Medtronics Reports FDA Approval Of Capsurefix Novus MRI Surescane 5076; BioLife Media Products Used at NeoStem Subsidiary Progenitor Cell Therapy Print E-mail
By Marilyn Mullen   
Tuesday, 14 October 2014 20:07
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 14, 2014.
Medtronic ( (NYSE: MDT) announced the U.S. FDA approval of its CapSureFix Novus(TM) MRI SureScan® 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker.

The 5076 lead, previously approved for use with Medtronic's non-MR-conditional pacemakers, has been well-received because of its handling and proven reliability. Since its introduction more than 10 years ago, physicians have implanted more than 3 million 5076 leads in patients.

With the new FDA approval, two 5076 MRI leads can now be paired with dual-chamber Medtronic Advisa MRI(TM) or Revo MRI(TM) SureScan® pacemakers, allowing patients with these complete SureScan pacing systems to undergo full-body MRI scans. Medtronic 5076 MRI lead lengths approved for these scans range in length from 35cm to 85cm. Patients who previously had two 5076 leads implanted with non-MRI pacemakers will have the option to receive MRIs if MR-conditional SureScan pacemakers are implanted when replacement devices are needed.

"The 5076 lead has proven to be one of the most reliable pacing leads for more than a decade, and due to extensive testing, now also can undergo MRI scans," said Brian Urke, vice president and general manager of the bradycardia business at Medtronic. "This is especially important for patients who need MRIs and received 5076 leads at the time of their initial implants; although they may not have received MR-conditional pacemakers initially, they now have the option to get a pacemaker approved for MRI when they require a device change-out, making the entire system MR-conditional."

Medtronic has spent more than 17 years studying the MRI environment, and was the first in the industry to introduce a pacemaker system specifically engineered for this purpose. Since its first MR-conditional pacing system was approved in Europe in 2008, Medtronic has continued to design and test its products for safe use during MRI scanning. Advances in computer modeling have allowed Medtronic to vigorously evaluate the 5076 lead across more than 2 million scanning scenarios.  Medtronic also conducted the 5076 MRI Clinical Study, a global, multi-center, study to evaluate the safety and effectiveness of the 5076 lead in the MRI environment.



 

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BioLife Solutions, Inc. (NASDAQ: BLFS),
a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and
cryopreservation freeze media and

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precision thermal shipping products for cells and
tissues  ("BioLife" or the "Company"), today provided an update on use of the Company's HypoThermosol storage/shipping media and CryoStor cryopreservation freeze media by Progenitor Cell Therapy, LLC (PCT), a wholly owned subsidiary of NeoStem, Inc., (NASDAQ: NBS) a leader in the emerging cellular therapy field.
PCT is an internationally recognized contract development and manufacturing organization (CDMO) focused on providing exceptional service, quality and value to its regenerative medicine clients, which include an expanding range of development stage organizations, Fortune 500 biotechnology, pharmaceutical and medical product companies, as well as leading academic research institutions. PCT operates two state-of-the-art, accredited and certified U.S. facilities, one in Allendale, New Jersey and the other in Mountain View, California.

Robert A. Preti, PhD, President & Chief Scientific Officer at PCT, commented on the use of BioLife products by stating, "Two critical commercialization challenges for novel cell and tissue-based products stem from limited shelf life and poor quality following preservation.  Over the last several years we have evaluated many custom formulations and commercial preservation media products for storage, shipping, freezing, and administering cell-based biologics in clinical applications.  The biopreservation efficacy of BioLife's clinical grade HypoThermosol and CryoStor is very impressive.  There is a high degree of awareness of these products in the field and we use BioLife products in several of our current cell therapy development projects, including some of NeoStem's clinical product candidates along with many programs for mutual customers of BioLife and PCT."


 
Also Tuesday:


 
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces its results for the three and six-months ended August 31, 2014.

Advaxis, Inc. (Nasdaq:ADXS)
, a cancer immunotherapy company, today announced that preclinical and clinical data highlighting the potential of its proprietary Lm-LLO immunotherapy technology to treat cancers have been selected for three poster presentations at the Society for Immunotherapy of Cancer (SITC) 29th Annual Meeting, November 6-9, 2014 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopaedic implants, is pleased to announce that it has entered into a multi-year private labeling agreement with Spinal Kinetics, a leading innovator of advanced artificial spinal disc technology.

Applied Genetic Technologies Corporation (Nasdaq:AGTC)
, a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, announced BioFlorida has awarded it the 2014 David J. Gury Company of the Year Award.

