Day: July 11, 2022

REGULATED INFORMATION
INSIDE INFORMATION

Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio® in Complete Concentric Collapse Patients

First ACCCESS patient expected to be implanted in Q4 2022

Mont-Saint-Guibert, Belgium – July 11, 2022, 8:00am CET / 2:00am 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 announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to enable Nyxoah to initiate a clinical trial, called ACCCESS, to evaluate the use of the Genio® system for the treatment of adult patients with moderate-to-severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA had previously granted Breakthrough Device Designation to Genio® to treat CCC patients.

In the ACCCESS trial, Nyxoah will implant up to 106 patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both assessed at 12 months post-implant.  The first patient is expected to be implanted during the fourth quarter of 2022, in-line with prior guidance.

“The ACCCESS IDE approval is an important first step to unlocking an enormous patient population, as more than 30% of OSA patients in the U.S. have CCC. Nyxoah is the only hypoglossal nerve stimulation (HGNS) company with a positive CCC clinical trial and CCC approval in Europe, and the ACCCESS study further strengthens our leadership position in addressing the needs of these patients,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “CCC patients who are refractory to CPAP are left with no option other than major palate surgery to treat their OSA. Our BETTER SLEEP trial, which enabled Nyxoah to secure a CCC label expansion in Europe and FDA Breakthrough Device Designation, demonstrated that Genio® can provide these patients with a minimally invasive solution for their disorder. Nyxoah is already the only HGNS company with European CCC approval, bilateral stimulation and both 1.5T and 3.0T full-body MRI compatibility, and the ACCCESS trial is further demonstrating Nyxoah’s mission of offering HGNS solutions to all patients suffering from CCC. We are seeing outstanding results in CCC patients treated with Genio® in Europe and are excited to begin the ACCCESS study and make Genio® available to as many patients as possible.”

“Patients with Complete Concentric Collapse at the soft palate, who have failed CPAP, represent a significant unmet need in the treatment of OSA since, currently, the only FDA approved hypoglossal nerve stimulation therapy is contraindicated for these patients,” commented Dr. Maria Suurna, Otolaryngologist and Director of Sleep Surgery at the University of Miami Health. “The ACCCESS study provides hope for these patients, and their treating physicians, that there may soon be a minimally invasive surgical solution to address their OSA. I, along with the entire sleep community, applaud Nyxoah for developing Genio® with bilateral hypoglossal nerve stimulation and for conducting the ACCCESS trial to provide a treatment alternative for this underserved population.”

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 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.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

Attachment

• ENGLISH_ACCCESS IDE Approval PR _FINAL

• The new agreement will see OKX become Official Training Kit partner for the 2022/23 season.
• To celebrate the announcement, OKX has commissioned renowned street artist Akse P19 and Global Street Art Agency to create artworks featuring Manchester City players Haaland, Grealish, Cancelo and Stones, across four locations in Manchester.
• Last week, OKX were also announced as presenting partner of Man City’s Trophy Tour 2022, as it returns for the first time since 2019.

MANCHESTER, United Kingdom, July 10, 2022 (GLOBE NEWSWIRE) — OKX, one of the world’s leading cryptocurrency platforms, today announced that it will be the Official Training Kit Partner of Manchester City for the 2022/2023 season.

The agreement will see OKX featured across the training kit of the Manchester City men’s and women’s first teams. The men’s first team will debut the training kit when returning for their first pre-season training session today, with the women’s team wearing the kit on their return to training next month. OKX was announced as Manchester City’s Official Cryptocurrency Exchange Partner in March.

Haider Rafique, Global Chief Marketing Officer, OKX, said: “The real grit and perseverance is built on the training ground. This is the way we want to nurture new users on our platform. Being Man City’s Official Training Kit Partner helps us extend that mindset from the training ground over to our trading app community. We want our community to learn from that mindset and use our demo trading feature to train for the real exchange just like Man City players train before the beginning of the season. Our partnership with Man City has provided a great platform through which we have the opportunity to educate those curious about crypto and offer those already involved the training they need to participate responsibly.”

OKX’s training kit partnership with Manchester City is based on shared values. Just as Man City emphasises training innovatively to achieve excellence, OKX’s mission is to educate and inform customers in order to make them responsible long-term traders. It is this shared focus on being at the cutting edge of the industry that will lead to a new era of disruptive fan engagement and web3-based experiences.

