SomnoMed
SomnoMed, an Australian company, is recognized globally as a leader in the design and manufacture of custom-made oral appliances for treating Obstructive Sleep Apnea (OSA). Since establishing its presence in 2004, the company has continuously focused on enhancing comfort and efficacy, leading to the development of the SomnoDent family of oral devices. These appliances, such as the SomnoDent Avant, Classic, and Herbst Advance, are custom-fit and manufactured in state-of-the-art, ISO 13485 certified facilities. SomnoMed leverages its proprietary b-flex comfort liner in many of its devices to ensure superior patient retention and comfort, distinguishing its offerings in the market. The company’s products are designed to shift the jaw slightly forward during sleep, maintaining an open airway. The SomnoDent Herbst Advance, for example, is Medicare-approved and features a visual indicator for easy adjustment tracking. By emphasizing high-quality materials, precise manufacturing, and patient-centric design, SomnoMed has built a strong distribution network across Europe and North America, solidifying its position among the top companies providing effective, clinically proven alternatives to CPAP therapy.
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ProSomnus Sleep Technologies
ProSomnus Sleep Technologies, based in the US, is a rapidly growing and influential player in the oral appliance market, distinguished by its focus on integrating digital technology and innovation into the treatment of Obstructive Sleep Apnea. The company has gained a significant market share by developing highly precise, non-invasive, and comfortable devices, positioning them as the patient-preferred therapy over traditional solutions like CPAP. ProSomnus utilizes advanced digital workflows, Artificial Intelligence (AI)-assisted design, and robotic manufacturing processes to ensure custom-fit precision and scalability, setting them apart from many competitors. Their flagship product, the ProSomnus EVO, exemplifies this approach, using advanced medical-grade plastic and materials for durability and comfort. ProSomnus prioritizes low-profile designs that allow for full lip seal and natural movement, leading to high patient adherence. Their business model, which includes accepting medical insurance and offering flexible payment plans, along with the device’s lower long-term costs due to minimal maintenance, reinforces its status as a technological leader driving the next generation of oral appliance therapy.
ResMed
ResMed, a globally recognized US-based medical device company, is a prominent leader in the sleep health industry, known for providing advanced technology-driven solutions for managing sleep apnea, including both CPAP machines and oral appliances. While heavily invested in CPAP technology, ResMed maintains a strong and active presence in the custom mandibular advancement device (MAD) market. Their highly regarded oral appliance, the Narval CC, is known for being one of the lightest, most discreet, and comfortable devices available, custom-fabricated using advanced CAD/CAM technology for a precise fit. The Narval CC is FDA-cleared and provides an effective alternative for patients with mild to moderate OSA, especially those who struggle with CPAP adherence. ResMed’s commitment to continuous research and development, coupled with its global manufacturing and distribution capabilities—including new centers like the one in Singapore—allows the company to consistently deliver high-quality, innovative solutions that expand treatment access and improve patient outcomes across the Asia Pacific and emerging markets.
Panthera Dental
Panthera Dental, through its Panthera Sleep division, is a world leader in the design and manufacture of custom dental sleep appliances, utilizing cutting-edge digital technology and Industry 4.0 manufacturing processes. Based in Canada, the company specializes in highly precise CAD/CAM techniques for 3D printing its oral appliances, ensuring high quality, reduced human error, and perfect adaptation to each patient’s unique morphology. Their products, such as the Panthera Classic, are constructed from medical-grade polyamide type 12 (nylon), offering exceptional strength, thinness, and biocompatibility. Panthera appliances are designed for user-friendliness, featuring easy adjustability via interchangeable rods in fine increments, a significant titration range, and customization options for TMJ disorders. The company’s focus on durability and advanced materials—including a 3-year warranty—provides clinicians and patients with reliable, highly comfortable devices for treating sleep apnea and snoring. Panthera Sleep’s commitment to digital workflow innovation has been instrumental in making personalized sleep appliance treatment accessible, including devices billable for Medicare beneficiaries.
Glidewell
Glidewell is a prominent dental laboratory and technology company that offers a comprehensive portfolio of oral appliances for sleep apnea, distinguishing itself through an emphasis on high volume manufacturing and robust clinical support. The company has successfully delivered hundreds of thousands of its mandibular advancement devices (MADs), demonstrating significant market reach. Glidewell produces both established and advanced devices, including the popular Silent Nite® (a flexible thermoplastic design known for comfort, especially in small mouths) and the newer Silent Nite® 3D (a precision-fit, 3D printed appliance with enhanced tongue space). Furthermore, Glidewell offers a range of devices under its brand, such as the flexTAP and dreamTAP, many of which are PDAC-verified for Medicare reimbursement. By leveraging a fully digital workflow for its latest products and providing excellent warranties, Glidewell effectively serves both patients seeking budget-friendly options and those requiring highly precise, micro-adjustable custom appliances, supporting dentists in offering effective sleep therapy solutions.
DynaFlex
DynaFlex is a notable US-based company specializing in orthodontic and sleep apnea dental appliances, recognized for producing reliable and precisely engineered mandibular advancement devices (MADs). The company’s offerings in the sleep apnea market are highlighted by the DynaFlex Herbst® appliance, a fixed-hinge device that leverages 3D milled acrylic construction for a high degree of precision and comfortable fit. The Herbst design is particularly valued for being gentle on the temporomandibular joint (TMJ), and DynaFlex customizes its model to accommodate specific TMJ disorders. The device allows for micro-adjustments in 0.1 mm increments, giving dentists precise control over mandibular advancement to optimize airway opening. Additionally, the appliance often incorporates rubber band hooks to encourage nasal breathing. DynaFlex focuses on integrating durability with ease of adjustment and maintenance, ensuring that its appliances provide effective, long-term non-CPAP therapy for patients with obstructive sleep apnea, reinforcing its position as a key manufacturer of professional dental sleep products.
Airway Management
Airway Management is a dedicated medical device company focused on developing and commercializing oral appliance therapy (OAT) solutions for sleep-disordered breathing. The company is primarily known for the Thornton Adjustable Positioner (TAP) family of appliances and the Elastic Mandibular Advancement (EMA) device, which are widely prescribed custom MADs. The TAP appliance is distinguished by its three-part mechanism—upper, lower tray, and a connector piece—which allows patients to easily adjust the jaw position at any time for optimal comfort and effectiveness, based on the principles of CPR jaw positioning. The EMA appliance offers a unique approach by utilizing flexible elastic straps instead of rigid connectors, which permits more natural lateral and vertical mandibular movement during sleep, enhancing comfort. Both TAP and EMA are FDA-cleared and are valued by clinicians for their superior adjustability and effectiveness in treating mild to moderate OSA, providing reliable custom-fitted alternatives to CPAP with a focus on maximizing patient adherence and quality of life.
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