Pioneering Histotripsy Device Receives FDA Clearance for Liver Cancer Treatment

Newswise – As a revolutionary breakthrough in cancer treatment, research and medical technology, the US Food and Drug Administration (FDA) has approved The HistoSonics' Edison Histotripsy A device for the treatment of liver cancer. Submitted for marketing authorization through the FDA's De Novo classification application process, an intensive review of the medical device market that has no equivalent, Edison will be the first and only histotripsy platform available in the country.

The state-of-the-art medical device and its technology were developed in part by a Kendall and Laura Hendricks Jr. Faculty Fellowship. Eli VlaisavlevichIn collaboration with the University of Michigan and HistosonicsA private medical device company.

According to HistoSonics, Edison uses advanced imaging to provide personalized, non-invasive histotripsy treatment with precision and control. The FDA approval marks a major step forward in medical innovation and will open up access to technologies that hospitals and treatment centers can use to treat liver cancer patients.

Proprietary technology provides several advantages to both patients and their treating physicians. Treating cancer without radiation or chemotherapy means less pain, shorter recovery times and less risk of complications for patients. The high-intensity focused ultrasound used in histotripsy offers physicians exceptional precision, allowing them to target diseased tissues with considerable precision. And because the treatment is non-invasive, patients experience fewer side effects compared to traditional surgical procedures. There is no incision, which reduces the risk of infection and scarring.

In addition, preliminary findings indicate that histotripsy can potentially cause an immune response where other untreated cancer cells It is released by the body's natural reaction to histotripsy. This unexpected result broadened the potential benefits of histotripsy in cancer treatment.

“There is a lot of excitement about the potential systemic side effects of histotripsy, which has been shown to have the potential to stimulate an anti-tumor immune response when the body begins to recognize and attack untreated tumors,” Vlaisavlevich said. “We hope that the combination of histotripsy with other systemic therapies can improve treatment outcomes even in patients with late-stage disease.”

Targeting cancer with focused precision

Histotripsy, a new therapeutic technique, targets and destroys diseased tissues, including cancerous tumors, without invasive surgery. Instead of traditional surgical methods or radiation, histotripsy uses high-intensity focused ultrasound power to fragment and liquefy targeted tissues. This non-invasive approach allows for more precise treatment and reduces the risks associated with invasive surgery, making it a game changer in the medical field.

Vlaisavlevich, associate professor Department of Biomedical Engineering and Mechanics, was an undergraduate student at Michigan Technological University when he was first introduced to histotripsy through a seminar by University of Michigan researcher Zhen Xu. Xu recently successfully completed his first histotripsy treatment. Intrigued by the technology's potential, Vlaisavlevich entered the university's graduate program and began developing histotripsy for liver cancer. His research was motivated by a close relationship with this disease: his mother, Teresa, died of liver cancer when he was 4 years old.

After earning his doctorate in biomedical engineering, Vlaisavlewicz began a two-year position at HistoSonics, where he built the prototype that would eventually become Edis.on.

In 2017, Vlaisavlevich joined Virginia Tech and continued his research on histotripsy for the treatment of liver and other cancers. Laboratory of therapeutic ultrasound and non-invasive therapy. An ongoing collaboration with HistoSonics has produced the first successful clinical trial for the use of histotripsy in liver cancer in Barcelona, ​​Spain, in 2018. The study was called Teresa's studyIn memory of Vlaisavlevich's mother. Building on this success, HistoSonics launched a much bigger one #Hope of the liver Litigation in both the United States and Europe.

“This is the culmination of a very long process of work by many people, both in academia and industry, to get it to this amazing milestone,” said Vlaisavlewicz.

Advancing the future of histotripsy through collaboration

As Edison and Histotripsy enter the healthcare arena, both serve as a beacon of hope for patients and demonstrate the limitless potential of innovative minds working collaboratively.

Vlaisavlevich and his team are currently leading major projects to improve histotripsy for the treatment of other cancers, including Pancreas, breast, bone (osteosarcoma), soft tissue sarcoma, brain and oral cavity,As in other applications.

“The FDA approval opens up the potential of histotripsy for all the other types of cancer we're working on,” Vlaisavlewicz said. “For me personally, it also means a lot, based on my long history of working on this issue, my mother, and most importantly, the many patients who can now begin treatment with histotripsy.”

Strong academic and industrial partnerships helped histotripsy reach this breakthrough moment, which Vlaisavlevich called a victory for “team science.” As he and his colleagues continue to develop histotripsy at Virginia Tech, he said they remain committed to the university's interdisciplinary and multi-institutional model of collaborative translational science. This was critical in developing potentially revolutionary technology such as histotripsy and getting it to patients as soon as possible, he said. And the work is not done yet.

“This is an exciting milestone and hopefully the first of many applications that will be approved for histotripsy in the future,” Vlaisavlevich said. “Now, we're going after all cancers.”