Maverix Medical Announces FDA 510(k) Clearance for the Narwhal™ Cryo System

Console-free, single-use cryoprobe brings cryobiopsy to the bronchoscopy suite without dedicated capital equipment

MENLO PARK, Calif., Aug. 20, 2026 /PRNewswire/ -- Maverix Medical, a company focused on revolutionizing the diagnosis and treatment of lung cancer, today announced that the U.S. Food and Drug Administration granted 510(k) clearance on June 30, 2026 for the Maverix Narwhal™ Cryo System, a single-use flexible cryoprobe that requires no console.

The system comprises the Maverix Narwhal Cryoprobe and a single-use cryo cartridge, available separately or as a kit. The Maverix Narwhal Cryobiopsy Probe is indicated for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion, for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.

A console-free approach

Conventional flexible cryoprobes run off a dedicated cryosurgical console with an external compressed-gas cylinder and footswitch. The Maverix Narwhal Cryoprobe is instead powered by a single-use nitrous oxide (N₂O) cartridge activated by an integrated handle, eliminating the requirement to purchase or service a console.

Design features include:

• Self-contained cryo cartridge. Approximately 160 seconds of total freeze endurance per probe, and roughly 80 seconds per disposable N₂O cartridge suspended outside the sterile field.
• Selectable freeze length. An adjustable sheath enables the user to select exposed cryotip length to approximately 3 mm or 6 mm, matching the freeze zone to the target.
• Low-profile, pointed, radiopaque tip. Facilitates direct access with a 1.3 mm shaft and a 115 cm working length compatible with bronchoscopes and endoscopes with working channels 2.0 mm or larger.

In bench and animal testing conducted in support of the 510(k) submission, the Narwhal Cryoprobe met all predefined performance and safety endpoints.¹

"As lung cancer screening gains traction, interventional pulmonologists are committed to providing more patients the answers they deserve, which starts with safe and adequate tissue sampling," said Jeremy Durack, MD, Chief Medical Officer at Maverix Medical. "We designed the Narwhal with input from busy practices, so workflow efficiency with minimal equipment investment were central to our design."

Interest in bronchoscopic cryobiopsy continues to grow following recent randomized data from the FROSTBITE2 Study published in JAMA showing a 10% lift in diagnostic yield with a 1.1 mm cryoprobe over forceps transbronchial biopsy.² "Cryobiopsy is in a moment where the evidence base and the clinical interest are both building," said Krish Bhadra, MD, Clinical Assistant Professor at Stanford Medicine.³ "The question for the field now is how widely it can be practiced. Taking the console out of the equation is a serious attempt at addressing that problem."

"Adding cryo capability, in a form designed to lower the barrier to adoption, extends our reach across the continuum of lung cancer care," said Carla Jung, Chief Executive Officer of Maverix Medical. "What drives us is straightforward. Lung cancer is still found too late too often, and every part of that pathway we can make faster or simpler is worth the work. This clearance is a crucial aspect of that effort."

The Narwhal Cryo System is expected to be broadly available in the United States in 2027, distributed by Thoracent, a Maverix company. Contact a Thoracent representative for ordering information.

FDA cleared (K261068), not yet distributed. Rx only.

Footnotes

1. Data on file at Maverix. Predefined performance and safety endpoints: avulsion success rate, biopsy weight, usability, bleeding, pneumothorax, gross necropsy, histological accessibility, and percent artifact-free biopsy samples. Fluoroscopy time and radiation dose were also characterized in this analysis. Minor bleeding was observed in some samples; it was not clinically significant, met the pre-determined acceptance criteria, and was statistically equivalent to the predicate device. As with any cryosurgical procedure, bleeding and pneumothorax are potential risks — refer to the Instructions for Use. Preclinical results may not be representative of clinical performance.
2. Thiboutot J, et al. Cryobiopsy vs Forceps for Bronchoscopic Lung Biopsy: The FROSTBITE-2 Randomized Clinical Trial. JAMA. 2026; doi:10.1001/jama.2026.7908.
3. Dr. Bhadra is a paid consultant to Maverix Medical.

About Maverix Medical

Maverix Medical aims to improve and save lives by revolutionizing the diagnosis and treatment of lung cancer. We seek to bring cutting-edge technologies to lung cancer care, empowering clinicians to diagnose lung cancer earlier and treat patients more effectively.

Media Contact:

Will Kynes, Director of Marketing and Communications
[email protected]
www.maverixmedical.com

SOURCE Maverix Medical