Amplitude Vascular Systems secures US $36 million for next-gen IVL technology

USA – Amplitude Vascular Systems (AVS), a Boston-based company specializing in medical devices, has raised US $36 million in a Series B funding round.

The funds will be used to advance clinical trials and prepare for the U.S. launch of the company’s innovative Pulse IVL platform.

“We are pleased to see strong, sustained investor excitement around this technology,” said Mark Toland, chairman of the board for AVS.

He emphasized that intravascular lithotripsy (IVL) has become a well-established therapy, creating a growing need for advanced solutions to treat patients with severely calcified arterial disease.

The Pulse IVL platform uses a unique approach to break through calcified plaques in arteries. It delivers high-frequency pulsatile pressure waves at a rate of 15 per second, with up to 5,000 pulses used in a single case.

Unlike traditional systems that rely on electrical emitters, the Pulse IVL system sends pressure waves along the entire length of a balloon.

Dr. Steven Yakubov, medical director of the OhioHealth Research Foundation and a member of the AVS Physician Steering Committee, highlighted the benefits of this design.

“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,” he explained.

Currently, AVS is enrolling patients in the POWER PAD II trial, which includes up to 120 participants in the U.S. with calcific femoropopliteal arteries undergoing treatment with the Pulse IVL platform.

The company is also planning additional trials for coronary and carotid patients. However, the Pulse IVL system is not yet approved by the U.S. Food and Drug Administration (FDA).

Intravascular lithotripsy (IVL) has become a highly sought-after technology in healthcare, offering cardiologists a safer way to break up heavily calcified plaques and prepare patients for percutaneous coronary intervention.

The popularity of IVL was boosted by the success of Shockwave Medical, now part of Johnson & Johnson MedTech.

Other companies are also entering this competitive field, and the recent funding round positions AVS to work toward FDA approval and establish its place in the market.