Harvest Receives FDA Concurrence to Market its SmartJet(TM) Bone Grafting Applicator System
Harvest receives FDA clearance to market its SmartJet(TM) Bone Grafting
Applicator system. The SmartJet is designed to facilitate pre-mixing of bone
substrates and materials such as platelet rich plasma (PRP).
PLYMOUTH, Mass., Aug. 7 /PRNewswire/ -- Harvest(R) Technologies Corporation, announced today that it had received its third FDA clearance for its biomaterials product portfolio. The company received FDA clearance to market its SmartJet(TM) Bone Grafting Applicator system. The SmartJet is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials for application to a surgical site. The SmartJet can be used with I.V. fluids, autologous blood, plasma, platelet rich plasma (PRP) or other specific blood component(s) deemed necessary by clinical use requirements. Harvest Technologies had previously received FDA clearance to market it's SmartPReP(TM) Platelet Rich Plasma System as well as clinical indications for the use of PRP. The SmartPReP system is designed for the safe and rapid preparation of autologous platelet rich plasma from a small sample of blood. The PRP can be mixed with autograft or allograft bone grafting material prior to application as deemed necessary by the clinical use requirements. 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. Mr. Gary Tureski, Harvest's President states: "Whereas the SmartPReP system automates and simplifies reproducible production of PRP, the SmartJet facilitates simple, precise, and accurate deliver of PRP. The latest clearance further positions 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(TM) label to the orthopedic markets in the US and has an option for international markets. Harvest, designing innovative products for accelerating healing, naturally(TM). MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X66879452
SOURCE Harvest Technologies Corporation
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