CryoLife Receives FDA Clearance For Next Generation HeRO Device; Aastrom Enrollls First Patients in ixCELL-DCM Print E-mail
By Staff and Wire Reports   
Thursday, 04 April 2013 18:36
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 4, 2013.

CryoLife (NYSE: CRY)
, a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced it has received U.S. FDA 510(k) clearance for a next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis. CryoLife anticipates launching the next generation HeRO device during the fourth quarter of 2013 following scale up and validation of the manufacturing process.

The newly cleared version features an adaptor that provides the option to pair the HeRO device's proprietary venous outflow component with certain other available dialysis access grafts, including early access arterial grafts. The current generation includes a standard ePTFE graft, which requires the placement of a temporary dialysis catheter for approximately 2-3 weeks until the graft incorporates into the surrounding tissue and can be used for hemodialysis access. By design, early access grafts allow access in a matter of days, thus eliminating the need for an accompanying dialysis catheter.

"We are pleased to receive FDA clearance for our next generation HeRO device, which will provide our customers with the option of using a standard or early access arterial graft in conjunction with the device's proprietary venous outflow component," noted Steven G. Anderson, chairman, president and CEO of CryoLife. "Early access grafts eliminate the need for temporary dialysis catheters, which are associated with increased risk of infection, further enhancing the clinical benefits of the HeRO device. Over the next several months we will work to optimize and validate the manufacturing processes for this next generation system, which includes scaling up our manufacturing supply chain."


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Aastrom Biosciences, Inc. (Nasdaq: ASTM)
, the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, announced the first patients have been enrolled in the ixCELL-DCM clinical trial. This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).

The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.



Also Thursday:



BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that the Organization for Safety, Asepsis and Prevention ("OSAP") has recently welcomed BIOLASE as a member of its prestigious Super Sponsor partnership.

Cepheid (Nasdaq: CPHD)
today announced that it will report financial results for its 2013 first quarter ended March 31, 2013 on Thursday, April 18, 2013, after the close of the market.

Decision Diagnostics Corp. (OTCBB: DECN)
the exclusive world-wide sales, service and regulatory processes agent for the Shasta GenStrip, the revolutionary at-home glucose test strip specifically designed to work with the Johnson & Johnson's LifeScan family of glucose testing meters, announced today that on March 28, 2013 the company and its subsidiary PharmaTech Solutions, Inc. filed antitrust counterclaims against LifeScan, Inc. and LifeScan Scotland, Ltd. (collectively, "LifeScan") in a patent action brought by LifeScan (2011cv04494) that is presently pending in the Northern District of California.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that it will report financial results for the first quarter 2013 on Thursday, May 2, 2013, after market close.

Gilbert Amelio, former CEO of Apple, and Rod Martin, former counsel to PayPal, both on the Board of Directors of Galectin Therapeutics (NASDAQ: GALT) authored an opinion piece in today's Atlanta Journal Constitutiondiscussing the future of Atlanta as the emerging Silicon Valley for changing the world by curing the big diseases, and why they moved Galectin Therapeutics to Atlanta.

GreenGro Technologies (PINKSHEETS: GRNH)
, a highly-effective developer and marketer of world class indoor growing technologies, announced today that it has exercised its option to acquire 33% of Vertical HydroGarden, Inc. (http://www.verticalhydrogarden.com).

Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY)
, a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced today that one of its flagship portfolio companies, Enlivex Therapeutics, was awarded orphan drug status by the FDA for its ApoCell treatment.

IBM (NYSE: IBM)
Blue Gene/Q, the most powerful single architecture supercomputer in Poland, has been chosen by The Interdisciplinary Centre for Mathematical and Computational Modeling, University of Warsaw (ICM) of Poland to support the country's largest biomedical and biotechnological research initiative called, "Centre for Pre-clinical Research and Technology (CePT)."

IGI Laboratories, Inc. (NYSE MKT: IG)
, a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second abbreviated new drug application (ANDA) in 2013 to the US FDA, which brings the company’s total number of submissions to ten.

Illumina, Inc. (NASDAQ:ILMN)
today announced the next product in its TruSight line of content sets, TruSight Tumor, for NGS-based somatic variant detection in solid tumors.

Ingen Technologies, Inc. (PINKSHEETS: IGNT)
is pleased to announce that on March 28, 2013, Ingen received a purchase order for its Smart Nasal Cannula ® from the US Forest Service.

Medical Marijuana Inc (OTC Pink: MJNA)
is pleased to inform shareholders that all Company divisions are healthy and foresee increasing revenues from overall operations. With the close of the first quarter of 2013, the Company has seen its revenue and net income increase significantly over the prior quarter.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced top-line results from the interim analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma.

NewLink Genetics Corporation (NASDAQ: NLNK)
is a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics.

Opexa Therapeutics, Inc. (NASDAQ: OPXA)
, a biotechnology company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at The Second International Vatican Adult Stem Cell Conference: Regenerative Medicine — A Fundamental Shift in Science & Culture, taking place from within The Vatican, April 11-13, 2013.

Pall Corporation (NYSE:PLL),
a global leader in filtration, separation and purification, today confirmed plans for a state-of–the-art Life Sciences Centre of Excellence at its new Harbourgate site in Portsmouth in the United Kingdom (UK).

Pfizer Consumer Healthcare (NYSE: PFE)
, makers of Advil®, is kicking off its Advil® Relief in Action campaign today that honors volunteers who don’t let pain get in the way of providing relief to others in need. Advil® Relief in Action celebrates the efforts of these tireless everyday heroes, as well as supports and contributes to the efforts of Habitat for Humanity and Wounded Warrior Project® (WWP), whose volunteers exemplify Relief in Action and work to improve the lives of others every day.

Pressure BioSciences, Inc. (OTCQB: PBIO)
("PBI" or the "Company") today announced that scientists from Florida International University ("FIU") reported further advancements in their goal to develop an improved method for rape kit testing based on PBI's patented pressure cycling technology (PCT) platform.

pSivida Corp. (NASDAQ:PSDV; ASX:PVA)
, a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that it has signed a funded technology evaluation agreement with a leading global pharmaceutical company.
Rite Aid Corporation (NYSE: RAD) today announced sales results for March.

SK3 Group, Inc. (OTC Pink: SKTO)
today announced that it has recently contracted over a dozen healthcare facilities and providers in Southern California to become their Medical Cannabis Administrator (MCA).

Synthetic Biologics, Inc. (NYSE MKT: SYN)
, a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases, to the Regents of the University of California which includes claims to the use of the Company's drug candidate, Trimesta™ (oral estriol), in combination with glatiramer acetate injection (Copaxone®).

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)
today announced that Jim Kelly, Vanda's Chief Financial Officer, will deliver a corporate presentation at the BioCentury Future Leaders in the Biotech Industry Conference in New York on Friday, April 5, 2013 at 2:30 p.m. Eastern Time.

VG Life Sciences, Inc. (OTC Pink: VGLS)
, a biotechnology company focused on leveraging its innovative platform technologies for the discovery and development of drug therapies for cancer, infectious disease, and inflammation, announced today positive results from stage two of its Pre-IND Phase I Study to test tolerability and toxicity in patients with advanced stage solid tumors.

Vycor Medical, Inc. ("Vycor") (OTCBB: VYCO)
outlined today its multi-pronged strategy to continue to drive adoption for its Vycor Medical division's ViewSite™ Brain Access System ("VBAS").



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