DirectSync Surgical, a company specializing in medical devices for spine and orthopedic conditions, has announced that its patient-powered smart spinal fusion device has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). This designation signifies that the device, known as the DirectSync Surgical interbody device, may offer a more effective treatment for debilitating conditions compared to the current standard of care.
The smart implant delivers localized electrical stimulation and provides post-operative diagnostics to improve fusion outcomes in patients requiring spinal fusion. The FDA's Breakthrough Devices Program aims to expedite the development and review of medical devices designed to address serious or life-threatening diseases.
DirectSync Surgical's CEO, Zygmunt Porada, expressed the significance of this milestone, emphasizing the need to enhance spinal fusion outcomes and provide better post-operative care. Porada stated that obtaining the breakthrough designation from the FDA indicates that their technology will significantly improve the standard of care and increase access to patients and healthcare providers.
Dr. Paul Arnold, Chairman of Neurosurgery at Carle Foundation Hospital and Co-Founder of DirectSync Surgical, shared his enthusiasm for the device, highlighting its potential to revolutionize medical practices by combining therapeutic aspects with diagnostic capabilities to monitor the progress of fusion.
DirectSync Surgical has successfully completed a Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH), which supported a comparative randomized pre-clinical bone growth assessment. Additionally, the company is currently finalizing a second Phase I SBIR grant from the NIH to integrate diagnostics for monitoring crucial healing metrics. DirectSync Surgical is actively raising funds through a Seed Round to expedite the initiation of first-in-human studies.
https://www.globenewswire.com/news-release/2023/5/2/2659409/0/en/DirectSync-Surgical-receives-Breakthrough-Device-Designation-from-FDA-for-its-Patient-Powered-Smart-Implants.html
