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Inspire Medical Systems, Inc. Announces Countrywide Reimbursement in France

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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) ha annunciato il rimborso nazionale per la sua terapia Inspire in Francia, ampliando l'accesso al suo trattamento innovativo per l'apnea ostruttiva del sonno (OSA). Questo sviluppo segna un traguardo significativo per Inspire, poiché la Francia rappresenta il secondo mercato OSA più grande in Europa. La strategia dell'azienda di garantire il rimborso prima della commercializzazione si è rivelata vincente, con la Francia che si unisce ad altri importanti paesi europei nel fornire copertura per la terapia Inspire.

Tim Herbert, Presidente e CEO di Inspire, ha sottolineato l'efficacia clinica e la sicurezza della loro soluzione minimamente invasiva per OSA da moderata a grave. La terapia, che ha ricevuto la Marcatura di Conformità Europea nel 2010, è ora pronta a beneficiare i pazienti e i medici francesi. Andreas Henke, VP esecutivo e Direttore generale Europa, ha evidenziato che questa approvazione per il rimborso offre ai medici del sonno francesi un nuovo opzione terapeutica per i pazienti OSA non trattati.

Inspire Medical Systems, Inc. (NYSE: INSP) ha anunciado el reembolso a nivel nacional para su terapia Inspire en Francia, ampliando el acceso a su tratamiento innovador para la apnea obstructiva del sueño (OSA). Este desarrollo marca un hito significativo para Inspire, ya que Francia representa el segundo mercado de OSA más grande de Europa. La estrategia de la empresa de asegurar el reembolso antes de la comercialización ha demostrado ser exitosa, y Francia se une a otros países europeos clave en proporcionar cobertura para la terapia Inspire.

Tim Herbert, Presidente y CEO de Inspire, enfatizó la eficacia clínica y la seguridad de su solución mínimamente invasiva para OSA moderada a severa. La terapia, que recibió la Marcación de Conformidad Europea en 2010, ahora está lista para beneficiar a los pacientes y médicos franceses. Andreas Henke, VP ejecutivo y Director General de Europa, destacó que esta aprobación de reembolso ofrece a los médicos del sueño franceses una nueva opción terapéutica para pacientes con OSA no tratados.

Inspire Medical Systems, Inc. (NYSE: INSP)는 프랑스에서 Inspire 치료에 대한 국가적 환급을 발표했습니다, 이는 폐쇄성 수면 무호흡증 (OSA)에 대한 혁신적인 치료 접근을 확대합니다. 이 발전은 Inspire에게 중요한 이정표가 되며, 프랑스는 유럽에서 두 번째로 큰 OSA 시장을 차지하고 있습니다. 상업화 전에 환급을 확보하는 회사의 전략은 성공적이었으며, 프랑스는 Inspire 치료에 대한 보장을 제공하는 다른 주요 유럽 국가들에 합류하게 되었습니다.

Inspire의 회장 겸 CEO인 Tim Herbert는 중증 OSA에 대한 최소 침습적 솔루션의 임상 효능 및 안전성을 강조했습니다. 2010년에 유럽 적합성 마크를 받은 이 치료법은 이제 프랑스의 환자와 의사에게 혜택을 줄 준비가 되었습니다. 유럽의 전무이사이자 총괄 이사인 Andreas Henke는 이 환급 승인이 프랑스의 수면 의사들에게 치료되지 않은 OSA 환자들에 대한 새로운 치료 옵션을 제공한다고 강조했습니다.

Inspire Medical Systems, Inc. (NYSE: INSP) a annoncé le remboursement national pour sa thérapie Inspire en France, élargissant l'accès à son traitement innovant pour l'apnée obstructive du sommeil (OSA). Ce développement marque une étape significative pour Inspire, car la France représente le deuxième plus grand marché de l'OSA en Europe. La stratégie de l'entreprise d'assurer le remboursement avant la commercialisation s'est avérée réussie, la France rejoignant d'autres pays européens clés en fournissant une couverture pour la thérapie Inspire.

Tim Herbert, Président et CEO d'Inspire, a souligné l'efficacité clinique et la sécurité de leur solution mini-invasive pour l'OSA modérée à sévère. La thérapie, qui a reçu le marquage CE en 2010, est désormais prête à bénéficier aux patients et aux médecins français. Andreas Henke, VP Exécutif et Directeur Général Europe, a souligné que cette approbation de remboursement offre aux médecins du sommeil français une nouvelle option thérapeutique pour les patients non traités pour l'OSA.

Inspire Medical Systems, Inc. (NYSE: INSP) hat die landesweite Erstattung für die Inspire-Therapie in Frankreich bekannt gegeben, was den Zugang zu ihrer innovativen Behandlung der obstruktiven Schlafapnoe (OSA) erweitert. Diese Entwicklung stellt einen bedeutenden Meilenstein für Inspire dar, da Frankreich den zweitgrößten OSA-Markt in Europa repräsentiert. Die Strategie des Unternehmens, die Erstattung vor der Kommerzialisierung zu sichern, war erfolgreich, und Frankreich reiht sich in die Reihe anderer wichtiger europäischer Länder ein, die eine Deckung für die Inspire-Therapie bieten.

