Amplitude Vascular Systems (AVS Pulse) - Comprehensive Analysis Report
Summary
Amplitude Vascular Systems (AVS), established in 2017, is a medical device company dedicated to revolutionizing the treatment of calcified arterial disease. The company's core mission is to safely and effectively address severely calcified lesions through its innovative Pulse IVL™ system. AVS aims to redefine interventional therapy, thereby transforming how physicians manage this challenging condition. Positioned as a pioneer in its field, AVS seeks to significantly impact patient outcomes by providing advanced, user-centric solutions.
1. Strategic Focus & Objectives
Core Objectives
AVS is strategically focused on developing pioneering solutions for calcified arterial disease. Its primary objective is to advance its flagship Pulse IVL™ system for treating severely calcified lesions across various vascular beds, including peripheral, coronary, and carotid arteries.
Specialization Areas
The company specializes in pulsatile intravascular lithotripsy (PIVL) technology. Its unique value proposition lies in the Pulse IVL™ system's design, which offers a minimally invasive, efficient, and user-centric approach to fracturing calcium and expanding narrowed vessels.
Target Markets
AVS primarily targets patients suffering from calcific femoropopliteal arteries. Furthermore, the company is actively developing solutions and conducting trials for coronary and carotid indications, aiming to expand its reach across critical vascular segments.
2. Financial Overview
Funding History
Amplitude Vascular Systems has successfully raised a total of $70.4 million across five funding rounds to date.
Seed Round:
Date: July 7, 2020
Amount: $1.24 million
Series B Financing (Initial Close):
Date: January 2023
Amount: $20 million
Series B Financing (Additional Close):
Date: May 2023
Amount: $8.8 million (bringing this phase of Series B to $28.8 million)
Series B Round (Most Recent):
Date: October 15, 2024
Amount: $36 million
Key Investors: Notable investors include BioStar Capital, Cue Growth Partners, Corewell Health Ventures, Michigan Biomedical Venture Fund, Invest Detroit Ventures, and the University of Michigan Endowment.
Fund Utilization: The capital raised is strategically designated to support the U.S. peripheral commercial launch of the Pulse IVL™ system. It also funds U.S. investigational device exemption (IDE) trials for coronary and carotid applications, research and development efforts, operational expansion, and manufacturing capacity growth.
3. Product Pipeline
Key Products/Services
Pulse IVL™ System
Product Description: The flagship technology of AVS, the Pulse IVL™ System, employs pulsatile intravascular lithotripsy (PIVL) to address severely calcified arterial disease. It utilizes pulsatile pressure waves transmitted from an external source through a balloon to fracture calcium.
Development Stage:
Completed the POWER PAD I clinical trial (first-in-human study).
Initiated the POWER PAD II U.S. pivotal study in October 2024. This is a single-arm, prospective, multi-center trial evaluating the technical and clinical success for calcific femoropopliteal arteries.
Advancing preclinical work and IDE trials for coronary and carotid indications.
Target Market/Condition: Patients with calcific femoropopliteal arteries, with future indications for coronary and carotid vasculatures.
Expected Timeline:
POWER PAD II study enrollment anticipated to be completed by mid-2025.
Primary endpoints for POWER PAD II are expected to be presented as a Late Breaking Clinical Trial at the VIVA Conference in November 2025.
The first commercially available product for the peripheral vasculature system is targeted for early 2026.
Key Features and Benefits:
Generates pulsatile pressure waves from outside the body, eliminating the need for specialized electrodes or lasers at the distal catheter end.
Hydraulic energy delivery results in a lower profile and more flexible device, enhancing deliverability and energy efficiency.
Generates approximately 15 pulses per second, offering up to 5,000 pulses per case.
Features "smart" IVL capability providing intra-procedural feedback to physicians, guiding treatment duration and lesion progression.
Mechanism of action creates multi-directional fractures in calcium, increasing vessel compliance for safer expansion and sustained patency.
4. Technology & Innovation
Technology Stack
AVS's core platform is built around the Pulse IVL™ System, which leverages Pulsatile Intravascular Lithotripsy (PIVL).
Proprietary Developments
A key innovation is the system's ability to generate pulsatile pressure waves from outside the body, which are then transmitted through a balloon in contact with the vessel wall. This distinct approach eliminates the need for specialized electrodes or lasers or gear at the distal end of the catheter, leading to several advantages:
Lower Profile and Enhanced Flexibility: Improves device deliverability in complex anatomies.
Hydraulic Energy Delivery: Distinguishes it from traditional methods, enhancing efficiency.
High Pulse Rate: Generates approximately 15 pulses per second, providing up to 5,000 pulses per case.
Smart IVL Capability: Offers industry-first intra-procedural feedback, guiding physicians on treatment duration and lesion management.
