PRESS RELEASE

Relievant Medsystems, Inc. Secures $36 Million in Equity Financing for INTRACEPT® Clinical Development and Commercial Launch Preparation

Redwood City, CA – October 11, 2016 – 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.

Important Safety Information

The INTRACEPT Procedure, as with any surgical procedures, has risks that should be discussed with your medical professional.

Relievant Medsystems, Inc. will attend the North American Spine Society (NASS) meeting in Boston, October 26-29 (Booth #1365). For additional information, visit www.relievant.com.

Contact:
Carolyn Hawley
Canale Communications
619-849-5382
Carolyn@canalecomm.com

SOURCE: Relievant Medsystems, Inc.

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Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT® for the Relief of Chronic Low Back Pain

Landmark Level 1 Clinical Study Provides Compelling Data for New Therapy

Redwood City, CA – July 21, 2016 – Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced today that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.

The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least six months of conservative care caused by changes associated with degeneration of spinal vertebral bodies and the associated intervertebral discs.

The INTRACEPT System uses radio frequency (RF) energy, delivered through specially designed instruments via a minimally invasive approach to access and ablate the basivertebral nerve (BVN.) The BVN is a sensory nerve within each vertebral body, which transmits the sharp, aching or throbbing pain experienced with degenerated vertebral bodies. Spine specialists can use the INTRACEPT System to treat one or more levels between L3 and S1 in the lower spine.

The FDA clearance followed the Agency’s review of the Company’s landmark SMART (Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) study, a 225-patient, Level 1, international, prospective, randomized, double-blind, sham-controlled clinical trial, that evaluated the safety and effectiveness of the INTRACEPT therapy for the treatment of chronic low back pain. Patients were followed at two and six weeks, and at three, six, 12 and 24 months. Endpoints included Oswestry Disability Index (ODI), a validated assessment that measures a patient’s disability due to their back pain.

Key findings from the Level 1 SMART study include:

“Chronic low back pain is one of the most prevalent and expensive medical problems in the United States and worldwide,” said Alex DiNello, President and CEO of Relievant Medsystems. “Relievant’s minimally invasive INTRACEPT System is intended to fill the large therapeutic gap that currently exists between conservative treatments such as physical therapy or narcotics, and highly invasive surgical interventions such as spinal fusion surgery.”

Jeffrey Fischgrund, MD, principal investigator of the SMART study and Professor and Chairman of the Department of Orthopaedic Surgery at Beaumont Health System in Royal Oak, Michigan stated, “We see patients every day with greater than 6 months of chronic low back pain that is not responsive to conservative care. INTRACEPT, as demonstrated in the rigorously designed and executed SMART trial, is an important breakthrough therapy with clinically meaningful results for patients and has an excellent safety profile.”

“We are pleased to receive the FDA’s 510(k) clearance and to see the excellent clinical outcomes obtained from the robust SMART study,” Richard Mott, Relievant’s Executive Chairman of the Board of Directors stated. “They are important milestones for the Company, and we look forward to bringing this new therapeutic option to clinicians to enable them to treat their patients who suffer from chronic low back pain.”

About the Chronic Low Back pain

CLBP affects nearly one-third of the U.S. population and represents the largest and most expensive non-lethal 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 face limited options, including escalating use of narcotic pain medications, invasive surgical procedures (including spinal fusion) or continued suffering.

About INTRACEPT and Basivertebral Nerve (BVN) Ablation

The INTRACEPT Intraosseous Nerve Ablation System is a patent-protected, minimally invasive, implant-free therapy that utilizes radiofrequency energy delivered into the vertebral body of the spine to ablate the BVN. This nerve, characterized in peer-reviewed literature reporting studies of pain signal transmission and in preclinical and clinical evaluations, is a significant contributor in the transduction of pain arising from degeneration of the vertebral bodies associated with CLBP. The INTRACEPT Intraosseous Nerve Ablation System leverages proprietary instruments and methods to disable this nerve.

Important Safety Information

The INTRACEPT Procedure, as with any surgical procedures, has risks that should be discussed with your medical professional.

About Relievant Medsystems

Relievant Medsystems, Inc. is a privately held medical device company based in Redwood City, California. The Company’s investors include Canaan Partners, Emergent Ventures, Morgenthaler Ventures, New Enterprise Associates and ONSET Ventures.

Contact:
Carolyn Hawley
Canale Communications
619-849-5382
Carolyn@canalecomm.com

SOURCE: Relievant Medsystems, Inc.

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October 31, 2011

Relievant MedSystems Begins SMART Trial for the Alleviation of Chronic Low Back Pain

REDWOOD CITY, Calif., Oct. 31, 2011 – Relievant MedSystems Inc. today announced the company has enrolled the first patient in its SMART trial to evaluate the Intracept® Basivertebral Nerve Ablation Procedure. The Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (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 landmark SMART trial is enrolling 200 patients in up to 20 leading 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 (ODI) 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.

"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." stated Jeffrey S. Fischgrund, M.D., Professor of Orthopaedic Surgery at Oakland University William Beaumont School of Medicine in 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."

"The Intracept system brings important new capabilities to spine specialists to treat chronic low back pain. This revolutionary procedure and Level 1 clinical study demonstrate our commitment to advancing patient care for millions of pain sufferers," said CEO Alex DiNello. Relievant is also initiating a separate and similar Level 1 study in Europe. Enrollment for both studies is expected to be completed in early 2013.

Chronic low back pain impacts nearly one-third of the population and represents the largest and most expensive non-lethal condition in our health care system. Every year, approximately 12 million new patients seek treatment for back pain. Unfortunately, nearly 2 million of these patients fail to respond to conservative therapies, and these patients have few options – escalating use of pain medications, invasive surgical procedures (including fusions) or continued suffering. The Intracept procedure may be a viable treatment alternative for patients who suffer from chronic low back pain but no longer respond to conservative therapies.

