Real Heart: Continued progress in the second preclinical trial

On Wednesday, May 9, the second of four planned preclinical tests of Real Heart ™ on calves were conducted at the laboratory in Belgium. The goal was from the beginning to conduct an acute test without waking up the calf from anesthesia but since the calf showed stable hemodynamic parameters, we decided to wake up the calf for a limited period of time.

We could also this time note that the connection of the heart pump to the calf’s vascular system works very well. The heart pump also delivered, as before, good values for oxygenation, pulse and blood pressure. In addition, we managed to get space enough to implant a flowmeter for the first time. This is used to monitor the amount of blood pumped from the heart pump. The adjustment of the heart pump in the chest, which was a bit of problem two weeks ago, also worked well. We now entered the chest cavity at the level of the 5th rib, instead of the 4th rib. This worked better, which means that one of the most critical issues is now solved.

After the surgery, the calf had very good vital parameters. We therefore decided to wake up the animal from anesthesia for a limited time and let the calf breathe on its own for approx. 10 minutes.

Despite the positive outcome, however, we still have a problem to solve with respect to the de-airing of the cardiac pump. Our de-airing valves are designed so that the air bubble sits at the highest point when the operation is performed with the calf lying on its back. The operations in Leuven are, however, carried out with the calf lying on its side, and then the air bubble is a couple of centimeters from the de-airing valves. The location of the valves should therefore be adjusted. The risk is that air that cannot be vented and instead goes on from the pump into the vascular system, causing an air embolus. The results of future survival trials can therefore be adversely affected even by a small remaining air bubble.

“We are incredibly proud of what we have achieved so far. To see the animal live and breathe with the help of our heart pump was an emotional moment for everybody involved. Our successes are the result of intensive work and careful planning in combination with the support we have received from our shareholders. Together, we step-by-step approach our goal to help many patients with heart disease.” says Azad Najar, CEO and innovator.

The overall result of this calf test is once again encouraging and better than expected. We have now decided to carry out the first survival attempt on calves already at the next operation on June 6th. The goal of the next operation is that the calf should live with the heart pump for a few hours – but maximum for 24 hours. Before this operation, we must solve the problem of the de-airing valves.