterone, or low T. Testosterone is the main sex hormone in men. It stimulates your sperm production, supports your sex drive, and helps build your bone and muscle mass.

To help relieve night sweats and other symptoms of low T, your doctor may recommend hormone replacement therapy.

Night sweats can also be caused by other conditions. If youre experiencing them, make an appointment with your doctor. They can help diagnose the cause of your symptoms and recommend a treatment plan.

Low T is a relatively common hormonal condition in men. It happens when you produce levels of levels of testosterone that are lower than normal. Its also known as male hypogonadism.

As men age, its normal for their testosterone levels to drop. According to the Mayo Clinic, testosterone levels typically decline by about 1 percent per year starting around age 30 or 40.

This natural occurrence isnt generally considered low T. But if your testosterone levels decline at a faster rate, you may be diagnosed with low T.

The symptoms of low T can vary from one case to another. They may include:

Low T can be caused by a variety of things, including:

Low T is only one of several potential causes of night sweats. In some cases, they are caused by other medical conditions. Night sweats can also result from:

If you experience night sweats, make an appointment with your doctor. They can help diagnose the cause of your symptoms and recommend an appropriate treatment plan.

If your doctor suspects you have low T, they will likely order blood tests to check your testosterone levels. According to treatment and management guidelines, a value under 300 nanograms of testosterone per deciliter (ng/dL) of blood is generally considered too low.

If your testosterone levels are low, your doctor may order additional tests or evaluations to determine the cause of your hormonal imbalance. If your testosterone levels are normal, they may check you for other potential causes of night sweats.

To treat night sweats and other symptoms of low T, your doctor may recommend testosterone replacement therapy. It can be administered using a variety of products, such as:

Testosterone replacement therapy can help alleviate symptoms of low T, including night sweats. But it isnt entirely without risk. Side effects can include:

If you have prostate cancer, testosterone therapy is not advised. It can make the tumor grow.

Talk to your doctor about the potential benefits and risks of testosterone replacement therapy. They can help you decide if its the best option for you. If youre at an increased risk of prostate cancer, they may advise against testosterone replacement therapy.

According to the Hormone Health Network, you may be more likely to develop prostate cancer if youre:

If you have any of these risk factors, and you decide to undergo testosterone replacement therapy, your doctor should monitor you for signs of prostate cancer while youre receiving treatment.

Testosterone therapy has been shown to stimulate growth of prostate cancer in people who already have the cancer.

Depending on the underlying cause of your low testosterone levels, your doctor may recommend other treatments.

Currently, no over-the-counter supplements have been proven to treat night sweats or low T.

If youre experiencing night sweats caused by low T, treating your low testosterone levels may help relieve them. If you continue to experience night sweats on a regular basis, despite following your doctors recommended treatment plan, make a follow-up appointment.

They may prescribe other forms of treatment or check for other underlying medical conditions.

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Does Low Testosterone Cause Night Sweats?

What Are T-Cells and Can They Protect You from COVID-19? – Labmate Online

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In the latest attempt to develop a treatment for COVID-19, British scientists are testing a drug called interleukin 7 that could help treat the life-threatening symptoms that appear in severe cases. Working from the Francis Crick Institute, Guy's and St Thomas' Hospital and King's College London, the team is developing the treatment based on evidence that patients with severe cases of COVID-19 also have extremely low T-cell counts.

Developed in the thymus gland and used to fight off infections, T-cells are central to the bodys immune response. When patients dont produce enough T-cells the body cant fight off the virus. After analysing the immune cells of 60 COVID-19 patients, the team found T-cell counts were consistently low.

To treat this immune signature the team have launched a clinical trial exploring the potential of a drug called interleukin 7, which actively increase T-cell numbers. Professor Adrian Hayday, who worked on the study at the Francis Crick Institute, hopes interleukin 7 can be used to boost T-cell levels and ramp up the bodys immunological response in seriously ill patients.

"They're trying to protect us, but the virus seems to be doing something that's pulling the rug from under them, because their numbers have declined dramatically, says Hayday.

In a microlitre of blood taken from the average healthy adult, T-cell counts range from between 2000 to 4000. In COVID-19 patients, T-cell counts are alarming low at just 200 to 1200. The team say the clinical trial could be used to develop a fingerprint test to analyse T-cell levels and identify patients at risk of developing severe symptoms. Theres also the potential to use interleukin 7 to develop a treatment that reverses the sharp T-cell decline seen in COVID-19 patients.

Manu Shankar-Hari, who works as an ICU consultant at Guy's and St Thomas' Hospital, says that approximately 70% of COVID-19 patients admitted to ICU have T-cell counts of just 400 to 800 per microlitre.

When they start to recover, their lymphocyte level also starts to go back up," he says. "We are hoping that [when we increase the cell count] the viral infections gets cleared.

Moving forward, Hayday says the research could prove extremely helpful in offering researchers insight into the mechanics of COVID-19 and how it affects the immune system.

The virus that has caused this completely Earth-changing emergency is unique - it's different. It is something unprecedented," he says. This virus is really doing something distinct and future research - which we will start immediately - needs to find out the mechanism by which this virus is having these effects.

