Spineguide Technologies, a start-up medical device company, today announced the successful completion of its Q-Submission meeting with the U.S. Food and Drug Administration (FDA) for CurvRITE for the treatment of early onset scoliosis (EOS) and adolescent idiopathic scoliosis (AIS).
The purpose of the meetings was to discuss and confirm the company's regulatory pathway and clinical plan. FDA confirmed that no additional animal studies outside of those already conducted are needed to support a future marketing submission.
"We look forward to working with the FDA to bring this much-needed treatment option to young children living with scoliosis as rapidly as possible. Personally, I am fully committed by putting my thriving clinical practice on hold since 2018 and started full time to bring this device to the market to benefit the patients sooner,” said Dr. Kai Li, Founder, and CEO of SpingGuide, an orthopedic surgeon for 15 years. “We thanked FDA for their guidance during CurvRITE’s design process for the last three years. After 6 years and 40 procedures & observation in sheep, we are convinced that CurvRITE works better than anything else on the market and will help patients tremendously.
Currently, we are preparing clinical evidence to support the marketing submission.” added Dr. Li.