SAN FRANCISCO–Applaud Medical, Inc. (Applaud), an emerging leader in the treatment of kidney stones, today announced announced enrollment of the first patient in the company’s prospective, multicenter, randomized, double-blind AEROLITH (Acoustic Enhancer Research on Laser Lithotripsy) study. This U.S. Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) trial is studying the use of Applaud’s Acoustic Enhancer technology when used in conjunction with Ureteroscopy with Laser Lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. Applaud Medical received IDE approval for the study from the FDA in September 2020.
“We are pleased with the progress we have made to date initiating the IDE study for our Acoustic Enhancer technology and are enthused with the enrollment of the first patient in this trial,” said Thomas Kenny, PhD, Co-Founder and Chairman of Applaud Medical. “The study is planned to enroll almost 200 patients at 15 clinical sites across the U.S. with a primary objective of demonstrating the absence of or having residual fragments stone measuring less than or equal to 2 mm following the use of the Acoustic Enhancer in conjunction with URS-LL.”
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 Ureteroscopy with Laser Lithotripsy (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.