SAN FRANCISCO–Applaud Medical, Inc. (Applaud), an emerging leader in the treatment of kidney stones, today announced it has received approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal study of the company’s Acoustic Enhancer technology for the fragmentation of calcium-based urinary stones. The Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH) study (NCT04563039) is a prospective, multicenter, randomized, double-blind trial for the Acoustic Enhancer when used in conjunction with Ureteroscopy with Laser Lithotripsy (URS-LL).
“This is a key milestone for Applaud Medical since it enables us to initiate a clinical trial focusing on the use of our Acoustic Enhancer technology to treat urinary stones,” said Thomas Kenny, PhD, Co-Founder and Chairman of Applaud Medical. “We look forward to the implementation and completion of this study since it is designed to provide data which demonstrating the clinical utility of the Acoustic Enhancer technology and also support our planned future regulatory filing in the U.S.”
Applaud Medical’s 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.
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.