Domestic Clinical Trials and Global Expansion of SI-449 Adhesion-Prevention Material

「We filed an application for medical-device manufacturing and marketing approval in August 2025 and obtained approval in April 2026.」

「The company filed an application for marketing approval for a medical device in August 2025 and is responding to the review process toward approval.」

「The company is currently selecting a sales partner and constructing commercial production facilities, while preparing to file a marketing application in the third to fourth quarter of the fiscal year ending March 2026.」

「In the gynecology pilot trial aimed at expanding the product's applications, no major safety or usability issues were identified. The company is currently selecting a sales partner and preparing for an early marketing application.」

「In the pivotal trial in gastrointestinal surgery that has been conducted since May 2020, results obtained in July 2023 showed a statistically significant effect in preventing adhesions for the primary endpoint, presence or absence of postoperative adhesions, and the secondary endpoints, severity and extent of adhesions. No notable safety issues were identified. In the gynecology pilot trial aimed at expanding the product's applications, no major safety or usability issues were identified. Going forward, following detailed analysis of the data obtained from both trials and selection of a sales partner, we aim to file a marketing application.」

「At the same time, we will steadily advance our existing pipeline, targeting approval and launch of SI-6603, a treatment for lumbar disc herniation, in the United States; completion of the SI-614 Phase III clinical trial in the United States; and approval of the SI-449 adhesion barrier in Japan and the start of a clinical trial in the United States.」

「Although the trial schedule had been delayed by the spread of COVID-19, subject enrollment in the pivotal trial in gastrointestinal surgery was completed in September 2022. The trial is being conducted to assess efficacy, including prevention of adhesions, safety and usability in gastrointestinal surgery. Subject enrollment in the gynecology pilot trial, aimed at expanding the product's applications, had also been completed in May 2022. Following the follow-up periods for both trials, we aim to file a marketing application based on the data obtained.」

「Subject enrollment in the pilot trial in gynecology was completed in May 2022. The trial is being conducted to expand the product's applications by assessing usability and safety in gynecology.」

「In November 2021, we began a pilot trial in the field of gynecology. The trial is being conducted to expand the range of applications by confirming operability and safety in gynecology.」

「We began a pivotal trial in May 2020 to assess efficacy, safety and usability, but the trial schedule has been delayed by the spread of COVID-19. We are currently implementing measures to recover the delay, including expanding the number of trial sites and using remote methods at sites subject to visit restrictions.」

「We began a pivotal trial in May 2020 to assess efficacy, including prevention of adhesions, safety and usability, but the trial schedule has been delayed by the spread of COVID-19. We are currently implementing measures to recover the delay, including expanding the number of trial sites and using remote methods at sites subject to visit restrictions.」

「Following confirmation of favorable results in the pilot trial launched in May 2018, we began a pivotal trial in May 2020 to evaluate efficacy, safety and operability, including the prevention of postoperative adhesions.」

「The domestic clinical trial, a pilot study of the adhesion barrier SI-449 that began in May 2018, has been progressing smoothly. Subject enrollment was completed in April 2019, and follow-up is currently under way.」

「In May 2018, we began a domestic clinical trial, a pilot study, of SI-449, an adhesion barrier used in surgical procedures. The trial will assess usability and safety and explore efficacy. SI-449 is a medical device whose main ingredient is a cross-linked form of chondroitin sulfate, created using our proprietary glycosaminoglycan cross-linking technology. It absorbs water and swells, and is expected to prevent or reduce postoperative adhesions by forming a barrier between the surgical wound and surrounding tissue after application. SI-449 consists of substances found in the body, including the cross-linking agent, and is therefore considered to have high biocompatibility. As a powdered product, it adheres well to tissue surfaces with many irregularities and is also considered easy to use in laparoscopic surgery, which is becoming increasingly widespread. We will continue developing this product with a view to global expansion as well as commercialization in Japan.」