The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for DirectSync Surgical’s patient-powered, smart spinal fusion device.
The BDD was granted based on the FDA’s review of the company’s preliminary data. The regulator determined that the interbody device may offer a more effective treatment of an irreversibly debilitating condition compared to the existing standard of care.
The new DirectSync Surgical interbody device has been designed to provide targeted mechanically synced electrical stimulation to improve bone healing.
Additionally, the device offers post-operative diagnostics for achieving fusion more effectively for patients who are indicated to receive spinal fusion.
The postoperative data collection helps to optimise the treatment regimen between the doctor and the patient.
DirectSync Surgical CEO Zygmunt Porada said: “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.
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“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.”
The FDA’s Breakthrough Devices Program was established to accelerate the development and review of medical devices for the treatment of life-threatening and debilitating diseases.
The company has completed a National Institutes of Health (NIH) Phase II SBIR grant that was used to support a comparative randomised pre-clinical bone growth assessment.
Currently, DirectSync Surgical is completing a second NIH Phase I SBIR grant for the integration of diagnostics to monitor important healing metrics.
Furthermore, it is securing financing from a seed round to commence the first-in-human trials.