Latest news with #neurostimulation
Bloomberg
5 days ago
- Business
- Bloomberg
ICYMI: Inspire's Big Buyback
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 neuro-stimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea. The company last week cut its revenue guidance for the full year, saying the US commercial launch for Inspire V is going slower than expected. On Monday, however, it announced a $200 million stock buyback plan, which representing 8.5% of the company's current market value, data compiled by Bloomberg show. Tim Herbert, Inspire's Founder, Chairman, President and CEO discusses the reasons for the repurchase program and the health of the company overall. Tim speaks with Tim Stenovec and Carol Massar on Bloomberg Businessweek Daily.
Yahoo
07-08-2025
- Business
- Yahoo
Robert W. Baird Remains a Buy on Inspire Medical Systems (INSP)
Inspire Medical Systems, Inc. (NYSE:INSP) is one of the top oversold NYSE stocks to buy now. Robert W. Baird analyst David Rescott maintained a Buy rating on Inspire Medical Systems, Inc. (NYSE:INSP) on August 5, setting a price target of $150.00. A medical professional performing a minimally invasive procedure while using the company's technology. The rating update came after Inspire Medical Systems, Inc.'s (NYSE:INSP) release of its fiscal Q2 2025 earnings on August 4. Inspire Medical Systems, Inc. (NYSE:INSP) generated $217.1 million in revenue in fiscal Q2 2025, reflecting an 11% rise over the same quarter last year. Gross margin for the quarter reached 84.0%, while net loss was $3.6 million. The company reported $13.3 million in adjusted net income, while adjusted diluted earnings per share were $0.45 for fiscal Q2 2025. Inspire Medical Systems, Inc. (NYSE:INSP) also announced the initiation of the full launch of the Inspire V neurostimulation system in the United States. Inspire Medical Systems, Inc. (NYSE:INSP) is a medical technology company that develops and commercializes innovative, minimally invasive solutions for obstructive sleep apnea. The company offers Inspire therapy, which includes implantable components with a pressure-sensing lead, a stimulation lead, and a neurostimulator, operable through a remote control. While we acknowledge the potential of INSP as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
04-08-2025
- Business
- Yahoo
Inspire Medical Systems, Inc. Announces Second Quarter 2025 Financial Results and Updates 2025 Outlook
MINNEAPOLIS, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire, or the company), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, today reported financial results for the quarter ended June 30, 2025. Recent Business Highlights Generated revenue of $217.1 million in the second quarter of 2025, an 11% increase over the same quarter last year Achieved gross margin of 84.0% in the second quarter of 2025 Net loss was $3.6 million in the second quarter of 2025. Adjusted net income was $13.3 million Loss per share was $0.12 in the second quarter of 2025. Adjusted diluted earnings per share was $0.45 Initiated the full launch of the Inspire V neurostimulation system in the U.S. 'The full launch of our FDA-cleared Inspire V system in the U.S. is an important milestone for Inspire. We have been receiving strong positive feedback from both surgeons and patients who value the simplified procedure and excellent patient outcomes enabled by this next generation technology,' said Tim Herbert, Chairman and CEO of Inspire. 'In the near future, we look forward to presenting the clinical evidence collected to date.' 'The broad enthusiasm for Inspire V gives us confidence that it will be a growth engine for the Company. However, the U.S. commercial launch is progressing slower than expected, and the timeline to complete the full transition to Inspire V has been pushed forward, which will impact financial results for the year.' 'Importantly, we believe the operational headwinds are temporary, and actions are underway to address them,' continued Mr. Herbert. 