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XPEL DEADLINE ALERT: ROSEN, RECOGNIZED INVESTOR COUNSEL, Encourages XPEL, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important October 7 Deadline in Securities Class Action – XPEL

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of XPEL, Inc. (NASDAQ: XPEL) between November 8, 2023 and May 2, 2024, both dates inclusive (the “Class Period”), of the important October 7, 2024 lead plaintiff deadline.

SO WHAT: If you purchased XPEL 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 XPEL class action, go to https://rosenlegal.com/submit–form/?case_id=20245 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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 October 7, 2024. 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 litigate 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 or 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, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) XPEL’s competitors were siphoning an increasingly large segment of the market; (2) as a result, XPEL’s revenue growth became increasingly dependent upon existing customers and partners; (3) as a result, XPEL’s revenue growth for 2023 and 2024 dwindled; and (4) as a result, defendants’ positive statements about XPEL’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the XPEL class action, go to https://rosenlegal.com/submit–form/?case_id=20245 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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
        case@rosenlegal.com
        www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 9237818)

Late Stage DEADLINE TOMORROW: ROSEN, RECOGNIZED INVESTOR COUNSEL, Encourages Late Stage Asset Management, LLC Investors with Losses in Excess of $500K to Secure Counsel Before Important September 30 Deadline in Securities Class Action

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of Pre–IPO shares through funds issued by Late Stage Asset Management, LLC between March 2019 and March 2023, both dates inclusive (the “Class Period”), of the important September 30, 2024 lead plaintiff deadline.

SO WHAT: If you purchased Pre–IPO shares through funds issued by Late Stage Asset Management, LLC between March 2019 and March 2023, 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 Late Stage class action, go to https://rosenlegal.com/submit–form/?case_id=27548 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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 September 30, 2024. 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 litigate 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 complaint, during the Class Period, the defendants orchestrated a scheme whereby a network of unregistered sales agents fraudulently offered and sold retail investors purportedly “no–fee” unregistered securities in private (Pre–IPO) companies, which turned out to have artificial prices inflated with fees that the defendants took as profit. The complaint further alleges that the defendants made numerous false and misleading statements during the sale of these illegal, unregistered securities in violation of the federal securities laws.

To join the Late Stage class action, go to https://rosenlegal.com/submit–form/?case_id=27548 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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
        case@rosenlegal.com
        www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 9237752)

ABR DEADLINE ALERT: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Arbor Realty Trust, Inc. Investors to Secure Counsel Before Important September 30 Deadline in Securities Class Action – ABR

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Arbor Realty Trust, Inc. (NYSE: ABR) between May 7, 2021 and July 11, 2024, both dates inclusive (the “Class Period”), of the important September 30, 2024 lead plaintiff deadline.

SO WHAT: If you purchased Arbor Realty 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 Arbor Realty class action, go to https://rosenlegal.com/submit–form/?case_id=20777 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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 September 30, 2024. 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 litigate 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, during the Class Period, defendants provided investors with false and/or materially misleading information concerning Arbor Realty’s operational and financial health, including its balance sheet loan book and net interest income. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Arbor Realty class action, go to https://rosenlegal.com/submit–form/?case_id=20777 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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
        case@rosenlegal.com
        www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 9237774)

INDV DEADLINE NOTICE: ROSEN, TOP RANKED GLOBAL COUNSEL, Encourages Indivior PLC Investors with Losses in Excess of $100K to Secure Counsel Before Important October 1 Deadline in Securities Class Action – INDV

NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Indivior PLC (NASDAQ: INDV) between February 22, 2024 and July 8, 2024, both dates inclusive (the “Class Period”), of the important October 1, 2024 lead plaintiff deadline.

