GAINESVILLE, Fla., Sept. 24, 2015 (GLOBE NEWSWIRE) — AmnioLife Corporation, a human cells, tissues, and cellular and tissue-based products developer, today announced it has successfully completed sterilization validation testing using electron beam sterilization technology on its human demineralized bone matrix (DBM) allograft product line, Oncor™, for both U.S. and international commercialization. The Company expects to launch this product line during the fourth quarter of 2015 through its surgical distribution partners.
The Oncor™ DBM product line will be available for use in orthopedic applications such as spinal fusion, joint replacement, and trauma surgeries. The product family will consist of compressive strips, particulate, and flowable putty and moldable paste. The U.S. market for human DBM and other orthopedic biomaterials is expected to grow from $1.39B to $1.78B by 2020, or 66% market share in bone graft materials (http://healthcare.globaldata.com).
AmnioLife has successfully commercialized two other technologies it launched earlier in 2015: ProLifix™, an amniotic collagen matrix for surgical applications in various soft tissue surgeries, and Xceed™, a purified amniotic fluid product for use as a non-structural allograft used in joint and other musculoskeletal applications, for both in-office and in surgical applications.
AmnioLife is a research and development organization focused on placental-derived technologies and is building a GxP manufacturing program at its Gainesville, FL facility. The Company aims to commercialize a suite of minimally manipulated tissue products, global sales channel partners, and develop a strong IP-position for advanced biologic products. For more information, visit our website at http://www.amniolife.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws that are forward-looking, and based on the current expectations and beliefs of AmnioLife’s management team. The forward-looking statements contained in this press release are subject to a number of factors and uncertainties that could cause actual results to differ materially. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and marketplace requirements; delays or obstacles in launching and/or successfully completing some of the clinical study initiatives; products may not be approved by regulatory agencies or regulations may change affecting desired results; inability to retain or attract key employees whose knowledge is essential to the development of required technologies and products; unforeseen scientific difficulties may develop with our process; our patent(s) may not be sufficient; inability to timely develop and introduce new technologies; inability to obtain additional funding; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of AmnioLife to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, AmnioLife disclaims any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.