Amplitude Vascular Systems (AVS) develops the PULSE IVL™ (Pulse Intravascular Lithotripsy™) platform, an investigational device for treating severely calcified arterial disease. The PIVL™ device is designed to improve deliverability, crossability, and efficiency in challenging peripheral, coronary, and carotid cases by using a mechanism that eliminates electrical emitters. AVS is preparing a U.S. peripheral commercial launch and is conducting multiple IDE trials, including a POWER PAD II U.S. peripheral IDE that began enrolling in October 2024. POWER PAD II is a prospective, single-arm, multi-center study that will enroll up to 120 patients across 20 U.S. sites, with enrollment expected to complete mid-2025. The company is partnering with the Jacobs Institute for a U.S. carotid IDE trial and also plans a U.S. coronary IDE study. AVS is based in Boston, MA and is backed by investors including BioStar Capital, Cue Growth Partners, and others; the PULSE IVL™ System remains investigational and is not yet cleared for commercial distribution. Amplitude Vascular Systems develops the Pulse IVL system, which generates pulsatile pressure waves delivered through a balloon to create multi-directional fractures in intravascular calcium and thereby increase vessel compliance. The device generates energy outside the body and amplifies it without electrodes or lasers in the balloon, yielding a low crossing profile, greater flexibility, and a non-compliant balloon designed to expand vessels without traumatizing healthy tissue. Pulse therapy is delivered at higher frequency and uniformly along the balloon length, aiming to reduce procedure time and the need for ancillary devices. AVS completed a first-in-human study showing benefits in calcific femoropopliteal arteries and recently received FDA IDE approval to begin a 20-site pivotal peripheral trial in the U.S., with a target enrollment of 120 patients. The company plans clinical testing in coronary and carotid indications, aims for a first commercial peripheral product in early 2026, and is developing an AI-powered “Smart IVL” to inform operators of treatment success in real time. Financially, the company raised over $250,000 in non-dilutive grants during early work, a $1.5M initial funding round to transfer technology from the University of Michigan, and secured $29M in a Series B in late 2023.

Total raised

$65M

Funding rounds

2

Latest round

Series B

Latest activity

Jan 2025