LuxCreo, a platform specialising in personalised medical and dental devices, has formed a partnership with EMA Sleep to enhance in-clinic and scaled advanced manufacturing of the latter’s 3D-printed device, designed to treat obstructive sleep apnea (OSA).
Obstructive sleep apnea affects over 40 million individuals in the US. If left untreated, it can lead to significant health issues such as cardiovascular disease, strokes, and chronic daytime drowsiness.
The EMA device, originally invented more than 30 years ago by Don Frantz to address his own sleep apnea, operates by opening the bite and gently moving the jaw (mandible) forward using elastic straps to expand airway space.
Previously, the US Food and Drug Administration (FDA)-cleared Class II EMA device was produced manually through a thermoforming process, a method which posed limitations for broader adoption.
In 2024, two key developments enabled the launch of a next-generation 3D-printed version of the EMA device, known as EMA 3D, making same-day sleep treatment and wider market adoption possible.
The first was the FDA’s issuance of a new 510(k) clearance (K232735) for the 3D printing of the EMA device. The second was EMA Sleep’s discovery of a comprehensive design and 3D printing solution that addressed their production challenges, LuxCreo’s iLux Pro Dental platform.
LuxCreo’s platform is said to facilitate the production of EMA 3D through an end-to-end personalised medical device solution at the point-of-care. This system includes specialised automated design software for the EMA 3D, a compact iLux Pro Dental production system, proprietary FDA-cleared resin, and an automated workflow designed for ease of learning and use.
LuxCreo co-founder and chief revenue officer Michael Strohecker said: “The global MedTech industry is expected to grow from $500bn to over $800bn by 2032.
“LuxCreo is solving a critical challenge to this growth by delivering precisely customised, high-performance medical devices directly at the point of care — where they can have the most immediate impact on patient outcomes.”
