Inteleos Foundation annonce les lauréats du Prix MedMissions 2026 pour renforcer l’accès à l’échographie maternelle dans cinq nations

ROCKVILLE, Maryland, 15 avr. 2026 (GLOBE NEWSWIRE) — La Inteleos Foundation a annoncé aujourd’hui les cinq organisations bénéficiaires de son Prix MedMissions 2026, une initiative visant à améliorer l’accès à l’échographie en santé maternelle au Malawi, en Sierra Leone, au Kenya, en Ouganda et en Côte d’Ivoire. Ce programme annuel soutient les initiatives locales menées par des ONG, visant à élargir la formation à l'échographie au point de soins (Point-of-Care Ultrasound), à renforcer les systèmes de référence et d’orientation des patients et à améliorer la prise en charge des grossesses à haut risque dans des milieux à ressources limitées.

Désormais dans sa huitième année, le Prix MedMissions s’attaque à l’un des défis les plus urgents de la santé mondiale — le manque d’accès à l’imagerie médicale pour près de 5 milliards de personnes. En soutenant la formation et les connaissances et en établissant des partenariats stratégiques, l’initiative contribue à rendre l’échographie accessible à tous.

Lauréats du Prix MedMissions 2026

Pour cette édition, la Fondation a sélectionné les organisations à but non lucratif suivantes pour déployer et mettre en œuvre des interventions locales en santé maternelle dans cinq pays :

  • GAIA Global Health : œuvrant pour améliorer l’accès à des services d’échographie obstétricale de qualité et favoriser des grossesses et des accouchements plus sûrs dans les communautés rurales du Malawi.
  • Seed Global Health : visant à développer la formation et la prestation des services d'échographie au point de soins (Point-of-Care Ultrasound), pour renforcer les soins maternels et néonatals dans les établissements de santé en Sierra Leone.
  • Kenyatta University : ayant pour objectif de déployer l’échographie pour améliorer la détection précoce, le suivi obstétrical et l’orientation des grossesses à haut risque dans les quartiers informels reculés du comté de Nairobi, au Kenya.
  • Babies and Mothers Alive Foundation: visant à améliorer la qualité des soins obstétricaux, en intégrant l’échographie au point de soins (POCUS) dans les consultations prénatales de routine à travers les établissements de santé de la région du Grand Masaka, en Ouganda.
  • Muso : visant à renforcer les compétences en échographie des prestataires à la première ligne des soins, afin d’améliorer les résultats obstétricaux et périnatals en Côte d’Ivoire.

Le Prix MedMissions établit un consortium d’organisations de santé et de ministères de la Santé locaux pour faire progresser la formation à l’échographie au point de soins (POCUS) et les systèmes d’orientation des patients, tout en renforçant les capacités des personnels de santé de première ligne dans les communautés isolées d’Afrique subsaharienne.

Les lauréats sélectionnés adopteront une approche centrée sur les résultats pour évaluer l’impact clinique chez les patients, l’utilisation de l’échographie et son adoption par les communautés. Ces partenariats permettront de transformer les données de terrain en politiques de santé nationales, de renforcer durablement les capacités de la main-d’œuvre et de favoriser une meilleure intégration des interventions dans les structures existantes des systèmes de santé. Pour la Inteleos Foundation, ces initiatives établiront les bases d’infrastructures essentielles et de modèles de formation reproductibles, permettant ainsi un accès universel à l’imagerie médicale pour les professionnels de santé et leurs patients.

Pour en savoir plus à propos des Prix MedMissions, veuillez consulter le lien suivant :  https://inteleosfoundation.org/medical-missions

À propos de la Inteleos Foundation :

La Inteleos Foundation est une organisation mondiale à but non lucratif qui soutient des interventions technologiques communautaires et axées sur les résultats, afin de transformer la prise en charge des patients dans les zones mal desservies et à faibles ressources. Notre travail repose sur trois priorités majeures : renforcer la formation et la certification des professionnels de santé en imagerie médicale ; développer les compétences en échographie pour favoriser les opportunités économiques dans le secteur de la santé ; et améliorer l’accès aux services diagnostiques au sein des systèmes de santé grâce à la collaboration en réseau.

Contact Presse :

Samantha Forcum
Directrice de la Inteleos Foundation
[email protected]
(240) 386-1710


GLOBENEWSWIRE (Distribution ID 9690510)

Inteleos Foundation Announces 2026 MedMissions Award to Advance Maternal Health Ultrasound Access in Five Nations

ROCKVILLE, Md., April 15, 2026 (GLOBE NEWSWIRE) — The Inteleos Foundation today announced five recipients of its 2026 MedMissions Award, supporting maternal health ultrasound access in Malawi, Sierra Leone, Kenya, Uganda, and Côte d’Ivoire. The annual award advances locally led nonprofit initiatives that expand point-of-care ultrasound training, strengthen referral pathways, and improve care for high-risk pregnancies in resource-limited settings.