'We remain steadfast in our commitment to serving the many patients who struggle with untreated moderate to severe OSA, delivering strong patient outcomes and executing on our strategy to drive profitable growth and value creation for all stakeholders.' Second Quarter 2025 Financial Results Revenue was $217.1 million for the second quarter, an 11% increase from $195.9 million in the corresponding prior year period. U.S. revenue for the quarter was $207.2 million, an increase of 10% as compared to the prior year quarter. Second quarter revenue outside the U.S. was $9.9 million, an increase of 23% as compared to the second quarter of 2024. Gross margin was 84.0% for the second quarter of 2025 compared to 84.8% in the second quarter of 2024. The decrease is primarily due to a $2.1 million charge associated with excess components inventory related to Inspire IV. Operating expenses were $185.7 million for the second quarter of 2025, as compared to $160.9 million in the corresponding prior year period, an increase of 15%. This increase primarily reflected ongoing investments in the expansion of the U.S. sales organization, patient marketing expenses, and general corporate costs, partially offset by a reduction in R&D. Operating expenses also included an additional one-time charge of $11.2 million of accelerated stock-based compensation expense for employees who are retirement eligible in accordance with changes to the Inspire incentive award plan upon the employee's death, disability, or retirement, and finally, $1.7 million in certain litigation-related legal expenses. These items do not reflect costs associated with our ongoing operations and a reconciliation table has been included at the bottom of this release. Operating loss was $3.3 million for the second quarter of 2025, as compared to operating income of $5.1 million in the prior year period, a decrease of 165%. Net loss was $3.6 million for the second quarter of 2025 as compared to a net income of $9.8 million in the corresponding prior year period. The net loss includes a $4.0 million non-cash impairment of a strategic investment. Adjusted EBITDA for the second quarter of 2025 was $44.1 million as compared to $38.7 million in the corresponding prior year period. The diluted net loss for the second quarter of 2025 was $0.12 per share, as compared to a net income of $0.32 per share in the prior year period. The adjusted net income for the second quarter of 2025 was $0.45 per share. As of June 30, 2025, cash, cash equivalents, and investments were $410.7 million compared to $516.5 million on December 31, 2024. Executive Retirement 'Randy Ban, our Executive Vice President of Patient Access and Therapy Development, recently notified us of his intention to retire on January 30, 2026. During his tenure, Randy has been one of Inspire's most influential leaders, and as our initial commercial leader, he played a significant role in advancing access to Inspire therapy and building a strong, mission-driven organization. We are grateful for Randy's many contributions and wish him the best in his retirement,' concluded Mr. Herbert. Full Year 2025 Guidance Inspire currently anticipates full year 2025 revenue guidance to be in the range of $900 million to $910 million, which represents growth of 12% to 13% over full year 2024 revenue of $802.8 million. This compares to the prior guidance range of $940 to $955 million. The company is maintaining its full year 2025 gross margin guidance of 84% to 86%. Inspire anticipates diluted net income per share guidance for the full year 2025 to be in the range of $0.40 to $0.50. This compares to the prior guidance of $2.20 to $2.30 per share. Webcast and Conference Call Inspire's management will host a conference call after market close today, Monday, August 4, 2025, at 5:00 p.m. Eastern Time to discuss these results and answer questions. To access the conference call, please preregister on Registrants will receive confirmation with dial-in details. A live webcast of the event can be accessed on A replay of the webcast will be available on starting approximately two hours after the event and archived on the site for two weeks. 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 of its kind that provides a safe and effective treatment for moderate to severe obstructive sleep apnea. For additional information about Inspire, please visit Use of Non-GAAP Financial Measures This press release includes the non-GAAP financial measures of Adjusted net income, Adjusted earnings per share ("EPS"), Adjusted EBITDA, and Adjusted EBITDA margin, which differ from financial measures calculated in accordance with U.S. generally accepted accounting principles ('GAAP'). We define Adjusted net income as net income or loss, plus items that are not indicative of our ongoing operations. Net income is the most directly comparable GAAP financial measure to adjusted net income. Adjusted EPS is calculated as adjusted net income divided by the dilutive weighted average shares outstanding. Diluted EPS is the most directly comparable GAAP financial measure to adjusted EPS. We define Adjusted EBITDA as net income or loss, less interest