Intracept

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Relievant Medsystems Announces $70M Financing to Accelerate U.S. Commercialization of Intracept Procedure

Financing to build on significant 2020 commercial momentum following the publication of 5-year data demonstrating the long-term clinical benefits of the Intracept Procedure

MINNEAPOLIS, Oct. 29, 2020 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), announced today the completion of a $70 million equity financing. The round was led by new investor Vensana Capital alongside Lightstone Ventures with participation from existing investors Endeavour Vision, New Enterprise Associates, Morgenthaler Ventures and Canaan Partners.

“This oversubscribed financing round is a great vote of confidence in our team, product and mission to change the treatment paradigm for CLBP,” said Art Taylor, President and CEO of Relievant Medsystems. “2020 will be a record year for Relievant and the commercialization of the Intracept Procedure. With the recent publication of our 5-year data showing sustained improvements in pain and function, we expect even greater adoption in 2021 as more and more physicians make Intracept a core part of their CLBP patient care pathway. We are delighted to have such strong financial support to fuel this rapid commercial growth and to make this much-needed treatment available to more patients and physicians.”

Chronic low back pain is a widespread and often severely debilitating condition estimated to affect nearly 30 million people in the U.S., with over 70 percent failing to find adequate relief with conservative care and are not candidates for surgery. Until recently, the intervertebral discs have been thought to be the primary source of pain, referred to as discogenic pain, in most patients with CLBP. Relievant’s Intracept Procedure is a minimally invasive treatment based upon ground-breaking anatomic research that demonstrated many of these patients actually suffer from vertebrogenic pain – pain originating from the vertebral endplates that is transmitted through the basivertebral nerve. The Intracept Procedure is supported by two Level I randomized controlled clinical trials and long-term data demonstrating improvements in pain and function lasting more than 5-years post-procedure. It is estimated that over five million CLBP patients in the U.S. have vertebrogenic pain and are candidates for the Intracept Procedure.

As part of the financing, Justin Klein, MD, JD, Co-Founder and Managing Partner at Vensana Capital, will join Relievant’s board of directors.

“The team at Relievant has created a category-defining medical procedure that truly has the potential to transform the treatment of CLBP,” said Justin Klein. “The Intracept procedure is a safe, patient-friendly treatment that has resonated with physician leaders in the field and has been proven to significantly reduce pain and disability, now beyond five years in well-conducted clinical trials. With the millions of patients in the U.S. suffering from chronic axial low back pain indicated for Relievant’s Intracept Procedure, we believe Intracept is an outstanding example of medical technology innovation and is one that can also positively impact our country’s ongoing opioid epidemic.”

About Relievant Medsystems
Relievant Medsystems is a privately-held medical device company that is transforming the treatment of Chronic Low Back Pain (CLBP) with the Intracept Procedure

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health

Relievant Announces Positive 12-Month Intracept Effectiveness Study Results From Community Based Practices

MINNEAPOLIS, Oct. 22, 2020 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced the North American Spine Society Journal publicationi of results from an effectiveness study showing that the significant improvements in function and pain initially reported at an interim analysis of three monthsii following the Intracept Procedure remained significant through one year.

The prospective, open-label, single-arm study followed 47 patients treated with the Intracept procedure for chronic low back pain through 12 months at two community-based practices – led by Kevin Macadaeg, MD at Indiana Spine Group and Eeric Truumees, MD at Ascension Texas Spine and Scoliosis Center. Inclusion criteria were more permissive than those employed in the previously-reported SMART and INTRACEPT randomized controlled trials (RCT’s), including patients having undergone prior discectomy and utilizing extended-release narcotics, reflective of patients found in “real world” spine and pain practices versus previous highly controlled study protocols.

Results 12-months post-procedure included the following:

  • Mean ODI improvement of 32.31 (p<0.001) from a baseline of 46.98 (more than twice the established minimal clinically important difference (MCID) of 15)

  • Mean VAS reduction of 4.31 (p<0.001) from a baseline of 6.82 (more than twice the established MCID of 2)

  • 69% of patients reported >50% reduction in pain while 38% reported being pain free

  • 70% of the patients who were using opioids at baseline were no longer actively using opioids at 12 months (> 1 time per week)

  • 96% of the patients who had injections prior to treatment did not have any injections in the 12 months after treatment

  • 84.4% of patients rated their condition as improved (60% vastly improved) and 89% indicated they would have the procedure again

“Previous, highly-controlled studies have shown the positive outcomes achieved following the Intracept procedure are both significant and durable,” said Kevin Macadaeg, MD, Minimally Invasive Spine Specialist at Indiana Spine Group and the principal investigator of the study, “This study demonstrates that patients treated in a typical spine practice can achieve similar outcomes a year post-procedure as those previously reported – meaningful improvements in function and pain that reduce healthcare utilization and improve patient satisfaction.”

“It’s important for physicians to know that patients in their own practice can achieve similar improvements as those reported in the significant body of evidence supporting the Intracept procedure – including two Level I RCTs and a long-term, 5-year study,” said Art Taylor, President & CEO of Relievant Medsystems. “This evidence further indicates that the effectiveness and strong safety profile of the Intracept procedure can be achieved at typical spine practices, bringing relief to vertebrogenic CLBP patients who have often suffered from their condition for years. Physicians, payers, and most of all, CLBP patients are excited by the unparalleled level of evidence supporting the Intracept procedure in this difficult-to-treat population.”

The publication is currently available via open access and can be found at the following link: https://doi.org/10.1016/j.xnsj.2020.100030

About Relievant Medsystems
Relievant Medsystems is a privately-held medical device company that

Read More