HistoSonics
Pioneering Innovations In Non-Invasive Therapeutics

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.

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.