income, plus interest expense, plus income tax expense, plus depreciation and amortization, plus stock-based compensation expense, plus litigation-related legal expenses and other non-operating expenses less non-operating income. Net income is the most directly comparable GAAP financial measure to Adjusted EBITDA. We define Adjusted EBITDA margin in this release as Adjusted EBITDA divided by revenue. Net income margin is the most directly comparable GAAP measure to Adjusted EBITDA margin. Reconciliations of these non-GAAP financial measures to their most directly comparable GAAP measures are included in this press release. These non-GAAP financial measures are presented because we believe they are useful indicators of our operating performance. Management uses these measures principally as measures of our operating performance and for planning purposes, including the preparation of our annual operating plan and financial projections. We believe these measures are useful to investors as supplemental information and because they are frequently used by analysts, investors and other interested parties to evaluate companies in our industry. We also believe these non-GAAP financial measures are useful to our management and investors as a measure of comparative operating performance from period to period. These non-GAAP financial measures should not be considered as an alternative to, or superior to, the most directly comparable GAAP financial measures, as measures of financial performance or cash flows from operations, as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and they should not be construed to imply that our future results will be unaffected by unusual or non-recurring items. In addition, Adjusted EBITDA is not intended to be a measure of cash flow for management's discretionary use, as it does not reflect certain cash requirements such as tax payments, capital expenditures and certain other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized. In evaluating our non-GAAP financial measures, you should be aware that in the future we may incur expenses that are the same as or similar to some of the adjustments in this presentation. Our presentation of non-GAAP financial measures should not be construed to imply that our future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on our GAAP results in addition to using non-GAAP financial measures on a supplemental basis. Our definition of these non-GAAP financial measures is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. 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 full year 2025 financial outlook and our expectations regarding the launch of our Inspire V neurostimulation system, including the timeline to complete the full transition to that product. 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, our history of operating losses and dependency on our Inspire therapy for revenues; commercial success and market acceptance of our Inspire therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy or any future products we may seek to commercialize; competitive companies, technologies and pharmaceuticals in our industry; our involvement in current or future legal disputes or regulatory proceedings; our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire therapy; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; our ability to accurately forecast customer demand for our Inspire therapy 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 therapy in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; our ability to address quality issues that may arise with our Inspire therapy; our ability to successfully integrate any acquired business, products, or technologies; changes in global macroeconomic trends; challenges experienced by patients in obtaining prior authorization, our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy; our business model and strategic plans for our products, technologies and business, including our implementation thereof; the impact of glucagon-like peptide 1 class of drugs on demand for our Inspire therapy; risks related to information technology and cybersecurity; our ability to commercialize or obtain regulatory approvals for our Inspire therapy, or the effect of delays in commercializing or obtaining regulatory approvals; and FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally. 