Monthly Archives: August 2017

EDAP TMS Reports Record Second Quarter and First Half 2017 Results – GlobeNewswire (press release)

Posted: August 25, 2017 at 4:14 am

August 23, 2017 16:01 ET | Source: EDAP TMS SA

EDAP-TMS Reports Record Second Quarter and First Half 2017 Results

LYON, France, August 23, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, announced today financial results for the second quarter ended June 30, 2017, and provided an update on strategic and operational accomplishments.

"We are incredibly pleased to announce record second quarter revenue of 9.3 million", said Marc Oczachowski, EDAP's Chief Executive Officer. "Additionally, the 25% growth in HIFU revenues compared to the first quarter of 2017 shows a significant return from our increased sales and marketing efforts. We also submitted our 510(k) filing to the FDA for our novel Ablatherm Fusion device recently, and are working to file a new 510(k) application with the FDA for the Focal One device in the U.S. The addition of these HIFU devices to our U.S. marketing efforts, coupled with the active C-Code, should serve to help our customers service the widest possible range of patients."

Second Quarter 2017 Results

Total revenue for the second quarter 2017 was EUR 9.3 million (USD 10.4 million), compared to EUR 8.2 million (USD 9.2 million) for the second quarter of 2016, a 13.7% increase and the highest second quarter revenue in EDAP's history.

For the three months ended June 30, 2017, total revenue for the Lithotripsy division was EUR 6.4 million (USD 7.2 million), a 33.9% increase compared to EUR 4.8 million (USD 5.4 million) during the year-ago period. During the second quarter of 2017, EDAP sold 7 lithotripsy devices compared to 6 lithotripsy devices sold during the second quarter of 2016.

Total revenue in the HIFU business for the second quarter was EUR 2.9 million (USD 3.2 million) compared to EUR 3.4 million (USD 3.8 million) for the second quarter of 2016. During the second quarter of 2017, EDAP sold 1 Focal One and 2 Ablatherm HIFU devices compared to 1 Focal One and 3 Ablatherm devices during the second quarter of 2016.

Gross profit for the second quarter 2017 was EUR 4.0 million (USD 4.5 million), compared to EUR 3.5 million (USD 3.9 million) for the year-ago period. Gross profit margin on net sales expanded to 43.2% in the second quarter of 2017, compared to 42.2% in the prior year period, primarily due to increase in revenues.

Operating expenses for the second quarter of 2017 totaled EUR 4.4 million (USD 5.0 million) for the second quarter of 2017, compared to EUR 3.8 million (USD 4.3 million) for the same period in 2016. The increase reflects increased sales and marketing efforts associated with the expansion of the HIFU and UDS businesses.

Operating loss for the second quarter of 2017 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.3 million (USD 0.4 million) in the second quarter of 2016.

Net loss for the second quarter of 2017 was EUR 1.7 million (USD 2.0 million), or loss of EUR 0.06 per diluted share, as compared to net income of EUR 2.5 million (USD 2.8 million), or earnings of EUR 0.09 per diluted share in the year-ago period. Net loss during the second quarter of 2017 included a non-cash interest expense of EUR 0.6 million (USD $0.6 million) to adjust the accounting fair value of the outstanding warrants.

First Six Months 2017 Results

Total revenue for the first half of 2017 was EUR 18.0 million (USD 19.7 million) - a new record level for the period, up 6.3% compared to EUR 16.9 million (USD 18.8 million) for the first half of 2016. For the six months ended June 30, 2017, total revenue for the Lithotripsy division was EUR 12.8 million (USD 14.0 million), an increase of 24.6% when compared to EUR 10.2 million (USD 11.4 million), during the year ago period. This increase was driven by growth in both the distribution business and lithotripsy device sales.

Total revenue in the HIFU division for the first six months 2017 was EUR 5.2 million (USD 5.7 million) compared to EUR 6.7 million (USD 7.4 million) for the six months ended June 30, 2016. This decrease was primarily due to slow U.S. sales of HIFU devices during the first half of the year, tempered by an increase in HIFU treatment driven revenues.

Gross profit for the first half of 2017 was EUR 7.6 million (USD 8.3 million) and gross profit margin was 42.1%, compared to 45.8% in the year ago period. The contraction in gross profit margin was primarily due to an unfavorable mix of HIFU and UDS segment revenues.

The Company recorded an operating loss for the first half of 2017 of EUR 0.8 million (USD 0.9 million), compared with an operating profit of EUR 0.4 million (USD 0.4 million) in the first six months of 2016.

