News Article | May 10, 2017
Revenue for the third quarter of fiscal 2017 was , a 7% increase compared to revenue for the third quarter of fiscal 2016 and a 24% increase from reported in the second quarter of fiscal 2017. The increase in revenue is primarily due to improving results from the investments in sales personnel and implementation of a more aggressive sales and marketing strategy made earlier in the fiscal year. Prostate brachytherapy represented 89% of total revenue for the third quarter of fiscal 2017 compared to 82% in the third quarter of fiscal 2016 and 86% in the second quarter of fiscal 2017. Gross Profit was compared to in the same period last year and a gross loss in the second quarter of fiscal 2017. Gross Profit Margin was 23% in the third quarter compared to 6% in the third quarter of fiscal 2016. Gross Profit was positively impacted by process and manufacturing cost reductions and the leveraging of the increased revenue from improved sales. The 23% Gross Profit Margin for the third quarter is a 337% gain from the third quarter fiscal 2016. Total operating expenses were $1.68 million in the third quarter of fiscal 2017, a 21% increase compared to $1.39 million recorded in the third quarter of fiscal 2016. Increases in research and development and sales and marketing expenses of 79% and 76% respectively, were partially offset by a 9% decrease in general and administrative (G&A) expenses. The G&A decrease is primarily due to lower legal fees as well as the absence of other one-time personnel related expenses recorded in the year ago period. Operating loss was $1.39 million, a slight increase from the operating loss of $1.33 million for the third quarter of fiscal 2016. The net loss was $1.36 million, or $(0.02) per basic and diluted share, compared to a net loss of $1.20 million, or $(0.02), per basic and diluted share, for the same period of fiscal 2016. Basic and diluted per share results are based on weighted average shares outstanding of approximately 55.0 million shares in both periods. IsoRay had cash, cash equivalents and certificates of deposit of $10.4 million as of March 31, 2017, and no debt. "IsoRay's sales improved in the third quarter with revenue increasing 7% from the same period last year and 24% from the previous quarter. The revenue increase was driven by the more aggressive sales and marketing strategy we introduced earlier in the fiscal year that positions IsoRay and Cesium-131 as a leader in brachytherapy for prostate cancer treatment. This turnaround also underscores the quality of our recently expanded sales force, which is comprised of highly experienced brachytherapy sales people, most of whom are new to IsoRay. Combined with our renewed commitment to the prostate brachytherapy community, our message is gaining traction as our client roster has expanded with both new and returning accounts," said Thomas LaVoy, Chairman and CEO. "Our results also benefited from the cost reductions and production and process improvements that we've put in place over the last year. These actions, in concert with the quarterly revenue increase, led to an expansion of the Gross Profit Margin to 23%, a significant increase over prior periods. We've strategically reallocated the funds we've freed up from operating more efficiently throughout our organization into revenue producing areas such as sales and marketing and research and development, and we believe that it is these substantial investments which have led to the improved results in the third quarter." "We continue to have an ongoing commitment in the development of the GammaTile, a novel system that is a combination of Cesium-131 seeds embedded into collagen tiles, developed and owned by GammaTile LLC, that delivers brain brachytherapy treatment at the time of surgery. GammaTile LLC collaborates with the Barrows Neurological Institute, one of the largest neurological disease treatment and research institutions and consistently ranked as one of the best neurosurgical training centers in U.S. Over 80 patients have been treated in clinical trials with GammaTile to date and results point to an extension of the median time to recurrence and a very low rate of side effects. We submitted an application for 510(k) clearance in March, 2017 related to embedding our Cesium-131 seeds into collagen tiles and look forward to the FDA's decision in the coming months. Other R&D investments include updates to loading and other placement devices for prostate applications," continued Mr. LaVoy. "We were pleased that the study entitled "Long-term Quality of Life in Prostate Cancer Patients Treated with Cesium-131" was accepted for publication in the highly respected International Journal of Radiation Oncology, Biology, Physics (the "Red Journal"). The study was conducted by a respected team of doctors from the departments of Radiation Oncology and