LuxCreo, Inc., a leading platform for personalized medical and dental devices, has partnered with EMA Sleep, Inc. to revolutionize the manufacturing of the EMA device, designed to treat Obstructive Sleep Apnea (OSA). OSA, affecting over 40 million Americans, can lead to serious health issues like heart disease and strokes if left untreated. The EMA device, invented by Dr. Don Frantz over 30 years ago, gently advances the jaw with elastic straps to increase airway space and improve breathing during sleep.
Traditionally, the FDA-cleared Class II EMA device was manually manufactured using a thermoforming process, limiting its scalability. In 2024, two breakthroughs paved the way for a next-generation, 3D-printed EMA device, known as EMA 3D: the FDA’s new 510(k) clearance (K232735) for 3D printing the EMA device, and LuxCreo’s iLux Pro Dental platform, which enabled efficient, scalable production.
LuxCreo’s platform, featuring automated design software, the iLux Pro Dental production system, and FDA-cleared resin, allows for point-of-care manufacturing of the EMA 3D device. This streamlined approach provides same-day service, enhancing patient care and broadening market adoption.
Sonnie Bocala, EMA Sleep’s manufacturing expert, praised LuxCreo’s comprehensive solution, saying, “LuxCreo’s personalized medical device platform addressed all our production challenges. Their design software, technical support, and responsiveness were exceptional.”
Michael Strohecker, LuxCreo’s co-founder and chief revenue officer, highlighted the broader impact: “As the MedTech industry grows from $500 billion to over $800 billion by 2032, LuxCreo’s platform is crucial for delivering high-performance, customized medical devices at the point of care, significantly improving patient outcomes.”
LuxCreo and EMA Sleep officially announced their partnership at the Grand Opening of LuxCreo’s National Education Center in Chicago on September 28, 2024.