In its eighth year of operation, the MedMissions Award confronts one of global health's most urgent crises — 5 billion people without access to medical imaging — building the evidence base and partnerships needed to make ultrasound accessible to all.

2026 MedMissions Award Recipients

This year, the Foundation has selected the following nonprofit organizations to drive locally-led maternal health interventions in five nations:

  • GAIA Global Health: Expanding access to quality obstetric ultrasound services to support safer pregnancies and deliveries in rural communities in Malawi.
  • Seed Global Health: Expanding point-of-care ultrasound training and services to strengthen maternal and newborn care in health facilities across Sierra Leone.
  • Kenyatta University: Deploying ultrasound to improve early detection and referral for high-risk pregnancies in remote informal settlements of Nairobi County, Kenya.
  • Babies and Mothers Alive Foundation: Improving the quality of obstetric care by integrating point-of-care ultrasound into routine antenatal practice in health facilities in Uganda’s Greater Masaka region.
  • Muso: Enhancing ultrasound capacity for frontline providers to improve obstetric and perinatal outcomes in Côte d’Ivoire.

The MedMissions Award establishes a consortium of health-focused organizations and local Ministries of Health to advance point-of-care ultrasound training and referral pathways for frontline health workers in remote communities across Sub-Saharan Africa.

Selected awardees will use an outcomes-based approach to evaluate patient health outcomes, ultrasound utilization, and community adoption. These partnerships are designed to help translate field-level evidence into national policy, long-term workforce capacity, and more sustainable health system integration. For the Inteleos Foundation, these interventions will establish critical infrastructure and replicable education models that will drive universal access to medical imaging for health providers and their patients.

To learn more about MedMissions, visit: https://inteleosfoundation.org/medical-missions

Inteleos Foundation
The Inteleos Foundation is a global nonprofit organization that fosters community-led, outcomes-driven technology interventions that transform patient care in low-resourced communities. Our work is guided by three key priorities: enriching healthcare provider training and certification in medical imaging, catalyzing workforce development with ultrasound to advance economic opportunities in healthcare, and addressing gaps in diagnostic service delivery across health systems through network collaboration.             

Media Contact

Samantha Forcum
Director of the Inteleos Foundation
[email protected]
(240) 386-1710


GLOBENEWSWIRE (Distribution ID 9690008)

AI-Enabled Fertility Care and Longevity Provider ONTO Health Closes $20 Million Series funded by ARTIS and Humania

Chicago, IL, April 15, 2026 (GLOBE NEWSWIRE) — ONTO Health (“ONTO”), an AI-enabled, physician-led fertility and longevity provider, has announced the close of a $20 million Series A financing round funded by long-time healthcare investors, ARTIS and Humania. The ONTO Health platform combines evidence-based fertility care with AI-driven diagnostics, clinical automation, and longevity science. The new funding will support additional clinical operations in the U.S., as well as expansion into the Gulf Cooperation Council (GCC) region.

ONTO was founded by ARTIS and ONTO’s CEO, Roohi Jeelani, MD, FACOG, a double board-certified Reproductive Endocrinology and Infertility specialist recognized for her leadership in fertility care and women’s health innovation. ONTO’s AI integrates automation, advanced diagnostics, and individualized treatment planning to support clinical decision-making and improve patient outcomes.

Dr. Roohi Jeelani, ONTO Health’s CEO and Co-Founder, said: “ONTO was built to meet people where they are and to stay with them as their needs evolve. Fertility care has often been too narrowly focused. We view reproductive care as part of a broader, lifelong health journey rather than a single episode of treatment, and are dedicated to a comprehensive, human-centered approach to both. This includes AI-powered, physician-led clinical programs that are rigorous, collaborative, and patient-centered. We are dedicated to offering a holistic care system that is reflective of how the body functions as an interconnected system.”

“ONTO Health is addressing one of the most complex and emotionally significant areas of medicine with a model that is both clinically rigorous and deeply compassionate,” said Stuart Peterson, CEO and Managing Partner of ARTIS. “Dr. Jeelani has already demonstrated that fertility care can be proactive, integrated, and scalable without losing sight of the human experience. Under her leadership, ONTO is building a platform capable of expanding access to high-quality reproductive care across geographies, and we’re proud to partner with Humania to support that growth.”

“We are proud to co-lead this investment in ONTO, which reflects our commitment to bringing best-in-class healthcare technology to the Gulf region and beyond,” said Makarem S. Batterjee, Vice Chairman of Saudi German Group and Founder & President of Humania. “The integration of AI and automation into fertility care represents a transformative leap, enhancing diagnostics, personalization, and outcomes while making high-quality treatment more accessible for families across the region. With ARTIS, we are building a partnership that identifies the most promising healthcare innovation globally and deploys them where needed most. We look forward to welcoming ONTO into our network of eighteen tertiary hospitals and over 50 outpatient facilities across the Gulf and North Africa.”

