Congratulations, Ashok Khandkar PhD
Garje Marathi Global is very proud to be associated with Ashok Khandkar PhD , since our inception.
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. Elute’s product is a combination product that combines a bone void filler device with an antibiotic, promises to transform the treatment of patients by providing a scaffold for new bone growth and delivering an antibiotic locally in a targeted area, for an unprecedented 8-week extended duration. It is designed to be used as a bone void filler device to treat patients with deep bone infections that develop following a hip or knee replacement.
Over 1 million Americans undergo hip or knee replacements every year, and between 60,000 to 100,000 of them suffer from infections. These infections are difficult to treat and require a 2-stage surgical procedure spaced between 10- 12 weeks apart. Overall, such 2-stage treatments take 6 months out of a patients’ life with sub-optimal outcomes: about 1 in 4 patients continue to have recurring infections! Surgeons are looking for a better solution to address this unmet need, which hasn’t changed in the last 3 decades.
Combination products are therapeutic products that combine drugs, devices, and/or biological products, and hence don’t neatly fall into a single category: devices, or drugs etc, which are regulated by different centers or authorities that specialize in these categories. As technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, combination products raise challenging regulatory and management challenges. With the FDA’s primary responsibility of eliminating risk to the general public from medical products, it is all not uncommon for the FDA to adopt the most conservative process that strains the budgets of smaller, more nimble and innovative companies developing products, effectively delaying the commercial release of new products.
Elute is proud to have been granted a fast-track “de novo” pathway for its novel combination product. As we understand it, this not only was this a historic industry first for FDA authorization of a fast-track deNovo regulatory pathway for a combination device + drug product but was also one of the fastest approvals of an IDE study.