Therapy Areas: Devices
CryoConcepts awarded US FDA market clearance for two cryosurgical devices
9 May 2019 -

Cryosurgical products company CryoConcepts LP revealed on Wednesday the receipt of the US FDA's clearance for two new, patent pending, cryosurgical devices, CryoTouch and CryoLab, for the physician's office market.

CryoTouch is a portable cryosurgical device that delivers cryogen to lesion sites and can use either applicators or cones based on the physician's preference.

CryoLab is a benchtop unit that delivers cryogen for medical practices that perform a high volume of cryosurgery.

The new platforms have been cleared to treat up to 23 different indications, CryoConcepts said.

Following the US FDA's marketing approval, the company plans aggressive introductions into a variety of professional medical markets during 2019.

According to the company, the largest portion of the professional cryosurgical market consists of two basic product categories: Liquid nitrogen-based delivery systems used mainly by dermatologists that require frequent refills due to evaporation, as well as the portable devices including Histofreezer and Verrucae Freeze that are disposable can-like devices used by paediatricians and general practitioners.

"Histofreezer and Verrucae Freeze established the disposable cryosurgical market in the early 90s," said Bill Hinchey, CMO of CryoConcepts. "Our new products are easy-to-use and deliver more effective treatments while being highly efficient."

CryoConcepts currently markets other cryo devices under the CryOmega, CryoClear and CooLifting brand names.