About Relievant Medsystems
Relievant Medsystems is a privately held company based in Redwood City, California. Its Intracept® System is a minimally invasive procedure that uses radiofrequency energy delivered through a small access tube into the vertebral body to ablate the Basivertebral nerve. The nerve, thought to significantly contribute to chronic low back pain, can no longer generate pain signals following ablation. Relievant's primary investors include Canaan Partners, Emergent Ventures, Morgenthaler Ventures, and ONSET Ventures.

SOURCE: Relievant Medsystems, Inc. ( Download Press Copy )

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August 23, 2011

Relievant Medsystems Appoints Alex M. DiNello as President and Chief Executive Officer

DiNello brings significant spine and commercialization experience REDWOOD CITY, Calif., Aug. 23, 2011 /PRNewswire/ -- Relievant Medsystems, Inc., today announced the appointment of Alex DiNello to the position of president and chief executive officer and as a member of the company's board of directors. The Company recently received FDA approval of an Investigational Device Exemption (IDE) to begin its SMART pivotal trial. The Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) trial is a prospective, randomized, double-blind, sham-controlled investigation evaluating the reduction of pain in patients with chronic axial low back pain that is targeting to enroll 200 subjects. "As a minimally invasive therapy for those who suffer from inadequately treated chronic low back pain, the Intracept System has the potential to significantly and positively affect people's lives," said Mr. DiNello. "I joined the Relievant team because I believe the Intracept System brings a highly innovative, differentiated technology requiring no implant to spine specialists and their millions of patients who suffer from this debilitating and painful condition."

Mr. DiNello brings over 20 years of experience in the medical device industry, including 18 years focusing on spinal therapies and related medical devices. He has extensive product development, clinical, and commercialization experience including over 60 products successfully launched across the globe. Prior to joining Relievant, DiNello served as vice president and general manager for Medtronic Kyphon. Prior to that, he served as vice president of research and development for Medtronic Kyphon. Previous to that, he was vice president of research and development for Abbott Spine. He also served as vice president of strategic development and research and development at DePuy Spine, a Johnson & Johnson company.

"Alex is uniquely suited to lead the company during this critical phase of executing the SMART clinical study and laying the groundwork for successful commercialization in both US and international markets," said Art Taylor, chairman of the board for Relievant Medsystems. "He is deeply versed in spinal pathologies, is well known and regarded by the spine specialist community and has a proven track record of developing and delivering therapeutic devices to the market. We are pleased to have his leadership during this exciting time for the Company."

Relievant Medsystems is a privately held company based in Redwood City, California. Its Intracept System is a minimally invasive procedure that uses radiofrequency energy delivered through a small access tube into the vertebral body to ablate the basivertebral nerve. The nerve, thought to significantly contribute to chronic low back pain, can no longer generate pain signals following ablation.

Relievant's primary investors include Canaan Partners, Emergent Ventures, Morganthaler Ventures, and ONSET Ventures.

SOURCE: Relievant Medsystems, Inc. ( Download Press Copy )

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August 8, 2011

Relievant Medsystems Receives FDA Approval to Begin Pivotal Study to Evaluate the Intracept System for Minimally Invasive Treatment of Chronic Low Back Pain

REDWOOD CITY, California, August 8, 2011 /PRNewswire/ -- Relievant Medsystems, Inc. today announced the company has received Food and Drug Administration approval of an Investigational Device Exemption (IDE) to begin their SMART pivotal trial to evaluate the safety and effectiveness of the Intracept® System for treatment of chronic low back pain.

The SMART trial (Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) is a prospective, randomized, double-blind, sham-controlled investigation evaluating the reduction of pain in patients with chronic axial low back pain. The pivotal study will treat 200 patients at major medical centers around the United States with the Intracept System to determine the safety and effectiveness of this product. Enrollment in the SMART trial will begin this summer, with data analysis after the last subject has completed six months of follow-up.

Based on the research of Michael Heggeness, MD, PhD of the Baylor College of Medicine, 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 significantly 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

Chronic low back pain impacts nearly one-third of the population and represents the largest and most expensive non-lethal condition in our health care system. Every year, approximately 12 million new patients seek treatment for back pain. Unfortunately, nearly 2 million of these patients fail to respond to conservative therapies, and these patients have few options – escalating use of pain medications, a major, invasive surgery (such as spinal fusion) or continued suffering. The Intracept procedure may be a viable treatment alternative for patients suffering from axial low back pain who no longer respond to conservative therapies.

"Relievant's Intracept procedure is simple, easy to perform, and the results seen in the pilot study are encouraging," said Jeffrey S. Fischgrund, M.D. of the Oakland University William Beaumont School of Medicine in Royal Oak, Michigan and the Principal Investigator of the trial. "Given the ineffectiveness or limitations of existing options that are available to this very large, underserved group of suffering patients, Intracept could represent one of the most significant advances in the treatment of chronic low back pain. The SMART trial is designed to provide level 1 clinical evidence in determining the safety and effectiveness of the Intracept procedure."

"In the initial pilot study of the Intracept system, treated patients reported immediate relief and were able to resume normal activities the next day," stated Adam Savakus, President and Chief Executive Officer of Relievant Medsystems. "We look forward to working with some of the leading spine specialists in the United States to investigate this promising technology and providing definitive results in our pivotal trial." Relievant Medsystems is a privately held company based in Redwood City, California.

 

SOURCE: Relievant Medsystems, Inc. ( Download Press Copy )