MedTech Pioneers – Moray’s Robotic Trans-Catheter Mitral Repair System

Co-founders: Mark Barrish BSME, JD, CEO and Phillip Laby, MSME, CTO

Moray Medical, a Silicon Valley-based medtech startup, is developing a structural heart robotic delivery system for edge-to-edge valve leaflet repair. Moray was one of the 5 top finalists out of 1,000 candidates in the 2020 Medtech Innovator accelerator cohort. Veranex (formerly Ximedica) is a sponsor of Medtech Innovator and our team regularly mentors and advises many of the accelerator’s startups. I had the opportunity to catch up with Moray’s co-founders, Mark Barrish BSME, JE, CEO, and Phillip Laby, MSME, CTO, about their technology and plans for 2021.

 

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First off, how did you two meet?

[MB] I have been working a couple of decades on medical device startups and loving my job. Early in my career and I was lucky to work with an SRI spin-out, Intuitive Surgical. At the time the only competitor we had was Computer Motion in Santa Barbara. Funnily, my undergrad roommate, Phillip Laby, was with Computer Motion. We actually reconnected at a wedding back in 1994 and we agreed not to talk business as we were on opposite sides.

[PL] – Before Mark joined Intuitive Surgical, I helped start Computer Motion and invited him to join me at Computer Motion; he turned me down having recently joined a prominent law firm.

How did you both decide to form Moray Medical?

[MB] Intuitive Surgical and Computer Motion eventually had the good sense to merge. At that point, I worked for the combined company but Phillip had already left. Phillip helped start InTouch Health which recently sold to Teledoc. I went on to work with medtech startups, some of which grew into large companies, such as AneuRx (acquired by Medtronic) and Visx (a laser eye surgery company that was acquired by Abbott). I was working my way up the ranks of a law firm and managing a lot of device startups. After a while, I felt like I was ready for a new challenge and I reached out to Phillip, who had coincidentally moved to the Bay Area. Phillip was interested in collaborating and was consulting with a few companies. We met up and decided to do something together. Collectively, we decided to develop flexible robotic structures to meet the needs of cardiovascular interventionalists. We both recognized the limitations of the pull-wire systems in structural heart applications and felt we could do better.

[PL] I was going to grad school and launching InTouch at the same time. I finished both and moved to Bay Area. I was consulting and working in the surgical robotic field with Neoguide, TransEnteryx and others. These companies were dealing with pull wire systems and were running into problems. I could see this was a real issue. I had been thinking about this and thought that Mark and I should do something about it. I wanted to look at articulation in a different way – with microfluidics. In order to use microfluidics, you need moderately-high pressure and disposable Nitrous cannisters (already used in transcatheter cryogenic procedures) were ideal for what we wanted to do. We felt we had a winning combination – we understood the top-level needs of the physicians and the issues with the current designs. We decided to build a technology to address these issues. We took a look at how to make our company successful; we were not worried about the development of the technology. We knew we needed to tailor the system to the clinical needs, and to get the business strategy and model right. It took a lot of time, but I think we are now on the right track.

Tell us about the market opportunity in structural heart.

[PL] We decided to focus on structural heart needs to improve the quality of life for the millions suffering with leaky heart valves. We felt transcatheter mitral therapy delivery was going to be the next big thing. The structural heart market is currently one of the fastest growing medical-device fields, and that growth is accelerating with the emergence of the Transcatheter Mitral Valve repair (TMVr), and more specifically the multi-billion dollar Transcatheter Edge-to-Edge Repair (TEER) market.

[MB] Before our technology was working, we spoke to mitral space KOLS and this led us to Dr. Fred St. Goar, a creative and entrepreneurial doctor and an amazing resource for the medtech community. When we explained what we were doing, Fred leaned back and asked us why we didn’t do this 20 years earlier, because it would have made his life so much easier. We took that message to heart and focused on the MitraClip™ delivery system, which we could see was becoming the baseline for transcatheter mitral valve therapies. The MitraClip™ is an incredible therapy – there is tremendous patient need and real benefits, but for it to become widespread we must overcome the challenges of existing pull-wire systems. Placing the mitral clip has a hard learning curve and it is a difficult procedure. We felt that a robotic solution could reduce the skill level needed.

How does the Moray technology work?

