SUNNYVALE, Calif, Oct. 18, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, today announced the appointment of Ray M. Baker, M.D., as Chief Medical Officer. Dr. Baker will report to Relievant’s Chief Executive Officer, Kevin Hykes.

“Ray is an internationally recognized, highly respected clinician bringing over 30 years of pain management expertise and industry leadership to Relievant,” said Kevin Hykes, President and Chief Executive Officer of Relievant Medsystems. “His deep experience as an interventional pain management specialist, and as past president of both the North American Spine Society and the Spine Intervention Society will be instrumental in shaping the commercial introduction of the Intracept® Procedure. We look forward to his contributions as the company enters its next phase of growth.”

As Chief Medical Officer, Dr. Baker will be an integral part of the executive team at Relievant, guiding technology development, clinical research strategy, and commercial initiatives. Prior to joining Relievant, Dr. Baker served as VP & Executive Medical Director at Evergreen Health in Kirkland, WA. He brings both academic and private practice experience to the position, having previously served as a Clinical Professor and Director of Interventional Pain Services at the University of Washington. In addition to presiding over the North American Spine Society and Spine Intervention Society, he has held a number of prominent board and leadership positions within the industry, including serving as the Founding Chairman of the CMS Multi-Society Pain Workgroup, and Chairman of the UnitedHealthcare National Spine Advisory Board.

“I have consulted for Relievant since the company’s inception – the depth, experience and talent of the executive leadership team are extraordinary, and I am thrilled to be on board,” said Dr. Baker. “Throughout my time as a practicing interventionalist, I have had the opportunity to be involved with the development of a number of novel technologies.  The FDA-cleared Intracept Procedure has been built on a foundation of level one evidence and clinical strength. I am acutely aware of how few options are open to these patients and am excited to be part of the team bringing this important new therapy to market.”

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN).  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use: 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.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com

October 18, 2017

NEW YORK: On August 2, 2017, an American surgical team conducted a surgery to replace the sternum and partial ribcage of a 20 year-old woman using a custom 3D-printed composite titanium/porous polyethylene implant. It is the first time this technology has been used in the United States and only the second time in the world that a 3D-printed composite sternum and ribcage has been implanted. 

The implant was designed and created for a patient named Penelope Heller by Anatomics, an Australian company that specializes in the manufacture of patient specific implants for surgeons around the world, and was made available to the patient via the United States Food & Drug Administration’s (FDA) Expanded Access (Compassionate Use) Program. Anatomics’ custom 3D printed implants do not have marketing approval in the US. The FDA’s Expanded Access Program provides a path to accessing devices for patients whom the treating physician believes may provide a benefit, but have not received FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical cardiothoracic surgery at Weill Cornell Medicine, undertook the operation to revise a prior sternum/ribcage removal and reconstruction conducted in 2014. The patient underwent the original procedure to remove a malignant bone tumor after she was diagnosed with chondrosarcoma, a rare cancer affecting the bones and joints that is resistant to chemotherapy and radiotherapy and requires surgical removal.

In the original resection surgery, the cancer was successfully removed and the previous surgeon created an implant for the patient, using off-the-shelf Gore-Tex (low-density porous polytetrafluoroethylene, or PTFE) and Bone Cement (methyl methacrylate, or MMC). Afterward, the patient was cancer-free but continued to experience pain and issues with breathing that did not improve with time. Online research led the patient to a similar surgery performed in Spain using a custom implant also developed by Anatomics. The patient and her family then worked with the staff at NewYork-Presbyterian/Weill Cornell Medical Center and Anatomics to access the implant under the FDA’s Expanded Access program.

The custom implant was designed using high-resolution CT scans of the patient’s chest that were sent to Anatomics engineers via the secure AnatomicsRx software platform. After Dr. Port reviewed and confirmed the design on-line with the engineers, a biomodel of the patient’s sternum and ribcage was created and a build code was sent to Australia’s Commonwealth Scientific & Industrial Research Organisation’s (CSIRO) 3D printing laboratory, Lab 22. The patient’s custom sternum implant is the second in the world to also use Anatomics’ PoreStar technology, a proprietary porous polyethylene material with bone-like architecture. PoreStar is currently awaiting FDA marketing approval.

“After my initial resection and reconstruction surgery, I continued to experience breathing issues and pain,” said Ms. Heller. “With a long, active life ahead of me, I wanted to participate in activities that I love fully and without pain. Electing to have this procedure was a big decision, and I’m coming forward to empower other people in the same position.”

Anatomics’ Executive Chairman Paul D’Urso, MBBS (Hons) Ph.D. FRACS said, “Anatomics is humbled by the strength of the thousands of patients we have helped over 25 years since inventing BioModeling technology. The patient’s story is one of many, but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at  NewYork-Presbyterian/Weill Cornell, Anatomics, and the FDA came together to make this story a reality. It was a group effort that began with the patient’s pursuit of information.”

About Anatomics

Anatomics is an Australian medical device company that has been manufacturing and marketing surgical products to surgeons locally and internationally since 1996. Anatomics pioneered CT scan derived surgical implant technology and was first to market with an innovative, quality product that assists surgeons to produce better surgical outcomes and reduce expensive operating time. For more information, visit http://www.anatomics.com and follow the company on twitter at https://twitter.com/anatomicsrx. 

For further information contact: 

(Media) Tiberend Strategic Advisors, Inc

Janine McCargo, Senior Vice President

Telephone: +1 (646) 604-5150

e-mail: jmccargo@tiberend.com

Anatomics United States

Dr. Dean Carson, Vice President US Operations

951 Mariners Island Blvd. San Mateo, CA 94404 (CSIRO Office)

Telephone: +1 (415) 806-2599

e-mail: dean.carson@anatomics.com

Anatomics Australia

Dr. Paul D’Urso, Executive Chairman

Suite 1, 23-27 Wellington Street, St Kilda, Victoria, 3182, Australia

Telephone: +61 3 9529-8088

e-mail: contact@anatomics.com

October 18, 2017

October 17, 2017