BioLife Solutions CryoStor® Cell Freeze Media Used in Mayo Clinic Safety and Feasibility Study of Umbilical Cord Blood-Derived Cells for Pediatric Cardiac Regeneration

No Mortality or Toxicity Noted With CryoStor Deployed as Vehicle Solution for Cells and Placebo in Direct Intramyocardial Injections

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BioLife Solutions, Inc.

Mar 03, 2015, 06:00 ET

BOTHELL, Wash., March 3, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), today announced its CryoStor cell freeze media was utilized in a porcine animal study of umbilical cord blood-derived mononuclear cells (UBC-MNC) to evaluate the safety and feasibility of these cells for cardiac regeneration in pediatric congenital heart disease (CHD).

The safety and feasibility study was performed at the Mayo Clinic in Rochester, Minnesota, with the results recently published in an article titled Safety and Feasibility for Pediatric Cardiac Regeneration Using Epicardial Delivery of Autologous Umbilical Cord Blood-Derived Mononuclear Cells Established in a Porcine Model System, which appeared in the peer reviewed clinical journal Stem Cells Translational Medicine.

Umbilical cord blood-derived mononuclear cells were frozen in protein-free, serum-free CryoStor CS10, containing 10% dimethyl sulfoxide (DMSO). Thawed cells were administered to piglets via intramyocardial injections, with follow up extended to three months. CryoStor CS10 was also used as the placebo control solution without cells, which was injected into randomized piglets.

The authors observed no mortality or toxicity in any study animals and concluded:

"To date, no large clinical trials have been reported using any type of stem cells to augment CHD management in the pediatric setting."
"… there are no long term safety studies that have investigated the comprehensive profile of UCB-MNC transplantation into juvenile cardiac tissue recapitulating the pediatric setting."
"… this clinical-grade pipeline has now established the baseline safety profile of autologous UCB-MNC that demonstrates no measurable toxicity attributable to cell-based cardiac regenerative strategies within the innate physiological challenges of a juvenile/pediatric heart."
"The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD."

Mike Rice, BioLife President & CEO, stated, "The data from this study further support the use of our proprietary biopreservation media products in clinical applications. We are quite pleased to have an institution as renowned as the Mayo Clinic evaluate and use our products in their important clinical research."

BioLife management estimates that the Company's CryoStor cryopreservation freeze media and HypoThermosol^® storage and shipping media have been incorporated into the manufacturing and clinical delivery protocols of more than 175 cell and tissue-based regenerative medicine clinical trials for new products and therapies.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol^® and CryoStor^® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media 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 commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

This press release contains forward-looking statements, including, but not limited to, statements concerning the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; reliance upon SAVSU for completing the development and manufacturing of biologistex CCM's products; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.