GAINESVILLE, Fla., July 11, 2014 (GLOBE NEWSWIRE) -- AmnioLife Corporation, a human cells, tissues, and cellular and tissue-based products developer, today announced it has begun operations from its newly renovated facility based in Gainesville, FL. The Company executed a deal earlier this year for the 7,200 square foot manufacturing and research facility when an opportunity was presented to take over a location which was previously occupied by a privately held FDA-registered musculoskeletal tissue processing and manufacturing establishment until it was acquired late last year.
The Company was founded in 2013 by two American Association of Tissue Bank Certified Tissue Bank Specialists (CTBS), and is focused on the development of both acellular and cellular regenerative biologics for various surgical applications. AmnioLife filed a US Provisional Patent Application earlier this year related to its collagen preservation technology, ProLifixTM, which it is working to commercialize. Additionally, the Company is focusing on the development of a cryopreserved growth factor and stem cell composition, AmnioCelTM, an amniotic fluid-derived technology. Chris Broderick, Chief Executive Officer, states, "AmnioLife has been given an incredible opportunity to commence its early-stage manufacturing initiatives much sooner than we would have ever expected. The timing of this facility's availability to us could not have come at a more opportune time and offers us significant scalability to support our long-term objectives."
The facility design, build-out, and improvements have been led by Gene Elliott, the Company's Chief Operating Officer, who previously has been responsible for the development of 12 tissue manufacturing and processing facilities around the globe, and was instrumental in the development of BioCleanse®, a processing technology owned by Regeneration Technologies.
AmnioLife's Chief Technology Officer, Dr. Sean O'Connell, has been leading the Company's cellular product research and development. Dr. O'Connell previously served as Medical Director in Novartis Pharmaceutical's Tissue Engineering division and participated on the scientific launch of Apligraf®, a diabetic foot ulcer biologic product with over $125M in sales reported in prior years.
"There are a number of companies who have moved into amniotic technologies, many of whose products demonstrate improved surgical outcomes across various surgical applications. We feel there is an opportunity for us to provide a stronger biological characterization of our products that will allow for an improved clinical understanding of the mechanisms related to the healing properties of our amniotic technologies," stated Broderick.
AmnioLife is a human cells, tissues, and cellular and tissue-based products developer focused on placental-derived technologies, and is building a Quality System around GTP and GMP at its manufacturing and research facility located in Gainesville, FL. The Company aims to develop a strong intellectual property position, global sales channel partners, and has a seasoned management and advisory team. 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.
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