We are thrilled to share an article about Vivalyx which was published in Business Insider Gruenderszene. Please find an English translation below.
Please find the original article here:
This Aachen Startup is Researching a Revolution for Organ Donation – Mario Götze Invests
Waiting lists for organ donations are long and transplantations are declining. The founders of Vivalyx have developed a solution aimed at enabling more procedures.
An Italian Bolognese takes about four hours to simmer until it’s tasty. The ICE Sprinter train by Deutsche Bahn takes precisely four hours from Cologne’s main station to Berlin – when things go smoothly. US singer Taylor Swift recently performed a concert in just under four hours. In the operating room, there is no more than four hours to transplant a heart that has been “on ice”. Beyond this, the organ can suffer irreversible damage, putting immense pressure on doctors. For kidneys, this window extends to a total of 16 hours.
Newer medical techniques, like the so-called “cold perfusion”, which involves transporting donor organs in a 4°C preservation solution and mechanically pumping them, allow surgeons at least 24 hours. However, risks still exist: the function of the organs drops to ten percent during this process, and there’s no accurate monitoring of the organs during this time.
Contrarily, the “warm perfusion” technique circulates organs with body-warm fluid during transportation, allowing them to function as normal. This method also enables continuous monitoring and can rejuvenate the organs using medications. The downside: the procedure is intricate and expensive as the nutrient-rich solution has to be mixed with suitable red blood cells, a scarce commodity.
The science startup Vivalyx, founded in Aachen in 2022, is hopeful for a medical breakthrough. Led by CEO Andreas Schumacher and organ researcher Benedict Doorschodt, they’ve developed a new fluid that improves organ preservation on ice and enhances the „pumping“ in both cold and warm solutions. The founders‘ objective is to increase the availability of donor organs.
Organ donations are decreasing in Germany.
The demand is immense: In Germany, about 6,300 patients await a healthy kidney, over 800 need a liver urgently, and another 680 are on the list for heart transplantation, according to May 2023 data from Eurotransplant and the German Organ Transplantation Foundation (DSO). The latter organization is responsible for extracting organs from the deceased and overseeing their transportation.
Eurotransplant decides which organs go where internationally. This foundation collaborates closely with organ donation organizations, transplantation centers, and hospitals in eight European countries. Last year in Germany, kidney transplants were the most common, with nearly 1,400 cases. Heart transplants occurred only 312 times. Overall, organ donations decreased by 6.9% last year, as reported by the DSO.
Benedict Doorschodt, Vivalyx’s co-founder, earned his PhD in organ preservation in 2011 in Aachen. The native Dutchman has been passionate about transplantation research since his medical training 23 years ago. „I saw the challenges with the prevalent methods of organ preservation and transplantation back then,“ Doorschodt shares. This prompted him to consider improvements, leading to initial projects at the University of Amsterdam.
His earliest preservation solution comprised around 60 components. As body-temperature-based perfusion emerged, he further refined the solution in collaboration with René Tolba, director of the Institute at RWTH Aachen University, and organ preservation researcher Christian Bleilevens. „Today, our solution uses only 18 substances, has better stability, and works more efficiently,“ states Doorschodt.
To launch their product, the team sought co-founders with startup experience, bringing Andreas Schumacher into the mix. Schumacher, the current CEO with a background in business administration, worked as a consultant at BCG and, during his PhD, joined the Aachen start-up center, which he led. Together with his PhD supervisor from RWTH, Malte Brettel, and Medtech founder Marius Rosenberg, they established Vivalyx.
Solution of this startup saves blood
Vivalyx’s solution, “Omnisol”, is compatible with all three preservation techniques and has shown better outcomes in preclinical trials. An example is the time factor: compared to the simple cooler method most commonly used in Germany, Omnisol could extend the storage time for kidneys to at least 24 hours.
A significant advantage of the startup’s solution during warm perfusion is that Omnisol doesn’t require red blood cells. The solution contains vital nutrients like amino acids and glucose and can carry oxygen molecules, which helps to better maintain the organ’s vitality. As a result, two blood bags are saved per perfusion. Simultaneously, the condition of donor organs improves, indicated by declining damage markers such as lactate levels. Doorschodt points out, „Blood is an organ itself and can cause issues during and after warm perfusion.“ CEO Schumacher emphasizes that the complication rate in preclinical studies with Omnisol has significantly decreased.