Urology at the University of Pittsburgh Medical Center (UPMC) that we have worked closely with. The aim of the study was to evaluate the long-term quality of life (QOL) as reported by men treated at UPMC with Cesium-131 prostate brachytherapy. The report concluded that patients treated with Cesium-131 are able to recover from prostate cancer treatment quickly and then maintain their baseline quality of life over the long term. These results, combined with results from other recent studies that support triple therapy - external beam radiation, brachytherapy and hormone therapy – have begun to drive increasing growth in multiple prostate patient segments such as targeted and salvage treatments and higher risk patients." "Looking ahead, we're encouraged by the third quarter results. We believe that IsoRay's renewed commitment and messaging is resonating with the brachytherapy community. We're also continuing to invest in sales and marketing activities and the automation of our production processes which are expected to continue to lower our cost of production in the months ahead. As such, if revenue levels continue to increase, and costs stabilize or move lower, as we experienced this quarter, our financial results are expected to benefit from increasing operating leverage in the fourth quarter and next fiscal year. We remain on track for a combined third and fourth quarter revenue increase of approximately 20% over last year's second half revenue," concluded Mr. LaVoy. For the first nine months of fiscal 2017 ended March 31, 2017, revenue was $3.39 million, a 7% decrease compared to revenue of $3.65 million for the same period of fiscal 2016. Prostate brachytherapy represented 88% of total revenue for the first nine months of fiscal 2017 and 86% of total revenue in fiscal 2016. Operating expenses were $4.78 million, a 19% increase compared to $4.00 million for the nine months ended March 31, 2016. Operating loss was $4.44 million for the nine months ended March 31, 2017, compared to a $3.83 million operating loss for the comparable period of fiscal 2016. The net loss for the nine month period was $4.31 million, or $(0.08) per basic and diluted share, compared to a net loss of $3.54 million, or $(0.06), per basic and diluted share, for the nine month period of fiscal 2016. Basic and diluted per share results are based on weighted average shares outstanding of approximately 55.0 million shares in both periods. About IsoRay, Inc. IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook/IsoRay. Follow us on Twitter @IsoRay. Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether the new marketing strategy will increase sales, whether the changes to the sales staff will result in increased sales, whether the additional resources being added to IsoRay's online presence will increase patient or clinician engagement and interest, whether use of Cesium-131 in non-prostate applications will increase revenue, whether we obtain and the timing of obtaining our application for 510(k) clearance, our ongoing relationship with GammaTile LLC, whether further automation of production processes will be completed or will result in lower costs, whether revenue will increase and costs decrease in the upcoming quarters, the perception by patients of quality of life outcomes, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient quality of life results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases whether or not used in conjunction with other treatments, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, the procedures and regulatory requirements mandated by the FDA for 510(k) approval and agreements we ultimately negotiate with third parties related to distribution of GammaTile products, changes in laws and regulations applicable to our products, the scheduling of physicians who either delay or do not schedule patients in the six month period that an increase is anticipated, the use of competitors' products in lieu of our products over the six month period we expect an increase, less favorable reimbursement rates during the six month period we expect an increase, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/isoray-announces-third-quarter-fiscal-2017-financial-results-300454868.html
News Article | April 25, 2017
