Fukui Tateami Co., Ltd.
Teijin Limited
Osaka Medical and Pharmaceutical University, Fukui Tateami Co., Ltd. and Teijin Limited announced today that the consortium has applied for approval to market the OFT-G1 (development code) patch for cardiovascular surgery in Japan. Teijin Medical Technologies Co., Ltd., a Teijin Group company, will be responsible for developing, manufacturing and distributing the OFT-G1.
The three parties, having established the OFT-G1's efficacy and safety by conducting cases in Japan, will continue to improve their current technologies as well as develop a product pipeline strategy aimed at contributing to the treatment and quality of life of patients with congenital heart defects (CHD) in Japan and ultimately worldwide.
Teijin Medical Technologies has extensive experience in manufacturing and sale of biodegradable surgical materials with quality-control technologies. The company's expertise will be leveraged in order to launch and deliver the OFT-G1 to patients with congenital heart disease as quickly as possible.
Thanks to medical advances in recent decades, the vast majority of pediatric patients with heart diseases reach adulthood. A considerable number of these patients, however, eventually require re-interventions, such as repeat surgery or catheter therapy, due to problems with the implanted surgical materials. There still exist unsolved drawbacks of the existing materials, such as deterioration, calcification, and thickening with pseudo-intimal proliferation. Furthermore, such materials have no size adaptability to body growth. As a result, hemodynamic disturbance often occurs again to be treated by the re-interventions in their long life.
To solve this significant clinical problem, the three parties have devoted their efforts to researching and developing the OFT-G1 by introducing a totally new concept. The OFT-G1 is a knitted fabric consisting of bio-absorbable and non-absorbable yarns coated with cross-linked gelatin. After implantation into the body, own native tissue grows and gradually surrounds the stretchable non-absorbable yarn while the bio-absorbable parts disappear. The regenerated tissue has the potential to reduce the risk of inflammatory reactions and degradation and thereby prevent the need for re-intervention.
In a clinical trial started in Japan since May 2019, no problems or reoperations due to OFT-G1 have currently occurred. As such, the OFT-G1 patch is expected to alleviate not only physical problems but also psychological burdens due to unwanted re-interventions.
The development of the OFT-G1 has been supported by the Ministry of Economy, Trade and Industry since 2014 as well as a program launched in 2017 by the Japan Agency for Medical Research and Development (AMED) to facilitate collaboration between medical academia and industry. Japan’s Ministry of Health, Labor and Welfare designated the OFT-G1 as a “SAKIGAKE” device in April 2018, providing various incentives to speed up an approval for clinical use.
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 are conducted 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 the state-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 78 years of experience and advanced technology, has become one of Japan's largest manufacturers of warp-knitted fabric with a wide spectrum of applications, 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 JPY2.8 billion (USD 26 million) and total assets of JPY 2.6 billion (USD 23 million) in the fiscal year ending on March 31, 2022.
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 the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement “Human Chemistry, Human Solutions”, Teijin aims to be a company that supports the society of the future. The group comprises some 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 926.1 billion (USD 7.2 billion) and total assets of JPY 1,207.6 billion (USD 9.4 billion) in the fiscal year that ended on March 31, 2022.
Please visit www.teijin.com
Press Contact
Investor and Public Relations Department
Teijin Limited
+81 3 3506 4055
pr@teijin.co.jp