ECHO Spotlight Series: Heart Squared’s Next-Generation Ventricular Assist Device

Entrepreneurship for Cardiovascular Health Opportunities (ECHO) is a 12-month national training program supporting cardiovascular research commercialization through education, mentorship, networking, and funding. Led by a diverse team of experts, ECHO fosters successful startups in cardiovascular health, culminating in an annual pitch competition (ECHO PITCH) offering up to $250,000 in funding.

With the upcoming 2023-2024 ECHO cohort preparing to pitch this fall, we took the opportunity to sit down with some of the ventures involved in the program to learn more about them, their commercialization process, and how the ECHO program has helped their entrepreneurship journey so far. Today we’re speaking with Ghassan Maraouch, Lead Designer of Heart Squared and PhD candidate in Mechanical Engineering at Concordia University. Heart Squared is a novel ventricular assist device (VAD) implanted in a minimally invasive manner to improve quality of life for patients living with advanced heart failure. Heart Squared is also supported by Dr. Brian J. Potter (MDCM SM, interventional cardiologist from the CHUM) as a clinical advisor, Jean-Pierre Desmarais (Axelys affiliate, serial entrepreneur) as a business advisor and Dr. Lyes Kadem (PhD, Ing) as a scientific advisor.

What was the inspiration behind creating Heart Squared? 

The danger of cancer is well known to the public. However, despite causing more deaths per year than cancer, heart diseases are not as well known ^[1]. Heart failure is a condition that prevents the heart from adequately pumping blood throughout the body.  As of today, there is no cure for heart failure. There are medications available to help slow its progression, but those eventually lose effectiveness once advanced heart failure is reached. At this stage, patients have difficulty doing simple tasks, such as going on a walk.

In Canada alone, it is estimated that 750,000 people currently have heart failure and the incidence rate is 100,000 per year ^[2]. The advanced heart failure population is estimated to be anywhere from 10-15% of the heart failure population, meaning there’s anywhere between 75,000–112,500 Canadians with advanced heart failure and 15,000 new patients each year ^[3].

The gold standard treatment for advanced heart failure is a heart transplant. The unfortunate reality is that there simply too many advanced heart failure patients compared to the number of hearts available—this leaves many patients with very little options. Ventricular assist devices (VADs) offer advanced heart failure patients who are not eligible for a heart transplant an alternative treatment option. However, VADs have historically been plagued with complications and adverse events, giving them a bad reputation.

Heart Squared was created to develop a new VAD that is designed to be implanted in a minimally invasive manner. Minimally invasive surgeries have seen a rise in popularity for valvular intervention due to the reduced hospitalization time required and faster recovery time for patients. One of Heart Squared’s objectives is to deliver our device through a catheter, which would also increase the number of physicians who could implant a VAD. 

Can you explain how the technology used by Heart Squared works for patients undergoing a heart transplant? 

VADs are classified under three categories for their use: bridge to transplant, bridge to recovery, and destination therapy. Bridge to transplant, as its name suggests, aims to keep patients alive long enough for them to receive a heart transplant. Bridge to recovery devices are designed to unload the ventricle, reduce the oxygen requirement, and aid in recovery of some heart function. Destination therapy devices are for long-term use; these are for patients who are not eligible for heart transplants and will use a VAD for the remainder of their life.

Heart Squared is developing a VAD for destination therapy, but it could also be used for bridge to transplant. Essentially, our device offers an alternative to a heart transplant. Similar to other VADs, Heart Squared assists the heart in pumping blood so advanced heart failure patients can live a more normal life, including activities like going for walks and going out to restaurants.

What makes Heart Squared distinct from other treatments currently available for patients undergoing heart transplants? 

VADs are categorized as either pulsatile flow or continuous flow devices. Pulsatile flow devices are those that beat at the same rhythm as a heart. Continuous flow devices, on the other hand, generate a constant stream of blood flow without a pulse. If the heart of a patient with a continuous flow device were to stop beating, they would have no pulse but blood would continue circulating. Continuous flow devices have seen a rise in popularity as they have been proven to be more durable while also being less bulky. However, it has been determined that some pulsatility is important for preventing aortic valve cusp fusion and to improve coronary perfusion.

