Pacira Pharma Announces sNDA Submission for EXPAREL; FDA Approves BIOTRONIK Entovis Pacemaker System Print E-mail
By Mary Davila   
Wednesday, 07 May 2014 19:18
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 7, 2014.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX)
announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for a nerve block indication for EXPAREL® (bupivacaine liposome injectable suspension). The sNDA is based on positive data from a Phase 3 study assessing the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty, and will also include additional safety data from a Phase 3 study of EXPAREL used to perform an intercostal nerve block for thoracotomy.

The timeline for review of the sNDA, under the Prescription Drug User Fee Act (PDUFA), is 10 months. If the FDA accepts the sNDA filing, a PDUFA target date of March 5, 2015 is expected.


BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has granted approval for its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo Magnetic Resonance Imaging (MRI) scans with a limited exclusion zone. FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads.

Approximately 50,000 single-chamber pacemakers are currently implanted in the U.S. each year; until now, these patients have not been able to access MRI scans. BIOTRONIK is the first company in the U.S. to offer both single- and dual-chamber pacemakers approved for use in an MRI environment. Also, BIOTRONIK is the first company worldwide to offer the current generation of pacing leads with ProMRI® pacemakers. Setrox, including versions released under other names, is the most used lead in MRI pacemakers on the market today with over 850,000 leads sold worldwide.

“With the Entovis longevity and the history of lead reliability, this is a system that will serve a wide variety of pacemaker patients for the foreseeable—and unforeseen—future needs,” said Carleton Nibley, M.D., electrophysiologist at John Muir Medical Center in Concord and Walnut Creek, California, and a participant in the ProMRI® study.

The Entovis system presents advantages over existing pacemakers approved as MR conditional. Patients with approved Entovis pacemakers and leads need only alert radiology staff of their device and the staff will verify the patient meets the criteria to undergo an MRI scan.

Several million patients are currently implanted with pacemaker systems worldwide, and recent studies estimate that a sizeable portion of them will develop a clinical need for an MRI scan during their lifetimes.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT), or ultrasound. However, the strong forces applied during MRIs can have a negative effect on the pacing system and have been contraindicated for pacemaker patients in the past.

FDA approval comes only 16 months after the initial clinical study was launched, and five months after the approval of that study’s expansion to include full-body MRI scans. These studies are required by FDA for product evaluation, and are designed to assess the safety and efficacy of BIOTRONIK’s existing single- and dual-chamber Entovis pacemaker systems and Setrox 53 and 60cm leads during MRI scans. These devices are already commercially available in the U.S., but lacked FDA approval for use in the MRI environment.

“The BIOTRONIK Entovis ProMRI® pacemaker system is the latest example of our commitment to excellence and meaningful innovation in supporting patient treatment and quality of life,” said Paul Woodstock, BIOTRONIK Executive Vice President of Sales and Marketing. “We are proud to be able to satisfy the demand for state-of-the-art devices that allow physicians to deliver optimal care to the increasing number of pacemaker patients who may someday need an MRI.”

Entovis devices include BIOTRONIK Home Monitoring® technology, which provides daily monitoring of the patient’s device, and offer the most advanced physiological therapy available via Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to ensure excellent handling and stable fixation, as well as optimal electrical performance.

Also Wednesday: 

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced the closing of its previously announced initial public offering of 1,500,000 shares of its common stock at a price to the public of $8.00 per share.

Amedisys, Inc. (Nasdaq:AMED),
one of America's leading healthcare at home companies, today announced that Ronald A. LaBorde, President and Interim Chief Executive Officer, and Dale E. Redman, Interim Chief Financial Officer, will present at the 2014 Bank of America Merrill Lynch Health Care Conference in Las Vegas, NV on Wednesday, May 14, 2014.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular diagnostics company specializing in oncology biomarker detection and monitoring through circulating tumor cells (CTCs) and cell-free circulating tumor DNA, today announced that it has closed a loan facility of up to $10 million with Oxford Finance LLC.

Caribbean International Holdings (Pink Sheets:CIHN)
through its subsidiary, Regenerative BioScience, Inc., ("RBS") today announced that a noted member of its Advisory Board and a scientific advisor for Regenerative Biosciences, Rafael Gonzalez, Ph.D. has been conducting negotiations on the Company's behalf with a California based "stem cell banking" company.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay will present at the Bank of America Merrill Lynch 2014 Health Care Conference to be held May 13 - 15, 2014, in Las Vegas.

Corium International, Inc. (Nasdaq:CORI)
today announced that it will release second quarter fiscal year 2014 financial results on Tuesday, May 13, 2014 after the close of the U.S. financial markets.

The Ensign Group, Inc. (Nasdaq:ENSG),
the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it has acquired Mt. Ogden Health & Rehabilitation Center, a 108-bed skilled nursing facility in Ogden, Utah.

Foundation Healthcare Inc. (OTCQB:FDNH)
, an owner and operator of surgery focused hospitals that facilitate and enhance the surgical experience for surgeons and their patients, announced today it will host an earnings call to discuss the Company's first quarter 2014 financial results at 4:30 p.m. EDT (3:30 p.m. CDT) on Thursday, May 15, 2014.

Hyperion Therapeutics (Nasdaq:HPTX)
today announced that the company is scheduled to present at the Bank of America Merrill Lynch 2014 Health Care Conference on Tuesday, May 13, 2014, at 1:40 p.m. PT.

Immunomedics, Inc., (Nasdaq:IMMU)
today reported financial results for the third quarter ended March 31, 2014.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced that Keith Leonard, president and chief executive officer, will present at the Bank of America Merrill Lynch 2014 Health Care Conference in Las Vegas.

LDR Holding Corporation (NASDAQ: LDRH),
a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today reported its financial results for the first quarter of 2014.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, today announced its financial results for the three months ended March 31, 2014.

MannKind Corporation (Nasdaq:MNKD)
, focused on discovering, developing and commercializing treatments for diabetes, announced today that it will present at the Bank of America Merrill Lynch 2014 Health Care Conference on Wednesday, May 14, 2014 at 8:40 am Pacific Time at the Encore at the Wynn Hotel in Las Vegas, Nevada.

NanoString Technologies, Inc. (Nasdaq:NSTG)
, a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the three months ended March 31, 2014.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the first quarter ended March 31, 2014.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2014.

The Spectranetics Corporation (Nasdaq:SPNC)
announced successful completion of the first live case using the TightRail™ Rotating Dilator Sheath performed by Charles Love, MD.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
today reported consolidated financial results for the first quarter ended March 31, 2014.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced that it will hold a conference call and webcast on Wednesday, May 14, 2014 at 1:30 pm Pacific Time (4:30 pm Eastern Time) to provide a corporate update and report financial results for the first quarter ended March 31, 2014.

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