Maverix Medical Advances Lung Cancer Diagnosis With Narwhal

Menlo Park, California, August 20, 2026

FDA Clearance Supports Console-Free Cryobiopsy

The Maverix Narwhal Cryo System consists of the Narwhal Cryoprobe and a single-use cryo cartridge, which can be supplied individually or as a kit. The cryoprobe is indicated for palliative devitalization of tissue during interventional procedures through extreme cold and cryo-adhesion. Its applications include removal of foreign bodies, mucus plugs, blood clots, necrotic tissue and tissue tumors, as well as tissue biopsies. The device is designed to operate without a separate cryosurgical console, external compressed-gas cylinder or footswitch, potentially lowering infrastructure requirements for healthcare facilities adopting cryotherapy-assisted procedures.The system incorporates several design features intended to support clinical use. Its integrated cryo cartridge provides approximately 160 seconds of total freeze endurance per probe, while an approximately 80-second disposable nitrous oxide cartridge is positioned outside the sterile field. An adjustable sheath allows clinicians to select an exposed cryotip length of approximately 3 mm or 6 mm, helping match the freezing zone to the intended target. The device also features a low-profile, pointed and radiopaque tip, with a 1.3 mm shaft and 115 cm working length, designed for compatibility with bronchoscopes and endoscopes having working channels of at least 2.0 mm.

Narwhal Targets Growing Interest in Lung Cryobiopsy

Maverix Medical said the Narwhal system was developed with workflow efficiency and equipment accessibility in mind as interest in bronchoscopic cryobiopsy continues to develop. In testing supporting the FDA submission, the cryoprobe met predefined performance and safety endpoints in bench and animal evaluations. The company noted that these preclinical findings are not necessarily representative of clinical performance, and potential risks of cryosurgical procedures include bleeding and pneumothorax. The company also highlighted emerging evidence supporting cryobiopsy in lung procedures. Recent randomized data from the FROSTBITE2 study, published in JAMA, reported a 10% increase in diagnostic yield with a 1.1 mm cryoprobe compared with forceps transbronchial biopsy. These developments reflect increasing clinical interest in obtaining adequate tissue samples for diagnosis, particularly as lung cancer screening expands and clinicians seek effective approaches for evaluating suspicious lesions.

Medical Device Could Expand Access to Cryotherapy

According to Maverix Medical, removing the requirement for a dedicated console may help reduce barriers to adoption for interventional pulmonology practices. The company believes the single-use Narwhal Cryoprobe could provide a more accessible approach to incorporating cryotherapy and cryobiopsy capabilities into existing bronchoscopy workflows. The device’s applications across tissue biopsy and palliative tissue devitalization could also provide clinicians with additional procedural options within lung cancer care. Maverix Medical expects the Narwhal Cryo System to become broadly available in the United States in 2027, with distribution planned through Thoracent, a Maverix company. The product is FDA cleared under K261068 and is designated for prescription use. The clearance represents an important regulatory milestone for Maverix as it works to advance technologies intended to support earlier diagnosis and treatment of lung cancer.

Source: Maverix Medical press relese