Osiris Therapeutics, Inc. engages in the research, development, manufacturing, marketing and distribution of regenerative medicine products. The company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine—including bioengineering, stem cell research and viable tissue based products. Product Portfolio Grafix Grafix is a cryopreserved placental membrane that preserves the native properties and inherent functionality of the tissue. The conforming three—dimensional matrix is designed for direct application to hard-to-treat acute and chronic wounds, including but not limited to diabetic foot ulcers, venous leg ulcers and burns. Grafix is produced by utilizing the company’s BioSmart Intelligent Tissue Processing, which retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue. Grafix is stored at –80 degrees Celsius and has a two-year shelf life. BIO4 BIO4 is a bone allograft that contains both viable cells and growth factors. It is an alternative to autograft that minimizes the potential for harvest site co-morbidities. BIO4 includes a structural extracellular matrix, osteogenic and angiogenic growth factors, endogenous mesenchymal stem cells and osteoblasts. It possesses osteoconductive, osteoinductive, osteogenic and angiogenic properties that are required for bone repair and regeneration. Originally branded as OvationOS, the company’s viable bone matrix tissue form would be marketed by a subsidiary of Stryker Corporation (Stryker) under the brand name, BIO4. BIO4 is stored at –80 degrees Celsius and has a two-year shelf life. Cartiform 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 the company’s proprietary cryopreservation technology. Cartiform is stored at –80 degrees Celsius with a two year shelf life and could be implanted in a single step procedure. Cartiform is marketed and distributed by Arthrex, Inc. Grafix, BIO4, and Cartiform are regulated for their indicated applications by the United States Food and Drug Administration (FDA) under 21 CFR Part 1271 Part 361 of the Public Health Service Act, Human Cells, Tissues and Cellular and Tissue-based Products. The company is registered with the FDA as a tissue establishment and is accredited by the American Association of Tissue Banks. Sales, Marketing and Distribution The company markets and distributes Grafix directly to hospitals, clinics and physician offices primarily through its direct sales organization and with limited marketing through agents and distributors. The company has developed a proprietary direct sales force in the field of wound care. The company marketed and distributed Cartiform and OvationOS during much of 2014 directly to hospitals and through selected specialty distributors. BIO4: In 2014, the company entered into an exclusive, worldwide partnership with Howmedica Osteonics Corp., also referred to as Stryker Orthopaedics, a subsidiary of Stryker, for the commercialization and development of the company’s viable bone matrix allograft, previously branded as OvationOS. Beginning in 2015, Stryker intends to market and promote the viable bone matrix allograft under the name, BIO4. The company would be responsible for supply, manufacturing, inventory management, shipments to customers, continued research and product improvement activities. Stryker would be responsible for the commercialization and marketing of BIO4 for use in all surgical applications, including spine, trauma, extremity, cranial, and foot and ankle surgery. Strategy The three pillars of the company’s business strategy are to continue its history of innovation, bring about commercial transformation, and ensure differentiation of the company. Government Regulation In addition to privacy law requirements and regulations enforced by the FDA, the company is subject to various local, state and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the distribution of human tissue and tissue products, experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including chemicals, micro-organisms and various radioactive compounds used in connection with its research and development activities. These laws include, but are not limited to, the Occupational Safety and Health Act, the Toxic Test Substances Control Act, and the Resource Conservation and Recovery Act. Trademarks Osiris, Grafix, OvationOS and Cartiform are registered trademarks of the company. History Osiris Therapeutics, Inc. was founded in 1992 as a Delaware corporation.
osiris therapeutics inc (OSIR:NASDAQ GM)
7015 Albert Einstein Drive
Columbia, MD 21046
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