U.S.-based medical device company Airway Management has received FDA clearance for the Nylon flexTAP, described as the world’s first digitally printed single-point midline oral appliance for sleep apnea. The device, manufactured in the U.S., combines the company’s patented Vertex Technology with a design intended for patients with mild to moderate obstructive sleep apnea (OSA). By using digital printing, the Nylon flexTAP enables a custom fit without requiring bite registration, which can simplify the fitting process for clinicians and patients.
“We are thrilled to introduce the Nylon flexTAP, a game-changer in oral appliance therapy,” said Charles Collins, CEO of Airway Management. “Feedback from key opinion leaders in our TAP Sleep Care system highlights its superior effectiveness and patient comfort. Peer-reviewed studies also confirm that our patented mouth shield, which promotes nasal breathing, significantly improves treatment outcomes. This innovation underscores our commitment to advancing sleep health.”
Positioning in Sleep Apnea Therapy
The Nylon flexTAP includes features such as dual-axis movement to increase airway space, a 17mm range of mandibular advancement adjustable in 1/3 mm increments, and thin custom trays designed to enhance comfort. It is produced with BPA- and metal-free materials and comes with a mouth shield and AM Aligner to support nasal breathing and reduce common side effects of oral appliance therapy. The product carries a four-year warranty.
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 since 2015. With FDA clearance, the Nylon flexTAP enters the market as a digitally manufactured alternative, now available through Airway Labs, with PDAC coverage (E0486) pending.
Other 3D Printed Devices for Sleep Apnea
The Nylon flexTAP is not the only device advancing oral appliance therapy through 3D printing. In 2024, 3D printing solutions provider LuxCreo partnered with oral appliance specialist EMA Sleep to introduce a 3D printed medical device for obstructive sleep apnea. Originally invented by Dr. Don Frantz more than three decades ago, EMA’s appliance treats OSA by opening the bite and moving the lower jaw forward to increase airway space and improve nighttime breathing.
Elsewhere, Oventus, an Australian company, has teamed with the Commonwealth Scientific and Industrial Research Organization (CSIRO) in an effort to use 3D printing to aid people suffering from sleep apnea. The device is custom-made using impressions or CT scans, which are digitally processed and then 3D printed in batches. Its design includes a front airway that bypasses obstructions from the lower jaw, tongue, or nasal blockages, allowing patients to breathe more easily during sleep.
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Featured photo shows Nylon flexTAP. Image via Airway Management.
