Focused Cryo, Inc., an Atlanta-based medical device company, today announced the completion of its first clinical cases with the Focused Cryotherapy System, an FDA-cleared (K250742) cryoablation platform that lets physicians select either a conventional circumferential freeze or a directional freeze concentrated on one side of the probe.
Four procedures were performed by interventional radiologists in Atlanta during the week of October 19, 2026, including peripheral nerve ablation (cryoneurolysis) and tumor ablation. Directional mode was used in both nerve and tumor procedures, and technical success was achieved in all four procedures.
“Cryoablation has traditionally been a symmetric tool: the ice grows the same in every direction, and the physician plans around that,” said David Prologo, MD, interventional radiologist and co-founder and Chief Medical Officer of Focused Cryo. “Being able to direct the freeze toward the target gives us a different way to plan these procedures, and these first cases let us see that on CT in patients.”
“These first cases move Focused Cryo from a cleared device to a clinical one,” said Yogi Patel, PhD, Founder & Chief Executive Officer of Focused Cryo. “Our goal is to make cryoablation a practical option for more nerve and tumor procedures, and directional control is how we intend to get there.”
About the Focused Cryotherapy System
The Focused Cryotherapy System consists of a console and a single-use 2.1 mm cryoprobe. In directional mode, the probe produces an ablation zone concentrated on one side (~180°) of the probe; in circumferential mode, it produces a conventional ablation zone. The system is FDA-cleared (510(k) K250742) for cryoablative destruction of tissue during surgical procedures, including use in oncology, neurology (including cryoanalgesia), general surgery, thoracic surgery (excluding cardiac tissue), urology and other fields. See the Instructions for Use for full indications, contraindications, warnings and precautions.
About Focused Cryo
Focused Cryo, Inc. is an Atlanta-based medical device company developing directional cryoablation for interventional radiology, interventional oncology and pain management. Learn more at focusedcryo.com.
Disclosure: Dr. Prologo is a co-founder, Chief Medical Officer and equity holder of Focused Cryo.
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