HERON Receives TFDA Approval for BNCT Treatment Planning System

Source: Economic Daily News (Taiwan)

   HERON Advances Neutron Irradiation System

TFDA Approval Now Covers BNCT Treatment Planning System, Completing the Precision Medicine Ecosystem

 

HERON Neutron Medical Corp. announced on the 26th that its core product, the Neutron Irradiation System, has officially received regulatory approval from Taiwan Food and Drug Administration (TFDA). The approval has now been expanded to include the critical Treatment Planning System (TPS), marking a major milestone in the clinical advancement of Boron Neutron Capture Therapy (BNCT). This achievement transforms BNCT from a traditionally costly and time-intensive experimental therapy into a more precise, efficient, and clinically accessible cancer treatment solution. HERON highlighted three key innovations of its newly approved TPS: 1. 3D Navigation for Precision Targeting The system reconstructs a 3D model based on CT imaging, enabling accurate dose distribution calculations and optimized irradiation parameters—including beam entry position, angle, and duration. This acts as a “3D navigation system” for clinicians, maximizing tumor targeting while protecting healthy tissues. 2. Breakthrough Computing Speed: Hours to Minutes Traditional BNCT planning relies on general-purpose Monte Carlo method software, often requiring hours per treatment field. HERON has developed a dedicated BNCT Monte Carlo engine, capable of completing calculations within minutes using standard multi-core computers—significantly reducing patient waiting time. 3. Enhanced Clinical Flexibility and Treatment Quality High-performance computation enables clinicians to evaluate multiple treatment scenarios within limited timeframes. This improves responsiveness in dynamic clinical situations and enhances overall treatment quality. HERON noted that conventional BNCT systems depend on nuclear reactors, posing logistical challenges. Since its founding, the company has focused on developing Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT), successfully miniaturizing the system for installation in hospitals. This advancement accelerates the localization and accessibility of next-generation radiotherapy. In recent years, HERON has achieved several milestones in AB-BNCT development. While BNCT has traditionally been used for refractory head and neck cancers, HERON is now expanding clinical research into thoracic tumors, sarcomas, and rare brain tumors through collaborations with leading medical centers. To date, the company has accumulated over 200 clinical and compassionate-use treatment cases, establishing standardized clinical workflows and building a strong foundation for expanding indications.
HERON is also among the few companies globally capable of developing a fully integrated BNCT ecosystem, including: 

• Hardware systems
• Core treatment planning software
• Boron-based therapeutics 

In parallel with device optimization, HERON is advancing the development of boron-containing drugs such as B10-LBPA and diagnostic radiopharmaceutical F18-FBPA, strengthening its end-to-end BNCT capabilities. The company’s innovation has gained international recognition. Recently, HERON partnered with institutions including the National University Hospital to establish Southeast Asia’s first AB-BNCT R&D center, reinforcing Taiwan’s leadership in precision oncology across the Asia-Pacific region. The inclusion of the Treatment Planning System in TFDA approval represents not only a major breakthrough in BNCT clinical application and computational performance, but also signifies that HERON has completed a critical component of its integrated AB-BNCT solution. Moving forward, HERON will continue to leverage Taiwan as its innovation hub while expanding into global markets.