Breakthrough Device Designation Granted to Applaud Medical’s Acoustic Enhancer

Applaud Medical Inc. (Applaud) has has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Acoustic Enhancer technology.

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, 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, Ph.D., 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.”
 
Applaud is a privately held company founded in 2014 that aims to improve treatment methods, patient experiences, and costs for patients suffering from kidney stones. The company is actively conducting a prospective, multicenter, randomized, double-blind study for the Acoustic Enhancer when used in conjunction with URS-LL.