COVID-19: T cells offer clues to the potential power of Roche’s Actemra – FierceBiotech

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The successful activation of T cells is critical to the immune system's ability to clear infections. A new retrospective study from China found that COVID-19 patients had remarkably low T-cell counts in their blood. And they had sky-high levels ofsome pro-inflammatory cytokines such as IL-6which Roches Actemra targets.

Actemra has previously shown promise at controlling potentially life-threatening cytokine storm in COVID-19 patients in China and France, and Roche is running a large phase 3 to confirm its effectiveness in treating patients with COVID-19.

In thestudy from China, published in Frontiers in Immunology, a group of scientists analyzed T-cell counts in 499 COVID-19 patients being treated for the disease in the city of Wuhan. They found a negative correlation between T-cell numbers and cytokines. The team suggested that the novel coronavirus doesnt attack T cells directly, but rather triggers an overproduction of cytokines, which in turn contributes to the depletion and exhaustion of T cells.

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The Chinese researchers noticed that about 76% of patients had insufficient T cells, and the level was much lower in those in intensive care. They then examined the concentrations of cytokines from the blood of these patients and found that the levels of TNF-alpha, IL-6 and IL-10 were significantly increased in infected patients. The elevation was even more pronounced in ICU patients.TNF-alpha is known to promote T-cell death, and dysregulated IL-6 has been shown to induce chronic inflammation.

As the patients gradually recovered, their T cell counts improved, while levels of those cytokines dramatically declined. Sothe researchers hypothesize that the depletionof T cells in COVID-19 patients may be the result ofcytokines impedingT-cell survival or proliferation.

Whats more, the T cells that did survive showed signs of exhaustion, with markedly higher expression of immune-inhibitory factors such as PD-1 and Tim-3 on their surface. That was a sign that their functioning was impaired, the researchers reported.

Based on these findings, the team arguedthe secretion of pro-inflammatory cytokines likely does not come from T cells, butthat the cytokine storm may promote the death of the critical immune cells.

RELATED:Reviving tired T cells to improve immuno-oncology treatments

Finding new ways to restore the vigor of immune cells hasbeen of interest in the biomedical research community, notably in oncology. A team at the University of Pennsylvania, for example, found that a protein called TOX in T cells controls the balance of effector T cells and exhausted T cells, suggesting it could be targeted to improve immuno-oncology treatments. And scientists at the La Jolla institute for Immunology recently showed that crippling all three proteins of Nr4a transcription factors could rejuvenate exhausted CAR-T cells to fight solid tumors in mice.

Based on their findings, the Chinese team suggested thatfuture COVID-19 research should focus on identifying more drugs that provide much-needed support toT cells.

We should pay more attention to T cell counts and their function, rather than respiratory function of patients, the studys corresponding author, Yongwen Chenof the Third Military Medical University in China, said in a statement, adding that more urgent, early intervention may be required in patients with low T lymphocyte counts.

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COVID-19: T cells offer clues to the potential power of Roche's Actemra - FierceBiotech

New clues on how to treat COVID-19 from T cell counts – The Nation

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ISLAMABAD-Cytokine storms may affect the severity of COVID-19 cases by lowering T cell counts, according to a new study published. 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.

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New clues on how to treat COVID-19 from T cell counts - The Nation

Low T Treatment in Texas | SynergenX | Licensed …

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Low T, which is a lower-than-normal level of the male hormone testosterone, can affect men in a variety of ways. It can also have a number of potential causes, including:

Really, age is the most common reason for Low T. Thats because most men begin to experience a decline in testosterone, albeit a gradual one, after age 30. Generally, testosterone levels peak during adolescence or early adulthood, and its pretty much all downhill from there. The older you become, the lower your T levels, and its faster for some men than for others.

Whatever the reason or reasons behind it, Low T can cause or contribute to a number of conditions that disrupt Mens lives and can affect their productivity, relationships and sense of worth or self-identity. These include:

At SynergenX, we treat Low-T with hormone replacement therapyand we do it differently. We tailor the treatment and dose to each mans individual needsas informed by lab tests. We also differ from the typical hormone treatment protocol by testing continually and varying the dose as your T levels rise and fall, because they do. By continually, actively monitoring patients and adjusting treatment, we minimize the risksand help most men achieve a marked, positive change and a reinvigorated life and sense of self.

SynergenX also offers a tailored, effective weight management program to help men lose weight, keep it off for optimal health, and maximize the effects of their Low T treatment to both feel and look great. And speaking of looking your best, SynergenX offers aesthetic services designed to bring your appearance into harmony with how great you feel on the inside.

For more information about the conditions and symptoms SynergenX can help with, or to schedule an appointment for a FREE Low T test in Texas, in McKinney, Texas, North Park, Woodlands, Kingwood, Vintage Park, Katy, Galleria, Cypress, Burr Ridge, TX, Sonterra San Antonio, Dallas, Houston, Chicago, IL, or Northwest San Antonio, call 877-915-2554 or use our easy online form.

