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Kern Singh, M.D. / Courtesy of Midwest Orthopaedics at Rush, Wikimedia Commons, and Brandonng06

New MIS Spine Study Group Launch; New Study Targets Cellular RA Triggers; Active Implants Names Ted Davis President, CEO

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, March 8th, 2017

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Kern Singh, M.D., Launches Minimally Invasive Spine Study Group

The dynamic Kern Singh, M.D., co-director of the Minimally Invasive Spine Institute at Midwest Orthopaedics at Rush, has founded the Minimally Invasive Spine Study Group (MISSG). A 501(c)(3) nonprofit with a mission to promote research and advance the field of minimally invasive spine surgery, the MISSG is a collaboration between numerous thought leaders in the world of minimally invasive spine surgery.

According to the January 25, 2017 news release, “MISSG houses an online patient registry called REDCAP which currently contains data from 3,000 unique patients treated via minimally-invasive approaches. Organization members can add patients to the registry through an online portal. The data for each patient ranges from preoperative demographics, operative characteristics and many spine specific measures that can be utilized for healthcare outcomes and risk-related research.”

“Dr. Singh is joined on the board of directors by Frank Phillips, M.D. and Sheeraz Qureshi, M.D. Dr. Phillips, Co- Director of the Minimally Invasive Spine Institute at Midwest Orthopaedics at Rush, will serve in the capacity of Secretary. Dr. Qureshi, Associate Professor of Spinal Surgery at the Hospital for Special Surgery in New York City, will serve as the Treasurer.”

Asked what projects they will be undertaking, Dr. Singh told OTW, “There are many initiatives that will not only improve outcomes research but also will improve and advance the field. First and foremost, will be a standardized database to collect all the necessary surgical variables. Second, we will be able to track outcomes over multiple centers and institutions. Third, we will have the capacity to conduct organized multicenter clinical trials with improved ease, allowing for us to statistically power studies that can quickly evaluate new technologies. Lastly, we can also rapidly evaluate cost inefficiencies in treatments rendered to MIS spine patients.”

Asked how this project is special, he noted, “It is the only minimally invasive spine surgical database of its kind. Furthermore, it’s one of the most extensive surgical databases with over 300 variables per patient collected. Lastly, the database is already powered with 3,000 patients, which provides a working foundation for meaningful quality outcomes assessment.”

Shifting Focus to Cellular Triggers of RA

It could lead to a major shift in focus for rheumatoid arthritis (RA) researchers. A team of scientists has published work indicating that clinical trials for new RA drugs should aim not only for relieving inflammation, but they need to tackle the cells that produce autoantibodies. The research was conducted at NYU Langone Medical Center and the University of Pittsburgh, and led by senior author Gregg Silverman, M.D., professor in the Departments of Medicine and Pathology at NYU Langone and co-director of its Musculoskeletal Center of Excellence.

According to the February 23, 2017 news release, “Silverman and his colleagues developed sensitive assays to detect a range of different autoantibodies present in the disease. The researchers then established a cell culture system to stimulate memory B cells, and used the assays to test what kind of antibodies the B cells produced.”

“The researchers tested blood samples from RA patients and from healthy donors. They found high levels of APCA [anti-citrullinated protein antibodies]-secreting memory B cells in the blood of patients with these autoantibodies, but not in patients without autoantibodies or in the healthy volunteers. They then looked at patients who had achieved remission with either methotrexate or a TNF [tumor necrosis factor] inhibitor. The researchers found that APCA levels were directly proportional to the recirculating memory B cells in the blood stream, confirming that current drug treatments do not affect the underlying autoimmunity in rheumatoid arthritis.”

Dr. Silverman told OTW, “As a physician and immunologist I have been concerned that we have hit a plateau level in our treatments, as we are not really thinking about the long-term benefits and risks of our treatments. We found that we are treating the inflammation that often follows the autoimmune disease, but not treating the autoimmune disease itself.”

“When I was a fellow it was controversial as to whether rheumatoid arthritis was really an autoimmune disease. While we have made progress in our investigations in the causative drivers, we have neither refined our treatments nor our measurement of responses to evaluate whether our therapeutic interventions change the autoimmune drivers of disease.”

“We thought that the autoantibodies in the blood, like anti-CCP [cyclic citrullinated] antibodies, were coming from long-lived plasma cells in the bone, which could be like fossil records of an autoimmune phase of the disease. We were surprised that circulating autoantibody levels were directly linked to levels of autoimmune disease associated memory B cells in the bloodstream. These persistent autoantibodies are direct reflections of the continued high levels of active autoimmune disease lymphocytes, which can at any time colonize new joints to spread the disease.”

“When a surgeon operates to correct the damage to a joint, he/she would like to be confident the disease will not return shortly thereafter to destroy your repairs.”

Ted Davis: New Active Implants President, CEO

Ted Davis, a 25-year veteran of the life science industry, has been appointed president and chief executive officer of Active Implants LLC, a company headquartered in Memphis, Tennessee. Davis succeeds Henry Klyce, who will continue as chairman of the board.

According to the February 22, 2017 news release, “…Davis has 25 years of experience in the life sciences industry as an investor and senior executive, including chief executive officer of MicroPort Orthopedics and president of its predecessor Wright Medical Technology’s global OrthoRecon division from 2012 through 2015. Prior to leading the carve out and integration of the OrthoRecon platform, Davis led Wright’s business development, corporate development and research & development functions from 2006 to 2012, with increasing responsibility for the business development, government affairs, national accounts, reimbursement, medical education and global research & development teams.”

“Davis oversaw the acquisition and integration of a series of extremities and biologics platforms during Wright’s transformation into the market leader in the extremities market segment. Prior to joining Wright in 2006, Davis spent 10 years in the life sciences venture capital field, serving on the boards of multiple biotechnology and medical device companies while at MB Venture Partners and Vector Fund Management. He holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree in engineering from Vanderbilt University.”

Davis told OTW, “Having been a member of the Board for the past year, my priorities will be to continue the projects Henry and the team have in motion including accelerating the transition from a development-stage company to a commercial-stage company. We will focus on completing the enrollment of our two clinical trials for the NUsurface here in the U.S. and our limited commercial release in Europe. Additionally, in the current healthcare market environment, clinical and economic justification have become critical to the commercial success for any new device, so we will be increasing our investment in these efforts as our clinical data matures.”

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