10.10.2024
SONIRE Therapeutics (Headquarters: Tokyo, Japan; President and CEO: Tohru Satoh; hereinafter referred to as ‘SONIRE’) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative High-Intensity Focused Ultrasound (HIFU) system, designed to treat pancreatic cancer—an disease with few effective treatment options.
SONIRE is advancing cancer treatment by utilizing acoustic engineering (ultrasound) to develop a next-gen ultrasound-guided HIFU treatment device, starting with pancreatic cancer. This FDA designation allows for expedited communication and priority review, accelerating the path to clinical use.
FTI remains committed to the success of Sonire and the development of HIFU as a transformative cancer treatment.
About SONIRE Therapeutics: SONIRE was established in February 2020 to develop the next-generation High-Intensity Focused Ultrasound (HIFU) system using the technology and clinical know-how has been built by Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected as a new cancer treatment because it is non-invasive with no risk of radiation, so patients can receive the treatment repeatedly. SONIRE has developed the HIFU therapy system as a new treatment modality targeting intractable cancers such as pancreatic cancer. Visit our homepage here: https://www.sonire-therapeutics.com/en/
About Fast Track Initiative:
Established in 2004, Fast Track Initiative, Inc. (FTI) is a life science venture capital firm focusing its investments on early-stage startups with a strong focus on biotech and therapeutics. FTI has a strict mission to make a ground-breaking impact on the quality of our life and human wellness through investments across a broad range of areas in the life science community including therapeutics, diagnostics, digital health, healthcare services, and more. The company provides valuable, hands-on support to its 30+ portfolio companies through business and R&D strategy, partnering, investor syndication, and more, including access to its network of professionals in Japan.
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