|FDA Approves the Medtronic's VenaSeal Closure System; Cytori Receives Positive European Opinion on Orphan Drug Status|
|By Marilyn Mullen|
|Tuesday, 24 February 2015 19:58|
Medtronic plc (NYSE: MTD) announced U.S. Food and Drug Administration approval for VenaSeal(TM) closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such as the great saphenous vein in patients with symptomatic venous reflux.
Venous reflux disease, also known as chronic venous insufficiency, occurs when valves in the veins of the lower leg no longer function properly. This allows blood to flow backward, or reflux, resulting in enlarged, or varicose veins as well as other symptoms. If left untreated, the condition can progress and, in severe cases, can result in lifestyle-limiting lower leg pain, swelling, skin damage and ulcerations.1
The VenaSeal procedure is the only non-tumescent, non-thermal, non-sclerosant procedure approved for use in the U.S. that uses a specially formulated medical adhesive that closes the vein. This unique approach may eliminate the risk of nerve injury that is sometimes associated with certain thermal-based procedures.2 The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks.2,3 Patients also report minimal-to-no bruising post procedure. 4
"The VenaSeal system is an advanced varicose vein procedure that delivers results that are comparable to current methods," said Dr. Nick Morrison, national principal investigator of the VeClose Trial, Morrison Vein Institute, Scottsdale, Ariz. "As the patient does not require multiple injections of a local anesthetic (tumescent anesthesia), there is minimal to no bruising and patients are often able to quickly return to normal activities."
The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials. Closure rates in the first in human trial were 92 percent at 12 and 24 months, respectively.3,5 Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study published in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 92.9 percent and improvement in quality of life scores at 12 months.2 Additionally, the three month results of the VeClose pivotal study published in the Journal of Vascular Surgery in January continue to demonstrate safety and efficacy of the VenaSeal procedure with excellent closure rates of 98.9 percent.4
"The FDA approval of the VenaSeal system strengthens our endoVenous portfolio, providing physicians and their patients with a non-tumescent treatment option," said Sandra Lesenfants, vice president and general manager of the endoVenous franchise in Medtronic`s Aortic and Peripheral Vascular business. "The VenaSeal System, together with our Venefit(TM) procedure, provides physicians and patients with leading treatment options."
The VenaSeal system is currently approved in the U.S., Australia, Canada, Europe and Hong Kong, and more than 2,000 patients have been treated with the system. U. S. launch of the VenaSeal system is expected this spring.
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) issued a positive opinion toward Cytori's application for an orphan drug designation for the new Scleroderma therapeutic ECCS-50, which contains adipose tissue-derived stromal vascular fraction cells derived from Cytori's proprietary Celution® System.
Cytori has also recently received FDA approval to study the same therapeutic, ECCS-50, in an 80 patient Phase 3 pivotal study for Scleroderma associated hand dysfunction. This trial is currently planned to begin enrolling this year in approximately 12 U.S. sites.
"The COMP's supportive opinion is first and foremost a key step toward receiving orphan designation in the European Union for Cytori Cell Therapy® in Scleroderma associated hand dysfunction," said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics, "In the bigger picture, this opinion is a validating event for our broader strategy to achieve disease-specific claims and reimbursement in nearer term indications, such as those for orphan indications."
"Orphan designation in Europe comes with significant benefits," said Ken Kleinhenz, Cytori Vice President of Global Regulatory and Quality Affairs. "Companies who obtain orphan designation from the European Commission benefit from a number of incentives including: protocol assistance, significant fee reductions, access to the centralized procedures, and market exclusivity of 10 years once the medicine is on the market."
Orphan medicines are eligible to be assessed through the centralized procedure that allows companies to make a single application to the European Medicines Agency that would result in a single opinion and a single decision from the European Commission that would be valid in all EU Member States. Conditional approval is also available to orphan medicines through the centralized process. Orphan medicines benefit from ten years of protection from market competition with similar medicines with similar indications once they are approved.
"We have been extremely encouraged by the positive results from our open label clinical trial evaluating Cytori Cell Therapy (autologous adipose derived stromal vascular fraction) in patients with impaired hand function due to Scleroderma. The orphan status should help accelerate our ability to ultimately provide Cytori Cell Therapy (autologous adipose derived stromal vascular fraction) to our patients who are truly in need of additional effective therapies," said Prof. Brigitte Granel from the North Hospital, Assistance Publique Hopitaux de Marseilles and first author of the publication describing the results of the SCLERADEC–I trial.
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced today that it has entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. for a term loan of up to $25.0 million.
BSD Medical Corporation (Nasdaq:BSDM), a leading provider of medical systems that utilize heat therapy to treat cancer, today unveiled its new name and corporate identity, Perseon Corporation (Perseon).
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that it is offering 7.25 million shares of its common stock in a proposed underwritten public offering.
Codexis, Inc. (Nasdaq:CDXS), a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced that it will report fourth quarter and full year 2014 financial results after market close on Tuesday, March 3, 2015.
Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, today reported its financial results for the fourth quarter and year ended December 31, 2014.
Curis, Inc. (Nasdaq:CRIS), announced today that it has commenced an underwritten public offering of shares of its common stock.
Foundation HealthCare, Inc. (OTC Markets:FDNH), which is an owner and operator of surgical hospitals, announced today the Company's financial results for the fourth quarter and year-end which ended December 31st, 2014.
Greatbatch, Inc. (NYSE:GB), today announced results for its fourth quarter and full-year ended January 2, 2015 highlighted by 10% year over year improvement in adjusted operating income and 15% improvement in adjusted diluted EPS over 2013.
iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three months and fiscal year ended December 31, 2014.
Intuitive Surgical, Inc. (Nasdaq:ISRG), the global leader in robotic-assisted minimally invasive surgery, today announced its founding partnership in the American Hernia Society Quality Collaborative (AHSQC).
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that it has received approval to list its common stock on the Nasdaq Global Market. Lion expects its shares to begin trading on Nasdaq on Thursday, February 26, 2015 under the company's current stock symbol "LBIO".
Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced that Mahesh Patel, President and Chief Executive Officer, and Morgan Brown, Executive Vice President and Chief Financial Officer, will present a company overview at the Cowen and Company 35th Annual Health Care Conference on Wednesday, March 4, 2015 at 10:40 a.m. ET.
MannKind Corporation (Nasdaq:MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2014.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced record revenues of $132.8 million for the quarter ended December 31, 2014, an increase of 11% over revenues of $120.0 million for the quarter ended December 31, 2013.
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that its board of directors has approved an additional $200 million authorization for its share repurchase program.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the fourth quarter and year ended December 31, 2014.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel cancer therapeutics, announced that Dai Chaplin, Ph.D., president and chief executive officer, will provide a corporate overview at the 27th Annual ROTH Conference on March 11, 2015.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that Dr. Matthius Löhr, Chairman of its Scientific Advisory Board, together with his colleagues Dr. Verbeke, Dr. Severin Karlsson and Dr. Del Charro from the Karolinska Institute in Stockholm, Sweden, have published a medical and scientific review article that is directed to improving the treatment of pancreatic cancer.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, today announced that President and Chief Executive Officer, Robert E. Ward, will present at the Cowen and Company 35th Annual Health Care Conference on March 3, 2015 at 9:20 a.m. EST at the Boston Marriott Copley Place, Boston, Mass.
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that it has commenced an underwritten public offering of up to $130,000,000 of shares of its common stock.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, reported today its financial results for the fourth quarter and full year ended December 28, 2014.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the appointment of Michael Narachi to the company's Board of Directors effective February 20, 2015.