ENT (Otorhinolaryngology) in Wisconsin

Serena Sleep manufactures FDA-cleared, custom-fitted oral appliances for sleep apnea and related sleep-disordered breathing conditions. The company specializes in digitally designed, 3D-manufactured mandibular advancement devices constructed from medical-grade nylon. Product lines include the Elevate 9A (with standard and L Block variants) and EMA appliances, all featuring thin, flexible construction with minimal intraoral hardware and no buccal fins or straps. The company also produces night guards and orthotic devices. All appliances are manufactured in the USA and backed by a 3-year warranty. Serena Sleep markets primarily to dental sleep medicine practitioners and their patients, emphasizing durability, comfort, and clinical effectiveness. The appliances are designed to allow unrestricted lateral and protrusive jaw movement, reducing TMJ discomfort and patient adaptation time. The company highlights reduced chair-time requirements during fitting and minimal post-delivery adjustments. Manufacturing capabilities include proprietary finishing processes and custom titration sets (3 upper, 3 lower appliances per patient). No explicit regulatory certifications beyond FDA clearance are mentioned on the site.

BioMed ENT specializes in innovative biologic and biopolymer medical devices for otolaryngology (ENT) procedures. The company is a global leader in biologics and regenerative medicine, with licensed tissue banks in California, New York, and Florida, and international operations across Europe and Asia. BioMed ENT manufactures advanced surgical solutions for minimally invasive ENT procedures, including tissue-engineered patches and hemostatic gels. The company distinguishes itself through deep expertise in international medical device regulation (MDR compliance) and the ability to navigate diverse global regulatory frameworks. ISO 13485 certified for medical device manufacturing, BioMed ENT partners with leading universities and hospitals to develop products that improve patient outcomes while maintaining compliance with stringent U.S. and international standards.

Cytophil, Inc. is an ISO 13485:2016 and EN ISO 13485:2016 certified manufacturer of non-active implantable medical devices specializing in regenerative medicine solutions. Since 2005, the company has pioneered proprietary products across orthopedics, dental reconstruction, otolaryngology (ENT), and medical aesthetics. Cytophil operates as both a branded product manufacturer and contract manufacturing partner, offering comprehensive services including product development, design engineering, cleanroom processing, manufacturing, quality testing, product validation, regulatory clearance support, packaging, and distribution. The company's expertise spans synthetic bone graft substitutes, bone void fillers, dental implants, and other implantable biomaterial-based devices. Cytophil serves medical device companies seeking manufacturing, quality assurance, and commercialization support to bring innovative implantable devices to market while maintaining stringent regulatory and quality standards.