Since starting their tenure at the company in 2017, President and CEO Mike Blue and Senior Medical Advisor Fred Lee, Jr., MD, have strategically re-envisioned and successfully transformed HistoSonics into a company that is finalizing the development of “Edison,” a truly scalable robotic platform capable of delivering noninvasive, non-thermal histotripsy treatment across multiple applications.
2019 has been a pivotal year for this company. HistoSonics closed a $54M Series C financing round, added new strategic investors (Varian Medical Systems, Johnson & Johnson), successfully completed their first-in-human liver tumor study, opened a new manufacturing facility in Minneapolis, and won several innovation awards for their new platform and technology. These accomplishments are the result of a pivotal change in strategy.
We interviewed Mr. Blue to learn more about how this dynamic and unique company reinvented itself to become one of the fastest growing in the field.
Remind us of HistoSonic’s company history.
HistoSonics was founded in 2009 by the scientists and great minds at the University of Michigan who discovered and developed the science of histotripsy as a nonthermal therapeutic ultrasound application with the capability to precisely destroy targeted tissue almost anywhere within the body. Like other biomechanisms of focused ultrasound, histotripsy is image guided – but its imaging technique is performed in real-time and does not require measuring temperature data. Histotripsy uses the mechanical pressure of focused ultrasound, not thermal heating, to create tissue destruction at the cellular and even sub-cellular level. Based on the almost eight years of research the university team provided prior to founding the company, it was given a tremendous head start.
The Foundation’s 2014 HistoSonics company profile provided a snapshot from five years ago, when the company was developing histotripsy for the treatment of benign prostatic hyperplasia (BPH).
The past three years have created a new chapter in the company’s history. We have been able to leverage much of what the company had done for BPH, both from a technology standpoint as well as critical learnings, and apply it to a scalable platform with a broad range of potential clinical applications. As we navigated this transition, critical input from Dr. Lee and his 30+ years of clinical experience with a number of other treatment modalities was instrumental for guiding decisions. We shared the vision for developing a revolutionary platform that could be globally adopted by a variety of physician specialties. In the past three years, we have transformed HistoSonics into a company that has developed a sophisticated, noninvasive, autonomous robotic platform with the capability of delivering an effective novel therapy: histotripsy.
When did you join HistoSonics, and why?
I joined HistoSonics in 2017 after almost 20 years in the medical device sector, and almost exclusively in interventional oncology. Fred and I had just previously worked together at a company he founded, NeuWave Medical, to commercialize their best-in-class microwave ablation technology, which is used to treat tumors in the liver, kidney, lung, and others. NeuWave was acquired by Johnson & Johnson in 2016.
I feel fortunate in my career to have always represented evolutionary, market leading technologies, but HistoSonics was an opportunity to be a part of something completely revolutionary. Leading HistoSonics is a once-in-a-lifetime opportunity to create meaningful and transformative change for both patients and physicians, for a long time. And that’s what it’s all about.
Describe the evolution of the company’s leadership team. How many employees does the company have now?
In the last three years, we have added significant talent, domain expertise, and leadership to what was already a fantastic core team at HistoSonics. We complimented our deep experience in ultrasound and histotripsy by adding team members who had developed complex interventional procedures and robotics platforms and those with backgrounds in interventional oncology. We have grown from 12 employees to almost 40, plus additional strategic partnerships (and a lot more people) around the globe. Many of the key personnel (who have been added to every function of the organization) were my colleagues at either superDimension, acquired by Covidien in 2012, or NeuWave Medical. Others were targeted and recruited based on their specific talent and experience. I feel fortunate to be surrounded by such a talented team and great group of people who share the same passion.
What is your new histotripsy platform called, and what does it do?
Our first robotic system is named Edison. Because we want the patient and physician experience to be personal, we wanted our robot to have a person’s name – a name that people could relate to. We also wanted a name that reflected innovation and advancement and that was relevant and recognizable around the world. So the decision became pretty easy.
Edison is a completely noninvasive, autonomous robotic platform that delivers a novel sonic beam therapy. We call it Robotically Assisted Sonic Therapy, or RAST. It uses the science of histotripsy to destroy unwanted diseased tissue or tumors within the body. Edison has been designed to destroy targeted tissue at a subcellular level without damaging surrounding tissue or critical structures and without many of the common side effects of the other well-known modalities that are used today (e.g., radiofrequency ablation).
What clinical trials are currently underway or have been completed with the robotic platform?
We have recently completed an exciting clinical trial in Barcelona, Spain. This study focused on acute safety and technical success of our first-generation platform in patients who have primary or metastatic liver tumors, and it exceeded our expectations. The principle investigators were Joan Vidal-Jove, MD, PhD, from Mutua Terrassa Hospital, and Xavier Serres, MD, from Vall D’Hebron Hospital, both in Barcelona, and we had significant support from our partners at the University of Wisconsin. We are planning future studies in both the US and Europe.
How has HistoSonics grown in recent years?
HistoSonics was built on a strong scientific and research foundation from the University of Michigan, and we are fortunate for their ongoing partnership and collaboration. In the past three years, we have also added a team from the University of Wisconsin that excels in translational medicine: specifically, Dr. Lee and his team. Preclinical research performed at the University of Wisconsin has provided critical product development capabilities and validation of our noninvasive approach across multiple applications. I’ve also mentioned that our new leadership team has added a wealth of industry experience along with new strategic partners, investors, and board members. Finally, our new corporate offices and manufacturing facility are located in Plymouth, MN.
What is on the horizon for 2020 – any expected milestones?
2020 promises to be another exciting year for HistoSonics. We will continue to work with regulatory bodies on a plan for the clearance of our Edison platform and focus on starting new clinical studies, expanding clinical applications, and continuing to grow our teams in Ann Arbor, Minneapolis, and elsewhere. HistoSonics will be busy in 2020 and beyond.
HistoSonics Raises $54M to Advance Noninvasive Robotics Platform – April 2019
HistoSonics Top “Flyover Tech” at JP Morgan Conference – January 2019
Focused Ultrasound Comes of Age (Blog) - April 2019
FUS Partners Shares Early Success Story - June 2018
HistoSonics Expands Leadership Team, Accelerates Growth - September 2017
HistoSonics Appoints New CEO; Completes First Close of Series B Financing - March 2017
HistoSonics Partners with Ethicon in Tumor Treatment - February 2016
Focused Ultrasound Revolutionizes Prostate Treatment - January 2016
HistoSonics Raises Additional $2.1 Million for Vortx Rx Development - August 2015
Company Profile: HistoSonics - April 2014
Focus Feature: Histotripsy - April 2014
HistoSonics is Michigan's "INNO-VATOR" of the Year - November 2013
HistoSonics Technology Could Be a Game-changer for Treating Prostate Disease – March 2013