29 October 2024

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LuxCreo and EMA Sleep Unveil Advanced 3D-Printed EMA Device for Sleep Apnea

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LuxCreo, Inc., the leading platform for personalized medical and dental devices, has partnered with EMA Sleep, Inc. to scale and enable in-clinic advanced manufacturing of the industry-leading EMA device to treat Obstructive Sleep Apnea (OSA).

OSA affects more than 40 million Americans and, if untreated, can lead to major health issues such as heart disease, stroke, and excessive daytime sleepiness. Over 30 years ago, Dr. Don Frantz invented the EMA device to treat his own sleep apnea. The EMA device works by opening the bite and gently advancing the mandible (jaw) using elastic straps, which increases airway space.

Until now, the FDA-cleared Class II EMA device has been manufactured manually through a thermoforming process, which has inherent limitations for wider adoption. In 2024, two significant developments finally enabled same-day sleep medicine and broad market adoption of the next-generation 3D-printed EMA device, EMA 3D: (1) the FDA issued a new 510(k) clearance for the 3D printing of the EMA device (K232735); and (2) EMA Sleep, Inc. identified LuxCreo’s iLux Pro Dental platform as the comprehensive design and 3D printing solution that overcame their production challenges.

LuxCreo’s ability to produce EMA 3D with its end-to-end personalized medical device platform at the point of care was the long-sought solution: an automated, EMA 3D-specialized design software, a compact iLux Pro Dental production system, proprietary FDA-cleared resin, and easy-to-use workflow automation.

Sonnie Bocala, EMA Sleep’s manufacturing expert and industry veteran, praised the partnership with LuxCreo: “I can’t commend the entire LuxCreo team enough. LuxCreo’s personalized medical device platform solved many issues for us, but we also needed a design software solution tailored specifically for the EMA device—and LuxCreo delivered. Whether it was troubleshooting, technical support, or responsiveness, I have been extremely impressed with the entire LuxCreo organization.”

“The global MedTech industry is expected to grow from $500 billion to over $800 billion by 2032. LuxCreo is addressing 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, LuxCreo’s co-founder and chief revenue officer. “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 striving to achieve in treating sleep apnea across all patient populations.”

LuxCreo and EMA Sleep formally announced their partnership at LuxCreo’s Grand Opening of its National Education Center in Chicago, IL, on September 28, 2024.

About LuxCreo

LuxCreo is a platform for personalized medical and dental devices. With LuxCreo, doctors can control the design, creation, and delivery of same-day, customized treatments that improve smiles, health, and well-being.

About EMA Sleep

EMA Sleep is a leading innovator and supplier of devices for treating Obstructive Sleep Apnea. Its EMA device has been clinically proven to be effective since 1993.

Source: https://luxcreo.com