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PulseCath will revolutionise the medical devices industry during the next five years: Oren Malchin, CEO

“With our forthcoming generation of products, the market will undergo a significant change.”

PulseCath BV is a Netherlands-based medical device company that develops, manufactures and markets circulatory support systems. It has developed unique and proprietary platform technology to provide a short-term circulatory support system for cardiologists and cardiac surgeons.

The company is focused on expanding its global distribution, generating innovation and new products to broaden product portfolio to become the world's circulatory support leader.

PulseCath was founded in 2007.

The Silicon Review reached out to Oren Malchin, CEO of PulseCath BV, and here’s what he had to say.

Interview Highlights

Q. When it comes to longevity, PulseCath BV has it. I find it unique that an organization has what it takes to continue to offer services for 15 years. How did your company continue to adapt?

This is a very interesting question. In response to market demands, we improve our product. For instance, 10-15 years ago, it was uncommon to perform a large bore access from the femoral, but we had a product that was 21 French and that went through the subclavian artery or a full surgical set up. When the femoral complete percutaneous method became available, we modified the product to 17 and 16 French. Simply put, we had to make changes to the product to stay current as we’re conscious of the market changes taking place. We act in accordance with recent advancements and novel treatment approaches that are always evolving.

Q. What various technologies does PulseCath BV employ to introduce more competitive devices and catheters?

I can tell you that generally speaking, the heart failure condition is treated using a variety of technologies, but this is a very difficult question to address in a single line. There are various and well-known methods, one of which is a short-term mechanical circulatory support system. Continuous flow is one of the choices, and we're working on a pulsatile synchronised pump that synchronized with the heartbeat supports the left ventricle during or along failure. In fact, the left ventricle is bypassed as we pulsatile pump blood from the ventricle to the circulatory system. The ease of use of the system is one of its benefits because it already exists in hospitals; you don't need a specific console to accomplish it. Every hospital has a standard IAB console, and we are of course very competitively priced when compared to our rivals.

Q. What can you tell us about iVAC 2L?

iVAC 2L is our flagship device. This comprehensive percutaneous short-term mechanical secretary support system is mostly utilised during very high risk percutaneous coronary intervention (PCI) operations. The device's main functions are to raise cardiac output and augmented systemic pressure, alleviate myocardial tension, and unload the ventricle throughout the process. The danger of the patient collapsing during the surgery is reduced by more than 50% by doing it during the manipulation of the stents or balloons in the coronary.

Q. What new strategies did your company employ to address post-Covid issues and what new technologies did it introduce?

It was challenging to present our product at hospitals during Covid-19. Due to the strain on the ICU department, PCI operations were completely discontinued in hospitals. We used that time to concentrate on R&D, spending two years developing new items that we will now market over the course of the following two years. We discovered that in a pandemic situation, substantial support is required, such as an ECMO (extracorporeal membrane oxygenation). So we created a pulsatile ECMO device that performs a complete heart and lung bypass. ECMO is a very aggressive last resort treatment that can prolong the patient's life and avert death when there is a severe flu, disease, or pandemic like Covid-19. We created the ECMO system with a five-liter per-minute flow rate as well as a left-ventricular assist device (LVAD) and right-ventricular assist device (RVAD) system that can sustain a failing heart in this type of circumstance.

Q. What step does PulseCath BV take to broaden its product portfolio and become the world's Circulatory support leader?

We’re focusing on several levels. One of them is our technology, which is straightforward and simple to use. Without any special training, it can be supplied to various nations worldwide. Online training is available, and we used it both before and after the pandemic. So expanding is done in this manner. Importantly, our devices are far simpler than with the other competitors' systems, which require a rigorous training regimen.

We are the only company that provides technology like this at competitive prices to nations like China, India, Southeast Asia, Africa, and South America (continent). This is how we can initially help these nations where there are a lot of people from low-income backgrounds who otherwise cannot buy this expensive technology. Because of the larger population in these regions than in the US and Europe combined, we will overtake the competition and take the lead in the market.

Q. What do you have to say about your team? What value do they bring to the company?

This is our main success factor. We have a top-notch group of engineers, regulatory specialists, marketing, sales, and medical professionals. Our clinical advisory board is really helpful, sharing all of its information and suggestions with us so we may create new products and enhance our current ones. The primary traits we look for in members of our team are self-managing individuals who set their own goals and adhere to both their own personal plans and the company's overall strategic plan. We pay close attention to the needs of our team members, both personally and professionally. In this sense, our company is highly transparent and helpful.

Q. How do you see PulseCath in the next five years and how do you see yourself creating that change?

PulseCath will revolutionise the world, in my opinion, during the next five years. With our forthcoming generation of products, the market will undergo a significant change. To treat heart and lung failures, we are introducing a completely new approach. All of the components will be quite affordable, and the platform we develop will be able to support heart failure at any stage, from mild to severe. The devices I am talking about will be relatively simple to operate and cost up to 2000 euros. The console is no longer required as you don't need to buy any capital equipment.

It will be a platform that the doctor can utilise based on the requirements and circumstances of the patient, without any guidelines on how to use it. In five years, the company will be in a great situation since the platform is a game-changer for the industry. Due to its rarity, I believe one of the major players will likely take over this platform.

My contribution to the company is that I am the creator of a brand-new platform that has already been granted a patent.

Q. What is your final message to the Silicon Review readers, your current and upcoming partners?

The message is that, as we deal with the medical industry, medical devices, and life-saving technology, we need to take a step back and view the situation from a larger perspective. As leaders, we must ensure that we are not only bringing cutting-edge technology to market, but also that it will be accessible to everyone, not just the wealthy. The reason I believe this to be the most important lesson is because every company, including Medtronic, Abiomed, and Johnson, is only interested in making a profit and does not consider what is best for humanity. Regardless of size, companies should offer solutions that are within everyone’s budget. The main message is this.

“To treat heart and lung failures, we are introducing a completely new approach.”