Tim Herbert, Vorsitzender und CEO von Inspire, betonte die klinische Wirksamkeit und Sicherheit ihrer minimalinvasiven Lösung für moderate bis schwere OSA. Die Therapie, die 2010 die europäische Konformitätsmarkierung erhielt, ist nun bereit, französischen Patienten und Ärzten zugutekommen. Andreas Henke, Executive VP und Geschäftsführer Europa, hob hervor, dass diese Genehmigung zur Erstattung den französischen Schlafärzten eine neue therapeutische Option für unbehandelte OSA-Patienten bietet.

Positive
  • Secured countrywide reimbursement for Inspire therapy in France
  • Expanded market access to the second-largest OSA market in Europe
  • Reimbursement approval consistent with other European and global markets
  • Successful implementation of strategy to secure reimbursement before commercialization
Negative
  • None.

Insights

The reimbursement approval for Inspire therapy in France marks a significant milestone for Inspire Medical Systems, Inc. (INSP). This development opens up a lucrative market, as France is the second-largest obstructive sleep apnea (OSA) market in Europe. The French Social Security's endorsement provides a robust financial foundation for future revenue.

Financially, this means:

  • Inspire can now expect a substantial increase in revenue from the French market, boosting its overall earnings.
  • Reimbursement ensures that patients can afford the therapy, potentially leading to a higher adoption rate.
  • This move aligns with Inspire’s strategic approach to secure reimbursements before full-scale commercialization, minimizing financial risks and assuring investor confidence.

Short-term, investors could anticipate a positive market reaction, likely leading to an uptick in stock prices. Long-term, sustained revenue growth and market expansion in Europe could further solidify Inspire's financial stability and market position.

Inspire therapy's reimbursement in France is a testament to its clinical credibility and safety profile. This therapy has a strong foundation of clinical evidence backing its efficacy for moderate to severe OSA. With the French Social Security's support, it is now more accessible to a broader patient population.

Medical and Clinical Insights:

  • This approval reflects the therapy's ability to meet rigorous health standards and prove its value in clinical settings.
  • It enhances Inspire’s reputation among sleep physicians, who can now offer a validated and reimbursed alternative to traditional OSA treatments.
  • This could drive more clinical trials and studies, further bolstering the evidence of its effectiveness and possibly leading to more innovations and improvements.

For retail investors, understanding the clinical value helps in recognizing the long-term potential of the company. The consistent evidence and clinical backing significantly mitigate the risk associated with medical technology investments.

This reimbursement approval significantly enhances Inspire Medical Systems’ market penetration strategy. France, being a major European market, offers substantial opportunities for growth and increased market share in the OSA treatment segment.

Market Implications:

  • By securing reimbursement, Inspire can now aggressively market its therapy, leveraging the social security's coverage to attract a larger patient base.
  • It sets a precedent for other countries, potentially facilitating smoother and quicker reimbursements in other untapped markets.
  • The move also positions Inspire favorably against competitors, providing a unique selling proposition that includes widespread reimbursement approval.

For investors, this approval is a strong indicator of Inspire’s strategic market expansion and competitive edge. It will likely lead to increased market share and drive revenue growth, making it a compelling addition to an investment portfolio.

MINNEAPOLIS, July 23, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced today the publication of the reimbursement of Inspire therapy in France.

“We are thrilled to offer our clinically proven treatment option for moderate to severe OSA to patients and physicians in France,” said Tim Herbert, Chairman and Chief Executive Officer of Inspire. “Inspire therapy is backed by a strong body of evidence and years of clinical experience demonstrating the safety and efficacy of our therapy.”

Inspire therapy received European Conformity Marking for commercialization in Europe in 2010. Since that time, the company’s approach has been to secure reimbursement in targeted countries prior to commencing commercialization efforts. Inspire has already established reimbursement in many key European countries, and the addition of full reimbursement in France expands the market opportunity as France is the second largest OSA market in Europe. The approval in France provides reimbursement consistent with other European and global markets.

“Thanks to the reimbursement of Inspire therapy by the French Social Security, sleep physicians now have a new therapeutic option for patients with untreated OSA,” said Andreas Henke, Executive Vice President, Managing Director Europe.

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com or www.inspiresleep.fr.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, those regarding our expectations to commercialize Inspire therapy in France. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under the captions “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Investor and Media Contact
Ezgi Yagci
Vice President, Investor Relations
ezgiyagci@inspiresleep.com
617-549-2443


FAQ

What is the significance of Inspire Medical Systems' reimbursement approval in France?

The reimbursement approval in France is significant as it expands access to Inspire therapy in the second-largest obstructive sleep apnea (OSA) market in Europe, potentially increasing Inspire Medical Systems' market reach and revenue opportunities.

When did Inspire therapy (INSP) receive European Conformity Marking?

Inspire therapy received European Conformity Marking for commercialization in Europe in 2010.

How does Inspire Medical Systems' approach to market entry differ from other companies?

Inspire Medical Systems' approach is to secure reimbursement in targeted countries prior to commencing commercialization efforts, ensuring market access and financial viability before entering new markets.

What condition does Inspire Medical Systems' (INSP) therapy treat?

Inspire Medical Systems' therapy treats moderate to severe obstructive sleep apnea (OSA).

Inspire Medical Systems, Inc.

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