Inspire Medical Systems Inc is a medical technology company that develops and commercializes innovative minimally invasive solutions for patients with obstructive sleep apnea. Its flagship product the Inspire system is the first neurostimulation therapy to receive FDA approval European Union MDR approval and Japan approval for treating moderate to severe obstructive sleep apnea. The Inspire system uses a closed loop algorithm that senses breathing and delivers mild…
Inspire Medical Systems Inc is a medical technology company that develops and commercializes innovative minimally invasive solutions for patients with obstructive sleep apnea. Its flagship product the Inspire system is the first neurostimulation therapy to receive FDA approval European Union MDR approval and Japan approval for treating moderate to severe obstructive sleep apnea. The Inspire system uses a closed loop algorithm that senses breathing and delivers mild hypoglossal nerve stimulation to keep the airway open during sleep. More than 125000 patients have received Inspire therapy in the United States Europe and Asia since its launch. The device obtained premarket approval from the FDA in 2014 a CE mark in Europe in 2010 and regulatory clearance in Japan in 2018.
Inspire Medical Systems generates revenue primarily by selling the Inspire system to hospitals and ambulatory surgery centers. In the United States and select European markets the company uses a direct sales force to call on ENT physicians and sleep centers. In Japan and Singapore Inspire therapy is sold through independent distributors. Revenue also comes from related services such as patient support programs prior authorization assistance and the SleepSync cloud based platform. Hospitals and ambulatory surgery centers bill third party payors including commercial insurers Medicare and Medicaid for the procedure and device costs.
Inspire Medical Systems holds a first mover advantage in the neurostimulation space for obstructive sleep apnea. It is the only company with an FDA approved closed loop system that senses respiration and delivers timed hypoglossal nerve stimulation. Competitors include Nyxoah which offers an open loop bilateral stimulation device and LivaNova which has submitted a hypoglossal nerve stimulation device for FDA review. Traditional continuous positive airway pressure providers such as ResMed Philips and Fisher & Paykel remain the first line therapy but face compliance challenges. Invasive surgical options like uvulopalatopharyngoplasty and maxillomandibular advancement serve as alternative second line treatments. Inspire differentiates itself through a robust body of clinical evidence including over 385 peer reviewed publications long term data from the STAR trial and real world results from the ADHERE registry. The company also benefits from a strong intellectual property portfolio with 119 issued US patents 83 issued foreign patents and numerous pending applications. Its market access team helps secure prior authorizations and coverage policies with commercial payors and Medicare facilitating reimbursement for patients and providers. Direct to consumer marketing and patient education programs further drive demand and brand awareness.
Inspire Medical Systems serves hospitals and ambulatory surgery centers that perform the implantation procedure. These customers are located throughout the United States in selected European countries and in Japan and Singapore through distributor partners. The company also works closely with ENT physicians sleep centers and referral sources who identify appropriate patients for Inspire therapy. While specific customer names are not disclosed the base includes academic medical centers community hospitals and independent surgery centers. Patients who have failed or cannot tolerate continuous positive airway pressure therapy represent the target end user group for the Inspire system.
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Sector: Healthcare Industry: Medical Devices CIK: 0001609550