Aamir Rehan, CEO of Humania, added: “ONTO represents exactly the kind of company we built this partnership to find, a U.S. leader using AI and automation to solve a real clinical need, with a model ready to scale into the markets we know best. Our partnership with ARTIS gives us a shared lens to identify transformative healthcare companies in the U.S. and bring them to the Gulf region, where the demand for world-class care is accelerating. We're proud to co-lead this round and look forward to supporting Dr. Jeelani as ONTO expands access to advanced fertility care for families across the GCC.”

About ONTO Health

ONTO Health combines personalized care with evidence-based medicine to identify and address the factors impacting health across the lifespan. By viewing fertility as a marker of overall health, ONTO partners with patients to provide high-quality reproductive care alongside proactive management of long-term well-being.

By integrating advanced data infrastructure with proven integrative protocols, ONTO delivers earlier insights, greater clinical precision, and highly individualized treatment plans — improving outcomes while reducing the time and cost burden that defines the current standard of care.


GLOBENEWSWIRE (Distribution ID 9690316)

Helus Pharma nomme Michael Cola au poste de directeur général pour piloter la prochaine phase de développement et d’exécution

  • Ancien président de la division pharmaceutique spécialisée de Shire PLC (« Shire »), il cumule plus de 30 ans d’expérience dans les domaines des neurosciences, des maladies rares et des produits pharmaceutiques spécialisés, notamment à des postes de direction chez Astra-Merck et AstraZeneca PLC.
  • Leader reconnu dans le développement clinique avancé, la commercialisation mondiale et la formation de capital pour les programmes relatifs au système nerveux central (« SNC »)
  • Cette nomination intervient alors qu’Helus Pharma fait progresser son portefeuille de produits vers des étapes cliniques clés, notamment les données de phase 2 attendues pour HLP004 ce trimestre et les principaux résultats de phase 3 pour HLP003 plus tard cette année.

Cette annonce constitue un « communiqué de presse désigné » aux fins du supplément de prospectus de la Société daté du 30 décembre 2025, à son prospectus simplifié préalable daté du 17 septembre 2025, tel que modifié le 19 décembre 2025.

BOSTON et TORONTO, 11 févr. 2026 (GLOBE NEWSWIRE) — Helus PharmaTM (« Helus ») (Nasdaq : HELP) (Cboe CA : HELP), une société pharmaceutique en phase clinique engagée à contribuer à la guérison mentale en développant de nouveaux agonistes sérotoninergiques (« ASN »), a annoncé aujourd’hui la nomination de Michael Cola au poste de directeur général, avec effet immédiat.

La nomination de M. Cola intervient à un moment charnière, alors qu’Helus fait progresser son portefeuille de traitements de santé mentale de nouvelle génération vers des étapes cliniques et commerciales clés, notamment la publication prévue des données de phase 2 pour HLP004 ce trimestre et des données principales de phase 3 pour HLP003 au quatrième trimestre 2026. En parallèle, Helus continue de développer un patrimoine de propriété intellectuelle vaste et solide couvrant son portefeuille multi-actifs, avec plus de 350 demandes de brevets déposées dans le monde entier et plus de 100 brevets accordés. La Société poursuit des programmes différenciés conçus pour traiter les troubles mentaux graves. Alors que la transition du développement clinique précoce à l’exécution des phases ultérieures est en cours, la Société se concentre de plus en plus sur l’engagement réglementaire mondial et la planification commerciale à long terme. Cette évolution souligne l’importance d’un leadership expérimenté dans le développement de médicaments, la formation de capital et l’expansion mondiale.

« Michael possède une combinaison rare d’expertise approfondie en neurosciences, d’expérience en commercialisation mondiale et de leadership éprouvé sur les marchés financiers », a déclaré le cofondateur et président exécutif Eric So. « Alors qu’Helus développe son portefeuille de produits différenciés en santé mentale, son expérience dans la création de franchises de premier plan dans le domaine du SNC et dans le développement d’organisations mondiales fait de lui le candidat idéal pour diriger Helus tandis que nous nous efforçons de traduire nos découvertes scientifiques en traitements significatifs pour les patients et en valeur à long terme pour les actionnaires. »

Fort de plus de 30 ans d’expérience dans les neurosciences, les maladies rares et les produits pharmaceutiques spécialisés, M. Cola apporte une expertise approfondie dans l’accompagnement de projets innovants ciblant le SNC tout au long de leur développement et sur les marchés mondiaux, dans la création d’organisations performantes et dans la création de valeur à long terme pour les actionnaires. Son parcours professionnel comprend des postes de direction de haut niveau dans les domaines de la R&D, de la commercialisation, de la stratégie d’entreprise et de la formation de capital, ce qui le positionne idéalement pour mener Helus dans sa prochaine phase de croissance.