Roel de Vries, Group Chief Operating Officer, City Football Group, said, “We are pleased to expand our relationship with OKX today, as they become the Official Training Kit Partner of Manchester City. OKX and Man City are aligned on values such as innovation and success and for both parties, everything starts with training and education. Since the initial partnership began in March 2022, we have worked together to ‘supercharge the fan experience’ through a number of exciting content activations ahead of high profile fixtures during the culmination of the 2021/22 season and we look forward to continuing to develop these opportunities over the coming year.”

In line with the training kit announcement, OKX has commissioned renowned street artist Akse P19 and Global Street Art Agency to create artworks featuring Erling Haaland, Jack Grealish, João Cancelo and John Stones across four locations in Manchester. The murals will be fitted out with QR codes that fans can scan for a chance to win their very own season ticket in the OKX Hospitality Box.

OKX is also the presenting partner of Manchester City’s first global Trophy Tour since 2019 following the club’s fourth title win in five years. The tour will see Manchester City and OKX take the Premier League trophy to the doorsteps of fans in markets including France, Spain, the UAE, Korea, and, for the first time ever, Mexico, Norway and South Africa.

OKX’s future ambitions with Manchester City include continuing to supercharge the fan experience, providing key learning initiatives and resources to help customers trade responsibly, and delivering programs to empower and enrich the Manchester community.

For further information, please contact:
Media@okx.com

About OKX
OKX is a leading crypto trading app, and a Web3 ecosystem. Trusted by more than 20 million global customers in over 180 international markets, OKX is known for being the fastest and most reliable crypto trading app of choice for traders globally.

Since 2017, OKX has served a global community of people who share a common interest in participating in a new financial system that is designed to be a level playing field for everyone. We strive to educate people on the potential of crypto markets and how to trade responsibly. Beyond the OKX trading app, the OKX Wallet is our latest offering for people looking to explore the world of NFTs and the metaverse while trading GameFi and DeFi tokens.

To learn more about OKX, download our app or visit: okx.com

About Manchester City Football Club:
Manchester City FC is an English Premier League club initially founded in 1880 as St Mark’s West Gorton. It officially became Manchester City FC in 1894 and has since then gone onto win the European Cup Winners’ Cup, eight League Championship titles, including six Premier League titles (2012, 2014, 2018, 2019, 2021, 2022), and six FA Cups. Manchester City FC is one of 12 clubs comprising the City Football Group and counts New York City FC and Melbourne City FC among its sister clubs.

Under manager Pep Guardiola, one of the most highly-decorated managers in world football, the Club plays its domestic and UEFA Champions League home fixtures at the Etihad Stadium, a spectacular 55,000 seat arena that City have called home since 2003. Today, the Stadium sits on the wider Etihad Campus, which also encompasses the City Football Academy, a state-of-the-art performance training and youth development facility located in the heart of East Manchester. Featuring a 7,000 capacity Academy Stadium, the City Football Academy is also where Manchester City Women’s Football Club and the Elite Development Squad train on a daily basis and play their competitive home games.

For more information, please visit www.mancity.com

NEW YORK, July 10, 2022 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Teladoc Health, Inc. (NYSE: TDOC) between October 28, 2021 and April 27, 2022, both dates inclusive (the “Class Period”), of the important August 5, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Teladoc Health securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Teladoc Health class action, go to https://rosenlegal.com/submit-form/?case_id=6818 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 5, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) increased competition, among other factors, was negatively impacting Teladoc Health’s BetterHelp and chronic care businesses; (2) accordingly, the growth of those businesses was less sustainable than defendants had led investors to believe; (3) as a result, Teladoc Health’s revenue and adjusted EBITDA projections for its fiscal year 2022 were unrealistic; (4) as a result of all the foregoing, Teladoc Health would be forced to recognize a significant non-cash goodwill impairment charge; and (5) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Teladoc Health class action, go to https://rosenlegal.com/submit-form/?case_id=6818 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

        Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

NEW YORK, July 10, 2022 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Okta, Inc. (NASDAQ: OKTA) between March 5, 2021 and March 22, 2022, both dates inclusive (the “Class Period”), of the important July 19, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Okta securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Okta class action, go to https://rosenlegal.com/submit-form/?case_id=6365 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 19, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Okta had inadequate cybersecurity controls; (2) as a result, Okta’s systems were vulnerable to data breaches; (3) Okta ultimately did experience a data breach caused by a hacking group, which potentially affected hundreds of Okta customers; (4) Okta initially did not disclose and subsequently downplayed the severity of the data breach; (5) all the foregoing, once revealed, was likely to have a material negative impact on Okta’s business, financial condition, and reputation; and (6) as a result, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Okta class action, go to https://rosenlegal.com/submit-form/?case_id=6365 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

        Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com