InGeneron, Inc. Announces EU Quality Management System Certificate Under MDR Regulation (EU) 2017/745 for Medical Devices

HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a biotechnology company pioneering autologous regenerative cell therapies, today announced receipt of a CE Certificate (No. 28620235524 issued January 19, 2026) for the Transpose Ultra^® (Sterile Kit) and the Processing Unit (Centrifuge) in accordance with Regulation (EU) 2017/745 on medical devices (the Medical Device Regulation, MDR). Intertek Medical Notified Body AB (2862) conducted an extensive review of the submitted Technical Documentation and performed Quality Management System audits in accordance with ISO 13485. The Transpose Ultra System was first certified in the European Union on March 25, 2015, as a “Class I Sterile” device under the Medical Device Directive (MDD 93/42/EEC) thereby allowing the CE mark to be affixed to the product and its labeling.

Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important milestone in the Company’s continued ability to provide cell therapy medical devices in the European Union and for future growth in other markets. This certification by Intertek, an independent regulatory body, provides patients, physicians and other healthcare providers assurance that stringent requirements for safety, performance and quality have been met under the most rigorous review process.

About InGeneron - InGeneron is a biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to further validate our technology as a disease-modifying treatment. Backed by more than 20 years of research and a growing body of clinical evidence, we are committed to advancing safe, effective, and disease-modifying therapies that improve long-term patient outcomes. In the U.S., Transpose Ultra^® is available for investigational use only and remains under clinical evaluation in several FDA-approved clinical trials.

www.ingeneron.com