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

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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

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Recalling Shinzo Abe with Respect

By Osamu Kusumoto
TOKYO, Jul 11 2022 – Shinzo Abe, the longest-serving Prime Minister of Japan, has died. It was a murder caused by a personal grudge rather than political terrorism. And it was not a direct grudge against Mr. Abe. A religious group had supported Mr. Abe, and a murderer with a grudge against the religious group killed him. Murders targeting politicians are often related to political messages or claims. This is a very unique case in that the murder was committed out of a personal grudge, not against the individual for what he did, but against the organization that supported the individual.

Osamu Kusumoto

In Japan, guns are strictly regulated and crimes involving guns are extremely rare. The gun used was a homemade gun, not one that is sold on the market. Therefore, it was an extremely difficult case to prevent through institutional efforts such as gun control. In many ways, we believe that a fairly in-depth analysis of the current state of Japanese society is required to understand how this could have happened.

As for Prime Minister Abe’s political achievements, he has just passed away, and I believe that there are many aspects of his life that we can only wait for history to judge.

Abe’s grandfather, Nobusuke Kishi, former prime minister of Japan, understood that Japan’s prewar population growth caused poverty and that poverty and population pressure were major factors in World War II. Together with General Draper, the U.S. Undersecretary of Defense, and others, he worked to stabilize the world’s population problem and established the first bipartisan parliamentary group, the Japan Parliamentarians Federation for Population (JPFP), to address the issue of the population to achieve world peace.

Abe’s father, former Foreign Minister Shintaro Abe, was also involved in population politics, serving as the third president of the JPFP. Late Shinzo Abe himself attended a meeting of the International Parliamentarians Meeting on Population and Social Development in Copenhagen, Denmark, in 1995, when he had just become a member of Parliament, held in conjunction with the World Summit on Social Development.

I was involved in that conference as the Japanese secretariat and worked with Mr. Abe for about a week. I was impressed by Mr. Abe’s cheerful personality and proactive thinking. Mr. Abe is well known for his loving wife, and I saw this in Copenhagen, which made me smile.

As I said at the beginning, we will have to wait for history to judge Mr. Abe’s political achievements. However, in my close contact with him and watching his actions, I felt that he had inherited the political philosophy of his grandfather, Nobusuke Kishi, from his father, Shintaro Abe.

Japan was defeated in World War II and had to realize the reconstruction of its devastated land. One of those who took charge of this was my grandfather, former Prime Minister Nobusuke Kishi. For the politicians in charge of politics, the various political decisions of the time can only be said to be the result of the best decisions made under the conditions given at that time. It is the job of historians to weigh the pros and cons of such decisions, but I believe that Mr. Abe witnessed and understood the background of the political decisions that his grandfather and father were forced to make as they ran the country.

Seventy-seven years after its defeat in World War II, Japan has not yet escaped the effects of the war, as evidenced by the application of the UN’s “enemy clause. As a result, from the perspective of international common sense, I think there is room for debate as to whether Japan is in an adequate situation as a nation-state in the international community.

During his tenure as prime minister, Mr. Abe has focused on diplomacy. He actively engaged in what is known as “globe-trotting diplomacy,” traveling around the world and maintaining close contact with world leaders. Although Abe’s political beliefs were often described as right-wing, he also repeatedly communicated closely with the leaders of the former communist bloc.

What is clear from these actions of Mr. Abe is that he wanted to make termination of Japan’s postwar period situation. I understand that this is not a matter of left-wing and right-wing, and conservatism or liberalism, but rather a desire to remove the fetters of defeat and create a normal country.

I feel that he had a passionate desire to create a Japan that is respected by the world, as stipulated in the Constitution.

He lost his life at a very young age as a politician. I believe that he was a rare politician who was able to pursue his political ideals, including the environment in which he was blessed to grow up. I sincerely regret his death and pray for his soul.

Osamu Kusumoto, Ph.D Lecturer, Nihon University
Founder, Global Advisors for Sustainable Development (GAfSD)

IPS UN Bureau

 


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