DirectSync Surgical, a medical device company focused on enhancing the lives of patients with spine and orthopedic diseases, recently announced that its patient-powered smart spinal fusion device has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). The FDA reviewed the company's initial data and determined that the DirectSync Surgical interbody device could offer a more effective treatment option for irreversibly debilitating conditions compared to the current standard of care.
This device utilizes electrical stimulation in targeted areas, improving post-operative evaluations for patients who've undergone spinal fusion procedures. The FDA's Breakthrough Devices Program expedites the development and review of medical devices that tackle critical or life-threatening illnesses.
DirectSync Surgical views this designation as a significant milestone, highlighting the pressing need to enhance spinal fusion outcomes and empower healthcare professionals and patients with comprehensive post-operative care. The company believes that obtaining the breakthrough designation signifies a substantial improvement in the standard of care and facilitates timely access to the device for patients and healthcare providers.
The National Institutes of Health (NIH) granted DirectSync Surgical a Phase II Small Business Innovation Research (SBIR) grant, which the company successfully completed. This achievement allowed for a comparative randomized pre-clinical evaluation of bone growth. DirectSync Surgical is now finalizing a Phase I SBIR grant from the same funding agency, which will enable the company to integrate diagnostic instrumentation for monitoring critical healing metrics. Furthermore, DirectSync Surgical is currently soliciting funds through a Seed Round to accelerate its efforts and start first-in-human trials.