Net loss for the first half of 2017 was EUR 0.1 million (USD 0.1 million), or EUR 0.00 per diluted share, as compared to a net income of EUR 3.9 million (USD 4.3 million), or EUR 0.14 per diluted share, in the first half of 2016. Net income for the first six months of 2017 included non-cash interest income of EUR 1.4 million (USD 1.5 million) to adjust the accounting fair value of the outstanding warrants

At June 30, 2017, cash and cash equivalents, including short-term treasury investments, were EUR 18.6 million (USD 21.2 million).

Conference Call

An accompanying conference call will be conducted by Philippe Chauveau, Chairman of the Board, Marc Oczachowski, Chief Executive Officer; and Francois Dietsch, Chief Financial Officer, to go over the results. The call will be held at 9:00 AM ET, on Thursday, August 24, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Date:Thursday, August 24, 2017, 9:00 AM ET Conference dial-in:877-269-7756 International dial-in:201-689-7817 Conference Call Name:EDAP-TMS Second Quarter 2017 Results Conference Call Webcast Registration:Click Here

Following the live call, a replay will be available on the Company's website, http://www.edap-tms.com under "Investors Information."

About EDAP TMS SA

EDAP TMS SA markets today Ablatherm for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. Ablatherm Fusion is not FDA cleared yet. The Company also markets an innovative robot-assisted HIFU device, the Focal One, dedicated to focal therapy of prostate cancer. Focal One is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, andhttp://www.hifu-planet.com.

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

EDAP TMS S.A. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Three Months Ended: Three Months Ended:

Net sales of RPP and Leases

1,304

1,316

1,458

1,474

2,037

1,611

NOTE: Translated for convenience of the reader to U.S. dollars at the 2017 average three months' noon buying rate of 1 Euro = 1.1181USD, and 2016 average three months' noon buying rate of 1 Euro = 1.1203 USD.

EDAP TMS S.A. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Six Months Ended: Six Months Ended:

Net sales of RPP and leases

2,599

2,578

2,844

2,865

3,879

3,078

4,244

3,421

NOTE: Translated for convenience of the reader to U.S. dollars at the 2017 average six months' noon buying rate of 1 Euro = 1.0942USD, and 2016 average six months' noon buying rate of 1 Euro = 1. 1116 USD.

EDAP TMS S.A. CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S. Dollars)

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1412 USD, on June 30, 2017 and at the noon buying rate of 1 Euro = 1.0697 USD, on March 31, 2017.

EDAP TMS S.A. CONDENSED STATEMENTS OF OPERATIONS BY DIVISION SIX MONTHS ENDED JUNE 30, 2017 (Amounts in thousands of Euros)

HIFU Division

UDS Division

Corporate

Sales of goods

2,626

8,852

11,478

Research & Development

(1,211)

OPERATING PROFIT (LOSS)

(884)

804

(768)

(847)

Contact Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 bconfort@edap-tms.com

Investors Rich Cockrell CG CAPITAL 877.889.1972 investorrelations@cg.capital

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Like most families, Test Match Special has had some bitter rows – Telegraph.co.uk

Posted: at 4:14 am

To celebrate TMSs 60th birthday, a match is being played (and commentated upon) in Leeds. Agnews team will take on Geoffrey Boycotts; with the two broadcasting greats represented by their respective on-field captains Phil Tufnell and Vaughan. I think I may have drawn the short straw with my captain, Agnew said with a smile.

TMS favourites will play, as well as celebrities including Jim Carter of Downton Abbey, sprinter Yohan Blake and McFly drummer Harry Judd (a good cricketer, according to Agnew).

They could have sold 10 times the tickets, Agnew said. The TMS mystique remains strong.

It is amazing how much this programme continues to appeal, Agnew said.

Our audience numbers go up and up.

It is a companion for people: most are listening in a confined space, car, headphones in the office, in bed. Often for seven hours a day, five days at a time. There is a feeling of camaraderie, that we are in it together.

For many, TMS has been there during good times and bad. Agnew himself experienced this recently.

My wife Emma has been diagnosed with breast cancer, he said. Because of the nature of the relationship we have with listeners, if I am not on it, people will ask wheres Aggers?