SO WHAT: If you purchased Indivior 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 Indivior class action, go to https://rosenlegal.com/submit–form/?case_id=27690 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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 October 1, 2024. 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 litigate 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, throughout the Class Period, defendants made false and misleading statements regarding Indivior’s business, operations, and prospects. Specifically, defendants: (1) grossly overstated their ability to forecast the negative impact of certain legislation on the financial prospects of Indivior products, which forecasting ability was far less capable and effective than defendants had led investors and analysts to believe; (2) overstated the financial prospects of SUBLOCADE (a monthly injection used to treat moderate to severe opioid use disorders), PERSERIS (an injection to treat schizophrenia in U.S. adults) and OPVEE (a nasal spray to reverse opioid overdoses on an emergency basis), and thus overstated Indivior’s anticipated revenue and other metrics; (3) knew or recklessly disregarded that because of the negative impact of certain legislation on the financial prospects of Indivior’s products, Indivior was unlikely to meet its own previously issued and repeatedly reaffirmed Fiscal Year 2024 net revenue guidance, including its Fiscal Year 2024 net revenue guidance for SUBLOCADE, PERSERIS and OPVEE; (4) knew or recklessly disregarded that Indivior was at a significant risk of, and/or was likely to, cease all sales and marketing activities related to PERSERIS; and (5) knew or recklessly disregarded that, as a result of the foregoing, Indivior’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 Indivior class action, go to https://rosenlegal.com/submit–form/?case_id=27690   or call Phillip Kim, Esq. toll–free at 866–767–3653 or email case@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
        case@rosenlegal.com
        www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 9237795)

Les Données de l'Étude Pivot DREAM Présentées lors de l'International Surgical Sleep Society 2024 Educational Update

Les Données de l'Étude Pivot DREAM Présentées lors de l'International Surgical Sleep Society 2024 Educational Update

Des données cliniques supplémentaires sur des patients souffrant d'apnée obstructive du sommeil (AOS) démontrent une réduction médiane cliniquement significative de 71,0 % de l'indice d'apnée–hypopnée (IAH) en position couchée sur le dos à 12 mois par rapport à la valeur de référence.

82,0 % des patients ayant passé une polysomnographie à 12 mois avaient un IAH inférieur à 15, et 67,4 % des patients ayant passé une polysomnographie à 12 mois avaient un IAH inférieur à 10.

Mont–Saint–Guibert, Belgique – 27 septembre 2024, 10h30 CET / 16h30 ET – Nyxoah SA (Euronext Bruxelles/Nasdaq : NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques révolutionnaires pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a présenté aujourd'hui les données de l'étude pivot DREAM U.S. lors d'une séance orale lors de l’International Surgical Sleep Society (ISSS) 2024 Educational Update qui a eu lieu les 26 et 27 septembre à Miami, en Floride.

Des données supplémentaires ont été présentées pour la réduction de l'IAH en position dorsale et non latérale. La stimulation bilatérale Genio a entraîné une réduction médiane cliniquement significative de 71,0 % de l'IAH en position dorsale à 12 mois par rapport à la valeur de référence. Cette réduction se compare à une réduction médiane de l'IAH à 12 mois de 70,8 % dans toutes les positions de sommeil.

En ce qui concerne les critères d'évaluation secondaires rapportés à l'ISSS, les sujets ont montré des améliorations significatives de la qualité de vie. Plus précisément, une augmentation moyenne de 2,3 points a été observée dans l'évaluation du questionnaire Functional Outcomes of Sleep Questionnaire (FOSQ). En outre, le score de somnolence d'Epworth a été réduit de 3,4 points en moyenne par rapport à la situation initiale.

La présentation comprenait des données précédemment annoncées montrant que l'étude avait atteint ses critères d'évaluation co–principaux du taux de réponse à l'IAH à 12 mois, selon les critères Sher, et du taux de réponse à l'indice de désaturation en oxygène (ODI), tous deux sur la base de l'intention de traiter (ITT ). Dans l'étude principale DREAM, 115 patients ont reçu l'implant Genio et ont été inclus dans l'analyse de sécurité. Ces patients avaient un IAH moyen de 28,0 au départ, un ODI moyen de 27,0 et un indice de masse corporelle moyen de 28,5. Après 12 mois, 73 sujets se sont révélés être des répondeurs IAH selon les critères Sher*, ce qui a donné un taux de réponse IAH ITT de 63,5 % (p=0,002), de plus, 82 sujets ont été identifiés comme répondeurs ODI, ce qui a donné un taux de réponse ODI de 71,3 % (p<0,001). Les résultats d'innocuité étaient conformes à ceux d'autres thérapies de neuromodulation, avec 11 événements indésirables graves, ou EIG, chez dix sujets, entraînant un taux d'EIG de 8,7 %. Sur les 11 SAE, trois étaient liés à des dispositifs, et trois étaient des explants.

