HistoSonics | Top Emerging Medtech Company 2022

MedTech Outlook Magazine

HistoSonics
Pioneering Innovations In Non-Invasive Therapeutics

Joshua King, VP of Marketing, HistoSonics Inc., HistoSonicsJoshua King, VP of Marketing, HistoSonics Inc.
Minimally invasive is not minimal enough; this was the driving motto for a few scientists at the University of Michigan who set out to find non-invasive alternative therapies to many of today’s more morbid surgical procedures performed on patients—a “surgery without needles or knives.” One such procedure led by the multi-disciplinary team of physicians and researchers at the University looked at how to non-invasively solve a rare prenatal, pediatric congenital heart condition called hypoplastic left heart syndrome where necessary blood circulation in the heart is prevented.



The conventional treatment required a minute incision to create a blood flow between the atrial septum, which damaged the surrounding tissue and caused extreme stress on the newborn. Additionally, other visionaries saw an opportunity to non-invasively remove tumours from the liver, kidney, brain, pancreas, and prostate without ever having to enter the body. To overcome the problems of invasive surgical procedures, the scientists developed a method to deliver higher surgical precision and accuracy without needing to make an incision into the body or use common treatments with known adverse effects.

The discovery of a purely mechanical way to destroy targeted tissue inside the body using only sound waves was the innovation that gave the scientists and physicians hope that they could one day transform surgery. This innovation was called histotripsy, the first ultrasound-based, a non-invasive, non-ionizing, and non-thermal treatment that potentially overcomes many of the challenges of surgery, radiation, chemotherapy and thermal ablation. Spurred by the breakthrough, the scientists formed HistoSonics to license the histotripsy science and technology, continue the development of a clinically viable platform and ultimately make it accessible to hospitals.

“At HistoSonics, we want to bring the power of histotripsy to patients and physicians worldwide. Our mission and passion are to advance our solution to transforming experiences for patients and physicians and helping them to overcome some of their most challenging issues when dealing with significant disease, starting in the liver,” says Josh King, Vice President of Marketing at HistoSonics.

Histotripsy is a technique where physicians use high energy but very short, pulsed sound waves to create a strong negative pressure ‘that expands naturally occurring dissolved gas bubbles from their normal nano-sized state to much larger bubbles. This expansion of these “bubble clouds” is very rapid, as it collapses thousands of times per second at a known point in the tissue as directed by a physician.

The bubble clouds’ constant formation and collapse within a few millimeters of volume create mechanical shearing forces, tearing apart and destroying the target cells, making it an ideal treatment protocol for targeted tissue and tumor removal.
A unique feature of histotripsy is its ability to precisely confine tissue bioeffects within targeted volumes.

Histotripsy is administered through HistoSonics’s Edison™, a sophisticated platform leveraging advanced imaging and proprietary sensing technology. It delivers pulsed sonic energy into the body without incisions or needles while enabling physicians to monitor the bubble clouds and continuously improve treatment efficacy.

Early and ongoing clinical results are promising and suggest that our ability to precisely destroy targeted liver tissue, completely non-invasively, and without the challenges associated with ionizing radiation or other locoregional therapies, provides advantages to patients and physicians that don’t exist today

During treatment, Edison’s ultrasound transducer is placed on the patient’s body and is directed at the targeted tumor site through a single-use patient coupling membrane. Once the treating doctor creates the treatment volume encasing the targeted tissue and margin, then Edison’s software guides the physician through the planned volume to collect a series of ultrasound sensing pulses (less than 50 microseconds) to discrete points within the target area. These sensing pulses are modified by the doctor until they generate adequate pressure to liquefy and destroy targeted tissues at sub-cellular levels. Once the energy level is met to create the “bubble cloud” the Edison system logs that value and allows the physician to move on through other areas of the targeted volume to create personalized treatment plan. The software creates a 3D tumor volume to provide constant visuals for the attending physician, who monitors the therapy’s real-time effect. The technology uniquely allows physicians to create a personalized treatment plan for each target within the patient’s liver as the software ensures physician control throughout the procedure. The platform’s compactness and modularity make it cost-effective, empowering physicians to turn their back on clunky surgical equipment and less-effective procedures.

Beyond eliminating tumors in the liver, the precision platform shows promise for treating underserviced diseases pertaining to the kidney, pancreas, brain, and other organs. HistoSonic’s Edison-based non-invasive surgical procedure is active in clinical trials in the U.S. and Europe and has completed the enrollment threshold for submission to the U.S. FDA.

One of the primary goals of new medical technologies is the reduction of morbidity and complications during treatment, and HistoSonics attunes itself to that. HistoSonics has finalized the renovation of its 30,000 square feet headquarters in Minneapolis with its firm footprints in the medical field. It will have manufacturing, education, and executive offices. Moving ahead, HistoSonics is set to expand and innovate itself, augmenting newer imaging capabilities and growing its team by partnering with world-leading physicians.

Top 10 Emerging Medtech Companies – 2022

Company
HistoSonics

Management
Joshua King, VP of Marketing, HistoSonics Inc.

Description
HistoSonics is a venture-backed medical device start-up company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy. The company’s Edison platform delivers personalized, tissue-specific treatments with precision and control and without the undesirable side effects of many of today’s interventional and surgical modalities.

