×

FL-Based Biotech, AmnioLife, Completes Product Sterilization Validation

GAINESVILLE, Fla., Apr. 08, 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 on two product categories that will allow for U.S. commercialization. The products include a human amniotic collagen membrane allograft, ProLifixTM, and an injectable acellular amniotic fluid allograft, XceedTM. The Company is manufacturing both products at their Florida based facility acquired in 2014.

The Company also completed a series of preclinical studies to characterize collagen retention, protein integrity, presence of growth factors, as well as quantify protein concentrations, providing a profile of the biological morphologies and properties of their products. Product literature will summarize the results as well as potential clinical applications.

AmnioLife Corporation utilizes GxP-implemented manufacturing software to allow for serialized inventory and traceability of donor material and the resulting products. The Company anticipates continued growth into additional biological manufacturing categories.

About AmnioLife

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.

Contact Information: AmnioLife Corporation 352-505-3363 Investors: investor.relations@amniolife.com Media: press@amniolife.com

Source:AmnioLife Corporation