Australasian Dentist Magazine Sept-Oct 2021

Category 68 Australasian Dentist S o, why are humans exceptional? To paraphrase Steve Jobs, the ability to build and use tools is what makes humans exceptional. Bicycles amplify human locomotion. Computers amplify our ability to calculate. The industrial revolution represents a collection of tools that amplify human labor. Imagining, building, and using tools have exponentially amplified the human existence since the beginning of time. Tens of millions of adults need “tools” to breathe at night. Without them their airways collapse, depriving their bodies of oxygen, and eventually causing dire medical, economic, and societal consequences. Although current tools like legacy OAT devices and CPAPs are deemed better than placebo, significant opportunity for improvement exists. A study of 150 sleep physicians identified a willingness to quadruple referrals for OAT if the devices, the tools, could be improved to be more comfortable, reliable, easy to use, and consistently effective every night. Sleep physicians, DSM providers, and patients want a tool they can truly trust. Imagine the impact on DSM if that happened! A New Sleep Breathing Tool ProSomnus® EVO™ is a new FDA Cleared OAT medical device that is engineered to address the challenge for a better sleep breathing tool. Featuring a low profile, anatomical, monolithic, iterative advancement design, EVO is the first OAT device to utilize MG6™ technology. Just as Tesla accelerated the auto industry with the use of advanced materials, Artificial Intelligence, and robotics, ProSomnus is doing this with EVO to create an optimal OAT device. Above all, EVO is designed to earn the trust of DSM providers, sleep physicians, and patients. Let’s take a closer look at this new sleep breathing tool. Precision Fit and Easy Delivery One objective for EVO is to make a device that is easy to deliver without compromising precision fit. Liners are a way to achieve easier deliveries. However, liners require significant clinical tradeoffs in the form of suboptimal fit, performance, biocompatibility, bulkiness and repair costs – the very types of quality and cost issues that concern sleep physicians and discourage patients. ProSomnus EVO uses patented and proprietary innovations to resolve this compromise. EVO is the first OAT device made from a medical grade Class VI rated material. EVO’s advanced material has better modulus, negating the need for liners. This means the material better conforms to dental anatomy and adapts to variances in dental impressions without conceding precision fit, the orthodontic retention of teeth, nor the other tradeoffs associated with liners. Clinical research indicates that 21% of legacy OATs require problem appointments (Craig et al, 2014). Over 100 EVO cases have been delivered to patients at the time of writing this article. None have required remakes, repairs, or problem appointments. Robustness and Comfort Another objective for EVO is to develop a device that is both more robust and more comfortable. There are reasons for DSM providers and OAT manufacturers to chase robustness and comfort. 89% of sleep medicine physicians view poor robustness and 79% view patient discomfort as barriers to more OAT referrals (Granik, 2020). Legacy OAT devices have a high rate of failure, despite efforts to add bulk and reinforcements. One study reported that 13% (41/309) of legacy OAT devices required manufacturer repairs or remakes (Craig et al, 2014). EVO uses advanced materials and optimized design to achieve robustness and comfort. EVO material is 10 times more durable than traditional acrylic. EVO features a monolithic splint design, with no secondary components like titration screws or straps. In safety testing for the FDA clearance process, EVO exhibited 52% better anterior/posterior torque strength and 17% better lateral torque strength than the predicate device. As expected, predicate devices exhibited catastrophic failures such as fractures, Better Sleep Breathing Requires Better Tools clinical Are humans the fastest runners? No. Cheetahs are twice as fast. Do humans have the best eyesight? Nope. Many birds have double the visual acuity. Are humans the best swimmers? Not even close. by Len Liptak, MBA, Mark T. Murphy, DDS, D.ABDSM, and Keith Batcheller, BS, MA Figures 1–3