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, 2024, as updated in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 to be 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 and the Investors page of our website at 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 & Media ContactEzgi YagciVice President, Investor Relationsezgiyagci@ Inspire Medical Systems, Statements of Operations and Comprehensive Income (Loss) (unaudited)(in thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Revenue $ 217,086 $ 195,885 $ 418,403 $ 359,895 Cost of goods sold 34,672 29,843 65,381 54,600 Gross profit 182,414 166,042 353,022 305,295 Operating expenses: Research and development 26,209 28,859 54,012 57,709 Selling, general and administrative 159,521 132,084 303,811 257,705 Total operating expenses 185,730 160,943 357,823 315,414 Operating (loss) income (3,316 ) 5,099 (4,801 ) (10,119 ) Other (income) expense: Interest and dividend income (4,486 ) (5,882 ) (9,552 ) (11,805 ) Interest expense 4 — 4 — Other expense, net 3,498 135 2,920 195 Total other income (984 ) (5,747 ) (6,628 ) (11,610 ) Income (loss) before income taxes (2,332 ) 10,846 1,827 1,491 Income taxes 1,260 1,053 2,427 1,703 Net income (loss) (3,592 ) 9,793 (600 ) (212 ) Other comprehensive income (loss): Foreign currency translation gain (loss) 191 (39 ) (109 ) (173 ) Unrealized loss on investments (22 ) (200 ) (31 ) (742 ) Total comprehensive income (loss) $ (3,423 ) $ 9,554 $ (740 ) $ (1,127 ) Net income (loss) per share: Basic $ (0.12 ) $ 0.33 $ (0.02 ) $ (0.01 ) Diluted $ (0.12 ) $ 0.32 $ (0.02 ) $ (0.01 ) Weighted average shares outstanding: Basic 29,506,807 29,728,849 29,604,043 29,672,006 Diluted 29,506,807 30,408,439 29,604,043 29,672,006 Inspire Medical Systems, Balance Sheets (unaudited)(in thousands, except share and per share amounts) June 30,2025 December 31,2024 Assets Current assets: Cash and cash equivalents $ 106,927 $ 150,150 Investments, short-term 193,968 295,396 Accounts receivable, net of allowance for credit losses of $1,229 and $880, respectively 137,687 93,068 Inventories, net 121,633 80,118 Prepaid expenses and other current assets 12,974 12,074 Total current assets 573,189 630,806 Investments, long-term 109,830 70,995 Property and equipment, net 85,274 71,925 Operating lease right-of-use assets 24,524 23,314 Other non-current assets 9,376 11,343 Total assets $ 802,193 $ 808,383 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 53,162 $ 38,687 Accrued expenses 40,197 49,814 Total current liabilities 93,359 88,501 Operating lease liabilities, non-current portion 30,909 30,039 Other non-current liabilities 111 148 Total liabilities 124,379 118,688 Stockholders' equity: Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding — — Common Stock, $0.001 par value per share; 200,000,000 shares authorized; 29,569,477 and 29,740,176 issued and outstanding at June 30, 2025 and December 31, 2024, respectively 29 30 Additional paid-in capital 969,903 981,043 Accumulated other comprehensive income 396 536 Accumulated deficit (292,514 ) (291,914 ) Total stockholders' equity 677,814 689,695 Total liabilities and stockholders' equity $ 802,193 $ 808,383 Inspire Medical Systems, of Non-GAAP Financial Measures (unaudited)(in thousands, except share and per share amounts)Reconciliation of GAAP Net Income (Loss) and Income per Share to Non-GAAP Adjusted Net Income and Adjusted Net Income per Share Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Net income (loss) $ (3,592 ) $ 9,793 $ (600 ) $ (212 ) Stock-based compensation expense(1) 11,155 — 11,155 — Legal fees(2) 1,736 — 1,736 — Other(3) 4,046 — 4,046 — Adjusted net income (loss) $ 13,345 $ 9,793 $ 16,337 $ (212 ) Net income (loss) per share: Basic $ (0.12 ) $ 0.33 $ (0.02 ) $ (0.01 ) Diluted $ (0.12 ) $ 0.32 $ (0.02 ) $ (0.01 ) Adjusted net income per share: Basic $ 0.45 $ 0.33 $ 0.55 $ (0.01 ) Diluted $ 0.45 $ 0.32 $ 0.55 $ (0.01 ) Weighted average shares outstanding: Basic 29,506,807 29,728,849 29,604,043 29,672,006 Diluted 29,506,807 30,408,439 29,604,043 29,672,006 (1) Represents accelerated stock-based compensation expense for certain employees who are retirement eligible in accordance with the implementation of changes to the treatment of equity awards under the Inspire Medical Systems, Inc. 2018 Incentive Award Plan upon the holder's death, disability, or retirement. (2) These costs represent legal-related expenses related to a civil investigative demand from the Department of Justice and a patent infringement suit that we filed against Nyxoah S.A. and its wholly-owned subsidiary, Nyxoah, Inc. These costs do not reflect costs associated with our normal ongoing operations. (3) Represents a non-cash impairment of a strategic investment, which does not reflect costs associated with our