Amplitude Vascular Systems (AVS) is an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease. Pulse 2.0 interviewed Amplitude Vascular Systems Chief Technology Officer (CTO) Dr. Robert Chisena to learn more about the company.
Dr. Robert Chisena’s Background
What is Dr. Robert Chisena’s background? Dr. Chisena said:
“I am originally from Long Island, New York. My undergraduate studies were in Mechanical Engineering at the Pennsylvania State University, where I was introduced to cutting edge biomedical research and medical device development. I thoroughly enjoyed the deep dive into complex topics, so I decided to pursue my doctorate in Mechanical Engineering at the University of Michigan in Ann Arbor. There, I explored the concept of pulsatile intravascular lithotripsy, a method for using impact energy to safely fracture intravascular calcium, which brings me to where I am today – innovating in the intravascular lithotripsy (IVL) device space as the co-founder and Chief Technology Officer at AVS.”
Formation Of AVS
How did the idea for AVS come together? Dr. Chisena shared:
“AVS was founded to solve the difficulty of treating intravascular calcium, a challenge encountered daily by my co-founder, Dr. Hitinder Gurm. I met him through a prior relationship with my lab and began to work with him on a proof-of-concept for his idea to pulse pressure inside of a standard angioplasty balloon, a strategy he’d been thinking about since 2015.”
“We started from a bottom-up approach studying the properties of intravascular calcium and quantifying the amount of energy required to create multi-planar calcium fractures. We simultaneously investigated the potential user experience to ensure that we were developing a technology that could easily be integrated into the standard hospital workflow.”
“Dr. Gurm and I raised over $250,000 in non-dilutive grant funds to support these efforts and developed an early version of the product that we demonstrated could effectively and safely fracture calcium.”
Primary Responsibilities
What are Dr. Chisena’s primary responsibilities at the company? Dr. Chisena pointed out:
“I work with our Quality, Regulatory, and Operations counterparts to determine the requirements for verifying and validating our design for quality, reliability, manufacturing and scalability. I also oversee efforts to demonstrate safety and efficacy of our device as we work towards regulatory approvals. I wake up every day with the goal of ensuring that AVS is designing and producing the safest, highest quality product with the best end-user experience, encouraging my team of R&D engineers to start with a “fail-forward” methodology so that we are constantly learning and quickly improving.”
Core Products
What are the company’s core products and features? Dr. Chisena explained:
“The AVS device is called Pulse IVLTM which stands for Intravascular Lithotripsy. Urologists have used lithotripsy as a therapy to break down kidney stones for decades, but the use of high-intensity pressure waves to break up calcium in the arteries of the heart or legs is relatively new.”
”To fracture intravascular calcium, the Pulse IVL System generates pulsatile pressure waves which are delivered through a balloon in contact with the vessel wall. Short bursts of high-pressure waves impact the calcium through the balloon and create multi-directional fractures. Fracturing calcium increases vessel compliance, which allows the vessel to safely expand and remain expanded when the device is removed.”
“Compared to other similar technologies, our device generates pulsatile energy outside of the body and amplifies the energy to fracture calcium without the need for specialized electrodes or lasers in the balloon. For this reason, our device has a low crossing profile and is more flexible, which allows physicians to treat more diseased vessels.”
“Pulse therapy is also unique because the energy waves are administered at a higher frequency compared with other therapies and are delivered uniformly along the entire length of the balloon. This feature makes the procedure much more efficient and reduces the number of other devices that need to be used.”
Favorite Memory
What has been Dr. Chisena’s favorite memory working for the company so far? Dr. Chisena reflected:
“Seeing the Pulse IVL device improve the lives of patients with severe peripheral artery disease has been the best memory. During one of our first cases, we treated a patient with severe calcium and a chronic total occlusion (long closure of the vessel) of her entire above-the-knee artery. After treatment, the patient’s blood flow through the vessel and mobility was completely restored. After years of development, we are starting to achieve clinical results that are improving quality of life for our patients.”
