Relievant Medsystems won FDA investigational device exemption for its Intracept back pain therapy, paving the way for the medical device company to continue its SMART pivotal clinical trial.
The Redwood City, Calif.-based company said it will expand the 200-patient randomized, controlled trial to 20 sites across the U.S., where it will evaluate the Intracept therapy in treatment of chronic low back pain.
Relievant also made some changes to its senior management team. Av Edidin, former VP of science and technology at Medtronic (NYSE:MDT), will join the company as chief scientific officer and VP of R&D, according to a press release.
In addition Mike Welch will join Relievant as the VP of global market development. Welch has 25 years of experience at various medical device companies and has worked on product commercialization in over 40 countries, Relievant noted.
"The expertise Av and Mike bring from their pioneering work in kyphoplasty and renal denervation will be a tremendous asset as we work to advance Intracept’s scientific, educational and market development globally," said CEO Alex DiNello in prepared remarks."Both have a passion for creating entirely new therapeutic categories and for demonstrating the value that those therapies can bring to patients through rigorous scientific study and clinical validation. We’re delighted to welcome them to the team."