Combat Medical Advances HIVEC HEAT Trial for BCG-Unresponsive Bladder Cancer with £2.6 Million Series A Funding
Key Insights
Combat Medical (search) raised £2.6 million in Series A funding led by T&J Meyer Family Foundation (search) to advance its HIVEC (search) HEAT FDA registration trial for BCG-unresponsive bladder cancer (search) treatment.
The ongoing phase 3 trial across 25 UK sites aims to enroll 238 patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (search) using hyperthermic mitomycin C chemotherapy.
Early data shows HIVEC (search) treatment achieved up to 83% disease-free survival after one year and nearly 80% bladder preservation rate after two years.
Combat Medical (search) has secured £2.6 million in Series A funding to advance its pivotal HIVEC (search) HEAT trial, a phase 3 study investigating hyperthermic intravesical chemotherapy as an alternative to radical cystectomy for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (search) (NMIBC). The funding round was led by T&J Meyer Family Foundation (search), with participation from Varia Ventures (search), NW Angel Fund (search), and non-institutional investors.
The medical device company presented an update on the HIVEC (search) HEAT trial at the American Urological Association Annual Meeting, highlighting the study's potential to expand bladder-preserving treatment options for cancer patients. Professor Leyshon Griffiths, the trial's Chief Investigator, outlined the study design and recruitment process for the FDA registration trial.
Trial Design and Patient Population
The HIVEC (search) HEAT trial is a phase 3, single-arm study being conducted across 25 sites in the UK, designed to enroll 238 patients with BCG-unresponsive, high-risk NMIBC. This patient population faces limited treatment options, with radical cystectomy remaining the standard treatment approach despite its life-changing implications.
The trial investigates the efficacy of hyperthermic intravesical 80 mg mitomycin C chemotherapy delivered through Combat's bladder recirculation system (BRS). Patients receiving HIVEC (search) treatment receive mitomycin C precisely heated to 43°C and administered over 60 minutes. The 80 mg dose level, at which penetration was shown to saturate in preclinical studies, is recirculated at a concentration of 1 mg/mL over a 48-week treatment period.
Clinical Outcomes and Safety Profile
Early data from the HIVEC (search) treatment program demonstrates promising clinical outcomes. BCG-unresponsive patients receiving HIVEC treatment delivered by the Combat BRS showed up to 83% disease-free survival after one year post-treatment, with a bladder preservation rate of almost 80% after two years.
The treatment has also demonstrated better tolerability and safety compared to alternative therapies in development, while offering a considerably lower treatment cost. Combat's installed base of over 350 systems has completed over 100,000 HIVEC (search) treatments to date, demonstrating efficacy and use as a safe and well-tolerated, bladder-sparing alternative to radical cystectomy.
Technology Platform and Market Impact
Combat's BRS was developed using the company's patented hyperthermic platform technology, which delivers chemotherapy at precisely controlled temperatures with the aim of increasing anti-tumor activity while offering an alternative bladder-preserving treatment approach. The technology provides an improved quality of life for patients compared to radical surgery.
Edward Bruce-White, Chief Executive Officer of Combat Medical (search), emphasized the significance of the advancement: "Our installed base of over 350 systems and the completion of over 100,000 HIVEC (search) treatments to date demonstrates efficacy and use as a safe and well-tolerated, bladder-sparing alternative to radical cystectomy in BCG-unresponsive, high-risk NMIBC. Setting a new standard for patient care, it also provides clinicians and payers with advanced, affordable options that can easily be built into current treatment pathways."
Future Development Plans
The Series A funding will support the ongoing pivotal FDA registration trial, with Combat planning to use future financings to complete FDA registration and scale operations. The company aims to expand its existing clinical programs for advanced bladder cancer (search) (HIVEC (search)) and peritoneal cancer (HIPEC), with a focus on US market entry.
Balint Nemeth from T&J Meyer Family Foundation (search) noted: "Combat Medical (search) is leading the development and clinical use of device assisted therapies with potential to disrupt current treatment standards. With systems in wide clinical use and already impacting patient outcomes, we are excited to support the company as HIVEC (search) progresses through clinical trials."
The HIVEC (search) HEAT trial represents a significant step toward providing bladder cancer (search) patients with an alternative to radical surgery, addressing a critical unmet need in a patient population where treatment choices remain limited despite early disease detection.