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Neurotechnology and the Future of Hope – Robotics Tomorrow (press release)

Posted: at 4:13 am

If researchers can use implanted BCIs to allow people to bypass their muscles, indeed, if these scientists can find a cost-effective, reliable way to work around a damaged or compromised nervous system, people suffering paraplegia, amputation, multiple sclerosis, Lou Gehrig's, and a host of other diseases that rob them of their independence, may soon find that the frustrations of daily life are lessened.

Richard van Hooijdonk | Richard van Hooijdonk

Bill Kochevar wears a bright red shirt and what looks like a cast on his right arm. As he raises a fork to his mouth, his movements are awkward and slow, supported by a gravity defying brace mounted on the floor next to his wheelchair.

Hes got a fork full of mashed potatoes, and as he raises it to his mouth, the joy on his face is unmistakable.

It was amazing...I thought about moving my arm and it did!

That may seem unremarkable to you, but since a bicycle collision with a mail truck, Kochevar has been paralysed from the neck down.

Just imagine being paralysed.

Its the stuff of nightmares--wanting to flee and finding your legs rooted in place, unresponsive.

And weve all slept on an arm for long enough to render it dead. Think about that experience now. When you woke up, your limb was just meat, just dead weight that wouldnt move at your beck and call as it should.

Now imagine knowing that no amount of waiting will summon the pins and needles that mean your arm is coming back from the dead, that instead, itll hang lifeless at your side for the rest of your life, and that far from being indispensably useful, youll instead spend every waking moment trying to compensate for this new obstacle, adjusting everything you do from brushing your teeth to driving a car to typing at work--if, indeed, you can work.

Now extend that to multiple limbs or remove them altogether.

You can start to see what its like to live in a body that refuses to cooperate.

Paralysis affects far more people than you might realise. For instance, the Reeve Foundation recently found that 1 in 50 Americans struggle with paralysis caused by stroke, spinal injury, and muscular sclerosis. Nearly a majority are unable to work, a staggering 41.8%.

For them, independence is a dream, something they might remember but no longer experience. But now, advances in neurotech may help them live fuller, more self-sufficient lives.

Mind-controlled wheelchairs and the next step

To help those whove suffered a profound loss of motor control, researchers have been exploring mind-controlled wheelchairs. Rodrigo Quevedo, a Chilean engineer, has developed a design in his Idea factory. His motivating passion, he says, is to do something so [paraplegics] can move. Rodrigos current designs steer the chair by subtle head movements, but hes hoping to make the move to neural control soon.

Diwakar Vaish beat Rodrigo to the punch. This young Indian tech guru has developed the first commercially available wheelchair that features a brain computer interface (BCI). The user need only wear a headset that collects information from her brains electrical impulses, the neural storm that accompanies thought. The BCI translates these minute electrical signals into a language a computer can understand, something like a sophisticated google translate of thoughts. Now that the computer can grasp what a particular thought looks like, it can react and obey.

In Vaishs system, the non-invasive headset connects the users brain to the chair via Bluetooth, and augmented by proximity and terrain sensors, this has allowed even the most stricken patients a measure of autonomy. All thats demanded of the user is a healthy brain, so even those trapped by Locked-in Syndrome can use the new chair. As Vaish told The Sunday Guardian, We have tried it on patients who are in a vegetative state, but their brain is functional and it was successful.

The next steps are to move beyond motorised chairs and into the world of exoskeletons. Miguel Nicolelis, a Brazilian neuroscientist, has been working together with colleagues at Duke University as part of the Walk Again Project to design a wireless system that allows control of a wheelchair with thought alone. By implanting a tiny BCI in the brain of two rhesus monkeys, chosen for their similarity to human beings, they were able to demonstrate that it could control the movements of the chair. Hes pursuing this method because, as he explained to the Mirror, In some severely disabled people, even blinking is not possible. For them, using a wheelchair or device controlled by non invasive measures like an EEG, a device that monitors brain waves through electrodes on the scalp, may not be sufficient. To provide the control they need, invasive measures are necessary.

Nicolelis goal, then, isnt to duplicate Vaishs design. Instead, he wants eventually to develop robotic exoskeletons that are nothing less than an extension of their users mind, a dream he thinks is within reach given the data from these early experiments. For his test monkeys, the chair became something more than a means to get from one place to another; in fact, the wheelchair is being assimilated by the monkeys brain as an extension of its bodily representation of itself. If Nicolelis is right, he might be taking the first steps toward real mobility for paraplegics and others with profound motor impairment. We are not focused on the wheelchair, he promises.