HistoSonics News

La FDA autorise le système d'histotripsie inédit Edison® d'HistoSonics

MINNEAPOLIS - HistoSonics® (www.histosonics.com), the producer of the Edison® system and novel histotripsy treatment platforms, has announced today that it has received marketing authorization from the US Food and Drug Administration (FDA) following a De Novo classification request, a rigorous pre-market evaluation mechanism for medical devices without any existing predicate. This marketing authorization makes Edison the first and only histotripsy platform available in the United States.
The FDA partly granted this authorization based on data from the #HOPE4LIVER trials conducted at 13 sites in Europe and the United States. Data from trials conducted in Europe/the UK and the United States were combined and used to assess the safety and clinical efficacy of histotripsy when applied to target primary and secondary liver tumors. By collectively reviewing this data, histotripsy was found to meet key criteria for effectiveness and safety, with safety assessed in 44 subjects and treatment efficacy evaluated for 44 tumors. Notably, the treated subjects exhibited heterogeneity, including 18 with hepatocellular carcinomas (HCC) and 26 with liver metastatic tumors originating from the colon, rectum, breast, and other sites. As recently reported in a presentation at the annual CIRSE (Cardiovascular and Interventional Radiological Society of Europe) congress in Copenhagen, a technical success rate of 95.5% was achieved, demonstrating the ability of physicians to precisely target and destroy unresectable liver tissues and tumors. Furthermore, only three grade 3 or higher adverse events, according to the CTCAE classification, were observed among the 44 treated subjects in the 30 days following histotripsy, representing a complication rate of 6.8%, with these effects being non-specific to histotripsy and common in conventional focal therapies.
"This is the most significant milestone reached by HistoSonics to date. It represents over two decades of hard work, from the creation of the system at the University of Michigan in 2001 - which was once considered impossible - to mastering the numerous intricacies of histotripsy and integrating it into a completely non-invasive clinical platform," explained Mike Blue, President and CEO of HistoSonics. The company has stated that it has expanded its commercial and operational capabilities compared to the previous year in preparation for commercialization. Mr. Blue added, "We have strategically surrounded ourselves with professionals with extensive experience in operational, educational, and market development aspects, and we are ready to begin physician training planning immediately. It is a fantastic day for patients who will benefit from the revolutionary advantages of histotripsy, and I commend the FDA for working diligently with us throughout the evaluation process."
Histotripsy science utilizes focused sound energy to generate controlled acoustic cavitation, liquefying and mechanically destroying targeted liver tissues at subcellular levels, including tumors. HistoSonics' Edison system utilizes advanced imaging techniques and exclusive technology to offer non-invasive and personalized histotripsy treatments with precision. The company believes that the new mechanism of action of its proprietary technology could provide significant benefits to patients, including rapid healing and resolution of the treated organ. Specifically, HistoSonics' platform also allows physicians to monitor tissue destruction through continuous real-time visualization and control, a capability not currently offered by any other device.
"For a surgeon, it is gratifying to be able to offer a procedure that provides the opportunity to precisely destroy liver tumors without the use of scalpels or needles, which should allow the patient to heal quickly while avoiding certain complications related to surgical site infections or radiation exposure from other methods," said Dr. Joe Amaral, Vice President of Medical Affairs at HistoSonics. "Given the data and patient experiences in our studies, we are confident that histotripsy will have a significant impact on patients with unresectable liver diseases, including tumors. We look forward to seeing the role histotripsy will play in future therapeutic strategies," Dr. Amaral commented.
The Edison system aims for non-invasive ablation of liver tumors, including unresectable liver tumors, using a mechanical, non-thermal process based on focused ultrasound.
About HistoSonics HistoSonics is a private medical device company that has developed an exclusive therapy utilizing sonic beams and a non-invasive platform based on histotripsy science, an innovative mechanism of action that employs focused ultrasound to mechanically liquefy and destroy tumors and undesirable tissues. The company is currently focusing on marketing its Edison hepatic treatment system in the United States and specific global markets while expanding histotripsy applications to other organs such as the kidneys, pancreas, etc. HistoSonics has offices in Ann Arbor, Michigan, and Minneapolis, Minnesota.
For more information, visit: www.histosonics.com/.
Please note that the text of this release, derived from a translation, should not be considered official. The only version of the release that is authoritative is the one in its original language. The translation should always be compared to the source text, which takes precedence.

Worlds First Kidney Tumor Treated Using the HistoSonics Edison® Histotripsy System

HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive platform and innovative sonic beam therapy known as histotripsy, announced the initiation of treatment for the first patient in its pivotal #HOPE4KIDNEY Trial. This investigational device study, FDA-approved last year, aims to assess the safety and effectiveness of the company's groundbreaking Edison System. The Edison System is designed to obliterate targeted kidney tumors entirely through a non-invasive approach, eliminating the need for needles or incisions. The #HOPE4KIDNEY Trial is a multi-center, open-label, single-arm trial set to enroll up to 68 patients.
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HistoSonics Raises $102M in Series D Financing

HistoSonics, a Minneapolis, MN-based manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, closed $102m Series D financing.
The round was led by Alpha Wave Ventures, 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.
Led by Mike Blue, President & CEO, HistoSonics is a 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.
The Series D funding will be used to accelerate 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.