Dr. Spivak now participates with Horizon NJ Health Network/ Total Care (HMO SNP) Plans, ExecutiveSpineSurgery.com reports Hackettstown, NJ - April 25, 2017 /MarketersMedia/ — Dr. Carl Spivak, a Back Surgeon in NJ, proudly announces he has joined Horizon NJ TotalCare (HMO SNP). Doing so allows Dr. Spivak to treat more patients and provide them with the help they need to live the highest quality of life achievable. He specializes in minimally invasive endoscopic spine surgery and is one of a few neurosurgeons in the state experienced in both this technique and interventional pain management. As a result, he brings a unique perspective to each case, one that helps him determine the optimal treatment for the individual patient. "Endoscopic spine surgery offers numerous benefits over traditional back surgery. First and foremost, patients find their recovery time is minimized and they experience less pain following the procedure. Numerous factors play a role in this, but patients may find they are able to return home the same day. The extent of the surgery and the patient's overall health are two factors, and some patients find they can return to work in only a matter of weeks. Others may need a few months of restricted activity before they are fully back on their feet," Dr. Spivak explains. Dr. Spivak undertook specialized fellowship training at Stanford University in the areas of complex spine and peripheral nerve surgery. In addition, he completed a specialized fellowship at Semmes-Murphey Spine and Neurological Institute in minimally invasive spine surgery and interventional pain management. Today, he offers the interventional and surgical expertise patients need when dealing with a disease that affects the spine and nerves. "Patients want minimal downtime and the fewest complications possible. Any surgery does come with risks, yet these risks can be reduced. When a person opts for endoscopic spine surgery, the risk of infection is minimized. This is due to the small area to be operated on and the reduced incision size. Other complications are likewise minimized, due to less tissue and muscle being affected by the procedure," Dr. Spivak continues. Endoscopic surgery also reduces scarring on account of the small incision. In fact, in many cases, the incision is no bigger than a dime in terms of size. Patients find they no longer must deal with large scars to obtain the relief they need, and this is only one of the many options available today. "Visit Laser Spine Surgery New Jersey to learn more. From spinal injections to endoscopic surgery, this is a treatment for everyone dealing with back pain. Contact us today to schedule your appointment, and we'll be happy to help you determine which option is right for you," Dr. Spivak announces. About Executive Spine Surgery: Executive Spine Surgery takes a multidisciplinary approach to spinal disorders combining the best of conservative and operative treatments. The practice offers a full range of surgical treatments and every effort is made to provide clients with the least invasive, cutting-edge surgical techniques. Contact Info:Name: Dr. Carl SpivakOrganization: EXECUTIVE SPINE SURGERYAddress: 657 Willow Grove St Ste 402 Hackettstown, NJ 07840Phone: 800-494-6914Source URL: http://marketersmedia.com/executive-spine-surgery-announces-dr-carl-spivak-joins-new-health-plans/190056For more information, please visit http://directory.horizonnjhealth.com/physicians/profile/0/spivak-carl-j-mdSource: MarketersMediaRelease ID: 190056
News Article | October 26, 2016
You probably know someone who has it. It is the most common movement disorder, yet most people don't even know its name. Essential tremor affects nearly one per cent of the world's population, increasing to four per cent of those over 40. The involuntary shaking of hands is the most common symptom, but symptoms can also include shaking of the head and legs. Often misdiagnosed as Parkinson's disease, essential tremor has less severe health impacts, but does get worse over time and can have debilitating consequences. Essential tremor has a large genetic component; it is common to have large families with several members affected. Until recently, however, the genetic mechanism behind the disease remained unknown. Researchers at the Montreal Neurological Institute and Hospital of McGill University and Kiel University in Germany have led a large international collaborative study that sheds new light on the genetics behind essential tremor, in a paper published in Brain Journal on Oct. 21, 2016. It is the largest study on essential tremor to date. Studying a group of 2,809 patients, the researchers found a strong correlation between essential tremor and a gene known as STK32B. They also found two other genes correlated to a lesser extent with the disease. Now they plan to test even more patients to understand how these genes may contribute to the development of the disease and find other predisposing genes. "We have the first clue now, but we want to expand on that because we still have much to learn" says Simon Girard, now a professor at the Université du Quebec à Chicoutimi and the paper's lead author. Ideally to follow up this study the team needs to recruit 10,000 additional essential tremor sufferers. These new subjects would be studied to identify new genes that predispose individuals to essential tremor. Once there is a more complete understanding of the genetic basis of essential tremor, scientists will be in a