PLYMOUTH, MA (February 5, 2001) - Harvest®Technologies Corporation, announced today that it had received its second FDA clearance on its SmartPReP™ PRP System. The SmartPReP is designed 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 can be mixed with autograft or allograft bone grafting material prior to application as deemed necessary by the clinical use requirements. The process makes available PRP for mixing with bone grafting materials for delivery to the intended site using a bone graft delivery syringe or other suitable mixing containers (e.g. bone grafting material mixing cup). The platelet rich plasma may improve the handling characteristics of the bone graft material, facilitate fixation of the bone graft material to the intended surgical site and may help to optimize conditions for bone healing.
The Harvest FDA clearance is the first issued for any clinical PRP indication. Platelets natural physiological function is to release proteins that can promote cell migration and growth. For years, clinicians have taken advantage of this function, using platelet rich plasma (PRP) as a means to potentially assist healing in numerous clinical applications, including bone graft procedures. However, up until now, PRP collection was accomplished using devices cleared for other clinical applications. The Harvest SmartPReP System is the first and only device to receive marketing clearance for preparation of autologous PRP for bone grafting procedures. The SmartPReP System provides a simple and reproducible process to prepare PRP at the patients' point of care using only a small sample of the patients' blood (approx. 50cc). The entire process is completely automated and takes less than 15 minutes.
Mr. Gary Tureski, Harvest's President states: "We see PRP eventually being utilized in a multitude of surgical procedures as a natural, safe autologous biologic. This clearance is the first step that will position Harvest to aggressively participate in the rapidly growing Autologous Biologic Market (biologically based products that aid in replacing, repairing, and regenerating tissue). Harvest believes this FDA clearance will also significantly aid its strategic partner Depuy Orthopedic (a Johnson & Johnson Company) in their entry in the rapidly growing orthopedic biomaterials market." Depuy markets the Harvest SmartPReP under the Symphony™ label to the orthopedic markets in the US and has an option for international markets.
For more information contact:
Harvest Technologies Corporation
40 Grissom Road
Suite 100
Plymouth, MA 02360
Tel: 508-732-7500
Fax: 508-732-0400
Email: info@harvesttech.com