Summary: LuxCreo has partnered with EMA Sleep Inc to scale the manufacturing of a next-generation 3D-printed EMA oral appliance for sleep apnea. This partnership follows FDA 510(k) clearance for the device and the adoption of LuxCreo’s iLux Pro Dental platform, enabling same-day, in-clinic production. The new manufacturing solution aims to overcome previous limitations of manual production and support broader market adoption.
Key Takeaways:
- FDA Clearance Enables 3D Printing of EMA Device: The 3D-printed EMA device received FDA 510(k) clearance in 2024, opening the door for advanced production methods.
- LuxCreo Partnership with EMA Sleep: LuxCreo’s iLux Pro Dental platform allows for in-clinic, same-day manufacturing of the EMA device.
- Focus on Personalized Medical Devices: LuxCreo’s platform is designed to deliver customized medical devices at the point of care, aiming to improve patient outcomes and address production challenges in the medtech industry.
LuxCreo Inc, a platform for personalized medical and dental devices, has partnered with EMA Sleep Inc, an innovator and supplier of oral appliances to treat obstructive sleep apnea (OSA), to achieve in-clinic and scale advanced manufacturing of the EMA device.
More than 30 years ago, Don Frantz, DDS, invented the EMA—elastic mandibular advancement—device to treat his own sleep apnea. EMA works by opening the bite and gently advancing the mandible with elastic straps to increase airway space.
Until now, the FDA-cleared Class II EMA device has been manufactured manually through a thermoforming process, which has inherent limitations for adoption. In 2024, to enable a next-generation, 3D-printed EMA device, EMA 3D, two developments occurred to allow for same-day sleep medicine and wide market adoption: The company received US Food and Drug Administration 510(k) clearance for 3D printing of the EMA device, and EMA Sleep Inc found a design and 3D printing solution that broke through previous production barriers, LuxCreo’s iLux Pro Dental platform.
LuxCreo is able to produce EMA 3D with its end-to-end personalized medical device platform at point-of-care.
“True, LuxCreo’s personalized medical device platform solved so many issues for us. But we also needed a design software solution tailored to the EMA device—and LuxCreo delivered,” says EMA Sleep’s manufacturing expert Sonnie Bocala in a release. “Whether it was troubleshooting, technical support, or responsiveness, I have been extremely impressed with the entire LuxCreo organization.”
Michael Strohecker, LuxCreo’s co-founder and chief revenue officer, adds in a release, “The global medtech industry is expected to grow from $500 billion to over $800 billion by 2032. LuxCreo is solving a critical challenge to this growth by delivering precisely customized, high-performance medical devices directly at the point of care—where they can have the most immediate impact on patient outcomes.”
LuxCreo and EMA Sleep formally unveiled the partnership at LuxCreo’s grand opening of its National Education Center in Chicago on Sept 28.
Photo caption: LuxCreo Inc has partnered with EMA Sleep Inc to scale advanced manufacturing of the EMA device.
Photo credit: LuxCreo Inc
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