LuxCreo Helps Unlock Same-Day Sleep Apnea Treatment with EMA 3D

More than 30 years ago, orthodontist Dr. Don Frantz invented the EMA device to treat his own obstructive sleep apnea (OSA) – a serious medical condition impacting more than 40 million Americans. EMA works by opening the bite and gently advancing the mandible (or jaw) with elastic straps to increase airway space.

For years, manufacturing limitations have prevented widespread access to OSA care, which was always a focus for Dr. Frantz. Historically, the FDA-cleared Class II EMA device has been manufactured manually through a traditional thermoforming process. Dr. Frantz’s son, Joe, and his partner from Apex Dental Sleep Lab, Sonnie Bocala, had been searching for years for the right 3D printing solution (resins, hardware, and design software) that truly could allow same-day delivery of EMA to a suffering patient at a reasonable price.

Sonnie has operated dental sleep and TMJ laboratories for decades, including developing various OSA appliances for the industry. Apex Dental Sleep Lab currently manufactures 14 different sleep and snoring appliances, including several variations of the well-known EMA device.

Over the years, processes and materials have improved to allow the traditional thermoformed EMA device to be expanded to include milled and Serena Nylon versions. Each of these digital devices delivers a beneficial EMA device to the patient, but the EMA 3D is more economically priced. And 3D printing an EMA device allows for rapid and scaled delivery to patients, as Sonnie explains: “With a full solution for 3D printing, a doctor can design and print multiple EMA cases in a two-hour workflow. We needed to find the right partner to make it happen.”

The search ended in November 2023, when Sonnie and Joe visited blustery Chicago to work with LuxCreo in its newly opened headquarters and printing laboratory. They worked with the LuxCreo technology with an eye toward the performance needs for EMA.

By the time they left, Sonnie and Joe knew many of their hurdles for EMA 3D could be cleared with LuxCreo’s end-to-end 3D printing system: automated and EMA-specialized design software, four integrated pieces of iLux Pro Dental hardware, and a proprietary FDA-cleared resin. Once the FDA issued a new 510(k) clearance for 3D printing of the EMA device (K232735) in May 2024, the pieces were in place to change the course of dental sleep medicine.

Why EMA 3D? Immediate OSA Treatment

While there are many benefits EMA 3D provides to doctors and patients, none may be more important than the immediate relief of a patient’s sleep apnea. For the first time, a doctor can deliver the proven EMA device to an OSA patient within hours of a scan, rather than waiting weeks to receive the appliance from the doctor’s dental laboratory. For a patient suffering multiple apnea events every hour, time-to-treatment matters.

For the doctor, the AI-powered design software allows the EMA 3D appliance to be digitally designed in less than 10 clicks and 10 minutes. Print and processing time with LuxCreo’s integrated solution is under 2 hours.

Ease and speed of manufacturing and delivery of EMA 3D are only the start of the benefits of the product. Other significant benefits to the doctor and patient include:

• Outstanding material durability
• Digitally precise fit and accuracy
• Patient comfort from thinner trays (0.9 mm) than other apnea devices
• Easy to remake or sell in duplicates
• Eliminate costs for lab shipping fees and dental models

Experienced sleep doctors are adopting EMA 3D in their practices and loving the easy workflow, doctor control, and rapid OSA treatment. Dr. Michael Bennett has spent decades treating sleep disorders in Provo, Utah. He explained why the EMA 3D workflow is perfect for his practice and patients: “The process of design is very intuitive and easy to learn. We have happier patients that are getting into treatment sooner than current options. It usually takes 3-4 weeks to get a device in a patient’s mouth, which we can now do in hours. The EMA 3D software gives me a lot of control in my own hands to easily design an FDA-approved apnea device.”

