BioLife Solutions Provides Update on Clinical Use of CryoStor® and HypoThermosol® Cell and Tissue Biopreservation Media Products
Proprietary, Clinical Grade Media Could Emerge as Gold Standard for Freezing, Storing, and Shipping Source Material and Manufactured Cell Products in High Growth Regenerative Medicine Market
BOTHELL, Wash., Sept. 3, 2013 /PRNewswire/ — BioLife Solutions, Inc. (OTCQB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media products for cells and tissues, and contract aseptic media manufacturer, today published on its corporate website an updated listing of over 85 clinical trial and hospital -approved uses of its proprietary biopreservation media for cells and tissues. The Company’s cGMP, protein-free, serum-free CryoStor freeze media and HypoThermosol storage and shipping media are currently incorporated as ancillary or excipient reagents used to store, ship, and freeze cell and tissue source material such as peripheral and cord blood, bone marrow, skeletal muscle tissue, skin, and cartilage, and also a great variety of final cell dose formulations currently in FDA and internationally approved clinical trials for treatment of heart disease, movement disorders, stroke, vision loss, neurologic disorders, various cancers, and other life-impacting and life-threatening diseases and disorders.
Mike Rice, BioLife Solutions President and CEO, remarked on the growing adoption of the Company’s biopreservation media products by stating, “We are very pleased to provide an update to our customers, shareholders, and industry on the significant traction and franchise we have built as a supplier of critical reagents to the high growth regenerative medicine market. While the use of home-brew biopreservation media cocktails remains a traditional, non-optimized approach in clinical applications of cells and tissues, the quality profile and superior preservation efficacy of HypoThermosol and CryoStor are causing many groups designing clinical trials to evaluate and adopt our proprietary products. Existing customers are also maintaining their preference for our products in their subsequent applications, since the value and benefits have previously been quantified and qualified in their manufacturing and quality systems.”
The regenerative medicine market is expected to grow to more than $35 billion by 2019, according to TriMark Publications’ recently published “Regenerative Medicine Markets” report. BioLife’s addressable portion of the market is the demand for reagents used to store, ship and freeze source material and manufactured doses of cell-based products and therapies.
Rice continued, “Most of our regenerative medicine customers are progressing to complete Phase II trials, and while we cannot predict which customers will obtain regulatory approval and successfully commercialize their cell and tissue based products, our regenerative medicine franchise represents a significant long term potential growth area for revenue, profit, and shareholder value. Sequential quarterly revenue from the regenerative medicine segment is highly unpredictable due to the nature of clinical trial enrollment, but we are confident that apart from the hospital-based applications where annual demand for our products is lower, any single commercial customer obtaining regulatory approval and commencing commercial shipments of their regenerative medicine product represents a significant increase in product sales revenue.”
To view a listing of clinical trials and uses incorporating BioLife’s HypoThermosol and CryoStor biopreservation media products, please visit www.biolifesolutions.com/cryostorclinicaluse and www.biolifesolutions.com/hypothermosolclinicaluse
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions for cells, tissues, and organs. The Company’s proprietary HypoThermosol(®) and CryoStor(®) platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife’s enabling technology provides academic and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. BioLife Solutions is certified to ISO13485:2003. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions’ actual results to differ materially are discussed in the Company’s recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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