Heart Squared’s VAD is a pulsatile device. Historically, pulsatile devices have been bulky and have had durability problems. Our device is being designed to be delivered through a catheter, which will reduce the bulkiness of the device itself and the invasiveness of the surgery. Durability in pulsatile devices tends to be more difficult than in continuous flow devices because generating a pulsatile motion requires a reciprocating motion. On average, a human heart will beat at 70 beats per minute, which consists of 100,800 beats in a day and 36,792,000 beats in a year— this is no easy feat!

What are the next steps in the development pathway for Heart Squared? 

Our next step is to start pre-clinical studies. So far, we’ve demonstrated that we can generate a pulsatile flow in our in-vitro pulse duplicator. Pre-clinical studies will help us prove the viability of our technology and improve the credibility of our science. Another short-term goal is to improve the reliability of our device and to complete design optimizations.

You’ve been a part of the ECHO program since the fall of 2023. What makes ECHO unique compared to other accelerators/programs available to health entrepreneurs?  

Prior to joining the ECHO program, I had joined the Quebec Scientific Entrepreneurship Program for the Fall 2020 cohort. The information in that program was great for learning the fundamentals of entrepreneurship, but I felt that it lacked a lot of crucial information related to the health sector. ECHO has been a great program to bridge the gap in the knowledge that I felt was missing. Having experts in the domain go into details on some of the challenges of bringing a medical device to market, the clinical trial requirements, product development, and regulatory affairs in different regions has been very insightful. Having entrepreneurs share their personal stories on their ventures has also been great to learn about the hardships they had to face to get to their current stage.

What has been the biggest benefit of being part of the ECHO program so far, and what are you looking forward to in the remaining half of the program? 

Joining the ECHO program has been a great experience! I’ve learned so much about the requirements of bringing a medical device to market. Joining the program is a time commitment, but it’s definitely worth it. After all, entrepreneurship is an even bigger commitment. Another benefit of ECHO is simply being around other people who are going through their venture at different stages; there is a feeling of empowerment when you’re surrounded by people with the same drive. I’m definitely looking forward to the remainder of the program as there is so much more that I don’t know and would like to learn about. The worst unknowns are the ones that we aren’t aware of, so learning more can only improve the chances of succeeding.  

How does Heart Squared plan to expand or evolve in the next five to ten years? 

Bringing a device such as this one to market requires a lot of resources, funding, and time. We’re hoping that within the next 5 to 10 years, we’ll have built a strong multidisciplinary team to support the development of the device. We’re also hoping to have started clinical trials within the next five years. All of this requires significant funding. Medical devices, especially high-risk ones, are difficult to bring to market as there is no revenue to be generated until the device has been approved by regulatory agencies. Our expansion will require us to obtain funds from angel investors, grants, and/or venture capitalists. To raise those funds, we will need to demonstrate strong scientific evidence that proves the benefit of our device.

ABOUT ECHO

ECHO is a specialized training program led by veteran entrepreneurs and consultants across a variety of sectors. Its mission is to:

• Provide entrepreneurship training, mentorship, partnership, and funding opportunities for innovators of cardiovascular technologies.
• Create more successful start-ups in the cardiovascular health sector.
• Accelerate the application of cardiovascular innovations and their transfer from bench to bedside.

ECHO is funded and organized by the Translational Biology and Engineering Program at the University of Toronto and the Ted Rogers Centre for Heart Research, in partnership with the Health Innovation Hub (H2i). To learn more, please visit https://tedrogersresearch.ca/echo-pitch.

References

[1]       Avery CL, Howard AG, Nichols HB. Trends in US Cancer and Heart Disease Mortality, 1999-2018. Circulation 2021;143:287–8. https://doi.org/10.1161/CIRCULATIONAHA.120.051451.

[2]       Heart and Stroke Foundation. Heart failure in Canada complex incurable and on the rise | Heart and Stroke Foundation. Hear Stroke Canada 2022.

[3]       Miller L, Birks E, Guglin M, Lamba H, Frazier OH. Use of Ventricular Assist Devices and Heart Transplantation for Advanced Heart Failure. Circ Res 2019;124:1658–78. https://doi.org/10.1161/CIRCRESAHA.119.313574.