BioLife Solutions Customer Capricor Therapeutics Provides Update on Heart Failure Cell Therapy Safety Data at American Heart Association Scientific Sessions

Clinical Grade CryoStor® Cryopreservation Media Used to Freeze and Administer Cells to Patients in DYNAMIC Clinical Trial

23 Nov, 2015, 06:00 ET from BioLife Solutions, Inc.

BOTHELL, Wash., Nov. 23, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced its customer Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, announced positive six-month safety and adverse event data from its ongoing DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial evaluating CAP-1002 in patients with advanced heart failure.  The data were highlighted in a poster presentation on November 9 at the 2015 American Heart Association (AHA) Scientific Sessions in Orlando, FL. 

BioLife's CryoStor cryopreservation media is an integral component in the manufacturing process of CAP-1002 and is used to freeze and administer these therapeutic cells to heart failure patients.  CAP-1002 is Capricor's lead investigational allogeneic, cardiosphere-derived cell (CDC) therapy.

Multi-vessel intracoronary infusion of CAP-1002 in subjects with dilated cardiomyopathy was shown to be safe in this study with no major adverse cardiac events reported at one month or at six months post-infusion. Though this trial was intended as an early safety study, the six-month data demonstrated encouraging and congruent preliminary efficacy signals in multiple parameters, including subjective well being, exercise capacity, ejection fraction and ventricular volumes.

Mike Rice, BioLife's President & CEO, said, "We are pleased that Capricor used our CryoStor cryopreservation media in its successful DYNAMIC trial.  We look forward to the results of the HOPE-Duchenne trial, which has recently opened for enrollment, and also the ALLSTAR Phase II trial. CryoStor is also used in these clinical trials. To date, CryoStor and our HypoThermosol® cell and tissue storage and shipping media are now embedded in over 200 pre-clinical validations and clinical trials of new cell-based products and therapies."

About BioLife's Addressable Markets

In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030. The Global Healthcare Cold Chain Logistics Market Report & Forecast published by the IMARC Group forecasts that the demand for cold chain packaging and instrumentation services will grow from $3.2 billion in 2013 to $5.1 billion in 2018. BioLife management believes its addressable market for small payload shippers and related monitoring devices is several hundred million dollars.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics 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 new products, the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, and, projected financial results and liquidity. 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; 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.

Media & Investor Relations Daphne Taylor Senior Vice President, Chief Financial Officer (425) 402-1400 dtaylor@biolifesolutions.com

 

SOURCE BioLife Solutions, Inc.



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