SpineGuide Receives U.S. FDA Breakthrough Device Designation for AIS
St Paul, Minnesota, September 11, 2023 ---- SpineGuide Technologies, a global medical device company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CurvRITE System to treat Children with Early Onset Scoliosis (EOS).
The Breakthrough Device program is intended to expedite the process of bringing to market devices. The benefits of the program include priority review for regulatory submissions and the opportunity for regular and interactive engagement with the FDA to facilitate the efficient clinical and technical development of the device. 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 EOS indication.
“Breakthrough Device Designation is an important recognition from FDA about the potential for our CurvRITE System to address a serious unmet medical need and will definitely help bring the device to patients as quickly as possible.” said Kai Li, M.D., the inventor of CurvRITE and CEO of SpineGuide Technologies.
The CurvRITE system has introduced a quality of life enhancing option for young patients with early EOS and AIS. The system is the world’s first and only growth friendly implant with 3D correction for Both EOS and AIS. The innovative technology not only eliminates painful repeated lengthening surgeries, typically performed every six months but also the most invasive spine surgery, final fusion.
“We were excited to find in the First-in-Human study that the clinical results exceeded our original expectations. This discovery motivated us to delve deeper and conduct extensive research using various mechanical models. Our research findings were very promising, as we further discovered that the CurvRITE system should perform exceptionally well based on fundamental principles of mechanics,” said Dr. Kai Li.
The company is currently in the process of raising funds to conduct the pivotal study to support FDA pre-market submission.
About SpineGuide Technologies
SpineGuide Technologies. is a global medical device company with offices 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/.