ongoing of GAAP Net Income (Loss) to Non-GAAP Adjusted EBITDA Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Net income (loss) $ (3,592 ) $ 9,793 $ (600 ) $ (212 ) Interest and dividend income (4,486 ) (5,882 ) (9,552 ) (11,805 ) Interest expense 4 — 4 — Income taxes 1,260 1,053 2,427 1,703 Depreciation and amortization 3,414 1,383 6,458 2,222 EBITDA (3,400 ) 6,347 (1,263 ) (8,092 ) Stock-based compensation expense(4) 41,724 32,322 72,780 58,644 Legal fees 1,736 — 1,736 — Other 4,046 — 4,046 — Adjusted EBITDA $ 44,106 $ 38,669 $ 77,299 $ 50,552 (4) Total stock-based compensation expense. Reconciliation of GAAP Net Income Margin and Non-GAAP Adjusted EBITDA Margin Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Net income margin(5) (2) % 5 % — % — % Interest and dividend income (2) % (3) % (2) % (3) % Interest expense — % — % — % — % Income taxes 1 % 1 % 1 % — % Depreciation and amortization 2 % 1 % 2 % 1 % Stock-based compensation expense(4) 18 % 16 % 16 % 16 % Legal fees 1 % — % — % — % Other 2 % — % 1 % — % Adjusted EBITDA margin(6) 20 % 20 % 18 % 14 % (4) Total stock-based compensation expense. (5) Net income margin is calculated as net income (loss) divided by total revenue. (6) Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by total revenue.
Yahoo
30-07-2025
- Business
- Yahoo
BrainsWay to Report Second Quarter 2025 Financial Results on August 13, 2025
BURLINGTON, Mass. and JERUSALEM, July 30, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ('BrainsWay' or the 'Company'), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it will report its second quarter 2025 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, August 13, 2025. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. Conference Call Dial-In & Webcast Information Date: Wednesday, August 13, 2025 Time: 8:30 AM Eastern Time United States: 1-877-300-8521 International: 1-412-317-6026 Israel: 1-80-921-2373 Conference ID: 10201287 Webcast: Link The conference call will be broadcast live and will be available for replay for 30 days on the Company's website, Please access the Company's website at least 10 minutes ahead of the conference call to register. About BrainsWayBrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit Contacts: BrainsWay:Ido MaromChief Financial Investors:Brian RitchieLifeSci Advisorsbritchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CNN
11-07-2025
- Health
- CNN
Most sleep apnea treatments blow. This one sucks. Is it on to something?
For a potentially serious medical condition, it's remarkable how few people know they have obstructive sleep apnea (OSA). OSA, in which a person's upper airway collapses, causing irregular breathing, is the most common sleep-related breathing condition. One study estimated well over 900 million adults between 30 and 69 years old may have it worldwide, though as many as four in five moderate-to-severe cases are undiagnosed. Left untreated, it can increase the risk of high blood pressure, cardiovascular disease, hearth attack, stroke, and type 2 diabetes, and yet untreated is what most cases — diagnosed and undiagnosed — are. The good news is that for people with a diagnosis, there have never been more ways to remedy the problem. With the global sleep apnea device market valued at $8.52 billion in 2024 and projected to rise to nearly $13 billion by 2030, according to one 2025 report, medical tech companies are developing new solutions. Continuous positive airway pressure (CPAP) machines, which push air into the mouth to maintain open airways, are highly effective and have long been considered the gold standard treatment. However, CPAP can have a high initial dropout rate, with users citing the discomfort of wearing a mask strapped to the face, or the lifestyle adaptations required to use the machine. Despite CPAP's dominance, the marketplace for solutions is opening up. Mandibular advancement devices worn over teeth hold the lower jaw and tongue forward; neurostimulation implants trigger the hypoglossal nerve into action to prevent the tongue and soft tissues from blocking airways; there's also a drug being trialed that's designed to stimulate the nerve. Another alternative is negative pressure devices, which unlike CPAP, suck instead of blow, pulling the tongue and soft tissues up and forward in the mouth. So far, such devices haven't been shown to be as effective as CPAP, but the technology is slowly finding its place in the market, with Taiwanese company Somnics Health carving out a foothold. Roughly the size of a smartphone, Somnics' iNAP is a battery-powered device that attaches to a narrow tube with a flexible mouthpiece at the other end. That is worn inside the mouth, and once switched on, negative pressure keeps airways open. Users then breathe through their nose as normal. 