VCU news

By Nicky Colomb
Virginia BioTechnology Research Park

Hemodyne, Inc., which has developed products to diagnosis blood disorders related to stroke and other cardiovascular diseases, will begin selling its innovative Platelet Analysis System (PAS) in Europe.

Hemodyne, founded by VCU blood disorder expert Marcus E. Carr, Jr., M.D., Ph.D., has been testing the PAS at major universities for seven years in the United States and Europe. It chose Europe as its first commercial market because hospitals, physicians and blood banks there have demonstrated a keen interest in adopting the PAS for use in four key areas:

• Gauging excessive bleeding risk prior to surgery
• Enabling, for the first time, the accurate dosing and monitoring of a variety of key cardiology and blood-disorder drugs
• Assessing, for the first time, the viability of platelets
• Determining risk for development of coronary artery disease

"Our clinical team, led by Dr. Carr, has an exquisitely complete understanding of blood, its behavior under specific clinical conditions, factors that affect that behavior and the interplay with drugs and other body systems," says Devinder Bawa, president and CEO of Hemodyne, which is headquartered at the Virginia BioTechnology Research Park. "Hemodyne's Platelet Analysis System represents the state-of-the-art in assessing platelet health and will offer physicians critical, new information to better manage patients' cardiovascular health, bleeding risk and a variety of drug therapies."

The system also will enable blood banks to assess how long they can store platelets.

"Today, the standard of care in Europe is to discard platelets after four days," says Carr, professor of internal medicine and pathology at VCU. "The PAS can, for the first time, directly gauge platelet viability. Through studies, we have shown that platelets are indeed viable substantially beyond four days. If, through our test, we can help increase the standard for platelet storage by blood banks to five days, we would have increased the world's platelet supply by 25 percent without a single additional donor. That's a remarkable opportunity."

Platelets are small pieces of cells in the blood that help to form clots that stop a wound from bleeding. Inadequate Platelet Contractile Force (PCF(tm)) can cause someone to bleed excessively, and excessive PCF(tm) could cause a patient to develop thrombosis - a potentially deadly blood clot in an artery or the heart. Hemodyne's PAS is the only method available worldwide to measure platelet force, thereby allowing direct assessment of platelet function or quality.

The Platelet Analysis System was developed by Carr at VCU and is licensed to Hemodyne. This unique technology offers two proprietary measurements: Platelet Contractile Force," or PCF(tm), and Thrombin Generation Time, or TGT(tm). PCF measures the force platelets exert during the clotting process. TGT indicates the time a patient's blood requires to produce thrombin, an enzyme that signals the start of the clotting process.

The PCF measurement will help physicians determine whether patients are at risk for various health problems, including stroke, coronary artery disease and excessive bleeding during surgery. PCF also can measure how long platelets held in blood bank storage are good. PCF(tm) and TGT(tm) can serve as "markers" for physicians, helping them to accurately dose and monitor a variety of cardiac medications as well as drugs for blood disorders.

Hemodyne's plans call for seeking FDA clearance later this year in order to offer the PAS domestically by mid-to-late 2004.