« Je suis honoré de rejoindre Helus à ce moment charnière et stimulant », confie M. Cola. « Grâce aux données cliniques très différenciées déjà disponibles concernant l’HLP003 et à un portefeuille prometteur de nouvelles molécules en développement, Helus est idéalement placée pour proposer un nouveau paradigme dans le traitement des troubles mentaux graves. Je suis ravi de collaborer avec le Conseil d’administration et l’équipe d’Helus pour tirer parti de ces bases et traduire les progrès scientifiques en un impact durable pour les patients et les actionnaires. »

En tant que président de la division pharmaceutique spécialisée de Shire, M. Cola a contribué à faire de l’entreprise un leader mondial dans le domaine du SNC, en lançant et en développant des traitements révolutionnaires, notamment en faisant de Vyvanse une franchise de plusieurs milliards de dollars et en contribuant à la croissance de la capitalisation boursière de Shire, qui est passée de 5 milliards de dollars à 20 milliards de dollars, ce qui a permis de positionner l’entreprise en vue de son acquisition ultérieure par Takeda pour 62 milliards de dollars, l’une des plus importantes acquisitions pharmaceutiques du secteur. Au début de sa carrière, M. Cola a été l’un des premiers employés de Merck sélectionnés pour contribuer à la création d’Astra-Merck, l’une des entreprises pharmaceutiques dérivées les plus réussies, formée pour commercialiser le Prilosec, une franchise qui a généré à un moment donné plus de 6 milliards de dollars de revenus annuels. Il a ensuite occupé des postes de direction chez AstraZeneca PLC, participant à l’expansion du cycle de vie du Prilosec et à la transition vers le Nexium.

Plus récemment, M. Cola a occupé les fonctions de président et de directeur général d’Avalo Therapeutics, Inc., où il a mené la transition vers une spécialisation dans les maladies rares et la médecine génomique, a concédé des licences pour des actifs de première génération en phase clinique et a levé des fonds importants. Il a également occupé des postes de direction au sein de conseils d’administration, notamment en tant que président de Phathom Pharmaceuticals, Inc. et ancien membre du conseil d’administration de Sage Therapeutics, Inc., accompagnant des organisations lors de phases cliniques cruciales et de lancements commerciaux.

M. Cola est titulaire d’une licence en biologie de l’Ursinus College, d’une maîtrise en sciences et ingénierie biomédicales de l’Université Drexel et a étudié la bioingénierie à l’Université de Pennsylvanie, où il a également travaillé comme ingénieur biomédical dans son hôpital affilié.

À propos de Helus Pharma

Helus Pharma™, nom commercial de Cybin Inc., fondée en 2019 (la « Société »), est une société pharmaceutique en phase clinique qui s’engage à aider l’esprit à guérir en développant des ASN exclusifs, de nouveaux agonistes sérotoninergiques : des molécules synthétiques conçues pour activer les voies de la sérotonine censées favoriser la neuroplasticité. Les ASN exclusifs de la Société sont destinés à répondre à l’important besoin non satisfait des personnes souffrant de dépression, d’anxiété et d’autres troubles de santé mentale.

S’appuyant sur des données de pointe, Helus Pharma ambitionne d’améliorer le paysage thérapeutique grâce à l’introduction d’ASN visant à apporter des améliorations durables en matière de santé mentale. Helus Pharma développe actuellement le HLP003, un ASN exclusif, en phase 3 de développement clinique pour le traitement adjuvant du trouble dépressif majeur, qui a reçu la Désignation de thérapie innovante de la Food and Drug Administration américaine (FDA), et le HLP004, également un ASN exclusif, en phase 2 pour le trouble d’anxiété généralisée. De plus, Helus Pharma possède un vaste portefeuille de recherche sur les ASN expérimentaux.

La Société exerce ses activités au Canada, aux États-Unis, au Royaume-Uni et en Irlande. Pour obtenir des informations actualisées sur la Société et en savoir plus sur Helus Pharma, visitez www.helus.com ou suivez l’équipe sur X, LinkedIn, YouTube et Instagram. Helus PharmaTM est une marque déposée de Cybin Corp.

