LAUSANNE, Switzerland, and IRVINE, Calif., Dec. 1 /PRNewswire-FirstCall/ -- IsoTis OrthoBiologics (SWX/Euronext Amsterdam: ISON; TSX: ISO) announces the establishment of EpiSource to create an independent vehicle and a potential spin-off company for its wound management portfolio. EpiDex, Allox, and AcuDress, the three products that constitute the EpiSource portfolio, have all achieved major milestones.
The Swiss agency OFAS has approved the reimbursement of EpiDex, an innovative solution for the treatment of recalcitrant skin ulcers, starting January 1, 2004 for an initial period of two years. EpiSource intends to commercialize EpiDex in Switzerland through an independent distribution channel.
Patient recruitment for the Allox Phase II dose escalation trial has been recently completed as scheduled. Data analysis is anticipated for June 2004, and an IND filing with the US Food and Drug Administration in the course of September 2004. Allox is the subject of a high-profile deal with US market leader HealthPoint Ltd. that was concluded in August 2003. HealthPoint will assume further clinical and commercial development of Allox once the IND filing is approved.
AcuDress, a cutting-edge burn wound treatment, has been successfully transferred from Bilthoven, The Netherlands, to EpiSource in Lausanne, Switzerland, and will in future be manufactured and shipped from there.
Jacques Essinger, Chief Executive Officer of IsoTis Orthobiologics, said: "We are very gratified with OFAS' re-evaluation of EpiDex and its reimbursement in the Swiss market. Patients and medical professionals in Switzerland will now get access to state-of-the-art wound management technology that goes beyond the traditional treatment paradigm. With EpiDex reimbursed, AcuDress on the market, and Allox meeting its critical milestones, the commercial value of the pipeline of the new subsidiary EpiSource is materializing, giving it an excellent position to seek partners in Switzerland to further advance its business potential."
Profile IsoTis OrthoBiologics
IsoTis OrthoBiologics was created in Q4 2003 through the merger of GenSci OrthoBiologics, a US-based orthobiology company, and IsoTis SA, a Swiss-Dutch biomedical company. IsoTis OrthoBiologics has approximately 150 employees, a product portfolio with 6 orthobiology products on the market and 9 others in development, pro-forma product sales of US$ 23 million in 2002, an established North American independent distribution network of 400 sales representatives, and a rapidly expanding international presence.
The field of orthobiologics combines advances in biotechnology, materials sciences and tissue biology to promote and enhance the body's natural ability to regenerate and repair musculoskeletal tissue. The company is a dedicated and global orthobiologics player focused on the market of orthopaedics and bone graft substitutes. IsoTis is developing a broad presence in both "natural" demineralized bone matrix (DBM) products and "synthetic" bone graft substitutes, carrier technologies and biologically-based growth factors. Orthobiologics is the fastest growing segment of the US$16 billion orthopedics market.
For additional information on IsoTis Orthobiologics, its products, and the orthobiologics market, please visit the company's new website at http://www.isotis.com/.
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