BioLife Solutions Readies New BloodStor® 27 NaCl Cryopreservation Media to Support Customer Clinical Use of Frozen Platelets

Over 2 Million Fresh Platelet Doses Administered Annually in the US Alone; Significant Growth Opportunity to Supply GMP Freeze Media for Cryopreserved Platelets

Jul 15, 2015, 06:00 ET from BioLife Solutions, Inc.

BOTHELL, Wash., July 15, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and related cloud hosted biologistics cold chain management app for smart shippers today announced that manufacturing process validation has commenced to support the launch of a new product, BloodStor 27 NaCl, targeting end user cryopreservation applications including freezing of platelets for clinical administration. 

In the US alone, over 2 million doses of fresh platelets are administered annually.  Frozen storage of therapeutic platelets could improve logistics in caring for hemodynamically unstable patients, in situations where fresh platelets are unable to be collected or administered following collection.

Mike Rice, BioLife Solutions CEO, remarked, "We have been monitoring clinical use of frozen platelets for hemodynamically unstable patients and have been in discussions with leading international clinical centers about the need for a stable supply of GMP manufactured, clinical grade freeze media for freezing therapeutic platelets. Additionally, there is clearly strong interest to improve battlefield trauma care for wounded warriors.  We believe that we can add incremental revenue by expanding our product portfolio with this new GMP grade biopreservation media."

Ongoing military research on the use of frozen and thawed platelets includes a US Army Medical Research and Materiel Command clinical trial titled Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets (CPP1-05), to "evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion."

About BloodStor® 27 NaCl

BloodStor 27 NaCl, with a fill volume of 80 ml, has the same formulation as the home-brew media currently in use to freeze therapeutic platelets.  This pre-formulated product is packaged in sterile, single use DMSO-compatible bags with sterile weldable tubing and a separate luer connector and is quality tested against robust release criteria including sterility per USP<71>, endotoxin per , DMSO content, specific gravity, osmolality, and appearance for absence of visible particulates. BioLife expects inventory of BloodStor 27 NaCl to be available for customer orders early in the fourth quarter of 2015.  The product part number is 327207. A Master File for BloodStor 27 NaCl will be submitted to the United States Food and Drug Administration for customers to cross reference in regulatory filings.

Regulatory note: BloodStor 27 NaCl is labeled For Research Use, For Human Cell and Tissue Preservation. Customers that incorporate the product into their frozen storage protocol for cells and tissues intended for human clinical uses are responsible for validation and fulfilling any required regulatory requirements related to the use of BloodStor 27 NaCl.

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® biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  This 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, projected financial results, 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.

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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