[PL] Moray’s robotic system, with its digital user interface, enables a single hand to control the placement of a mitral clip. Powered by microfluidics, the catheter system is fast, precise, and intuitive; yet comparable in size to existing manual systems, and costs less to manufacture. By simplifying the percutaneous delivery of valve therapies, we think Moray will enable millions of patients to benefit from this cost-effective and easy-to-learn-and-use delivery system.

What has the physician feedback been like?

[MB] Feedback has been strong and consistent.  Even before we shared our concept with structural heart key opinion leaders, Dr. Louie Canon (an Interventional Cardiologist and entrepreneur based in Michigan) and Dr. Juan Granada (an Interventional Cardiologist and CEO of CRF based in New York) recorded a great discussion at TCT 2018 explaining why the time was right for robotics in the structural heart field. As they noted, human beings were not designed to obtain 2D imagery, and to think in 3D, and to manipulate their hands to deliver a structural heart therapy with mechanical tools. Both agreed with the need for robotics to raise the bar for those operators who will deliver structural heart therapies.

[PL] We met with Dr. Carlos Ruiz (a pioneer of structural heart therapies based in New Jersey) and showed him our robotic solution and its user interface in a 3D schematic. He liked not only moving it in the immersive environment but also the ability to plan a movement during a procedure to see if it was going to be the right thing to do before implementation.

Where is Moray Medical now as a company?

[MB] We are now completing our end-to-end proof-of-concept TEER clip therapy system. We have performed validation benchtop studies and a limited number of animals. We have been working on these technologies for 3+ years to bring each component into existence from scratch. Next step includes opening a dialogue with the FDA.

You have a stellar investors; can you tell us about them?

[MB] We are very grateful for the roster of investors that have come on board to support Moray and they include:

• Fred St. Goar MD, Inventor of the MitraClip
• Tom Fogarty, Founder of the Fogarty Institute
• Yulun Wang, Founder of InTouch Health and Computer Motion
• Ron Williams, Co-founder of Myoscience, Cryovascular Systems and EndoVascular Technologies

They really are a fabulous group that has been a huge help to our venture.

How has COVID impacted Moray?

[PL] It has actually helped because it made us push forward with software for driving over the internet.  We can now remotely test-drive our system with investors, physicians and partners across the US and around the world.

What has been the biggest hurdle?

[MB] The biggest hurdle is the preconceived notion of what surgical robotics are and what they need to be. Intuitive Surgical and Auris have large complicated systems. All imaging is handled by the robotic system and they take over the surgical suite. They do a wonderful job and are terrific at what they do, but they are not capable of structural heart therapies. As for robotic catheters, prior approaches had significant challenges – including economic ones as they were expensive. More importantly, while they make some of the hard parts of a procedure easier, the easier parts too often got harder. Set-up is an example. If the set-up of the robotic catheter takes too long, it doesn’t matter if the tissue-remodeling portion of the procedure gets shorter. Access and set-up are much less of a burden on work-flow with the Moray system, which is accomplished by using tools that the physician is already familiar with.

What is next for Moray and the team?

[MB] We are taking our end-to-end system and moving out of preclinical testing and toward the clinical environment. We are at an exciting stage. We have begun to share things publicly with users and investors. We are defining our clinical approach and the testing needed to validate its potential for improving patient outcomes, patient experience and the experience of support staff and interventional cardiologists and healthcare economics.

[PL] – We developed a full robot system – the UI and layers of technology. Then you have to build all the layers on a system that are more specific to the first application. Then you have to figure out the boundaries – how to get in and out. And the details are now all coming together. The collection of all the layered technologies is greater than the sum of the whole.

[MB] The next big milestone on the horizon involves our dialogue with FDA and a pre-sub meeting.

[PL] Now that people are seeing what our Moray technology can do – the MitraClip™ is a wonderful beachhead for Moray—but others want to explore other applications. We know there are a lot of other applications.

[MB] Long-term, when these robotic valve therapies are performed for the mass market, not all will be done by KOL physicians at top tier institutions.  Most TEER therapies will be conducted at smaller regional hospitals, and eventually at ambulatory care centers. Moray technology is well-suited for this evolution – we can price it so that heart valve therapies can be delivered where the patients are and so that clips can be deployed very precisely and economically, by leveraging technology to deliver improved, accessible patient care.

For More about Moray Medical, visit https://moraymedical.com/