position to better understand the roles these genes play in the disease, and devise better diagnostic tools and treatments. Girard says recruiting the large number of patients needed will be a challenge, in part because many sufferers do not seek medical care. "Essential tremor is the most common movement disorder, but many sufferers don't seek medical help," he says. "People suffer from the tremor, but they tend to make do as best they can. Some people have had a tremor for 10-20 years or more. They know they have a tremor and they live with it." Anyone who would like to participate in the study should contact research coordinator Vessela Zaharieva at firstname.lastname@example.org. If they are found to be eligible, they will be contacted via telephone to answer more questions and invited to participate in the study if they wish. "People suffering from essential tremor have a chance to help us better understand this complex disease," says Guy Rouleau, director of the MNI and the study's senior author. "The findings will improve the chances of developing drugs to lessen or halt the symptoms, a benefit not only to today's sufferers but those of the future." This study was made possible with funds from Canadian Institutes for Health Research, Canada Research Chair in Genetics of the Nervous System, and Deutsche Forschungsgemeinschaft. The Montreal Neurological Institute and Hospital - The Neuro - is a world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the world's top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre.
News Article | February 15, 2017
NEWTOWN, PENNSYLVANIA--(Marketwired - Feb. 9, 2017) - Helius Medical Technologies, Inc. (TSX:HSM)(TSX:HSM.S)(OTCQB:HSDT) ("Helius") is pleased to announce that the clinical results from its Multiple Sclerosis (MS)-Pilot Study, performed at the Montreal Neurological Institute, were published in the peer reviewed journal Multiple Sclerosis Journal: Experimental, Translational and Clinical, January-March 2017:p1-9. The publication, "Non-invasive tongue stimulation combined with intense cognitive and physical rehabilitation induces neuroplastic changes in patients with multiple sclerosis: a multimodal neuroimaging study," can be accessed online at http://journals.sagepub.com/doi/pdf/10.1177/2055217317690561. "We would like to thank Drs. Leonard, Ptito and their team at the Montreal Neurological Institute for their work on this important study and congratulate them on this peer reviewed publication," said Dr. Jonathan Sackier, Helius' Chief Medical Officer. "Understanding the additional, positive effects we are seeing with the investigational PoNS™ therapy compared to physiotherapy alone, is core to our clinical development. This publication should prove insightful to two key care givers, the physician and the therapist." The Portable Neuromodulation Stimulator (PoNS™) is an investigational non-invasive device designed to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the device with physical therapy and is currently being evaluated in a multicenter clinical trial for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury. Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain's ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com. The Montreal Neurological Institute and Hospital - ("The Neuro") is a world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the world's top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre. The Toronto Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release. Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws ("forward-looking statements"). All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, statements regarding ongoing or planned clinical research, expected future development timelines, regulatory approvals, business initiatives and objectives and use of proceeds from financings or other business initiatives. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the failure of the Company to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators. The reader is cautioned that assumptions used in the preparation of any forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking statement. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Risks and uncertainties about the Company's business are more fully discussed in the Company's disclosure materials, including the short form prospectus filed in connection with the Offering, its Annual Report on Form 10-K filed with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
News Article | October 31, 2016