« L'étude DREAM a démontré l'efficacité de la stimulation bilatérale du nerf hypoglosse à l'aide de Genio pour le traitement de l'apnée obstructive du sommeil. Des améliorations cliniquement significatives des critères d'évaluation primaires et secondaires ont été observées », a déclaré B. Tucker Woodson, MD, Chef, Professeur – Medical College of Wisconsin et Investigateur principal de l'étude DREAM. « Genio a le potentiel de nous aider à faire progresser la thérapie de neuromodulation pour le traitement du SAOS. »
« L'obtention de réductions significatives de l'IAH, quelle que soit la position de sommeil, est une validation clinique de notre approche centrée sur le patient », a déclaré Olivier Taelman, CEO de Nyxoah. « La stimulation bilatérale Genio a également permis à plus de 80 % des patients d'atteindre 12 mois avec un IAH inférieur à 15, ce qui a eu un impact positif sur leur qualité de vie globale et a réduit la somnolence. Nyxoah entre maintenant dans la phase réglementaire finale et progresse vers l'approbation de la FDA. Il s'agira d'une étape importante dans notre mission qui consiste à mettre Genio à la disposition des patients souffrant d'AOS aux États–Unis. »

À propos de Nyxoah
Nyxoah réinvente le sommeil pour le milliard de personnes qui souffrent d'apnée obstructive du sommeil (AOS). Nous sommes une société de technologie médicale qui développe des alternatives de traitement révolutionnaires pour l'AOS grâce à la neuromodulation. Notre première innovation est Genio®, un dispositif de neuromodulation hypoglosse sans pile, inséré par une simple incision sous le menton et contrôlé par un dispositif portable. Grâce à notre engagement en faveur de l'innovation et des preuves cliniques, nous avons obtenu les meilleurs résultats de sa catégorie en matière de réduction du fardeau du SAOS.

Suite à l'achèvement réussi de l'étude BLAST OSA, le système Genio® a reçu son marquage CE européen en 2019. Nyxoah a réalisé deux introductions en bourse réussies : sur Euronext Bruxelles en septembre 2020 et sur le NASDAQ en juillet 2021. Suite aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu l'approbation du marquage CE pour l'élargissement de ses indications thérapeutiques aux patients atteints d'effondrement concentrique complet (CCC), actuellement contre–indiqués dans la thérapie des concurrents. En outre, la société a annoncé les résultats positifs de l'étude pivot DREAM IDE en vue de l'approbation de la FDA et de la commercialisation aux États–Unis.

Pour plus d'informations, veuillez consulter le rapport annuel de la société pour l'exercice 2023 et visiter le site http://www.nyxoah.com/.

Attention – Marquage CE depuis 2019. Dispositif expérimental aux États–Unis. Limité par la loi fédérale américaine à un usage expérimental aux États–Unis.

Déclarations prospectives

Certaines déclarations, croyances et opinions contenues dans le présent communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la société ou, le cas échéant, des administrateurs ou de la direction de la société concernant le système Genio® et les études cliniques en cours sur le système Genio® ; les avantages potentiels du système Genio® ; les objectifs de Nyxoah concernant le développement, la voie réglementaire et l'utilisation potentielle du système Genio® ; l'utilité des données cliniques pour l'obtention éventuelle de l'approbation de la FDA pour le système Genio® ; la communication des données de l'essai pivot DREAM U. U. de Nyxoah ; la demande d'approbation de la FDA ; et l'entrée sur le marché américain. De par leur nature, les déclarations prospectives impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs susceptibles d'entraîner une différence matérielle entre les résultats ou événements réels et ceux exprimés ou sous–entendus dans les déclarations prospectives. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence négative sur les résultats et les effets financiers des plans et des événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2023, déposé auprès de la Securities and Exchange Commission (” SEC ») le 20 mars 2024, et des rapports ultérieurs que la société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent de manière significative de tout développement anticipé. Les déclarations prospectives contenues dans le présent communiqué de presse concernant des tendances ou des activités passées ne constituent pas des garanties de performances futures et ne doivent pas être considérées comme une déclaration selon laquelle ces tendances ou activités se poursuivront à l'avenir. En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements peuvent ne pas être représentatifs des résultats ou développements des périodes futures. Aucune déclaration ou garantie n'est donnée quant à l'exactitude ou à la justesse de ces déclarations prospectives. En conséquence, la société décline expressément toute obligation ou tout engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement des attentes ou d'un changement des événements, conditions, hypothèses ou circonstances sur lesquels ces déclarations prospectives sont basées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni les dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans ce communiqué de presse ou quant à la survenance effective des développements prévus. Vous ne devriez pas accorder une confiance excessive aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contacts :

Nyxoah
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com

Media
Etats–Unis
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

Belgique/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

International/Allemagne
MC Services – Anne Hennecke
nyxoah@mc–services.eu

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1000994495)

DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update

DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update

Additional clinical data on patients suffering from Obstructive Sleep Apnea (OSA) demonstrate a clinically significant 71.0% median reduction in Apnea–Hypopnea index (AHI) while sleeping supine
at 12 months compared with baseline.