Generally, the availability of donor organs could increase, as the warm perfusion combined with the startup’s solution could make previously rejected kidneys due to poor condition transplantable. „Surgeons want to ensure successful outcomes of their procedures,“ says Schumacher. In the US, the rejection rate for organs stands at around 25 percent.
According to the founder, more transplants could be realized with better control and a liquid in which organs can be revitalized. A better quality of the organs, in turn, affects how high the costs for post-treatment are. Depending on how well a donor kidney is accepted, a patient may have to take expensive immunosuppressants after the surgery or be connected to dialysis, a blood-cleaning machine.
Startup transplanted a total of 80 organs in preclinical studies
So far, the Aachen startup has transplanted 50 kidneys and 30 livers in preclinical trials using their solution. Now, things are getting serious. „With the results, we are able to move into clinical trials. Now our product truly reaches the patient,“ says Doorschodt. The trials will only be conducted in teaching hospitals in Western Europe and the USA – where the startup also plans its market entry.
The founders are currently developing protocols for the exact procedure, which must then be approved by the ethical committees of the clinics. However, it will still be several months before Vivalyx’s solution is officially registered and approved as a medical product.
„Realistically, we believe we will enter the market by the end of 2024 with the first indication. This, of course, also depends on the speed of the official approval process,“ says CEO Schumacher. The European medical market is now more regulated than the American one, making processes longer. Co-founder Doorschodt is confident their solution will quickly penetrate the market. „We are now benefiting from research, experience, and our network.“
Mario Götze invests as a Business Angel in Vivalyx
To get approval, Vivalyx has to invest a single-digit million amount and bear the costs for employees and production. The founders secured this money in June during a pre-seed funding round from investors and business angels: Transplantation experts, professors, an angel fund, a shareholder of a life science company, and professional soccer player Mario Götze jointly invested in Vivalyx.
The world champion commented on the professional network LinkedIn: His investment focus is on companies from the science and tech sector that also serve a societal purpose. Although he had no deeper knowledge of the matter, he was quickly convinced by the Aachen startup’s team and fascinated by their concept, Götze wrote.
The founders are already in talks for another funding round in early 2024. The startup plans to transplant hearts, lungs, and pancreases using the Omnisol solution in the future. Different organ types require varying amounts of their preservation liquid. For example, storing a kidney requires two liters of the solution. A liver needs significantly more for preservation, according to Schumacher.
The startup intends to price their product in line with current transplantation solution manufacturers. For instance, prices are around 200 euros per liter. While the direct purchasers of the product are donor organizations or hospitals, the costs are ultimately borne by health insurance companies.
Politics is slowly making progress on organ donation laws
In Germany, organ donation is a highly political issue. For years, there has been debate about how to increase the number of available donor organs without crossing ethical boundaries. Citizens can currently voluntarily indicate if they would donate organs in the event of their death – either through an organ donation card or a living will.
In a 2022 study by the Federal Centre for Health Education, about 43% of respondents stated they had expressed their will in writing. Around 60% also said they had made a decision. The number of potential donors is thus difficult to pin down. However, legislative measures are still hard to implement.
Former Federal Health Minister Jens Spahn last attempted in 2020 to introduce a so-called „opt-out solution“. The idea was that citizens should actively object if they disagree with an organ donation after death; otherwise, everyone would be considered a donor. The reform failed. Instead, an online register that regularly asks citizens about their willingness to donate was to be implemented.
Due to the „complexity of the project“, there have been delays. The register’s commissioning is now expected in the first quarter of 2024, according to the Ministry of Health. Federal Health Minister Karl Lauterbach also plans to push forward again on the organ donation law – the specifics, however, remain unclear.
The Ministry of Health told Gründerszene that Lauterbach recently advocated for another attempt at the „opt-out solution“ since there had been no improvements for people needing life-saving organ transplants. „Whether an initiative will be launched again from the German Parliament during this legislative period remains to be seen,“ the agency continued.
The founders of Vivalyx would welcome legal regulation: „Even if an opt-out solution can seem daunting to people in the short term, there are clear long-term advantages.“