Welcome to our dedicated page for Inspire Medical Systems news (Ticker: INSP), a resource for investors and traders seeking the latest updates and insights on Inspire Medical Systems stock.
Inspire Medical Systems, Inc. (INSP) is a pioneering medical technology company headquartered in Maple Grove, Minnesota. Specializing in the development and commercialization of innovative, minimally invasive solutions, Inspire focuses on providing effective treatments for patients with obstructive sleep apnea (OSA). The company's flagship product, the Inspire system, is a revolutionary neurostimulation technology designed to safely and effectively treat moderate to severe OSA.
Inspire operates primarily across the United States and Europe, with the bulk of its revenue generated from the U.S. market. The company has seen significant growth, reporting a 65% increase in year-over-year revenue for the second quarter of 2023, reaching $151.1 million. This growth is attributed to increased utilization at existing sites, the addition of 72 new implanting centers, and 19 new U.S. sales territories.
In recent business highlights, Inspire has achieved several key milestones. These include the submission of the Inspire V neurostimulation PMA supplement application to the FDA and receiving two critical FDA approvals which expand the upper limit of the Apnea-Hypopnea Index (AHI) to 100 events per hour from 65 and raise the BMI warning in the labeling to 40 from 32. Additionally, Inspire received approval for its SleepSync™ physician programmer. These advancements are expected to enhance the company’s product offerings and market reach.
Financially, Inspire ended the second quarter of 2023 with a gross margin of 83.9% and operating expenses of $143.4 million, reflecting ongoing investments in U.S. sales expansion, direct-to-patient marketing, and product development. Despite a net loss of $12.0 million for the quarter, this marks an improvement from the $14.5 million loss in the same period the prior year.
Looking ahead, Inspire has increased its full-year 2023 revenue guidance to between $600 million and $610 million, reflecting a growth of 47% to 50% over the previous year. The company is committed to opening new medical centers and expanding its U.S. territories, anticipating sustained organic growth driven by its innovative therapies and strengthened leadership team.
For current updates and detailed information about Inspire Medical Systems, visit inspiresleep.com.
Inspire Medical Systems, Inc. (NYSE: INSP) has received FDA approval for its Inspire V therapy system, a next-generation neurostimulator for treating obstructive sleep apnea (OSA). The system includes a new neurostimulator, Bluetooth® patient remote, and physician programmer. This approval is a significant milestone for Inspire therapy's future. The company is focusing on operational readiness, including product manufacturing and inventory buildup. Inspire plans a soft launch in late 2024 and a full launch in 2025 for the U.S. market. This advancement reinforces Inspire's commitment to developing innovative, minimally invasive solutions for OSA patients.
Inspire Medical Systems, Inc. (NYSE: INSP) has announced preliminary, unaudited results for Q2 2024 and updated its 2024 revenue outlook. The company, which specializes in minimally invasive solutions for obstructive sleep apnea, expects Q2 revenue of $195.9 million, a 30% increase year-over-year. U.S. revenue is anticipated to be $187.8 million, up 30%, while revenue outside the U.S. is expected to reach $8.1 million, a 27% increase.
Inspire has also raised its full-year 2024 revenue guidance to $788-$798 million, representing 26-28% growth over 2023. This is a $13 million increase from the initial guidance. The company cites strong execution and accelerating U.S. revenue growth as key factors in this positive outlook.
Inspire Medical Systems, Inc. (NYSE: INSP) has announced countrywide reimbursement for its Inspire therapy in France, expanding access to its innovative treatment for obstructive sleep apnea (OSA). This development marks a significant milestone for Inspire, as France represents the second-largest OSA market in Europe. The company's strategy of securing reimbursement before commercialization has proven successful, with France joining other key European countries in providing coverage for Inspire therapy.
Tim Herbert, Chairman and CEO of Inspire, emphasized the clinical efficacy and safety of their minimally invasive solution for moderate to severe OSA. The therapy, which received European Conformity Marking in 2010, is now poised to benefit French patients and physicians. Andreas Henke, Executive VP and Managing Director Europe, highlighted that this reimbursement approval provides French sleep physicians with a new therapeutic option for untreated OSA patients.
Inspire Medical Systems, Inc. (NYSE: INSP) has appointed Melissa J. Mann as Chief People Officer, effective July 22, 2024. Mann brings over 25 years of experience in human capital management, previously serving at UnitedHealth Group's Optum division and Target She replaces Steven L. Jandrich, who retired in May after 6 years with Inspire. Tim Herbert, Chairman and CEO, expressed excitement about Mann's ability to leverage her vast experience as the company continues to grow.
Mann's role will involve shaping the human capital strategy and ensuring a strong team and culture to support Inspire's mission of serving patients with untreated obstructive sleep apnea (OSA). The company has grown to over 1,000 team members under Jandrich's leadership.
Inspire Medical Systems, Inc. (NYSE: INSP) has announced CE mark certification under the European Union's Medical Device Regulation (EU MDR 2017/745) for its Inspire therapy, a minimally invasive solution for patients with obstructive sleep apnea (OSA). This certification maintains Inspire's uninterrupted CE mark approval since 2010 and complies with the new, more stringent regulatory framework enacted in 2017.
Two significant changes are now CE marked under the EU MDR: Inspire patients in the EU can undergo full-body MRI scans in the 1.5T MRI environment, subject to specified conditions, and the current version of Inspire therapy's leads with silicone insulation are now CE marked in the EU. This certification is a critical milestone for Inspire, ensuring continued delivery of their product in several European countries.
Inspire Medical Systems, Inc. (NYSE: INSP) has received CE Mark certification for full-body MRI compatibility under the European Union's Medical Device Regulation. This approval expands the use of Inspire therapy, allowing patients with the Inspire IV neurostimulator to undergo full-body MRI scans, in addition to previously approved head, neck, and extremity scans. The certification applies retroactively to all patients with the device implanted since 2018.
This milestone enhances Inspire's ability to serve patients with obstructive sleep apnea (OSA) who struggle with CPAP. The full-body MRI compatibility, already available in the United States for two years, addresses a significant barrier for potential patients concerned about future access to MRI diagnostics. Inspire has conducted extensive testing to ensure safe performance in 1.5T MRI environments.
Inspire Medical Systems (NYSE: INSP) announced it will release its second quarter 2024 financial results on August 6, 2024, after market close. Following the release, the management team will host a conference call at 5:00 p.m. Eastern Time to discuss results and recent business developments. The webcast will be accessible via Inspire's Investor Relations page. Questions for management can be submitted through a provided registration link, which will generate a unique access code for the live call. A replay of the call will be available approximately two hours after the event and will remain accessible for two weeks on the company's website.
Inspire Medical Systems (NYSE: INSP) will present at the Truist Securities Medtech Conference on June 18, 2024, at 10:40 a.m. ET. The company specializes in minimally invasive solutions for obstructive sleep apnea. The presentation will be accessible via a live webcast, with a replay available for two weeks on Inspire's investor website.
Inspire Medical Systems, a medical technology company specializing in innovative, minimally invasive solutions for obstructive sleep apnea, announced its participation in the Jefferies Global Healthcare Conference. Scheduled for June 6, 2024, at 11:30 a.m. Eastern Time, the presentation will be accessible via a live webcast with a replay available for two weeks on Inspire’s Investor website.
Inspire Medical Systems, Inc. reported a 28% year-over-year revenue growth in the first quarter of 2024, reaching $164.0 million. The company expects profitability for the full year 2024, increasing revenue guidance to $783 million to $793 million, reflecting growth of 25% to 27% over 2023. With improved outlook and strong performance, Inspire is optimistic about the remainder of 2024.
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