Seattle, Washington (PRWEB) January 17, 2016
Inmedix, the leader in heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, beginning with the more than two million U.S. patients with rheumatoid arthritis (RA), today announced the members of their Scientific Advisory Board. The board will play a vital role in 2016 as the company continues work to receive FDA 510 (k) clearance of their ANS Neuroscan™ and initiate a study to apply for a historic first time FDA claim to accurately predict treatment outcome for patients with RA.
Although the use of HRV as a medical tool is essentially new for rheumatologists treating autoimmune disease, including RA, there are more than 5,000 peer review studies describing medical application of HRV, predominantly in cardiology. Since 2008, Inmedix research has validated their HRV as the first and only actionable predictor of RA treatment at one year with profoundly high sensitivity (90%) and specificity (95.7%). The company has also demonstrated how HRV singularly identifies patients able to respond to biologic therapy with Enbrel®(etanercept) alone versus those who require etanercept with methotrexate.
The Inmedix HRV medical tool, known as ANS Neuroscan™, has the potential to profoundly impact the U.S. specialty pharmacy market, specifically the 4,000 rheumatologists and roughly $16 billion dollars spent on RA. Currently, only 25% of patients with RA can be effectively controlled with one of the 10 available biologics. The remaining 75% continue methotrexate and steroids while cycling through the biologics. Essentially, 3 out of 4 patients with RA are treated insufficiently.
Inmedix has published data to demonstrate that the ANS Neuroscan™ is able to prospectively identify patients with RA who will or will not respond to therapy. “This is a quantum leap to avoid ineffective treatment,” said Andrew J. Holman MD, Co-founder and CEO, Inmedix. “When a patient’s poor ANS state is addressed, our tool increased the rate of RA disease control from 25% to 79%. It also represents a significant savings to payers because we only need to test 4 patients to identify one patient likely to fail to respond to an expensive biologic. Thus, for every 4 patients tested, the ANS Neuroscan™ identifies the one that will fail a $30,000-dollar biologic.”
The Inmedix Scientific Advisory Board oversees the company’s research and advises on regulatory affairs with the FDA and strategic partnerships with pharmaceutical companies. Board members may also speak at key industry events, both domestic and international, regarding the Inmedix national physician education initiative. “Inmedix has a unique opportunity to bring a revolutionary shift in the treatment of autoimmune disease,” said Robert Ettlinger, MD and board member. “Despite all of the gains in RA therapy, the percentage of patients in remission or good control remains unchanged regardless of the target addressed by treatment. As a physician, I’m excited that the ANS Neuroscan could predict who can expect these outstanding results and conversely who would be better served by multi-system therapies.”
In addition to obtaining FDA 510(k) clearance of its ANS Neuroscan™ and starting a study in 2016 for its first FDA claim, Inmedix is also focused on using its tool to help doctors achieve historic treatment outcomes and developing strategic relationships with key pharma industry companies.
Inmedix Scientific Advisory Board
- Edward Keystone, MD – rheumatologist, Professor of Medicine, University of Toronto; Director, Rebecca MacDonald Centre for Arthritis and Autoimmune Disease; Mount Sinai Hospital.
- Vibeke Strand MD – rheumatologist, biopharmaceutical consultant and Adjunct Clinical Professor of Medicine, Stanford University School of Medicine.
- Mark Genovese, MD – rheumatologist, James W. Raitt MD Professor of Medicine, Stanford University, Co-Chief Division of Immunology & Rheumatology, Stanford University School of Medicine.
- Daniel Furst MD - rheumatologist, Professor Emeritus, Carl Pearson Professor of Medicine, UCLA School of Medicine.
- Robert Ettlinger, MD – rheumatologist, panel member Western Institutional Review Board, Puyallup, WA. Former Head, Tacoma Center for Arthritis Research, conducting 250+ clinical research trials over 35-year career.
- Edmund Ng, PhD – Biostatistician - Edmund Ng Consulting LLC. Former biostatistician for Amgen’s Kineret studies.
About Inmedix, LLC
Seattle-based biotech Inmedix is committed to engaging in world class research to discover innovative solutions for pressing healthcare needs related to the autonomic nervous system (ANS). Inmedix’s ANS Neuroscan™ is the leading heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, beginning with U.S. patients with rheumatoid arthritis (RA). The company’s science and technology raises therapeutic outcomes and retention so that patients no longer need to cycle through failure of one biologic after another. Visit http://www.inmedix.com