New pump aims to increase survival of heart patients
After major heart surgery or a heart attack, patients are often supported with a heart assist device to help off-load the weakened heart and maintain normal blood pressure. This support allows the heart to recover and helps to protect other vital organs, such as the kidneys, from further damage.
CardiacBooster, a spin-off from the Radboud University in Nijmegen, develops a cardiac assist device that is designed with the goal of improving patient support above and beyond existing pumps. Its innovative design aims to provide strong pump support without significantly damaging red blood cells, and allowing for a small delivery profile. The company expects to start clinical trials in the near future.
Our device is an innovative pump system that is designed to provide greater flow, ease of use and improved safety compared to existing pump systems
“Our device is an innovative pump system that is designed to provide greater flow, ease of use and improved safety compared to existing pump systems”, says Florian Ludwig, CEO of CardiacBooster. “Existing clinical data indicates that patient survival in cardiogenic shock may increase with pump capacity. With our novel design, we are aiming to provide a device with stronger pump support to the interventional cardiologist. In addition, we aim to make it easier for the physician operator to deliver the pump (which is located at the tip of a catheter) to its target location within the patient. To deliver the device, the interventional cardiologist introduces the catheter device into a patient’s vasculature at an access point in the groin, and subsequently navigates the catheter (a long thin tube) through the blood vessel system to the heart. There, the cardiologist places the pump in the left ventricular heart chamber from which it pumps oxygen-rich blood into the aorta. This pump is a temporary device. It is typically removed after a few hours or days, depending upon the state of the patient and the indication for using the device.”
‘Percutaneous ventricular assist device’ is the official name of these pumps, whereby ‘percutaneous’ stands for access through the skin, in this case in the groin. ‘Ventricular’ or ‘ventricle’ is the heart chamber that pumps the blood through the body.
Novel, differentiated pumping mechanism
Most of the current blood pump manufacturers, including the market leader Abiomed (part of the Johnson & Johnson medical group), use a rotating impeller (a small spiral pump screw) to pump blood. Such an impeller must be quite small to fit onto a cardiovascular device and as a result has to rotate at high speed to generate clinically meaningful flow.
“ Our device works by expanding and contracting within the heart, similar to the action of the heart muscle”
“Rather than rotating an impeller blade, our device works by expanding and contracting within the heart, similar to the action of the heart muscle. With this mechanism, we expect to achieve higher flow than existing pumps, at a smaller pump size, such that interventional cardiologists can easily place it. In addition, we expect this novel and differentiated pumping mechanism to be gentler on red blood cells and cause less hemolysis”, Ludwig explains.
“The goal is to support the heart during a highrisk stenting procedure, and/or give it time to rest and recover from an injury such as sustained in a severe heart attack complicated by cardiogenic shock. Only about half of cardiogenic shock patients survive. With a more powerful pump, we expect survival rates to increase”, Ludwig explains.
CardiacBooster places high value on its intellectual property and is diligently building its patent portfolio. That patent portfolio was reviewed by an independent law firm during the due diligence for the last financing round and additional patent applications have been filed since.
Development started at Radboudumc
CardiacBooster’s pumping concept was conceived more than a decade ago by Daniël van Dort, who is currently Chief Scientific Officer at the company. At that time, he worked as a researcher at the Radboud University Medical Center, where he still works part-time. In 2018, he founded CardiacBooster together with Thuja Capital and Radboudumc, in order to accelerate development. Thuja Capital is a Dutch venture fund who invests in medtech and pharma/biotech companies. After its incorporation, CardiacBooster received support from the RedMedTech Discovery Fund, the Rabobank (via an AIL, a subordinated Innovation loan), as well as from MIT, EIT Health Headstart and Eurostars grants.
The RedMedTech Discovery Fund provides financial support for start-ups developing innovative medical technology, especially in the East of the Netherlands.
“Thuja is different from other investment firms in that it dares to invest money in innovative development at an early stage. This means that Thuja is more involved than is typical in the early stages of a project”, Ludwig explains.