82.0% of patients who completed a polysomnography at 12 months had an AHI below 15, and 67.4% of patients who completed a polysomnography at 12 months had an AHI below 10.

Mont–Saint–Guibert, Belgium – September 27, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that data from the DREAM U.S. pivotal study were presented in an oral session at the International Surgical Sleep Society (ISSS) 2024 Educational Update, taking place from September 26 –27 in Miami, Florida.

Additional data were presented for AHI reduction in supine and non–supine positions. Genio bilateral stimulation resulted in a clinically meaningful 71.0% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12–month AHI reduction of 70.8% across all sleeping positions.

With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality–of–life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.

The presentation included previously announced data demonstrating that the study achieved its co–primary endpoints of 12–month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent–To–Treat (ITT) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001). Safety results were in line with other neuromodulation therapies, with 11 serious adverse events, or SAEs, in ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related, and there were three explants.

“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea. Clinically significant improvements in primary and secondary endpoints were observed,” said B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM study. “Genio has the potential of helping us advance neuromodulation therapy for the treatment of OSA.”

“Achieving meaningful AHI reductions regardless of sleep position is a clinical validation of our patient–centric approach,” said Olivier Taelman, CEO of Nyxoah. “Genio bilateral stimulation also enabled more than 80% of patients to hit 12 months with an AHI below 15, positively impacting their overall quality of life and reducing sleepiness. Nyxoah is now entering the final regulatory phase and is progressing toward FDA approval. This will be a huge milestone in our mission to make Genio available to OSA patients in the US.”

About Nyxoah

Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery–free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best–in–class outcomes for reducing OSA burden.

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 announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please see the Company’s annual report for the financial year 2023 and 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 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; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. 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
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com

For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

In International/Germany
MC Services – Anne Hennecke
nyxoah@mc–services.eu

Attachment


GLOBENEWSWIRE (Distribution ID 1000994495)

Bitget Partners with Cats (CATS) for Gas-free Airdrop Claim and Launchpool Listing

VICTORIA, Seychelles, Sept. 27, 2024 (GLOBE NEWSWIRE) — Bitget, the leading cryptocurrency exchange and Web3 company, has announced a partnership with Cats (CATS), a trending meme coin from the TON ecosystem. Bitget users will now be able to claim the CATS token airdrop on Telegram with zero gas fees. These tokens will be automatically credited to users' Bitget accounts before CATS spot trading begins in early October. Additionally, CATS will be featured on Bitget Launchpool, a free–to–farm platform, starting October 30, 2024, with a total distribution of 19.5 billion CATS tokens.

These initiatives aim to enhance user engagement with the Cats platform while providing substantial rewards for early adopters and supporters.

Earlier in September, Bitget listed CATS in its Pre–market, serving as a vital resource for traders and investors eager to engage with promising tokens ahead of their broader market release. By facilitating early trading opportunities for tokens like CATS, Bitget enhances trading options for its users, offering a unique chance to capitalize on market trends before they enter the mainstream. As of September 27, CATS is trading at 0.00043 USDT in the Bitget Pre–market, with total volume surpassing 1.5 million USDT.

CATS is a meme coin that embodies the playful spirit and culture of the Telegram community. Similar to its counterpart, Dogs ($DOGS), loyal Telegram users can claim CATS airdrops based on factors such as account age, premium status, and activity levels. To date, the project has attracted over 40 million holders through its viral Telegram mini–app, establishing itself as one of the most popular meme coins on the TON blockchain.

The listing of CATS on Bitget Launchpool marks a significant milestone in expanding its reach and influence within the blockchain gaming industry. This listing underscores CATS's potential as a trending TON–based project and reaffirms Bitget's commitment to supporting innovative TON–based initiatives that drive the future of decentralized ecosystems.

As the staking period commences, users are encouraged to participate actively and seize the rewards offered through this unique opportunity. With CATS's growing popularity and its innovative approach to gaming, the listing on Bitget Launchpool is expected to attract considerable attention from both gaming and blockchain communities.