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Treating low testosterone levels – Harvard Health

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Testosterone is the hormone that gives men their manliness. Produced by the testicles, it is responsible for male characteristics like a deep voice, muscular build, and facial hair. Testosterone also fosters the production of red blood cells, boosts mood, keeps bones strong, and aids thinking ability. Lack of testosterone, often nicknamed, low-t, can cause unwanted symptoms.

Testosterone levels peak by early adulthood and drop as you ageabout 1% to 2% a year beginning in the 40s. As men reach their 50s and beyond, this may lead to signs and symptoms, such as impotence or changes in sexual desire, depression or anxiety, reduced muscle mass, less energy, weight gain, anemia, and hot flashes. While falling testosterone levels are a normal part of aging, certain conditions can hasten the decline. Low t risk factors include:

Millions of men use testosterone replacement therapy to restore low levels and feel more alert, energetic, mentally sharp, and sexually functional. But it's not that simple. A man's general health also affects his testosterone levels. For instance, being overweight, having diabetes or thyroid problems, and taking certain medications, such as glucocorticoids and other steroids, can affect levels. Therefore, simply having low-t levels does not always call for taking extra testosterone.

Doctors diagnose low testosterone based on a physical exam, a review of symptoms, and the results of multiple blood tests since levels can fluctuate daily.

If your doctor diagnoses low testosterone, other tests may be considered before therapy. For example, low-t can speed bone loss, so your doctor may recommend a bone density test to see whether you also need treatment for osteoporosis.

Prostate cancer is another concern, as testosterone can fuel its growth. As a result, the Endocrine Society recommends against testosterone supplementation for men in certain situations, including those who:

Other circumstances in which testosterone supplementation is not recommended include:

In most cases, men need to have both low levels of testosterone in their blood and several symptoms of low testosterone to go on therapy.

It is possible to have low levels and not experience symptoms. But if you do not have any key symptoms, especially fatigue and sexual dysfunction, which are the most common, it is not recommended you go on the therapy given the uncertainty about long-term safety.

Even if your levels are low and you have symptoms, low-t therapy is not always the first course of action. If your doctor can identify the source for declining levelsfor instance, weight gain or a particular medicationhe or she may first address that problem.

If you and your doctor think testosterone replacement therapy is right for you, there are a variety of delivery methods to consider, as found in the Harvard Special Health Report Men's Health: Fifty and Forward.

Most men feel improvement in symptoms within four to six weeks of taking testosterone replacement therapy, although changes like increases in muscle mass may take from three to six months.

By Matthew SolanExecutive Editor, Harvard Men's Health Watch

Disclaimer:As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

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Hypogonadism – Wikipedia

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"Low T" redirects here. It is not to be confused with LOWT or T Low.

Endocrine disease

Hypogonadism means diminished functional activity of the gonadsthe testes or the ovariesthat may result in diminished production of sex hormones.

Low androgen (e.g., testosterone) levels are referred to as hypoandrogenism and low estrogen (e.g., estradiol) as hypoestrogenism. These are responsible for the observed signs and symptoms. Hypogonadism can decrease other hormones secreted by the gonads including progesterone, DHEA, anti-Mllerian hormone, activin, and inhibin. Sperm development (spermatogenesis) and release of the egg from the ovaries (ovulation) may be impaired by hypogonadism, which, depending on the degree of severity, may result in partial or complete difficulty or inability to have children.

In January 2020, the American College of Physicians issued clinical guidelines for testosterone treatment in adult men with age-related low levels of testosterone. The guidelines are supported by the American Academy of Family Physicians. The guidelines include patient discussions regarding testosterone treatment for sexual dysfunction; annual patient evaluation regarding possible notable improvement and, if none, to discontinue testosterone treatment; physicians should consider intramuscular treatments, rather than transdermal treatments, due to costs and since the effectiveness and harm of either method is similar; and, testosterone treatment for reasons other than possible improvement of sexual dysfunction may not be recommended.[1][2]

Deficiency of sex hormones can result in defective primary or secondary sexual development, or withdrawal effects (e.g., premature menopause) in adults. Defective egg or sperm development results in infertility. The term hypogonadism usually means permanent rather than transient or reversible defects, and usually implies deficiency of reproductive hormones, with or without fertility defects. The term is less commonly used for infertility without hormone deficiency. There are many possible types of hypogonadism and several ways to categorize them. Hypogonadism is also categorized by endocrinologists by the level of the reproductive system that is defective. Physicians measure gonadotropins (LH and FSH) to distinguish primary from secondary hypogonadism. In primary hypogonadism the LH and/or FSH are usually elevated, meaning the problem is in the testicles, whereas in secondary hypogonadism, both are normal or low, suggesting the problem is in the brain.

