|Intersect ENT Enrolls First Patient in Pivotal Study to Evaluate the NOVA Sinus Implant; Summit Therapeutics Receives FDA Fast Track Designation for SMT19969|
|By William Kent|
|Wednesday, 08 July 2015 19:55|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 8, 2015.
Intersect ENT, Inc. (NASDAQ: XENT), announced the enrollment of the first patient in the company's pivotal study of its latest bioabsorbable steroid releasing sinus implant, currently called NOVA. NOVA is designed to mechanically prop sinuses open while delivering anti-inflammatory medication following surgical interventions such as sinus surgery in the operating room or in-office sinus dilation. NOVA's unique hourglass shape and lower profile is designed to allow for placement in the smaller frontal and maxillary sinus openings, and may expand the applicable patient population for steroid releasing implants.
The NOVA study is a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess implant safety and efficacy. The company is conducting the NOVA trial as a second cohort of patients of the PROGRESS study.
The first cohort of the PROGRESS study was an 80-patient prospective, randomized blinded multi-center trial to assess the safety and efficacy of the PROPEL® mini drug eluting implant to improve outcomes following frontal sinus surgery and was designed to support an expanded indication for PROPEL mini, currently approved for use in the ethmoid sinus.
In addition to announcing the initiation of patient enrollment in the NOVA study, the company also announced that enrollment in the PROPEL mini cohort of the study has recently been completed.
"Clinical evidence to date has shown that PROPEL® and PROPEL mini meaningfully improve the outcomes of patients undergoing ethmoid sinus surgery. Patients with chronic sinusitis may benefit similarly from a steroid-releasing implant as part of treatment of the frontal sinus," said Tim Smith, M.D., M.P.H., F.A.C.S, of Oregon Health and Science University, who serves as the principal investigator of the study. "I am pleased to be involved with the clinical assessment of both PROPEL mini and NOVA and believe that each of these products has the potential to offer a differentiated solution in the continuum of care for patients with chronic sinusitis."
"We are excited to commence enrollment in our pivotal study of NOVA and to have completed enrollment in the PROPEL mini cohort of the PROGRESS trial," said Lisa Earnhardt, president and CEO of Intersect ENT. "Intersect ENT is committed to furthering clinical evidence that expands options for people suffering from sinusitis, a chronic condition that severely impacts quality of life."
Summit Therapeutics plc (AIM:SUMM) (NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), announces that the US Food and Drug Administration ('FDA') has granted Fast Track designation for the Company's novel antibiotic for the treatment of CDI. SMT19969 is a highly selective antibiotic candidate currently being evaluated in a Phase 2 proof of concept trial in CDI patients in North America.
"Fast Track designation recognizes the serious healthcare threat posed by C. difficile due to a high rate of disease recurrence, the key clinical issue in treating CDI, and underscores the importance of developing a candidate like SMT19969, which has significant potential to address both the initial infection and recurrence," said Glyn Edwards, Chief Executive Officer of Summit.
Fast Track designation is awarded to expedite the development and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. SMT19969 is also designated a Qualified Infectious Disease Product ('QIDP') under the Generating Antibiotic Incentives Now Act ('GAIN Act'), which allows Summit to benefit from a number of incentives supporting development of new antibiotics, and if SMT19969 receives marketing approval from FDA, a five year extension of market exclusivity.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today announced the effectiveness of a one-for-four reverse stock split of its common stock.
BioCorRx Inc. (OTCQB:BICX), developer of the Start Fresh Program ® used for the treatment of alcohol and opioid dependence, today announced that it has retained Maxim Group LLC, a leading investment banking, securities, and investment firm, to provide strategic corporate planning and investment banking services. Maxim will focus on assisting BioCorRx in its strategies for maximizing shareholder value through its full scope of investment banking services.
Carbylan Therapeutics (NASDAQ:CBYL), a specialty pharmaceutical company focused on the development of novel and proprietary combination therapies, today announced that Dr. Prem Ramiya has joined the Company as Vice President, Pharmaceutical Development & Supply Chain.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced the appointment of Alan List, MD as Chair of the Scientific Advisory Board.
Connecture, Inc. (NASDAQ:CNXR), a provider of web-based information systems used to create health insurance marketplaces, today announced that executives from the company will present the second webinar in a two-part series on the 2016 Medicare Annual Enrollment Period, or AEP. Part two of the series will occur on Thursday, July 9, 2015 at 12 p.m. CDT / 1:00 p.m. EDT.
General Cannabis Corp. (OTCQB:CANN), a service provider to businesses in the regulated cannabis industry, today announced that it has been selected by The Marijuana Index for inclusion in its MJIC US Reporting Index.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the launch of six of its spinal systems in Singapore and Hong Kong.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the pricing of the previously announced offering of shares of its common stock, which includes 750,000 shares offered by the Company and 3,750,000 shares offered by the selling stockholders named in the registration statement (the "selling stockholders"), at a price to the public of $22.60 per share.
Lexmark (NYSE:LXK) announced today that it has received 510(k) Class II clearance from the U.S. Food and Drug Administration (FDA) for Lexmark NilRead, a web-based, zero-footprint enterprise diagnostic viewer.
MedAssets, Inc. (NASDAQ:MDAS) today announced that it plans to release its financial results for the second quarter and six-month period ended June 30, 2015 after 4:00 p.m. ET on Wednesday, July 29, 2015.
MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that the company will release the results for its second quarter ended June 30, 2015 before the market opens on Wednesday, August 12, 2015.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Alessandra Cesano, M.D., Ph.D. has been named Chief Medical Officer, effective July 6, 2015.
Natus Medical Incorporated (Nasdaq:BABY) today announced that the Company will release its 2015 second quarter financial results before the market opens on Wednesday, July 22nd. Natus management will host an investment-community conference call the same day beginning at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time) to discuss those results and to answer questions.
NewLink Genetics Corporation (NASDAQ:NLNK) today announced that it will provide a company update at its 2015 Investor Day on Tuesday, July 14 beginning at noon ET at the St. Regis in New York City.
Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the appointment of James J. Marino J.D., MBA, to its Board of Directors.
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading shock wave technology company, today announced that the Company will have poster presentations and a laboratory demonstration of its patented shock wave technology at the Center for Biofilm Engineering's 2015 Biofilm Science and Technology Meeting held at Montana State University in Bozeman, Montana on July 13-16, 2015.
Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that the first procedure with its Niobe® ES magnetic navigation system has been performed in Japan.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, announced that it has received an equity investment of $8 million from Arise Asset Management Private Limited (Arise).
Vocera Communications, Inc. (NYSE:VCRA), a mobile healthcare communications company, today announced that Stillwater Medical Center improved care team collaboration and patient experience by integrating the Vocera® Communication System with the hospital's computerized physician order entry (CPOE) system.