ThermoGenesis Announces 510(k) Approval for Use of Res-Q in Preparation of Platelet Rich Plasma

ThermoGenesis Corp. KOOL said today it has received FDA clearance of its 510(k) submission for the use of its Res-Q™ 60 (Res-Q) System technology to be used for the safe and rapid preparation of autologous platelet rich plasma from a small sample of blood at the patient's point-of-care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The Res-Q 60 technology is a point-of-care platform designed for the preparation of cell concentrates. Our first product, Res-Q 60 BMC is currently used to concentrate stem cells from bone marrow aspirate. A slightly modified version has been designed for use with peripheral blood in the preparation of a PRP concentrate. PRP is a rich source of growth factors which has been shown to enhance healing. "This represents a major regulatory milestone for the Company and a key element of our product line extension strategy. The Res-Q technology is well suited for the preparation of PRP and literature has demonstrated that there is a wide range of potential applications for PRP including orthopedic and cardiovascular indications among others. Our market research suggests that this could be an important market opportunity for the Company," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.