For more information on CATS, visit the community or check out the Launchpool.

About Bitget

Established in 2018, Bitget is the world's leading cryptocurrency exchange and Web3 company. Serving over 45 million users in 150+ countries and regions, the Bitget exchange is committed to helping users trade smarter with its pioneering copy trading, AI bot and other trading solutions. Bitget Wallet is a world–class multi–chain crypto wallet that offers an array of comprehensive Web3 solutions and features including wallet functionality, swap, NFT Marketplace, DApp browser, and more. Bitget inspires individuals to embrace crypto through collaborations with credible partners, including being the Official Crypto Partner of the World's Top Professional Football League, LALIGA, in EASTERN, SEA and LATAM, as well as a global partner of Olympic Athletes Buse Tosun Çavuşoğlu (Wrestling world champion), Samet Gümüş (Boxing gold medalist) and İlkin Aydın (Volleyball national team).

For more information, visit: Website | Twitter | Telegram | LinkedIn | Discord | Bitget Wallet

For media inquiries, please contact: media@bitget.com

Risk Warning: Digital asset prices may fluctuate and experience price volatility. Only invest what you can afford to lose. The value of your investment may be impacted and it is possible that you may not achieve your financial goals or be able to recover your principal investment. You should always seek independent financial advice and consider your own financial experience and financial standing. Past performance is not a reliable measure of future performance. Bitget shall not be liable for any losses you may incur. Nothing here shall be construed as financial advice. For more information, see our Terms of Use.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/68ef6b6b–69ef–41cc–b86f–4b31ee2882e4


GLOBENEWSWIRE (Distribution ID 1000994380)

BUSINESSNEXT and MongoDB team up to accelerate autonomous operations in financial services

NEW DELHI, Sept. 27, 2024 (GLOBE NEWSWIRE) — BUSINESSNEXT, a global leader in composable enterprise solutions for financial services, has partnered with MongoDB to accelerate autonomous operations powered with specialized predictive and generative AI for banking and insurance. Headquartered in New York, MongoDB empowers innovators to create, transform, and disrupt industries with the power of software and data.

The collaboration between BUSINESSNEXT and MongoDB will empower banking and financial services with the technology needed to deliver exceptional customer experiences and drive autonomous operations.

By combining BUSINESSNEXT’s deep expertise in financial services with MongoDB’s flexible, scalable database platform that has industry–leading encryption, access controls, and data protection protocols, the partnership will deliver innovative solutions that address the evolving needs of the industry. BUSINESSNEXT’s suite of solutions to drive autonomous banking includes real–time AI at the core powering modern CRM, digital journeys, lending platforms, risk–rating platforms, workforce assistants, customer chatbots and more.

MongoDB’s document–oriented data model, with its flexible schema, nicely complements BUSINESSNEXT’s AI–driven capabilities. The partnership will enable banks to harness the power of their data to create personalized customer journeys, optimize lending processes, and make data–driven decisions.

“We are excited to partner with MongoDB to deliver cutting–edge solutions to our financial services clients,” said Sushil Tyagi, Executive Director at BUSINESSNEXT. “MongoDB’s industry–leading data protection protocols and our ability to handle complex data structures and scale effortlessly aligns with our vision of providing a modern, agile platform for banks.”

“Independent software vendors are an integral part of the enterprise software stack in India, and BUSINESSNEXT is a great example of the kind of ISV we want to work with,” said Sachin Chawla, Vice President, India and South Asia at MongoDB. “This partnership will help a large number of financial services organizations to accelerate their modernization initiatives and use AI to drive differentiation,” added Chawla.

Key benefits of the partnership include:

  • Autonomous Banking operations
  • Enhanced customer experiences
  • Accelerated lending processes
  • Improved operational efficiency
  • Strengthened risk management

This partnership marks a significant milestone for both BUSINESSNEXT and MongoDB, and it is expected to drive significant value for financial institutions worldwide.

For more information,

visit BUSINESSNEXT website https://www.businessnext.com/

and MongoDB website https://www.mongodb.com/.

For Media Inquiries:

Ajay Joshi

ajay.joshi@businessnext.com


GLOBENEWSWIRE (Distribution ID 9237628)

Activists Call on World to ‘Imagine’ Peace, End Nuclear Arms

The panel for the session on “Remembering Hiroshima and Nagasaki: Imagining a World without Nuclear Weapons.” Credit: AD McKenzie/IPS

The panel for the session on “Remembering Hiroshima and Nagasaki: Imagining a World without Nuclear Weapons.” Credit: AD McKenzie/IPS

By AD McKenzie
PARIS, Sep 27 2024 – In any discussion of world peace and the future of humanity, the issue of nuclear arms must be addressed, and now.

