COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading cellular and regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today that it has entered into an exclusive commercial and development partnership for its cartilage product, Cartiform, with Arthrex, Inc. Arthrex is a global medical device company and the leader in new product development and medical education in orthopaedics and sports medicine, operating in over 90 countries throughout the world.
"We are excited to enter this strategic partnership with Arthrex, the clear industry leader in sports medicine, as well as in foot and ankle devices and instrumentation, to address an unmet need in cartilage repair that demands an innovative cellular regenerative medical solution," said Dwayne Montgomery, Osiris’ General Manager of Orthopaedics and Sports Medicine. Cartiform, a viable chondral allograft, offers a unique solution to repair and restore damaged cartilage in the knee, foot, ankle, and other major joints. Cartiform has demonstrated promising clinical outcomes.
The cartilage repair market represents a significant opportunity, with up to 500,000 patients needing treatment in the U.S. per year. Cartilage has limited ability to self-repair and the current standard of care, microfracture or bone marrow stimulation, remains unsatisfactory. Cartiform combines distinct clinical advantages of fresh stored allograft with the logistical and delivery advantages of non-viable, point of care implants.
“Arthrex is excited for the opportunity to partner with Osiris on the commercialization of the Cartiform technology. Arthrex has the product development and distribution capabilities to train and educate surgeons about the unique characteristics of Cartiform and to help them better treat their patients,” said David Shepard, Orthobiologics Director of Arthrex.
The Agreement provides Arthrex with exclusive commercial distribution rights to Cartiform. Osiris will be responsible for the manufacturing, continued research and product improvement activities. The responsibilities related to the design and conduct of future clinical development programs will be shared between both organizations.
Cartiform is a viable chondral allograft containing viable chondrocytes, chondrogenic growth factors, and extracellular matrix proteins within the intact architecture of healthy hyaline cartilage. Cartiform promotes articular cartilage repair to treat focal chondral defects. Cartiform combines the safety and proven success of fresh osteochondral allografts with ease of use resulting from Osiris’ proprietary cryopreservation technology. Cartiform is stored at -80 degrees Celsius with a two year shelf life and can be implanted in a single step procedure.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading cellular regenerative medicine company, having developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Osiris’ products include Grafix® for acute and chronic wounds, Cartiform®, a viable cartilage mesh for cartilage repair and the latest addition to Osiris’ line of products, OvationOS®, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests.
Osiris, Grafix, Cartiform, and OvationOS are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
Arthrex, Inc. is a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide. Arthrex remains dedicated to delivering uncompromising quality to the healthcare professionals who use Arthrex products, and ultimately, the millions of patients whose lives these products impact.
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our product and product candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for marketed Biosurgery products (including Grafix, OvationOS and Cartiform) and Biosurgery products under development; our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to address medical needs; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available products, to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Additional risks and uncertainties related to the sale of our ceMSC assets and the related transactions contemplated by the Purchase Agreement with Mesoblast include typical business transactional risks, the risk of changing relationships with customers, suppliers or employees, the risk associated with the disposition of our ceMSC assets and the increased relative dependence on and importance of our other business including our Biosurgery business, the risk that we may not be able to fully benefit from the transactions through milestone payments or royalties, payment risks, including the risk associated with receipt of equity as consideration, in lieu of cash, and the risk of dependence on others to achieve results upon which milestone or royalty payments to us are conditioned. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.