Company Profile
Airiver Medical is a US-based clinical-stage manufacturer of drug-coated balloons (DCB) for respiratory tract conditions, headquartered in Brooklyn Park, Minnesota, USA. Founded in 2022 by Lixiao Wang, Ph.D., the company operates as an independent private entity, serving US interventional pulmonology and ENT markets with investigational device platforms.
Core Products ＆ Technologies
Pulmonary Drug-Coated Balloon
• Airiver Pulmonary DCB: Paclitaxel-coated balloon for benign central airway stenosis, combining standard balloon dilation with proprietary localized drug delivery to maintain patency and prevent recurrence
• Airiver ESSpand Sinus DCB: Drug-coated balloon adjunct to endoscopic sinus surgery (ESS) for chronic rhinosinusitis, designed to prevent scarring and renarrowing of sinus drainage passageways
Drug Delivery Platform
• Proprietary Paclitaxel Coating: Thin-layer coating enabling localized drug delivery to targeted tissue while limiting exposure to surrounding healthy tissue
Market Position ＆ Certifications
Airiver Medical holds an emerging innovator position in the respiratory interventional devices market, developing alternatives to Boston Scientific airway stenting and bare balloon dilation platforms. Key strengths include:
• 4 years of US R＆D heritage in respiratory drug-device combinations
• Dual IDE pipeline: Two active FDA-approved pivotal trials for pulmonary and sinus indications
• Regulatory milestones: FDA Breakthrough Device Designation for pulmonary DCB (March 2026); IDE approvals for both pulmonary (August 2025) and sinus (December 2025) pivotal studies
• Clinical progress: First patient treated in pulmonary DCB pivotal trial by Dr. Ashli O'Rourke at Medical University of South Carolina
• Venture backing: $14M Series A1 led by HM Venture Partners
Corporate Timeline
2022 — Founded in Brooklyn Park, Minnesota, USA
2025 — Received FDA IDE approval for pulmonary DCB pivotal trial (August; up to 200 patients)
2025 — Received FDA IDE approval for ESSpand sinus DCB pivotal trial (December; up to 300 patients)
2026 — Granted FDA Breakthrough Device Designation for pulmonary DCB (March); first patient treated in pivotal trial
Target Markets ＆ Applications
• Central Airway Stenosis: Pulmonary DCB for recurrent airway narrowing associated with prolonged intubation, tracheostomy, stenting, tuberculosis, or lung transplant
• Chronic Rhinosinusitis (CRS): ESSpand DCB as adjunct to ESS for CRS with and without nasal polyps, aiming to reduce revision surgery rates
• Recurrent Respiratory Obstructions: Minimally invasive drug-device combinations targeting sustained patency and fewer retreatments
Contact Information
Global Headquarters
Address: 7601 Northland Drive N, Suite 170, Brooklyn Park, MN 55428, USA
Email: info@airiver.com
Corporate Status
Entity Type: Independent Private Company (No Parent Company)
Stock: Not Publicly Traded
Website: airiver.com
