Breakthrough Results Shown in Blood Platelet Storage Research.

Business Editors

PALO ALTO, Calif.--(BUSINESS WIRE)--Jan. 17, 2001

HyperBaric Systems (OTCBB:HYRB) (www.hyperbaricsystems.com), a Palo Alto-based bio-medical technology company with research laboratories in Krasnoyarsk, Russia, is quietly making dramatic breakthroughs in the preservation of platelets, the clotting component of blood.

Harry Masuda, CEO and founder, announced today that they have completed a series of research tests that have produced results he describes as a milestone event. "Using our proprietary technology, we have, in essence, preserved functionality and shape of refrigerated blood platelets for a longer period than any other research group in history," he said.

"All the papers we have researched and all the people we have spoken to including doctors, scientists and professors, have very specifically stated that prior to our testing, 100% of all platelets were transformed from discs to spheres within a four hour period after refrigeration," continued Masuda. "Prior research has shown that platelets that have undergone this transformation will not survive for more than a few hours after transfusion. The platelets must be able to survive for at least two days, particularly to help cancer patients who have been treated in chemotherapy programs."

The HyperBaric Systems recent testing program showed the following results:

(a.) After 24 hours of refrigeration: Up to 95% of platelets were intact, and 68% retained their shape.

(b.) After 5 days of refrigeration: Up to 83% of platelets were intact, and 10% retained their shape.

It is generally conceded by the international medical community that the collection and preservation of blood is in a crisis state. Although blood donations have increased by more than 2% during the past year, the need for transfusions has increased by more than 4%.

More than $500 million worth of blood platelets had to be discarded last year because they couldn't be used in time. "When catastrophic events occur and the available blood supply is used up, it encourages people to donate more blood, but because of the current short storage capabilities, these donations sometimes become discarded," said Masuda. "Luck, timing and publicity all play a role in this delicate scenario."

Dr. Michael Strong, Operations Director for the Puget Sound Blood Center, said that more blood donors are needed every day. "We have a significant problem with blood supply and it would be of great benefit if we could store platelets longer," he said. "Platelets are in great demand, particularly in cancer centers. The accomplishments of Hyperbaric Systems are unprecedented and very important."

Currently, regulatory authorities allow storage of blood platelets for no more than five days and they must be stored at room temperature. "This greatly increases the risk of bacterial growth and decay of platelet function," stated Masuda. "Our initial goal is to double the preservation life of blood platelets, which, in essence, will virtually solve the current blood shortage crisis and potentially save hundreds of thousands of lives throughout the world. Once we are satisfied that we have maintained platelets with the desired characteristics after five to seven days cold storage, it is our intent to rapidly begin preliminary clinical studies of the survival of these platelets after transfusion into human subjects."

The team of medical technicians and scientists at HyberBaric Systems is using a three-tiered approach in their quest to meet this elusive but attainable goal. "We are combining our proprietary cooling technology, non-toxic preservation solutions and precise timing methods," said Masuda. "After more than two years of intense research and testing, we are beginning to see a clear light at the end of the tunnel."

In the initial research testing, HyperBaric Systems applied the use of hyperbaric conditions in combination with reduced temperatures, based upon their proprietary biophysical intellectual property. This procedural and biophysical implementation was utilized to maintain the integrity function and membrane activity of platelets in cold storage.

Although this approach was met with a considerable amount of success, it was obvious to the researchers that a great deal of development work remained to be done on device design, additive components and methodology to produce results positive enough to advance to clinical testing.

"The current development target is to define methodology and additive components for refrigerated storage of platelets for five to seven days without added pressure," said Masuda. "The refrigerated platelet product is intended to be superior to the current stored product because of reduced risk of bacterial growth and greater platelet function."

Dr. David Lucas, Scientific Director for HyperBaric Systems, said that they have discovered the primary obstacle to overcome in the cold storage of platelets is the membrane phase transition. "As platelets are cooled, the lower temperatures cause changes in the arrangement and physical structure of lipids in the membrane," he said. "We are making good progress and believe we are close to solving this problem. It just requires testing again and again. The positive aspect of testing for platelet preservation is that it only takes a few days to get results."

Founded in 1998, HyperBaric Systems is focused on developing safe preservation methods and products that achieve longer shelf life for blood platelets, organs and tissues. The company is headquartered in Palo Alto, with additional offices and technology centers in Michigan, Mexico and Russia.