That was the message from a range of delegates at the “Imaginer la Paix / Imagine Peace” conference, held in Paris September 22 to 24, and organized by the Sant’Egidio Community, a Christian organization founded in Rome in 1968 and now based in 70 countries.

Describing its tenets as “Prayer, service to the Poor and work for Peace,” the community has hosted 38 international, multi-faith peace meetings, bringing together activists from around the world. This is the first time the conference has been held in Paris, with hundreds traveling to France, itself a nuclear-weapon state.

Occurring against the backdrop of brutal, on-going conflicts in different regions and a new race by some countries to “upgrade” their arsenal, the gathering had a sense of urgency, with growing fears that nuclear weapons might be used by warlords. Participants highlighted current and past atrocities and called upon world leaders to learn from the past.

“After Hiroshima and Nagasaki, we have been blessed with many who have said ‘no’—’no’ a million times, creating movements and treaties, (and) awareness… that the only reasonable insight to learn from the conception and use of nuclear weapons is to say ‘no’,” said Andrea Bartoli, president of the Sant’Egidio Foundation for Peace and Dialogue, based in New York.

Participating in a conference forum Monday titled “Remembering Hiroshima and Nagasaki: Imagining a World Without Nuclear Weapons,”  Bartoli and other speakers drew stark pictures of what living in a world with nuclear weapons entails, and they highlighted developments since World War II.

“After the two bombs were used against Hiroshima and Nagasaki, humans built more than 70,000 nuclear weapons and performed more than 2,000 tests. Still today we have more than 12,500, each of them with power greatly superior to the two used in August 1945,” Bartoli said.

Despite awareness of the catastrophic potential of these weapons and despite a UN treaty prohibiting their use, some governments argue that possessing nuclear arms is a deterrent—an argument that is deceptive, according to the forum speakers.

Anna Ikeda, program coordinator tor disarmament at the UN Office of Soka Gakkai International. Credit: AD McKenzie/IPS

Anna Ikeda, program coordinator for disarmament at the UN Office of Soka Gakkai International. Credit: AD McKenzie/IPS

Jean-Marie Collin, director of ICAN (the International Campaign to Abolish Nuclear Weapons, a movement launched in the early 2000s in Australia and recipient of the Nobel Peace Prize in 2017), said that leaders who cite deterrence “accept the possibility of violating” international human rights.

“Nuclear weapons are designed to destroy cities and kill and maim entire populations, which means that all presidents and heads of government who implement a defense policy based on nuclear deterrence and who are therefore responsible for giving this order, are aware of this,” Collin told the forum.

ICAN campaigned for the Treaty on the Prohibition of Nuclear Weapons that was adopted at the United Nations in 2017, entering into force in 2021. The adoption came nearly five decades after the Treaty on the Non-Proliferation of Nuclear Weapons (NPT), which entered into force in 1970.

The terms of the NPT consider five countries to be nuclear weapons states: the United States, Russia, the United Kingdom, France, and China. Four other countries also possess nuclear weapons: India, Pakistan, North Korea, and Israel.

According to a 2024 ICAN report, these nine states jointly spent €85 billion (USD 94,6 billion) on their atomic weapon arsenals last year, an expenditure ICAN has called “obscene” and “unacceptable.” France, whose president Emmanuel Macron spoke about peace in broad, general terms at the opening of the conference, spent around €5,3 billion (about USD 5,9 billion) in 2023 on its nuclear weapons, said the report.

The policy of “deterrence” and “reciprocity,”  which essentially means “we’ll get rid of our weapons if you get rid of yours,”  has been slammed by ICAN and fellow disarmament activists.

“With the constant flow of information, we often tend to lose sight of the reality of figures,” Collin said at the peace conference. “I hope this one will hold your attention: it is estimated that more than 38,000 children were killed in the atomic bombings of Hiroshima and Nagasaki. Children!”

All those killed—an estimated 210,000 people by the end of 1945—died in horrific ways, as survivors and others have testified. Delegates said that this knowledge should be the real “deterrent.”

