Key Points
- With regulatory approvals already in place in many countries, a wide variety of focused ultrasound companies have entered the pancreatic cancer market.
- Progress is also being made in the United States, with two companies receiving breakthrough device designation.
Nine focused ultrasound companies are developing devices for treating pancreatic cancer. Focused ultrasound treatment for pancreatic cancer has regulatory approval in Europe, Korea, Russia, and China. There are two devices with FDA Breakthrough Device Designations.
- Alpinion: This Korea-based focused ultrasound manufacturer has offices in the US, Germany, and China. The company’s Alpius high-intensity focused ultrasound (HIFU) device treats uterine fibroids and adenomyosis, and clinical trials are underway for pancreatic cancer.
- Arrayus: As a Canadian medical technology company that is developing a noninvasive focused ultrasound therapy platform to revolutionize the standard of oncological care, the company is creating a next-generation, MR-guided (initially) focused ultrasound system that can deliver multimodal energy for treating many clinical applications in the pelvis and abdomen.
- Chongqing Haifu Medical Technology: This global company is headquartered in China. It manufactures noninvasive ultrasound therapeutic systems for both malignant and benign tumors. The company’s system uses ultrasound-guided HIFU.
- FocalTherics (formerly EDAP): This French company with offices in the US and Europe develops, manufactures, promotes, and distributes minimally invasive medical devices worldwide. Its devices treat various conditions, and it has developed proprietary HIFU technology for the treatment of pancreatic tumors.
- HistoSonics: Built on a strong scientific and research foundation from the University of Michigan, this rapidly growing company is based in the US. Its noninvasive Edison platform uses an image-guided, sonic beam therapy system to deliver histotripsy that mechanically destroys targeted pancreatic tumors and tissue. In 2025, HistoSonics executed a majority stake acquisition by a group of globally recognized private and public investors, valuing the company at $2.25 billion.
- IMGT: This Korean company is developing a nanotechnology-based gene and drug delivery system for enhanced immunotherapy solutions. Its IMD10 system uses non-destructive histotripsy to improve tissue penetration of anticancer drugs without causing tissue damage.
- OxSonics Therapeutics: This is a clinical-stage oncology company that has developed an ultrasound-based drug delivery platform. SonoTran uses low-intensity focused ultrasound combined with injectable ‘SonoTran Particles’ to enhance the dose and penetration of unmodified cancer drugs into solid tumors, enabling more effective therapies for cancer patients.
- Profound Medical: A Canadian company with its original technology developed at the Sunnybrook Hospital in Toronto, its Sonalleve MR-Guided System uses HIFU guided by MRI for several applications.
- Sonire Therapeutics: Headquartered in Tokyo, Japan, Sonire recently announced a new clinical trial assessing its novel focused ultrasound device for treating unresectable pancreatic cancer. The Suizenji System is an ultrasound-guided HIFU therapy device.