In 2022, two US life science investors joined CardiacBooster’s shareholder base: Lightstone Ventures and Santé Ventures. Together with Thuja Capital, they invested a significant amount in CardiacBooster’s Series A financing round. The funds are being used to accelerate development. The company’s aim is to enter clinical trials as soon as possible, with cardiac patients receiving temporary support from this device under
controlled study conditions. “Before that happens, we must first complete design verification and pass various pre-clinical tests to ensure proper working of the device and to minimize the residual risk to study patients”, Ludwig explains.
CardiacBooster has strengthened its team to go through this trajectory. Since last year, the number of CardiacBooster employees has more than doubled. “We have built up a sizeable team across two locations. A part of the team is located in Nijmegen, Netherlands, and a part in Galway, Ireland. We also work with suppliers specialized in catheter development and manufacturing.”
In Q4 of 2022, CardiacBooster received € 485,000 in financing from Mibiton Solo. Mibiton provides funding in the form a financial leasing structure through which the company has purchased equipment, inter alia, to test the characteristics of catheters. Among other, a bench model of the human vasculature has been purchased to test whether the catheter and pump can be properly routed to the heart through the body’s blood vessels.
We were able to lease the equipment earlier than planned through the Mibiton Solo Fund, which allowed us to accelerate product development
One of the conditions of the Solo financing is that the amount is repaid in instalments within four or five years, with eight percent interest applicable on the outstanding amount. Despite the relatively high interest rates, Ludwig finds this form of financing attractive: “We were able to lease some test and production equipment earlier than planned, which allows us to accelerate product development. Given the fast growth of our company, we expect that the company’s value creation will by far outpace the interest costs”, says Ludwig.
Clinical investigation provides quick read-out
Clinical trials can start once design validation and assessment of the safety and performance of the device has been successfully completed in non-clinical models. “Physician investigators will look to evaluate pump performance and handling, and pay close attention to patient recovery and outcomes at 30 days after the procedure. As the pump is removed after a few hours or a few days (depending on the state of the patient and the indication for use), no implant remains. This allows physicians to determine the success of the temporary support of the heart rather quickly. With a hip prosthesis, you want to know if it still works after five years. In our case, it will be clear within a few days whether the pump is functioning
properly, and the treatment is successful”, says Ludwig.
Physician investigators will look to evaluate pump performance and handling, and pay close attention to patient recovery and outcomes at 30 days after the procedure
It is difficult to predict how soon the device will be allowed into the US and European markets. “It depends on which clinical studies the US FDA (Food & Drug Administration) requires and what additional questions will be asked. We obviously want to launch the pump on the market as soon as possible, but it will certainly take a few years before we can introduce it”, Ludwig explains.
CardiacBooster is likely to produce the pump in-house, in collaboration with suppliers. If necessary, the company may decide to subcontract the production to another company with an appropriate production line, but this choice has not yet been made. “In the first instance, CardiacBooster will retain close control over the building and quality control of the device”, says Ludwig.
As a medical device start-up, CardiacBooster focuses on creating value by reducing technical and other risks associated with developing a new technology. Innovative technology start-ups such as CardiacBooster are typically financed by venture capital from venture investors with the intention of addressing an unmet clinical need and an attractive market. While CardiacBooster is prepared to execute the development of its device independently, there are potential advantages in an early partnership with a larger strategic.
The structure and scale of a larger company allows to accelerate execution of larger clinical studies and ultimately make the device available to physicians and patients worldwide more quickly than would be possible for CardiacBooster on its own. In such a partnership, the larger strategic company benefits because it gets access to innovative technology, allowing it to better serve its customers”, says Ludwig.
CardiacBooster anticipates a potential growth of the global market for supporting heart pumps up to €10 billion per year
CardiacBooster anticipates a potential growth of the global market for supporting heart pumps to up to €10 billion per year. “There are opportunities for growth, especially if pumps become easier to insert and maintain, allowing interventional cardiologists to use them more broadly”, Ludwig predicts.