C2 Therapeutics’ Focal Ablation System Performs Well in Recent Studies

Redwood City, Calif.-based C2 Therapeutics Inc.’s its Coldplay Cryoballoon focal ablation system made a good showing in two recent efficacy and safety studies presented at United European Gastroenterology Week, held in Barcelona, Spain from Oct. 24-28.

The first study was an oral presentation of an ongoing multicenter prospective trial evaluating the efficacy and performance of the Coldplay Cryoballoon in treating patients with flat, dysplastic Barrett’s esophagus (BE). Barrett’s esophagus develops as a result of chronic injury from gastroesophageal reflux disease. Over time, the normal esophageal lining is replaced with abnormal cells, putting patients at greater risk of developing cancer of the esophagus.

A total of 37 ablations were performed in 26 patients with a median cryoablation procedure time of 5 minutes. Follow-up endoscopy with biopsy was performed in 24 of 26 patients with no strictures detected. Complete eradication of BE islands was observed in 35 of 37 (95 percent) of treated areas. In two patients, residual BE was observed during follow-up. Of these, one patient received incomplete ablation at the time of the procedure and another experienced residual BE (50 percent of original size) after initial, endoscopically complete ablation of the island. No adverse events occurred during ablation. Seven patients (27 percent) reported mild pain directly after the procedure and two patients reported mild pain during swallowing at two days post-procedure.

“Radiofrequency ablation (RFA), the current gold standard treatment for eradicating Barrett’s esophagus, has several limitations including the requirements for cumbersome control units and multiple deployment steps,” said Bas Weusten, M.D., Ph.D., professor of innovative gastrointestinal endoscopy, St. Antonius Hospital – Gastroenterology and Hepatology, The Netherlands, and presenting study author. “These data demonstrate that treatment of Barrett’s esophagus using C2 Therapeutics’ Cryoballoon focal ablation system is an attractive and effective solution enabling a short and convenient 10-second treatment time.”

A second study presented at the conference evaluated the feasibility of endoscopic eradication of early esophageal squamous cell neoplasia (ESCN) with the Coldplay Cryoballoon focal ablation system.

C2 Therapeutics makes technology to improve treatment of precursors to esophageal cancer.