Hypogonadism can involve just hormone production or just fertility, but most commonly involves both.

Women with hypogonadism do not begin menstruating and it may affect their height and breast development. Onset in women after puberty causes cessation of menstruation, lowered libido, loss of body hair, and hot flashes. In men it causes impaired muscle and body hair development, gynecomastia, decreased height, erectile dysfunction, and sexual difficulties. If hypogonadism is caused by a disorder of the central nervous system (e.g., a brain tumor), then this is known as central hypogonadism. Signs and symptoms of central hypogonadism may involve headaches, impaired vision, double vision, milky discharge from the breast, and symptoms caused by other hormone problems.[5]

The symptoms of hypogonadotrophic hypogonadism, a subtype of hypogonadism, include late, incomplete or lack of development at puberty, and sometimes short stature or the inability to smell; in females, a lack of breasts and menstrual periods, and in males a lack of sexual development, e.g., facial hair, penis and testes enlargement, deepening voice.

Low testosterone can be identified through a simple blood test performed by a laboratory, ordered by a health care provider. Blood for the test must be taken in the morning hours, when levels are highest, as levels can drop by as much as 13% during the day and all normal reference ranges are based on morning levels.[6] However, low testosterone in the absence of any symptoms does not clearly need to be treated.

Normal total testosterone levels depend on the man's age but generally range from 240950ng/dL (nanograms per deciliter) or 8.3-32.9 nmol/L (nanomoles per liter).[7] According to American Urological Association, the diagnosis of low testosterone can be supported when the total testosterone level is below 300ng/dl.[8] Some men with normal total testosterone have low free or bioavailable testosterone levels which could still account for their symptoms. Men with low serum testosterone levels should have other hormones checked, particularly luteinizing hormone to help determine why their testosterone levels are low and help choose the most appropriate treatment (most notably, testosterone is usually not appropriate for secondary or tertiary forms of male hypogonadism, in which the LH levels are usually reduced).

Treatment is often prescribed for total testosterone levels below 230ng/dL with symptoms.[9] If the serum total testosterone level is between 230 and 350ng/dL, free or bioavailable testosterone should be checked as they are frequently low when the total is marginal.

The standard range given is based on widely varying ages and, given that testosterone levels naturally decrease as humans age, age-group specific averages should be taken into consideration when discussing treatment between doctor and patient.[10] In men, testosterone falls approximately 1 to 3 percent each year.[11]

A position statement by the Endocrine Society expressed dissatisfaction with most assays for total, free, and bioavailable testosterone.[12] In particular, research has questioned the validity of commonly administered assays of free testosterone by radioimmunoassay.[12] The free androgen index, essentially a calculation based on total testosterone and sex hormone-binding globulin levels, has been found to be the worst predictor of free testosterone levels and should not be used.[13] Measurement by equilibrium dialysis or mass spectroscopy is generally required for accurate results, particularly for free testosterone which is normally present in very small concentrations.

Testing serum LH and FSH levels are often used to assess hypogonadism in women, particularly when menopause is believed to be happening. These levels change during a woman's normal menstrual cycle, so the history of having ceased menstruation coupled with high levels aids the diagnosis of being menopausal. Commonly, the post-menopausal woman is not called hypogonadal if she is of typical menopausal age. Contrast with a young woman or teen, who would have hypogonadism rather than menopause. This is because hypogonadism is an abnormality, whereas menopause is a normal change in hormone levels. In any case, the LH and FSH levels will rise in cases of primary hypogonadism or menopause, while they will be low in women with secondary or tertiary hypogonadism.

Hypogonadism is often discovered during evaluation of delayed puberty, but ordinary delay, which eventually results in normal pubertal development, wherein reproductive function is termed constitutional delay. It may be discovered during an infertility evaluation in either men or women.

Screening males who do not have symptoms for hypogonadism is not recommended as of 2018.[14]

Male primary or hypergonadotropic hypogonadism is often treated with testosterone replacement therapy if they are not trying to conceive.[9] Adverse effects of testosterone replacement therapy include increased cardiovascular events (including strokes and heart attacks) and death.[15] The Food and Drug Administration (FDA) stated in 2015 that neither the benefits nor the safety of testosterone have been established for low testosterone levels due to aging.[16][17] The FDA has required that testosterone pharmaceutical labels include warning information about the possibility of an increased risk of heart attacks and stroke.[16][17]

While historically, men with prostate cancer risk were warned against testosterone therapy, that has shown to be a myth.[18]

Other side effects can include an elevation of the hematocrit to levels that require blood withdrawal (phlebotomy) to prevent complications from excessively thick blood. Gynecomastia (growth of breasts in men) sometimes occurs. Finally, some physicians worry that obstructive sleep apnea may worsen with testosterone therapy, and should be monitored.[19]

Another treatment for hypogonadism is human chorionic gonadotropin (hCG).[20] This stimulates the LH receptor, thereby promoting testosterone synthesis. This will not be effective in men who simply cannot make testosterone anymore (primary hypogonadism) and the failure of hCG therapy is further support for the existence of true testicular failure in a patient. It is particularly indicated in men with hypogonadism who wish to retain their fertility, as it does not suppress spermatogenesis like testosterone replacement therapy does.

