IRVINE, California, May 3 /PRNewswire-FirstCall/ -- IsoTis, Inc. , the orthobiologics company, today announced that the United States Patent and Trademark Office has awarded US Patent No. 7,205,337, which relates to the company’s Reverse Phase Medium (RPM) carrier technology.
The patent covers the use of IsoTis’ current RPM technology in combination with various demineralized bone matrix (DBM) formulations, such as those based on the company’s innovative Accell technology. IsoTis has also received a notice of allowance for a patent application covering the use of the entire RPM formulation in combination with a complete range of synthetic and natural bone graft substitute compounds.
The favorable handling characteristics of a number of IsoTis’ products, such as Accell Connexus, are to a large extent attributable to the RPM technology. RPM technology enables the product to flow at operating room temperature but thicken to a gel when placed in the body and warmed to body temperature. Orthopedic surgery is often open surgery, requiring regular irrigation and suction at the surgical site to clear the operating field. RPM enables the surgeon to shape and form the product outside the body to fit the surgical site, and once the product is placed within the body, it thickens and can resist displacement by irrigation. By resisting displacement, more of the components with osteoinductive potential of the product are held in place at the graft site, where they can effect bone formation.
Pieter Wolters, President and CEO of IsoTis said, “The RPM technology is an essential part of a number of our products. We believe that RPM contributes to the favorable handling characteristics of our products, which differentiate us from other products in the market. Following the key patent awarded last year for our Accell platform technology, we believe this patent and the notice of allowance further secure intellectual property protection for our 2nd platform technology. “
About IsoTis, Inc.
IsoTis is a leading orthobiologics company that develops, manufactures and markets proprietary products for the treatment of musculoskeletal diseases and disorders. IsoTis’ current orthobiologics products are bone graft substitutes that promote the regeneration of bone and are used to repair natural, trauma-related and surgically-created defects common in orthopedic procedures, including spinal fusions. IsoTis’ current commercial business is highlighted by its Accell line of products, which the company believes represents the next generation in bone graft substitution.
Certain statements in this press release are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including those that refer to management’s plans and expectations for future operations, prospects and financial condition. Words such as “strategy,” “expects,” “plans,” “anticipates,” “believes,” “will,” “continues,” “estimates,” “intends,” “projects,” “goals,” “targets” and other words of similar meaning are intended to identify such forward-looking statements. One can also identify them by the fact that they do not relate strictly to historical or current facts. Such statements are based on the current expectations of the management of IsoTis only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of IsoTis. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting IsoTis’ business, including, but not limited to, a competitive sales and marketing environment, the timely commencement and success of IsoTis’ clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (a.o. EMEA, CE), including the risk that the FDA determines that our Accell Putty and Accell TBM products are not human tissue or class II medical devices, that the Company is unable to obtain 510(k) clearance for its Accell products, that the FDA requires the Company to obtain premarket approval of its Accell products prior to continuing their marketing, that the FDA requires the Company to produce additional clinical data to support approval or clearance of its products, that the FDA imposes compliance measures against the Company for the marketing of its Accell products, including imposing fines and injunctions or causing the Company to recall its Accell products, market acceptance of IsoTis’ products, effectiveness of IsoTis’ distribution channels, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet, conditions imposed for required governmental and regulatory approvals and consents. IsoTis expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting IsoTis, refer to the Annual Report on Form 20-F for the fiscal year ended December 31, 2005 of IsoTis SA, the predecessor of the Company, filed with the SEC, to IsoTis SA’s reports filed from time to time with the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V., SEDAR at www.sedar.com and the Toronto Stock Exchange (TSX), and to the reports filed from time to time by the Company with the SEC.
Isotis Inc
CONTACT: For information contact: Rob Morocco, CFO,+1-949-855-7155,robert.morocco@isotis.com; Hans Herklots, Director IR, +1-949-855-7195 or+41-21-620-6011, hans.herklots@isotis.com