Until now, if you lost an arm--but still had enough of one to be fitted for a prosthesis--doctors could fit you with an artificial arm that you could learn to control by moving the muscles left in your stump. These cumbersome systems are hobbled on a lot of these ifs: if the patient has enough remaining tissue, if the tissue still allows muscle movement, if the prosthetic arm can work well enough outside the lab.

These ifs fall on patients live like a thick blanket of snow, quickly obscuring the way forward. Thats why as many as half of these patients find their new arms collecting dust.

But scientists are well aware of these technological limitations, and their working to overcome them. One example of promising research comes from Johns Hopkins. Working with an epilepsy patient who needed his brain mapped to help him combat his seizures, a process wherein doctors implant tiny electrodes to stimulate the brain at precise--and unique--points, a research team led by Nathan Crone was able to implant a tiny BCI as well. 128 sensors in an areas about the size of a credit card were attached to the part of the mans brain that controls the arm and hand. After mapping exactly how the patients brain worked with a special glove, this interface allowed the Hopkins team to bypass the patients body and use only his thoughts to control the individual fingers of a robotic hand.

Initial results were promising; after mapping his brain, the test patient was able to control the robotic hand with 76% accuracy. By refining the control of the prosthesis--pairing the ring and pinky fingers together, that number rose to 88%. Thats no small feat!

The advantage of a system like this is not only that it can allow functional independence to people who had given up on caring for themselves, but also that it isnt artificial. Patients need merely think about what they want to do--and the artificial limb, chair, or robotic appendage does what its supposed to do. Case Western Reserve University is experimenting with implanted BCIs that have returned a measure of control to Kochevar. Now able to feed himself, hold a cup, and manipulate a fork, he explains, I think about what I want to do and the system does it for me. Its not a lot of thinking about it. When I want to do something, my brain does what it does. The researchers working with him think this is only the beginning.

With further development, we believe the technology could give more accurate control, allowing a wider range of actions, which could begin to transform the lives of people living with paralysis, Bolu Ajiboye, the lead scientist for this study told The Guardian.

Ajiboyes optimism is bolstered by the success of patients like Kochevar, who can slowly raise a mug to his lips and drink from a straw. For someone with quadriplegia to gain even this limited mobility is life-changing, and this advance charts the course for future innovations and provides powerful new tools to help those in need.

If researchers can use implanted BCIs to allow people to bypass their muscles, indeed, if these scientists can find a cost-effective, reliable way to work around a damaged or compromised nervous system, people suffering paraplegia, amputation, multiple sclerosis, Lou Gehrig's, and a host of other diseases that rob them of their independence, may soon find that the frustrations of daily life are lessened. For futurists and trendwatchers, the promise is clear.

This new breed of BCI, powered by advances in neuroscience, isnt just technology.

Its hope.

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Technology Key to Fighting Neurological Disease – R & D Magazine

Posted: at 4:13 am

New technologies may be on the way to better help doctors diagnose and treat patients with neurological diseases.

Researchers from the National Neuroscience Institute (NNI) and Nanyang Technological University, Singapore (NTU) have come together to develop several new technologies, including an artificial intelligence system that can accurately identify types of traumatic brain injuries from computed tomography (CT) scans.

Innovation occurs at intersections of disciplines, knowledge and expertise, associate professor Ng Wai Hoe, Medical Director of the National Neuroscience Institute, said in a statement. Doctors have a deep understanding of clinical needs from their everyday interactions with patients.

Our unique collaboration brings these medical needs to engineering laboratoriesan environment where imagination is encouraged in the form of technological advances and capabilities.

The researchers also plan to develop a computer algorithm for more precise identification of tissues during brain surgeries, which aim to restore the neurological functions of patients suffering from various conditions including Parkinsons disease.

A new fellowship programmanaged by NTUs Institute for Health Technologieswill see up to two neurosurgical residents at NNI work full-time with NTU professors on campus, with each resident receiving $100,000 to complete and commercialize these projects.

The program was designed to foster a relationship over the next three years between medical practitioners and engineers through annual fellowships and student attachment programs.

The rapidly ageing population will lead to a significant rise in neurological diseases globally, Hoe said. By harnessing the power of the human brain, neurotechnology can provide solutions to revolutionize the treatment of brain disorders.

This partnership has great potential to be an innovation launchpad for neurotechnology.

A student attachment program aimed at grooming multidisciplinary scientists will also be introduced, giving students an opportunity to widen their engineering knowledge into medical practice, gaining first-hand exposure to various aspects of clinical medicine by interacting with neurosurgeons.

