SurGenTec® Receives FDA Clearance for OsteoFlo® HydroPutty™, a Hydrophilic Synthetic Bone Graft
BOCA RATON, Fla., March 07, 2024--(BUSINESS WIRE)--SurGenTec, a pioneering medical device company specializing in orthopedic and spine technologies, proudly announces the first implantations and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary OsteoFlo HydroPutty Synthetic Bone Graft.
OsteoFlo HydroPutty represents a significant advancement in bone graft technology, featuring a combination of proprietary hydrophilic carriers designed to absorb fluids such as bone marrow aspirate, blood or saline. This innovative formulation turns to a putty and offers superior handling characteristics with a resorption profile optimized for bone growth.
Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec, expressed enthusiasm about this milestone achievement: "We are thrilled to add OsteoFlo HydroPutty to our portfolio. Its unique hydrophilic bonds enable the attachment of growth factors and provide an ideal scaffolding for bone growth. This product underscores our commitment to developing next-generation solutions for physicians and patients."
OsteoFlo HydroPutty is supplied in a sterile vial as a dry formulation, accompanied by a mixing spatula. Upon the addition of fluid, the hydrophilic bonds swiftly absorb the desired fluid to form a putty with superior handling characteristics. This versatile product can be packed into voids, resists irrigation, and may even be delivered seamlessly through the Graftgun® bone graft delivery system.
Dr. Ashish Patel, MD, Chairman of Spine Surgery at Duly Health and Care, lauded OsteoFlo HydroPutty for its remarkable handling characteristics. "OsteoFlo HydroPutty, with its ability to absorb autologous blood products and its ease of use, fills a critical gap in the realm of synthetic bone grafts. Its unique capability to blend with allograft and flow through small apertures makes it extremely useful when performing both open and minimally invasive surgical procedures."
Echoing Dr. Patel's sentiments, Dr. Tim O'Connor, M.D., Neurosurgeon and Director of Minimally Invasive and Robotic Spine Surgery at Baptist Health, emphasized the product's versatility and simplicity. "OsteoFlo HydroPutty provides a transformative solution that incorporates growth factors like Bone Marrow Aspirate to enhance fusion opportunity. Most synthetic putties are hydrophobic and repel fluid. HydroPutty differentiates itself by allowing me to deliver next generation hydrophilic bone graft to maximize fusion in minimally invasive surgery."
OsteoFlo HydroPutty provides physicians with a fully synthetic bone graft option, minimizing the risks associated with human tissue. By offering cutting-edge technology while alleviating concerns such as disease transmission and storage issues, SurGenTec is empowering healthcare providers to deliver optimal care to their patients. Short-term and long-term pre-clinical studies showed excellent bone growth and integration at all time points.
SurGenTec, headquartered in Boca Raton, Florida, is dedicated to developing and manufacturing innovative products for the orthopedic and neurosurgical spine fields. With a strong presence both domestically and internationally, SurGenTec is committed to optimizing fusion through its pipeline of synthetic biologic product development.
For more information about OsteoFlo HydroPutty and SurGenTec's groundbreaking technologies, please visit www.SurGenTec.com.
About SurGenTec:
SurGenTec is a privately owned medical device company based in Boca Raton, Florida, specializing in unique technologies for orthopedic and spine treatments. With a focus on next-generation synthetics to optimize healing, SurGenTec is dedicated to advancing patient care worldwide.
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