Inspire Medical Systems, Inc. Announces FDA Approval of the Inspire V System

Rhea-AI Summary

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.

Positive

• FDA approval of next-generation Inspire V therapy system
• Planned soft launch in late 2024 and full launch in 2025
• Advancement in minimally invasive OSA treatment technology

Negative

• None.

Medical Device Expert

The FDA approval of Inspire Medical Systems' next-generation Inspire V therapy system represents a significant advancement in obstructive sleep apnea (OSA) treatment. This approval underscores the company's commitment to innovation and could potentially strengthen Inspire's market position in the OSA treatment space.

Key features of the Inspire V system include:

• A new neurostimulator design
• Bluetooth®-enabled patient remote
• Updated physician programmer

These enhancements likely aim to improve patient experience, treatment efficacy and physician control over the therapy.

The phased launch strategy, with a soft launch in late 2024 and full launch in 2025, suggests a cautious approach to market introduction. This timeline allows Inspire to build inventory, train healthcare providers and ensure a smooth rollout. It also provides time to gather real-world data on the system's performance, which could be important for wider adoption and potential insurance coverage decisions.

While the approval is promising, investors should note that market success will depend on factors beyond regulatory approval, such as:

• Clinical performance in real-world settings
• Physician adoption rates
• Patient satisfaction and outcomes
• Reimbursement policies

The company's focus on operational readiness indicates an understanding of these challenges and a commitment to a successful product launch.

Financial Analyst

The FDA approval of Inspire Medical Systems' new Inspire V therapy system is a positive development for the company's financial outlook. This approval could potentially drive revenue growth and market expansion in the coming years.

Key financial implications to consider:

• Revenue Potential: The new system could lead to increased sales, both from new patients and potential upgrades for existing users.
• Market Share: An advanced product may help Inspire maintain or expand its market share in the competitive OSA treatment space.
• R&D Investment Return: The approval validates the company's R&D investments and may justify continued innovation spending.
• Operational Costs: The focus on operational readiness suggests potential near-term increases in manufacturing and inventory costs.

The phased launch strategy (soft launch in late 2024, full launch in 2025) indicates a measured approach to revenue recognition. This could result in a gradual ramp-up of sales rather than an immediate spike, which may impact short-term financial projections.

Investors should monitor:

• Gross margins, as the new system may have different production costs
• Sales and marketing expenses related to the launch
• Inventory levels and cash flow management during the production ramp-up
• Potential impact on the existing product line's sales

While the approval is undoubtedly positive, the full financial impact may not be evident until the 2025 full launch and beyond. The company's ability to execute the launch strategy and gain market traction will be important for realizing the financial benefits of this regulatory milestone.

MINNEAPOLIS, Aug. 02, 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), today announced the FDA approval of the Inspire V therapy system which includes the next generation neurostimulator and the associated Bluetooth® patient remote and physician programmer.

“We are thrilled to announce the FDA approval of our next generation Inspire neurostimulation system,” said Tim Herbert, Chairman and Chief Executive Officer of Inspire Medical Systems. “The FDA approval marks a key milestone for the future of Inspire therapy and reinforces the many years of hard work by our team members.”

The company’s focus remains on operational readiness, which includes product manufacturing and establishing inventory levels to support a full commercial launch in the United States. The company continues to target a soft launch in late 2024 and a full launch in 2025.

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, EU MDR, and PDMA-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.

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, statements regarding our planned timing to launch our Inspire V therapy system.   In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; the impact of macroeconomic trends; general and international economic, political, and other risks, including currency, inflation, stock market fluctuations and the uncertain economic environment; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, including our next generation Inspire therapy system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; and the timing or likelihood of regulatory filings and approvals. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found 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, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

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

FAQ

What is the Inspire V therapy system approved by the FDA for INSP?

The Inspire V therapy system is a next-generation neurostimulator approved by the FDA for treating obstructive sleep apnea (OSA). It includes a new neurostimulator, Bluetooth® patient remote, and physician programmer.

When will Inspire Medical Systems (INSP) launch the Inspire V system in the US market?

Inspire Medical Systems plans a soft launch of the Inspire V system in late 2024, followed by a full launch in 2025 in the United States market.

What is Inspire Medical Systems (INSP) focusing on after FDA approval of the Inspire V system?

After FDA approval, Inspire Medical Systems is focusing on operational readiness, which includes product manufacturing and establishing inventory levels to support a full commercial launch of the Inspire V system.

How does the Inspire V therapy system differ from previous versions for INSP?

The Inspire V therapy system is a next-generation neurostimulator that includes new features such as a Bluetooth® patient remote and an updated physician programmer, representing an advancement in Inspire's minimally invasive OSA treatment technology.