For both men and women, an alternative to testosterone replacement is low-dose clomifene treatment, which can stimulate the body to naturally increase hormone levels while avoiding infertility and other side effects that can result from direct hormone replacement therapy.[21] Clomifene blocks estrogen from binding to some estrogen receptors in the hypothalamus, thereby causing an increased release of gonadotropin-releasing hormone and subsequently LH from the pituitary. Clomifene is a selective estrogen receptor modulator (SERM). Generally, clomifene does not have adverse effects at the doses used for this purpose. Clomifene at much higher doses is used to induce ovulation and has significant adverse effects in such a setting.

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Hypogonadism - Wikipedia

Viewpoint: Time to stop thinking of testosterone as a ‘magic male molecule’ – Genetic Literacy Project

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We place unreasonable trust in biological explanations of male behavior. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men (presumably those with more T) have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientificstudyto date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies (TRTs) went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognized, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined1 per cent annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: thesciencedoesnt support this conclusion either. Some of the famous earlystudieslinking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men (read: darker-skinned men), which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorousresearchshowinglittlerelation between T and aggression (except at very high or very low levels) is just now reaching the general public.

Whats more, it turns out that T is not just one thing (a sex hormone) with one purpose (male reproduction). T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California,compileda table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were newfindingsin this period showing the importance of T in promotingovulation. There is also a difference between correlation and cause (T levels and aggression, for example, provide a classic chicken-egg challenge). As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man (or woman, for that matter), you cant predict their T level.

Testosterone is a molecule that wasmislabeledalmost 100 years ago as a sex hormone, because (some things never change) scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything:sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is evenevidencethat men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a US Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh: one commentator inForbeswrote about testosterone-induced gang rapes; another, interviewed on CNN, asked: But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school?; and a third, in a column inTheNew York Times, wrote: Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain (and sometimes excuse) male behavior in articles and speeches every day. Poetic license, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behavior, we can inadvertently excuse male behavior as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalize the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defense not guilty, by reason of hormones.

Invoking mens biology to explain their behavior too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about theresearchshowing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in theirbookTestosterone(2019) asocialmolecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

Matthew Gutmannis professor of anthropology and faculty fellow at the Watson Institute for International and Public Affairs at Brown University. His latest book isAre Men Animals? How Modern Masculinity Sells Men Short (2019). Follow him on Twitter @MCGutmann

A version of this article was originally published at Aeon and has been republished here with permission. Follow the site on Twitter @aeonmag

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Viewpoint: Time to stop thinking of testosterone as a 'magic male molecule' - Genetic Literacy Project

Low T Symptoms Quiz: Do I Have Low Testosterone Quiz …

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As we age, hormone production begins to decrease. For men, this means producing lower levels of testosterone which, if left untreated, can cause an array of unpleasant symptoms. Need to know if youre experiencing symptoms of Low T? Take this quiz below and find out.

Low testosterone can manifest itself in a number of ways. Some of the most common symptoms experienced are weight gain, weakness, fatigue, loss of libido, mood disturbances, and hair loss.

Testosterone has a widespread impact on the way the body works and affects nearly every organ system. T plays a key role in metabolism, by affecting how the body uses its caloric intake and encouraging muscle protein synthesis. Excess abdominal fat can decrease the bodys levels of testosterone and boost estrogen production in males.

The most common reason for lowered T production is simply aging. Research has shown that testosterone levels in aging males fall 1-2% each year after age thirty.

Scientists have also found a link between low T and chemical imbalances in the brain, which may be why men with low T frequently report symptoms such as low libido, fatigue, and mood disturbances.

In recent years two different studies one done by researchers at Saint Louis University and the other by the Kobe University Graduate School of Medicine in Japan found that testosterone replacement therapy was an effective treatment for mild depression.

Men who have low T frequently report muscle weakness this is sometimes due to a decrease in muscle mass caused by low T levels.

Evidence has shown that both high and low levels of T can cause mood disturbances and emotional side effects.

Low libido is a common side effect of low T and is one of the main reasons men with low T pursue hormone replacement therapy,

As testosterone levels decrease men usually begin to see an increase in weight gain. Stomach fat, in particular, can increase estrogen levels in men, which can make T levels drop even further.

Often, low T goes hand-in-hand with low bone density (osteoporosis). The Endocrine Society lists TRT as an effective treatment option for men with low bone density and hypogonadism.

Testosterone plays a vital role in muscle building and maintenance. When T levels drop, men frequently report a decrease in muscle mass and strength.

