Tuesday, September 24, 2013

BioCer Present Newly EU Approved Super Rapid Plant-based Hemostat at EACTS

BAYREUTH, Germany, September 24, 2013 /PRNewswire via COMTEX/ -- BioCer Entwicklungs GmbH (BCE) a German implantable biological medical device development and manufacturing company announced today that it has achieved commercial approval to begin distribution in the EU, and international markets where CE mark is accepted of HaemoCer Plus. HaemoCer Plus is an Absorbable Polysaccharide Hemostat (APH) and an innovative powerful hemostatic technology that exhibits exceptional speed and ratio of absorbency.
"HaemoCer Plus follows 2 years of development and is a huge technological milestone with clear efficiency benefits. In comparative testing with our first agent HaemoCer the accelerated absorbent product nature is significant, and clearly evident to a far greater extreme with older plant-based powdered agents. As surgeons experience the rapid mode of action of HaemoCer Plus we expect they will convert, and this product will rapidly dominate this market segment," stated Dr. Markus Heinlein, Managing Director BCE. "As problematic bleeding in cardiac surgery is a constant challenge, BioCer are pleased to present and launch HaemoCer Plus at the EACTS."
Haemocer Plus APH is a plant-based hemostatic agent that utilizes the same raw material as BCE's flagship product HaemoCer. HaemoCer Plus APH technology is delivered in a powder format developed utilizing a new modification to Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) manufacturing process. The new highly absorptive, biocompatible agent now performs at exceedingly fast absorptive speeds achieving results twice as fast and at double the capacity of HaemoCer.
HaemoCer Plus will be presented at the EACTS 5th-9th October 2013 in Vienna, Austria. Other meetings in 2013 include Medica (Germany) and Asia Pacific Hernia Society (Hong Kong) at BioCer's booth. BioCer also plan to attend Arab Health and welcome expressions of interest in distribution or licensing queries to please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

Monday, September 9, 2013

FDA Accepts Biomedica MC Investigational New Drug Filing for ClotFoam®

The U.S. Food and Drug Administration (FDA) has accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company is developing ClotFoam as the leading agent of a portfolio of hemostatic products based on its proprietary “CLOT” technology. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health.

ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.

ClotFoam’s ability to control bleeding is based on rapid and powerful activity of fibrin monomer carried by a foam with high affinity to endothelial tissue. ClotFoam has shown promising results in animal models of large organ resection without need of compression and with minimally invasive application methods. Preliminary assays indicate that the agent is also effective in controlling severe acute menstrual cycle disorders (i.e. menorraghia) and post-partum hemorrhage, which is the most common cause of perinatal maternal death in the developed world and is a major cause of maternal morbidity worldwide. These types of severe clinical situations are well adapted for the ClotFoam technology because of it’s self-expanding and non-compressible hemostatic action, unlike common hemostats available in the operating room today.

Biomedica plans to complete Phase I in the course of 2013 and initiate Phase 2 clinical trials as an adjunct to hemostasis in the first quarter of 2014. The company has requested Fast Track Designation for ClotFoam. This designation is reserved for drugs that advance novel technologies, and are expected to provide significant therapeutic advantages over existing products while addressing unmet medical needs. Fast Track designation benefits form priority review status. Orphan Drug Status will be requested for the ClotFoam Battlefield special formulation. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About Biomedica’s CLOT development Program. The Clot technology
uses fibrin monomer manufactured under proprietary methods that produce stronger, faster, less expensive and purer hemostats. Clot bypasses the conversion of fibrinogen by thrombin allowing for instant polymerization at lower concentration. Clot products resist degradation, do not contain thrombin, and can be shaped as a foam, a gel, a patch, a pellet, a screw or a spray.

Biomedica’s proprietary technology has produced ClotGel, ClotBlock, ClotCut, EyeClot and ClotSpray. While ClotGel is similar in appearance and efficacy to the leading hemostatic agent Floseal, it does not contain thrombin allowing for intraoperative blood salvage and minimal swelling. ClotBlock has important applications in orthopedic surgery as well as in persistent solid organ bleeding. ClotCut is a promising solution of cutaneous bleeding in emergency medicine, and ClotSpray may replace many of the current fibrin sealant applications with a more simple one-component solution stored at refrigerated conditions (compared to frozen fibrin sealant), faster polymerization times, and easier-to-use surgeon application characteristics.

About Biomedica Management Corporation. Biomedica is a clinical-stage federally funded research and development company headquartered at the SUNY Downstate Biotech Center in Brooklyn, NY, with biochemistry laboratories at the UMBC TechCenter in Baltimore, MD. The company was funded in 1999 as a collaborative effort between scientists in the fields of biochemistry, immunology, and trauma surgery The Company operates under an innovative business model that fosters the development of critical technologies with the vision of academic scientists and the guidance of marketing experts. Biomedica brings to the market affordable and effective technologies targeting unmet needs in coagulopathic-related conditions, inflammation, sepsis and wound healing. The Company’s most clinically advanced product candidate ClotFoam is derived from its proprietary Clot ™ platform designed to improve hemostasis in patients undergoing a wide range of surgical and medical procedures. The product development has been supported by the National Institutes of Health, the US Army Medical Research and Materiel Command and by TEDCO, the Technology Corporation of Maryland.

Tuesday, September 3, 2013

Cohera Medical Completes Sylys® Surgical Sealant Clinical Trial

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has treated its last patient for the clinical trial for Sylys®, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures. The results of the study will be released later this fall.
The European study is evaluating the safety of Sylys as an adjunct to standard closure techniques following bowel resections. The study included patients enrolled at two sites in the Netherlands.
Anastomotic leaks, on average, occur in 3 - 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 - 4B market.
"We are thrilled to be collaborating with leading surgeons in the Netherlands to treat patients with our Sylys product, our second class III product designed to support more natural healing and help reduce post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "Completing the treatment of the last patient in this study brings us one step closer to putting this innovative sealant in the hands of surgeons and reducing anastomotic leakage after colorectal surgery."




Read more here: http://www.sacbee.com/2013/09/03/5702571/cohera-medical-completes-sylys.html#storylink=cpy