Sigimedtec Receives Organizational Bank Approval for 'Regen Hub'... hECM and CDMO Business Set to Launch in Earnest

Targeting the Global Human Tissue CDMO Market

Sigimedtec has obtained approval for a change of organizational bank for its Regen Hub, a human tissue research and production hub located in Seongnam, Gyeonggi Province. With this approval, the company will officially launch its human-derived extracellular matrix (hECM)-based biomaterial platform and contract development and manufacturing organization (CDMO) business for human tissues.

On July 27, Sigimedtec announced that it had received approval from the Seoul Regional Office of Food and Drug Safety to add Regen Hub as a location for its organizational bank, allowing for the storage and processing of skin and bone human tissues.

A view of the Gyeonggi Seongnam Regen Hub Center. Siji Medtech

With this authorization, Sigimedtec plans to expand its business from being a medical device manufacturer to becoming a biomaterial platform company based on human tissues, and to establish a new growth axis targeting the global regenerative medicine market.

Initially, Regen Hub will produce skin-derived hECM biomaterials and bone regeneration biomaterials. The company plans to gradually build a diversified hECM platform sourced from various tissues, such as adipose and bone tissues.

Sigimedtec also aims to accelerate the development of a human tissue CDMO platform at Regen Hub. The company will offer a one-stop CDMO service, supporting the entire lifecycle from research and development to production, quality control, regulatory approval, and commercial supply of hECM biomaterials and human-tissue-based medical products tailored to client requirements.

After completing the verification of its production process, Sigimedtec plans to establish a production system capable of manufacturing 10,000 units per month by the end of this year and 30,000 units per month by the first half of next year, with the capability to scale up to 60,000 units per month according to future demand. The company is also pursuing the registration of Regen Hub as a satellite facility of CGBio’s organizational bank by the end of this year. Once satellite registration is complete, Regen Hub will be operated under the same global quality management system as CGBio.

Hyunseung Yoo, CEO of Sigimedtec, stated, “This organizational bank modification approval marks a significant turning point for Sigimedtec as it transforms into a human-derived biomaterial platform company. We aim to develop Regen Hub not as a simple production facility, but as a core base for our hECM biomaterial platform and human tissue CDMO business, thereby securing differentiated competitiveness.”

This content was produced with the assistance of AI translation services.