ThermoGenesis Announces 510(k) Approval for Use of Res-Q in Preparation of Platelet Rich Plasma
RANCHO CORDOVA, Calif., June 2, 2011 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, 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 (PRP) 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.
"We currently have one Res-Q PRP distribution agreement in place and, over the past several months, have had encouraging discussions with other potential distribution partners for Res-Q in the PRP market. With this FDA clearance, we hope to complete one or more additional agreements in the coming months and begin commercial sales later this year," he added.
In October 2010, the Company announced a license and distribution agreement for Res-Q with BioParadox, Inc., a newly-formed regenerative medicine company focusing on point-of-care cardiovascular therapies. Under the agreement, ThermoGenesis has granted BioParadox exclusive worldwide rights for use of Res-Q technology to automate the preparation of PRP from peripheral blood for use in cardiovascular therapy, subject to BioParadox meeting appropriate regulatory approval for use, including initiation and completion of clinical trials.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include:
- The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
- AXP® AutoXpress™ Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP™ MarrowXpress™ and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting.
- The Res-Q™ 60 BMC (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates.
- The CryoSeal® FS System, an automated device and companion sterile blood processing disposable, used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.
This press release contains forward-looking statements. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including timing of FDA approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2011, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2011. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
ThermoGenesis Corp.Web site: http://www.thermogenesis.comContact: Investor Relations+1-916-858-5107, firstname.lastname@example.org
SOURCE ThermoGenesis Corp.