Spearheading studies like the T-cell clinical trial calls for the latest laboratory equipment. Find out more about the state-of-the-art technology developed by Scientific Laboratory Supplies (SLS)at Automated Cell Counting Shouldnt Cost the Earth.

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Ego might drive men to testosterone therapy, but it helps with certain conditions – The Columbus Dispatch

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Many companies push testosterone-boosting supplements, but experts say theyre helpful only for certain conditions.

The popular ad features graying men whose female partners gaze longingly at them.

They proclaim: "Men: Feel younger and stronger," "Boost performance" and "Have sex again!"

The ads promote pills, creams and injections, and guide those yearning for their youth to clinics that can offer life-changing results.

Critics say the testosterone replacement therapy industry relies on aggressive marketing, touts some dubious claims and targets men who lack real medical needs.

Gahannas Low T Center has heard the good and the bad, and staff members must help new patients overcome objections and myths. Many customers are drawn in by ego and societys view of male virility.

"One of the main things that keeps guys from coming in is that they may think its like a hit to their man card," said Kortney Doss, a nurse at the Gahanna clinic.

The clinic and its sister location in Dublin each serves about 100 men daily, providing their weekly testosterone injections. The coronavirus pandemic has cut the visits in half, said Doss.

Its customers who continue coming, even during a health emergency, that clinics say are proof of the treatments effectiveness.

The same is true at Restorative Health in Dublin, which has as many as 900 regular patients many of them women, said Don Hale, the companys business consultant and spokesman.

Whether treating men or women, the marketing is driven by the male role in relationships, he said.

"A man will do anything to get and maintain an erection," he said. "I think it comes down to a mans ego."

A clinic typically performs a full physical, blood analysis and consultation at the first visit.

Even though testosterone is a natural hormone in both men and women, it can decline 1% per year after age 30 in men.

That "low normal" is not enough alone to prescribe testosterone, said Dr. Robert Murden, a geriatric specialist at Ohio State Universitys Wexner Medical Center.

Among his many patients, only six are doing TRT due to hypogonadism, an abnormally low hormone level, resulting in either low libido, erectile dysfunction, or loss of facial or body hair.

"Its specifically not recommended for people who are just tired. You shouldnt just try it. You dont give these things, with downsides, without clinical indications."

The risks include elevated red blood cell count, elevation in estrogen, acne or other skin reactions, testicular atrophy, and cardiovascular or liver complications.

Testosterone levels below 300 nanograms per deciliter put you in Low T territory, said Dr. Gregory Lowe, an OhioHealth urologist. That might cause fatigue, lack of sexual desire, worsening erections, issues with concentration and memory, or diminished recovery from workouts.

Some men come to him after seeing the ads.

"The main thing I hear from guys is to be able to put on muscle in the weight room and to be 18 again in the bedroom," he said.

But not all symptoms are caused by low testosterone. Lowe said they might instead be remedied by exercise, stress reduction, more sleep or improved diet.

"I always want my patients to be very critical of the therapy were providing, to tell me how it is helping," he said.

Lowe said he has no major complaints with private clinics where testosterone treatments include gels, patches or pellets injected in the buttocks to release the hormone slowly.

Dr. John Oliver DeLancey, an assistant professor of urology at Wexner Medical Center, said patients should first check with their primary care physicians before seeking treatment elsewhere.

"Testosterone replacement therapy gets sort of a bad rap for being overused and without appropriate testing and monitoring," he said.

"As long as you follow appropriate guidelines and put thoughtful care into why you are doing so and for the right reasons, it can be very safe and effective," DeLancey said.

Asked whether slowing down, and some of these changes, might not be just a normal part of aging, Hale, of Restorative Health, responded: "Is it normal to lose your teeth or hearing when you age, and do nothing about it?

"If so, I dont want to be normal."

Thirteen years ago, he and his wife, then both 57, began testosterone treatments and havent stopped.

"Weve been on a honeymoon ever since," Hale said.

The cost of treatment at the Dublin clinic is $3,950 per year for men and $2,950 for women. Some insurance plans reimburse up to half of that, whats considered routine blood work.

Dee Miller, a standout wide receiver for the Ohio State University football team (1994-98), said he was lethargic, overweight and often stressed out before beginning treatments in 2016.

"My wife even thought I was cheating on her" due to his lack of energy and romance, he recalled, laughing.

Since then, he said, "I feel mentally better. As for your libido, most honestly, yes."

An insurance agent, Miller is a paid endorser of Low T Center.

The treatments, he said, "are hitting all three facets: physical, emotional and socially."

dnarciso@dispatch.com

@DeanNarciso

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Ego might drive men to testosterone therapy, but it helps with certain conditions - The Columbus Dispatch

Low T Therapy Market Report 2020 Global Industry Analysis, Trends, Market Size and Forecasts Up to 2027: AbbVie, Endo International, Eli Lilly – 3rd…

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The Global Low T Therapy Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. Low T Therapy market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This Low T Therapy market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

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AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

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This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the Low T Therapy market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

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Worldwide Market Reports is your one-stop repository of detailed and in-depth market research reports compiled by an extensive list of publishers from across the globe. We offer reports across virtually all domains and an exhaustive list of sub-domains under the sun. The in-depth market analysis by some of the most vastly experienced analysts provide our diverse range of clients from across all industries with vital decision making insights to plan and align their market strategies in line with current market trends.

