Funding to Advance New Histotripsy Applications and Launch Innovative BOOMBOX Master Study

HistoSonics, the manufacturer of the Edison^® Histotripsy System and novel histotripsy therapy platforms, announced today the completion of an oversubscribed $102 million Series D financing. The round was led by Alpha Wave Ventures, a world leader in growth stage investments, with participation from new investors Amzak Health and HealthQuest Capital, and existing investors Johnson & Johnson Innovation - JJDC, Inc. (JJDC), Venture Investors, Lumira Ventures, Yonjin Venture, the State of Wisconsin Investment Board, and others.

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HistoSonics Edison® Histotripsy System (Photo: Business Wire)

Histotripsy is a novel form of focused ultrasound that uses high amplitude, very short pulses to create a “bubble cloud” that is designed to mechanically destroy and liquefy targeted liver tumors. These bubble clouds form and collapse in microseconds, creating mechanical forces strong enough to destroy tissue at cellular and sub-cellular levels in a non-invasive and non-thermal method. Histotripsy offers a promising alternative to treatments such as surgery, radiation and chemotherapy, which often have significant side effects.

The Series D funding will be used to accelerate category defining advancements to its non-invasive histotripsy platforms, support commercial growth in the US and in planned global markets, and initiate the company’s innovative, prospective BOOMBOX Master Study that will evaluate HistoSonics’ Edison System for the treatment of liver tumors across multidisciplinary users. The Edison Histotripsy System was granted FDA De Novo clearance in October 2023. HistoSonics is currently partnering with leading institutions across the US and internationally in developing multi-disciplinary histotripsy liver programs.

“Histotripsy is a paradigm-changing treatment option for patients who want a non-invasive approach to target and destroy tumors without the need for needles or incisions,” said Mike Blue, President & CEO, HistoSonics. “We’re thrilled to announce this top-tier investor syndicate led by Alpha Wave, which reinforces the confidence in our mission to impact patients’ lives with our current liver application and expanded use in kidney, pancreas, prostate, brain and other tumor types. This funding will accelerate key projects designed to enhance core technical capabilities impacting current and future platforms, and support collaboration with physicians and researchers studying innovative ways to use histotripsy’s unique mechanism of action to improve patient outcomes. By pioneering a new category of medicine with histotripsy, HistoSonics is redefining liver tumor treatment and providing hope for millions of people worldwide who desperately need new options.”

“Alpha Wave is proud to lead the investment in HistoSonics, a pioneer in the use of histotripsy,” said Chris Dimitropoulos, Managing Director, Healthcare Investments at Alpha Wave Global. “Histotripsy’s unique non-invasive approach uses focused ultrasound to precisely target and destroy diseased tissue without damaging surrounding healthy tissue. This groundbreaking technology has the potential to transform the treatment landscape for a variety of challenging clinical conditions, offering patients improved outcomes and recovery times. The level of adoption we’ve seen from leading hospital centers across the country and overseas highlights the huge unmet medical need. We are excited to support HistoSonics in accelerating the development and availability of this innovative therapy.” In connection with this financing, Mr. Dimitropoulos will join the HistoSonics Board of Directors.

HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control. The novel mechanism of action of this proprietary technology may provide significant patient advantages, including the ability of the treatment site to recover and resorb quickly. 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.

About HistoSonics

HistoSonics is a privately held medical device company developing non-invasive platforms 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 their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, brain, and others. HistoSonics has offices in Ann Arbor, Michigan, and Minneapolis, Minnesota. The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease or condition. Patients seeking information on histotripsy and if they may be a candidate for histotripsy can learn more at www.myhistotripsy.com.

Use of the Edison System in kidney applications is limited by federal law to investigational use. The #HOPE4KIDNEY Trial is designed to support a future expansion of the indication to include the destruction of kidney tissue/tumors.

About Alpha Wave

Alpha Wave is a global investment company with three main verticals: private equity, private credit, and public markets. It is led by Rick Gerson, Navroz Udwadia, and Ryan Khoury. Its flagship global private equity fund, Alpha Wave Ventures, aims to invest in best-in-class growth-stage companies and endeavors to be helpful long-term partners to the founders and management teams.

Alpha Wave has offices in Miami, New York, London, Monaco, Madrid, Abu Dhabi, Tel Aviv, Bangalore, and Sydney. For more information, please visit www.alphawaveglobal.com.

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

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