Combat Medical Raises £2.6 Million Series A Funding 

Combat Medical has raised £2.6 million in the first close of a Series A financing to advance its hyperthermic intravesical chemotherapy treatment, HIVEC, through phase 3 clinical trials and toward U.S. Food and Drug Administration (FDA) registration. The round was led by T&J Meyer Family Foundation, and included investment from Varia Ventures, NW Angel Fund, and non-institutional family offices and individuals. 

The funding will be used to further fund the ongoing pivotal FDA registration trial, HIVEC HEAT, to investigate the effectiveness of Combat Medical’’s HIVEC treatment of BCG unresponsive non-muscle-invasive bladder cancer (NMIBC). The primary objective is to generate phase 3 clinical data to evidence the company’s patented HIVEC treatment as an effective, safe, and tolerable alternative to the current care standard, which is radical cystectomy. 

“Our installed base of over 350 systems and the completion of over 100,000 HIVEC treatments to date demonstrate efficacy and use as a safe and well-tolerated, bladder-sparing alternative to radical cystectomy in BCG-unresponsive, high-risk NMIBC,” Combat Medical CEO Edward Bruce-White said. “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. We are proud to have our investors on board as we progress through to FDA approval.”

Combat will use future financings to complete FDA registration, grow operations to scale, expanding its existing clinical programs for advanced bladder cancer (HIVEC) and peritoneal cancer (HIPEC), with a focus on U.S. market entry.

Bladder cancer accounts for 213,000 deaths globally each year, with 573,000 new cases diagnosed. NMIBC typically accounts for 75% (430,000 new cases) of all bladder cancer cases at presentation; the five-year global prevalence is estimated at roughly 1.7 million.

Current NMIBC treatment is complete tumor resection with adjuvant BCG intravesical installation recommended to reduce the risk of recurrence and progression in patients with high-risk NMIBC. The standard of care for BCG-unresponsive patients is radical cystectomy. While curative in 80% to 90% of cases if performed before progression to muscle-invasive bladder cancer, surgery is associated with a higher degree of morbidity and mortality, with some patients refusing it on health or quality-of-life grounds.

“Combat Medical is leading the development and clinical use of device-assisted therapies with the 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 progresses through clinical trials,” stated Balint Nemeth, T&J Meyer Family Foundation.

Combat Medical is a medical device company with a patented hyperthermic drug delivery platform technology shown to increase the effectiveness of chemotherapy compared to its delivery at room temperature. The company’s hyperthermic delivery systems continuously deliver routine therapeutics at an optimal temperature, improving therapeutic efficacy, tolerability, and outcomes for patients, as well as providing clinicians with advanced, streamlined, and affordable treatment options.

With more than 100,000 treatments completed in 40-plus 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 more than 40 clinical trials already published and many more underway, Combat continues to drive and support the research in this area. The technology has been used to develop Combat’s first two revenue-generating products- Combat BRS HIVEC and Combat PRS+ HIPEC for treating bladder and peritoneal cancer, respectively.