Does the VAD market need a helping hand?

David Hawks, Hydrix’s  Senior Vice President of Business Development and Strategy, talks with industry experts on the back of recent positive, and less positive news, in the cardiac-assist market.

In recent months we’ve experienced some highs and lows in the sometimes-turbulent Mechanical Circulatory Support market. Exciting announcements around successful capital raises for BiVACOR, Carmat and AdjuCor, and clinical trial traction for Procyrion, have been tempered by the recent news that Medtronic was stopping the sale and distribution of its HeartWare Ventricular Assist Device (HVAD) System.

So where are we? In light of the just completed ASAIO conference, and recent financing and company announcements, I spoke this week with a few well placed industry connections for their insights on the state of the market: Ben Hertzog, industry expert, former CEO at Procyrion and  Entrepreneur In Residence at the J&J Center for Device Innovation at the Texas Medical Center (CDI@TMC) and, Dr. Paul Kelly, Managing Partner at OneVentures, an early investor in the BiVACOR TAH technology. Both of them shared what they think are the challenges from a development and funding perspective, and where they see opportunities for market growth: 

Ben Hertzog - There is still energy in the market

While I thought the Medtronic market announcement was just another data point demonstrating how difficult this market is from a technology perspective, I still believe that despite the challenges, the circulatory support space will continue to be an exciting space with many new opportunities.

There has been a lot of amazing science, and so many really smart people working on this for a long time, but LVADs are surely some of the most complex medical devices you could work on. There is still energy in the market and I think we are going to see a lot of excitement about technologies that intervene earlier in the spectrum of heart failure, that are less invasive, and that can maybe change the trajectory of the disease and keep patients out of that late-stage heart failure. Don’t get me wrong, there’s always going to be patients that need durable support – artificial heart or LVAD, but it’s a really hard challenging market.

I think the trend is just like in other therapeutic areas; how can we go after these very same patients, but focus on the episodic nature of the disease and intervene earlier in the progression of heart failure?

One area where I predict continued market growth will be for temporary solutions (e.g. acutely decompensated heart failure, cardiac shock, post MI recovery, bridge to recovery, etc.). One of the fundamental challenges with TAH and traditional VADs is you somehow must convince the patient that they want it. Theoretically, you can make a very black and white case and say you are either dead or you get it, but it is a lot more nuanced than that. There’s a financial burden, there’s a psychological consideration, it’s a really difficult decision point.

On the temporary side however, there are many more patients and it’s an easier sell. You know we are going to do this cath lab procedure, which doesn’t even require general anesthesia. We’ve got all these patients that come to the hospital, acutely decompensated, diuretic resistant, drugs don’t work anymore and that’s where we haven’t had any tools. But these same patients who may eventually end up needing VADs or TAH, are much healthier at this earlier stage. I think there will be a greater investment focus, and development opportunities to bridge the gap if we can intervene in those patients earlier. And the hope is, we then prevent them from ever needing these very expensive and very invasive solutions.

It is going to be an exciting field to watch. There are still significant unmet clinical needs and many of the best medical and engineering minds are focused on this opportunity.

Paul Kelly - Helping patients earlier is a smart sell

OneVentures invested early in the BiVACOR TAH device because we saw the tremendous unmet need not currently addressed by HVADs or transplantation. I thought it was superb that it could simulate both the right and left sides of the heart, and the initial animal trial data they had was excellent. BiVACOR’s ability to adapt to all the physiological requirements in the body – running, walking, sleeping etc, was also unmatched. And the fact that their TAH could be made to fit children and smaller framed people was another advantage.

In relation to the current market trends, OneVentures remains interested in investing further in the cardiovascular space. I’m seeing a lot of innovation in the sector, particularly around temporary LVADS to help support the heart after surgery or post a myocardial infarct. Just like we support a damaged limb until it has healed, it makes sense to support a weakened heart until it is strong again, or using temporary LVADs as a bridge to longer term implants, like a BiVACOR!

Despite the recent Medtronic announcement, from my perspective it feels as though the energy is returning to the market.  While the diagnostics market really exploded during the first year of COVID-19, the inverse felt true in cardiac assist device development as projects were put on hold, or funding was delayed or redirected. But we’re now seeing some really exciting innovations being revealed. The deal flow appears to be strong which is bringing renewed confidence to a market that addresses some of the most prevalent global health challenges.

David Hawks is Senior Vice President, Business Development and Strategy.
Based in Minneapolis, David’s experience spans technology solutions in software, communications and networking, investment banking, and more than 15 years in the life sciences sector.  

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