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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