C2 Therapeutics today released data from a study of its ColdPlay cryoballoon focal ablation system reporting no adverse events or complications with the device.
The Redwood City, Calif.-based company’s device is designed to treat precursors to esophageal cancer known as Barrett’s esophagus. The Coldplay device uses extreme cold to destroy targeted diseased tissue while minimizing damage to healthy tissue.
“Radiofrequency ablation, the current gold standard treatment for eradicating Barrett’s esophagus, has several limitations including the requirements for cumbersome control units and multiple deployment steps. 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,” study author Dr. Bas Weusten of The Netherlands’ St. Antonius Hospital said in a press release.
Data from the study, an ongoing 26-patient prospective trial evaluating the efficacy of the ColdPlay device in treating patients with flat, dysplastic Barret’s esophagus, reported a median procedure time of 5 minutes and no strictures detected after follow-up endoscopy. Complete eradication of Barrett’s esophagus island was reported 95% of treated areas, the company said..
Residual Barrett’s esophagus was observed during follow-up in 2 patients, C2 Therapeutics said, with one patient having received incomplete ablation and the other experiencing a 50% reduction in BE size post-ablation.
No adverse events were reported, but 27% of patients reported mild pain directly after the procedure and 2 reported mild pain when swallowing at 2-days post procedure.
C2 Therapeutics said it also reported on a study of the feasibility of “endoscopic eradication of early esophageal squamous cell neoplasia” with the Coldplay device, but did not release data from the study.
Last month, C2 Therapeutics said its Coldplay cryoballoon system won CE Mark approval in the European Union. The device will be available for commercial use initially in parts of western Europe, C2 Therapeutics said.
In July, C2 said it won FDA 510(k) clearances for its Coldplay cryoballoon full ablation system and swipe ablation system.
Last October, C2 Therapeutics raised $11.6 million in equity funding, according to a regulatory filing.