Nyxoah Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full PMA approval in the second quarter
Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)
('Nyxoah' or the 'Company'), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system.
On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system.
The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system.
Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.
'We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.'
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.
For more information, please visit
http://www.nyxoah.com/
.
Caution
– CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States
FORWARD-LOOKING STATEMENTS
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Contacts:
Nyxoah
John Landry, CFO
[email protected]
For Media
In United States
FINN Partners – Alyssa Paldo
[email protected]
In International/Germany
MC Services – Anne Hennecke
[email protected]
In Belgium/France
Backstage Communication – Gunther De Backer
[email protected]
Attachment
ENGLISH_Update on FDA Approvable Letter_FINAL
GlobeNewswire Distribution ID 1001078888
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Daily Tribune
a day ago
- Daily Tribune
Bahrain Kuwait Insurance Company discloses financial results for half year ended 30th June 2025 showcases BD 2.7 million net profit
Bahrain Kuwait Insurance Company (BKIC) B.S.C. (trading code in Bahrain Bourse 'BKIC' and in Boursa Kuwait 'BKIKWT') announced its consolidated financial results for the six months ended 30th June 2025. Three months ended 30th June 2025 The consolidated financial results showed a net profit after tax attributable to shareholders of BD 1.089 million, compared to BD 1.258 million for the same period last year, representing a 13% decrease. This variance is due to the first-time implementation of the 15% Domestic Minimum Top-up Tax in Bahrain and Kuwait, which came into effect in January 2025 for multinational companies and was not reflected last year. However, the Company recorded growth of 2% in profit attributable to shareholders before tax. Earnings per share for the quarter reached 7 fils, marking a decrease of 1 fils compared to the same period in 2024. The total comprehensive income attributable to the shareholders increased by 52% and reached BD 1.122 million in Q2-2025 compared to BD 0.736 million in Q2-2024. The Company reported insurance revenue of BD 27.719 million for the second quarter of the current year, compared to BD 29.317 million in the same period last year. The insurance service result stood at BD 1.076 million in comparison to BD 1.206 million in the same period last year, impacted by an increase in claims and the Company's continued prudent approach to strengthening reserves. Meanwhile, total investment income saw a robust growth of 81%, rising from BD 0.862 million in the second quarter of last year to BD 1.558 million this year. Six months The consolidated net profit after tax attributable to shareholders stood at BD 2.685 million for the half-year ended 30th June 2025, compared to BD 2.938 million in the corresponding period of 2024, representing a decrease of 8% following the first-time implementation of the new 15% Domestic Minimum Top-up Tax. However, the Company reported a 1.4% increase in profit attributable to shareholders before tax for the current period compared to the same period last year, reflecting continued operational strength. Earnings per share for the period were 18 fils, compared to 20 fils in the same period last year. Meanwhile, total comprehensive income attributable to shareholders increased significantly by 29%, reaching BD 2.892 million versus BD 2.243 million in the prior-year period. The Company recorded a 5% growth in gross written premiums, reaching BD 56.562 million during the first half of the year, compared to BD 53.695 million in the same period of 2024, reflecting continued business expansion and strong market presence. However, there was a marginal decline of 1.6% in Insurance revenue from BD 56.658 million in last year to BD 55.751 million in current year. The Insurance service results reduced from BD 2.204 million in the First half of last year to BD 2.025 million in the first half of the current year primarily due to an increase in reported claims mainly from the Motor Portfolio. In contrast, total investment income delivered strong growth of 26%, rising to BD 3.142 million from BD 2.495 million in the same period last year. The total shareholders' equity as at end of June 2025 was BD 43.959 million compared to BD 44.901 million as at end of last year, representing a decrease of 2% mainly due to allocation towards increased shareholders' dividends payouts. The total assets by the end of June 2025 reached BD 186.652 million compared to BD 186.017 million as at end of last year, representing a marginal increase of 0.3%. The net Insurance contract liabilities increased from BD 64.433 million at the end of the last year to BD 67.145 million at the end of the current period. Board of Directors' Comments All members of the Board expressed their satisfaction: 'Not only is the Board pleased with the results for the first six months of 2025, but all evidence suggests that, whilst monitoring the key strategic projects, the Company is progressing in a very robust, sound, and prudent manner.' Notably, the 2025 results would be impacted with the Domestic Minimum Top-up Tax for the first time after its implementation at 1/1/2025. Therefore, the Board calls upon all shareholders to also consider the 'Pre-Tax Profits' when comparing the Company's results against previous years or against other peers in the marketplace. Chief Executive Officer's Comments BKIC's CEO Dr. Abdulla Sultan stands firm in assessing the 1st half of 2025 consolidated results as satisfactory albeit the significant increase in both Motor claims frequency and severity in 2025, a trend mainly driven by claims inflation. Notwithstanding, the Company has thus far obtained the necessary approvals to implement a stringent plan to ensure enhanced customer service whilst maintaining the overall profitability in the Motor portfolio. Dr. Sultan commented with great prominence: 'The Company is very pleased to announce that its parent GIG Kuwait has obtained an AM Best issuer Credit Rating upgrade to A+.' And in conclusion, he also remained resolute and passionate in his words of praise: 'On this occasion, I would like to thank all teams at BKIC Bahrain, BKIC Kuwait, and our subsidiary for their unfaltering efforts throughout the first half of 2025. The teams remain determined and consistently continue to demonstrate their outstanding dedication, hardwork, and commitment to the Company.'
