NEWS RELEASESYNFOLIUM®, a Novel Cardiovascular Surgical Patch,
to Be Marketed in Japan on June 12
Tokyo, Japan, May 27, 2024 --- The consortium of Teijin Limited, Fukui Tateami Co., Ltd., and Osaka
Medical and Pharmaceutical University announced today that a novel surgical patch (development code:OFT-G1), to be marketed under the brand name SYNFOLIUM®, will be released for manufacturing anddistribution by Teijin Medical Technologies Co., Ltd., a Teijin Group company, on Wednesday, June 12,2024.
SYNFOLIUM® is a surgical patch with knitted fabric consisting of both bio-absorbable and non-absorbableyarns, which are coated with cross-linked gelatin. After the patch is surgically implanted in the body, thepatient’s tissue grows and gradually surrounds the expandable, non-absorbable portion, while the bioabsorbable portion degrades. The regenerated tissue has the potential to reduce the risk of inflammatory
reactions, foreign body reactions and cell death, which often cause deterioration of the implants.

This new product is designed to be used in surgical treatment of patients with congenital heart disease(CHD). The prevalence of CHD is 1 in 100 people globally, and in Japan, it is estimated thatapproximately 10,000 neonates are born with the disease each year. Newborns and infants with CHD
generally undergo surgeries to correct hemodynamic problems due to septal defects or narrowed
blood vessels (stenosis) by implanting a medical patch, usually made from synthetic or animal-derived
materials. However, over a long period after surgery, a considerable number of patients eventuallyrequire re-interventions, such as repeat surgery or catheter therapy, due to the deterioration of theimplanted patch. This deterioration can be caused by an immune-mediated foreign body reaction or
the development of stenosis due to the inability of the patch to stretch in response to the growth ofcardiac and vascular tissue.
To address this clinical problem, Shintaro Nemoto, M.D., Ph.D., of Osaka Medical and Pharmaceutical
University, created an idea for a patch that could accommodate the growth of patients’ bodies throughrestoration by the patient’s own tissues. In 2012, he began research and exploration to make this ideaa reality.
Fukui Tateami, a pioneer in warp-knitting technology based in Fukui Prefecture, turned Dr. Nemoto’s
idea into the novel concept of an expandable cardiovascular patch. Based on advanced warp knitting
technology it developed over the 80 years since its founding, the company created a special knitted
fabric structure to accommodate tissue regeneration.
Teijin developed the technology to coat knitted fabric with gelatin, which can prevent blood leakage andcan be replaced by the patient’s own tissue. The company has been proceeding with design anddevelopment, clinical trials, establishment of a commercial production system, and application formanufacturing and marketing approval in Japan.

The three parties have been collaborating on the development of this product since 2014.
The development of SYNFOLIUM® has been supported by the Ministry of Economy, Trade and Industry
since 2014, as well as by a program launched in 2017 by the Japan Agency for Medical Research andDevelopment (AMED) to facilitate collaboration between medical academia and industry. Japan’s Ministryof Health, Labor and Welfare designated SYNFOLIUM® as a “SAKIGAKE” device in April 2018, providing
various incentives to speed up approval for clinical use. In addition, the Japanese Society of Pediatric
Cardiology and Cardiac Surgery cooperated by assisting with clinical trials and providing advice on
creating guidelines for appropriate use.
Clinical trials that began in 2019 were completed in 2022, and Teijin Medical Technologies applied for
manufacturing and sales approval to the Ministry of Health, Labor and Welfare in January 2023. The
company received approval in July of the same year.
Going forward, Teijin and Teijin Medical Technologies, Fukui Tateami, and Osaka Medical andPharmaceutical University will provide clinical information about this product to medical institutions tofacilitate its use in patients with CHD. Teijin and Teijin Medical Technologies will continue to collect andanalyze cases using SYNFOLIUM® to establish its long-term safety and efficacy.
Furthermore, to help improve the quality of life of patients with CHD around the world, the consortium plans
to market SYNFOLIUM® overseas by working to gain manufacturing and marketing approval in the UnitedStates, the European Union and other countries.
Using knowledge and technology gained through the development of this product, the consortium will workon developing other products targeting unmet medical needs, such as valved conduit for the treatment ofCHD and materials for valve reconstruction.

About the Teijin GroupTeijin (TSE: 3401) is a technology-driven global group with two core businesses: high-performancematerials and healthcare solutions. Established in 1918 as Japan’s first rayon manufacturer, Teijin today
comprises some 170 companies employing 20,000 people in 20 countries. Through “Human Chemistry,Human Solutions,” Teijin relentlessly strives to aims to be a company that supports the society of the futureby protecting the global environment and addressing the needs of people and communities. Teijin posted
consolidated sales of JPY 1,032.8 billion (USD 6.6 billion) and total assets of JPY 1,251.0 billion (USD 8.0billion) in the fiscal year ending March 31, 2024.
Press Contact
Investor and Public Relations Department
Teijin Limited
pr@teijin.co.jp

About Fukui Tateami Co., Ltd.
With 80 years of experience and advanced technology, Fukui Tateami has become one of Japan's largest
manufacturers of warp-knitted fabric used in a wide spectrum of applications, including fashionwear,
sportswear, automotive interiors and industrial materials. After installing a fully equipped clean room in
2017, the company expanded its business into medical textiles. Fukui Tateami was the first textile company
in Japan to obtain ISO13485 certification. It posted sales of JPY 3.2 billion (USD 20 million) and total
assets of JPY 2.7 billion (USD 17 million) in the fiscal year ending March 31, 2024.

Please visit http://www.fukutate.co.jp/en
Press Contact
General Affairs
Fukui Tateami Co., Ltd.
+81 776 54 3602
info@fukutate.co.jp

About Osaka Medical and Pharmaceutical University
Osaka Medical and Pharmaceutical University is a comprehensive institution that offers education andresearch in medicine, pharmacy and nursing. The university educates thousands of clinical professionals
through its unique curriculum. Not only basic scientific research but also interdisciplinary research activities
are conducted there to solve unmet medical needs. Various medical devices have been invented at theuniversity by active industry-academia-government collaborations. The University Hospital provides
advanced medical treatments such as state-of-the art cancer therapy, including boron neutron capture
therapy, robotic surgery and genomic medicine.
URL: https://www.ompu.ac.jp/
Press Contact
Planning and Public Relations Section, Department of General Affairs
Osaka Medical and Pharmaceutical University
hojin-koho@ompu.ac.jp