Sea Worm Provides Model for Surgical Adhesive

Scientists at the University of Utah have uncovered a way to produce a synthetic adhesive based on a natural glue created by the sandcastle worm. This ocean worm builds its home by sticking pieces of sand and shells together, and the result is strong enough to withstand ocean tides. Researchers think this glue could have applications for bone repair in trauma cases, where fast setting time, ease of use and low risk of infection can benefit both the patient and the surgeon.

Russell Stewart, Ph.D., who led the Utah team, said his goal was to develop a water-based adhesive that remained insoluble in wet environments and was able to bond to wet objects. Curing time was another key issue for Stewart. The the team learned that pH changes cause the glue to set, a response that was copied for the synthetic version. The final result is "at least as strong as Super Glue" and is twice as strong as the sandcastle adhesive. So far, it has passed toxicity studies in cell cultures. In addition to its adhesive applications, Stewart is exploring how the glue could also be used to deliver antibiotics or materials that could aid in healing, like BMPs or other small molecules.

Surgical adhesives offer a number of benefits over fixation devices, among them more effective wound closure, less risk of leakage and infection and ease of handling and application. Similar to the sandcastle glue, many adhesives are derived from natural sources. For example, fibrin sealants are blood-derived, CryoLife's BioGlue is bovine-derived and some hemostatic products come from snake venom.

Zymogenetics says rival’s product could be deadly

ZymoGenetics Inc. Thursday filed a petition with the U.S. Food and Drug Administration, saying that a rival drug company’s product could cause patients’ deaths and is asking the FDA to remove the drug from the market “in the interest of patient safety.”
The Seattle biotech (NASDAQ: ZGEN) filed a citizen petition, asking the FDA to remove King Pharmaceuticals Inc.’s Thrombin-JMI Thrombin topical (bovine origin) drug from the market because of “recent report of serious or fatal bleeding-related adverse events in surgical patients exposed to bovine (cattle-derived) thrombin.”
“Serious adverse events, including death, linked to bovine thrombin continue to be reported to the FDA. These adverse events are a serious, ongoing safety issue for patients undergoing surgery,” said Dr. George Rodgers, professor of medicine and pathology at the University of Utah, and medical director of the coagulation laboratory at ARUP Laboratories.
A spokesman for King said the Bristol, Tenn. company (NYSE: KG) had “no comment” on ZymoGenetics’ allegations.

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.

Orthovita Powerhouse validates future Hemostasis Growth

Orthovita have released convincing data relaying their belief in the Orthopedic hemostasis market......see below......

Changes ahead in the coagulation factor market by new entrants and technologies

The worldwide market of recombinant and plasma derived coagulation factors grew to more than US$ 7.5 bln in 2008 and will be fundamentally challenged by over 40 projects in the R&D pipeline

Barcelona, Spain | August 14, 2009 | The Business Intelligence firm La Merie S.L. conducted an analysis of the coagulation factor R&D pipeline and benchmarked the over 50 companies active in the field within their peer group. The study revealed that the total market of recombinant and plasma-derived products of more than US$ 7.5 bln in 2008 will be fundamentally challenged by new players with improved next generation molecules as well as with lower priced molecules without being biosimilars. In contrast to other therapeutic proteins, recombinant first generation coagulation factors VIII, IX and VIIa have not been replaced by longer acting successors right in time before patent expiration. Failure of life cycle management efforts further put at risk future growth rates of product sales. This allows new market entrants to position themselves on the same level as the established marketers. New recombinant coagulation factors, e.g von Willebrand factor, fibrinogen, thrombin and F. XIII are challenging plasma derived products, especially in the field of topically used haemostats as an aid to stop bleeding and tissue sealants for wound healing. As the current generation of novel coagulation factors is focused on modifying half-life, there remains room for further improvement by non-invasive delivery or by reducing immunogenicity.These results and more were found in the search conducted by La Merie Business Intelligence. The report can be acquired at La Merie’s online store (www.pipelinereview.com/store ).

The report “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark Analysis” analyzes and assesses the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies.

EMS Hemostasis Articles

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Poll Result - Hemostatic Agents are utilized by myself or my customers primarily as?

Data is rounded to nearest full number.