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


5/13/2008 12:53:18 PM

LOS ANGELES, May 13 /PRNewswire/ -- New soluble polymer material designed to stop bone bleeding in surgery improves bone fusion and healing, according to 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 the use of the new polymer may lower the risk of surgical infections.

Researchers from the Medical University of South Carolina at Charleston and Keck School of Medicine at the University of Southern California in Los Angeles compared the effects of a newly available polymer (Ostene(R)) and of bone wax on the bone's ability to heal following median sternotomy -- a procedure with which most open heart surgeries begin. There are approximately 640,000 such procedures performed in the United States each year, and the rate of post-operative sternal complications is estimated at 2% to 8%.

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

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

Bone wax, a beeswax-based product, is the most commonly used bone hemostasis material despite its well-documented side effects. Numerous studies have indicated that bone wax interferes with the body's ability to clear bacteria and increases the risk of hospital-acquired infections; as the new MUSC / USC study confirms, bone wax also inhibits bone growth and bone healing after surgery.

Ostene(R) offers an alternative to bone wax without the added risk. Ostene(R) is a sterile mixture of water-soluble alkylene oxide copolymers formulated into an affordable, easy-to-handle synthetic bone hemostasis material. The use of Ostene in cardiac surgery may help reduce serious post-operative complications, such as the separation of the sternum or sternal wound infection. Wax-like and malleable during application, the biomaterial dissolves rapidly and is eliminated from the body unmetabolized within days after surgery. Ostene(R) is used in cardiac, orthopedic, and oral surgery and in neurosurgery.

Ostene(R) is the only product specifically designed to stop bone bleeding in surgery that will not interfere with bone healing or increase the risk of surgical infections. Other applications under development include the use of Ostene(R) as a safe, soluble delivery vehicle for a variety of therapeutic agents, 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 on our alkylene oxide copolymers' unique properties, we are currently developing the next generation of Ostene(R), otherwise known as AOC, available in various levels of viscosity, from paste to a hard solid. AOC has great potential as an inert, soluble carrier that delivers a broad range of therapeutic agents to bone defects, from antibiotics to growth stimulants, without increasing risk to patient. We are able to custom-manufacture compounds using each OEM proprietary material in combination with the AOC carrier."

About The Company:

Ceremed, Inc. is a privately held medical device corporation formed in 2002 by a surgeon and a group of scientists from the University of Southern California. The company has unique expertise and a portfolio of innovative proprietary technology in the field of soluble alkylene oxide copolymers (AOC). These copolymers have multiple medical applications, including bone hemostasis, porous implant coatings, and delivery systems for a variety of therapeutic agents.

For additional information about the Company or for an abstract of the study, please contact Danielle Nolan at 310-815-2125 or info@ceremed.com

CONTACT: Danielle Nolan, +1-310-815-2125, info@ceremed.com



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