SALT LAKE CITY, June 8, 2021 /PRNewswire/ -- Elute, Inc., announced today it has received authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycintm in a pivotal clinical trial.
This Investigational Device Exemption (IDE) authorization, involving the use of a resorbable bone void filler that delivers a broad-spectrum antibiotic in a local and targeted manner, is to investigate use in the surgical treatment of bone infections following hip or knee replacements. This is the first FDA authorization to use EP Granules with Tobramycin in patients with such difficult to treat bone infections.
"We are pleased to note that the supporting pre-clinical data including safety and efficacy studies of EP Granules with Tobramycin we presented to the FDA merited the approval of our IDE. We believe that the authorization of this randomized, blinded, prospectively controlled IDE clinical evaluation will enable further evaluation of this new product to support a future premarket submission, with significant potential to improve patient care and satisfaction," said Dr. Ashok Khandkar, President and CEO of Elute. Denny Farrar, Executive Chairman of Elute, said, "We are committed to expediting the development and availability of novel solutions that address unmet needs in treating bone infections."
"With a significantly increasing number of knee replacements year after year, there is a rising number of revisions, many unfortunately due to infections, which are treated by removing the infected device in a two-stage approach. Bony deficiencies occur with the removal of the implants. It would certainly be extremely advantageous to have the tobramycin eluting EP Granules bone graft that has the potential to not only remain uninfected but also restore bone stock. This type of bone graft would also be attractive in complex revision arthroplasty which is complicated by significant bone deficits. Therefore, it is my clinical conclusion that the addition of this tobramycin eluting bone graft to the surgical armamentarium of arthroplasty surgery has the potential to be of substantial benefit", said Dr. Adolph Lombardi MD, Joint Implant Surgeons, Columbus, Ohio.
"EP Granules with Tobramycin is designed to fill a major void in our current treatment of orthopedic infections. I look forward to the potential to improve clinical outcomes for our patients," said Bruce Evans, M.D., Joint Reconstructive Surgeon at Steward Orthopedic and Sports Medicine Group, Salt Lake City, Utah, Chair of Elute's Clinical Advisory Board.
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.
EP Granules with Tobramycin is an investigational device that is limited to investigational use in the United States.
SOURCE Elute, Inc.
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