Cynosure Receives FDA 510(k) Clearance for SculpSure; BlueBird Bio Drug Up For Accelerated OK In U.S., Europe Print E-mail
By Josh Gee   
Tuesday, 19 May 2015 20:16
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 19 2015.
 
Cynosure, Inc.  (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SculpSure™, the world's first hyperthermic laser treatment for non-invasive lipolysis of the flanks. Cynosure plans to introduce SculpSure through its U.S. direct sales force late in the second half of 2015.
Utilizing patented technology, SculpSure is a clinically proven and safe treatment designed to reduce fat non-invasively by disrupting subcutaneous fat cells. The versatile, hands-free device features a flexible applicator system to treat multiple anatomical areas of the body. SculpSure, which uses a 1060 nm laser, can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery.
"SculpSure represents an entirely new approach to non-invasive lipolysis, one that is safe and highly effective in reducing adipose tissue and does so in significantly less time than other current treatments," said Cynosure Chairman and CEO Michael Davin. "We believe that the combination of these benefits enables us to offer practitioners the lowest total cost of ownership of any non-invasive lipolysis treatment on the market today, which in turn significantly enhances their return on investment."
Abstracts presented at the 2015 American Society for Laser Medicine and Surgery Annual Conference featured clinical data from approximately 100 subjects treated with SculpSure in multicenter studies at two U.S. sites. Researchers saw statistically significant reduction in adipose layer thickness, six and 12 weeks post-treatment. SculpSure is intended for individuals with a body mass index (BMI) of 30 or less. According to the World Health Organization, in 2014 approximately 1.3 billion adults 18 years and older worldwide were overweight.
"While SculpSure is our first non-invasive lipolysis treatment, the device leverages the expertise we have gained through the successful development and commercial launch of products including SmartLipo™ and Cellulaze™," Davin said. "It is a customer base and a treatment area we know extremely well. This clearance marks an important step in a broader marketing strategy that includes expanded treatment indications and new geographic markets. Currently, for example, we are pursuing FDA 510(k) clearance of SculpSure for non-invasive lipolysis of the abdomen, one of a number of potential catalysts we believe will help drive adoption of this technology."
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Bluebird Bio Inc.  (NASDAQ: BLUE) fluttered up Tuesday on news that approvals for its LentiGlobin for treating a rare blood disorder might get accelerated.
The company said it reached agreement with U.S. regulators on two 24-month clinical trials that, together with current studies, could form the basis of approval for LentiGlobin as a treatment for beta-thalassemia major, a rare and potentially fatal drug disorder.
Beta-thalassemia affects about 15,000 patients in the U.S., but LentiGlobin is also under separate study as a treatment for sickle cell disease, which affects up to about 100,000 Americans.
In addition, a pilot program of the European Medical Agency may allow conditional approval of the drug as a beta-thalassemia treatment on the basis of results from current studies, the company said.
Protocol for one of the pending U.S. studies is slated for review by regulators June 9. Protocol for the second study doesn't require review or discussion, under a decision by a committee of the National Institutes of Health, Bluebird said.
"These discussions have resulted in general agreement from both agencies regarding bluebird bio's development plans, which could potentially result in accelerated approvals," David Davidson, Bluebird's chief medical officer said in a statement Tuesday.
LentiGlobin obtained "breakthrough" designation from the Food and Drug Administration in February.  The drug treatment entails inserting a functional human blood-related gene into the patient's own stem cells and then transplanting those modified cells into the patient through the bloodstream.
Bluebird, which held a conference call with investors about the news earlier, traded recently at $169.02, up $12.62.
  
Also Tuesday: 
 
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a non-exclusive research and clinical trial collaboration agreement with Sorrento Therapeutics, Inc. (Nasdaq:SRNE) to evaluate combinations of Advaxis's Lm-LLO cancer immunotherapy technology platform, including ADXS-HPV, ADXS-PSA and ADXS-HER2, with Sorrento's fully human antibodies targeting immune checkpoints, including GITR, OX40, LAG-3 and TIM-3. 
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that it will be presenting at two upcoming investor conferences.
Assembly Biosciences, Inc. (Nasdaq:ASMB) today announced that Adam Zlotnick, PhD, Assembly's Chief Scientific Advisor and Chair of its HBV & Virology Science Advisory Board, discussed the science underlying the company's Core Protein Allosteric Modifiers (CpAMs) at the Second ANRS HBV Cure Workshop sponsored by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS). 
AXIM Biotechnologies, Inc. (OTC:AXIM), a leader in industrial hemp biosciences, is proud to announce the launch of its new website at www.AXIMbiotech.com. 
BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, today announced financial results for the first quarter ended March 31, 2015.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, is presenting results from its Phase 3 clinical trial demonstrating the statistical non-inferiority of oral solithromycin versus oral moxifloxacin for the treatment of community acquired bacterial pneumonia (CABP). 
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the Company has appointed Julian Gangolli as President, North America and is also relocating its Chief Executive Officer, Justin Gover, to the United States.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) today announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. 
KemPharm, Inc. (Nasdaq:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity ("NME") prodrugs, announced today that its Executive Vice President of Research and Development, Sven Guenther, Ph.D., will present a review of the current status of scientific research in the field of pain therapeutics including a case study on the development of the Company's novel pain drug candidate, KP201/APAP, at the Abuse Deterrent Formulations Summit being held May 19-20, 2015, in Washington, DC.
LifeVantage Corporation (Nasdaq:LFVN), has announced the launch of the LifeVantage Sport Science Lab at Real Salt Lake.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAA), today announced that the first procedures were successfully performed in Japan using the Company's unique Aorfix™ Endovascular Stent Graft with the new AorFlex™ Delivery system. 
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the pricing of its underwritten public offering of 7,250,000 shares of its common stock at the public offering price of $19.00 per share. 
Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced that it, along with its marketing partner BLDG Health, won Gold in the Hermes Creative Awards 2015 competition presented by the Association of Marketing and Communication Professionals (AMCP) for its Aurix™ Patient Brochure. 
OraSure Technologies, Inc. (Nasdaq:OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced its support of numerous rapid hepatitis C (HCV) testing events for National Hepatitis Testing Day, taking place on May 19, 2015. 
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced it will conduct a conference on Monday, May 25, 2015 at 8:30 AM, at the Tel Aviv Stock Exchange's conference center. 
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today reported financial results for its fourth quarter and fiscal year ended March 31, 2015.
Transcat, Inc. (Nasdaq:TRNS), a leading provider of accredited calibration and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, today reported financial results for its fourth quarter and fiscal year ended March 28, 2015. Included in the reported results are those of Ulrich Metrology Inc., acquired on August 31, 2014, and Apex Metrology Solutions, acquired on March 6, 2015.
Vapir Enterprises, Inc. (OTCQB:VAPI), a developer and manufacturer of revolutionary, state-of-the-art, and user friendly medical-grade vaporization devices, successfully completed a $500,000 capital raise in preparation for the pending retail launch of its state-of-the-art, ultra-portable Prima Vaporizer.



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