Growing data points towards use of HIVEC® in high-risk and BCG-unresponsive patients following publication of HIVEC® bladder cancer RCT results


Press release, 22 August 2022

Combat Medical is pleased to announce the results of the HIVEC® II trial, published in European Urology on 20 August 20221. It is one in a series of recent HIVEC® publications helping chemo-hyperthermia to find its place in the treatment of bladder cancer.

Combat Medical CEO Edward Bruce-White said, “While we are disappointed that HIVEC® shows only non-inferiority to cold chemotherapy in this intermediate-risk group trial, other recent HIVEC® publications have shown promising results in high risk2 and BCG-unresponsive patients3,4. Upcoming publications and trials in these groups are giving urologists more treatment options, especially in times of BCG shortage.

“Of course we would have liked a more positive result but accept that sometimes to progress you have first to understand what doesn’t work. Initial results from another phase III RCT in Spain, in a similar group of patients, show that HIVEC® maintenance therapy improves outcomes.

“Combat has published and will continue to publish positive evidence in higher-risk groups, supported by phase II and real-world series data. Combat continues to support high-quality clinical trials to establish HIVEC® treatment and is shortly launching several new trials.

“We see a great future for HIVEC® in the treatment of high-risk and BCG-unresponsive patients.

“We would also like to thank Wei Shen Tan, Professor Kelly and all of the contributors for their hard work.”


For further information, please contact:

Guy Cooper,
Sales and Marketing Director, Combat Medical

Notes for editors


  1. Wei Shen Tan et al. Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non–muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial, European Urology, 2022
  2. Felix Guerrero-Ramos et al. Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer: results of the HIVEC-HR randomized clinical trial, World Journal of Urology, January 2022
  3. Andrew Stemberger et al. MP54-15 A multicenter study of 2-year outcomes following hyperthermia therapy with mitomycin C in treating BCG unresponsive non-muscle invasive bladder cancer: recirculant hyperthermic intravesical chemotherapy, The Journal of Urology, May 2022
  4. Olga M Pijpers et al. Long-term efficacy of hyperthermic intravesical chemotherapy for BCG-unresponsive non-muscle invasive bladder cancer, Urologic Oncology: Seminars and Original Investigations, February 2022

About Combat Medical

Combat Medical Ltd is a UK-based medical-device company with a platform technology for heating and circulating chemotherapy for bladder cancer and cancers of the abdomen and peritoneum.

With over 65,000 treatments done in 35+ countries, Combat leads the global development and clinical use of device-assisted therapies to treat many common cancers, including bladder cancer, colorectal cancer, ovarian cancer and pancreatic cancer. With 20+ clinical trials already published and many more underway, Combat continues to drive and support the research in this area.

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