LuxCreo to 3D print EMA 3D sleep apnea device
Until now, the device has been manufactured manually through a thermoforming process
LuxCreo, a personalized medical and dental device company, has partnered with EMA Sleep to achieve in-clinic and scale advanced manufacturing of the EMA 3D device to treat Obstructive Sleep Apnea (OSA).
OSA reportedly impacts more than 40 million Americans, which, if untreated, can lead to major health problems such as heart disease, strokes, and excessive daytime sleepiness. More than 30 years ago, Dr. Don Frantz invented the EMA device to treat his own sleep apnea. EMA works by opening the bite and gently advancing the mandible (or jaw) 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 major things occurred to allow for same-day sleep medicine and wide market adoption finally: (1) the FDA issued a new 510(k) clearance for 3D printing of the EMA device (K232735); and (2) EMA Sleep found one complete design and 3D printing solution that broke through their various production barriers – LuxCreo’s iLux Pro Dental platform.
LuxCreo’s ability to produce EMA 3D with its end-to-end personalized medical device platform at point-of-care was the long-sought-after answer: automated EMA 3D-specialized design software, compact iLux Pro Dental production system, proprietary FDA-cleared resin, and workflow automation that is easy to learn and to use.
“I can’t praise the entire LuxCreo team enough. 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. Whether it was troubleshooting, technical support, or responsiveness, I have been extremely impressed with the entire LuxCreo organization,” said Sonnie Bocala, industry veteran and EMA Sleep’s manufacturing expert.
“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,” said Michael Strohecker, Co-founder and Chief Revenue Officer of LuxCreo. “It has been gratifying to see how LuxCreo’s personalized medical device platform is bringing value to what Sonnie, Joe Frantz, and their team are trying to achieve in treating sleep apnea across all patient populations.”