Gulf Insider
08-08-2025
- Gulf Insider
Americans Reject Fall COVID Shot, Don't Trust CDC Or FDA
A new KFF (formerly known as the Kaiser Family Foundation) poll reveals that the majority of Americans do not intend to get the COVID-19 vaccine this fall, and less than half trust the CDC or FDA to ensure vaccine safety. The nationwide erosion of confidence in federal health agencies and their pharmaceutical partnerships is welcomed by those who have long called for accountability, transparency, and the restoration of informed consent in American Say 'No' to COVID Vaccine According to the KFF Health Tracking Poll on Health Information and Trust, conducted July 8–14, 2025: 59% of U.S. adults say they will either 'definitely not' or 'probably not' receive a COVID-19 vaccine this fall. Only 21% say they will 'definitely get' the shot. Republicans are the least likely to receive the vaccine, with 59% stating they will 'definitely not' take it. Among White adults, 42% say they will 'definitely not' get the shot. These findings follow a growing body of evidence discrediting the effectiveness and safety of the COVID-19 vaccines. 📊 Americans Say 'No' to COVID Shot as Trust in CDC, FDA Crumbles🚨 59% of Americans refuse the fall COVID jab📉 Fewer than half trust CDC/FDA on vaccine safety🧠 Even The Hill is admitting it—kind ofIn this report, I break down the KFF poll, the media spin, RFK Jr.'s… — Jon Fleetwood (@JonMFleetwood) August 5, 2025 A recent JAMA Health Forum study admitted that the shots 'saved far fewer lives than first thought,' especially in younger shots have been linked to 38,709 deaths, 221,030 hospitalizations, and a total of 1,665,264 injuries—though these numbers represent less than 1% of actual adverse events, according to a U.S. Department of Health and Human Services-commissioned report by Harvard Pilgrim Healthcare. These staggering figures may help explain why a clear majority of Americans are now refusing the shot. Just 49% of U.S. adults say they have confidence in federal health agencies like the CDC and FDA to ensure the safety and effectiveness of vaccines approved for use in the U.S. Only 42% believe these agencies make decisions based on science rather than the personal views of agency officials. Just 37% believe the CDC and FDA act independently, without influence from outside interests. These numbers reflect the ongoing fallout from the COVID-19 response, which congressional investigators recently confirmed involved the CDC and White House using 'deeply flawed' messaging and 'overpromising' vaccine safety 'without evidence.' This collapse in public trust is unsurprising given the government's admitted reliance on arbitrary '6-feet' distancing rules, unproven mask mandates, and harmful lockdowns—none of which were grounded in transparent science, but all of which inflicted lasting damage on public health, the economy, and institutional credibility, according to a two-year investigation by the Congressional Select Subcommittee on the Coronavirus Pandemic. Public awareness of recent changes to U.S. vaccine policy remains limited, despite multiple headlines since the appointment of HHS Secretary Robert F. Kennedy Jr.—likely due to mainstream media blackout, institutional resistance, and a legacy press unwilling to cover reforms that threaten the pharmaceutical establishment. (This is why independent media is so important.) 52% say RFK Jr. has made changes to U.S. vaccine policy. Only 26% describe those changes as 'major.' 40% say they don't know enough to characterize the changes. Among parents, confusion is also evident: In fact, the CDC's updated guidance does not formally recommend the shot for healthy children, stating the decision should be made between the provider and the family. 48% are unsure whether federal agencies are currently recommending the COVID-19 vaccine for healthy children this fall. When asked whether RFK Jr.'s changes will make Americans safer: 36% said the changes will make people less safe. 20% said they will make people safer. 31% said they don't know enough to say. 13% believe the changes will not make a difference. The response is largely partisan: 62% of Democrats say RFK Jr.'s changes make people less safe. 41% of Republicans say the changes will make people safer. This split comes despite Kennedy's sweeping reforms—including pulling the CDC's COVID shot recommendation for children and pregnant women, banning mercury in flu vaccines, blocking the WHO's pandemic treaty, defunding Gates-linked GAVI, ending coercive hospital vaccine incentives, and firing all 17 members of the CDC's vaccine advisory panel—each a bold move to restore public health integrity and medical freedom. However, health realists are still waiting for Kennedy to pull the deadly COVID shots from the market. The most trusted source for vaccine information remains personal healthcare providers: 83% of Americans say they trust their doctor 'a great deal' or 'a fair amount.' Trust in government entities is notably lower: CDC: 57% Local public health departments: 62% State government officials: 43% HHS Secretary