SALT LAKE CITY, Nov. 30, 2021 /PRNewswire/ — Following Elute, Inc.’s Investigational Device Exemption (IDE) authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycin™ in a pivotal clinical trial, the Hospital for Special Surgery (HSS), and the Rothman Orthopaedic Institute (Rothman) have agreed to become clinical sites to evaluate the safety and efficacy of the EP Granules. This addition of HSS and Rothman as clinical partners demonstrates the interest in exploring additional treatment options for difficult to treat periprosthetic joint infections, and expands the number of sites, facilitating patient enrollment. HSS and Rothman will join a group of Elute’s clinical partners focused on improving patient care and driving clinical value.
"I’m pleased to be a part of the clinical collaboration and help evaluate new technologies and products that have the potential to improve outcomes for our patients today. A product that is designed to address infection burden in total joint surgery is worth investigating," said Amar Ranawat, a leading orthopaedic surgeon at HSS who has focused much of his practice on hip and knee replacement, researching major advancements in technique and technology. He is Professor of Clinical Orthopaedic Surgery at Weill Cornell Medical College and an attending orthopaedic surgeon at HSS and New York Presbyterian Hospital.
"Rothman/Jefferson is happy to participate in this important clinical trial that will evaluate the role of an important and innovative product that offers the potential to help patients. As a clinician and researcher in the field of orthopedic infections, I am excited about the promise of this technology," said Dr. Javad Parvizi", a Board Certified, fellowship trained, orthopaedic surgeon and the Director of Clinical Research at Rothman, and the James Edwards Professor Chair of Orthopaedics at Thomas Jefferson University. He specializes in the management of patients with complex hip and knee conditions. He is a renowned world expert in the field of periprosthetic joint infection, joint preservation, and joint reconstruction. He has performed over 10,000 joint procedures including over 1,100 preservation surgeries. Dr. Parvizi travels extensively across the world to give lectures related to his area of expertise. He has served as the president of Musculoskeletal Infection Society (2013), Eastern Orthopedic Association (2018) and serves on the board of numerous organizations and societies. He will be the president of American Association of Hip and Knee Surgeons in 2023.
"We are pleased to welcome Drs Ranawat and Parvizi to our list of clinical partners. These are renowned and trusted leaders in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 130 countries" said Ashok Khandkar, PhD, CEO of Elute, Inc. "We’re honored to have them as collaborators for our FDA authorized pivotal, randomized, blinded, prospectively controlled IDE clinical evaluation as we work to advance the development of novel solutions that address unmet needs in treating bone infections."
About EP Granules with Tobramycin:
EP Granules with Tobramycin is a synthetic calcium-salt resorbable bone void filler that is designed to provide 8-week delivery of an antibiotic in a local targeted region while allowing growth of new bone.
About Elute, Inc.:
Elute, Inc. is an emerging leader in the development of its novel drug eluting device platform for controlled and sustained release of drugs. Elute’s lead product candidate is EP Granules with Tobramycin, a bone void filler that is designed to provide 8-week, delivery of an antibiotic while allowing growth of new bone.
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 12th consecutive year), No. 4 in rheumatology by U.S. News & World Report (2021-2022), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report "Best Children’s Hospitals" list (2021-2022). HSS is ranked world #1 in orthopedics by Newsweek (2021-2022). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. The global standard total knee replacement was developed at HSS in 1969. HSS also leads the field in research, innovation and education.www.hss.edu.
About Rothman Orthopaedic Institute:
The Rothman Orthopaedic Institute is a world leader in the field of orthopaedics. Year after year, it has been ranked among the nation’s best in orthopaedic providers and the best in Greater Philadelphia, according to U.S. News & World Report. The joint replacement surgeons at Rothman Orthopaedics collectively perform over 17,000 hip and knee procedures each year in both an inpatient and outpatient capacity.
EP Granules with Tobramycin is an investigational device that is limited to investigational use in the United States.
Ashok Khandkar, Ph.D., President and CEO
SOURCE Elute, Inc.