Professor Lam Khin Yong, NTU's Chief of Staff and Vice President for Research, said the new technology will assist the next wave of doctors.

This collaboration creates a unique multidisciplinary research environment by integrating healthcare with both medical and engineering expertise from NTU's Lee Kong Chian School of Medicine and College of Engineering, Yong said in a statement. This will not only nurture next-generation doctors armed with a multidisciplinary skillset to meet Singapore's healthcare needs, but also enhance medical technologies to diagnose and treat neurological conditions more effectively.

In Switzerland, additional technological advancements are making an impact in the treatment of neurological disorders.

Researchers from the National Centre of Competence in Research Robotics at cole Polytechnique Fdrale de Lausanne (EPFL) and at the Lausanne University Hospital in Switzerland, have developed an algorithm to help those paralyzed by a neurological disorder or injury. The algorithm helps a robotic harness facilitate the movements of patients, enabling them to move naturally. This new technology could help patients regain their locomotor skills

A variety of neurological disorders including stroke, multiple sclerosis, cerebral palsy, can lead to paralysis. Currently, people with motor disabilities rehabilitate by walking on a treadmill with the upper torso being supported by an apparatus. However, this can be either too rigid or does not allow the patient to move naturally in all directions.

Locomotor rehabilitation requires helping the nervous system relearn the right movements, which is difficult due to the loss of muscle mass in patients, as well as train the neurological wiring that has forgotten correct posture.

The researchers designed the algorithm to overcome these obstacles. The robotic rehabilitation harness was tested on more than 30 patients and markedly and immediately improved the patients locomotor abilities.

The harnesscalled the smart walk assistis a body-weight support system that manages to resist the force of gravity and push the patient in a given direction to recreate a natural gait and movement that the patient needs in their everyday lives.

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Canaccord Genuity Keeps Rating And Raises Price Target On Stryker Corporation (SYK) – Modern Readers

Posted: at 4:13 am

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Stryker Corporation (NYSE:SYK).

On June 30 analysts at Cantor Fitzgerald starting coverage on the stock giving it an initial rating of Neutral. On May 16, 2017 Goldman Sachs released its first research report on the stock by announcing an initial rating of Neutral.

In the market the company is trading down by -0.12% since yesterdays close of $138.36. Additionally the company recently declared a dividend which will be paid on Tuesday the 31st of October 2017. The dividend will be $0.425 per share for the quarter which is $1.70 annualized. The dividend yield will be $1.17. The ex-dividend date will be on Wednesday the 28th of June 2017.

The stock last traded at $138.19 which is marginally lower than the 50 day moving average of $144.81 and which is slightly above the 200 day moving average of $136.90. The 50 day moving average was down by -4.54% and the 200 day average went up $1.34 or +0.98%.

Stryker Corporation (Stryker), launched on February 20, 1946, is a medical technology company. The Company offers a range of medical technologies, including orthopedic, medical and surgical, and neurotechnology and spine products. The Businesss segments include Orthopaedics; MedSurg; Neurotechnology and Spine, and Corporate and Other. The Orthopaedics segment includes reconstructive (hip and knee) and trauma implant systems and other related products. The Businesss MedSurg segment consists of instruments, endoscopy, medical and sustainability products. The Neurotechnology and Spine segment includes neurovascular products, spinal implant systems and other related products..

Stryker Corporations P/E ratio is 30.86 and market capitalization is 51.71B. As of the last earnings report the EPS was $4.48 and is projected to be $6.50 for the current year with 374,063,000 shares outstanding. Analysts expect next quarters EPS to be $1.95 with next years EPS anticipated to be $7.11.

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Canaccord Genuity Keeps Rating And Raises Price Target On Stryker Corporation (SYK) - Modern Readers

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Red Sox place CF Jackie Bradley Jr. on DL with sprained left thumb – ESPN

Posted: at 4:12 am

CLEVELAND -- Boston Red Sox outfielder Jackie Bradley Jr. will have his sprained left thumb in a splint for five to seven days after being injured Tuesday night.

Bradley was placed on the 10-day disabled list Wednesday. He was injured while reaching for home plate during a slide in Tuesday night's game against the Cleveland Indians.

Bradley was sent back to Boston for an MRI on Wednesday. Manager John Farrell said the tests showed no tears or fractures.

Bradley won't be ready to come off the disabled list in 10 days, but the Red Sox are hopeful he will return before the postseason.