RFK Jr.: 37% However, RFK Jr. holds strong support among Republicans: 70% of Republicans trust RFK Jr. for vaccine information. Among MAGA-aligned Republicans, that figure rises to 77%. By contrast, only 11% of Democrats say they trust RFK Jr. Among adults who do plan to get the COVID-19 vaccine this fall, concerns about access are more common. But for the general population: Only 33% are concerned the vaccine might not be available. Only 34% of insured adults are concerned their insurance might not cover it. Among those unlikely to get the shot, concerns about access are negligible: Just 11% worry about vaccine availability. Only 14% are concerned about insurance coverage. This poll comes as the FDA expands its fast-track drug approval pipeline, clearing drugs for use in as little as 30 days. The agency has also confirmed plans to bypass normal clinical trial requirements for a new bird flu vaccine, using the same Emergency Use Authorization (EUA) pathway as it did with the COVID shots. In this regulatory environment, the KFF data reflects what many have long warned: Americans are rejecting medical coercion, questioning agency integrity, and demanding informed consent. The message from the American people is clear: we're done being lied to, we're done being experimented on, and we're done trusting captured agencies to protect us—this is the beginning of a public health reckoning, and it's long overdue. Also read: Kremlin Confirms Trump-Putin Meeting 'In Coming Days', Possibly In UAE
Gulf Insider
25-07-2025
- Gulf Insider
UAE Markets Free Of Salmonella-Contaminated Pistachio Spread
The Ministry of Climate Change and Environment (MOCCAE), in coordination with local regulatory authorities, has confirmed that the product 'Spread Pistachio Cacao Cream With Kadayef' under the Emek brand, which is manufactured outside the UAE, is not available in local markets. The product has been marketed as a chocolate inspired by the flavors of Dubai Chocolate. The ministry clarified that the widely known and available Dubai Chocolate products sold in the UAE are free from any Salmonella contamination. This clarification follows a statement issued by the US Food and Drug Administration (FDA), which confirmed that the affected product is limited to US markets. The ministry emphasized that the warning refers to a product being marketed under the Dubai Chocolate label, stressing that this product — manufactured abroad — is merely inspired by the distinctive flavours associated with the original Dubai Chocolate, a name commonly referring to the products of FIX Dessert Chocolatier, a Dubai-based brand known for its luxurious chocolates infused with flavors inspired by Middle Eastern cuisine. These products are subject to the highest safety and quality standards. The ministry reiterated its ongoing commitment to monitoring food safety and protecting public health, in coordination with all relevant authorities. An American retail company had recently recalled a batch of Dubai Chocolate due to concerns over possible Salmonella contamination. The FDA published the recall notice and upgraded its risk level to Class I — the most serious classification. According to the FDA notice, the company World Market recalled the 'Emek Spread Pistachio CaCao Cream With Kadayef' product due to possible Salmonella contamination. The affected items were distributed between June 11 and July 9, 2025. The recall was initiated after product samples tested positive for Salmonella during routine FDA inspections. The recall was first issued on July 14 and was escalated to a Class I recall three days later, as reported by Newsweek magazine. Salmonella is a pathogen that can cause serious, and sometimes fatal, infections — particularly in young children, the elderly, and individuals with weakened immune systems. According to the American company's statement, healthy individuals infected with Salmonella may experience symptoms such as fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. The statement added: 'In rare cases, the infection may spread to the bloodstream and lead to more severe illnesses such as arterial infections (e.g., infected aneurysms), endocarditis, or arthritis.' Although the recall was prompted by positive test results for Salmonella, no illnesses have been reported to date. Dubai Chocolate, a pistachio and kadayef-filled chocolate bar, gained viral popularity on TikTok in 2024. The original chocolate bar was created by FIX Dessert Chocolatier in Dubai but has since been replicated and modified by various brands, including Emek Gıda, whose product was affected by the current recall. FIX Dessert Chocolatier, a dessert brand founded in Dubai by Sara Hammouda, originated the pistachio-kadayef chocolate bar concept. Renowned Filipino pastry chef Noel Katis was brought on board by FIX to help develop the bar, which has since seen widespread popularity. Last month, the UK's Food Standards Agency reported that certain Dubai-style chocolates sold in UK retail markets may not comply with national standards and could contain banned additives or colorants.
