HistoSonics Files IPO Prospectus for Its Breakthrough Non-Invasive Histotripsy Platform Edison

Imagine a future where surgical procedures no longer require scalpels, needles, or even any incisions, but instead achieve cancer treatment through non-invasive methods. How feasible is this from a technical standpoint? Can it deliver the expected outcomes?

HistoSonics offers a new answer.

“Minimally invasive surgical incisions are still not small enough.” Therefore, HistoSonics has developed a non-invasive acoustic beam therapy platform capable of destroying diseased tissue at the subcellular level. Powered by histotripsy technology, pulsed sound waves can be delivered directly from outside the body and precisely targeted to internal sites to destroy diseased tissue and tumor cells. Building on this foundation, the non-invasive ultrasound surgical robotic platform, Edison, was launched.

HistoSonics, founded in 2009 and headquartered in Plymouth, Minnesota, USA, specializes in the development of non-invasive medical devices, interventional radiology technologies, and surgical robotics. Its goal is to enable physicians to precisely target and ablate tumors using its non-invasive solutions, thereby avoiding the side effects and complications associated with invasive surgeries or ablation procedures. Edison combines advanced imaging and targeting capabilities with real-time treatment monitoring, turning the concept of non-invasive surgery into a reality.

Histotripsy is a novel non-invasive acoustic beam therapy that utilizes mechanical forces generated by focused ultrasound transmitted through the body to ablate targeted liver tissue. It enables cell and subcellular destruction confined exclusively within the cavitation cloud, thereby achieving high-precision treatment while sparing non-targeted tissues.

Histotripsy, developed by ultrasound scientists at the University of Michigan, serves as a potential non-invasive alternative to certain surgical procedures. As a non-invasive, non-ionizing, and non-thermal ablation technology, histotripsy utilizes focused acoustic energy to generate “cavitation cloud bubbles” that disrupt targeted diseased tissue at the subcellular level. HistoSonics is integrating histotripsy into routine clinical practice through ongoing collaboration with multidisciplinary clinicians from the University of Wisconsin and the University of Michigan. Currently, HistoSonics has licensed this technology from the University of Michigan for commercialization and future development.

Edison is a non-invasive robotic ultrasound surgery platform developed by HistoSonics that leverages histotripsy. It is designed to mechanically ablate targeted liver tumors from outside the body using histotripsy. By integrating advanced robotics, imaging, and sensing technologies, it delivers precise, controlled, and personalized non-invasive ultrasound treatment plans.

Recent study results published in the International Journal of Hyperthermia (THERESA Trial) demonstrate that HistoSonics’ Edison histotripsy system met the co-primary endpoints of acute safety (30-day) and technical success (the ability to ablate the targeted liver tissue) in both primary and secondary liver tumors. Furthermore, the trial results indicate that Edison can successfully target and treat multiple tumors within a single procedure or session.

“Being able to safely target and treat tumors in patients with advanced-stage disease in a non-invasive manner and without ionizing radiation is not only significant for patients with multi-focal disease, but also provides early-stage patients with a new option: non-invasive surgery,” said Dr. Joan Vidal-Jove, MD, Co-Principal Investigator and Surgical Oncologist at the Institut Clínic de Ginecologia, Obstetrícia i Neonatologia (ICGON) of Hospital Clínic de Barcelona.

On October 18, 2021, HistoSonics announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device designation to Edison. Edison provides clinicians with the first automated, extracorporeal beam therapy that uses acoustic energy to disrupt and liquefy diseased liver tissue, without requiring incisions, ionizing radiation, or thermal energy. Early clinical and preclinical results also indicate that Edison largely preserves critical structures such as the liver capsule, as well as major blood vessels and ducts within or adjacent to the target tissue.

“The Power of Bubbles Has Never Been Stronger”—Microbubbles, once avoided in ultrasound applications, are now being used to precisely destroy diseased tissue and tumors. Edison delivers pulsed acoustic energy into the body, using pulsed sound waves to induce “bubble clouds” from gases naturally present in the target tissue. These bubble clouds form and collapse within microseconds, generating sufficient mechanical force to disrupt diseased tissue at the cellular and subcellular levels through a non-invasive, non-thermal ablation method. By harnessing the power of microbubbles to destroy target tissue, Edison avoids the ionizing radiation of radiotherapy, thermal injury associated with heat-based modalities, and the incisions required by traditional treatments.

