Osaka Medical College

Sept. 16, 2021 02:00 UTC OSAKA, Japan--(BUSINESS WIRE)-- Gunze Limited (Headquarters: Osaka, Japan, President: Toshiyasu Saguchi) [TOKYO:3002] is pleased to announce the use of Gunze’s biodegradable scaffolds for a meniscal repair clinical trial which will be conducted at Osaka Medical and Pharmaceutical University (hereinafter OMPU) to improve medial meniscal injury patient clinical outcome. This press release features multimedia. View the full release here: Figure: Biodegradable scaffold for meniscal repair (Photo: Business Wire) 1. Background The meniscus is C-shaped cartilage tissue located between the femur and tibia of the knee joint respectively, and acts as a cushion for the knee. Some people suffer from pain during daily life or exercise caused by the difficulty to bend and stretch the knee caused by meniscus damage which can occur because of injury or degeneration due to aging. In Japan, people with meniscus tears are usually treated by suture surgery. However, if suturing the tear isn’t possible, the only option is to remove the damaged part. By excising the damaged meniscus, the pain is relieved, but there is no longer a “cushion” in that part of the knee. The cartilage of the knee on the femur side may wear down or the bones may grind against each other. As a result, knee function deteriorates, and if symptoms progress, it may be necessary to replace the knee joint with an artificial one. To solve this problem, Gunze has developed a biodegradable scaffold for meniscal repair for patients suffering from knee pain which was developed by utilizing Gunze's absorbable medical device manufacturing technology together with Dr. Shuhei Otsuki in OMPU. The company has started a project to provide this new treatment to patients. Although there were some difficulties like cartilage tissue being difficult to regenerate in the knees of people who walk upright, and monitoring the relief of pain, the company was able to obtain an approval from the Ministry of Health, Labor and Welfare to conduct an exploratory clinical trial. 2. What is a meniscus scaffold? The biodegradable scaffold for meniscal repair is created by utilizing our bioabsorbable materials and fiber/polymer processing technology. The scaffold is cut according to the shape of the patient's injured meniscus and sutured to the patient's own meniscus to fix it. Initially, the scaffold (substitute meniscus) acts as a knee cushion, then the patient's own cells invade the substrate and it becomes their own tissue. In addition, all the materials are safe synthetic ones that have a long-term track record as medical devices and are expected to reduce the risk of infection. Previous studies using animals have confirmed that this regenerated meniscus tissue shows almost as the same strength as the original one for approximately one year. 3. Marketing strategy After completing the exploratory clinical trials at OMPU, Gunze will confirm and pursue the safety and efficacy of our biodegradable scaffolds for meniscal repair in clinical trials in 2028 and strive to build a sales system aiming for annual sales of 1.2 billion JPY five years after product launch. Gunze will leverage our strengths in “bioabsorbable materials” and “fiber/polymer processing technology,” to continue improving patients’ QOL through the development and advocacy of less-invasive medical devices and procedures. 4. About Gunze Gunze was founded in Kyoto, Japan in 1896, and today operates a diverse business as a leading developer and manufacturer of Medical Devices, Plastic Films, Engineering Plastics, Electronic Components, Apparel, and various other segments. Gunze employs more than 5,800 people worldwide throughout 10 countries. The Medical Device business, established in 1985, has a substantial footprint over 35 countries. Its head office and manufacturing facility is located in Kyoto, Japan, and has subsidiaries in the U.S., EU, and China. By applying innovative fiber and polymer processing technologies, Gunze manufactures a comprehensive range of medical products focused on bioabsorbable and biocompatible materials such as skin substitutes, tissue reinforcement felt, bone fixation devices, dura substitutes, and suture thread. Gunze’s mission will continue to be centered on advancing the quality of life of patients by providing innovative solutions to improve clinical outcomes. View source version on businesswire.com: Contacts Press: Gunze Limited, Corporate Communication Department Shinji Nonaka TEL: +81-6-6348-1314 shinji.nonaka@gunze.co.jp Source: Gunze Limited Smart Multimedia Gallery Photo Figure: Biodegradable scaffold for meniscal repair (Photo: Business Wire) Logo View this news release and multimedia online at:

he arthroscopic superior capsule reconstruction (SCR) surgical technique can offer patients with irreparable rotator cuff repairs the opportunity to return to sports and jobs that require heavy physical work, as presented in research at the American Orthopaedic Society for Sports Medicine’s Annual Meeting. “We studied 100 patients who did not improve after conservative treatment approaches, but then were treated with the arthroscopic SCR method our team developed,” notes lead research Teruhis Mihata MD, PhD, from Osaka Medical College in Osaka, Japan. “Our research found that this treatment method allowed all 26 patient athletes to return to their previous sports, and 32 patients with heavy workloads to return to their jobs.” The study focused on measuring shoulder range of motion (ROM) before surgery, at 3-, 6-, and 12- months, and yearly after that. Average pre-operative patient scores were 35.7 points on the ASES system, and 52.8 on the JOA system, out of 100. At final follow-up, scores averaged 92.4 and 91.4 points, respectively. In the entire study group, shoulder active range of motion improved from 55.5 degrees for elevation, 15.4 degrees for external rotation, and by three vertebral bodies for internal rotation. “Our research shows promise that this surgical option can offer restored shoulder function for patients who enjoy sports and do heavy physical work, after other treatment options have been unsuccessful,” says Mihata. Surgical complications were limited in the patients studied.