Sonire Therapeutics is developing an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system designed to non-invasively treat tumors from outside the body, with pancreatic cancer as its initial target indication. Founder and CEO Tohru Satoh has a background spanning oncology, global business development, medical technology innovation, and international commercialization. Pulse 2.0 interviewed Sonire Therapeutics Founder and CEO Tohru Satoh to learn more about the company’s technology, clinical development, and plans for global expansion.
Tohru Satoh’s Background
When asked about his background, Satoh shared:
I am the Founder and CEO of Sonire Therapeutics, where I focus on advancing non-invasive treatment options for patients with serious and difficult-to-treat conditions.
My background is rooted in oncology, global business development, and medical technology innovation, with a focus on translating innovative medical technologies into practical, commercially viable solutions that can reach patients globally.
Prior to founding Sonire, I worked at Ono Pharmaceutical, where I was part of the global strategy team driving the international expansion of Opdivo.
In that role, I was involved in global collaboration with Bristol Myers Squibb, as well as the establishment of Ono’s Korea and Taiwan subsidiaries for the launch and commercialization of Opdivo in those markets.
I later served as the head of the Taiwan affiliate. These experiences gave me firsthand exposure to global healthcare systems, regulatory environments, and international commercialization strategies.
I later served as Head of Business Planning at Oncolys BioPharma, a clinical-stage oncology biotech company, where I worked on the development and business strategy of novel cancer therapies, including oncolytic virus technologies.
I also served on the board of Liquid Biotech, a University of Pennsylvania-originated biotech company backed by Oncolys, which further expanded my experience in cross-border biotech collaboration, company building, and innovation.
Through these experiences, I developed a strong appreciation for the significant unmet needs in oncology and the importance of translating breakthrough science into meaningful value for patients through effective business execution, regulatory strategy, and global development.
How Sonire Therapeutics Started
When asked how the idea for the company came together, Satoh explained:
Sonire Therapeutics was founded by bringing together foundational high-intensity focused ultrasound (HIFU) technologies developed at Tohoku University and Tokyo Women’s Medical University, along with the clinical expertise built through pancreatic cancer HIFU treatment research at Tokyo Medical University.
For many years, these groups had independently advanced both the technological and clinical aspects of focused ultrasound therapy.
Around 2014, those efforts began to come together, significantly accelerating the development of next-generation ultrasound-guided HIFU technologies and their potential clinical application.
At the same time, there was a growing recognition of the substantial unmet medical need in pancreatic cancer, which remains one of the deadliest cancers with very limited treatment options.
We believed that HIFU had the potential to become a meaningful non-invasive treatment approach for these patients.
Sonire was ultimately established in 2020 to bring these technologies out of academia and into real-world clinical practice.
Today, I lead the company’s strategy across clinical development, regulatory planning, partnerships, and fundraising, while keeping our focus on delivering meaningful innovation for patients.
Favorite Memory
When asked about his favorite memory working for the company so far, Satoh said:
One of the most meaningful experiences has been seeing the company reach several major milestones over the past few years, including the first patient enrollment in our SUNRISE-I study in Japan in 2023, receiving FDA Breakthrough Device Designation in 2024, and the first patient treatment in our SUNRISE-II study in the United States in 2026.
Another particularly important milestone was completing our Series A financing led by Santé Ventures, which significantly strengthened our ability to advance global clinical development.
These moments reinforce why we are doing this work, because behind every step and every milestone there is the potential to meaningfully improve outcomes for patients facing very difficult cancers.
Core Products And Features
When asked about Sonire Therapeutics’ core products and features, Satoh detailed:
Our core focus is the development of an ultrasound-guided high-intensity focused ultrasound therapy system.
This treatment approach is designed to non-invasively treat tumors from outside the body without the need for surgical procedures involving skin incisions or organ removal, with the goal of reducing the burden on patients and potentially improving their quality of life.
We are currently developing the platform with pancreatic cancer as the initial target indication.
One of the key features of our technology is the use of an ultrasound-guided approach.
By utilizing cavitation bubbles generated during HIFU exposure, we are able to visualize the treatment area in real time while delivering therapy.
In addition, we use cavitation bubbles to improve heating efficiency, with the aim of enabling shorter treatment times compared with conventional approaches.
Furthermore, we are focused not only on technological innovation, but also on creating a treatment system that can be used practically in real clinical settings.
Our approach is designed to potentially avoid the need for general anesthesia and simplify procedural workflow, allowing treatment to be performed with fewer medical staff and in a broader range of healthcare settings.