Mises en garde et déclarations prospectives

Certaines déclarations contenues dans ce communiqué de presse concernant la Société constituent des déclarations prospectives ou des informations prospectives au sens des lois sur les valeurs mobilières applicables (collectivement, les « déclarations prospectives ») et sont de nature prospective. Les déclarations prospectives ne reposent pas sur des faits historiques, mais plutôt sur des attentes et des projections actuelles concernant les événements futurs et sont donc soumises à des risques et des incertitudes qui pourraient faire en sorte que les résultats réels diffèrent sensiblement des résultats futurs exprimés ou sous-entendus dans les déclarations prospectives. Ces déclarations peuvent généralement être identifiées par l’utilisation de termes prospectifs tels que « peut », « devrait », « pourrait », « potentiel », « possible », « a l’intention de », « estime », « planifie », « anticipe », « s’attend à », « croit » ou « continue », ou leur forme négative ou des variantes similaires. Les déclarations prospectives contenues dans ce communiqué de presse comprennent des déclarations concernant l’intention de la Société de faire progresser de manière significative le traitement des troubles mentaux graves ; la capacité des ASN de la Société à répondre aux importants besoins non satisfaits des personnes souffrant de dépression, d’anxiété et d’autres problèmes de santé mentale ; la publication des données de phase 2 pour HLP004 au premier trimestre 2026 et des données préliminaires de phase 3 pour HLP003 au quatrième trimestre 2026 ; et les projets de la Société de concevoir des plateformes exclusives de découverte de médicaments, des systèmes d’administration de médicaments innovants, de nouvelles approches de formulation et des schémas thérapeutiques pour les troubles mentaux.

Ces déclarations prospectives reposent sur des hypothèses et des estimations raisonnables de la direction de la Société au moment où elles ont été formulées. Les résultats futurs réels peuvent différer sensiblement, car les déclarations prospectives comportent des risques connus et inconnus, des incertitudes et d’autres facteurs qui peuvent faire en sorte que les résultats, le rendement ou les réalisations réels de la Société diffèrent sensiblement des résultats, du rendement ou des réalisations futurs exprimés ou sous-entendus dans ces déclarations prospectives. Ces facteurs comprennent notamment : les fluctuations de la conjoncture macroéconomique générale ; les fluctuations des marchés des valeurs mobilières ; les attentes concernant la taille du marché des ASN ; la capacité de la Société à atteindre ses objectifs commerciaux ; ses plans de croissance ; les incertitudes politiques, sociales et environnementales ; les relations avec les employés ; l’existence de lois et de règlements pouvant imposer des restrictions sur les marchés où la Société exerce ses activités ; les répercussions des épidémies sur les activités de la Société ; et les facteurs de risque énoncés dans le rapport de gestion de la Société pour les périodes de trois et six mois closes le 30 septembre 2025, ainsi que dans la notice annuelle de la Société pour l’exercice clos le 31 mars 2025, documents disponibles dans le profil de la Société sur SEDAR+ à l’adresse www.sedarplus.ca et auprès de la Securities and Exchange Commission des États-Unis sur EDGAR à l’adresse www.sec.gov/edgar. Bien que les déclarations prospectives contenues dans ce communiqué de presse soient fondées sur ce que la direction de la Société considère, ou considérait à l’époque, comme des hypothèses raisonnables, la Société ne peut garantir aux actionnaires que les résultats réels seront conformes à ces déclarations prospectives, car d’autres facteurs pourraient faire en sorte que les résultats ne soient pas ceux prévus, estimés ou attendus. Les lecteurs ne doivent pas accorder une importance excessive aux déclarations prospectives contenues dans ce communiqué de presse. La Société décline toute obligation de mettre à jour les déclarations prospectives relatives à ses convictions, opinions, projections ou autres facteurs, si ceux-ci venaient à changer, sauf si la loi l’exige.

La Société ne fait aucune allégation médicale, thérapeutique ou relative aux bienfaits pour la santé des produits qu’elle propose. La Food and Drug Administration américaine (FDA), Santé Canada ou d’autres autorités réglementaires similaires n’ont pas évalué les allégations concernant les ASN ou les programmes HLP003, HLP004 et autres programmes de la Société. L’efficacité de ces produits n’a pas été confirmée par des recherches approuvées. Il n’existe aucune garantie que l’utilisation des ASN, HLP003, HLP004 ou d’autres programmes de la Société puisse diagnostiquer, traiter, guérir ou prévenir une maladie ou un problème quelconque. Des recherches scientifiques rigoureuses et des études cliniques sont nécessaires. Si Helus Pharma ne parvient pas à obtenir les autorisations ou les recherches nécessaires à la commercialisation de ses activités, cela pourrait avoir un impact négatif important sur les performances et les opérations de la Société.

Ni Cboe Canada, ni la bourse Nasdaq Global Market, n’ont approuvé ou désapprouvé le contenu de ce communiqué de presse et ne sont responsables de l’exactitude et de l’exhaustivité des informations qui y figurent.