Scientists have identified a gene in the French-Canadian population that predisposes them to the development of intracranial aneurysm (IA), a potentially life threatening neurological condition that is responsible for approximately 500,000 deaths worldwide per year, half of which occur in people less than 50 years of age. Using genetic analysis, the team of researchers found rare variations of one gene, RNF213, that appeared more frequently in IA patients than in the control group. Both patients and the control group came from French-Canadian families. Their study was published in the American Journal of Human Genetics on Oct. 13. Scientists already knew that IA is inheritable, and a 1996 study found that 29.8 per cent of French-Canadian IA patients had a family member who also had IA, a higher percentage than the general population. This suggests the genetic link to IA in French-Canadians is stronger than average. The gene or genes responsible for this increased inheritability, however, remained a mystery. The team of researchers, including 13 from the Montreal Neurological Institute and Hospital, used exome sequencing to identify RNF213 as suspicious in a patient group of 26 people from six families who experienced IA. They then re-sequenced RNF213 in a larger control group of 189 people, and found 14 variants of the gene, unique to the French-Canadian patient group, at least two of which have functions that could increase risk of IA. Intracranial aneurysm is a dilation or ballooning of a blood vessel in the brain caused by a weakness in the arterial wall. The RNF213 variants may play a role in the development of weak arterial walls by affecting the delivery of energy in these cells. Ten per cent of the patient group had at least one of the rare and potentially damaging RNF213 variations, a higher percentage than the control group by a statistically significant margin. This suggests that while RNF213 is not the only factor playing a role in IA, it does increase the risk. Interestingly, RNF213 has also been found to be associated with moya moya disease (MMD), a condition where blood vessels in the brain are constricted, leading to the formation of abnormal vessels to compensate for the blockage. MMD is almost exclusively found in the East Asian population. This study and the prior association of RNF213 to MMD supports the theory that the gene plays a role in blood vessel development, but links to different cerebrovascular diseases in different populations. The worldwide prevalence of IA is one-to-three percent, and this condition entails severe consequences, particularly when the aneurysm bursts, which is known as a subarachnoid hemorrhage. When this occurs, 30 to 45 per cent of patients die within 30 days. While other health factors like smoking and hypertension are known to increase risk, researchers continue to search for genes that predispose people to IA. "By identifying RNF213 as gene associated with intracranial aneurysm, we help provide a better understanding of its genetic origins," says Sirui Zhou, a PhD candidate at the Montreal Neurological Institute and the University of Montreal. "Now researchers can focus on discovering the mechanism through which RNF213 affects the development of blood vessels." This research was funded by the Canadian Institutes of Health Research and The Canadian Heart and Stroke Foundation. The Montreal Neurological Institute and Hospital - The Neuro - is a world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the world's top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre. For more information, please visit http://www.
News Article | November 1, 2016
October 31, 2016--New research at Columbia University's Mailman School of Public Health reveals that foods like fruits and vegetables that are high in antioxidant nutrients and carotenoids are associated with better function in amyotrophic lateral sclerosis (ALS) patients around the time of diagnosis. This is among the first studies to evaluate diet in association with ALS function and the first to show that healthy nutrients and antioxidants are associated with better ALS functioning. The findings are published online in JAMA Neurology. ALS, also known as Lou Gehrig's Disease, is a severe neurodegenerative disorder that causes atrophy, paralysis, and eventually respiratory failure. Median survival for ALS patients ranges from 20 to 48 months, although 10 percent to 20 percent of patients can live longer than 10 years. Jeri W. Nieves, PhD, associate professor of Epidemiology, and co-authors examined the links between nutritional intake and severity of ALS for patients who had ALS symptoms for 18 months or less. The study, which relied on nutrient intake reported using a food questionnaire, followed 302 participants recruited at 16 clinical centers throughout the U.S. The researchers used a validated measure of ALS severity and respiratory function. "It appears that nutrition plays a role both in triggering the disease and why it progresses," said Dr. Nieves. "For this reason, ALS patients should eat foods high in antioxidants and carotenes, as well as high fiber grains, fish, and poultry." The researchers also found that milk and lunch meats were associated