Maverix Medical Expands the Narwhal™ Cryo Portfolio with FDA Clearance of the Narwhal Pro

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Oct 14, 2026, 07:50 ET

Second console-free cryoprobe connects directly to shorter bronchoscopes and optimizes probe positioning control

MENLO PARK, Calif., Oct. 14, 2026/PRNewswire/ -- Maverix Medical, a company focused on revolutionizing the diagnosis and treatment of lung cancer, has augmented its console-free cryoprobe portfolio. Today the company announced that the U.S. Food and Drug Administration granted 510(k) clearance on September 2, 2026, to the Maverix Narwhal™ Pro Cryo System, the second of two flexible cryoprobes built on the same cartridge-powered architecture.

Like the Narwhal Cryoprobe, cleared June 30, 2026, the Narwhal Pro Cryoprobe is powered by a single-use N₂O cartridge, allowing the fully disposable system to be used without purchasing or servicing a cryosurgical console. It also has a similar sharp, radiopaque tip and is compatible with bronchoscopes with a working channel inner diameter of 2 mm or larger. Narwhal Pro's working length, however, is optimized for shorter bronchoscopes that are 600 mm or shorter, and it includes adapters to connect directly with Olympus, Fuji, and Pentax scopes. It also features sheath and probe advancement handle controls for precise cryoprobe placement.

The Maverix Narwhal Pro Cryoprobe 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 growing evidence base for cryobiopsy

The FROSTBITE-2 study recently published in JAMA showed a 10% increase in diagnostic yield with a 1.1 mm cryoprobe over forceps transbronchial biopsy,¹ highlighting the modality's potential diagnostic value.

"With high-quality randomized data now demonstrating the advantages of cryobiopsy, our priority was making sure physicians have a cryoprobe built for the most commonly used endoscopes," said Jeremy Durack, MD, Chief Medical Officer at Maverix Medical. "We designed Narwhal and Narwhal Pro as a pair. The Pro is tailored to shorter scopes and mounts directly with supplied adapters, allowing the physician to set how far the sheath extends and better control cryoprobe advancement."

Probe comparison

Specification	Narwhal™	Narwhal™ Pro
Cryoprobe tip OD	0.8 mm	0.8 mm
Shaft / sheath OD	1.3 mm	1.9 mm
Working length	115 cm	74 cm
Tip / probe extension	3–6 mm adjustable tip	3 mm tip, 0–4 cm probe extension
Extension line	152 cm	137 cm
Refrigerant	N₂O • 14.3 g	N₂O • 14.3 g
Freeze endurance	~160 s • 2 cartridges	~160 s • 2 cartridges
Radiopacity	Tip + distal 6 mm	Tip + sheath
Compatible access	Bronchoscope / endoscope	Olympus / Fuji / Pentax adapters
Working channel compatibility	≥ 2.0 mm ID	≥ 2.0 mm ID, ≤ 600 mm scope
Reuse	Single-use	Single-use

Specifications per the Instructions for Use. Package contents: probe and biopsy scraper (sterile); Narwhal Pro also includes Olympus/Fuji/Pentax scope adapters (sterile). Cryo Cartridge supplied separately, shared by both probes.

"Cryobiopsy has become one of my preferred methods for acquiring tissue, and I want it available on the scope I have already chosen for the case, rather than planning the case around the probe," said Krish Bhadra, MD, Clinical Assistant Professor at Stanford Medicine.² "This additional probe option means I can choose cryo in more of my cases."

"Clearing two cryoprobes in nine weeks shows what this team can do," said Carla Jung, Chief Executive Officer of Maverix Medical. "We wanted to make cryobiopsy available in more cases, so we challenged the team to build a portfolio that needs no capital equipment, has a sharp tip, and adapts to different procedures. Narwhal and Narwhal Pro deliver on that."

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

The Narwhal Cryo System (K261068) and Narwhal Pro Cryo System (K262420) are FDA cleared but not yet commercially distributed. Rx only.

Footnotes

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.
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.

www.maverixmedical.com

SOURCE Maverix Medical