January 28, 2025 08:00 AM Eastern Standard Time

BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease with its novel PULSE IVL™ platform, announced today that it has completed a Series B round of financing of $36M. The funding will support the U.S. peripheral commercial launch as well as U.S. coronary and carotid IDE trials for the company’s Pulse Intravascular Lithotripsy™ (PIVL™) device.

“We are pleased to see strong, sustained investor excitement around this technology”Post this

“We are pleased to see strong, sustained investor excitement around this technology,” said Mark Toland, Chairman of the Board for AVS. “Intravascular lithotripsy now represents a large and well-proven therapy that demands new solutions for patients with severely calcified arterial disease. This investor confidence reflects accelerated execution of critical company milestones in 2024, including the initiation of our U.S. peripheral IDE. The commitment from our partners at BioStar Capital and Cue Growth Partners reinforces the great progress toward commercial approval with this technology in the IVL space.”

AVS began enrolling patients in October 2024 in the POWER PAD II U.S. IDE trial, which is a prospective, single-arm, multi-center study evaluating the technical and clinical success of the PULSE IVL™ System for treating patients with calcific femoropopliteal arteries. The study will enroll up to 120 patients at 20 U.S. sites and enrollment is expected to be completed mid-year 2025.

“AVS is the second company to conduct a peripheral intravascular lithotripsy pivotal IDE trial in the U.S. By introducing a new, innovative treatment for calcified arterial disease, we can make a dramatic impact on patient lives and improve outcomes,” said Dr. Chris Metzger, National Principal Investigator of the POWER PAD II Study and Interventional Cardiologist at OhioHealth Riverside Methodist Hospital.

The funding will also support the company’s coronary U.S. IDE study. “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,” said Steven Yakubov, Medical Director of the OhioHealth Research Foundation, Columbus, OH and member of AVS’ Physician Steering Committee.

Lastly, the capital raised will support the U.S. carotid IDE trial, as part of its partnership with the Jacobs Institute in Buffalo, NY, led by Dr. Adnan Siddiqui. “We are looking forward to studying the Pulse IVL™ System in carotids to improve stroke care. 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,” said Dr. Siddiqui.

To learn more about AVS and the PULSE IVL™ System, please visit: https://www.avspulse.com/.

About AVS

Amplitude Vascular Systems (AVS) is a medical device company based in Boston, MA, focused on safely and effectively treating severely calcified arterial disease. AVS is backed by global investors including BioStar Capital, Cue Growth Partners, and others. To learn more about pulsatile intravascular lithotripsy, visit www.avspulse.com.The Pulse Intravascular Lithotripsy™ (PIVL™) System is an investigational device and not yet cleared for commercial distribution within or outside the United States.

Contacts

Media:
Matter Health for AVS
Dan Ventresca
T: 617-874-5488
AVSPulse@matternow.com

Investor Relations:
Angie Volk
VP of Business Development
Angie.Volk@AVSPulse.com

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