At Combat Medical, we like to think that we are at the forefront of innovative cancer treatment technologies. Our primary focus is the development and delivery of chemo-hyperthermia therapy through HIVEC® (Hyperthermic Intravesical Chemotherapy). This cutting-edge treatment is explicitly designed to combat non-muscle-invasive bladder cancer (NMIBC) and is delivered using our Combat BRS (Bladder Recirculation System) combined with the chemotherapy drug mitomycin C.
Bladder cancer is one of the world’s most common cancers, with non-muscle-invasive bladder cancer (NMIBC) representing a substantial portion of cases. For patients who fail to respond to Bacillus Calmette-Guérin (BCG) therapy, the standard treatment option is often radical cystectomy, a major surgical procedure involving the removal of the bladder. While effective, this operation can severely impact a patient’s quality of life. Our HIVEC® treatment is designed to offer a safe, effective, and bladder-sparing alternative to these patients, with the aim of reducing the need for radical cystectomy while improving survival rates and minimising side effects.
The HIVEC® Advantage – Combining Heat and Chemotherapy
HIVEC® is a novel approach that combines the power of chemotherapy with the therapeutic benefits of hyperthermia. The treatment works by heating the chemotherapy drug mitomycin C and delivering it directly into the bladder using our Combat BRS technology. The hyperthermic environment enhances the efficacy of mitomycin C by improving drug penetration into the bladder wall and increasing cancer cell sensitivity to the drug. This synergistic approach maximises the cytotoxic effects on cancer cells while minimising harm to surrounding healthy tissues.
By heating the chemotherapy solution to 42°C (107.6°F), HIVEC® offers several key advantages over standard chemotherapy treatments. Hyperthermia improves drug absorption and has been shown to directly kill cancer cells, making the treatment more effective. Furthermore, patients experience fewer systemic side effects since the chemotherapy is confined to the bladder and not spread throughout the body. HIVEC® has proven to be well-tolerated by patients and offers a more comfortable and less invasive option compared to radical surgery.
HIVEC®-HEAT Trial – A New Partnership for Groundbreaking Research
To further validate the potential of HIVEC® as an alternative to radical cystectomy, we are excited to announce our partnership with the University of Leicester for a groundbreaking phase 3 clinical trial: HIVEC®-HEAT (HIVEC® for Patients with BCG-unresponsive Non-muscle-invasive Bladder Cancer). This multi-centre, single-arm interventional trial will take place across 25 NHS hospitals in the UK and aims to recruit 238 patients who are unresponsive to BCG therapy. The trial is set to begin recruitment this month, with a two-year recruitment period followed by a two-year follow-up.
The HIVEC®-HEAT trial represents a critical step forward in evaluating HIVEC® as a bladder-sparing treatment option for patients who would otherwise face radical cystectomy. The trial is designed to assess the efficacy, safety, and overall quality-of-life impact of HIVEC® in this high-risk patient population. As a result, we are hopeful that this trial will further solidify HIVEC®’s role as a superior treatment option for NMIBC, reducing the need for radical surgery and significantly improving patient outcomes.
Proven Efficacy and Cost-Effectiveness
HIVEC® is not just a promising treatment on paper; its real-world application has already demonstrated significant benefits in both prospective and retrospective studies. Over 100,000 treatments have been completed worldwide across more than 40 countries, and clinical evidence continues to grow in support of HIVEC®’s efficacy. For patients with BCG-unresponsive high-risk NMIBC, HIVEC® offers a bladder-sparing alternative that has been shown to be both safe and highly effective.
In addition to its clinical benefits, recent analyses have demonstrated that HIVEC® is a cost-effective treatment option, especially when compared to other alternatives such as pembrolizumab, an FDA-approved immunotherapy. HIVEC® has shown greater efficacy at a fraction of the cost, making it a financially viable option for healthcare systems globally.
A Game-Changer for Bladder Cancer Treatment
At Combat Medical, we believe that HIVEC® is poised to revolutionise the treatment of bladder cancer. Our technology has the potential to significantly reduce the need for invasive surgeries and improve the quality of life for patients who would otherwise face radical cystectomy. The success of our ongoing and upcoming trials will play a critical role in solidifying HIVEC® as the go-to treatment for BCG-unresponsive NMIBC.
With more than 100,000 treatments already performed, we are confident that HIVEC® will become a game-changer in bladder cancer treatment, delivering improved patient outcomes while lowering the cost burden on healthcare systems.
As we continue to advance research, such as through the HIVEC®-HEAT trial in partnership with the University of Leicester, we are committed to ensuring that HIVEC® reaches its full potential as a revolutionary cancer therapy. We would love to see a future where bladder cancer patients have access to innovative, less invasive, and more effective treatment options, ultimately improving their chances of survival and enhancing their quality of life.
