TamaBio Concludes Contract with Aichi Children’s Health and Medical Center;
Launches Clinical Observational Study Using “PeriBeam®” Pericardial Membrane.
TamaBio Co., Ltd. (Tokyo; Managing Director/CEO: Tetsuya Nagao; hereinafter “TamaBio”) announces that on January 6, 2026 it concluded a commissioned research agreement with Aichi Children’s Health and Medical Center (Aichi; Vice Director and Acting Director : Hiroomi Murayama,MD; hereinafter “The Center”) to initiate a observational study using TamaBio’s pericardial membrane, “PeriBeam®”, which has obtained regulatory approval in Japan and the United States and is used in cardiac surgery.
“PeriBeam®” has already begun to see growing clinical use in Japan and in the U.S.A. within pediatric and cardiovascular surgery as a synthetic-material–based pericardial membrane. Conventional synthetic products have been associated with low tissue affinity and risks such as infection and the need for reoperation, while biologic pericardial sheets have faced issues including calcification and degradation. “PeriBeam®” aims to address these problems through its high biocompatibility.
Surgical treatment for pediatric congenital heart disease carries a certain rate of postoperative reoperation, and when reoperation is required, there is a clinical need for pericardial patch materials that offer greater safety and efficacy while minimizing invasiveness. Appropriate selection of pericardial patch material is therefore clinically important. Accordingly, an evaluation of “PeriBeam®”, which is designed to modulate biological reactivity through surface modification, was desired to determine optimal usage and to assess tissue responses during cardiac surgery as well as the ease of explantation at reoperation.
As the only pediatric specialty medical center in Aichi Prefecture, the Center provides advanced, high-quality specialized care. Its Department of Cardiovascular Surgery treats complex congenital heart diseases and conducts clinical research. Through an evaluation of TamaBio’s “PeriBeam®”, the Center and TamaBio will compare how different types of synthetic pericardium and implantation techniques affect tissue responses, with the development goal of generating knowledge to inform future choices of cardiac surgical products and operative strategies, and will proceed with the research accordingly.
For further details, please contact:
Tetsuya Nagao／TamaBio Co.,Ltd. (MSE, Managing Director/CEO)
Registered (Tokyo) : A Class 1 Medical Devices Manufacturer & Distributor
PMDA Approval (DuraBeam® and PeriBeam®) : Class IV Highly Managed Medical Device
FDA Regulation Number : 870.3470, Classification Product Code DXZ
FDA Registration Number : 3041851334
Mobile +81 80 1196 3206 / Tel +81 422 53 5051 / FAX +81 422 38 5091
https://tamabio.com/en/
402 2-2-18 Sakai Musashino-shi Tokyo 180-0022 Japan
Aichi Children’s Health and Medical Center