At the forum, Anna Ikeda, program coordinator for disarmament at the UN Office of Soka Gakkai International, a global Buddhist movement, described testimony from a Hiroshima a-bomb survivor, Reiko Yamada, as one she would never forget.

“She (Yamada) stated, ‘A good friend of mine in the neighbourhood was waiting for her mother to return home with her four brothers and sisters. Later, she told me that on the second day after the bombing, a moving black lump crawled into the house. They first thought it was a black dog, but they soon realized it was their mother; she collapsed and died when she finally got to her children. They cremated her body in the yard,” Ikeda told the audience with emotion.

“Who deserves to die such a death? Nobody!” she continued. “Yet our world continues to spend billions of dollars to upkeep our nuclear arsenals, and our leaders at times imply readiness to use them. It is utterly unacceptable.”

Ikeda said that survivors, known as the “hibakusha” in Japan, have a fundamental answer to why nuclear weapons must be abolished—it is that “no one else should ever suffer what we did.”

Note: This article is brought to you by IPS Noram in collaboration with INPS Japan and Soka Gakkai International in consultative status with ECOSOC.

IPS UN Bureau Report

 


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Uptick in Mpox Cases Raises Concern Among Health Officials

Parfait Muhani, Project Supervisor at UNICEF-supported Congolese NGO REMED, is educating children about mpox symptoms and prevention measures in Chireja village, South Kivu province, DR Congo, on 13 September 2024. Credit: UNICEF/ Christian Mirindi Johnson

By Oritro Karim
UNITED NATIONS, Sep 27 2024 – Yesterday, India’s Federal Health Ministry reported the nation’s first documented case of mpox. The infected individual was reported to have contracted the clade Ib strain of the virus, which is a far deadlier variant than the more common clade II. This development has raised considerable concern among health officials around the world as the mpox epidemic had been contained in the Democratic Republic of Congo until recently.

In August, the World Health Organization (WHO) declared the emerging mpox epidemic to be a “global health emergency”. In the early stages of the epidemic, around 90 percent of all cases had been reported in the Democratic Republic of Congo. In the following weeks, infections were reported in neighbouring states, including Kenya, Burundi, and Rwanda. The virus had also spread to non-African countries, such as Pakistan, Thailand, and Sweden.

The Africa Centres for Disease Control and Prevention (ACDC) reported a 160 percent rise in cases from the previous year, adding that most of these cases are from the deadlier clade I variant. Additionally, in the past few weeks, there have been a considerable uptick in cases in Kinshasa, the capital city of Congo. According to the Democratic Republic of Congo’s Ministry of Health, Kinshasa had only seen 525 cases of transmission as of September 15. However, 10 percent of those cases had been reported in the final week of that testing period, indicating to analysts that rates of transmission are on the rise.

Although there have been few cases of the clade Ib strain detected, as well as zero fatalities, outside of Congo, health officials around the world have set up processes to track the spread and isolate infected individuals. The European Centre for Disease Prevention and Control (ECDC) urged for continued vigilance surrounding this epidemic, stating, “The size of these outbreaks could be larger than reported due to under-ascertainment and under-reporting”. It is estimated by the Congolese Health Ministry that only 20 percent of mpox cases are confirmed, with most never seeking care or having their symptoms brushed off as chickenpox.

Congolese health officials have long advocated for a strong mpox vaccination campaign to be conducted, believing that it is paramount to eradicating this health crisis. “The expanding outbreak and the ongoing difficulties controlling it using traditional public health measures highlight the clear role of vaccines as part of the comprehensive response. A strong, well-coordinated mpox vaccine rollout, built on the lessons learned from the COVID-19 and Ebola vaccine rollouts, among others, is essential”, stated WHO Regional Office of Africa.

On September 13th, WHO approved its first prequalification for a vaccine against mpox.

Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, states, “The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as Gavi and Unicef to help communities on the frontlines of the ongoing emergency in Africa and beyond”.

The MVA-BN vaccine is currently only licensed for people who are over 18 years of age and not pregnant or immunocompromised. Patients are given two doses of injections, delivered four weeks apart.

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization states that off-label use of the MVA-BN vaccine for all patients may be permitted as the benefits of widespread vaccination far outweigh potential risks. Studies show that one dose of the vaccine prior to infection boasts 76 percent immunization, while 2 doses yield 86 percent immunization. WHO is currently in the process of facilitating widespread vaccine rollouts and urges donor contributions so initiatives can be scaled up.

IPS UN Bureau Report

 


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