September 21, 2018
COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance and is proceeding with a full commercial launch of BIOSPHERE® MIS PUTTY. BIOSPHERE® MIS PUTTY utilizes a pre-loaded bone graft cannula and trigger-based delivery system specifically designed for the unique challenges of minimally invasive surgery (MIS). The system permits controlled placement of Synergy’s proven, next-generation bone graft product (BIOSPHERE®PUTTY) in open, mini-open, and percutaneous minimally invasive settings.
“BIOSPHERE® MIS PUTTY was engineered to create a functionally ergonomic and easy to use bone graft delivery system,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “With the launch of BIOSPHERE® MIS, surgeons now have the means to precisely deliver BIOSPHERE®PUTTY to the surgical location.”
The BIOSPHERE® MIS PUTTY bone graft delivery system consists of a hand-held dispenser and cannula pre-loaded with BIOSPHERE® PUTTY. The system is easy-to-use and has a one-step assembly process that is achieved by attaching the cannula to the dispenser. As the trigger is engaged during delivery, a metered amount of BIOSPHERE® PUTTY is extruded from the cannula. By design, BIOSPHERE® MIS PUTTY can be extruded around implanted hardware or to remote anatomic locations in a targeted fashion. Delivery is controlled and stops as soon as the trigger is released. The dispenser and cannula were specifically engineered with a narrow sight line profile that maximize the surgeon’s view during graft placement. BIOSPHERE® MIS PUTTY is available in a kit (that includes a dispenser and putty-filled cannula), and also individual replacement cannulas to reload the delivery system, if additional bone graft is needed.
“The BIOSPHERE® MIS PUTTY delivery system improves the ability of a surgeon to place a bone graft material at a desired location. The system is significantly easier to use than standard graft funnels and allows for increased graft delivery due to the targeted placement,” stated Dr. Derek Thomas, MD. “The BIOSPHERE® MIS PUTTY delivery system is not only useful for MIS procedures, but also for open procedures with hard to reach graft areas.”
BIOSPHERE® MIS PUTTY utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a moldable bone graft material that has one of the highest bioactive glass contents on the market.
Synergy will be showcasing BIOSPHERE® MIS PUTTY and other products at Booth 2555 at the 2018 North American Spine Society Meeting in Los Angeles (September 26th – 28th).
About Synergy Biomedical, LLC
Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.