CUTISS AG Market Research Report

Company Overview

• Name: CUTISS AG

• Mission: Delivering personalized bio-engineered tissue therapy to transform skin surgery.

• Founded By: CUTISS was established as a spin-off from University of Zurich (UZH) / University Children’s Hospital in 2017.

• Key People:

• Dr. Daniela Marino: CEO / Co-Founder / Member of Board of Directors

• Dr. Vincent Ronfard: Chief Innovation Officer

• Kathi Mujynya Ludunge: Chief Operating Officer

• Headquarters: Bio-Technopark, Zurich, Switzerland

• Number of Employees: Over 40 employees

• Revenue: No information is available

• Known For: Developing denovoSkin™, a personalized bio-engineered skin graft, and pioneering work in regenerative medicine and skin engineering technology.

Products

denovoSkin™

• Description: A personalized, bio-engineered skin graft, classified as an advanced therapy medicinal product (ATMP), engineered in large quantities from a small piece of the patient’s healthy skin.

• Key Features:

• Permanent treatment for skin defects and injuries

• Composed of an epidermis and dermis that grows with the patient and limits scarring

• Significantly reduces the number of follow-up surgeries required, especially in children

• Orphan Drug Designation for treatment of burns from Swissmedic, EMA, and FDA

• In late-stage clinical trials and available for compassionate use

VitiCell®

• Description: A cell therapy-based treatment for vitiligo and dyspigmented burn scars acquired under a global commercialization license from IBSA PHARMA.

• Key Features:

• CE marked for treatment at the point-of-care

• Treats skin pigmentation disorders with approximately 1-2% of the global population affected by vitiligo.

Recent Developments

• New Products and Partnerships:

• September 2023: Inauguration of CUTISS Innovation in Sophia Antipolis, France, focusing on R&D.

• October 2024: First U.S. application and compassionate use of denovoSkin™ conducted.

• November 2024: Swissmedic grants GMP and GDP certifications for CUTISS’s manufacturing facility.

• May 2024: CHF 25M Series C funding round closed.

• Clinical Trials and Approvals:

• December 2024: EMA authorized Phase 3 clinical trial of denovoSkin™ for burn patients, to be conducted across eight European countries.

• July 2024: Positive interim analysis on efficacy for denovoSkin™ in various patient demographics.

• Manufacturing Advancements:

• April 2023: CHF 2.5M grant awarded by Innosuisse for advancing automation of skin graft production, including development of denovoCast™.

• Innovations and Industry Impact:

• Continued collaboration with Santobono Hospital in Naples for pediatric burn care transformations.

• Granted European and U.S. patents for innovations related to personalized bioengineered human skin tissue therapy.

Industry Involvement

• Media and Recognitions:

• Recognized by Nasdaq in April 2023.

• Featured in panorama articles emphasizing Switzerland as an innovation hub.

• Scientific Contributions:

• Numerous publications in peer-reviewed journals outlining clinical advancements and case studies related to denovoSkin™.

• Awards: No specific awards available.

• Investment and Growth Strategies:

• Continuous search for investor partnerships focusing on long-term strategies and life sciences innovation.

• Plans for global commercialization of the VitiCell® once regulatory licensing is adapted to newer standards.

This report compiles known data and developments of CUTISS AG, illustrating its leading position in tissue engineering and regenerative medicine, particularly within the field of personalized skin therapy.