DirectSync’s Patient-Powered Smart Implants Get Breakthrough Status

DirectSync Surgical, a company focused on treating patients with spine and orthopedic diseases, has achieved Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its patient-powered, smart spinal fusion device.
 
According to the FDA, the DirectSync Surgical interbody device may provide a more effective treatment of an irreversibly debilitating condition than the current standard of care. It delivers localized electrical stimulation and offers post-op diagnostics to achieve fusion more effectively for patients indicated for spinal fusion.
 
“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,” Zygmunt Porada, CEO of DirectSync Surgical told the press. “Obtaining breakthrough designation from FDA indicates our technology will significantly improve the standard of care and provide more timely access to patients and healthcare providers.”
 
Dr. Paul Arnold, Chairman of Neurosurgery at Carle Foundation Hospital in Illinois and co-founder of DirectSync Surgical added: “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.”
 
DirectSync successfully completed an NIH Phase II SBIR grant that supported a pre-clinical bone assessment and is completing a second NIH Phase I SBIR grant to integrate diagnostics to monitor critical healing metrics. The company is raising a Seed Round to boost efforts to begin first-in-human studies.