SAN FRANCISCO–Applaud Medical, Inc. (Applaud), an emerging leader in the treatment of kidney stones, today announced that its Acoustic Enhancer technology has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Acoustic Enhancer technology is designed to be used in conjunction with Ureteroscopy with Laser Lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones of at least 6mm and not more than 20mm in diameter that are obstructing or deemed to present a significant risk of future obstruction by a urologist or other qualified physician, which can place patients at risk of future sepsis, chronic kidney disease, or end-stage renal disease. The Acoustic Enhancer microparticles generate additional stone-fragmenting shockwaves when used during a laser lithotripsy procedure.
“The microparticles in our Acoustic Enhancer are designed to capture energy from the acoustic impulses of URS-LL, and produce rapid, large-amplitude expansions and contractions, then a final cavitation collapse near the stone which causes erosion and fragmentation of the stone,” explained Thomas Kenny, PhD, Co-Founder and Chairman of Applaud Medical. “Receiving FDA Breakthrough Device Designation for our Acoustic Enhancer will help accelerate the process for obtaining regulatory authorization in the U.S. while also providing support for future incremental reimbursement initiatives for our technology. We are currently conducting a prospective, multicenter, randomized, double-blinded study for the Acoustic Enhancer when used with URS-LL.”
“There is an increasing prevalence of urinary stone disease due to the rising incidence of obesity, diabetes mellitus, hypertension and dyslipidemia, with obstructions associated with kidney stones at least 6mm and not more than 20mm in diameter, putting patients at risk of sepsis, chronic kidney disease, or end-stage renal disease,” stated Dr. Ojas Shah, M.D., George F. Cahill Professor of Urology at Columbia University College of Physicians and Surgeons, and Director of the Division of Endourology and Stone Disease at Columbia University Medical Center. “Applaud’s Acoustic Enhancer offers a new approach to breaking kidney stones into smaller fragments, potentially reducing the risk of these complications and the development of future obstructions.”
About Applaud Medical, Inc.
Applaud is a privately held company founded in 2014 which aims to improve treatment methods, patient experiences and medical costs for all patients experiencing the effects of kidney stones. The Company is developing the Applaud Acoustic Enhancer, an innovative technology designed to enhance URS-LL in the fragmentation of kidney stones. The Company is also actively conducting a prospective, multicenter, randomized, double-blind study (NCT04563039) for the Acoustic Enhancer when used in conjunction with URS-LL.