Key Points
- HistoSonics has commercialized the Edison histotripsy system, which is now being used at nearly 50 centers in the US, United Arab Emirates, and Hong Kong.
- Learn more about the company’s achievements, current direction, and future plans.
As HistoSonics marks its 16th year in business, its vision and execution in developing a noninvasive platform and proprietary sonic beam therapy – using the science of histotripsy – is exemplary. Since its last update in 2019, the company has grown from 40 employees to more than 200. Worldwide, HistoSonics’ Edison system has now been used to treat over 1,000 patients for liver tumors at almost 50 active centers in the US, as well as one in the United Arab Emirates and one in Hong Kong.
We recently spoke with CEO Mike Blue about the company’s achievements, current direction, and future plans.
It is clear that HistoSonics is growing rapidly. Have there been changes to the leadership team?
Our goal is to always be growing and expanding our team at every level, and over the past several years we have been fortunate to add a significant number of new positions and outstanding professionals to our leadership team, including vice presidents of reimbursement, clinical affairs, medical affair, and human resources. These are all medical device veterans, domain experts, who have helped take our company to the next level.
Has your infrastructure also grown?
Absolutely. In 2019, we moved our headquarters to Plymouth, Minnesota, and we have continued to expand that facility almost every year since. We have also now moved our Ann Arbor team into a beautiful state-of-the-art advanced histotripsy research center. We have over 50,000 square feet in Plymouth, including manufacturing, and almost 30,000 square feet in Ann Arbor, with additional planned expansions over the coming years, including a new office and labs for our growing number of employees in Wisconsin.
In 2019, you had just closed a large funding round. What is the current status of fundraising?
Over the past five years we have raised over $300M in equity financings, including our Series D this past summer of $102M led by Alpha Wave Ventures, a world leader in growth stage investments. We are incredibly fortunate to have a diverse and supportive group of investors who include some of the most well-known healthcare-focused investment firms and VC’s, strategics, and large institutional investors. We are always considering and evaluating new financing opportunities, including both private and public, and there are a number of considerations in making those decisions.
The Edison device was cleared by the US FDA in 2023. Tell us about that day.
It was a glorious day, Friday, October 6th, over 20 years in the making since the inception of histotripsy at the University of Michigan, that we received notice from the FDA of our De Novo grant and clearance. We announced the milestone to the entire organization, board of directors, and university teams early that afternoon, and then within one hour, we had our very first Edison histotripsy system order from one of the largest and most prestigious cancer centers in the world, so we immediately had another reason to celebrate. It was an incredible day of announcements and celebration.
Is there reimbursement for the procedure?
Yes, several years ago the American Medical Association issued a unique Category III CPT© code for histotripsy of liver tumors, and then in November of last year CMS assigned a national average payment of $17,500. Commercial payers set their own rates, and we are fortunate that many have been covering and paying across the country. We now also have a Category III CPT© code for histotripsy of kidney tumors and are planning to submit for a pancreas code later this year or early next.
The second histotripsy indication you are pursuing is kidney tumors. Tell us about that.
Yes, we believe histotripsy is a needed front-line therapy and alternative for patients with renal masses where surgery or other techniques are invasive, complex, and have risk. We believe our noninvasive platform in combination with its unique safety profile around critical structures, like the collecting system, make it an ideal alternative for the millions of patients in the world who have renal tumors. Our #HOPE4KIDNEY pivotal IDE trial is near complete, and we look forward to submitting this data to the FDA in 2026.
You’ve also started a research study exploring the use of histotripsy for treating pancreatic tumors. Tell us more.
There is a massive unmet clinical need for patients suffering from pancreatic cancer. Five-year survival rates remain the lowest of all malignant solid tumors. The GANNON Trial’s aim is to demonstrate safety and feasibility of histotripsy in later stage pancreatic cancer. Developing an effective, non-invasive, and repeatable treatment option has the potential to provide a breakthrough and revolutionary treatment for patients who currently have very few options.
You also have another trial ongoing called the BOOMBOX trial.
The BOOMBOX study is very unique for medical devices, maybe the first ever, because it is a clinical trial design typically used for oncology drugs. As a novel prospective master protocol study, it is similar to a registry in that it captures data from patients being treated in routine clinical care, including disease state, goal of care, and outcomes. These data are then monitored for trends. If the HistoSonics medical and clinical affairs team or an outside investigator notices any signals or patterns in the data, spin-off clinical trials can be initiated for further hypothesis-driven research studies. To be included in the BOOMBOX cohort, commercial patients who are being treated for liver tumors at participating sites must consent to join the study. The trial is designed to enroll up to 5,000 participants over 8 years.
Turning toward the commercialization of the technology, you recently had great news come from Hong Kong.
Yes, we recently launched our first center in Hong Kong and will be announcing others soon. We also announced earlier this month the first center in Singapore. We are very grateful to the Li Ka Shing Foundation for donating multiple systems in both markets, as well as the Temasek Trust for their donation in Singapore. Mr. Li Ka Shing’s vision and commitment of improving the lives of patients in Hong Kong, throughout Asia, and across the world is unparalleled, and we are happy to work alongside him and his Foundation.
What are some of the biggest challenges you have had to overcome as a company?
The company is growing at an incredible pace, and we are constantly learning and implementing new knowledge to improve patient care. It’s a wonderful challenge to have, but it also puts pressure on the organization to move at great speed to ensure we are maximizing outcomes for patients and our physician and hospital partners.
You’ve also dedicated company time and resources to giving back. Tell us about that.
Our team participates in a wide variety of philanthropy to give back to the community. For example, we choose employee nominated charities ever quarter to support in our “Histo Giving” program, and the response of our team blows me away every time. In addition, we try to help through donations and service when one of the communities is impacted by national disasters, like the flooding in NC and TN last year and the fires in CA. As another example, we are incredibly proud to partner with the Salvation Army every year to provide holiday gifts and cheer to needing local families around both our Plymouth and Ann Arbor offices.
How are you cultivating the next generation of STEM professionals?
We love when students of all ages visit our facility, either formally or informally. Multiple times a year we host middle school and high school STEM class students and allow them to get hands on with the Edison System and spend the day having fun engaged in interactive and educational sessions. We also offer summer and winter break internships for college students, and it’s been very rewarding to see that program grow every year and even more rewarding when graduates decideto come back and get hired full time. Our hope is that we can help kids get excited enough through interactions with our company that we can help to shape the future of innovative minds, potential engineers, and leaders in healthcare.
What is next for the company?
Our focus is on continued growth across every function of the organization. Over the coming years, we will be launching new indications, products, clinical trials, and much more. To support this growth, we will be continually adding people and expanding our facilities, as well as growing the number of academic partners. The vision and potential of histotripsy has always been to benefit patients across an unparalleled number of broad clinical applications, both malignant and benign, and we are just at the very, very beginning of our journey.