Combat Medical Highlights Patient Impact of HIVEC HEAT Trial at AUA 2026

Combat Medical has presented new updates from its ongoing HIVEC® HEAT FDA registration trial at the annual meeting of the American Urological Association (AUA), highlighting the potential of its hyperthermic intravesical chemotherapy technology to expand bladder-preserving treatment options for patients with high-risk non-muscle invasive bladder cancer (NMIBC).

The MHRA-approved phase 3 trial is currently recruiting across 25 clinical sites in the UK and is designed to support FDA registration of Combat Medical’s HIVEC treatment platform in the United States.

Professor Leyshon Griffiths, Chief Investigator of the HIVEC HEAT trial, shared details of the study’s design and recruitment progress during a presentation at the meeting, underscoring the urgent need for alternatives to radical cystectomy among patients with Bacillus Calmette-Guérin (BCG)-unresponsive disease.

For patients with BCG-unresponsive, high-risk NMIBC, removal of the bladder remains the current standard of care. Combat Medical’s bladder recirculation system (BRS) seeks to offer a bladder-sparing alternative by delivering chemotherapy at precisely controlled hyperthermic temperatures, with the goal of enhancing anti-tumour activity while preserving patient quality of life.

The ongoing HIVEC HEAT study is evaluating the efficacy of hyperthermic intravesical delivery of 80mg mitomycin C in patients with BCG-unresponsive, high-risk NMIBC. The single-arm phase 3 trial plans to enrol 238 patients over a 48-week treatment period.

Patients enrolled in the study receive mitomycin C heated to 43°C and administered over 60 minutes using Combat Medical’s patented recirculation platform. According to the company, the selected 80mg dose demonstrated saturation of tissue penetration in preclinical studies.

Combat Medical also highlighted previously reported clinical outcomes showing that patients treated with HIVEC achieved disease-free survival rates of up to 83% one year after treatment, alongside bladder preservation rates approaching 80% after two years. The company noted that the therapy has also demonstrated favourable tolerability and safety compared with alternative investigational therapies, while potentially offering a lower-cost treatment option.

“Bladder cancer is one of the most common cancers worldwide and treatment for both men and women remains challenging even when the disease is detected early,” said Edward Bruce-White, Chief Executive Officer of Combat Medical.

Non-muscle invasive bladder cancer accounts for the majority of newly diagnosed bladder cancer cases, but recurrence rates remain high, particularly among patients who no longer respond to BCG therapy. New bladder-preserving approaches are therefore considered a significant unmet clinical need.

The HIVEC HEAT trial forms part of Combat Medical’s broader strategy to establish hyperthermic intravesical chemotherapy as a viable and scalable alternative to more invasive surgical interventions in bladder cancer care.