SynerFuse, Inc., an Eden Prairie, Minnesota-based medical device company, announced today that an independent Data Safety and Monitoring Board (DSMB) met and recommended no changes after review of the first ten implanted subjects in the company’s ongoing proof-of-concept study.
The SynerFuse proof-of-concept study is a feasibility study being conducted under an Investigational Device Exemption (IDE) approved by the FDA. An independent DSMB composed of a neurosurgeon, an interventional pain medicine physician, and a biostatistician met on August 23 to review study data after ten subjects were followed through 10-20 days post-surgery. The DSMB determined that the study procedure met safety expectations and recommended to continue the study with no protocol modifications. The DSMB will continue to monitor subject safety data until the study is completed.
The SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the dorsal root ganglion (DRG), a key nerve structure along the spine that can be targeted with neuromodulation to address chronic neuropathic pain. The study is evaluating the safety and tolerability of the integrated therapy. Patients undergoing an initial spinal fusion, among other criteria, are eligible for the study.
“Gaining validation from the DSMB for the continued implementation of our proof-of-concept study is significant for SynerFuse, and we are thrilled about this milestone,” said SynerFuse co-founder, president, and CEO Justin Zenanko.
“Getting the green light from the DSMB once again to continue our proof-of-concept study with no changes to the protocol is a testament to the excellent collaboration we have experienced with our clinician partners,” said SynerFuse co-founder and Chief Scientific Officer Greg Molnar, Ph.D.
