1/29/2024
ARDEN HILLS (January 29, 2024) – Cryosa, Inc., a clinical stage, privately held medical device company today announced the first patient treated in the ARCTIC-3 clinical study evaluating the Cryosa™ System for treatment of moderate to severe obstructive sleep apnea.
The study is designed to evaluate the safety and efficacy of the Cryosa platform technology, which uses a controlled cooling process to selectively treat oral tissue and open the airway without the need for masks, hoses, incisions, or implants. The ARCTIC-3 Study is a multi-center, open label, single arm trial planned to enroll up-to 25 patients throughout sites in the U.S.
“Obstructive sleep apnea can be a debilitating disease for millions of people globally negatively impacting their daily lives and may lead to serious chronic conditions, “said Laura Stoltenberg, Cryosa CEO, “ARCTIC-3 is an important step in our journey to demonstrate the safety and efficacy of our solution in the US patient population and bring relief to millions of people.”
The first patient procedure was successfully completed by the team led by Albany ENT & Allergy Services, PC by Dr. Siobhan Kuhar and Dr. Nora Perkins with Dr. Gavin Setzen as study principal investigator at St. Peter’s Hospital in Albany, NY. “It is gratifying to know that this novel procedure has the potential to impact patients with OSA, improving their health outcomes and quality of life, without the painful recovery and morbidity associated with other surgical treatments for this condition.” said Dr. Setzen, “Cryosa has the potential to positively change the paradigm for the future management of sleep disordered breathing.”
About Cryosa: Cryosa is a privately held, clinical-stage medical device company headquartered in Arden Hills, MN. The Cryosa system is investigational and is not available for sale in the United States. It is limited to investigational use in the approved IDE studies. To learn more about the ARCTIC-3 study, visit clinicaltrials.gov.