Scientific Methodologies
The Pulse IVL™ system is designed to create multi-directional fractures in arterial calcium. This methodology improves vessel compliance, facilitating safer expansion of narrowed vessels and promoting sustained patency after the procedure.
5. Leadership & Management
Executive Team
The leadership team at Amplitude Vascular Systems combines extensive experience in foundational science, biomedical applications, and product development.
Mark Toland, Executive Chairman: As Executive Chairman, Mark Toland has been instrumental in securing investments and accelerating product development. He previously served as CEO of AVS.
Robert Chisena, Ph.D., Co-Founder & Chief Technology Officer: Dr. Chisena co-founded AVS in 2017. With a doctorate in Mechanical Engineering from the University of Michigan, his expertise is centralized on pulsatile intravascular lithotripsy. He is responsible for designing and producing safe, high-quality products and fostering an innovative "fail-forward" methodology within the R&D team.
Sean Gilligan, Chief Operations Officer: Appointed in April 2023, Sean Gilligan brings 30 years of executive leadership experience, including 15 years as Vice President of Program Management and R&D at Boston Scientific. His background encompasses overseeing an expanded portfolio and leading high-growth product development in interventional cardiology.
Angie Volk, Vice President of Business Development: Angie Volk leads the company's business development initiatives.
Elizabeth Galle, Vice President of Clinical Affairs: Elizabeth Galle oversees all clinical affairs, playing a critical role in advancing clinical trials.
Susie McAfee, VP of People and Administration: Susie McAfee manages human resources and administrative functions within the company.
Rob Lavado, Vice President of Regulatory and Quality: Rob Lavado is responsible for ensuring regulatory compliance and maintaining quality standards for AVS products.
Bob Haller, Corporate Controller: Bob Haller manages the financial accounting and reporting for the company.
Hitinder Gurm, M.D., Co-Founder: Dr. Gurm co-founded AVS in 2017. As an Interventional Cardiologist and Chief Clinical Officer at the University of Michigan, he conceived the foundational idea to pulse pressure inside a standard angioplasty balloon.
Recent Leadership Changes
Sean Gilligan was appointed as Chief Operating Officer in April 2023.
Elizabeth Galle was appointed as Vice President of Clinical Affairs.
6. Talent and Growth Indicators
Hiring Trends and Workforce
Amplitude Vascular Systems is in an accelerated growth phase, marked by significant expansion plans. The company aims to triple its workforce in Waltham, Massachusetts. This hiring initiative is focused on filling key roles necessary for its global operations, further development of the Pulse IVL™ System, and future commercialization efforts.
Company Size and Expansion Metrics
The company quadrupled its operational capacity with the opening of a new global headquarters in September 2025. This expansion is explicitly designed to support company growth, facilitate advanced R&D, and prepare for the upcoming U.S. commercial launch, creating new job opportunities.
7. Social Media Presence and Engagement
Digital Footprint
Amplitude Vascular Systems maintains an active digital presence, primarily on LinkedIn, where it shares company announcements, press releases, and insights into its technology and clinical progress. The company's official website also links to its LinkedIn profile and references its presence on X (formerly Twitter).
Brand Messaging and Positioning
AVS consistently reinforces its pioneering role in treating calcified arterial disease and revolutionizing intravascular lithotripsy. Its messaging highlights the innovative nature of its technology and its potential to transform patient care.
8. Competitive Analysis
Major Competitors
In the rapidly growing intravascular lithotripsy (IVL) market, Amplitude Vascular Systems competes with several established players and other innovative companies. Major competitors include:
Shockwave Medical: Recently acquired by Johnson & Johnson, a significant player in the IVL space.
Silk Road Medical
Lifetech Scientific Corporation
Supira Medical
Competitive Positioning
The IVL market is experiencing substantial growth and demands advanced solutions for patients with severely calcified arterial disease. While the market features well-proven therapies, AVS aims to differentiate itself through its unique Pulse IVL™ system, emphasizing its novel hydraulic energy delivery and "smart" IVL capabilities.
9. Market Analysis
Market Overview
The market for intravascular lithotripsy (IVL) is characterized by substantial growth and a critical need for innovative solutions to treat calcified arterial disease. Vascular calcification poses significant challenges to traditional angioplasty or stenting procedures and is associated with increased risks of major cardiovascular events, including heart attacks, strokes, blood clots, and limb amputations in peripheral arteries.
Growth Potential
The IVL market is considered "red hot," indicating high demand and significant growth potential for new and advanced approaches to address calcified lesions effectively.
Key Market Trends
Increasing Prevalence of Calcification: Vascular calcification is a prevalent and complex condition that complicates many interventional procedures.
Demand for Minimally Invasive Solutions: There is a strong market demand for minimally invasive, efficient, and safer methods to treat severely calcified arteries.
Focus on Improved Outcomes: Healthcare providers seek therapies that can improve vessel
