LuxCreo has announced a partnership with EMA Sleep to achieve in-clinic and scale advanced manufacturing of the EMA device to treat Obstructive Sleep Apnoea (OSA).
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 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 finally allow for same-day sleep medicine and wide market adoption. First, the FDA issued a new 510(k) clearance for 3D printing of the EMA device (K232735). Second, EMA Sleep finally found one complete design and 3D printing solution that broke through their various production barriers, the LuxCreo’s iLux Pro Dental platform.
LuxCreo’s ability to produce EMA 3D with its end-to-end personalised medical device platform at point-of-care was the long-sought-after answer: Automated EMA 3D-specialised design software, compact iLux Pro Dental production system, proprietary FDA-cleared resin, and workflow automation that is easy to learn and to use.
Industry veteran and EMA Sleep’s manufacturing expert, Sonnie Bocala, explained the value of the relationship with LuxCreo: “I canot 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 organisation.”
“The global MedTech industry is expected to grow from US$500bn to over US$800bn 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 LuxCreo’s co-founder and chief revenue officer, Michael Strohecker.
“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 apnoea across all patient populations.”
OSA impacts more than 40 million Americans, which if untreated, can lead to major health problems such as heart disease, strokes, and excessive daytime sleepiness.
LuxCreo and EMA Sleep formally unveiled their partnership at LuxCreo’s Grand Opening of its National Education Center in Chicago, US, on 2 Sep 2024.
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