Testosterone levels spiking during puberty leads to hair growth and other primary and secondary sex traits in young men. But as those levels diminish in older men, testosterone loss can often bring about thinner hair and male pattern baldness.

While low T isnt a direct cause of ED in aging men, its frequently seen as a contributor to sexual dysfunction because it decreases libido and can cause a lack of enjoyment of intimacy.

Testicular shrinkage and a decrease in sperm output is a common symptom of men with hypogonadism.

Though typically thought of as a menopause symptom, andropause can cause this uncomfortable side effect as well.

To find out if you have Low T, click the button below to take the quiz.

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Low T Symptoms Quiz: Do I Have Low Testosterone Quiz ...

Does Insurance Cover Low T Treatment – Mantality Health

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The physicians at Mantality accept insurance for the treatment of testosterone deficiency, or Low T, in order to make it the most affordable option for any man seeking treatment.

According to Mantality founder Kevin J. Meuret,my desire was to help get this type of care within the reach of any man who needed treatment. Many patients who could benefit from treatment dont seek it out because of the fear of cost. We have eliminated that concern by developing a program that is covered by insurance along with Board Certified physicians guiding care.

Mantality is staffed with Board Certified medical physicians, nurse practitioners, and nurses specializing in low testosterone treatment.

Putting care within reachof every man who needs treatment is at the heart of this clinic. Testosterone treatment used to be considered elective or optional. Today we know it is essential. Men suffering with Low T are no different than men suffering with diabetes. A medical condition that is treatable needs proper diagnosis, appropriate medication, and monitoring by specialists. This is exactly what we provide.

We believe men should have access to care, and our accepting insurance gives more people that convenience.

The treatments offered by the physicians at Mantalityare customized to fit individual testosterone needs with prescription medications that can only be prescribed by licensed practitioners. The treatment is simple, covered by insurance carriers, and can be available for less than $100 a month!

We acceptallmajor insurance providers so, if you dont see yours listed, give us a call.

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Does Insurance Cover Low T Treatment - Mantality Health

Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment…

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Company has Partnered with Sterling Medical to Finalize the Development of Cedars-Sinai-Developed 'Healight' Medical Device for Use in Patients with Coronavirus

ENGLEWOOD, CO / ACCESSWIRE / April 27, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

"Sterling has been working with the Cedars-Sinai team for the past several weeks on a very accelerated schedule to develop this much needed device," said Dan Sterling, President of Sterling Medical Devices. "We are happy to now be partnering with Aytu to further advance this critical project as fast as we possibly can for the many patients in need."

"The Aytu team is very pleased to be working with Sterling Medical on this important development program and in the fight against coronavirus," stated Josh Disbrow, Chairman and CEO of Aytu BioScience. Disbrow further commented, "Sterling has a stellar reputation as a best-in-class medical device product firm with more than 21 years of experience, over 1,100 projects engineered, with none failing to receive FDA regulatory approval upon submission. Our team is actively engaged with our colleagues at Sterling in an effort to finalize the device development, with hope of enabling human use in the very near future."

The company believes the Healight platform technology has the potential to positively impact outcomes for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the FDA to determine an expedited regulatory process to potentially enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

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. This point-of-care test has been validated in a 126 patient clinical trial in China and has received CE marking.

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.

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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 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, and compliance. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory approval 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 820, and 21 CFR 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, our ability to enforce the exclusivity provisions of the distribution agreement, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, the manufacturer of the COVID-19 Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, our ability to obtain additional COVID-19 Rapid Tests to meet demand, our ability to secure additional tests if the manufacture of the COVID-19 Rapid Tests is unable to meet demand, the 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.

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/587152/Aytu-BioScience-Signs-Development-Agreement-with-Sterling-Medical-Devices-to-Advance-the-Development-of-Healight-as-a-Potential-Coronavirus-Treatment

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Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment...

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

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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:

Global Low T Therapy market report provides exclusive coverage that has been provided for market drivers and challenges & opportunities for a country-level market in the respective regional segments. The report comprises a competitive analysis of the key players functioning in the market and covers in-depth data related to the competitive landscape of the market and the recent strategies & products that will assist or affect the market in the coming years.

Market Drivers and the Risks Associated with the Low T Therapy Market:

The international Low T Therapy market has been characterized by several primary factors, with each factor tends of playing a crucial role in the boom of the market. The growth in the products has doubled with the smoother availability of the customer base that has been helping the company of flourishing globally. On the other hand, the presence of a dynamic supply chain has helped the company to grow exponentially. Therefore, regarding the increase in the opportunities of the market Low T Therapy faces severe complaints from all the aspects.

Enumerating some of the fundamental parameters encompassed in the report:

Major Geographical Regions and Market of the Low T Therapy Market:

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 -...

Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company’s Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care…

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Commercial Distribution of First 100,000 Tests to Commence Upon Receipt of Inbound Product Shipment

ENGLEWOOD, CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we're optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we're now just days away from placing these COVID-19 test kits into the hands of healthcare professionals."

The COVID-19 IgG/IgM Rapid 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. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked.

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 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. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

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.

Story continues

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 completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, 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 Media and Investors:

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

Contact for COVID-19 IgG/IgM Rapid Test-Related Inquiries:COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/582030/Aytu-BioScience-Submits-Notice-of-Commercialization-to-the-FDA-Allowing-for-Companys-Distribution-of-its-2-10-Minute-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care...

Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited – Yahoo Finance

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ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the signing of a definitive agreement (the "Agreement") with Singapore-based Biolidics, Limited (SGX: 8YY; "Biolidics") to exclusively distribute Biolidics' COVID-19 IgG/IgM Rapid Test in the United States.

Under the terms of the Agreement, Aytu will exclusively distribute Biolidics' COVID-19 IgG/IgM rapid antibody test in the United States. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the Agreement. As an additional component of Aytu's exclusivity, the Company has committed to purchase a minimum of 1,250,000 tests within the first three months of the Agreement.

Biolidics' COVID-19 IgG/IgM Rapid Test has been issued Provisional Authorization for distribution by Singapore's Health Science's Authority (HSA), and the product has been authorized for export from Singapore. Biolidics' COVID-19 IgG/IgM Rapid Test will be supplied from Biolidics' facility in Singapore.

Aytu will collaborate with Biolidics and lead the U.S. clinical trials processes and plans to complete and obtain U.S. Food and Drug Administration ("FDA") 510k regulatory filing clearance of the COVID-19 IgG/IgM rapid test kits.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are pleased to be partnering with Biolidics in distributing this COVID-19 rapid test in the U.S. With the continued call in the United States for increased COVID-19 testing, we are entering this distribution Agreement at an excellent time. We have experienced significant demand for our current COVID-19 rapid test, so adding this test to our product offering will enable us to better meet the high demand in the U.S. We look forward to a productive working relationship with Biolidics and thank them for their confidence in allowing Aytu to take this product to market in the United States."

Incorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited is a Singapore-based precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.

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 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 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.

Story continues

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.

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: our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, risks associated with the our COVID-19 rapid tests including our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufactures of the COVID-19 rapid tests are unable to meet demand, the 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 Media and Investors:

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

Contact for COVID-19 IgG/IgM Rapid Test and Healight-Related Inquiries:

COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/586556/Aytu-BioScience-Announces-Exclusive-Distribution-Agreement-for-COVID-19-IgGIgM-Rapid-Test-with-Singapore-Based-Biolidics-Limited

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Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited - Yahoo Finance

Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico – Yahoo Finance

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Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures

ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.

The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."

The COVID-19 IgG/IgM Rapid 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. This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.

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 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. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

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.

Story continues

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 completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, 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 Media and Investors:

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

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/581543/Aytu-BioScience-Expands-Its-Distribution-Rights-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test-to-Canada-and-Mexico

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance

No, not everything about mens sexual behaviour can be explained by testosterone – Scroll.in

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We place unreasonable trust in biological explanations of male behaviour. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men presumably those with more T have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientific study to date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognised, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined 1% annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: the science doesnt support this conclusion either. Some of the famous early studies linking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men read: darker-skinned men which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorous research showing little relation between T and aggression, except at very high or very low levels, is just now reaching the general public.

Whats more, it turns out that T is not just one thing a sex hormone with one purpose male reproduction. T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California, compiled a table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were new findings in this period showing the importance of T in promoting ovulation. There is also a difference between correlation and cause. T levels and aggression, for example, provide a classic chicken-egg challenge. As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man or woman, for that matter you cant predict their T level.

Testosterone is a molecule that was mislabelled almost 100 years ago as a sex hormone, because scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything: sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is even evidence that men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a United States Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh. One commentator in Forbes wrote about testosterone-induced gang rapes. Another interviewed on CNN asked, But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school? Yet another column in The New York Times read, Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain, and sometimes excuse, male behaviour in articles and speeches every day. Poetic licence, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behaviour, we can inadvertently excuse male behaviour as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalise the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defence not guilty, by reason of hormones.

Invoking mens biology to explain their behaviour too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about the research showing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in their book Testosterone a social molecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

This article first appeared on Aeon.

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No, not everything about mens sexual behaviour can be explained by testosterone - Scroll.in

Aytu BioScience’s Coronavirus Rapid Test Featured on NBC and Fox News (VIDEOS): ”Englewood Company Says It Can Get COVID-19 Test Results in 2-10…

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ENGLEWOOD, CO / ACCESSWIRE / March 16, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today it was featured on a FOX segment titled: "Englewood company says it can get COVID-19 test results in 2-10 minutes," reported on by affiliated television station in Denver, Colorado, KDVR; and on an NBC segment titled "2-minute COVID-19 test results? Denver-area company wants to deliver that promise," reported on by affiliated television station in Denver, Colorado, KUSA.

