Endoscopic tissue ablation specialist C2 Therapeutics is touting results from four separate clinical studies which it says support the safety and efficacy of the company’s CryoBalloon™ Focal Ablation System (CbFAS). The data were presented at Digestive Disease Week (DDW) 2016, which has been taking place this week in San Diego.
C2 Therapeutics is a privately held company whose Coldplay Systems claim a new standard for simplicity in the endoscopic ablation of Barrett’s Esophagus. The technology comprises a through-the-scope, highly compliant balloon catheter that is simultaneously inflated and cooled by an inert cryogen delivered through a small disposable handheld unit. Operation is intuitive, fast and cost-effective. Furthermore the C2 system eliminates the need for precise sizing, multiple deployment steps, and controller units.
So what of the newly presented studies? In brief, one concludes the system represents a promising, safe and potentially effective endoscopic intervention for BE-associated neoplasia, one describes complete pathologic response in all five evaluable patients, one describes results from a single center case-series and says complete eradication was observed in 100 percent of BE islands that had been completely ablated during CbFAS treatment. And in the final paper investigators concluded that the use of cryoablation was feasible and safe for patients with mostly treatment resistant esophageal neoplasia, concluding that further study is required to determine how to optimize treatment response and efficacy in both treatment resistant and naive patients.
“The C2 CryoBalloon Focal Ablation System offers physicians and patients an innovative approach to removing pre-cancerous and diseased tissue with potentially fewer side effects than conventional surgical or endoscopic procedures,” said Peter Garcia-Meza, President and CEO of C2 Therapeutics. “The data presented this year at DDW provide additional support for the safety, efficacy, and clinical utility of the CryoBalloon System. Early interventions that effectively eradicate pre-cancerous or malignant cells are essential to preventing disease progression in these indications and C2 Therapeutics is committed to developing novel interventions that improve patient outcomes.”
Source: Business Wire