Non-Invasive Oncology Takes Center Stage at Sonire Therapeutics

As the global oncology landscape shifts toward precision, minimally invasive care, innovative technologies such as high-intensity focused ultrasound (HIFU) are gaining renewed attention. At the forefront of this evolution is Sonire Therapeutics, which is developing next-generation, image-guided ultrasound solutions aimed at addressing some of the most challenging solid tumours, including pancreatic cancer. By integrating real-time visualisation with enhanced energy delivery, the company is seeking to overcome long-standing limitations of conventional HIFU systems and expand the role of non-invasive therapies in clinical practice.

In this interview with MedTech Spectrum, Tohru Satoh discusses the technological innovations underpinning Sonire’s platform, the strategic direction following its recent Series A funding, and the potential of combining non-invasive ultrasound therapy with existing treatment modalities such as chemotherapy. He also shares insights into ongoing clinical programs, including the SUNRISE trials, and outlines how outpatient, anaesthesia-free procedures could improve both patient quality of life and healthcare system efficiency.

Technological Innovation: What were the key technological challenges you aimed to solve compared to conventional HIFU systems, and how does your solution improve clinical outcomes?

One of the key challenges we aimed to address compared to conventional HIFU systems was the limited ability to visualise the actual treatment area in real time. By leveraging cavitation bubbles, our technology enables real-time visualisation of the treatment zone, which has traditionally been difficult with conventional HIFU. This allows clinicians to confirm where the energy is being delivered during sonication, contributing to improved safety. In addition, cavitation enhances localised heating efficiency within the targeted area. This increases the volume of ablation achieved within a few seconds of sonication, enabling shorter and more efficient treatment procedures.

The pancreas is an anatomically complex organ surrounded by critical blood vessels and adjacent structures, which has historically limited the application of local therapies. Through these technological innovations, we are developing a system that enables safe and effective local treatment of pancreatic cancer without the need for general anaesthesia. As a result, we believe our approach can improve tumour control while reducing patient burden, ultimately helping to preserve quality of life through a minimally invasive treatment option.

Funding and Strategy: With the recent Series A funding, what are your immediate priorities regarding clinical development and your global commercialisation strategy?

Our immediate priority is to advance our clinical programs in both Japan and the U.S., with a particular focus on executing the SUNRISE-II feasibility study in the U.S. and completing follow-up for the SUNRISE-I randomised controlled trial conducted in Japan. We will be issuing press releases on both of these soon, and can send you an advanced look!

At the same time, we are strengthening our U.S. presence to support clinical development and prepare for future commercialisation. While our primary focus remains on generating robust clinical evidence, we are also exploring strategic partnerships as one of several options to ensure we can bring this therapy to patients as quickly and broadly as possible.

Clinical Impact: How does Sonire’s non-invasive approach complement existing therapies like chemotherapy, and what impact do you expect it to have on pancreatic cancer patient survival and quality of life?

Our non-invasive ultrasound therapy is not intended to compete with chemotherapy, but rather to complement it. While chemotherapy acts systemically, our approach enables the selective delivery of energy to the tumour site, which may contribute to improved local tumour control. Pancreatic tumours are known to have a dense stromal environment that can limit drug penetration, and our localised approach may also help improve drug delivery to the tumour. By combining systemic and local therapies, we believe this approach has the potential not only to suppress tumour progression but also to help alleviate symptoms and improve treatment continuity.

In addition, as our therapy is a minimally invasive approach that does not require general anaesthesia, it can be performed with reduced physical burden on patients. As a result, it is expected to help maintain or improve patients’ quality of life. The impact on overall survival is currently being evaluated through ongoing clinical studies; however, we believe that combining our approach with existing therapies has the potential to lead to improved treatment outcomes.

SUNRISE-I Trial: Could you share insights from the ongoing SUNRISE-I study and define what success looks like in terms of clinical endpoints?

SUNRISE-I is a randomised controlled trial conducted in Japan in patients with unresectable pancreatic cancer, designed to evaluate the clinical significance of combining our HIFU therapy with chemotherapy. The trial is ongoing and so we are not in a position to share detailed results at this time. However, our goal is to better understand the clinical value of integrating local therapy with existing systemic treatments.

In terms of clinical endpoints, OS is the primary endpoint, while PFS and safety are also key measures. To date, we have not observed any major safety concerns, although the study is still in progress. We also consider the impact on quality of life, including pain relief, to be an important aspect of evaluation. For us, success means first demonstrating that the therapy can be delivered safely, and ultimately showing clinically meaningful benefits for patients.

Operational Efficiency: Your system emphasises outpatient treatment without the need for anaesthesia. How do these features translate into cost efficiencies for healthcare providers?

Our system is designed for outpatient treatment without the need for anaesthesia, allowing it to be performed in a more flexible clinical setting without reliance on specialised facilities. In addition, as the procedure can be conducted by a single physician and does not require the preparation and recovery time associated with anaesthesia, it may help improve overall facility utilisation. These features are expected to contribute to more efficient use of clinical resources and may offer advantages from an investment and return perspective for healthcare providers.

Future Vision: How do you see the role of non-invasive, image-guided therapies evolving in oncology, and what is Sonire’s long-term vision for the standard of cancer care?

We believe that non-invasive, image-guided therapies, which enable treatment of tumors from outside the body, will play an increasingly important role in oncology. While cancer treatment has traditionally been centred on surgery, drug therapy, and radiation, we expect a growing need for approaches that complement these modalities by enabling non-invasive, precise treatment of tumours with real-time visualisation. In particular, the ability to perform treatment in real time under imaging guidance has important implications not only for improving safety but also for enhancing reproducibility and expanding clinical applicability.

Sonire’s long-term vision is to establish such non-invasive, image-guided therapies not as niche or specialised options, but ultimately as part of the standard of care in oncology. Rather than replacing existing treatments, we aim to complement them and deliver new therapeutic opportunities to as many patients as possible, as quickly as possible.