FDA Grants Breakthrough Designation to DirectSync’s Patient-Powered Smart Implants

DirectSync Surgical’s patient-powered smart spinal fusion device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

“[This] 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,” DirectSync Surgical CEO Zygmunt Porada said. “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.”
 
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. FDA’s Breakthrough Devices Program is intended to expedite development and review of medical devices that are designed to treat serious or life-threatening diseases.
 
“An all-in-one interbody fusion device that has a therapeutic aspect as well as a diagnostic tool to allow me to know when and if fusion is taking place has the potential to revolutionize my practice,” said DirectSync Surgical Co-Founder Paul Arnold, M.D., chairman of Neurosurgery at Carle Foundation Hospital in Illinois.
 
The company 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 currently is raising a seed round to fund and accelerate first-in-human studies.
 
DirectSync Surgical is developing the first-ever patient-powered smart implant that reduces reliance on constantly powering and monitoring the device remotely. While the patient goes about his or her daily life, the DirectSync interbody is hard at work providing targeted mechanically synced electrical stimulation for enhanced bone healing and post-operative data collection to inform and optimize the treatment regimen between the physician and their patient. The Lawrence, Kan.-based medical device company is dedicated to improving the lives of patients who suffer from spine and orthopedic diseases.