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Low T Therapy Market Report 2020 Global Industry Analysis, Trends, Market Size and Forecasts Up to 2027: AbbVie, Endo International, Eli Lilly - 3rd...

Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly – 3rd…

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The Low T Therapy Market (2020) research report explores the market in terms of Revenu, Emerging Market Trends and Driver includes up to date analysis and forecasts for various market segments, major players, and all geographical regions till 2027.

The coronavirus epidemic (COVID-19) has affected all aspects of life around the world. This has changed some of the market situation. The main purpose of the research report is to provide users with a broad view of the market. Initial and future assessments of rapidly changing market scenarios and their impact are covered in the report. The report will account for Covid19 as a key market contributor.

The top players covered in Low T Therapy Market are: AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

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This report sample includes: Brief Introduction to the research report, Table of Contents (Scope covered as a part of the study), Top players in the market, Research framework (presentation), Research methodology adopted by Worldwide Market Reports

Low T Therapy Market Outlook:

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When a better look taken at the areas, the market has concentrated, and the file interior the important makes a strong point of Europe, Middle East & Africa, Asia Pacific, Latin America, and North America. These areas have studied regarding the hooked-up traits and the diverse possibilities in addition to the outlook that allows inside the benefitting of the market ultimately.

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Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly - 3rd...

Aytu BioScience to Report Fiscal Q3 FY 2020 Results and Business Update – Yahoo Finance

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ENGLEWOOD, CO / ACCESSWIRE / May 7, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the quarter ended March 31, 2020 on May 14, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

1- 877-407-9124 (toll-free)1- 201-689-8584 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 34718.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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Aytu BioScience to Report Fiscal Q3 FY 2020 Results and Business Update - Yahoo Finance

T Cell Counts and Cytokine Storms May Hold Key to Effective COVID-19 Treatment – Technology Networks

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Cytokine storms may affect the severity of COVID-19 cases by lowering T cell counts, according to a new study published in Frontiers in Immunology. Researchers studying coronavirus cases in China found that sick patients had a significantly low number of T cells, a type of white blood cell that plays a crucial role in immune response, and that T cell counts were negatively correlated with case severity.Interestingly, they also found a high concentration of cytokines, a protein that normally helps fight off infection. Too many cytokines can trigger an excessive inflammatory response known as a cytokine storm, which causes the proteins to attack healthy cells. The study suggests that coronavirus does not attack T cells directly, but rather triggers the cytokine release, which then drives the depletion and exhaustion of T cells.

The findings offer clues on how to target treatment for COVID-19, which has become a worldwide pandemic and a widespread threat to human health in the past few months. We should pay more attention to T cell counts and their function, rather than respiratory function of patients, says author Dr. Yongwen Chen of Third Military Medical University in China, adding that more urgent, early intervention may be required in patients with low T lymphocyte counts.

Chen says he and his co-authors became interested in examining T cells when they noticed that many of the patients they treated for COVID-19 had abnormally low numbers of lymphocytes, a type of white blood cell that includes T cells. Considering T cells central role of response against viral infections, especially in the early stage when antibodies are not boosted yet, we took the T cells as our focal point, says Chen.

Authors examined 522 patients with coronavirus along with 40 healthy controls. All patients studied were admitted to two hospitals in Wuhan, China between December 2019 and January 2020, and ages ranged between 5 days and 97 years old. Of the 499 patients who had their lymphocytes recorded, 76% had significantly low total T cell counts. ICU patients had significantly lower T cell counts compared with non-ICU cases, and patients over the age of 60 had the lowest number of T cells.

Importantly, the T cells that did survive were exhausted and could not function at full capacity. Not only does this have implications for COVID-19 patient outcomes, but T cell exhaustion leaves patients more vulnerable to secondary infection and calls for scrupulous care.

Chen says that future research should focus on finding finer subpopulations of T cells in order to discover their vulnerability and effect in disease, along with identifying drugs that recover T cell numbers and boost function. Authors say that Tocilizumab is an existing drug that may be effective, but that it needs to be investigated in the context of coronavirus. Antiviral treatments, such as Remdesivir, may also prevent the progression of T cell exhaustion, but all future treatments will require further study.

In the meantime, this new research deepens our understanding of how the novel coronavirus affects the body and it indicates ways to lessen its impact.ReferenceDiao et al. (2020). Reduction and Functional Exhaustion of T Cells in Patients With Coronavirus Disease 2019 (COVID-19). Frontiers in Immunology. DOI: https://doi.org/10.3389/fimmu.2020.00827

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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T Cell Counts and Cytokine Storms May Hold Key to Effective COVID-19 Treatment - Technology Networks