Bone graft is all about promoting bone growth.
Quadphasic Synthetic Bone Graft Cleared by FDA
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Boca Raton, Florida-based SurGenTec’s recently FDA 510(k) cleared synthetic bone graft, OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft, is the world’s “first, and only quadphasic synthetic bone graft particles with nano-surface technology,” according to an August 26, 2020 company press release.
Company CEO Travis Greenhalgh told us that OsteoFlo, “compared favorably and exhibited accelerated early bone growth,” compared to a predicate device during GLP pre-clinical testing.
It took the FDA about seven months to clear the product.
Four-In-One
Greenhalgh told us his team put four biocompatible materials with different resorption profiles into one particle with nano-surface technology. “These particles are also suspended in a unique combination of bioresorbable polymers that give the product superior handling characteristics.”
The FDA clearance documents state the graft “is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass.” The graft material also contains micro-sized hydroxyapatite (HA) particles.
Phased Bone Growth
According to the press release, quadphasic scaffolding “aids bone growth at different phases during the healing process to maximize bone growth potential.” Nano-surface technology “increases surface area and stimulates cellular activity/osseointegration.” Combining quadphasic scaffolding and nano-surface technology “provide a synergistic effect to regenerate bone efficiently.”
The company says the particles used in the OsteoFlo formulation are smaller than most synthetic bone grafts on the market. “This helps maintain flowable properties for use in minimally invasive surgery. The product requires no mixing, reconstituting or preparation prior to use. The putty doesn’t harden and can flow through tiny apertures and voids.”
The graft comes in two packaging configurations, a standard syringe, or a pre-filled minimally invasive cartridge that may be used in conjunction with the company’s patented GraftGun.
The company plans to launch OsteoFlo in October 2020, with plans of obtaining CE mark to market overseas.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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