AVS Raises Financing to Support Pulse IVL System Launch in the United States

January 28, 2025—Amplitude Vascular Systems (AVS), developer of the Pulse intravascular lithotripsy (PIVL) platform for the treatment of severely calcified arterial disease, announced that it has completed a Series B round of financing of $36 million.

According to the company, the funding will support the United States peripheral commercial launch as well as the United States coronary and carotid investigational device exemption (IDE) trials for the PIVL system, which is an investigational device and not yet cleared for commercial distribution within or outside the United States.

AVS advised it began enrolling patients in October 2024 in the POWER PAD II United States IDE trial. POWER PAD II is a prospective, single-arm, multicenter study evaluating the technical and clinical success of the PIVL system for treating patients with calcific femoropopliteal arteries. The study will enroll up to 120 patients at 20 sites in the United States and enrollment is expected to be completed in the middle of 2025.

Chris Metzger, MD, who is an interventional cardiologist at OhioHealth Riverside Methodist Hospital in Columbus, Ohio, serves as National Principal Investigator of the POWER PAD II study.

“AVS is the second company to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the United States,” commented Dr. Metzger in the company’s press release. “By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes.”

The company stated that the funding will also support the company’s coronary United States IDE study.

Steven Yakubov, MD, stated in the press release, “Because the Pulse IVL device uses a unique mechanism of action that eliminates the need for electrical emitters, the deliverability, crossability, and efficiency are optimized for very challenging and tortuous coronary cases.” Dr. Yakubov is Medical Director of the OhioHealth Research Foundation in Columbus, Ohio, and a member of AVS’ Physician Steering Committee.

Finally, the company stated that the funding will support the United States carotid IDE trial, as part of its partnership with the Jacobs Institute in Buffalo, New York, led by Adnan Siddiqui, MD. The partnership was announced in August 2024.

“We are looking forward to studying the Pulse IVL system in carotids to improve stroke care,” stated Dr. Siddiqui in the press release. “We believe the differentiated efficiency of this device versus other IVL catheters will be an important solution for our carotid disease patients, where a shorter treatment time is of utmost importance.”