Advancing A Japan-Originated Technology Globally
When asked about recent challenges in the sector and how Sonire Therapeutics has addressed them, Satoh explained:
One of the major challenges for us has been advancing a novel Japan-originated medical technology into global clinical development, particularly in the United States.
This required not only strong technical and clinical progress, but also building credibility with physicians, regulators, and investors in a highly competitive oncology environment.
From an early stage, we pursued U.S. expansion by obtaining FDA Breakthrough Device Designation and advancing clinical development in collaboration with Stanford University.
At the same time, we have continuously worked to build relationships within the U.S. healthcare and investment ecosystem.
Our recent Series A financing led by Santé Ventures was an important milestone that we believe will further accelerate these efforts.
We are now continuing to strengthen our U.S. clinical development and organizational capabilities as we advance toward global expansion.
How The Technology Has Evolved
When asked how Sonire Therapeutics’ technology has evolved since launching, Satoh said:
Since inception, we have refined our HIFU technology to improve precision, safety, and usability in clinical settings.
This has included advancements in targeting accuracy, system design, and workflow optimization.
Our technology evolution has also been guided by ongoing feedback from clinicians, with a strong focus on developing a platform that can be used effectively and scaled in real-world clinical practice.
Key Company Milestones
When asked about some of Sonire Therapeutics’ most significant milestones, Satoh highlighted:
Some of our key milestones include the successful closing of our $18 million Series A financing round, advancing our HIFU therapy into U.S. clinical development, and expanding our presence and partnerships in key markets, with each of these milestones reflecting progress toward our goal of bringing this therapy to patients who need new treatment options.
Clinical Development
When asked whether he could share specific customer or patient success stories, Satoh said:
As we are currently in the clinical development stage, our focus is on generating robust clinical data, and while we are encouraged by early results and clinical interest, we are not yet in a position to share detailed patient case studies publicly.
Funding
When asked about funding and revenue metrics, Satoh revealed:
We recently announced the successful close of an $18 million Series A financing round.
The funding will support the advancement of our clinical programs, continued development of our HIFU platform, and the expansion of our operational and development capabilities in the United States.
As a clinical-stage medical device company, we are currently focused on technology development and the generation of clinical evidence supporting the safety and effectiveness of our platform.
Total Addressable Market
When asked about the total addressable market Sonire Therapeutics is pursuing, Satoh explained:
Pancreatic cancer is now the third leading cause of cancer death in the United States. According to the American Cancer Society, about 67,500 Americans will be diagnosed with the disease in 2026, and about 52,700 will die from it. The five-year survival rate remains only 13%. While I won’t quantify a specific TAM figure here, we see a meaningful opportunity given the limited treatment options currently available and the potential applicability of our technology.
Competitive Differentiation
When asked what differentiates Sonire Therapeutics from its competition, Satoh said:
Our differentiation comes from both our technology and the area we are focused on.
We are developing a non-invasive HIFU-based therapy for pancreatic cancer, a field where major technological innovation and treatment options have historically been limited.
One of our key characteristics is our strong emphasis on building clinical evidence while positioning the therapy to be used in combination with existing standard treatments.
In addition, we place significant importance on practical usability in real clinical settings.
Our approach is designed to potentially avoid the need for general anesthesia, support outpatient treatment, and enable workflows that can be managed by a relatively small number of medical staff.
We believe these features are also important differentiators that may support broader adoption across healthcare settings.
Future Goals
When discussing Sonire Therapeutics’ future goals, Satoh explained:
Right now, we are focused on steadily advancing our clinical trials in both Japan and the United States, further refining the technology, and building strong clinical evidence.
Over the longer term, we aim to expand into additional indications and new markets to make this treatment accessible to more patients.
Ultimately, our goal is to deliver better treatment options to as many patients as possible, as quickly as possible.
Translating Academic Innovation Into Clinical Practice
When invited to discuss another topic, Satoh concluded:
One topic I would emphasize is the importance of translating innovative academic technologies into real-world clinical practice.
Sonire was founded by bringing together technologies and clinical expertise developed across leading medical research universities in Japan, including pancreatic cancer treatment research conducted at Tokyo Medical University.
There is still significant room for innovation in pancreatic cancer, where treatment options remain limited and clinical outcomes continue to lag behind many other areas of oncology.
Additionally, our company name, “Sonire,” is derived from a combination of the words “Sonics” and “Future.”
It reflects our hope of bringing a new future to patients and their families through ultrasound technology.
We hope technologies such as ultrasound-guided HIFU can become an important part of future multimodality cancer treatment strategies.
