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DirectSync Surgical received Breakthrough Device Designation from FDA for its patient-powered smart spinal fusion device.
The company has developed a human-powered smart implant that harvests its charge from the patient’s natural walking motion. That energy powers small pulses of DC electrical stimulation to promote bone healing.
To meet the designation criteria, FDA has reviewed the company’s preliminary data and determined that the DirectSync Surgical interbody device may provide a more effective treatment of an irreversibly debilitating condition than the current standard of care. The product delivers localized electrical stimulation and provides post-operative diagnostics to achieve fusion more effectively for patients indicated for spinal fusion. The implant can sense and transmit load data to inform treatment decisions.
“Today’s announcement is an important milestone for DirectSync Surgical and highlights the urgent need to improve spinal fusion outcomes while empowering physicians and their patients with a more robust post-operative continuum of care,” said Zygmunt Porada, CEO of DirectSync Surgical. “Obtaining breakthrough designation from FDA indicates our technology will significantly improve the standard of care and provide more timely access to patients and health care providers.”
DirectSync Surgical has successfully completed a NIH Phase II SBIR grant that supported a comparative randomized pre-clinical bone growth assessment and is currently completing a second NIH Phase I SBIR grant to integrate diagnostics to monitor key healing metrics. DirectSync Surgical is raising a Seed Round to accelerate efforts to initiate first-in-human studies.
Source: DirectSync Surgical
