Nyxoah Provides General Corporate Update
Nyxoah Provides General Corporate Update
Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022
Mont-Saint-Guibert, Belgium – January 10, 2022, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided a general corporate update.
- Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently 15 active and enrolling patient sites in the U.S., with implants expected to be completed in Q1 2022
- Secured CE Mark MR conditional labeling for the Genio® system in January, ensuring that implanted patients can undergo full-body 1.5T and 3T MRI diagnostic scans
- Raised $97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah’s second IPO after previously raising $100 million in the September 2020 Euronext Brussels IPO
- Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate in September; engaged in sprint discussions with FDA regarding the IDE study for CCC patients in the U.S., which Nyxoah hopes to commence in the second half of 2022
- Received expanded CE Mark indication to treat CCC patients in October, thus increasing Nyxoah’s total addressable market by at least 30% and thereby enabling patients not to have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure prior to Genio® implantation
- Made strong commercial progress in Germany after obtaining a dedicated DRG code in January
- Obtained DRG coding in Switzerland in March and secured first revenue in Spain; submitted reimbursement files in other key European markets
- Entered exclusive licensing agreement with Vanderbilt University in February to develop next generation neurostimulation technologies, specifically a stimulator focused on the Ansa Cervicalis, which innervates the palatoglossus and/or the palatopharyngeus muscle; this collaboration has thus far resulted in initial prototyping discussions, and Nyxoah expects to make further progress on this project in 2022
- Appointed Loic Moreau as Chief Financial Officer effective January 1, 2022, replacing Fabian Suarez, who is pursuing a new opportunity as CEO of a startup MedTech company
- Announced the appointment of Rita Johnson-Mills to the Board of Directors in August
“2021 was a transformational year for Nyxoah as we achieved several important clinical, regulatory, commercial, and financial accomplishments and set ourselves up for continued progress in 2022 and beyond,” said Olivier Taelman, CEO of Nyxoah. “On the clinical front, we announced that our BETTER SLEEP clinical trial achieved a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post implantation for the entire cohort as well as for the subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC patients as well as by FDA in granting us Breakthrough Device Designation for the treatment of CCC patients in the U.S. We are also excited to partner with Dr. David Kent and his team at Vanderbilt University on the development of a next generation device that stimulates the Ansa Cervicalis, which Dr. Kent’s research suggests could be another effective way to treat OSA patients, and we look forward to advancing our work in creating a stimulator that leverages this novel approach.”
Mr. Taelman continued, “As we begin 2022, our primary clinical focus is on our DREAM U.S. IDE pivotal study in which patient enrollment and implants are well underway, and we still expect to complete our target of 134 implants by the end of Q1 2022. We continue to generate great enthusiasm from physicians and patients as we activate more sites and enroll more patients, and we are seeing implant rates accelerating as we move into the new year. We have also been encouraged by our sprint discussions with FDA regarding our IDE trial for CCC patients in the U.S., which we hope to commence in the second half of 2022. From a commercial standpoint, we have made tremendous progress in our key geographic markets, securing DRG codes in Germany and Switzerland, obtaining hospital reimbursement in Spain and awaiting reimbursement decisions in Belgium, the Netherlands, and the Nordic countries. Our commercial strategy centers on the concept of going deep as opposed to going wide; in other words, we want to focus our strategy on key Centers of Excellence with high levels of clinical expertise and patient care, large patient pools, and well-coordinated clinical and administrative infrastructures. This strategy, combined with our ability to treat CCC patients, has enabled us to gain meaningful market share in Germany, and we expect to exit 2022 as the market leader in that important country.”
Mr. Taelman concluded, “As proud and excited as we are of our significant accomplishments in 2021, we have our sights set much higher for 2022. Aiding our efforts is a strong balance sheet that we bolstered in July with close to $100 million raised in our Nasdaq IPO, less than one year after raising close to $100 million in our Euronext IPO in September 2020. This liquidity gives us ample flexibility to complete the DREAM study, conduct the ACCCESS study, invest further in our existing commercial operations, and begin to build out a U.S. commercial operation in anticipation of launch following FDA approval. We are extremely well positioned to execute on our clinical, regulatory, and commercial initiatives, and we look forward to providing further updates on our progress as the year unfolds.”
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 is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.
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.
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; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; 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. 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.
Loic Moreau, Chief Financial Officer
+32 473 33 19 80
Jeremy Feffer, VP IR and Corporate Communications
+1 917 749 1494
AttachmentTo view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Ahold Delhaize share buyback update16.8.2022 08:00:00 CEST | Press release
Zaandam, the Netherlands, August16, 2022 – Ahold Delhaize has repurchased 254,408 of its common shares in the period from August 8, 2022 up to and including August 12, 2022. The shares were repurchased at an average price of € 27.21 per share for a total consideration of € 6.9 million. These repurchases were made as part of the € 1 billion share buyback program announced on November 15, 2021. The total number of shares repurchased under this program to date is 20,621,088 common shares for a total consideration of € 561.6 million. Download the share buyback transactions excel sheet for detailed individual transaction information from https://www.aholddelhaize.com/en/investors/share-buyback-programs/2022/ This press release is issued in connection with the disclosure and reporting obligation set out in Article 2(2) of the EU Regulation that contains technical standards for buyback programs.
