HistoSonics Receives Regulatory Approval in Singapore, Advancing Expansion Across Asia-Pacific

HistoSonics today announced that the company has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison® Histotripsy System (under the device name HistoSonics Histotripsy System), marking another significant milestone in the company’s continued international expansion and creating new opportunities to advance access to histotripsy throughout the Asia-Pacific region.

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HistoSonics Edison® Histotripsy System

The Edison System is a novel, non-invasive, image-guided platform that uses the mechanical properties of focused ultrasound, known as histotripsy, to mechanically destroy and liquefy unwanted tissue and tumors. The technology offers a fundamentally new approach to tissue destruction without the need for invasive procedures, radiation, or thermal energy. The Edison System is currently authorized for the destruction of liver tumors in the United States and select international markets.

Singapore represents an important strategic market for HistoSonics, serving as a regional center for healthcare innovation, clinical collaboration, and advanced medical technology. Beyond establishing a pathway for commercialization within Singapore, HSA registration may also support regulatory submissions in several additional markets through established international regulatory reliance programs. These include Malaysia, Thailand, Australia, and the Philippines, where qualifying medical devices registered by HSA may be eligible for streamlined regulatory review, subject to individual country requirements.

The milestone comes as Singapore continues to strengthen its position as a global leader in medical device regulation. In March 2026, the World Health Organization recognized Singapore’s Health Sciences Authority as the first national regulatory authority globally to achieve Maturity Level 4, the highest classification under WHO’s benchmarking framework for medical device regulatory systems. This recognition further reinforces Singapore’s standing as an internationally respected regulatory authority and an important reference point for medical technology markets around the world.

“Receiving HSA registration in Singapore represents another important step in HistoSonics’ global expansion and our commitment to bringing histotripsy to more physicians and patients around the world,” said Mike Blue, Chairman and Chief Executive Officer of HistoSonics. “Singapore is an important healthcare and innovation hub for the Asia-Pacific region, and this approval creates opportunities that extend well beyond the Singapore market. As we continue to build our presence in Asia, we look forward to working with leading healthcare institutions and physicians to advance clinical experience, expand access to this technology, and support the growing global interest in histotripsy.”

HistoSonics has continued to expand its presence across Asia through physician education, clinical collaboration, and strategic partnerships. In May 2025, the company established its first Histotripsy Training Center in Asia at Gleneagles Hospital Hong Kong, which has since expanded to accommodate growing demand for physician training, clinical observation, and multidisciplinary education. The center serves as a regional resource for physicians seeking hands-on experience with histotripsy and support in developing successful programs within their institutions.

With regulatory approvals in the United States, Europe, Singapore, and other international markets, HistoSonics continues to advance its global commercialization strategy while expanding clinical research and future applications of histotripsy across additional organs, including the kidney, pancreas, and prostate.

The Edison Histotripsy System received its first marketing authorization via FDA De Novo grant in October 2023.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing its Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, MI, Minneapolis, MN and Madison, WI. For more information on the Edison Histotripsy System please visit: www.histosonics.com . For patient-related information please visit: www.myhistotripsy.com .

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Media Contacts

Rebecca Koupal

Sr. Director of Marketing

612-483-6378

Rebecca.Koupal@HistoSonics.com

Kimberly Ha

KKH Advisors

917-291-5744

kimberly.ha@kkhadvisors.com

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