Ceremed's OSTENE(R) Improves Bone Fusion and Healing After Surgery, New Study Shows

Wednesday, May 14, 2008 General News
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LOS ANGELES, May 13 New soluble polymer material designedto stop bone bleeding in surgery improves bone fusion and healing, accordingto a new animal study just published in the Annals of Thoracic Surgery (ATS).The findings come on the heels of recently published research showing that theuse of the new polymer may lower the risk of surgical infections.

Researchers from the Medical University of South Carolina at Charlestonand Keck School of Medicine at the University of Southern California in LosAngeles compared the effects of a newly available polymer (Ostene(R)) and ofbone wax on the bone's ability to heal following median sternotomy -- aprocedure with which most open heart surgeries begin. There are approximately640,000 such procedures performed in the United States each year, and the rateof post-operative sternal complications is estimated at 2% to 8%.

The study showed that the sternum heals faster and grows significantlystronger when treated with Ostene(R) than in the presence of bone wax, amaterial traditionally used to stop bone bleeding in surgically cut bonesurfaces. Bone wax inhibited new bone formation and healing, creating areas ofsternal non-union. By contrast, there was consistent bone fusion and normalhealing in the sternums treated with Ostene(R).

The results suggest that the use of Ostene(R) in sternotomy instead ofbone wax may help reduce the number of sternal complications, includingsternal non-union following cardiac surgery. The use of Ostene(R)is likely toimprove post-operative bone healing and patient recovery.

Bone wax, a beeswax-based product, is the most commonly used bonehemostasis material despite its well-documented side effects. Numerous studieshave indicated that bone wax interferes with the body's ability to clearbacteria and increases the risk of hospital-acquired infections; as the newMUSC / USC study confirms, bone wax also inhibits bone growth and bone healingafter surgery.

Ostene(R) offers an alternative to bone wax without the added risk.Ostene(R) is a sterile mixture of water-soluble alkylene oxide copolymersformulated into an affordable, easy-to-handle synthetic bone hemostasismaterial. The use of Ostene in cardiac surgery may help reduce seriouspost-operative complications, such as the separation of the sternum or sternalwound infection. Wax-like and malleable during application, the biomaterialdissolves rapidly and is eliminated from the body unmetabolized within daysafter surgery. Ostene(R) is used in cardiac, orthopedic, and oral surgery andin neurosurgery.

Ostene(R) is the only product specifically designed to stop bone bleedingin surgery that will not interfere with bone healing or increase the risk ofsurgical infections. Other applications under development include the use ofOstene(R) as a safe, soluble delivery vehicle for a variety of therapeuticagents, from antibiotics to bone growth stimulants for enhanced healing.Ostene(R) is authorized for sale both in the U.S. and in the European market.

Commenting on the study Ceremed's President and CEO Tadeusz Wellisz, M.D.,said, "The results confirm the effectiveness and safety of Ostene. Building onour alkylene oxide copolymers' unique properties, we are currently developingthe next generation of Ostene(R), otherwise known as AOC, available in variouslevels of viscosity, from paste to a hard solid. AOC has great potential as aninert, soluble carrier that delivers a broad range of therapeutic agents tobone defects, from antibiotics to growth stimulants, without increasing riskto patient. We are able to custom-manufacture compounds using each OEMproprietary material in combination with the AOC carrier."

About The Company:

Ceremed, Inc. is a privately held medical device corporation formed in2002 by a surgeon and a group of scientists from the University of SouthernCalifornia. The company has unique expe

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