Amplitude Vascular Systems Secures $36M for IVL Expansion
Amplitude Vascular Systems (AVS) has recently announced the completion of a significant Series B financing round amounting to $36 million. This funding is pivotal in supporting the company’s upcoming U.S. commercial launch of its innovative PULSE IVL™ platform, aimed at safely and effectively addressing severely calcified arterial disease.
Investment to Drive U.S. Launch
The financial backing from this funding round will primarily facilitate not only the commercial rollout of the PULSE IVL™ system in the U.S. but also support key investigational device exemption (IDE) trials for related products. These trials include the coronary and carotid applications of the Pulse Intravascular Lithotripsy™ (PIVL™) device, ensuring that AVS is well-positioned for impactful launches in the competitive landscape of medical devices focused on arterial health.
Commitment from Investors
Mark Toland, the Chairman of the Board for AVS, expressed enthusiasm about the strong and ongoing support from investors. He noted that the investor confidence underscores the pressing need for new solutions in treating patients suffering from severely calcified arterial conditions. This is particularly crucial as the company moves toward achieving significant milestones in the coming year.
Advancement in Clinical Trials
In line with the recent financing, AVS has commenced patient enrollment for the POWER PAD II U.S. IDE trial, which is an essential part of their research strategy. This prospective, multi-center, single-arm study is committed to evaluating both clinical success and the technical efficacy of the PULSE IVL™ system in treating calcified femoropopliteal arteries. With the trial aiming to enroll around 120 patients across 20 U.S. locations, it is expected that the patient enrollment will be concluded by mid-2025.
Innovative Treatment for Patients
Dr. Chris Metzger, the National Principal Investigator for the POWER PAD II study and an interventional cardiologist, highlighted that AVS is paving the way for innovative treatments for those with calcified arterial disease. The introduction of this new therapeutic modality is set to enhance patient outcomes significantly while transforming how calcified conditions are managed therapeutically.
Support for Diverse Research Initiatives
The financing will also empower AVS to pursue its coronary U.S. IDE study. This study is particularly noteworthy as the PULSE IVL™ device utilizes a unique mechanism of action, differentiating it from existing offerings by eliminating the need for electrical emitters. This innovation optimizes its deliverability and efficiency, making it highly effective for complex coronary interventions.
Collaboration in Research
Furthermore, the capital raised will contribute to a carotid IDE trial in partnership with the Jacobs Institute, led by renowned expert Dr. Adnan Siddiqui. This initiative aims to enhance stroke care solutions through the use of the Pulse IVL™ system, which promises greater efficiency compared to traditional IVL catheters, thereby reducing treatment times.
About Amplitude Vascular Systems
Amplitude Vascular Systems is a Boston-based company dedicated to developing innovative medical solutions for severely calcified arterial disease. The company is popularly known for its pioneering work in pulsatile intravascular lithotripsy and is backed by a robust network of global investors, including prominent names like BioStar Capital and Cue Growth Partners. For anyone interested in learning more about the PULSE IVL™ system and AVS's commitment to advancing vascular treatment, further information can be found through their official channels.
Frequently Asked Questions
What is the purpose of the $36 million funding?
The funding aims to support the U.S. commercial launch of the PULSE IVL™ platform, along with crucial IDE trials for related devices.
What are the key trials AVS is conducting?
AVS is conducting IDE trials for its PULSE IVL™ device, which includes studies in peripheral, coronary, and carotid applications.
Who is overseeing the POWER PAD II trial?
Dr. Chris Metzger serves as the National Principal Investigator for the POWER PAD II trial, overseeing its operations and research outcomes.
How does the PULSE IVL™ device work?
The PULSE IVL™ device employs a unique mechanism that enhances deliverability and efficiency in treating calcified arterial conditions.
Where can I learn more about AVS?
Additional information about Amplitude Vascular Systems and the PULSE IVL™ System is available through their official website and other promotional materials.
