Revolutionary AI Algorithm «Prostate.Carcinoma.ai» Achieves EU MDR Class IIa Registration

Zurich, 18th of December 2023: Xlife Sciences AG (SIX: XLS) achieves EU MDR Class IIa registration with the portfolio company FUSE-AI GmbH and reaches a milestone for medical technology. The AI algorithm «Prostate.Carcinoma.ai» from FUSE-AI GmbH can analyze a multitude of radiological images in a very short time with a lower error rate than the human eye.

The AI-based assistance diagnostic software «Prostate.Carcinoma.ai», developed for prostate gland segmentation and lesion detection, has been awarded the prestigious EU MDR Class IIa registration in December 2023. This registration marks a significant milestone in the journey of «Prostate.Carcinoma.ai», which began with the initial investment by Xlife Sciences AG in FUSE-AI GmbH in October 2019.

This is not only a success for FUSE-AI GmbH and Xlife Sciences AG, but also a milestone for technological development in radiology and the quality of radiological diagnostics in Europe. The software «Prostate.Carcinoma.ai» is the result of interdisciplinary collaboration between scientists, AI developers and radiologists. The timing of this milestone goes along with the global medical image analysis software market being projected to achieve a value of $4.545 billion by 2023, growing at a compound annual growth rate (CAGR) of 9.9%.

«Prostate.Carcinoma.ai» not only promises a 30% time saving per patient but also matches the accuracy of experienced radiologists in prostate volume determination. Its ability to predict and segment lesions as malignant or benign significantly assists radiologists in MRI analysis for prostate diagnosis. The objective is to decrease the error rate in this process from 14% to 1%.

The registration of «Prostate.Carcinoma.ai» is a crucial step towards a transformative era in global healthcare, as it enables the initiation of its market rollout. This significant development means that preliminary agreements will now evolve into binding contracts, and the pre-installed or test installations of the software in various medical facilities will become fully operational, paving the way for revenue generation. Strategically, «Prostate.Carcinoma.ai» is not just an isolated solution but a critical component of a broader ecosystem. FUSE-AI GmbH is committed to obtaining registrations for additional areas, thereby positioning «Prostate.Carcinoma.ai» as a vital part of a comprehensive plug-in solution. This approach is expected to establish FUSE-AI's presence in hospitals worldwide, making it an indispensable tool in the medical field.

Matthias Steffen, CEO of FUSE-AI GmbH, commented, «Two factors guarantee a positive continuation of our path: an interdisciplinary team that develops AI tools close to the needs of radiologists and a global sales structure that takes into account the regional macroeconomic conditions of the individual healthcare industries.»

Oliver R. Baumann, CEO of Xlife Sciences AG, stated «We are more than proud to see our portfolio company FUSE-AI not only contributing to but leading the AI-based assistance diagnostic software field. This will have a positive effect on many patients with radiology being only the beginning.»

As we celebrate this achievement, we look forward to the continued advancement of «Prostate.Carcinoma.ai» and the FDA approval in Q1 2024.

Financial calendar

Annual Report 2023                                                                                         23 April 2024

Annual Shareholders Meeting 2024                                                                 20 June 2024

Half-Year Report 2024                                                                                     19 September 2024

Contact 
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch
Information related to FUSE-AI GmbH: Anne Wesche, anne.wesche@fuse-ai.de

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch, 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange