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Inspire Medical (INSP) Gets FDA Nod for Inspire V System
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Inspire Medical Systems, Inc. (INSP - Free Report) recently announced that the FDA has approved its Inspire V therapy system. This next-generation system includes a cutting-edge neurostimulator and a Bluetooth-enabled patient remote and physician programmer to improve the management and treatment of obstructive sleep apnea (OSA).
Inspire Medical is a medical technology company dedicated to developing and commercializing innovative, minimally invasive solutions for OSA. Its proprietary Inspire therapy is the first and only neurostimulation technology approved by the FDA, European Union Medical Device Regulation (EU MDR) and Pharmaceuticals and Medical Devices Agency (PDMA), offering a safe and effective treatment for moderate-to-severe OSA.
Significance of the Approval
Per Inspire Medical, the FDA approval represents a significant advancement in the treatment of OSA. This milestone not only underscores the company's commitment to developing innovative, minimally invasive solutions but also sets the stage for a transformative shift in OSA management. The introduction of a Bluetooth-enabled neurostimulator and associated tools enhances the precision and convenience of treatment, promising improved patient outcomes and streamlined physician interactions. As Inspire Medical prepares for a full commercial launch in 2025, this approval paves the way for broader access to cutting-edge therapy for OSA patients across the United States.
Inspire Medical's market share in sleep apnea treatment has been expanding since a major recall affected traditional PAP maker Philips. Additionally, last month, Inspire Medical secured CE mark approval for its Inspire therapy under the new EU MDR regulations.
Industry Prospects
Per a report in Markets and Markets, the global sleep apnea devices market is expected to be worth $6.5 billion in 2024. It is anticipated to reach $9.3 billion by 2029 at a CAGR of 7.3%.
The robust growth is primarily driven by increased investments and funding from leading manufacturers. These investments lead to the development of more comfortable, efficient and user-friendly CPAP devices and diagnostics. Enhanced research and development efforts, supported by this funding, result in innovative technologies that improve patient compliance and therapeutic outcomes. Furthermore, the expanded market reach and improved accessibility to advanced sleep apnea solutions globally are direct outcomes of these financial commitments, collectively driving the demand for sleep apnea devices.
Other Recent Developments
In July, Inspire Medical announced preliminary, unaudited results for second-quarter 2024 and updated its full-year 2024 revenue outlook. The company anticipates second-quarter revenues to be $195.9 million, a 30% increase from second-quarter 2023, with U.S. revenues expected to be $187.8 million (up 30%) and international revenues to be $8.1 million (up 27%). Full-year 2024 revenues are projected to be between $788 million and $798 million, indicating 26% to 28% growth over 2023 and a $13 million increase from the initial guidance of $775 million to $785 million.
Last month, Inspire Medical announced that EU MDR has approved additional MRI scan conditions for its Inspire therapy. EU MDR’s new approval allows full-body MRI scans, expanding the previous labeling that permitted only head, neck, and extremity scans. This retroactive approval applies to all patients with the Inspire IV neurostimulator device, introduced in 2018. This milestone enhances the imaging options for current and future patients with obstructive sleep apnea who use Inspire therapy.
Price Performance
Shares of Inspire Medical have decreased 26.5% so far this year compared with a 15.8% decline in the industry. The S&P 500 has witnessed a 12.3% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inspire Medical carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the broader medical space are Universal Health Service (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) , and ABM Industries (ABM - Free Report) . While Universal Health Service sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Service has gained 41.1% compared with the industry's 34.8% rise so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics shares have gained 3.7% so far this year compared with the industry’s 10.2% rise.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% increase.
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Inspire Medical (INSP) Gets FDA Nod for Inspire V System
Inspire Medical Systems, Inc. (INSP - Free Report) recently announced that the FDA has approved its Inspire V therapy system. This next-generation system includes a cutting-edge neurostimulator and a Bluetooth-enabled patient remote and physician programmer to improve the management and treatment of obstructive sleep apnea (OSA).
Inspire Medical is a medical technology company dedicated to developing and commercializing innovative, minimally invasive solutions for OSA. Its proprietary Inspire therapy is the first and only neurostimulation technology approved by the FDA, European Union Medical Device Regulation (EU MDR) and Pharmaceuticals and Medical Devices Agency (PDMA), offering a safe and effective treatment for moderate-to-severe OSA.
Significance of the Approval
Per Inspire Medical, the FDA approval represents a significant advancement in the treatment of OSA. This milestone not only underscores the company's commitment to developing innovative, minimally invasive solutions but also sets the stage for a transformative shift in OSA management. The introduction of a Bluetooth-enabled neurostimulator and associated tools enhances the precision and convenience of treatment, promising improved patient outcomes and streamlined physician interactions. As Inspire Medical prepares for a full commercial launch in 2025, this approval paves the way for broader access to cutting-edge therapy for OSA patients across the United States.
Inspire Medical's market share in sleep apnea treatment has been expanding since a major recall affected traditional PAP maker Philips. Additionally, last month, Inspire Medical secured CE mark approval for its Inspire therapy under the new EU MDR regulations.
Industry Prospects
Per a report in Markets and Markets, the global sleep apnea devices market is expected to be worth $6.5 billion in 2024. It is anticipated to reach $9.3 billion by 2029 at a CAGR of 7.3%.
The robust growth is primarily driven by increased investments and funding from leading manufacturers. These investments lead to the development of more comfortable, efficient and user-friendly CPAP devices and diagnostics. Enhanced research and development efforts, supported by this funding, result in innovative technologies that improve patient compliance and therapeutic outcomes. Furthermore, the expanded market reach and improved accessibility to advanced sleep apnea solutions globally are direct outcomes of these financial commitments, collectively driving the demand for sleep apnea devices.
Other Recent Developments
In July, Inspire Medical announced preliminary, unaudited results for second-quarter 2024 and updated its full-year 2024 revenue outlook. The company anticipates second-quarter revenues to be $195.9 million, a 30% increase from second-quarter 2023, with U.S. revenues expected to be $187.8 million (up 30%) and international revenues to be $8.1 million (up 27%). Full-year 2024 revenues are projected to be between $788 million and $798 million, indicating 26% to 28% growth over 2023 and a $13 million increase from the initial guidance of $775 million to $785 million.
Last month, Inspire Medical announced that EU MDR has approved additional MRI scan conditions for its Inspire therapy. EU MDR’s new approval allows full-body MRI scans, expanding the previous labeling that permitted only head, neck, and extremity scans. This retroactive approval applies to all patients with the Inspire IV neurostimulator device, introduced in 2018. This milestone enhances the imaging options for current and future patients with obstructive sleep apnea who use Inspire therapy.
Price Performance
Shares of Inspire Medical have decreased 26.5% so far this year compared with a 15.8% decline in the industry. The S&P 500 has witnessed a 12.3% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inspire Medical carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the broader medical space are Universal Health Service (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) , and ABM Industries (ABM - Free Report) . While Universal Health Service sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Service has gained 41.1% compared with the industry's 34.8% rise so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics shares have gained 3.7% so far this year compared with the industry’s 10.2% rise.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% increase.