What You Should Know:
– 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.
Amplitude Vascular Systems Advances Intravascular Lithotripsy with Investor Support and U.S. IDE Trials
Amplitude Vascular Systems (AVS), a Boston-based medical device company, is pioneering safer and more effective treatments for severely calcified arterial disease. Backed by global investors, including BioStar Capital and Cue Growth Partners, AVS continues to make significant strides toward commercial approval of its innovative PULSE IVL™ System.
Investor Confidence and Technological Advancements
- Strong Investor Support: Mark Toland, Chairman of the Board for AVS, emphasized the sustained investor confidence in intravascular lithotripsy (IVL) and the company’s progress in 2024, particularly with the initiation of its U.S. peripheral IDE trial.
- Innovative IVL Technology: The PULSE IVL™ System provides a unique approach to treating severely calcified arterial disease, addressing a critical need in the evolving IVL space.
U.S. IDE Trials and Clinical Milestones
- Peripheral IDE Trial (POWER PAD II): Launched in October 2024, this prospective, single-arm, multi-center study evaluates the PULSE IVL™ System’s technical and clinical success in treating calcific femoropopliteal arteries. The trial will enroll up to 120 patients across 20 U.S. sites, with completion expected by mid-2025.
- Coronary IDE Study: The funding will also support the U.S. coronary IDE study. Dr. Steven Yakubov, Medical Director of the OhioHealth Research Foundation and AVS Physician Steering Committee member, highlighted the device’s optimized deliverability, crossability, and efficiency, making it particularly suited for complex coronary cases.
- Carotid IDE Trial: In collaboration with the Jacobs Institute in Buffalo, NY, and led by Dr. Adnan Siddiqui, AVS is advancing its carotid IDE trial as part of its broader research and development efforts.
With robust investor backing and a growing pipeline of clinical trials, AVS remains at the forefront of intravascular lithotripsy innovation, driving progress toward regulatory approvals and expanded patient access to next-generation arterial disease treatments.
