“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.
“We are committed to expediting the development and availability of novel solutions that address unmet needs in treating bone infections,” added Denny Farrar, executive chairman of Elute.