Aspen Group, Inc. (OTCBB:ASPU)
, parent of Aspen University, a nationally accredited online postsecondary education company, announced today the School of Nursing has grown to over 1,000 enrolled students.

Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of revolutionary bone graft material and coatings for medical applications, today announced preliminary, unaudited revenue for the third quarter of 2014.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has entered into an agreement to acquire patent rights from Medtronic, Inc. (NYSE:MDT) relating to the formulation and pump delivery of natriuretic peptides.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced data from a comprehensive, multi-year analysis of products of conception (POC) testing by chromosomal microarray analysis (CMA) showing that CMA yields a successful result in more than 85% of cases.

Cytomedix (OTCQX:CMXI)
, a pioneer in biodynamic therapies, today announced that it has re-launched its AutoloGel chronic wound care system under the AurixTM brand.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that Russ Angold, co-founder and President of Ekso Labs, is a keynote speaker at the RoboBusiness 2014 Conference on Thursday October 16th, at 3:30 pm EDT at the Hynes Convention Center, Boston, MA.

FutureWorld Corp. (OTCQB: FWDG)
, a leading provider of advanced technologies and solutions to the global cannabis industry, announces today that they are entering operations at the front end of the Cannabis value chain. 

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that that address major medical needs across the full spectrum of cancer care, today announced the notice of allowance from the Japanese Patent Office for NeuVax™ (nelipepimut-S) covering the use of NeuVax alone or in combination with other agents to prevent recurrence of any HER2/neu expressing breast cancer tumor having an immunohistochemistry (IHC) level of 1+ or 2+, or a fluorescence in situ hybridization (FISH) rating of less than about 2.0. NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials.

GeneNews Limited (TSX:GEN)
today announced that it has in-licensed two biomarker assays - sphingotest® pro-NT and sphingotest® pro-ENK – that aid physicians in identifying those females at highest risk for breast cancer in the general population.

GrowBLOX Sciences, Inc., (OTCQB:GBLX)
, a cannabinoid therapy research and development firm, has released the names of five doctors joining its scientific advisory board.

GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced preliminary topline results from a Phase 2a ulcerative colitis trial to be presented today at the Company's R&D Day event in New York City.

Healthcare Services Group, Inc. (Nasdaq:HCSG)
announced that in fiscal year 2015, it will transition its workers compensation and certain employee health & welfare insurance programs to HCSG Insurance Corp. ("HCSG Insurance" or the "Captive"), its wholly owned captive insurance subsidiary.

Idera Pharmaceuticals, Inc. (Nasdaq:IDRA)
, a clinical-stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, today announced it has advanced IMO-9200 into Phase 1 clinical development following acceptance of an Investigational New Drug application by the U.S. Food and Drug Administration.

Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced that it will release its financial results for the third quarter of 2014 after the close of trading on Tuesday, November 11, 2014.

Kips Bay Medical, Inc. (OTCQB:KIPS)
, a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, today provides an update on its clinical progress and business operations.

LifeVantage Corporation (Nasdaq:LFVN)
, has announced the hiring of Ann-Celeste Billings as Vice President of Marketing, Calli Mott as Vice President of Sales Administration, and John Genna as Vice President of Public Relations and Corporate Partnerships.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy elderly subjects.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
, announces its consolidated financial results for the three and six months ended August 31, 2014.

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II DNA Sequencing System, today announced that its Single Molecule, Real-Time (SMRT®) Sequencing technology will be featured in a number of presentations at the 2014 American Society of Human Genetics Annual Meeting taking place October 18-22 at the San Diego Convention Center.

Quotient Limited (Nasdaq:QTNT)
, an established, commercial-stage diagnostics company, today announced the approval and launch of four new products to expand its reagent red cell product offering.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today four investments: the acquisition of a portfolio of four memory care facilities in Texas, the acquisition of a portfolio of three senior housing facilities in Florida, the acquisition of an assisted living facility in Maryland and the origination of a loan with respect to a property for development in Florida.

Sanomedics International Holdings, Inc. (OTCQB:SIMH)
, announced today that the Company's Caregiver® TouchFree™ InfraRed Thermometers help to reduce contagion risk for health workers in hospitals, clinics and other healthcare facilities across the country.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
, a global biopharmaceutical company, today announced that it signed on October 9, 2014 an amendment to the existing collaboration and license agreement (Collaboration Agreement) covering the United States (U.S.) and Canada for AMITIZA® (lubiprostone) with Takeda Pharmaceutical Company Ltd.

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN)
today announced that on October 13, 2014, the Company received a Paragraph IV Notice Letter from Zydus Pharmaceuticals (USA) Inc. ("Zydus") advising Supernus of the filing by Zydus of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules.



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