SONIRE's HIFU Therapy System Designated as Breakthrough Device by FDA

SONIRE — Wed, 16 Oct 2024 15:00:00 +0900

TOKYO, Oct. 16, 2024 /Kyodo JBN/ --
SONIRE Therapeutics Inc.
SONIRE Therapeutics Inc. (hereinafter referred to as "SONIRE"), based in Tokyo, Japan, announces that its self-developed next-generation HIFU (High-Intensity Focused Ultrasound) therapy system (development code: Suizenji) has been designated as a breakthrough device by the U.S. Food and Drug Administration (hereinafter referred to as "the FDA") for the treatment of pancreatic cancer.

Logo: https://cdn.kyodonewsprwire.jp/prwfile/release/M107547/202410107892/_prw_PI1fl_w3RY8a4h.jpg

Image: https://cdn.kyodonewsprwire.jp/prwfile/release/M107547/202410107892/_prw_PI2fl_8yiEY846.jpg

The FDA's Breakthrough Device Program supports the development of medical devices that provide more effective treatment or diagnostic of life-threatening or irreversible human diseases. Through the program, SONIRE will receive an opportunity to interact with FDA experts through different program options to efficiently address topics as they arise during a premarket review phase. Therefore, it is expected that the program will prompt patients to access the new treatment provided by Suizenji as soon as possible.

For more information about the Breakthrough Device Program, please refer to the FDA website:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

SONIRE will continue to promote its business in order to realize the wish put in its company name at the time of its foundation: "Sonics brings new future full of hope to many cancer patients and their families as possible."

SONIRE Announces First Patient Enrolled in Randomized Phase 2 Study of Its Novel HIFU Therapy System

SONIRE — Thu, 02 Feb 2023 15:00:00 +0900

TOKYO, Feb. 2, 2023 /Kyodo JBN/ --
SONIRE Therapeutics Inc.
SONIRE Announces First Patient Enrolled in Randomized Phase 2 Study of Its Novel HIFU Therapy System for Unresectable Pancreatic Cancer Patients in Japan

SONIRE Therapeutics Inc. (hereinafter referred to as "SONIRE"), based in Tokyo, announces that it has commenced a randomized phase 2 study for the treatment of unresectable pancreatic cancer with SONIRE’s next-generation High-Intensity Focused Ultrasound (HIFU) therapy system (development code: Suizenji).

Logo: https://kyodonewsprwire.jp/prwfile/release/M107547/202301272458/_prw_PI1fl_1823Ko1T.jpg

The 5-year survival rate of pancreatic cancer is very low at 8.5%, and the number of deaths from it in Japan was estimated to be 37,677 patients in 2020, ranking fourth after lung cancer, colorectal cancer, and stomach cancer, and is increasing every year (*). In addition, treatment options for pancreatic cancer are limited, and there is a strong need for innovative treatment modalities. In this clinical trial, the efficacy of Suizenji in combination with second-line chemotherapy will be evaluated in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy, with overall survival as the primary endpoint (expected enrollment: 90 participants).

(*) Data from "Pancreatic, Statistical Information by Cancer Type," National Cancer Center's Cancer Information Service (updated on October 5, 2022)

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Details of the study can be found on the following websites:
- Japan Registry of Clinical Trials: https://jrct.niph.go.jp/en-latest-detail/jRCT2032220428
- U.S. National Library of Medicine's ClinicalTrials.gov:
https://clinicaltrials.gov/ct2/show/NCT05601323?term=NCT05601323&draw=2&rank=1

SONIRE was established in February 2020 to develop a next-generation ultrasound-guided HIFU therapy system by utilizing the technology and clinical know-how established by Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected to become a new treatment modality for cancer because it is minimally invasive, less burdensome to the body, and can be performed repeatedly without radiation exposure. SONIRE is developing the HIFU therapy system as a new treatment modality for pancreatic cancer, which is one of the most difficult-to-treat cancers.

法人別リリース

SONIRE's HIFU Therapy System Designated as Breakthrough Device by FDA

SONIRE Announces First Patient Enrolled in Randomized Phase 2 Study of Its Novel HIFU Therapy System