"It's hard to tell at this point," Farrell told reporters when asked if there's a general timeframe for Bradley's return. "I wish I had more of a definitive answer, but I just don't know."

Farrell said he's concerned whenever a hitter is dealing with a hand injury.

Bradley slid around catcher Yan Gomes' tag to score on Eduardo Nunez's seventh-inning double. Indians manager Terry Francona challenged the call, which was upheld after a review. Farrell said had the call been overturned he would have challenged that Gomes blocked the plate and didn't give Bradley a clear lane to slide.

"It's unfortunate that he wound up in an unfortunate position on the slide," Farrell said.

Andrew Benintendi was starting in center field with Brock Holt in left Wednesday. Chris Young will also see action in left field, and Farrell said Nunez may see time there as well when second baseman Dustin Pedroia (left knee inflammation) returns from the DL.

Pedroia remained in Boston while the team went on road. He's been running on the treadmill and hitting in the cages, but he hasn't begun any on-field work.

To take Bradley's spot on the roster, the Red Sox called up infielder Deven Marrero from Triple-A Pawtucket.

Bradley was batting .262 with 14 home runs and 54 RBIs this season, hitting .400 in his past seven games.

Marrero has played 58 games in three stints in the majors this season. He has batted .212 with 3 homers and 23 RBIs with the Red Sox.

ESPN's Scott Lauber contributed to this report.

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Brief reprieve at CF pool – Ocala

Posted: at 4:12 am

It will stay open through end of year to host high school swim teams

The Newton A. Perry Aquatic Center, which was set to close in about five weeks, will remain open through the end of the year now that the College of Central Florida agreed to extend the lease so that area high school swim teams can hold fall competitions.

The lease extension, which was approved by the colleges Board of Trustees on Wednesday, comes three months after CF President Jim Henningsen announced the pool complex would be closed. The pool was built by the college 39 years ago, but has not been needed for academics for about 25 years.

For more than a decade, Ocala Aquatics, a nonprofit group that offers swimming lessons and recreation team sports, has leased the facility from CF for $10 per year. The agreement was that Ocala Aquatics pay for the $180,000 annual upkeep and the college would take care of broken equipment in excess of $2,500.

Henningsen announced in May the college would not renew the lease with Ocala Aquatics. He said the complex would be closed on Sept. 30 because the college could not afford the $1.5 million needed to renovate the aging facility, which has become a liability. Ocala Aquatics did not have the money to pay for the renovation.

After the news of the impending closing, Marion County Superintendent of Schools Heidi Maier and her administrative team soon realized there are few pools available for high schools to conduct fall practices and competitions. Maier met with Henningsen and asked for the extension so that high school swimming programs could proceed. Henningsen agreed to bring the request before the Board of Trustees on Wednesday.

The swimming complex has the areas only certified Olympic-size swimming pool. Ocala Aquatics has held swimming lessons there for decades and high school swimming teams have used the facility.

We are thankful they did extend the lease, Maier said on Wednesday.

Maier said the district has been looking at leasing one of the city of Ocalas two public swimming pools. But both city pools are used by many groups and scheduling would be difficult. She said they have considered negotiating with the Frank Deluca YMCA to use its pool. However, it appears the YMCA pool, which is used often, is likely not a viable option.

Brandie Bennett, the chairwoman of the Ocala Aquatics' board of directors, said Wednesday the group is finalizing its plans to launch a massive capital campaign in October to build its own swimming complex. Bennett said the new facility would be built on property in the Ocala area. Bennett said she could not offer any more details until the board of directors finalized its plans in the coming months.

Henningsen told trustees on Wednesday that reputable Marion County businessmen have talked to him about the possibility of extending the lease beyond December so that funding can be secured to build a new swimming complex.

Henningsen told the board that he expects the group to ask for that extension later in the year. He said he will be willing to work with the group if an adequate fundraising campaign is underway and that immediate repairs of some of the biggest concerns are financed by the group.

Trustees agreed to give the three-month extension, though they insisted the college would not be responsible for any repairs or providing maintenance manpower. Henningsen said the lease extension with Ocala Aquatics is clear that the college would not be paying for any repairs or equipment during the lease extension.

When Henningsen announced in May that the college would not renew the lease, Ocala Aquatics officials balked, stating the complex is still operational. The nonprofit asked if they could conduct needed repairs in stages over years and not at one time. Henningsen declined the request, stating he had warned the group four years ago to start raising money to renovate the complex or he would be forced to close the pool. A study conducted several years ago showed the pool was in dire need of substantial repair.