Contact investisseurs :
Josh Barer
astr partners
Directeur général
(908) 578-6478
[email protected]

George Tziras
Directeur commercial
Helus Pharma
1-866-292-4601
[email protected] – ou – [email protected]

Contact médias :
Johnny Tokarczyk
RXMD
Directeur des relations publiques
[email protected]
(914) 772-7562


GLOBENEWSWIRE (Distribution ID 9652878)

Helus Pharma Nomeia Michael Cola como Diretor Executivo para Liderar a Próxima Fase de Escala e Execução

  • Ex-presidente da empresa farmacêutica especializada da Shire PLC (“Shire”), com mais de 30 anos de experiência em neurociência, doenças raras e produtos farmacêuticos especializados, incluindo cargos de liderança sênior na Astra-Merck e AstraZeneca PLC
  • Líder comprovado em programas de desenvolvimento clínico em estágio final, comercialização global e formação de capital em todo o sistema nervoso central (“SNC”)
  • Nomeado durante o avanço do pipeline de Helus Pharma em direção aos principais marcos clínicos, incluindo os dados esperados da Fase 2 do HLP004 neste trimestre e os dados de linha superior da Fase 3 do HLP003 ainda este ano

Este comunicado à imprensa constitui um “comunicado à imprensa designado” para os fins do suplemento do prospecto da Empresa datado de 30 de dezembro de 2025, ao prospecto de prateleira de base resumida datado de 17 de setembro de 2025, conforme alterado em 19 de dezembro de 2025.

BOSTON e TORONTO, Feb. 11, 2026 (GLOBE NEWSWIRE) — A Helus Pharma™ (“Helus”) (Nasdaq: HELP) (Cboe CA: HELP), uma empresa farmacêutica de estágio clínico focada em ajudar na cura das mentes por meio do desenvolvimento de novos agonistas serotoninérgicos (“NSAs”), anunciou hoje a nomeação de Michael Cola como Diretor Executivo, com efeito imediato.

A nomeação do Sr. Cola ocorre em um momento crucial para o avanço do pipeline da Helus de terapias de saúde mental de última geração focado nos principais marcos de influência de valor clínico e corporativo, incluindo a divulgação esperada dos dados da Fase 2 do HLP004 neste trimestre e os dados da linha superior da Fase 3 do HLP003 no quarto trimestre de 2026. Além disso, a Helus continua a desenvolver uma propriedade intelectual ampla e defensável para o seu pipeline de vários ativos, com mais de 350 pedidos de patentes em andamento em todo o mundo e mais de 100 patentes concedidas. A Empresa está avançando programas diferenciados projetados para tratar de transtornos graves de saúde mental. Com a transição do desenvolvimento clínico inicial para a execução em estágio posterior em andamento, a Empresa está cada vez mais focada no engajamento regulatório global e no planejamento comercial de longo prazo. Essa evolução ressalta a importância da liderança experiente no desenvolvimento de medicamentos, formação de capital e expansão global.

“Michael tem uma profunda experiência em neurociência, em comercialização global e liderança comprovada em mercados de capitais”, disse o cofundador e Presidente Executivo Eric So. “Com o avanço do pipeline diferenciado de saúde mental da Helus, o histórico de abertura de franquias de primeira classe no CNS e escalonamento de organizações globais de Michael o tornam excepcionalmente apropriado para liderar a Helus no nosso trabalho de traduzir a nossa ciência em terapias significativas para os pacientes e valor de longo prazo para os acionistas.”

Com mais de 30 anos de experiência em neurociência, doenças raras e produtos farmacêuticos especializados, o Sr. Cola tem uma profunda experiência em orientar ativos inovadores do SNC através do desenvolvimento e em mercados globais, criando organizações de alto desempenho e valor para os acionistas a longo prazo. Sua carreira abrange funções de liderança sênior em P&D, comercialização, estratégia corporativa e formação de capital, ideal para liderar a Helus na sua próxima fase de crescimento.

“É uma honra passar a fazer parte da Helus neste momento crucial e energizante”, disse o Sr. Cola. “Com dados clínicos altamente diferenciados do HLP003 já em mãos e um pipeline robusto de novos compostos em desenvolvimento, a Helus está excepcionalmente posicionada para promover um novo paradigma no tratamento de transtornos graves de saúde mental. Estou muito contente em trabalhar ao lado do Conselho e da equipe da Helus para criar essa base e traduzir o progresso científico em um impacto duradouro para os pacientes e acionistas.”

Como presidente da divisão Specialty Pharmaceutical da Shire, o Sr. Cola ajudou a transformar a empresa em uma líder global do SNC, lançando e ampliando terapias inovadoras, incluindo a transformação da Vyvanse em uma franquia multibilionária e contribuindo para o crescimento da Shire de US$5 bilhões para US$20 bilhões de capitalização de mercado, ajudando a posicionar a empresa para sua subsequente aquisição de US$62 bilhões pela Takeda, uma das maiores aquisições farmacêuticas do setor. No início da sua carreira, o Sr. Cola foi uma das primeiras contratações da Merck selecionadas para ajudar a criar a Astra-Merck, uma das spinouts farmacêuticas de maior sucesso, formada para comercializar o Prilosec, uma franquia que em determinado momento gerou mais de US$6 bilhões em receita anual. Depois disso ele ocupou cargos de liderança sênior na AstraZeneca PLC, apoiando a expansão do ciclo de vida do Prilosec e a transição para o Nexium.