HistoSonics’ image-guided histotripsy system leverages advanced imaging and proprietary sensing technologies to deliver precise, controlled, non-invasive, and personalized treatments. The Edison Platform also enables physicians to continuously plan, target, treat, and monitor lesion tissue in real time with visual guidance.

First, clinicians can review current computed tomography (CT) and magnetic resonance imaging (MRI) datasets to identify the target tissue. By integrating real-time ultrasound imaging technology, clinicians can align the treatment field with the target tissue using the “Plan Adjustment” tab on the display screen, define the appropriate treatment volume via the “Adjust Target Contour Dimensions” tab, finalize the location and shape of the target tissue, and plan the treatment area on the computer.

Next, the physician places a specialized treatment transducer on the patient’s skin, aligning it with the target tissue. The transducer emits high-intensity pulsed sound waves that penetrate the skin and other tissues, focusing on the target area. As the ultrasound energy converges on the target tissue, the resulting high pressure causes naturally occurring microscopic bubbles to expand through a phenomenon known as “acoustic cavitation,” growing many times larger than surrounding bubbles. The rapid expansion and collapse of these microbubbles form a bubble cloud, which generates powerful mechanical forces that liquefy the target tissue and separate it from the surrounding tissue.

Clinicians can use the Edison system to set the dosage and intensity of emitted pulsed acoustic waves and create personalized treatment plans for each target tissue. Notably, throughout the procedure, physicians can continuously monitor the “bubble cloud” in real time, assess the therapeutic effect on the target tissue by observing echogenic changes on ultrasound images, and adjust treatment parameters as needed. After treatment, the liquefied tissue is naturally absorbed or eliminated by the body, leaving no wounds or scars. As a result, patients experience less pain during the procedure and have a shorter recovery time. During the treatment, nothing other than energy enters the patient’s body. Hence, some experts have jokingly remarked, “In fact, this therapy could potentially be performed in an office setting rather than in an operating room.”

Given the substantial procedural and anatomical similarities between renal and hepatic therapies, HistoSonics has extended its expertise in targeted liver therapy to the field of renal tumors.

Although surgical intervention is the “gold standard” for resecting renal tumors, most current kidney treatments are invasive and prone to complications such as bleeding and infection. In contrast, non-invasive tissue ablation techniques can precisely target the intended tissue without damaging non-target renal parenchyma, thereby preserving the function of the urinary collecting system and eliminating some of the complications associated with existing invasive approaches.

On March 31, 2023, HistoSonics announced that the first renal patient had been treated using its Edison Platform. The procedure was performed in Leeds, UK, by Professor Tze Min Wah, Consultant Interventional Oncologist, Radiologist, and Clinical Lead for the Interventional Oncology Programme at Leeds Teaching Hospitals NHS Trust. This marks the first treatment in the HistoSonics-sponsored “CAIN” trial, representing the world’s first renal tumor therapy using histotripsy. The CAIN trial signifies a major milestone for histotripsy as a non-invasive technology for treating solid renal tumors, while also achieving a paradigm shift in tumor therapy.

Currently, HistoSonics is backed by numerous leading venture capital and healthcare investors, including Venture Investors Healthfund, which provides seed and early-stage venture capital to healthcare companies, and Johnson & Johnson Innovation – JJDC, which invests in and supports global entrepreneurial organizations to address critical healthcare needs. According to data disclosed on the Crunchbase website, HistoSonics has completed 10 rounds of financing, raising a total of $226.8 million.

HistoSonics’ histotripsy technology is currently used for research purposes only. The company intends to seek regulatory approval in the United States for an indication involving liver tissue ablation. The Edison System is still under development and has not yet been commercialized. HistoSonics is currently conducting a clinical study to evaluate the efficacy of histotripsy in ablating liver tumors, as well as preclinical translational research on pancreatic tumors.