St Paul, Minnesota, September 14, 2023 ---- SpineGuide Technologies, a global medical device company, announced today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CurvRITE System to treat Children with Adolescent Idiopathic Scoliosis (AIS), after receiving Breakthrough Device Designation for Early Onset Scoliosis (EOS) three days ago.
The Breakthrough Device program is intended to expedite the process of bringing to market devices. Since the program started in late 2016, only 101 devices in orthopedic have received the designation as of June 2023. SpineGuide's CurvRITE System has received Breakthrough Device Designation for two separates indications which are EOS and AIS.
CurvRITE system is the world's first and only growth friendly implant with 3D correction for both EOS and AIS. And it is the first system that received Breakthrough Device Designation for both indications.
“I find the concept intriguing, promising, and look forward to it helping patients,” said Paul Sponseller, M.D., Chief, Division of Pediatric Orthopaedics at The Johns Hopkins Hospital, Past President of Scoliosis Research Society (SRS).
"Our In vitro study, animal study, and First-in-Human (FIH) study have formed a strong evidence chain that our device will provide significant benefits to patients. To receiving Breakthrough Device Designation for two indications is such a recognition of the clinical advantage for the CurvRITE System.” said Kai Li, M.D., the inventor of CurvRITE and CEO of SpineGuide., “We expect this game-changing technology to become the golden standard for the next generation scoliosis surgical treatment and play a significant role in reducing the number of surgeries that young patients have to undergo and provide better correction and spine growth at the same time. Fewer complications, lower costs for the health care system and much better quality of life for the patients are expected.”
About SpineGuide Technologies
SpineGuide Technologies. is a clinical-stage global medical device company with office both in the US and China. The company is dedicated to the design, development, and commercialization of its evolving proprietary technology for scoliosis. This technology corrects the curved spine in just a single surgery and allows spine to grow noninvasively under the guidance of our device allowing surgeons to better address a range of clinical needs. For more information, visit http://www.spineguidetechnologies.com/.