Sanionas Kv7-program för epilepsi avanceras till leadoptimering16.8.2022 08:00:00 CEST | Pressemelding
PRESSMEDDELANDE 16 augusti 2022 Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling, meddelar idag att bolaget har avancerat sitt lovande Kv7-program för epilepsi till fasen leadoptimering – den sista fasen av läkemedelsupptäckt innan en klinisk kandidat väljs ut. Thomas Feldthus, VD: ”Vi tror att vi har löst knäckfrågorna för att utveckla nästa generation av läkemedelskandidater av den här klassen, och vi ser en betydande potential att ta fram nya banbrytande epilepsibehandlingar. Finansiellt kan uppsidan vara avsevärd, att döma av vissa viktiga läkemedelsavtal som nyligen slutits på Kv7-området.” Miljontals människor runt om i världen påverkas i dag av epilepsi, en sjukdom som kännetecknas av återkommande krampanfall. Det medicinska behovet är stort, eftersom omkring 30 procent av patienterna inte svarar på behandling med konventionella läkemedel mot epilepsi. Läkemedel mot kramper kan desutom ha funktionshämmande biverkningar, som ofta måste minimeras genom no
Saniona progresses its Kv7 epilepsy program into Lead Optimization16.8.2022 08:00:00 CEST | Press release
PRESS RELEASE August 16, 2022 Saniona (OMX: SANION), a clinical stage biopharmaceutical company, today announced that it has progressed its promising Kv7 epilepsy program into the Lead Optimization Phase, which is the last drug discovery phase before potential selection of a clinical candidate. Thomas Feldthus, CEO: “We believe that we have cracked the main challenges for making the next generation drug candidates of this class and see significant potential for delivering new breakthrough epilepsy treatments. The financial upside could be substantial based on very significant pharma deals recently executed in the Kv7 field”. Epilepsy, characterized by recurrent seizures, currently affects millions of people worldwide. There is a significant medical need as approximately 30% of patients are insensitive to treatment by conventional epilepsy medicines. Furthermore, anti-seizure therepy may cause disabling side effects and often require careful dose adjustment to minimize these. Kv7 ion ch
JULY VOLUME REPORT: STRONG PASSENGER RECOVERY, DROP IN CHANNEL FREIGHT MARKET16.8.2022 07:35:00 CEST | Press release
INVESTOR NEWS no. 24 - 16 August 2022 Ferry – freight: Total volumes in July 2022 were 6.2% below 2021. Activity was overall robust in freight markets except for parts of the Baltic Sea region and the Channel Dover Strait corridor. North Sea volumes were overall below 2021 as UK routes were on level while routes between Sweden and the Continent were below 2021. The latter decrease was due to lower automotive and paper volumes as well as high activity for these segments last year in July. Volumes in the Mediterranean network continued to grow reflecting a high level of Turkish industrial production and exports. Channel’s volumes were below 2021 following a decrease in total market volumes. Baltic Sea’s volumes were below 2021 due to the war in Ukraine. Volumes were mainly lower between Germany and Lithuania. For the last twelve months 2022-21, the total transported freight lane metres decreased 0.6% to 43.6m from 43.9m in 2021-20. Ferry – passenger: The number of passengers increased fi
JULI MÆNGDERAPPORT: STÆRKT PASSAGEROPSVING, NEDGANG I KANALENS FRAGTMARKED16.8.2022 07:35:00 CEST | pressemeddelelse
INVESTOR NEWS nr. 24 - 16. august 2022 Færge – fragt: De samlede mængder i juli 2022 var 6,2% lavere end i 2021. Aktiviteten var generelt robust på fragtmarkederne bortset fra dele af Østersø-regionen og Kanalens Doverstræde. North Seas mængder var samlet set lavere end i 2021, da ruterne til Storbritannien var på niveau, mens ruterne mellem Sverige og kontinentet var lavere end i 2021. Sidstnævnte nedgang skyldtes lavere bil- og papirmængder samt høj aktivitet for disse segmenter sidste år i juli. Mediterraneans mængder fortsatte med at stige, hvilket afspejler en fortsat høj tyrkisk industriproduktion og eksport. Channels mængder var lavere end i 2021 som følge af en nedgang i det samlede markeds mængder. Baltic Seas mængder var lavere end i 2021 på grund af krigen i Ukraine. Mængderne var primært lavere mellem Tyskland og Litauen. For de sidste 12 måneder 2022-21 var der en nedgang i det samlede antal transporterede fragt-lanemeter på 0,6% til 43,6 mio. fra 43,9 mio. i 2021-20. Færg