The college first tried to close the pool in 2003. The pool was only being used by the community and the college was paying all of the bills. College officials agreed then to lease the facility for $10 per year to Ocala Aquatics. The deal was that Ocala Aquatics had to pay the operational costs, which is about $180,000 annually. The college pays about $40,000 annually in other costs.

Henningsen told Ocala Aquatics in 2013 that the group needed to raise at least $1 million to pay for a renovation or he would shut it down. Since then, the group has raised $80,000. Henningsen decided early this year that the complex was too much of a safety risk to keep open.

Ocala Aquatics officials also said in June that Henningsen had promised the colleges help to raise the funds for the renovation. Henningsen said the CF Foundation initially agreed to help, but decided to focus instead on fundraising for the colleges academic programs. In 2011, a fire destroyed the main building at the pool complex and CF paid $2 million. Along with insurance funds, the building was rebuilt.

Joe Callahan can be reached at 867-4113 or joe.callahan@starbanner.com. Follow him on Twitter @JoeOcalaNews.

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Brief reprieve at CF pool - Ocala

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Slumping fertilizer producers gear up to fill truck demand (CF, AGU, DAI, YAR, POT, UPS, FDX) – Markets Insider

Posted: at 4:12 am

By Rod Nickel

Aug 24 (Reuters) - Fertilizer companies, coping with a stubborn price slump, are banking on tighter emissions standards for diesel trucks in the United States and Europe to buoy their balance sheets.

Nitrogen fertilizer producers including CF Industries Holdings Inc and Agrium Inc are accelerating output of diesel exhaust fluid (DEF), a water and urea solution used to reduce emissions of nitrogen oxide. The niche market offers premiums of $50 to $100 per short ton over the crop nutrients they sell at prices that are depressed due to excessive supplies.

DEF demand has risen since the U.S. Environmental Protection Agency set tighter emissions controls in 2010 for diesel trucks made by Volvo, Daimler AG and others. The European Union, in which DEF is known as AdBlue, introduced similar legislation in 2013.

Fertilizer companies have increased DEF output this year to coincide with openings of several new or expanded U.S. nitrogen plants, and as lower-emission trucks replace aging vehicles on the road.

"We love it - it's a great business for us," Bert Frost, CF Industries' senior vice-president of sales, market development and supply chain, said in a recent interview. "It builds our customer base and gives us (options) on production."

CF Industries started production this year in Louisiana to turn 400,000 tons of urea annually into DEF. Altogether, CF, the largest North American producer by capacity, can convert 800,000 tons of urea into DEF annually.

DOUBLING DEMAND

Total U.S. demand for DEF is about 1 million tons of urea equivalent, a fraction of North America's annual consumption of 14 million tons of urea, Frost said. But he added that DEF demand is likely to double within five years as 60 percent of U.S. heavy diesel trucks are replaced by models with lower-emission engines.

Engine technology called selective catalytic reduction (SCR) uses DEF to trigger a chemical reaction that converts nitrogen oxides, a pollutant, into natural components of air that are then expelled through the tailpipe.

The market hinges on the administration of U.S. President Donald Trump, which pulled the United States out of the Paris climate change agreement, continuing the country's move to lower-emission trucks.

The U.S. administration is unlikely to roll back emissions standards because trucking companies benefit from using more fuel-efficient vehicles and manufacturers have made huge investments in technology, said Allen Schaeffer, executive director of Diesel Technology Forum, a nonprofit group.

Global consumption of DEF may reach 10 million tonnes of urea equivalent annually by 2027 from 2 million currently, said Adam Panayi, research manager at Integer Research.

The market for DEF will peak in the United States and Europe toward the end of the 2020s, while potential growth continues in developing markets such as China and India, he said.

There may already be too much DEF available, said Andy Austin, senior vice-president of specialty products at Mansfield Energy Corp, which buys DEF from CF, Yara International ASA and Potash Corp of Saskatchewan, and distributes it to XPO Logistics Inc, United Parcel Service Inc and FedEx Corp for their trucks.

"I would say there is a glut," Austin said. "That risk is certainly there for (producers)." (Reporting by Rod Nickel in Winnipeg, Manitoba; Editing by Matthew Lewis)

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Slumping fertilizer producers gear up to fill truck demand (CF, AGU, DAI, YAR, POT, UPS, FDX) - Markets Insider

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New Combination Therapy for Cystic Fibrosis Being Reviewed by FDA and EMA – Rare Disease Report

Posted: at 4:12 am

Vertex Pharmaceuticals has announced that both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted its applications for the use of the tezacaftor/ivacaftor combination treatment in a subset of patients with cystic fibrosis (CF).