To view the video segments in their entirety and to read the articles, please visit the links below:

FOX (VIDEO & Article)

https://kdvr.com/news/coronavirus/englewood-company-says-it-can-get-covid-19-test-results-in-2-10-minutes/

NBC (VIDEO & Article)

https://www.9news.com/article/news/investigations/2-minute-coronavirus-test/73-dca03a0e-0452-42ba-8fe4-2fe8d8e0ffbe

The video segments and articles note:

Statements from the video segments and articles:

Inquiries from healthcare professionals and healthcare institutions should be directed via email to COVID-19@aytubio.com.

Media inquiries should be directed via email to james@haydenir.com.

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 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. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

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.

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: the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, 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, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, 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.

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Aytu BioScience's Coronavirus Rapid Test Featured on NBC and Fox News (VIDEOS): ''Englewood Company Says It Can Get COVID-19 Test Results in 2-10...

Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy – Yahoo Finance

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Updated FDA Policy Likely Enables Near-Term Availability of COVID-19 Test in the U.S.

ENGLEWOOD, CO / ACCESSWIRE / March 17, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of yesterday's updated FDA policy on coronavirus diagnostic testing.

On March 16, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."

The company will continue to provide updates about the near-term availability of the COVID-19 test.

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 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.

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: the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, 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, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, 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.

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Originally posted here:
Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy - Yahoo Finance

Low Testosterone – Symptoms & Treatment | Everyday Health

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Low testosterone levels, or "low T," can affect men and women alike.

Testosterone, the primary sex hormone in men, is produced mainly in the testicles, and causes men to develop a deep voice, large muscles, and body hair.

Testosterone is also essential for the production of sperm.

When levels of testosterone fall known as low testosterone or "low T" it can have a profound effect on men, both physically and psychologically.

Normal levels of testosterone in healthy men range from about 300 nanograms per deciliter (ng/dL) up to 1,000 ng/dL, according to Medline Plus.

The normal range is broad and varies by age. In older men, the lower end of "normal" may be lower than in younger men.

Levels of testosterone in the male body rise during and after puberty, then gradually decrease after age 30.

This gradual lowering of testosterone is sometimes referred to as andropause or male menopause.

Testosterone levels may also be lower in men with hypogonadism, a condition in which the body is unable to produce normal amounts of testosterone.

Hypogonadism can occur because of a problem with the testicles or with the pituitary gland, which controls the testicles.

Obesity, having medical conditions such as autoimmune diseases or type 2 diabetes, or using drugs including alcohol or opioids, can also contribute to low levels of testosterone.

Women also produce testosterone, although much less than men: A normal testosterone level in women is 15 to 70 ng/dL according to Medline Plus.

In women, testosterone is produced in the ovaries and the adrenal glands.

Similar to men, low T in women can be caused by a variety of medical conditions as well as by advancing age.

In the years leading up to menopause, women normally experience a drop in testosterone levels.

Low levels in women may be associated with decreased libido, low energy, and depressed mood.

There is some evidence that testosterone replacement therapy can increase sex drive and help with other sexual problems in some women.

But the long-term safety of this treatment is unknown, and some experts say it may raise the risk of breast cancer, though there has yet to be conclusive evidence.

Currently, testosterone preparations are not approved for use in women by the Food and Drug Administration (FDA).

Male hypogonadism may be present from birth or may develop later in life as a consequence of injury or infection.

In infants, symptoms of hypogonadism include:

In boys around the age of puberty, symptoms include:

In men, symptoms of hypogonadism include:

As the level of testosterone in the body decreases with age, men may also experience:

However, these symptoms are nonspecific, meaning they can be caused by many factors, not just low testosterone.

Male hypogonadism is diagnosed based on symptoms, blood tests of testosterone level, and other lab tests, as needed.

It's typicallytreated with testosterone replacement therapy and other therapies, depending on what's causing low T.

In men who are obese, or who have an underlying medical condition such as diabetes that can contribute to low T, losing weight or managing the underlying condition often causes testosterone levels to normalize.

In recent years, many advertising dollars have been spent on promoting testosterone replacement therapy to middle-aged men experiencing such symptoms as fatigue and low libido.

Whether treating such men with testosterone is safe or appropriate, however, is a matter of some controversy. Some doctors are strongly in favor of it, while others are much more cautious.

Learn More About Low Testosterone Causes

Learn More About Low Testosterone Symptoms

Learn More About Low Testosterone Treatment

Learn More About Low Testosterone In Women

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Low Testosterone - Symptoms & Treatment | Everyday Health

Getting Testosterone Down To The ‘T’ – Qrius

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We place unreasonable trust in biological explanations of male behaviour. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men (presumably those with more T) have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientific study to date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies (TRTs) went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognised, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined 1 per cent annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: the science doesnt support this conclusion either. Some of the famous early studies linking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men (read: darker-skinned men), which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorous research showing little relation between T and aggression (except at very high or very low levels) is just now reaching the general public.

