PLYMOUTH, MA January, 2004 - Harvest® Technologies Corporation, announced today that it had received authorization to mark its Autologous Thrombin Kit with the CE Mark and will begin immediate distribution in the European Union. The Autologous Thrombin Kit is a complete system which includes all reagents and necessary components to rapidly produce 4 cc. of autologous thrombin from only 8 cc. of whole blood. The Kit was designed to work in conjunction with the SmartPReP Platelet Concentrate System or as a stand alone system. Autologous thrombin produced by the Kit may be co-administrated with Harvest’s platelet concentrate APC+ product to produce a bioactive clot within 10 seconds.
The CE Mark for the Harvest Autologous Thrombin Kit is significant since it directly replaces bovine thrombin for which there is no readily available supply in the EU market. Platelet concentrates have not produced the interest within the EU as they have in the US mainly due to the lack of availability of a thrombin source. The platelet concentrate requires proper activation to release its wound healing proteins to accelerate the bodies healing process. Several attempts to produce an activation product such as calcium chloride have met with limited success due to their slow clotting times and partial to poor release of healing proteins. As a result patient outcomes have been limited.
Harvest GMBH, located in Munich, Germany, is planning to introduce the new Harvest Autologous Thrombin (HAT) to key customers as soon as next week. The availability of autologous thrombin in conjunction with Harvest's SmartPReP System will allow Harvest to market an extremely unique product, an autologous biologic to accelerate healing that is also an autologous haemostatic to aid in the cessation of capillary bleeding. This new product offering positions Harvest to participate in these large European markets with a unique proprietary product. Harvest is currently seeking partners for the fast entry into these markets.
Mr. Gary Tureski, Harvest's President, states: “With the concern over animal derived products in Europe we see our totally autologous product offering as a safe, effective, low cost option allowing Harvest to aggressively participate in the rapidly growing European biologic and haemostatic markets. The autologous thrombin system is being documented under an approved IDE for a future approval for the US market. We believe the future will only yield a greater concern over animal derived products. Harvest is focused on developing autologous biologically based products to help the body heal naturally.”
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