NEWS RELEASESYNFOLIUM®: Novel Cardiovascular Surgical Patch Receives
Manufacturing and Marketing Approval in JapanTokyo, Japan, July 12, 2023 --- The consortium of Osaka Medical and Pharmaceutical
University, Fukui Tateami Co., Ltd., and Teijin Limited announced today that a novel
surgical patch (development code: OFT-G1), to be marketed under the brand name
SYNFOLIUM®, has received a manufacturing and marketing approval in Japan from theMinistry of Health, Labor and Welfare on July 11. Teijin Medical Technologies Co., Ltd.,a Teijin Group company, will serve as a commerce manufacturer and distributor of theSYNFOLIUM® during fiscal 2023.

SYNFOLIUM®

SYNFOLIUM® is a surgical patch with knitted fabric consisting of both bio-absorbableand non-absorbable yarns coated with cross-linked gelatin. After the patch is surgicallyimplanted into the body, patient’s tissue grows and gradually surrounds the expandable,
non-absorbable portion while the bio-absorbable portion degrade. The regenerated
tissue has a potential to reduce the risk of inflammatory reactions, foreign body reactions,and cell death, that often cause deterioration of the implants.
This new product is to be used in the surgical treatment for patients with congenital heartdisease (CHD). Neonates and infants with CHD generally undergo surgeries to correct
hemodynamic problems due to septal defects or narrowed blood vessels (stenosis). Overa long period after surgery, a considerable number of them eventually require reinterventions, such as repeat surgery or catheter therapy, due to the deteriorations above.
To address this clinical problem, Shintaro Nemoto, M.D., Ph.D., of Osaka Medical andPharmaceutical University, created an idea of a patch that could accommodate thegrowth of patients’ bodies by being restored by the patients’ own tissues. Fukui Tateami,

a pioneer in warp-knitting technology, made Dr. Nemoto’s idea into a novel concept ofan expandable cardiovascular patch that has a special knitted fabric structure toaccommodate tissue regeneration and developed a prototype. Teijin, with experience inthe healthcare sector through its pharmaceutical and home healthcare businesses,
integrated the product design, development and regulatory works into the SYNFOLIUM®
patch. The three parties have been collaborating on development of this product since2014.
Japan’s Ministry of Health, Labor and Welfare designated the OFT-G1 as a “SAKIGAKE”
device in April 2018, providing various incentives to accelerate its approval for clinicaluse. In clinical trials of CHD surgery conducted in Japan between 2019 to 2022, there
occurred no reoperations and life-threatening events related to the patch. Based onthese results, Teijin Medical Technologiessubmitted a marketing authorization
application in Japan in January 2023.
Going forward, Osaka Medical and Pharmaceutical University, Fukui Tateami, Teijin andTeijin Medical Technologies will accelerate preparations for the launch of SYNFOLIUM®
in Japan to deliver it to patients as quickly as possible. The consortium will continue toimprove the current technology used for SYNFOLIUM®, and will also expand the rproductportfolio with the goal of improving the treatment and quality of life of patients with CHD
in Japan and worldwide.
3 months after implantation

2 years after implantation

Long-term after implantation

stretchable

Gelatin disappears

Bio-absorbable portions
disappear

Tissues grow and graduallysurround SYNFOLIUM®

"The mission was very challenging, but our development team persevered with strong
endurance. This significant milestone was achieved with incredible support fromacademic societies and regulatory authorities,’’ said Shintaro Nemoto, M.D., Ph.D.,
Department of Thoracic and Cardiovascular Surgery of Osaka Medical andPharmaceutical University. "However, there are still challenges to overcome. We willcontinue to work together to complete the process of making SYNFOLIUM® available tocardiac surgeons and their patients with CHD.”"We hope that SYNFOLIUM®, which we developed as a strong industry-academia team,will help reduce the burden of re-operation for patients and their families,’’ said YoshihideTakagi, President of Fukui Tateami Co., Ltd. "As we Fukui Tateami celebrate our 80thanniversary next year, we are delighted to contribute to the future of children and tosociety as a whole through SYNFOLIUM®.”

"Many surgeons want to reduce repeat procedures as they cause heavy burdens onpatients and their families,’’ said Takayuki Nakano, Ph.D., Mission Executive andGeneral Manager, Regenerative Medicine & Implantable Medical Device Division ofTeijin Limited. “We sincerely hope that the SYNFOLIUM®, an achievement of an industryacademia collaboration with various stakeholders, will solve the issues of patients andtheir families and help improve their quality of life. In addition, as a manufacturer, we will
work to expand the use of this groundbreaking surgical material from Japan to the world,
and to develop further medical devices that make use of the concept of SYNFOLIUM®.”SYNFOLIUM® is a significant success made by an industry-academia project, in which
academia extracted the concerns of patients in the treatment of CHD, medium and largesized enterprises brought their technological capabilities and know-how together andtheir strong cooperative relationships led to industrialization.

About Osaka Medical and Pharmaceutical University
Osaka Medical and Pharmaceutical University is a comprehensive institution that offers
education and research in department of medicine, pharmacy, and nursing. The
university has been providing thousands of clinical professionals by its unique curriculum.
Not only basic scientific research but also interdisciplinary research activities areconducted to solve unmet medical needs. Of note, various medical devices have been
invented there by active industry-academia-government collaborations.
The University Hospital provides various advanced medical treatments, such as thestate-of-the arts cancer therapy including boron neutron capture therapy, robot surgery,and genomics medicine.
URL: https://www.ompu.ac.jp/
Press Contact
Section of Promoting Academia-Industry-Government Cooperation
Center for Medical Research & Development
Osaka Medical and Pharmaceutical University+81 72 684 7141
sangakukan@ompu.ac.jp

About Fukui Tateami Co., Ltd.
Fukui Tateami with 79 years of experience and advanced technology, has become oneof Japan's largest manufacturers of warp-knitted fabric with a wide spectrum ofapplications, including fashionwear, sportswear, automotive interiors, and industrial
materials. After equipped with fully clean room in 2017, the company expanded its
business field into the medical textiles to solve medical unmet needs. Fukui Tateami is
the first textile company which obtained ISO13485 certification in Japan. Fukui Tateami
posted sales of JPY3.1 billion (USD 20 million) and total assets of JPY 2.6 billion (USD17 million) in the fiscal year ending on March 31, 2023.
Please visit http://www.fukutate.co.jp/en
Press ContactGeneral Affairs
Fukui Tateami Co., Ltd.
+81 776 54 3602
info@fukutate.co.jp
About the Teijin GroupTeijin (TSE: 3401) is a technology-driven global group with two core businesses: highperformance materials and healthcare solutions. Established in 1918 as Japan’s firstrayon 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 future by protecting theglobal environment and addressing the needs of people and communities. Teijin posted
consolidated sales of JPY 1,018.8 billion (USD 7.6 billion) and total assets of JPY 1,242.4
billion (USD 9.2 billion) in the fiscal year ending March 31, 2023.
Press Contact
Investor and Public Relations Department
Teijin Limited
pr@teijin.co.jp