C2 Therapeutics said today its Coldplay cryoballoon focal ablation system won CE Mark approval in the European Union.
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.
“C2’s Coldplay CryoBalloon technology blends the precision and controlled depth of radiofrequency ablation with the inherent benefits of cryotherapy, which until recently was lacking in control and visibility during therapy delivery. Coldplay’s unique characteristics include its contained cryotherapy diffuser – housed inside a self-sizing balloon – and an ability to direct cryoablation to targeted tissue in various zones. The CryoBalloon offers a solution that has the potential to address unmet medical needs in treating early Barrett’s neoplasia,” co-principal investigator Dr. Jacques Bergman of Amsterdam’s Academic Medical Center said in a press release.
Barrett’s Esophagus develops due to injuries from gastroesophageal reflux disease which wares down the esophageal lining, leaving previously healthy cells replaced by abnormal cells that are more vulnerable to cancer, C2 Therapeutics said.
“Gaining the CE Mark for the Coldplay System is an important milestone for C2 Therapeutics and sets the stage for the next phase of our corporate evolution as we develop new products to treat patients with Barrett’s Esophagus and other conditions that can be targeted with our novel cryoablation technology. CryoBalloon Focal offers several advantages over currently available options including reduced treatment duration, decreased post-procedure pain and broad utility in patients who may not be suitable candidates for radiofrequency ablation,” CEO Peter Garcia-Meza said in prepared remarks.
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.