Bridge to Life product receives FDA labeling approval

March 3, 2009

Ruling allows company to expand use of its organ storage solution

COLUMBIA, SC – March 2, 2009 – Bridge to Life, a development and commercialization-stage biotech company today announced that the U.S. Food and Drug Administration has given approval for a label change to the company’s Belzer UW® Cold Storage Solution, which is used in preserving donor transplant organs during procurement and shipping.  The label-change approval allows for Bridge to Life’s solution to be shipped and stored at room temperature.

The current leading brand of cold storage solution for donor organs must be transported and stored refrigerated at between two and eight degrees Celsius, according to FDA regulations.

“This approval by the FDA shows what great potential the Belzer storage solution can offer our customers. Our Cold Storage Solution product will help organ procurement organizations reduce costs and allow them to focus more on getting organs to locations where they are needed. It is a great credit to Bridge to Life’s development partners, and we are excited to continue providing state-of-the-art storage solutions to all our clients,” said Steve Schweighardt, Chief Executive Officer for Bridge to Life.

Prior to this Bridge to Life FDA approval, organ procurement organizations were required to maintain large refrigeration units, connected to backup generators in case of a power outage. However, prolonged power outages can lead to the organ procurement organization losing large batches of storage solution, in some cases losing as much as $100,000 or more. With Bridge to Life’s storage solution, which will carry a “room temperature” label, that problem has been eliminated.

“Providing innovative products is the cornerstone of success in any technology industry, and that is especially true in the biotech sector. We congratulate Bridge to Life on its research success and FDA approval of the label change for its product.  Bridge to Life is innovative in its field and a welcome addition to the state’s biotech community,” said Joe Taylor, Secretary of Commerce.

“We congratulate Bridge to Life on their FDA labeling approval, another important milestone for the company’s continuing success,” said Bill Mahoney, SCRA chief executive officer. “We are pleased to support Bridge to Life through our SC Launch program in partnership with the Department of Commerce, the Central S.C. Alliance and Richland County.”

Earlier this year, Bridge to Life announced that it would invest in South Carolina by establishing a new global headquarters facility in Columbia. The company stated it plans to invest $45 million in the venture and expects to create 70 new jobs.

The company is also pursuing other advances in the procurement and storage market, as well as the organ viability market segment. Bridge to Life’s liposomal ATP technology will significantly increase the amount of time an organ can be stored and improve the overall number of viable organs that can be procured.

Bridge to Life Ltd. is a development and commercialization-stage biotechnology company formed to advance the science of organ preservation and to develop, manufacture and sell medical technologies.  The company is a leading manufacturer of specialty medical solutions, offering services and products to the organ transplant community, as well as to physicians and hospitals.