The application acceptance is for people with CF ages 12 and older who have 2 copies of the F508del mutation or an F508del mutation and 1 residual function mutation that is responsive to tezacaftor/ivacaftor.

The news comes just 1 month after Vertex announced positive data from Phase 1 and Phase 2 studies of 3 drugs being used in CF patients with these mutations; 2 of those drugs were tezacaftor and ivacaftor and the third was VX-440. The combinations of tezacaftor/ivacaftor and tezacaftor/ivacaftor/VX-440 are being investigated separately in the same subset of CF patients (who have 2 copies of the F508del mutation or an F508del mutation and 1 residual function mutation).

In March, it was reported that Phase 3 studies testing the combination of tezacaftor and ivacaftor in CF patients met their primary endpoints with statistically significant improvements in lung function in CF patients.

CF is an often-life-threatening hereditary disorder that causes damage in patients lungs and digestive systems. Common symptoms include frequent lung infections, heavy coughing and difficulty breathing. Current treatment options for the condition include management of the symptoms, and, it currently affects an approximate 75,000 people in North America, Europe and Australia.

CF is caused by a faulty or absent cystic fibrosis transmembrane conductance regulator (CFTR) protein, and in CF patients with the F508del mutation, the CFTR protein is not processed, or folded, normally within the cell and usually does not reach the cell surface.

If approved, the tezacaftor/ivacaftor combination treatment would become Vertexs third medicine to treat the underlying cause of cystic fibrosis, offering an important new treatment option for a large group of patients with this rare and life-shortening disease, said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex in a press release. We look forward to working with the agencies to facilitate a rapid review of these applications.

Tezacaftor is intended to address the processing defect of F508del-CFTR and permit the protein to reach the cell surface, while ivacaftor can further enhance the it's function.

If approved, the combination will be the third of Vertexs drugs approved for CF patients and the second specifically intended to treat patients with F508del mutations; Orkami (lumacaftor/ivacaftor) is also approved for patients with mutations.

The third drug, Kalydeco(ivacaftor), is approved to treat CF in patients age 2 years and older who have one of the following mutations in their CF gene:G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R,orR117H.

For more on FDA applications, designations and approvals, follow Rare Disease Report on Facebook and Twitter.

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New Combination Therapy for Cystic Fibrosis Being Reviewed by FDA and EMA - Rare Disease Report

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Adam Jones Becomes 1st Orioles CF Since 1924 with 4-for-4, 2-Homer Night – Bleacher Report

Posted: at 4:12 am

Baltimore Orioles veteran Adam Jones finished Tuesday's game against the Oakland Athletics 4-for-4 with two home runs, becoming the team's first center fielder since William "Baby Doll" Jacobson in 1924 to post that stat line, per ESPN Stats & Info.

Jones's two home runs were both solo shots, but he did score three runs on the night en route to the team's 7-3 victory. His four hits on the night also increased his batting average from .275 to .281 on the season.

The 32-year-old has been on a tear during August, batting .342/.378/.605 with five home runs and 12 RBI over 76 at-bats. His output assisted in a win that keeps the Orioles within striking distance of the Wild Card.

Despite Jones' recent surge, the Orioles own just a 10-10 record during August and a 2-4 record in their last six games. The club sits 3.5 games back of the Minnesota Twins for the second wild-card spot following Monday's results.

Although the five-time All-Star and four-time Gold Glove-winner began his career with the Seattle Mariners when he debuted in 2006, he joined the Orioles two short years later and has roamed center field for the club ever since.

Since joining the outfield in Baltimore, he hasn't played fewer than 119 games in a season and has hit at least .265 in every campaign. Jones has also collected at least 25 home runs in each of the last six seasons and needs just one more to reach the mark again in 2017.

Jones has one additional year remaining on his contract with the Orioles in 2018, but his future with the club remains uncertain beyond that. He will be 33 years old entering 2019, so he should have at least a couple years of effectivenessremaining when his current deal expires.

For now, Jones and his teammates will continue to focus on inching up the standings toward a Wild Card berth. The club returns to action for the second of a three-game set against the Oakland Athletics on Tuesday evening.

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Adam Jones Becomes 1st Orioles CF Since 1924 with 4-for-4, 2-Homer Night - Bleacher Report

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