ATLANTA, Sept. 13, 2006 (PRIMEZONE) -- Clearant, Inc. (OTCBB:CLRI) announced that the company is now profiled on Market-Pulse.com. Individuals interested in more information on the company can view the profile at http://www.market-pulse.com/clriprofile.htm. Clearant, Inc. is a leading biotechnology company engaged in acquiring, developing, and marketing its pathogen inactivation technology, the patented protected Clearant Process(r) to producers of biological products, such as devitalized musculoskeletal tissue allograft implants, plasma protein therapeutics, recombinant protein therapeutics, medical devices, and blood and blood-related products.
The Clearant Process(r) offers manufacturers of therapeutic protein products to provide inactivation of a spectrum of pathogens at various stages in the manufacturing process, including treatment of source materials, growth media, in-process intermediates, or terminal sterilization of the final product. Clearant now offers its sterile implants for both soft tissue and cervical spinal bone allograft surgeries through its direct distribution channel.
By expanding its direct distribution initiative to include both soft and cervical spinal bone implants, Clearant has increased its addressable market from $100 million or more per year (for cervical spinal implants) to $350 million or more per year (for both soft tissue and cervical spinal implants). Cervical fusion and sports medicine surgeries using Clearant Sterile Implants were successfully performed at five leading medical institutions across the country in July.
Clearant recently announced that Phil Davidson, M.D., orthopedic surgeon at Tampa Bay Specialty Surgery Center presented clinical performance data on Clearant Process(r) implants at the American Association of Tissue Banks (AATB) Annual Meeting in San Diego. The new study concluded that allograft implants sterilized by the Clearant Process(r) achieved full recovery of range of motion at one year. The study evaluated 49 patients at 12 months post operatively following ACL surgery with tissue treated with the Clearant Process(r).
Alain Delongchamp, CEO of Clearant commented, "The recent events in the tissue industry continue to underscore the need for pathogen inactivation technologies that will protect patients against the risk of bacterial or viral infection associated with allograft tissue implants. Patients undergoing ACL reconstructive surgery deserve the assurance that their allograft implant is free of all bacteria and viruses. By offering a Clearant Process sterile implant with favorable patient outcomes, surgeons can offer peace of mind to their patients."
To date, Clearant has signed a total of 11 agreements with customers to utilize the Clearant Process(r) with their products. Through June 2006, they have signed six licensing agreements with tissue banks, and one with a manufacturer of recombinant protein products, in return for milestone payments and royalties on end-product sales. Clearant Process(r)-treated tissues produced by the company's licensees have been implanted by doctors in more than 8,000 patients since January 2004. The estimated 2005 $800 million to $1 billion U.S. tissue market made up of ligament, tendon and bone allografts is expected to grow to an estimated of 15-20% per year (Source: Emerging Growth Equities). Clearant anticipates that the number of tissue implants may increase as the market perceives these tissues to be safer due to the GTP regulations and the availability of an effective sterilization technology like the Clearant Process(r).
Worldwide end-product sales of biotechnology recombinant products are estimated to have been approximately $46.6 billion in 2003 and are expected to be approximately $74.6 billion in 2006, highlighting the need for a terminal sterilization step that can be economically scaled to accommodate this growth with minimal disruption of an existing manufacturing infrastructure. (Source: Ernst & Young 2004 Global Biotechnology Report.)
Dutton Associates recently updated its coverage of Clearant Inc. for announcement of formation of the FDA tissue safety task force, maintaining its rating at Speculative Buy and a $3.00 price target. Beyond the initial allograft tissue market, the company believes there are opportunities to apply its technology to the broader devitalized human tissue implant market. Clearant, Inc. is well positioned to take advantage of the changes facing the devitalized musculoskeletal human tissue allograft implant (tissue) market.
About Clearant, Inc.
Clearant, Inc. is a leader in pathogen inactivation for biological products. Clearant has developed the patent-protected Clearant Process, which substantially reduces all types of bacteria and viruses in biological products while maintaining the functionality of the underlying tissue implant or protein. The Company began to distribute directly to surgeons, hospitals and clinics Clearant Process sterile implants in June 2006; in addition, Clearant continues to license the Clearant Process and provides its patented sterilization services to tissue banks and other biological products manufacturers. As of the end of 1Q 2006, Clearant had 10 license and service agreements with tissue banks. To date more than 8,000 patients have been successfully implanted with Clearant Process sterile implants supplied by one of the Company's licensed partners. Whereas various competing sterilization methods only kill specific types of pathogens (such as bacteria or lipid-enveloped viruses) for specific products, the Clearant Process reduces all types of pathogens for products across many market segments including tissue implants, plasma proteins, recombinant products, medical devices and blood products. Also, the Clearant Process can be applied at various stages of product processing and/or manufacturing, including in the final packaging. For more information, please visit www.clearant.com.
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