HistoSonics’ Edison System Granted Early Market Access in Great Britian

HistoSonics’ Edison Histotripsy System for liver tumor destruction has won controlled early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), enabling patients to access the technology for treatment.

Available through the U.K.’s Innovative Devices Access Pathway (IDAP) program, the Edison System was one of eight available application spots last year, based on histotripsy’s potential to meaningfully address the U.K.’s top current and future healthcare needs. The IDAP program was launched by the U.K. government to help fast-track transformative medical technologies into the healthcare system.

Following a rigorous evaluation process, the U.K.’s medical device regulatory body (the Medicines and Healthcare products Regulatory Agency— MHRA) determined the histotripsy devices could be made available through a UCNA, highlighting the public health value the device may provide for patients with primary or metastatic liver tumors.

The Edison System is claimed to be the first and only platform to use histotripsy—a non-thermal, non-invasive focused ultrasound technology—to mechanically liquefy tumors without surgery, radiation, or systemic therapies. The device received U.S. Food and Drug Administration (FDA) De Novo clearance in October 2023. The HistoSonics platform uniquely enables physicians to plan, target, treat, and monitor tumor destruction with continuous real-time visualization and control.

“Securing GB controlled access through the IDAP pilot program is a tremendous milestone for HistoSonics and signals clear recognition of our technology’s potential to transform healthcare,” HistoSonics President/CEO Mike Blue said. “We are honored to work alongside the NHS and U.K. regulatory and access partners to bring histotripsy to patients across the U.K., many of whom have limited options. This progress builds on our strong clinical track record in the U.S., and our growing base of clinical evidence globally.”

After gaining FDA De Novo clearance in October 2023, the Edison System has been adopted at major U.S. academic centers and hospitals, including integrated health systems and community hospitals that are also eager to offer the non-invasive treatment to patients. Additional clinical trials are ongoing to expand the use of histotripsy to additional indications, including the non-invasive treatment of kidney tumors (HOPE4KIDNEY Trial) and pancreatic tumors (GANNON Trial) in advance of planned regulatory submissions for both indications.

The company believes strong clinical relationships within the United Kingdom, developed through multiple clinical trials conducted over previous years in both the liver and kidney, will help accelerate the histotripsy adoption in major U.K. health centers.

As part of the UCNA authorization, HistoSonics will work with the MHRA to evaluate patient outcomes and regularly collect and analyze real-world data on device performance and safety as part of a post-market surveillance program. HistoSonics is concurrently pursuing European regulatory approval through the European Conformity process (CE marking), which will enable broader commercial availability across the United Kingdom and Europe.

The Edison System has not been evaluated in the United Kingdom or United States for treating any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, five-year survival or overall survival).

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 liquify unwanted tissue and tumors. The company is currently focused on commercializing the Edison System in the United States and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Mich., and Minneapolis.

“The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes” published in Annals of Surgery by Ziemlewicz, et.al., is licensed under CC BY-NC-ND.