|Thoratec Receives Approval From FDA For Full Expansion Of HeartMate III™; PlasmaTech Announces $5 million private placement|
|By William Kent|
|Thursday, 02 April 2015 19:28|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2015.
Thoratec Corporation (NASDAQ: THOR), announced that it received final approval from the FDA to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites. This was based on the FDA's evaluation of safety data from the first ten HeartMate III implants performed in recent months during a limited enrollment phase at five sites.
"We are very pleased to reach this most recent milestone with our HeartMate III clinical program, along with the increasing enthusiasm for our latest product advancements," said D. Keith Grossman, President and Chief Executive Officer. "Building on our recent success with rapid enrollment in the HeartMate III CE Mark study, we look forward to bringing this differentiated technology to 60 of the most active implanting centers throughout the U.S.," he added.
HeartMate III is a centrifugal-flow chronic left ventricular assist system, utilizing a fully magnetically levitated technology foundation, designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size.
Additionally, Thoratec announced that it has named co-principal investigators for the HeartMate III U.S. clinical trial. They are Dr. Mandeep Mehra, Medical Director of the Brigham and Women's Health Heart and Vascular Center, Executive Director of the Center for Advanced Heart Disease, and Professor of Medicine at Harvard Medical School; Dr. Daniel Goldstein, Professor and Vice-Chair of the Department of Cardiothoracic Surgery and Surgical Director of the Mechanical Assistance Program at Montefiore Medical Center; Dr. Nir Uriel, Associate Professor of Medicine and Medical Director of the Heart Failure, Heart Transplant and Mechanical Assist Device Programs of the Division of Cardiology at the University of Chicago; and Dr. Joseph Cleveland Jr., Professor of Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support at the University of Colorado Anschutz Medical Center.
The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II®™ including a primary endpoint of survival free of device replacement and debilitating stroke. The first 294 randomized patients in the trial will be followed for six months to evaluate a short-term indication such as Bridge-to-Transplantation. The first 366 randomized patients will be followed for 24 months to evaluate a long-term indication such as Destination Therapy. The trial also allows for approximately 600 additional randomized patients to be enrolled beyond the pivotal cohort in order to assess superiority of pre-specified secondary endpoints. Outside of the U.S., Thoratec completed enrollment of the HeartMate III CE Mark study in late 2014 and continues to expect a commercial approval and launch in European markets during late 2015.
PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI), a biopharmaceutical company advancing protein biologic therapies and oncology supportive care products, announced it has entered into a definitive purchase agreement with Knoll Capital Management, a leading healthcare institutional investor, to raise $5.0 million in a private placement of common stock. The private financing is comprised of 1,666,667 shares of common stock, at a price of $3.00 per share. PlasmaTech plans to use the proceeds of the financing to accelerate development of its proprietary Salt Diafiltration (SDF™) Plasma Protein technology, working capital and general corporate purposes.
"We are pleased to add another leading healthcare and biotechnology investor to our shareholder base, and the additional capital enables the Company to build out its innovative, and potentially disruptive, technology platform in the high-growth plasma biologics arena," stated Steven H. Rouhandeh, PlasmaTech's Executive Chairman. "We appreciate the vote of confidence from Knoll Capital, and look forward to a productive relationship moving forward."
The closing of the offering is subject to the satisfaction of customary closing conditions. The securities sold in this financing have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, has signed an exclusive Master Distributor Agreement with ADS Inc. ("ADS") for the marketing and supply of Akers' rapid diagnostic assays to U.S. Government agencies and departments.
ABM (NYSE:ABM), a leading provider of facility solutions, announced today that ABM Healthcare Support Services has been recertified by the ISSA Cleaning Industry Management Standard (CIMS) with both the CIMS and the CIMS-Green Building (GB) Certification with honors.
BioCorRx, Inc. (BICX), developer of the Start Fresh Program® used for the treatment of alcohol and opioid dependence, announces its 2014 Financial Results with highlights as follows: Increased revenues by 64% over 2013 led by our Start Fresh Program fees.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, announced today that it has priced an underwritten public offering of 3,500,000 shares of its common stock at a price to the public of $5.75 per share.
Coronado Biosciences, Inc., (Nasdaq:CNDO) has formed a new subsidiary company, DiaVax Biosciences, to develop novel immunotherapies for the prevention and treatment of cytomegalovirus (CMV), a common virus that affects people of all ages.
Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced that Peter Staple, Corium's President and Chief Executive Officer, will present at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015 in New York City at The Westin New York Grand Central Hotel.
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 acquired Coral Desert Rehabilitation and Care, a 60-bed all-private/Medicare skilled nursing facility in St. George, Utah.
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on the design, development and commercialization of products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, announced that effective today, Robert White, President and Chief Operating Officer of the Company has been promoted to President and Chief Executive Officer and appointed to its Board of Directors. In a planned move, Brian Farley, the Company's current Chairman and Chief Executive Officer, has transitioned to Executive Chairman of the Board and part-time employment with the Company.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that Adam Gridley, President and Chief Executive Officer of Histogenics, will present at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015 at 10:40 AM EDT at the Westin Grand Central Hotel in New York City.
Immunomic Therapeutics, Inc., a privately-held biotechnology company pioneering next-generation vaccines based on its proprietary LAMP technology, today announces it will be presenting at the 15th Annual World Vaccine Congress, which will be held at the Walter E. Washington Convention Center in Washington, D.C. on April 7-9, 2015.
ImmuDyne, Inc. (OTCQB:IMMD) announces 1st quarter revenues rose more than 50%, year over year, to approximately $288,000.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired Geriatrics Associates, PC, "GAPC," a post-acute practice group headquartered in Albuquerque, New Mexico.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced that the company will participate in two upcoming investor and medical conferences.
Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), today reported financial results for the year ended December 31, 2014.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced several filings with the Securities and Exchange Commission (SEC): preliminary proxy materials requesting stockholder approval for an amendment to the Company's Amended and Restated Certificate of Incorporation, a transition report on Form 10-K for the period from September 1, 2014 to December 31, 2014; and a report on Form 8-K regarding closure of the sale of the Company's hyperthermia assets.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has successfully completed additional testing of its phase II Firefly Dx prototype handheld, real-time PCR (polymerase chain reaction) pathogen detection system, and detected multiple organisms with a multiplex assay designed to simultaneously test for up to four pathogens on the Firefly Dx PCR chip.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), a biopharmaceutical company focused on developing and commercializing transformative treatments for people affected by rare and debilitating diseases, today announced that it has priced an underwritten public offering of 9,500,000 shares of its common stock at a price to the public of $9.00 per share.
SAGE Therapeutics (Nasdaq:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced details of its planned SAGE-547 global Phase 3 development program for the treatment of patients with super-refractory status epilepticus (SRSE).
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (TASE:TEVA) and Xenon Pharmaceuticals Inc. (Nasdaq:XENE) today announced that the first patient has been enrolled into the Phase 2b study designed to evaluate the safety and efficacy of the novel topically applied TV-45070, (4% and 8% w/w Ointment) in patients with Postherpetic Neuralgia (PHN).
Vocera Communications, Inc. (NYSE:VCRA), the leading provider of intelligent, real-time communication and collaboration solutions for mission-critical mobile environments, announced today the introduction of enhanced functionality that enables interactive communications between Electronic Health Record systems (EHR) and the Vocera Communication System.