'The beauty of it is it allows natural breathing … and it's a very comfortable, quiet and efficient solution,' said Somnics general manager Olivier Lauzeral in a video interview. The iNAP was conceived over a decade ago by Somnics founder Chung Chu Chen, who combined his research with intellectual property purchased from US company Apnicure (which went out of business in 2017, said Lauzeral) to create a negative pressure product. Initial R&D and clinical work took place in Taiwan, where it was first approved by authorities. Since then it has been gradually introduced to new markets across Asia and Europe, winning multiple design awards. In 2020 it was cleared by the US Food and Drug Administration for use in the United States among adults with obstructive sleep apnea who won't use CPAP. Today, around 3,000 patients use the iNAP in the US, said Lauzeral, and around 10,000 worldwide. While studies have shown that negative pressure devices are less effective than CPAP, Lauzeral said that the company's target market is patients who decide not to use CPAP and mandibular devices, but are not ready for a surgical solution like neurostimulation. 'Seventy percent of our patients are 'CPAP failing,'' he explained. 'That was our first way to adopt patients — to talk to those who had that experience with CPAP. The other 30% are what we call 'naïve patients,' (meaning) they hadn't tried any other treatments before.' Lauzeral hopes that the convenience of a discreet and portable device that can run for five nights on a single charge will attract patients from younger demographics. 'Half of the population with sleep apnea is younger than 53,' he said. 'A lot of those patients don't want to touch a CPAP. 'What's sad to see is those people being in denial, not wanting to be treated when they're in their 30s or early 40s. They don't get into their treatment, then their sleep apnea deteriorates… 10 years later they have no choice but getting into CPAP and at that point their health is really not good.' Somnics has recently introduced a subscription model in the US, whereby patients can pay for the device in installments over 24 months, which retails at $1,399. Unlike most CPAP machines, the prescription-only iNAP is not currently covered by health insurance in the US, though Lauzeral said Somnics is hoping to change this. Dr. Hrayr Attarian, a sleep medicine specialist and professor of neurology at Northwestern University Feinberg School of Medicine, told CNN that there need to be bigger studies on the efficacy of iNAP. 'The research out there was done in small groups of people,' he said in an email. 'Even with those limitations,' studies showed improvements in 75% and 83% of patients, 'vs. close to 95% with CPAP,' he added. Attarian characterized the device as 'an alternative but not a replacement for CPAP,' though agreed that Somnics' treatment was 'less intrusive.' Surveying the market, although 'OSA treatments are going to be more fragmented… nothing so far has the same efficacy of CPAP,' he said. To become a viable competitor, negative pressure manufacturers need to conduct clinical trials with 'a larger number of participants with all degrees of (OSA) severity,' he added. Dr. Johan Verbraecken, pulmonologist and medical coordinator at the Sleep Disorders Centre, Antwerp University Hospital, agreed that more research would help establish the effectiveness of the iNAP. Currently, it's not a first-line treatment, he said — particularly for severe cases of OSA. Verbraecken described it as an 'add-on treatment instead of a standalone treatment.' He said that the iNAP has minimal side effects but argued that to compete with CPAP, the product needs to more effectively reduce patients' Apnea-Hypopnea Index (AHI) — how often a person's breathing slows or stops during sleep. 'There has always been an interest in (CPAP) alternatives,' he said. 'These numbers grow, given more patients get the diagnosis, while the absolute number of people not tolerant to CPAP is growing accordingly. On the other hand, the dropout rate is lowering, given better CPAP and mask technology.' Somnics will be banking that there will continue to be a percentage of patients who will remain averse to CPAP. 'We're ready to start working with partners that will help us really get to the next level and grow and capture all those patients,' said Lauzeral.
