FDA Clearance

Bethlehem, PA – CryoConcepts, LP, a market leader in the development and manufacture of cryosurgical products, announced today they have received FDA clearance on two new, patent pending, cryosurgical devices for the physician’s office market. Histofreezer® FLEX 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 bench top 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. “We are excited to get these clearances from the FDA,” said Sam Niedbala, Ph.D. and CEO of CryoConcepts, LP. “Histofreezer® FLEX and CryoLab® have been designed to address user needs in a product category that has not seen innovation in more than two decades. Our new, patent pending products will deliver greater efficacy and are much easier to use. These new products position CryoConcepts as the only company that is a one-stop source for cryosurgical products ranging from disposable devices to capital equipment,” he added. The largest portion of the professional cryosurgical market consists of two basic product categories – 1. Liquid Nitrogen-based delivery systems used mainly by Dermatologists which require frequent refills due to evaporation, and 2. Portable devices such as Histofreezer® and Verruca Freeze® that are disposable can-like devices used by Pediatricians and General Practitioners. “Histofreezer® and Verruca 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,” he added. The company plans aggressive introductions into a variety of professional medical markets during 2019. CryoConcepts currently markets other cryo devices under the CryOmega®, CryoClear®, and CooLifting® brand names.
About CryoConcepts, LP
CryoConcepts was founded by Sam Niedbala, PhD, in 2009 and is located in Bethlehem, PA. Dr. Niedbala was a co-founder and former Chief Science Officer of OraSure Technologies, Incorporated (NASDAQ: OSUR) and holds more than 50 US and international patents. The management team also includes another OraSure co-founder, Bill Hinchey, who was responsible for the US launch of Histofreezer® in 1991 and spent more than a decade in the cryosurgical business. Mr. Hinchey serves as Chief Marketing Officer of CryoConcepts. P. Michael Formica is CryoConcepts’ Chief Technology Officer and served as an Executive Vice President at OraSure Technologies from 2000 to 2016. Mr. Formica was General Manager of the domestic, international, and OTC Histofreezer® business during his tenure at OraSure. For more information, please visit.