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Airway Management's digitally printed sleep apnea treatment device receives FDA approval.

September 23, 2025 Applications 166

Nylon flexTAP, the world's first FDA-approved digitally printed midline oral appliance for mild-to-moderate OSA, enables custom fit via 3D printing without bite impressions, simplifying clinical workflow.

The U.S. medical device company Airway Management's Nylon flexTAP product has received FDA approval and is hailed as the world's first digitally printed single-point midline oral appliance for treating sleep apnea. This device is manufactured in the United States, incorporates Airway's patented Vertex technology, and is specifically designed for patients with mild to moderate obstructive sleep apnea (OSA). Nylon flexTAP uses digital 3D printing technology, enabling a custom fit without the need for bite impressions, thereby simplifying the fitting process for both clinicians and patients.

Charles Collins, CEO of Airway Management, stated: "We are thrilled to launch Nylon flexTAP, which transforms the landscape of oral appliance therapy. Feedback from key opinion leaders in our TAP sleep care system highlights its exceptional effectiveness and patient comfort. Peer-reviewed studies also confirm that our patented mask promotes nasal breathing and significantly improves treatment outcomes. This innovation demonstrates our commitment to advancing sleep health."

Nylon flexTAP. Image courtesy of Airway Management.

Positioning in Sleep Apnea Treatment

The Nylon flexTAP offers multiple functions, such as biaxial movement to increase airway space, a 17mm mandibular advancement range (adjustable in 1/3mm increments), and a thin custom tray designed for enhanced comfort. It is made from BPA-free and metal-free materials, and comes with a mask and AM Aligner to support nasal breathing and reduce common side effects of oral appliance therapy. The product is backed by a four-year warranty.

Since 2015, the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) have recommended oral appliance therapy as a treatment option for patients with mild to moderate sleep apnea. FDA-approved, Nylon flexTAP enters the market as a digitally manufactured alternative and is currently available for purchase through Airway Labs, with PDAC coverage (E0486) pending approval.

Other 3D Printed Devices for Treating Sleep Apnea

Nylon flexTAP is not the only device advancing oral appliance therapy through 3D printing technology. In 2024, 3D printing solutions provider LuxCreo partnered with oral appliance expert EMA Sleep to launch a 3D printed medical device for treating obstructive sleep apnea (OSA). The EMA device, originally invented by Dr. Don Frantz over 30 years ago, treats OSA by opening the bite and advancing the mandible forward to increase airway space and improve nighttime breathing.

Furthermore, Australian company Oventus, in collaboration with the Commonwealth Scientific and Industrial Research Organisation (CSIRO), is dedicated to utilizing 3D printing technology to assist patients with sleep apnea. The device is customized using impressions or CT scans, which are digitally processed before being 3D printed in batches. Its design incorporates a front air pathway that bypasses obstructions in the jaw, tongue, or nasal passages, allowing patients to breathe more smoothly during sleep.