Whats more, it turns out that T is not just one thing (a sex hormone) with one purpose (male reproduction). T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California, compiled a table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were new findings in this period showing the importance of T in promoting ovulation. There is also a difference between correlation and cause (T levels and aggression, for example, provide a classic chicken-egg challenge). As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man (or woman, for that matter), you cant predict their T level.

Testosterone is a molecule that was mislabelled almost 100 years ago as a sex hormone, because (some things never change) scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything: sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is even evidence that men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a US Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh: one commentator in Forbes wrote about testosterone-induced gang rapes; another, interviewed on CNN, asked: But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school?; and a third, in a column in The New York Times, wrote: Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain (and sometimes excuse) male behaviour in articles and speeches every day. Poetic licence, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behaviour, we can inadvertently excuse male behaviour as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalise the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defence not guilty, by reason of hormones.

Invoking mens biology to explain their behaviour too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about the research showing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in their book Testosterone (2019) a social molecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

Matthew Gutmann

This article was originally published at Aeon and has been republished under Creative Commons.

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Getting Testosterone Down To The 'T' - Qrius

Lost revenue from low T fares must be recouped – Boston Herald

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For those questioning how free for all policies espoused by progressive leaders on and off the presidential campaign trail would work in the real world, look no further than our own MBTA.

As the Boston Herald reported, the Ts Fiscal and Management Control Board met in December, and among the items on its agenda (besides the transit agencys expanding budget deficit) was discussion of means-tested fares, as in discounts for low-income riders.

We cant keep talking about this for years and years, board Vice Chairwoman Monica Tibbits-Nutt said. The community has been patient.

For those struggling to get by, T fares can take a big chunk out of the day-to-day budget, and the call for relief is understandable.

The Ts been studying the logistics, and this week revealed that an income-based MBTA fares option could boost ridership substantially. The bad news: It would cost the agency tens of millions of dollars in revenue.

Much depends on who would qualify for the lower fares, depending on where the income threshold would be set. Letting those who earn twice the federal poverty level ($26,200 for a family of four) qualify would bring in roughly 50,000 to 90,000 new commuters to the bus and subway every year, MBTA Deputy Director of Policy and Strategic Planning Lynsey Heffernan told the FMCB.

And those riders would cause the T to forgo between $23.3 million and $42.3 million in revenue each year.

The MBTA is spending on a lot of things, such as increased inspections and quality-control measures, in the wake of last years devastating report by a safety review panel. At the December meeting, the T said its budget was likely to run a $42.2 million deficit. Thats with riders paying their regular fares.

Gov. Charlie Bakers $18 billion transportation bond bill, meanwhile, has moved before the House Ways and Means Committee. Among the features: money for MBTA improvements, regional transit authority electrification and additional funding for the South Coast Rail and Green Line Extension projects, already underway.

The MBTA needs to make safety improvements, finish rail and subway projects and advance transportation options for Bay Staters outside of the Greater Boston area. That takes money, and Baker has put together a plan for borrowing it.

The House is rolling out its own transportation plan, one that may include a gas tax.

Inevitably, the proposal to institute an income-based MBTA fare system and lose revenue collides with efforts to borrow or raise revenue to maintain and bolster safety and advance capital improvements.

Which brings us to a key flaw in so many free for all proposals: There are many needs to be met, all of them come with costs, and revenue is not in inexhaustible supply.

Does one halt plans for regional transit authorities to pay for low-income fares in Greater Boston? Or put new buses and trains on hold, despite the rise in ridership such a fare program would initiate?And as many of the capital improvements are under the aegis of helping the environment by getting public transportation to more people, does one dial back the green agenda to assist low-income residents?

Or will someone hit the default switch and call for a tax hike to cover the tab? It takes little imagination to envision the reaction to that.

In the real world, even reducing costs can come at a high price, and when resources have to stretch to cover many needs, triage is a crucial part of the decision-making process.

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Lost revenue from low T fares must be recouped - Boston Herald

Aytu BioScience to Report Fiscal Q2 FY 2020 Results and Business Update – Yahoo Finance

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ENGLEWOOD, CO / ACCESSWIRE / February 6, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that the company will present its operational results for the quarter ended December 31, 2019 on February 13, 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- 844-602-0380 (toll-free)

1- 862-298-0970 (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) and using the replay access code 57940.

About Aytu BioScience, Inc.

Aytu BioScience is a 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'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.

Forward-Looking Statements

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: the effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, 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, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, 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.

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Aytu BioScience to Report Fiscal Q2 FY 2020 Results and Business Update - Yahoo Finance