2014

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).
 
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SOURCE Harvest Technologies Corporation

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