Date: Jun 27, 2013 Source: Company Data (
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New York, June 27, 2013. The U.S. Food and Drug Administration or FDA has accepted Biomedica's Investigational New Drug or 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 the 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. Preliminary assays indicate that the agent is also effective in controlling menstrual cycle disorders 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
Biomedica plans to complete Phase I in the course of 2014 and initiate Phase 2 clinical trials as an adjunct to hemostasis in the first quarter of 2015. supported by an award of Joint Warfighter Program, Department of Defense. 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 from 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, cheaper and purer hemostats. Clot bypasses the conversion of fibrinogen by thrombin allowing for instant polymerization at lower concentrations. More importantly Clot products are shipped and stored at room temperature and can be terminally sterilized by gamma radiation. 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 appearence and efficacy to Floseal (Baxter), it does not contain thrombin allowing for intraoperative blood salvage. ClotBlock has important applications in orthopedic surgery as well as in persistent solid organ bleeding. ClotCut is a promising solution of cutaneaous bleeding in emergency medicine, and ClotSpray may replace in the near future many of the current fibrin sealant applications. Potential benefits include lower infection rates, less clamping time, and minimal blood loss.
About Biomedica Management Corporation. Biomedica is a clinical-stage federally funded research and development company headquartered 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 designed to improve hemostasis in patients undergoing a wide range of surgical and medical procedures eexposed to severe bleeding
