UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2024
Commission File Number: 001-40552
NYXOAH SA
(Translation of registrant’s name into English)
Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
Appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer
On April 11, 2024, Nyxoah SA (the “Company”) announced the appointment of Dr. Maurits S. Boon, MD as the Company’s Chief Medical Officer. Dr. Boon joins the Company from Thomas Jefferson University, where he will continue to serve part time as a professor and Vice Chairman, Education. Dr. Boon is dual board-certified in otolaryngology and sleep medicine. Dr. Boon received an M.D. from the State University of New York, Buffalo School of Medicine and completed his residency at Thomas Jefferson University Hospital.
The information included under the heading “Appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer” of this report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-261233 and 333-269410) and Form F-3 (Registration Number 333-268955) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Press Release
On April 11, 2024, the Company issued a press release announcing the appointment of Dr. Boon as the Company’s Chief Medical Officer. A copy of the press release is attached hereto as Exhibit 99.1.
The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
Exhibits
| 99.1 | Press Release, dated April 11, 2024 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NYXOAH SA | ||
| Date: April 15, 2024 | By: | /s/ Loic Moreau |
| Name: | Loic Moreau | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Nyxoah Appoints Dr. Maurits S. Boon, MD as Chief Medical Officer
April 11, 2024
Nyxoah Appoints Dr. Maurits S. Boon, MD as Chief Medical Officer
Mont-Saint-Guibert, Belgium – April 11, 2024, 10:30pm CET / 4:30pm 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 announced the appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer.
Dr. Boon joins Nyxoah from the Thomas Jefferson University, where he will continue part time as a professor and Vice Chairman, Education. He is dual board-certified in otolaryngology – head and neck surgery, as well as sleep medicine. Dr. Boon is one of two sleep surgeons with Jefferson Health to pioneer the use of hypoglossal nerve stimulation therapy (HGNS) and is internationally recognized as one of the most experienced surgeons performing HGNS procedures. He has lectured worldwide on obstructive sleep apnea, has numerous publications and is co-editor of the first book on HGNS.
“As an academic physician who has dedicated my professional career to the care of patients with sleep disordered breathing, I was privileged to participate in the DREAM U.S. pivotal trial. I was initially impressed by the results I saw in my patients and then equally impressed by the data that were recently reported. As such, I am honored to have been offered a position to join Nyxoah at such an exciting time. Bilateral hypoglossal nerve stimulation with Genio has tremendous potential and I am thrilled to work with their talented team to make a meaningful impact on the lives of patients with obstructive sleep apnea,” commented Dr. Boon.
“I could not be more excited to have Dr. Boon join Nyxoah. He is one of the pioneers in hypoglossal nerve stimulation and his decision to become Nyxoah’s Chief Medical Officer reflects Genio’s ability to improve the lives of OSA patients,” commented Olivier Taelman, Chief Executive Officer. “Dr. Boon will play a critical role as we prepare to enter the U.S. market and achieve our mission of making sleep simple again.”
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.
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; 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. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313
Attachment
| · | ENGLISH Nyxoah Appoints Maurits Boon MD as Chief Medical Officer |