Mais recentemente, o Sr. Cola atuou como Presidente e CEO da Avalo Therapeutics, Inc., onde liderou a transição para um foco em doenças raras e medicina genômica, licenciou ativos de estágio clínico de primeira classe e levantou financiamento significativo. Ele também atuou em cargos de liderança do conselho sênior, incluindo como Presidente da Phathom Pharmaceuticals, Inc. e como ex-membro do conselho da Sage Therapeutics, Inc., apoiando organizações por meio de pontos de inflexão clínica e lançamentos comerciais.

O Sr. Cola é formado em Biologia pelo Ursinus College, mestre em Ciências Biomédicas e Engenharia pela Drexel University e estudou Bioengenharia na University of Pennsylvania, onde também trabalhou como engenheiro biomédico no seu hospital afiliado.

Sobre a Helus Pharma

Helus Pharma™, o nome operacional comercial da Cybin Inc., fundada em 2019 (a “Empresa”), é uma empresa farmacêutica de estágio clínico focada em ajudar as mentes a se curarem, desenvolvendo NSAs proprietários – novos agonistas serotoninérgicos: moléculas sintéticas projetadas para ativar as vias da serotonina que se acredita promoverem a neuroplasticidade. Os NSAs proprietários da Empresa destinam-se a atender à grande necessidade não atendida de pessoas que sofrem de depressão, ansiedade e outras condições de saúde mental.

Com dados líderes de classe, a Helus Pharma visa melhorar o cenário de tratamento através da introdução de NSAs que visam proporcionar melhorias duradouras na saúde mental. A Helus Pharma está desenvolvendo o HLP003, um NSA proprietário, no desenvolvimento clínico da Fase 3 para o tratamento adjuvante do transtorno depressivo maior que recebeu a Designação de Terapia Inovadora da Food and Drug Administration dos EUA e o HLP004, também um NSA proprietário na Fase 2 para transtorno de ansiedade generalizada. Além disso, a Helus Pharma tem um extenso portfólio de pesquisa de NSAs investigacionais.

A Empresa opera no Canadá, Estados Unidos, Reino Unido e Irlanda. Para atualizações da empresa e mais informações sobre a Helus Pharma, visite www.helus.com ou siga a equipe no X, LinkedIn, YouTube e Instagram. Helus PharmaTM é marca comercial registrada da Cybin Corp.

Advertência a Respeito de Declarações de Previsão

Certas declarações neste comunicado de imprensa relacionadas à Empresa são declarações de previsão ou informações de previsão na acepção das leis de títulos aplicáveis (coletivamente, “declarações de previsão”) e são de natureza prospectiva. As declarações de previsão não se baseiam em fatos históricos, mas em expectativas e previsões atuais sobre eventos futuros e, portanto, estão sujeitas a riscos e incertezas que podem fazer com que os resultados reais sejam substancialmente diferentes dos resultados futuros expressos ou implícitos nas declarações de previsão. Essas declarações geralmente podem ser identificadas pelo uso de palavras de previsão, como “pode”, “deve”, “poderia”, “potencial”, “possível”, “pretende”, “estima”, “planeja”, “antecipa”, “espera”, “acredita” ou “continua”, ou negativas ou variações semelhantes. As declarações de previsão neste comunicado à imprensa incluem declarações sobre a expectativa da Empresa de avançar significativamente no tratamento de transtornos graves de saúde mental; a capacidade dos NSAs da Empresa de atender à grande necessidade não atendida de pessoas que sofrem de depressão, ansiedade e outras condições de saúde mental; os dados da Fase 2 do HLP004 no primeiro trimestre de 2026 e os dados da Fase 3 do HLP003 no quarto trimestre de 2026; e os planos da Empresa de projetar plataformas proprietárias de descoberta de medicamentos, sistemas inovadores de distribuição de medicamentos, novas abordagens de formulação e regimes de tratamento para condições de saúde mental.

