Bimodal Electric Tissue Ablation: First-in-Person Clinical Study

Colorectal cancer is the second most common cause of cancer-related deaths in Europe and North America, after lung cancer (Jemal et al., 2007). In the UK, approximately 34,500 new cases of colorectal cancer and 16,200 deaths were registered in 2001 (Cancer Research UK, 2005). This equates to 1 death in the UK from colorectal cancer every 32 minutes.

About 70% of patients with colorectal cancer develop secondary malignant growths in the liver, known as colorectal liver metastasis (CLM; Rothbarth et al., 2005). Overall life expectancy is mainly determined by progression of CLM, rather than the primary cancer (Paschos and Bird, 2008). Without treatment, life expectancy with CLM is less than 1 year (McMillan et al., 2007).

Surgery to remove the entire metastasis is the only current hope of cure in CLM. Yet, 80% of patients with CLM are not suitable for surgery (NCCN guidelines, 2016), either because of the tumour's location (close to major blood vessels or bile ducts), or because the patient has limited liver function, or is considered high surgical risk (e.g., because of their age).

Thermal ablation is a promising CLM treatment, which relies on localised heating to destroy tumour cells. Most commonly, the heat is generated by radiofrequency alternating current (AC). However, radiofrequency ablation is only suitable for CLM with ? 5 lesions and tumour sizes < 3 cm in size (Crocetti et al., 2010). It is challenging to limit tissue heating and avoid charring and vaporisation (Guenette and Dupuy, 2010).

Ablatus was founded in 2015 and is the first spin-out from Norfolk and Norwich Hospital. Our novel technology, known as Bimodal Electric Tissue Ablation or BETA, was invented by Dr John Cockburn and Dr Simon Wemyss-Holden (Cockburn et al., 2007) and is now wholly owned by Ablatus. BETA is a disruptive and game-changing innovation that goes significantly beyond current state-of-the-art ablation techniques. We combine AC radiofrequency ablation with direct current (DC). DC induces water flow from surrounding tissues to the ablation site, protecting the tissues from desiccation, enabling much larger tumours to be treated, as well as potentially enabling ablation of previously untreatable tumours, with fewer adverse patient impacts, at a lower cost to the NHS.

This project builds on the successful delivery of Ablatus' previous Innovate UK project with eg technology (103351) and will support further collaborative prototype development between Ablatus and eg technology, culminating with first-in-person trials of our device with Addenbrooke's Hospital.