LuxCreo Targets Medical Sector with FDA-Cleared 3D Printed Sleep Apnea Devices

Application-focused additive manufacturing firm LuxCreo is now moving beyond dentistry to tackle the medical device space. To do so, the company has partnered with EMA Sleep, Inc. to enhance the manufacturing process of Elastic Mandibular Advancement (EMA) devices, a leading treatment for Obstructive Sleep Apnea (OSA). The collaboration aims to enable in-clinic production and scalable manufacturing of the device using LuxCreo’s 3D printing technology.

OSA affects over 40 million Americans and, if untreated, can lead to serious health issues such as heart disease, stroke, and excessive daytime sleepiness. While CPAP machines use continuous air pressure delivered through a mask to prevent airway collapse, EMA devices are custom-made oral appliances that gently advance the lower jaw to keep the airway open. EMAs are typically used for mild to moderate sleep apnea, offering a less intrusive alternative to CPAP therapy.

Much like invisible dental aligners, EMA devices are traditionally produced manually through a thermoforming process, which can limit scalability and rapid production. However, just as LuxCreo has become one of the few companies to directly 3D print dental aligners, the company is now using the same technology to 3D print EMAs.

This year, the U.S. Food and Drug Administration issued a new 510(k) clearance (K232735) for the 3D printing of EMA devices. Now, EMA Sleep has adapted LuxCreo’s iLux Pro Dental platform to manufacture them through a new platform that includes specialized design software, a compact production system, proprietary FDA-cleared resin, and an automated workflow.

“I can’t praise the entire LuxCreo team enough. LuxCreo’s personalized medical device platform addressed many of our challenges,” said Sonnie Bocala, EMA Sleep’s manufacturing expert. “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 impressed with the entire LuxCreo organization.”

The new workflow leverages LuxCreo’s experience in digital dentistry to produce personalized medical devices at the point of care. The iLux Pro Dental platform allows for same-day production of EMA devices, potentially reducing lead times and improving patient outcomes.

“The global MedTech industry is expected to grow from $500 billion to over $800 billion by 2032. LuxCreo is addressing a critical challenge by delivering customized, high-performance medical devices directly at the point of care—where they can have the most immediate impact on patient outcomes. It’s gratifying to see how LuxCreo’s platform is bringing value to what Sonnie, Joe Frantz, and their team are trying to achieve in treating sleep apnea across all patient populations,” Michael Strohecker, co-founder and Chief Revenue Officer of LuxCreo, stated.

This story introduces a number of interesting elements with implications not only for LuxCreo, but for the 3D printing industry as a whole. LuxCreo has already been a pioneer in the field of digital dentistry as one of the earliest printer manufacturers to enable direct printing of invisible aligners. And, while most dental 3D printing companies are openly discussing the possibilities for dentures, mouth guards, and other applications, LuxCreo is expanding further into the potentially more lucrative medical space.

This certainly signals a successful path ahead for LuxCreo in this niche, but it also opens up a new market for the firm’s competitors. As companies like 3D Systems, Desktop Metal/Nano Dimension, and Carbon expand their work in dental applications, they will further explore the ways they can port these solutions into the medical space as well.