LuxCreo and EMA Sleep launch 3D printing production for customized sleep apnea devices

The collaboration between LuxCreo, Inc. and EMA Sleep, Inc. marks a significant step in personalized medical technology. The goal is to manufacture and scale the EMA device to treat obstructive sleep apnea (OSA) directly in clinics. OSA affects over 40 million Americans and can have serious health consequences such as heart disease and stroke if left untreated.

The EMA device, developed over three decades ago by Dr. Don Frantz, works by opening the bite and carefully advancing the lower jaw using elastic straps to widen the airway. Previously, the FDA-approved Class II device was manually fabricated using thermoforming, which hindered widespread adoption due to technical and logistical limitations.

Industry veteran and EMA Sleep’s manufacturing expert, Sonnie Bocala, explained the value of the relationship with LuxCreo: “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.”

In 2024, two key developments paved the way for the next generation of the EMA device: Firstly, the FDA granted a new 510(k) clearance for 3D printing of the EMA device (K232735). Secondly, EMA Sleep found a comprehensive design and printing solution with LuxCreo’s iLux Pro Dental platform that overcame existing production obstacles. This platform enables the EMA 3D to be manufactured directly at the point of use, supported by automated design software, a compact production system and a proprietary FDA-approved resin formulation.

“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 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 apnea across all patient populations.”

The partnership was officially unveiled on September 28, 2024 at the opening of LuxCreo’s National Education Center in Chicago. This move underscores the ongoing integration of 3D printing technologies into personalized medicine and promises improved care for patients with sleep apnea.