Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones

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Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones
All 115 patients implanted in DREAM U.S. pivotal study
First DREAM PMA module submitted
First patient implanted in ACCCESS U.S. pivotal study

Mont–Saint–Guibert, Belgium "" March 6, 2023, 7:30am CET / 1:30am 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 Company has completed all 115 implants in its DREAM U.S. pivotal study, submitted the first module in the modular PMA submission and implanted the first patient in the ACCCESS U.S. pivotal study.

The DREAM study is a pivotal, investigational device exemption (IDE) trial designed to support the marketing authorization of the Genio hypoglossal nerve stimulation system (HGNS) in the United States. This multicenter, prospective, open–label, observational study enrolled 115 patients and has co–primary efficacy endpoints of the Apnea–Hypopnea Index (AHI) responder rate, per the Sher criteria, and the Oxygen Desaturation Index (ODI) responder rate, both at 12 months.

In the ACCCESS trial, Nyxoah will implant 106 complete concentric collapse (CCC) 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 achievement of these key clinical and regulatory milestones brings us closer to offering our patient centric Genio solution to all OSA patients in the U.S. The DREAM and ACCCESS studies demonstrate Nyxoah's mission of providing Genio to patients regardless of CCC status and without the requirement for a CCC diagnosis," commented Olivier Taelman, Nyxoah's Chief Executive Officer.

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. 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.

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; future financial performance and market position; 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, 2021, filed with the Securities and Exchange Commission ("SEC") on March 24, 2022, 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:
David DeMartino
Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

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GLOBENEWSWIRE (Distribution ID 1000796325)

Indigenous Conflicts over Land Spread, Fueling Debate in Argentina

Photo of an assembly of members of the Lhaka Honhat indigenous association in the province of Salta, in northern Argentina. Their claim to their ancestral territory has been recognized by the Inter-American Court of Human Rights, but they have not yet gained exclusive use of their land. CREDIT: Courtesy of CELS

Photo of an assembly of members of the Lhaka Honhat indigenous association in the province of Salta, in northern Argentina. Their claim to their ancestral territory has been recognized by the Inter-American Court of Human Rights, but they have not yet gained exclusive use of their land. CREDIT: Courtesy of CELS

By Daniel Gutman
BUENOS AIRES, Mar 6 2023 – In 1994 Argentina recognized in the constitution the ethnic and cultural pre-existence of indigenous peoples. However, enforcement of respect for their rights has fallen short and almost 30 years later the question of land is generating growing conflicts, which sometimes pit native communities against the rest of society.

On Feb. 5, a long convoy of some 500 vehicles driven by agricultural producers drove through the midwest province of Mendoza to defend “the sovereignty of our lands and private property” against growing and increasingly visible claims by indigenous people to their ancestral lands.

The demonstrators said that they do not want the same thing to happen in Mendoza as in the southern province of Río Negro, where there have been various violent incidents in recent years, which peaked in September 2022, when a group of indigenous people claiming their ancestral territory set fire to a National Gendarmerie mobile booth.“Due to economic interests over the land, we do not have a complete survey of indigenous territories in Argentina. That is the basic need, a diagnosis that is indispensable in order to solve this problem.”– Noelia Garone

Meanwhile, the vast majority of the country’s indigenous communities are still waiting for community property title to the lands they have ancestrally lived on, which they point to as the key to access other rights that have remained empty words in the constitution, such as participation in the management of their natural resources.

“There is no political will to resolve this issue, because there are very powerful interests in the oil, mining, or agricultural industries that oppose it,” Silvina Ramírez, a member of the Association of Indigenous Rights Lawyers (AADI) and professor of graduate studies at the University of Buenos Aires, told IPS.

“This has been aggravated because there is a communication campaign trying to spread the idea that indigenous people want to prevent progress and are the enemy,” she added.

On the other side, Andrés Vavrik, a cattle producer from Mendoza and one of the organizers of the demonstration there, told IPS: “No one is against indigenous peoples, but we are concerned that the national government recognizes the right to territory of anyone who self-identifies as indigenous, because there we enter a very debatable terrain.”

“We came out to defend private property,” he said from the town of General Alvear in Mendoza.

A leading role in the march was played by a group of veterans of the Malvinas/Falklands Islands War, which Argentina lost in 1982 against the United Kingdom, which occupied the South Atlantic islands 190 years ago.

The reaction came after the National Institute of Indigenous Affairs (INAI), the official body in charge of the study and delimitation of indigenous territories, recognized the rights of native communities to over 21,500 hectares of land in Mendoza.

Although the INAI clarified that its resolution “does not imply in any way the restitution or handing over of land,” since the agency does not have that power, the Mendoza government objected to the decision before the Supreme Court.