Challenges Faced
What challenges have Dr. Chisena and the team face in building the company? Dr. Chisena acknowledged:
“Growing the company during the COVID pandemic was one of the toughest challenges we faced. From developing a product to running a clinical trial while states and countries were shut down, COVID hardened our resolve and readied us for all challenges ahead.”
“Today, there isn’t a project that doesn’t present challenges. Engineering is a matter of trade-offs and determining which design elements are priorities over others. In the medical device space, we have some unique challenges in the form of regulatory standards and clinical trial enrollment. Every patient is unique, and we must design our devices to address those variations.”
Evolution Of AVS’ Technology
How has the company’s technology evolved since launching? Dr. Chisena noted:
“Because we are always innovating, Pulse IVL technology has drastically advanced and improved from our first concepts. As we evolve, we make improvements to the user experience, energy delivery, crossing profile and longevity of the balloon. We are continuing to push toward an AI-powered “smart” IVL device that will inform operators of the success of their treatment. Additionally, we are targeting both peripheral and coronary indications to start but will grow into other treatment areas that will expand our impact.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Chisena cited:
“We just reached our most significant milestone, earning FDA approval to begin a pivotal trial of our peripheral device at 20 sites here in the U.S. Prior to that, we completed our first-in-human study, which showed clear benefits to patients with calcific femoropopliteal arteries.”
Customer Success Stories
When asking Dr. Chisena about customer success stories, he highlighted:
“During the study I referenced above, we treated several patients with very long lesions who might have otherwise had no treatment options. One patient was 94 years old, and we positively changed her life and mobility. Despite its unique challenges, the opportunity to directly impact someone’s quality of life through your designs is one of the greatest rewards of working in the medical device space.”
Funding
Upon asking Dr. Chisena about the company’s funding details, he revealed:
“Our first funding round raised $1.5 million, which allowed us to transfer the technology from the University of Michigan to AVS. With this funding, we designed and developed the first generation of our device, demonstrated the efficacy of the technology in diseased cadaveric tissue with adjudication of the results by a well-respected outside lab, and kicked off our first-in-human trial. Because we continued to demonstrate success along the way, we’ve since secured an additional $29 million through our Series B funding effort in late 2023.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Dr. Chisena assessed:
“If you consider all potential applications of this technology, from the peripheral indication to coronary to carotids and TAVR (Transcatheter Aortic Valve Replacement) indications, we estimate the TAM to be north of $9 billion.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Chisena affirmed:
“There are several differentiating features we demonstrate based on our design. Because we have no electrodes or lasers in our balloon, we can have a much more deliverable device. Our pulsatile energy delivery mechanism transmits energy more uniformly and efficiently than other devices.”
“We also have the only IVL catheter to use a non-compliant balloon, which is proven to expand a given vessel more effectively without stretching or causing trauma to the healthy vasculature. Lastly, part of our pressure delivery mechanism involves a ‘smart’ component. In the future, Smart IVL will allow us to inform the physician in real time when they have effectively disrupted the calcium and changed the compliance of the vessel, which currently can only be accomplished manually or via X-Ray.”
Future Company Goals
What are some of the company’s future company goals? Dr. Chisena pointed out:
“Because we recently became one of the first companies to receive US FDA IDE approval to begin our pivotal trial for our peripheral device, our next immediate goal is to enroll 120 patients across 20 sites in that study. Each of these patients will be treated in the U.S.”
“We will follow the trial with clinical testing of our coronary and carotid indications. Our goal is to have our first commercially available product for the peripheral vasculature system in early 2026.”
Additional Thoughts
Any other topics you would like to discuss? Dr. Chisena concluded:
“I would like to end with how grateful I am to our talented team at AVS. In a short time, this team has continued to meet major milestone achievements. We are all looking forward to kicking off our clinical trial and demonstrating the positive effect of this device on patients’ lives.”
