- INTRACEPT® Intraosseous Nerve Ablation System recently received FDA clearance to treat chronic low back pain (CLBP) based on results of landmark SMART clinical trial.
- CLBP affects millions of patients in the United States and around the world, and effective, safe and durable treatments providing relief from CLBP are lacking.
- Financing led by New Enterprise Associates (NEA) and includes Canaan Partners, Emergent Medical Partners and Morgenthaler Ventures.
Relievant Medsystems, Inc., a privately held medical device company pioneering the therapeutic use of nerve ablation within vertebral bodies for the treatment of chronic low back pain (CLBP), announced today that it has secured $36 million in equity financing. New Enterprise Associates (NEA) led the financing with participation from Canaan Partners, Emergent Medical Partners and Morgenthaler Ventures.
In July 2016, the novel INTRACEPT Intraosseous Nerve Ablation System received 510(k) clearance from the FDA for the treatment of patients with CLBP. The proceeds from the financing will be used to advance additional clinical studies, expand and enhance the product portfolio, and accelerate commercial activities, including strategic initiatives with Medicare contractors and third-party private payors.
“We are proud to have our venture investment partners bolster our efforts to bring the novel INTRACEPT therapy to the millions of patients suffering from CLBP and establish INTRACEPT as a franchise opportunity in the marketplace,” said Alex DiNello, CEO and president of Relievant. “This capital will enable Relievant to accelerate execution of our product, clinical and market development activities to advance intraosseous basivertebral nerve ablation for CLBP ahead of successfully commercializing INTRACEPT worldwide.”
“NEA is excited to continue its partnership with Relievant in bringing a game-changing technology to the millions of people who suffer from chronic low back pain,” said NEA Partner Justin Klein, M.D. “The robust Level 1 SMART clinical trial results demonstrate the INTRACEPT system to be a safe, effective, durable and minimally invasive procedure that addresses a multi-billion dollar growth market. We believe the company’s dedication to demonstrating the benefits of Intracept through additional clinical development — working in close partnership with its clinical advisors, key societies and the payor community — is exactly the right approach to providing a therapy that addresses the needs of patients, spine surgeons and interventionalists, and payors.”
CLBP impacts nearly one third of the U.S. population and represents the largest and most expensive non-fatal condition in the healthcare system. Every year, approximately 12 million new patients seek treatment for back pain. Unfortunately, nearly two million of these patients fail to respond to conservative therapies and have few alternative options, which are limited to the use of narcotic pain medications including opioids, invasive surgical procedures (including fusion) or continued suffering. The intraosseous basivertebral nerve ablation procedure using Relievant’s proprietary INTRACEPT System represents a compelling treatment option for patients who suffer from chronic low back pain but no longer respond to conservative therapies.
About the SMART Clinical Trial
Relievant sponsored the Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) Trial. The SMART trial was a 225 patient, Level 1, international, prospective, randomized, double-blind, sham-controlled clinical study that evaluated the safety and effectiveness of the INTRACEPT therapy in patients suffering from CLBP. For patients who received the intended therapy and completed follow-up, the INTRACEPT treatment arm in the SMART study demonstrated a mean Oswestry Disability Index (ODI) improvement of 20.5 points or 48% decrease from baseline at 3 months. These results were sustained through 12 and 24 months of follow-up.
About Relievant Medsystems
Relievant Medsystems is a privately held medical device company based in Redwood City, California. Its Intracept System is a minimally invasive procedure that uses radiofrequency energy delivered into the vertebral body of the spine to ablate the basivertebral nerve. This nerve, which contributes to the disability and pain associated with chronic low back pain, can no longer transmit pain signals following ablation. The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
Relievant Medsystems, Inc. will attend the North American Spine Society (NASS) meeting in Boston, October 26–29, 2016 (Booth #1365). For additional information, visit www.relievant.com.
Important Safety Information
The INTRACEPT Procedure, as with any surgical procedures, has risks that should be discussed with your medical professional.
SOURCE: Relievant Medsystems, Inc.