with lower measures of function, or more severe disease. Two different statistical analyses by Dr. Nieves both indicate that diet may help minimize the severity of ALS and point to the role of oxidative stress in ALS severity. "The foods and nutrients that may help reduce the severity of ALS are very similar to the recommendation to prevent many other chronic diseases," noted Dr. Nieves. "Our cross-sectional study relied on a food questionnaire and those may not always represent a true daily diet," cautioned Dr. Nieves. "However, those responsible for nutritional care of the patient with ALS should consider promoting fruits and vegetables since they are high in antioxidants and carotenes. Future studies will look at follow-up-data on both dietary intake and progression of ALS." Co-authors are Pam Factor-Litvak of Columbia University's Mailman School of Public Health; Jonathan Hupf, Jessica Singleton, Valerie Sharf, and Hiroshi Mitsumoto, all of the Department of Neurology, Columbia University; Chris Gennings, Icahn School of Medicine at Mount Sinai; Bjorn Oskarsson, University of California-Davis, Sacramento; Fernandes Filho, University of Nebraska Medical Center; Eric J. Sorenson, Mayo Clinic; Emanuele D'Amico, Neurological Institute, Catania, Italy; and Ray Goetz, Department of Psychiatry, New York State Psychiatric Institute. The study was supported by the National Institute of Environmental Health Sciences, National Institutes of Health (Grant R01ES016348). The paper has additional funding sources and also non-conflict of interest statements. Founded in 1922, Columbia University's Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting New Yorkers, the nation and the world. The Mailman School is the third largest recipient of NIH grants among schools of public health. Its over 450 multi-disciplinary faculty members work in more than 100 countries around the world, addressing such issues as preventing infectious and chronic diseases, environmental health, maternal and child health, health policy, climate change & health, and public health preparedness. It is a leader in public health education with over 1,300 graduate students from more than 40 nations pursuing a variety of master's and doctoral degree programs. The Mailman School is also home to numerous world-renowned research centers including ICAP (formerly the International Center for AIDS Care and Treatment Programs) and the Center for Infection and Immunity. For more information, please visit http://www. .
News Article | December 2, 2016
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced one oral presentation and two poster presentations at the 27th International Symposium on ALS/MND in Dublin, Ireland. The posters will be presented on Wednesday, December 7, 2016, and will include the results of an international physician survey on the use of noninvasive ventilation in the treatment of ALS, and data on a machine learning model for the prediction of slow vital capacity, based on datasets from BENEFIT-ALS that Origent Data Sciences analyzed under a research collaboration with Cytokinetics that is funded by The ALS Association. On Friday, December 9, 2016, the baseline characteristics of patients enrolled in VITALITY-ALS will be presented in an oral presentation. Date: Wednesday, December 7, 2016 Location: The Forum, The Convention Centre Dublin Session: Poster Session A Presentation Time: 5:45 – 7:30 PM Poster Moderated: 6:00 – 6:20 PM Poster Number: P203 Theme: 7 - Improving Diagnosis and Prognosis Title: Machine Learning Model For The Prediction Of Slow Vital Capacity Poster Presenters: David L. Ennist, Ph.D., MBA, Chief Science Officer, Origent Data Sciences and Jinsy A. Andrews, M.D., Director of Neuromuscular Clinical Trials at Columbia University in New York City Date: Wednesday, December 7, 2016 Location: The Forum, The Convention Centre Dublin Session: Poster Session A Presentation Time: 5:45 – 7:30 PM Poster Moderated: 7:00 – 7:20 PM Poster Number: CW3 Theme: CW - Clinical Work in Progress Title: Understanding the use of noninvasive ventilation in the treatment of amyotrophic lateral sclerosis: results of an international physician survey Poster Presenter: Terry Heiman-Patterson, M.D., Drexel Neurological Institute, Philadelphia Date: Friday, December 9, 2016 Location: The Liffey B, The Convention Centre Dublin Session: 9B – Clinical Trials Presentation Time: 9:30 – 9:45 AM Title: VITALITY-ALS, a Phase 3 trial of the fast skeletal muscle troponin activator, Tirasemtiv, for the potential treatment of ALS: Study design and baseline characteristics Presenter: Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of VITALITY-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle troponin activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv, subject to an option held by Astellas Pharma Inc. Cytokinetics is also collaborating with Astellas to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy, chronic obstructive pulmonary disease and ALS. