Calciscon AG Company Profile

Background

Calciscon AG, established in 2013, is a Swiss diagnostic company specializing in the assessment, prevention, and treatment of biomineralization-related medical conditions. The company's mission is to enhance cardiovascular risk management, particularly for patients with chronic kidney disease (CKD), by providing innovative diagnostic tools. Calciscon's flagship product, the T50 Calcification Propensity test, is the first functional test designed to measure the speed of calcification in the body, thereby identifying patients at elevated cardiovascular risk and facilitating targeted therapeutic interventions.

Key Strategic Focus

Calciscon's strategic focus centers on advancing diagnostics for calciprotein particles (CPP), which are recognized as potent drivers of inflammation and calcification in various chronic diseases. The company aims to revolutionize the treatment of CKD patients by providing tools that enable personalized therapeutic interventions to slow disease progression. The T50 test, a CE-marked in vitro diagnostic product, is currently available through accredited medical laboratories in Switzerland, with plans for expansion into other European markets and the United States.

Financials and Funding

Calciscon has successfully secured multiple funding rounds to support its growth and product commercialization:

Series A Financing (April 2021): Raised CHF 2.5 million, led by Yellowstone Holding. The funds are allocated to accelerate the introduction of the T50 test into routine clinical use in Europe and to prepare for a U.S. launch.

Pre-Series A Financing (July 2020): Secured CHF 600,000 from lead seed investors and new strategic investors from the pharmaceutical and medical laboratory sectors. This financing facilitated the initiation of T50 test sales and preparation for the Series A round.

Cumulatively, Calciscon has raised approximately CHF 5 million in equity investment.

Pipeline Development

Calciscon's primary product, the T50 Calcification Propensity test, has undergone extensive clinical validation involving nearly 20,000 patients. Studies have demonstrated its efficacy in predicting cardiovascular complications in CKD patients. The company is also exploring the application of T50 measurements in other sample types, such as urine and amniotic fluid, to assess conditions like kidney stone formation and pregnancy-related complications.

Technological Platform and Innovation

Calciscon's innovation is anchored in its proprietary T50 test, which measures the propensity for calcification by assessing the transformation time of calciprotein particles in blood. This functional assay provides critical insights into an individual's risk of pathological calcification, enabling personalized therapeutic strategies. The company's ongoing research aims to expand the application of T50 measurements to various medical conditions, reflecting a commitment to leveraging scientific methodologies for improved patient outcomes.

Leadership Team

Dr. Vincent Linder, Ph.D. – Chief Executive Officer and Board Member. Dr. Linder is a serial entrepreneur with extensive experience in in vitro diagnostics (IVD) in both the USA and Europe. He has a background in product development, including CE and FDA approvals, and has successfully led companies through mergers and acquisitions.

PD Dr. Andreas Pasch, MD – Founder, President, Chief Medical Officer, and Chairman of the Board. Dr. Pasch is a practicing nephrologist and scientist, renowned for inventing the T50 test. He possesses deep expertise in the clinical application of T50 and calciprotein particles.

Chan-Yuan Lu – Non-Executive Director. Mr. Lu brings over a decade of global experience in the venture capital industry, with a focus on the USA, Taiwan, and Europe.

Karsten Uhlmann – Non-Executive Director. Mr. Uhlmann is the managing owner of an international brewing group and a seasoned entrepreneur.

Prof. Edward Smith, Ph.D. – Advisor. Prof. Smith is the inventor of the CPP assay and an expert in CPP biology.

Didier Falconnet, Ph.D. – Advisor. Dr. Falconnet is the former Director of IVD at GSK and has led R&D in two startups, including one that achieved an IPO.

Leadership Changes

In December 2019, Dr. Vincent Linder was appointed as Chief Executive Officer, succeeding Dr. Andreas Pasch, who continues to serve as President, Chief Medical Officer, and Chairman of the Board.

Competitor Profile

Market Insights and Dynamics

The global market for calcification propensity diagnostics is estimated to be between CHF 200 to 600 million annually, with significant potential for growth as awareness and adoption of such diagnostics increase. Chronic kidney disease affects approximately 9% of the global population, underscoring the substantial demand for innovative diagnostic solutions.

Competitor Analysis

While Calciscon is a pioneer in calcification propensity diagnostics, the broader diagnostic market includes companies developing tests for cardiovascular risk assessment and CKD management. Key competitors may include established diagnostic firms offering alternative biomarkers for cardiovascular risk, though none have introduced a functional test equivalent to the T50. The competitive landscape is characterized by ongoing research and development aimed at improving patient outcomes through early detection and personalized treatment strategies.

Strategic Collaborations and Partnerships

In January 2023, Calciscon, in collaboration with Amsterdam University Medical Centers and ADMESY, secured a €2 million Eurostars grant to develop a laboratory benchtop analyzer for the T50 test. This partnership aims to enhance the accessibility and efficiency of T50 measurements in clinical settings worldwide.

Operational Insights

Calciscon's strategic positioning is bolstered by its proprietary technology and focus on an unmet medical need. The company's commitment to quality is evidenced by its EN ISO 13485:2016 certification, ensuring compliance with international standards for the development and commercialization of in vitro diagnostic products.

Strategic Opportunities and Future Directions

Calciscon is poised to expand the availability of the T50 test beyond Switzerland, targeting additional European markets and preparing for entry into the U.S. healthcare system. The company is also exploring the development of therapeutic solutions based on its expertise in calciprotein particles, aiming to address a broader spectrum of calcification-related medical conditions.