Researchers investigating medical device technology often want to develop their concepts into products that benefit clinicians, caregivers, and patients. The journey of translational development requires learning new skills, being open to expert voices, and changing one’s mindset to think like an entrepreneur.
To learn more about this experience, we spoke with Robert Chisena, Co-Founder and Chief Technical Officer, AVS Pulse, and Upma Sharma, President and Chief Executive Officer, Arsenal Medical.
Robert explains, “I was a graduate student, and I always wanted to work with a physician, both from the research side and the product development side, to create a surgical device.” Robert met his co-founder, Dr. Hitinder Gurm, at the University of Michigan while in his PhD program. An interventional cardiologist, Dr. Gurm, had difficulty treating calcified arterial disease with the conventional tools. One option, a shockwave device, was effective for intravascular lithotripsy—a balloon-based, catheter-based procedure to break up calcium in arteries—operating on a mechanism of action that required electricity to generate pressure. Dr. Gurm thought, what about using impact energy inside the balloon? It would simplify the process and be just as effective, if not more so. Robert says, “He identified the unmet need, a serious problem for clinicians, and I had the engineering experience to build and test it.” Robert and Dr. Gurm focused on developing an intravascular lithotripsy technology that would perform the same function with a different mechanism of action. Robert says, “We realized we had something.”
Upma earned her PhD in chemical engineering from Princeton University and then completed a postdoctoral fellowship at Rice University. She says, “I really loved doing research. But during my PhD, working on a highly theoretical project, I began to feel that my research was too far removed from the patient. I moved to a more applied project during my postdoc, but still felt very far from the patient.”
She started at what is now Lyra Therapeutics as a bench scientist focused on developing a novel bioresorbable scaffold to treat chronic sinusitis. Upma says, “What I really enjoyed from the beginning was thinking about the clinical need in a much more real way. That included close collaboration with clinicians to understand the true pain points. In academics, it was, this is a cool material. How can we link it to an application? Here it was, let's talk to ten physicians and understand how they see the issues and identify the gap, and then, can we design something to fit that?”
The other difference Upma found between academia and entrepreneurship was working with an interdisciplinary team, all motivated by the same goal and mission. She says, “Your PhD is your PhD, and you're judged on your individual work. I realized I enjoyed having that team, with its different skill sets, come together to solve problems. In academia, you often don't know if the problems are solvable, but you have more time to look at them. In a startup, there are solvable problems, but the question is, can you solve them in a relevant timeframe with an appropriate amount of money?”
Upma says that for Arsenal Medical’s products, the process began by identifying the clinical need and then considering whether they could develop the right material for that need. DARPA put out a call for proposals to try to solve the problem of truncal bleeding, one of the leading causes of death in military conflicts. The product Arsenal Medical developed in response, ResQFoam™, is a hydrophobic foam that rapidly expands throughout the abdomen to control hemorrhage; the goal is to allow the patient time to reach potentially life-saving surgery. ResQFoam has been designated a breakthrough device by the FDA.
Upma says, “At some point, once we had a lot of experience in developing materials, we started talking to different physician groups and quickly realized that there was also a strong unmet need for brain hematomas.” Arsenal Medical then developed NeoCast™, an injectable biomaterial for deep neurovascular occlusion. Upma explains, “The competitive products were designed for other indications and adapted because clinicians have such a high need. Our approach was, rather than trying to adapt something, let’s try to understand what the right material would look like, and build that material from the ground up.”
Robert and Dr. Grum initially received funding support for their project from the NIH and the University of Michigan. At a certain point, they had taken advantage of all the help that the university could provide. Robert says, “From there it became, how do you keep the project going so that your innovation sees the light of day? And that was the next place that I wanted to go; I wanted to start the business, generate capital investment, and continue the project.”
Robert explains that AVS raised a small first round from BioStar Capital, and then needed to “stretch the dollar as long as we could.” He adds, “The entrepreneur in me—or the frugality in me—brought me to my parents' basement, where I had my engineering work in one room and my bed in the other.” It’s a classic entrepreneurial story. Robert says, “Over two and a half years, we stretched that small amount of money all the way to a first-in-human trial where we showed really incredible results.”
Upma says, “Our founders came out of MIT and Harvard and have always been strong believers in leveraging non-dilutive funding; that was core to the company. Our ResQFoam product would not be what it is today without the non-dilutive funding that has gone into it.” Eventually, Arsenal Medical brought in venture capital. Upma adds, “Fundraising was definitely a learning experience, and you need the right experts to guide you.”
AVS later raised nearly $30 million in a Series B round. When asked about the key to their fundraising success, Robert says, “I have to admit, we got lucky. Because number one, the intravascular space was exploding. We were in a perfect place at the right time. And number two, with BioStar Capital, we had a group of active investors who were really partners. BioStar saw the big market opportunity and believed in what we were doing. They put the first round forward, and they were right there to lead the second round. As we were developing the product and running the clinical trials, they helped to guide us. They're invested not just from a monetary standpoint but also from a desire to see the product in their hands.”
Academics strive to publish their concepts as quickly as possible. Entrepreneurs must protect their concepts as soon as possible before making anything public. Upma says, “That was another big learning in terms of being careful about your IP position in everything you do.”
AVS worked with the University of Michigan’s Tech Transfer office on their first patent, but before that, Robert says, “it was me, sitting and reviewing as many patents as I could get my hands on in that space, which in and of itself was an important undertaking. We really focused on what the white space would be for our system.”
AVS conducted the first-in-human trial at two international sites; they didn’t yet have the quantities required for the US investigational device exemption (IDE). Robert says, “The outcomes were great; it was awesome to see. We had one case in Australia, a 94-year-old woman whose arteries were totally occluded. The doctor treated the leg from the knee up to her hip, and the result was beautiful. She woke up and asked if we could do her other leg!” The clinicians were able to treat patients with a single product rather than placing multiple catheters, and they appreciated the device's effectiveness.
In 2024, AVS received an IDE from the FDA to begin its pivotal trial for pulsatile intravascular lithotripsy. The clinical study, which recently concluded, evaluated the safety and efficacy of AVS’s Pulse IVL™ System for treating patients with severely calcified peripheral arterial disease in the US. Robert says, “We had the same positive feedback from clinicians in the pivotal study that we heard in our first-in-human trials.” He adds, “One of the number one things I’ve learned is that if you don't have that clinical support in the medical device industry, it’s going to be tough to make your product.”
Arsenal Medical is currently in the clinical phase with its products, running the key pivotal studies required for FDA approval.
Robert says, “You can't think of yourself in one way. You can't be just a researcher. You can't be just a businessperson. You have to wear many hats, especially before you start hiring people, because that’s a quick way to burn cash. I still wear many hats today, even though the company is much bigger. I was the person in IT, inventory management, and shipping. I was the one racing down the street to hit the 6:00 PM UPS pickup. That's the mentality an entrepreneur should have.”
Consultants and other experts are important to fill in the gaps in your knowledge. For example, Robert worked with software consultants who handled the device's coding. He says, “I wasn’t going to learn to code, but I was in there with them, figuring out what’s right. You have to remain on top of things, and you need to be the subject matter expert.”
He adds, “I did as much as I could possibly get done, and as much as I could learn to get it done, and then eventually I brought in the right people on a consulting basis, and, eventually, on an employee basis. Also, leave your ego at the door; there are people smarter than you, and you want to find them. If you do, most likely you'll succeed.”
Upma agrees, “If you look at my journey, it's a journey of learning. You have to be open and willing to always learn, whether it’s how to manage people, how to talk to the FDA, or how to do an initial clinical study. No one person can be an expert in all of those things. You need to find the right experts who have technical expertise, work well with you, and give you the appropriate level of counsel. And that's a whole process you have to go through. Sometimes you have to kiss a lot of frogs to find the right person!”
She also notes that many challenging activities must occur early in the development process. You need to confirm with clinicians that there is an unmet need, and assess the commercialization potential, because while some doctors might be really excited about your concept, you might have too small a market or a too-niche condition. Upma says, “You have to understand your IP position. You have to understand the market size. You have to understand whether you can actually solve the problem technically. All of those things have to come together. And you need to answer key questions. What’s the timeline? How much capital do you have to raise to get to a meaningful milestone? What's going to be the return on investment to make it interesting for funders?”
Upma advises, “Be honest with yourself. Get people around you who will be critical of your idea. I’ve seen people fall in love with their technology without clinician buy-in. Then you're a technology looking for a problem, and that's never a good place to be. You want to find a problem that actually matters to people and solve that problem. Once you've done that, lean in, because it's so rewarding.”
Robert admits that it’s not all been easy. He says, “It's a crazy road, starting your own company. You have to be super sure of yourself, and even then, you will doubt yourself along the way. Be ready for some good times and some pretty brutal times. But I dreamed about it every night. I still do.” He adds, “As a leader, you need to be inspirational. People don't want to just show up to work every day and leave at 5:00 PM. They want a mission to make their life mean something, and if you can inspire them, then they'll dream about it too.”
The journey from academic to entrepreneur can be rewarding, both professionally and personally. After eight years, Robert says, “Seeing something that you built being used to treat people, and seeing them wake up and feel a difference, is just great.”
Upma says, “I’ve been at these two companies since I left academia, and now I’m the CEO. We have a team of employees who are dedicated to the mission. We’re working on truly cutting-edge products. And we're at a point where we’re starting to see impact. The joke internally is that I’m always telling everyone, ‘The next six months are going to be so exciting.’ And they say, ‘You've been telling us that for almost 20 years.’” Upma has been proven right over and over again. She says, “When they make fun of me now, I say, ‘What, was I wrong?’”
She adds, “When you draw something on the board, conceive a material, and then several years later, it's in a patient, and you're hearing about the clinical benefits, that's extremely rewarding.”
About Robert Chisena, PhD
About Upma Sharma, PhD