Relievant enrolls first patient in SMART nerve ablation trial

NewCo on the block

By OMAR FORD
Medical Device Daily Staff Writer

One of the most expensive non-lethal conditions in the healthcare system is chronic low back pain. Each year about 12 million new patients seek treatment for the back pain, but nearly two million of these fail to respond tho conservative therapies. In essence, these patients have few options – escalating use of pain medications, invasive surgical procedures or continued suffering.

Relievant MedSystems (Redwood City, California) is saying that its Intracept System could be an option provided it can secure FDA approval for the device. The company most recently reported that it it has taken steps forward in achieving this goal, by enrolling the first patient in its Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) trial to evaluate the Intracep Basivertebral Nerve Ablation Procedure.

“The device has an indication currently for soft tissue ablation and we’re looking for expanding that indication to the back pain and the ablation basivertebral nerve,” Alex DiNello, CEO of Relievant told Medical Device Daily. “It has a CE mark for the basivertebral nerve already.” The firm said that the SMART trial is a Level 1, prospective, randomized, double-blind, sham-controlled clinical trial evaluating the reduction of pain in patients with chronic axial low back pain.

The SMART trial will enroll up to 200 patients in up to 20 medical centers across the U.S. to determine the safety and effectiveness of the Intracept procedure. The primary endpoint is the evaluation of patient improvement in Oswestry Disability Index at three months compared to baseline between treatment and sham populations. In addition, change in multiple patient-reported outcomes from baseline will be assessed at three, six, and twelve months as well as safety evaluations at all time points. Importantly, patients and clinicians who perform the follow-up evaluations are blinded to the randomization of the sham vs. experimental procedure.

“As it relates to concluding patient enrollment, we anticipate that [to happen] by 1Q13,” DiNello said. “We’ll submit for FDA approval just beyond that.” DiNello declined to speculate on when the device could gain FDA approval. He added that Relievant is also initiating a separate and similar Level 1 study in Europe.

“The Relievant Intracept procedure is a potential breakthrough for the treatment of chronic low back pain, which addresses the unmet clinical need for patients who have failed traditional conservative treatment modalities,” said Jeffrey Fischgrund, MD, Professor of Orthopedic Surgery at Oakland University William Beaumont School of Medicine (Royal Oak, Michigan) and the Principal Investigator of the SMART trial. “I look forward to evaluating the Intracept procedure in the SMART trial which also has the opportunity of treating patients without the morbidity and expense of more invasive procedures.”

Based on the research of Michael Heggeness, MD, PhD, of the Baylor College of Medicine (Houston), Relievant’s Intracept System treats chronic low back pain with a simple, minimally invasive procedure using radiofrequency energy delivered through a small access tube into the vertebral body to ablate the basiverterbal nerve. The nerve, which is believed to signifi cantly contribute to chronic low back pain, no longer functions once it is ablated. There is no implant with the Intracept procedure, and based on a pilot study the treatment can usually be performed in about one hour.

The Intracept procedure may be a viable treatment alternative for patients suffering from axial low back pain who no longer respond to conservative therapies. “Currently patient outcomes with chronic low back pain are lackluster, so if the clinical trial proves out what the pilot study proved, then I see adoption ramping up fairly quickly,” DiNello said.

Relievant is a private company and was founded in 2006. Dinello said that the company was currently in a Series D fund raising round. He declined to say how much the company has raised since inception.

Back in July 2009 the firm reported completing a $20 million private equity financing. The financing was led by Morgenthaler Ventures (Boston) with existing investors Canaan Partnersand ONSET Ventures (both Menlo Park, California) and new investor Emergent Medical Partners (Portola Valley, California) participating (Medical Device Daily, July 8, 2009). 

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com