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics' specified development and commercialization participation rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the conduct, design, enrollment, progress and timing of results of the VITALITY-ALS Phase 3 clinical trial of tirasemtiv in patients with ALS; the significance and utility of preclinical study and clinical trial results; and the properties and potential efficacy and safety profile of tirasemtiv and Cytokinetics' other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, further clinical development of tirasemtiv in ALS patients will require significant additional funding, and Cytokinetics may be unable to obtain such additional funding on acceptable terms, if at all; the FDA and/or other regulatory authorities may not accept effects on slow vital capacity as a clinical endpoint to support registration of tirasemtiv for the treatment of ALS; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trial results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy, the FDA or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
News Article | October 28, 2016
DARIEN, IL - A new study shows that positive airway pressure (PAP) therapy for sleep apnea may have a positive impact on sleep-related functional outcomes among patients who also suffer from hypertension. The findings suggest that untreated sleep apnea may explain the quality of life impairments reported by many patients with high blood pressure. Results show consistent improvement of patient-reported outcomes in response to PAP therapy for sleep apnea in hypertensive patients. The study found significant improvement in daytime sleepiness, depressive symptoms and fatigue severity within a year following treatment initiation. Results were significant even in patients with resistant hypertension. "We found that consistently and notably there was no difference in patient-reported outcomes between resistant hypertension and non-resistant hypertension groups," said lead author Harneet Walia, MD, assistant professor of family medicine in the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. "What we found was that the improvement in the patient-reported outcomes was more pronounced in those with objective adherence to PAP therapy." Study results are published in the Oct. 15 issue of the Journal of Clinical Sleep Medicine. According to the American Academy of Sleep Medicine, 30 to 40 percent of patients with hypertension also suffer from obstructive sleep apnea, which is a sleep-related breathing disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. Adhering to sleep apnea treatment is a proven means of decreasing blood pressure and improving overall health. The single-center, observational study involved nearly 900 patients with sleep apnea and hypertension, of which 15 percent had resistant hypertension. Their mean age was 58 years, 52 percent were male, and 72 percent were Caucasian. They were being treated with PAP therapy through the Cleveland Clinic Sleep Disorders Center. Questionnaire-based patient reported outcomes were evaluated using the Epworth Sleepiness Scale, Patient Health Questionnaire-9 (depression), and Fatigue Severity Scale. The authors report that to their knowledge no previous study has examined changes in sleep-related functional outcomes with PAP therapy in a cohort comprising patients with hypertension, including some with resistant hypertension. The study was funded by grants from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), and by a Scholar Award from the Center for Outcomes Research and Evaluation at the Cleveland Clinic Neurological Institute. To request a copy of the study, "Impact of Sleep-Disordered Breathing Treatment on Patient Reported Outcomes in a Clinic-Based Cohort of Hypertensive Patients," or to arrange an interview with the study author or an AASM spokesperson, please contact Senior Communications Coordinator Amy Pyle at 630-737-9700, ext. 9366, or email@example.com The monthly, peer-reviewed Journal of Clinical Sleep Medicine is the official publication of the American Academy of Sleep Medicine, a professional membership society that improves sleep health and promotes high quality, patient-centered care through advocacy, education, strategic research, and practice standards (http://www. ). More information about sleep, and a searchable directory of AASM-accredited sleep centers, is available at http://www. .
News Article | November 3, 2016
RALEIGH, N.C., Nov. 2, 2016 /PRNewswire/ -- Raleigh-based Wake Research (Wake Research Associates, LLC) announces a partnership with Western Neurosurgery, Ltd., an affiliated partner of Carondelet Neurological Institute, headquartered in Tucson, Arizona. Tucson Neuroscience Research brings...