BioLife Solutions Products Embedded in Cook MyoSite® Phase 3 Cell Therapy Clinical Trial for Stress Urinary Incontinence

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Jul 18, 2016, 06:00 ET

BOTHELL, Wash., July 18, 2016 /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 a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced that its media products are embedded into the autologous cell therapy being developed by Pittsburgh-based Cook MyoSite, a subsidiary of the Cook Group, for treatment of female stress urinary incontinence.

In an ongoing phase 3 clinical trial, a muscle tissue biopsy is extracted from the patient and shipped to the Cook MyoSite processing lab, where the manufacturing process is completed. The manufactured dose is frozen and shipped back to the clinic, where the cells are thawed and injected back into the patient near the pelvic floor to improve bladder control.

Ron Jankowski, Vice President of Product Development at Cook MyoSite, commented, "Biopreservation management is critical to the success of our therapeutic products. We continue to gain confidence in our decision to incorporate BioLife's comprehensive biopreservation management solutions into our clinical development and commercialization plans."

Mike Rice, BioLife President & CEO, remarked, "We are very pleased to have a strong and long term relationship with Cook MyoSite. Their use of our products in their manufacturing process represents the optimal approach to maximize control of sensitive biologic materials. We look forward to data readouts on this important clinical trial and to a potential approval for this life-changing cell-based therapy for millions of patients suffering from stress urinary incontinence."

Based on early success of the technology, Cook MyoSite is expanding its manufacturing facility in RIDC park from about 21,000 to 66,000 square feet. The company is refurbishing a building next to its corporate offices, which will be redone to accommodate aseptic manufacturing practices and to create a global distribution center. Occupancy of the new building is expected by November. The company plans to invest at least $26 million into the project while continuing to explore use of its cell therapy platform for treatment of fecal incontinence and to restore tongue muscles weakened by radiation therapy. Cook MyoSite anticipates adding approximately 50 employees over the next few years to accompany the facility expansion.

About Cook MyoSite

In 2002, Cook MyoSite Incorporated was formed to guide the Cook Group organization into the expanding world of cellular technologies. Today, Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of a variety of disorders. To learn more about Cook MyoSite, visit cookmyosite.com and research.cookmyosite.com.

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. 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.

The biologistex cloud based cold chain management service is an integrated logistics and tracking and trace web app used by shippers of time and temperature sensitive biologic materials. The evo Smart Shipper is a state of the art precision thermal shipping container with embedded payload monitoring, GPS location tracking, and cellular communication electronics that transmit critical shipment information to the cloud. This SaaS app enables users to monitor high value shipments during transit and configure actionable alerts for downstream recipients for location, approaching destination, delivery, package open, and remaining shelf life or stability via the patent pending StableAlert™ countdown timer. 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, market adoption of biologistex, commercial manufacturing of our customers' products, potential proceeds from the credit facility, and projected financial results, cash flow and liquidity, including the potential for reaching positive cash flow from operations next year. 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
Roderick de Greef
Chief Financial Officer
(425) 686-6003
[email protected]

SOURCE BioLife Solutions, Inc.