Relievant Medsystems, 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.
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.
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.