How? Fully Integrated Design and 3D Print Solution

Founded in 2019, LuxCreo set out to change how clear dental appliances are designed and made for dental professionals and patients. LuxCreo engineered from scratch an end-to-end 3D printing system to solve the problems of directly printing clear orthodontic appliances, making the use easy and efficient for dental professionals to adopt in their clinic or laboratory. With a focus on delivering outstanding direct print aligners in just 2 hours from the patient’s scan, LuxCreo engineered one-click design and nesting software, four integrated pieces of hardware (taking just 40 inches of counter space), and its proprietary, FDA-cleared, Class II resins.

As a completely integrated system of design software, hardware, and resin, LuxCreo has enabled same-day direct clear aligner service and EMA 3D therapy.

• iLux Pro Dental: A high throughput, small footprint, heated, chairside DLP printer with 50-micron pixel resolution powered by LEAP technology. A single iLux Pro Dental is capable of printing up to 32 EMA 3D appliances in an eight-hour shift.
• LuxDesign Software: Generate tray designs, add bite pads and EMA buttons, and dynamic variable tray thickness for enhancing efficacy and patient comfort.
• iLuxCure Pro: A programmable, multi-wavelength, multi-direction, high-irradiance post-print cure that can cure six to eight EMA 3D devices within 30 minutes.
• Proprietary Printing Resin: The resin for EMA 3D is a tough, flexible, and accurate clear material with high transparency without manual polishing, enabled by LuxCreo’s Digital Polishing technology. The material has been FDA Class II 510(k) cleared for EMA 3D OSA indications.

For the clinic that adopts the EMA 3D workflow, the financial benefits will be immediate and impactful to the practice. The EMA 3D workflow and resulting device sold to a patient (with medical reimbursement) should yield profits more than 90% of the doctor’s cost to manufacture the device. Indeed, just fifteen EMA 3D cases will pay back the clinic or laboratory’s investment in the required FDA-cleared hardware and software.

The clinics and laboratories adopting the EMA 3D workflow will have the protection of being an authorized EMA 3D provider, including the international patents and regulatory clearances covering the workflow and products, and the infrastructure for insurance reimbursements.

LuxCreo’s Chief Revenue Officer, Michael Strohecker, observed, “It has been gratifying being able to leverage some of the special features of the iLux Pro Dental workflow – like digital polishing of devices and 1-click design and nesting capabilities – to really bring value to what Sonnie, Joe Frantz, and their team are trying to achieve in treating sleep apnea across all patient populations.”

Software Co-Development was the Key

The real engine behind EMA 3D is the co-developed design software: a customized, AI-driven design software that is integrated with a 3D printing solution, allowing an EMA 3D device to be designed in less than 10 clicks and 10 minutes and printed in under 2 hours. EMA Sleep’s expertise in OSA device manufacturing and LuxCreo’s expertise in creating an AI software module to go with its 4D Aligner design platform opened the door for success.

Through the second half of 2024, the two companies worked closely to automate the design of the EMA 3D device for the ease of the end-users. From figuring out how to automate the placement of the patented EMA buttons and bite pads, to understanding the dynamics of fit and jaw movement, to building an easy platform to use, the two companies worked to achieve a unique proposition for the dental professional.

Sonnie Bocala explained the value of the relationship with LuxCreo: “I cannot praise the entire LuxCreo team enough. LuxCreo’s technology allowed for the creation of an EMA-tailored design software solution, solving several key manufacturing challenges around design optimization, automation, and scale. The technical expertise, mechanical/materials experience, and developmental responsiveness of LuxCreo made it possible to create this unique LuxCreo-EMA 3D ecosystem.”

How to Get Started

A doctor or laboratory interested in becoming an authorized EMA 3D provider should contact either LuxCreo or EMA Sleep at: www.luxcreo.com/ema or www.ema-sleep.com for more information.

The process for training and software access is easy for everyone:

• Purchase LuxCreo’s iLux Pro Dental hardware and a subscription to the EMA 3D design software.
• Obtain EMA elastic connectors from approved reseller.
• Undergo training and quality assessment in the digital design and 3D print manufacturing of the EMA 3D device.
• Start making and rapidly delivering EMA 3D for patients.