 

More than 500 vehicles participated in a march in defense of national sovereignty in Mendoza, a province in central Argentina, which culminated in a demonstration in the city of Malargüe. The convoy was triggered by indigenous claims to their ancestral land in that province, to which agricultural producers are opposed. CREDIT: Courtesy of Diego Frutos

More than 500 vehicles participated in a march in defense of national sovereignty in Mendoza, a province in central Argentina, which culminated in a demonstration in the city of Malargüe. The convoy was triggered by indigenous claims to their ancestral land in that province, to which agricultural producers are opposed. CREDIT: Courtesy of Diego Frutos

 

Land emergency

Argentina is a country that formally promoted European immigration and the exclusion of indigenous people since it became a unified nation in 1853.

In the 2010 census, 955,032 people self-identified as descendants of or belonging to indigenous peoples, just over two percent of the total population. In the 2022 census, which showed a population of 46 million inhabitants, the question was asked again, but the results have not yet been released.

Although the recognition of the rights of native communities in the 1994 constitutional reform was a landmark from a legal and symbolic point of view, implementation has been another question, with the issue of land ownership seen as the central hurdle.

For this reason, in 2006 Congress enacted Law 26160 on Emergency Matters of Land Possession and Ownership of indigenous communities, which banned evictions of native communities for four years, blocking existing court rulings ordering evictions.

The first three years were to be used to carry out a survey of the lands where indigenous communities lived and promote the issuing of collective land titles.

However, 17 years later the law is still in force, since it had to be extended several times, which demonstrates the failure of its implementation.

 

A photo of Kolla indigenous women in the extreme northern Argentine province of Jujuy. Although the rights of indigenous peoples have been recognized in the constitution since 1994, they have not been enforced. CREDIT: Courtesy of Amnesty International Argentina

A photo of Kolla indigenous women in the extreme northern Argentine province of Jujuy. Although the rights of indigenous peoples have been recognized in the constitution since 1994, they have not been enforced. CREDIT: Courtesy of Amnesty International Argentina

 

The INAI completed surveys for only 46 percent of the legally constituted communities, as reported in late 2022. And today the road is much longer than before, because in 2007, when the communities started to register legally and the survey began, 950 registered, and the number has since grown to 1825.

But the survey does not imply that the land titling process is being carried out. This is an even more complicated step, because there is still no law in the country that regulates indigenous community property, which is different from the multi-owner residential development provided for under civil law, when there is more than one owner.

The community property law is another longstanding demand of indigenous peoples and human rights organizations, which Congress has not met.

Although some communities in the country have received their property title from the hands of provincial governments under different legal statuses, it is not known how many there are or what area these indigenous territories cover.

“The indigenous territorial emergency law was passed in a very particular context of expansion of the business of growing and exporting soybeans in Argentina, which caused a serious situation of constant evictions of indigenous communities,” Diego Morales, a lawyer with the Center for Legal and Social Studies (CELS), a human rights organization, told IPS.

“Since then, no government has wanted to hand over land to indigenous people and not even the associated communities in Lhaka Honhat (living in the province of Salta, in the north of the country) have been able to access a community property title and fully exercise their rights, even though they obtained a favorable sentence from the Inter-American Court of Human Rights,” he added.

Morales said the situation today is more difficult to resolve, because indigenous communities that have historically been discriminated against and neglected, who in recent years have become more aware of their rights, now not only lay claim to the land where they live but are also making cultural claims to territories from which their ancestors were driven.

 

A demonstration by indigenous Kolla people in the arid, mountainous landscape of northwestern Argentina. The country has declared a "territorial emergency" for indigenous peoples since 2006, but the vast majority of communities do not have title to their lands. CREDIT: Courtesy of Endepa

A demonstration by indigenous Kolla people in the arid, mountainous landscape of northwestern Argentina. The country has declared a “territorial emergency” for indigenous peoples since 2006, but the vast majority of communities do not have title to their lands. CREDIT: Courtesy of Endepa

 

Violence and debate

Diego Frutos, who suffered several occupations and attacks on his property in Villa Mascardi, in the province of Río Negro, by groups laying claim to his property for Mapuche indigenous communities, said there are people who are trying to take advantage of indigenous rights to reclaim land that does not belong to them.

“I do not deny the rights of the Mapuches, but those who attacked my property are not a registered community. They cannot be, because they do not have blood ties and they cannot show that they have had an uninterrupted occupation of a territory. They are a group of young people who seek to take advantage of the umbrella of indigenous rights,” Frutos told IPS from his town.

Frutos is convinced that those who attacked his property are backed by the administration of center-left President Alberto Fernández, who feels pressure from both sides while walking a minefield between indigenous people and the agricultural producers who settled on their lands, with neither side feeling satisfied with what his government has done.

Sandra Ceballos, a member of the Kolla people and vice president of AADI, the association of lawyers for indigenous rights, told IPS that the government is persecuting indigenous people, as demonstrated by the fact that an unusual joint command of federal and provincial forces was assembled in Río Negro, after the acts of violence in September.

Noelia Garone, a lawyer from the Argentine office of Amnesty International, said the lack of recognition of the right to land has triggered multiple violations of other rights of indigenous communities, such as education, healthcare, water or work.

“Due to economic interests over the land, we do not have a complete survey of indigenous territories in Argentina. That is the basic need, a diagnosis that is indispensable in order to solve this problem,” she told IPS.