HYPERBARIC ACHIEVES 7-DAY BLOOD PLATELET PRESERVATION.
"This achievement positions us for FDA approval and commercialization of our technology," Harry Masuda, HyperBaric CEO, said.
A seven-day platelet storage time has been an objective of blood bank administrators, and product managers for many years according to Vince Yalon, Administrator for the Stanford University Blood Center.
"Seven days would allow blood centers to better manage platelet inventory and reduce expenses and outdating, which now cost blood centers many hundreds of millions of dollars annually," Yalon stated.
Attempts by other individuals and organizations to store platelets at refrigerated temperatures have failed because of the extreme sensitivity of platelet cells.
Additionally, the additives used to protect the platelets from the cold temperatures were found to be ineffective.
"Although platelets stored in the cold without our patented process may exhibit some platelet function, they change their shape from discs to spheres within three to four hours, rendering them clinically useless after infusion," according to Dr. David Lucas, Scientific Director at HyperBaric.
"We are at the point where we have to take our technological accomplishments to the world blood market environment where they will be used for humanity."
"Refrigerated platelets should reduce the risk of infection after infusion because bacteria growth is minimized in comparison to platelets stored at room temperature," stated Dr. Paul Ness, director of Transfusion Medicine at Johns Hopkins Hospital.
"If HyperBaric Systems has achieved functioning platelets after seven days of refrigerated storage this will be a major step in reducing a serious transfusion problem."
According to Dr. Luis Toledo, HyperBaric's chief medical officer, "Platelet quality should be enhanced under refrigeration because cells decay at a much slower rate than platelets stored under current room temperature conditions."
"These test results are extremely significant. No one has ever come close to what we have accomplished. We actually have a potentially viable commercial product right now."
"These somewhat extraordinary results put us in good shape to reach even further milestones with very sophisticated and delicate modifications of our solution and procedures," he said.
Dr. Michael Strong, executive vice president Operations for the Puget Sound Blood Center, described the seven-day test results as "certainly a first, and a major breakthrough."
"We have an average platelet outdate rate of 15% which represents losses of several millions of dollars over the years," Strong said.
"Increased mandatory testing for bacterial and viral infections takes more time now than ever before. This additional shelf life will provide us with great savings in time and money."
"Major efforts now underway by companies to inactivate viruses and other pathogens in blood products may be unnecessary for blood platelets," according to Masuda.
"The main objective of inactivating bacteria and viruses in platelets is to extend the shelf life to seven days. We have now accomplished this without inactivation."
"The additional process of removing the toxic chemicals present in most inactivation processes will be expensive and reduce platelet quality," Masuda added.
"Our current process includes solutions that we believe can be directly transfused into the patient without washing the platelets."
HyperBaric Systems is headquartered in Palo Alto, California with additional research and testing facilities or offices in Russia, Michigan and the greater San Francisco Bay Area.
For more information, call 650/323-0943 or 800/631-8127.
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|Date:||Jun 1, 2001|
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