3D printing solutions provider LuxCreo has partnered with oral appliance specialist EMA Sleep to introduce a 3D printed medical device which treats Obstructive Sleep Apnea (OSA).
This collaboration reflects LuxCreo’s attempts to capitalize on the MedTech market, which is expected to grow from its current $500 billion valuation to $800 billion by 2032.
Reportedly affecting more than 40 million Americans, OSA causes the walls of the throat to narrow or close during sleep, interrupts normal breathing, reduces oxygen levels, and disturbs the sleep cycle. It is a serious health condition that can lead to heart disease, strokes, and excessive daytime sleepiness.
Invented by Dr. Don Frantz over three decades ago, EMA’s proprietary FDA-cleared Class II device treats OSA by opening the bite and moving the lower jaw forward. This increases airway space and improves nighttime breathing.
Previously, these devices were manually produced using a thermoforming process which had inherent adoption limitations and was unable to deliver devices to OSA sufferers quickly. 3D printing the appliances using LuxCreo’s iLux Pro Dental platform reportedly overcomes these issues and can produce a personalized EMA device within 2 hours of an oral scan.
With 24/7 production, a single 3D printer can fabricate 2,000 EMA devices per month, translating to 24,000 annually. This amounts to 80% of the 30,000 authorized appliances produced in the US last year.
LuxCreo’s co-founder and chief revenue officer, Michael Strohecker, believes the company is solving a key challenge in the MedTech industry. He emphasized that the company is “delivering precisely customized, high-performance medical devices directly at the point of care — where they can have the most immediate impact on patient outcomes.”
EMA Sleep’s patented sleep apnea treatment device. Image via LuxCreo.
Treating sleep apnea with 3D printing
2024 reportedly marked a key step in transitioning to 3D printing for the production of sleep apnea devices. Significantly, the Food and Drug Administration (FDA) issued 510(k) clearance for the production of EMA devices (K232735) using 3D printing, allowing them to be commercially sold in the US.
Now, EMA Sleep has identified LuxCreo’s iLux Pro Dental 3D printing platform as the ‘ideal design and 3D printing solution’ to break through their previous production barriers. This end-to-end solution is optimized for the production of medical and dental devices.
With a 192mm x 108mm x 200 mm build volume, the iLux Pro Dental DLP 3D printer offers 2560 × 1600 ppi resolution and 50 μm pixel pitch (XY). It incorporates the company’s proprietary Light Enabled Additive Production (LEAP) technology, which reportedly enhances the speed, accuracy, transparency, and elasticity of 3D printed parts.
LEAP tunes the software, hardware, resins and post-processing steps to reduce labor requirements and maximize production output. According to LuxCreo, the technology enables 80% higher part clarity, 75% less polishing time, 10x high elastic performance, and increases 3D printing speeds by up to 100x. These benefits reportedly allow users to triple revenue with the same workforce.
LuxCreo’s end-to-end iLux Pro Dental solution. Image via LuxCreo.
The company’s end-to-end offering also includes its EMA-optimized design software, proprietary FDA-cleared resin, and workflow automation. LuxCreo claims these capabilities are easy to learn and use, increasing accessibility to 3D printing for medical device manufacturers.
Manufacturing on Demand
Sonnie Bocala, EMA Sleep’s manufacturing expert, commented that LuxCreo’s production platform “solved so many issues for us.” He also noted that the company’s EMA-tailored design software has been essential to the expansion of OSA device production.
“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,” added Strohecker.
3D printed EMA sleep apnea mandibular bands. Image via LuxCreo.
The growth of 3D printed medical devices
The development and adoption of 3D printed medical devices and prostheses is expanding. According to 360 Market Updates, the global 3D printed dentures market size was over $1 billion in 2021 and is expected to exceed $2 billion by 2028.
One company working to capitalize on this growing market is US-based 3D printer manufacturer 3D Systems. Earlier this year, the company received 510(k) from the FDA for its multi-material, 3D printed denture offering. The jetted, monolithic (one-piece) dentures are said to offer unparalleled break resistance and optimal aesthetics.
Notably, this offering integrates 3D Systems’ NextDent Jet Denture Teeth and NextDent Jet Denture Base materials into a single denture prosthetic. It also employs the firm’s MultiJet Printing (<a href="https://facfox.com/service/polyjet-mjp-3d-printing-services” target=”_blank” >MJP) technology, software and services.
Similarly, it was announced earlier this year that Formlabs Dental, the dental business unit of Resin 3D printer manufacturer Formlabs, received 510(k) clearance for its Premium Teeth Resin.
The 3D printing material can be used by dental professionals in the US to 3D print temporary single units of crowns, inlays, onlays, veneers, and up to seven-unit temporary bridges. A nano-ceramic-filled biocompatible material, Premium Teeth Resin can create dental components that accurately mimic the translucency and opalescence of natural teeth.
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Author: Alex Tyrer-Jones
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