UnicoVial®, a patented cell storage container designed by UnicoCell, was granted the winner at the 19th National Innovation Award by the Institute for Biotechnology and Medicine Industry (BIMI). The award ceremony was held on December 3rd, 2022 at the Taipei Nangang Exhibition Hall during the Healthcare+ Expo, Taiwan with Chairwoman Ms. Tsai represented UnicoCell to receive the award. UnicoVial® is currently the only cell storage container obtained approval as a Class II medical device in the market. This product has been patented by the Republic of China, the United States, Japan, China, and Korea. It offers an additional layer of safety for patients with medical device approval, while the patent designed of this product brings convenience for clinical use. It is suitable for use in the cellular industry as well as in various biotech and medical related applications.
The implication of the cell storage container with medical device approval is that it greatly enhances the safety requirements of the end-use of the cellular industry supply chain, which is a great achievement for the integrity of the supply chain. UnicoVial® has undergone numerous improvements and refinements for several years during development. Omnimate Ent. Co., Ltd. was commissioned by UnicoCell to manufacture UnicoVial® due to the strict requirements for medical device materials. Omnimate Ent. Co., Ltd. not only passed domestic GMP and international ISO 13485 quality certification requirements, but also manufactured products that meet the requirements of US FDA and EU MDD regulations. With stringent quality control from R&D to manufacturing products, UnicoVial® has received strong industry recognition and a high repurchase rate since its launch.
UnicoCell has focused on developing new stem cell drugs for more than 10 years. New drug application for Phase III clinical trial for knee osteoarthritis has been submitted, while recruiting patients for Phase I/II clinical trial for chronic kidney disease has been completed and awaited for unblinding result. With the same spirit of strict, safe and effective requirements in developing new drugs, UnicoCell has developed a patented cell storage container with medical device approval, which demonstrates the company's core value of high quality standard and contributes to the advancement of cellular industry in regenerative medicine.
Contact: Terry Lee