Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
16.7%
Completed
2
33.3%
Not yet recruiting
1
16.7%
Recruiting
1
16.7%
Unknown
1
16.7%
No approval data available
- The FDA has approved the Allurion Gastric Balloon System, a swallowable device that expands in the stomach without requiring surgery, endoscopy, or anesthesia for obesity treatment. - The system is indicated for adults aged 22-65 with obesity who have had at least one unsuccessful weight loss attempt, targeting an estimated 80 million Americans within the approved BMI range. - The balloon remains in the stomach for approximately 4 months with an average residence time of 15.3 weeks before naturally passing, with up to two balloons permitted during a 10-month period. - Real-world data from over 200,000 patients outside the US shows 14% total body weight loss, with more than 20% weight loss following two treatment cycles.
- Allurion Technologies successfully passed critical FDA pre-approval and BIMO inspections with zero findings, advancing its Smart Capsule gastric balloon toward potential U.S. market approval. - The company completed its Day-100 Meeting with the FDA in October 2025 without requests for additional human clinical data, indicating progress in the final review stages. - Allurion secured $5 million in private placement financing and announced a debt exchange transaction that would eliminate all outstanding debt, strengthening its financial position. - The Smart Capsule represents the world's first swallowable, procedureless gastric balloon for weight loss, currently investigational in the United States pending FDA approval.
- Allurion Technologies has received two Issue Notifications from the USPTO for patents related to enhanced balloon technology for obesity treatment, scheduled to issue on March 11, 2025. - The patents cover an "Automatic-Sealing Balloon-Filling Catheter System" and "Balloon Sealing and Fill Valve," providing protection through April 2043 for Allurion's next-generation weight loss device. - With these additions, Allurion's intellectual property portfolio now encompasses 22 patents in the U.S. and 64 patents globally, strengthening their position in the obesity treatment market.
- Allurion Technologies plans to launch a clinical study exploring the combination of their gastric balloon with lower-dose GLP-1 agonists to improve treatment adherence and tolerability. - Current data shows significant GLP-1 therapy discontinuation rates, with 30% of patients stopping within the first month and 58% before achieving meaningful health benefits. - Previous research demonstrated enhanced weight loss outcomes when combining the Allurion Balloon with oral semaglutide compared to balloon therapy alone.
