Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

CSL Behring announced today thatHelixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
“The FDA's approval of this additional indication for Helixate FS will significantly benefit the bleeding disorders community,” said Garrett E. Bergman, M.D. Senior Director of Medical Affairs, U.S. Commercial Operations at CSL Behring. “Prophylactic treatment will reduce the frequency of bleeding episodes in children with hemophilia A which, over time, will help prevent additional joint damage caused by bleeds.”
"Bleeding into joints, including the ankles, elbows and knees, is a concern for children with hemophilia A and their treatment providers," said Jerry S. Powell, M.D., Director of the Hemophilia Treatment Center at the University of California, Davis. "The FDA's approval of Helixate FS for routine prophylaxis is an innovation that will help our patient population effectively manage their condition. Modern treatment of hemophilia means preventing bleeding through routine prophylaxis, and we eagerly anticipate our patients reaching young adulthood with minimal joint damage and the ability to pursue normal lives."
With more than 2.5 billion units infused to date, Helixate FS has been shown to be safe and effective in clinical studies as well as in post marketing use in the hemophilia community. For more information about Helixate FS, please visit www.HelixateFS.com or call CSL Behring Consumer Affairs at 1-888-508-6978

SMI Presentation Offers Plant Sourced Surgical Bleeding Solution.

SAN JOSE, Calif. - SMI (Starch Medical Inc.) is pleased to announce participation at the European Association of Cardio-Thoracic Surgeons congress (www.eacts.org/) in Vienna, 18-21 October to showcase their advanced PerClot® Chinese manufactured hemostatic products. SMI is currently seeking further representation in select markets within the EU (lang@starchmedical.com), Asia-Pacific and Middle East (phil@starchmedical.com) for PerClot, and welcome enquiries at their EACTS booth number 56.

An SMI Marketing Partners Conference will also be conducted on Sunday, 18 October at 19:00. The Conference will include a clinical review of PerClot® applications and new product developments.

About SMI.

SMI (Starch Medical Inc.) is a San Jose, CA based medical device company engaged in the design, manufacture and sale of innovative, absorbable surgical hemostats synthesized from Absorbable Modified Polymers (AMP™), a proprietary, patent pending technology. SMI has organized a global distribution network for the marketing and sales of PerClot® Polysaccharide Hemostatic System (PHS), which launched in the 4th Quarter, 2008.

About AMP Technology.

Absorbable Modified Polymer (AMP™) technology is a proprietary engineering process that modifies plant starch into ultra-hydrophilic, adhesive forming hemostatic polymers. AMP™ materials are biocompatible, absorbable polysaccharides containing no animal or human components. Utilizing this purified plant source material is critical to minimizing the risks of infection and bleeding-related complications during surgery.
AMP™ particles have a molecular structure that rapidly absorbs water from blood, creating a high concentration of platelets, red blood cells and coagulation proteins at bleeding site, which accelerates the physiologic clotting cascade. The AMP™ blood interaction rapidly produces a gelled matrix that adheres to and forms a mechanical barrier with the bleeding tissue. AMP™ particles are readily dissolved by saline irrigation and are totally absorbed within several days.