HistoSonics Announces First Ever Kidney Tumor Treatment Using Histotripsy

Leeds Teaching Hospitals NHS Trust,(UK) Performs Non-Invasive Histotripsy in Patient with Primary Solid Renal Tumor

MINNEAPOLIS,March 30,2023 -- HistoSonics,(www.histosonics.com),the developer of a non-invasive platform and novel sonic beam therapy called histotripsy,announced today the first kidney patient has been treated using the Company's histotripsy platform. The procedure was performed in Leeds,UK,by Professor Tze Min Wah,Senior Consultant Radiologist and Clinical Lead for Interventional Oncology Programat Leeds Teaching Hospitals NHS Trust,UK. This procedure marks the initial treatment in the HistoSonics sponsored "CAIN" Trial which is a Phase I prospective,multi-center study designed to evaluate the safety and technical success of the Company's histotripsy system in targeting and destroying primary solid renal tumors,completely non-invasively and without the need for incisions or needles. The trial is named in honor of Charles Cain PhD,former Chair of Biomedical Engineering at the University of Michigan,co-inventor of histotripsy,and co-founder of HistoSonics,who passed away in March of 2020.

Example of HistoSonics technology targeting kidney tissue to be destroyed in a non-invasive histotripsy procedure.

"This first treatment is a significant milestone for the Company as it represents expansion into our second active clinical application (after liver) and supports our mission to deliver histotripsy to patients who may potentially benefit from its unique capabilities," commented Mike Blue,President,and CEO of HistoSonics. Blue added,"Our goal is to enable physicians to precisely target and destroy kidney tumors with our novel,noninvasive solution,avoiding the morbidity and complications seen with current invasive surgery or ablative techniques."

Current kidney therapies such as partial nephrectomy and thermal ablation are invasive and exhibit complications from bleeding and infection that non-invasive histotripsy may avoid. While surgical intervention is the "gold standard" in removing kidney tumors,a non-invasive approach with histotripsy provides the potential to destroy targeted tissue without damaging non-targeted kidney tissue. Additionally,histotripsy's purely mechanical mechanism of cellular destruction could preserve function of the kidney's urine collecting system and eliminate certain complications seen with existing invasive approaches.

Professor Tze Min Wah commented,"I was delighted to lead the clinical team in carrying out this world's first kidney tumor treatment using histotripsy and a real privilege to have the trust of the patient and their family in translating this innovative technology into our clinic. The CAIN Trial represents a significant milestone for treatment of solid renal tumors with histotripsy as a needle-less technology and is a paradigm shift from this point onwards."

HistoSonics' image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive,personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients,including the ability of the treatment site to recover and resorb quickly. Uniquely,the HistoSonics' platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control,unlike any modality that exists today.

HistoSonics histotripsy systems are not currently available for sale. Any use is limited to clinical investigations. The HistoSonics Edison™ System is pending FDA review for a destruction of liver tissue indication. The CAIN Trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.

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 liquify unwanted tissue and tumors. The company is currently focused on the continued development of its Edison™Platform,global clinical studies,and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor,Michigan and Minneapolis,MN.

For more information please visit: www.histosonics.com/