Innovating Transplantation, Accelerating Research

Apersys AG, headquartered in Zurich, Switzerland, traces its origins to the Liver4Life project launched in 2015 through a collaboration between ETH Zurich and the University Hospital Zurich. The project achieved the development of a long-term normothermic (normal body temperature) organ perfusion device. This device represents a breakthrough in organ perfusion technology: It can preserve organs for 7 days, compared to the current gold standard of 6h and 24h of competitors.

We are on the mission to save more patients in need of an organ. Our perfusion platform technology paves the way for improving the number of transplantable organs and fostering translational research in a host of cutting edge technologies.

OVERCOMING ORGAN SHORTAGE

The continuously increasing number of patients on the organ waiting list is one of the greatest crises facing the transplant society. Liver transplantation is the second most performed transplant procedure (34,694 transplants in 2021), following kidney transplantation (92,532 transplants in 2021). Unlike kidney failure, there is no temporary treatment for patients affected by end-stage liver diseases, making the availability of a suitable organ for transplantation time critical.

Currently, the number of patients added to the waiting list exceeds the number of transplants performed, increasing organ shortage. A trend that has not changed for many years. Moreover, around 30% of the available organs are considered unsuitable for transplantation due to multiple factors as lack of time for assessment and suboptimal organ quality.

SOLUTION

Our solution, the Apersys Perfusion System, represents a groundbreaking platform technology that enables long-term perfusion of human organs outside the body (ex situ). The system offers preservation for up to 7 days, providing physicians with a drastic improvement vs the current gold standard. It opens the possibility for therapeutic interventions, and thereby replenishes the organ pool. This life-saving technology will transform organ transplantation into an elective procedure and improve clinical outcomes for patients. The device has been extensively tested with several discarded livers and has been proven in a successful first-in-human transplantation of a primarily discarded and injured liver, under compassionate use and is protected by two patents covering the perfusion loop. Furthermore, the algorithm developed to enable a long-term perfusion is held as a trade secret.

The following features are unique to our system:

– Transition from emergency to elective procedures – Better planning for transplant centers

– Sufficient time to evaluate the organ – Improved organ selection

– Physiological organ recovery – Increased organ pool

– Organ defatting (untapped market) – Increased organ pool

– Organ treatment – Increased organ pool

– Potential for other applications (e.g., gene therapy, immunomodulation, drug testing, etc.)

OPPORTUNITY

The initial target market is estimated to be USD 800M. It is based on our focus on ex situ, normothermic perfusion of human livers intended for transplantation (currently USD 400M) and a potential untapped market of marginal livers (USD 400M due to limitations of other technologies). The serviceable available market is estimated at USD 8.5Bn which includes expansion into additional organs such as Kidney and Heart. Lastly, expansion of the device applications in other fields as clinical research, and pharma/pre-clinical R&D would open avenues to a total market of USD 57.5Bn which grows at a CARG of 15-28% depending on the application.

GO-TO-MARKET STRATEGY

Apersys AG obtained the FDA Breakthrough Device Designation (BDD) in April 2023. This achievement accelerates our Go-to-Market and ensures an effective pivotal clinical trial that is set to commence by Q2 2026. While the US market is the primary target, a notify body, “BSI Group The Netherlands B.V.”, for EU market has already been identified. We are in the process of the defining the reimbursement scheme for our device through several governmental programs including the Transitional Coverage for Emerging Technologies and parallel review with both FDA and CMS (Center for Medicare and Medicaid Services). This approach will ensure alignment with both bodies for an optimal clinical trial and reimbursement pathway.

FUNDRAISING

Apersys is currently fundraising a Series A with a significant volume taking us through 2027 right up until an estimated commercial offering in the clinical pathway. We are aiming to close the round in Q1 2025. The proceeds are intended to execute an FDA-approved Multicenter clinical trial including US and EU sites, build our Industrialization process for production and distribution, expand the team to delivery on our ambitious goals and timelines and finally obtain FDA marketing authorization leading to product readiness for launch in the US market.

“Innovating Transplantation and Accelerating Research” via your generous support will help patients in need of an organ to obtain their live saving procedure and overcome organ shortage!

For more information please reach out to our CEO, Dr. Waldemar Hoffmann