As declarações de previsão têm por base as estimativas e opinião da administração da Empresa no momento em que as declarações são feitas. Os resultados futuros reais podem ser substancialmente diferentes, pois as declarações de previsão envolvem riscos, incertezas e outros fatores conhecidos e desconhecidos que podem fazer com que os resultados, o desempenho ou as realizações reais da Empresa sejam substancialmente diferentes de quaisquer resultados, desempenho ou realizações futuros expressos ou implícitos em tais declarações de previsão. Tais fatores, entre outras coisas, incluem: flutuações nas condições macroeconômicas gerais; flutuações nos mercados de valores mobiliários; expectativas em relação ao tamanho do mercado NSA; a capacidade da Empresa de atingir com sucesso os objetivos dos seus negócios; planos de crescimento; incertezas políticas, sociais e ambientais; relações com funcionários; a presença de leis e regulamentos que possam impor restrições nos mercados onde a Empresa opera; implicações de surtos de doenças nas operações da Empresa; e os fatores de risco estabelecidos em cada uma das discussões e análises da administração da Empresa para os períodos de três e seis meses findos em 30 de setembro de 2025, e o formulário de informações anuais da Empresa para o exercício encerrado em 31 de março de 2025, disponíveis no perfil da Empresa no SEDAR + em www.sedarplus.ca e na Comissão de Valores Mobiliários dos EUA no EDGAR em www.sec.gov/edgar. Embora as declarações de previsão contidas neste comunicado de imprensa sejam baseadas no que a administração da Empresa acredita, ou acreditava na época, serem suposições razoáveis, a Empresa não pode garantir aos acionistas que os resultados reais serão consistentes com tais declarações de previsão, pois pode haver outros fatores que fazem com que os resultados não sejam como previsto, estimado ou pretendido. Consequentemente, os leitores não devem depositar confiança indevida nas declarações de previsão contidas neste comunicado de imprensa. A Empresa não é obrigada a atualizar as declarações previsão em caso de mudanças de suposições, opiniões, projeções ou outros fatores, exceto quando exigido por lei.

A Empresa não faz nenhuma reivindicação médica, de tratamento ou de benefício à saúde quanto aos produtos propostos pela Empresa. A Food and Drug Administration dos EUA, a Health Canada ou outras autoridades reguladoras semelhantes não avaliaram reivindicações relativas a NSAs ou HLP003, HLP004 e outros programas da Empresa. A eficácia de tais produtos não foi confirmada por pesquisas aprovadas. Não há garantia de que o uso de NSAs, HLP003, HLP004 ou outros programas da Empresa possam diagnosticar, tratar, curar ou prevenir qualquer doença ou condição. São necessárias pesquisas científicas e ensaios clínicos rigorosos. Se a Helus Pharma não puder obter as aprovações ou pesquisas necessárias para comercializar seus negócios, isso poderá ter um efeito adverso relevante no desempenho e nas operações da Empresa.

Nem a CBOE Canada, nem a bolsa de valores Nasdaq Global Market aprovaram ou desaprovaram o conteúdo deste comunicado de imprensa e não são responsáveis pela adequação e precisão do conteúdo aqui contido.

Contato com o Investidor:
Josh Barer
astr partners
Diretor Administrativo
(908) 578-6478
[email protected]

George Tziras
Diretor de Negócios
Helus Pharma
1-866-292-4601
[email protected] – ou – [email protected]

Contato com a Mídia:
Johnny Tokarczyk
RXMD
Diretor de Relações Públicas
[email protected]
(914) 772-7562 


GLOBENEWSWIRE (Distribution ID 9652878)

Helus Pharma ernennt Michael Cola zum Chief Executive Officer für die Leitung der nächsten Skalierungs- und Durchführungsphase

  • Er ist ehemaliger President des Spezialpharmazeutika-Geschäftsbereichs von Shire PLC („Shire“) mit über 30 Jahren Erfahrung auf dem Gebiet von Neurowissenschaften, seltenen Erkrankungen und Spezialpharmazeutika, einschließlich Führungspositionen bei Astra-Merck und AstraZeneca PLC
  • Er verfügt über nachweisliche Führungskompetenz in der abschließenden klinischen Entwicklungsphase, globalen Kommerzialisierung und Vermögensbildung für verschiedene Zentralnervensystem („ZNS“)-Programme
  • Seine Ernennung bei Helus Pharma erweitert sein Portfolio auf wichtige klinische Meilensteine, einschließlich voraussichtlicher Phase-II-Daten zu HLP004 in diesem Quartal und Phase-III-Topline-Daten zu HLP003 im weiteren Jahresverlauf.

Diese Pressemittelung ist eine „designierte Pressemitteilung“ zum Zwecke des Prospektnachtrags des Unternehmens mit Datum vom 30. Dezember 2025 betreffend den Basisprospekt in Kurzform mit Datum vom 17. September 2025, in der am 19. Dezember 2025 aktualisierten Fassung.

BOSTON und TORONTO, Feb. 11, 2026 (GLOBE NEWSWIRE) — Helus PharmaTM („Helus“) (Nasdaq: HELP) (Cboe CA: HELP), ein Arzneimittelunternehmen im klinischen Stadium, das sich der Heilung psychischer Erkrankungen durch die Entwicklung neuartiger serotonerger Agonisten („NSAs“) verschrieben hat, hat heute die Ernennung von Michael Cola zum Chief Executive Officer mit sofortiger Wirkung bekanntgegeben.

Herrn Colas Ernennung überschneidet sich mit einem Schlüsselmoment von Helus, da das Unternehmen mit seiner Pipeline von Therapien der nächsten Generation für psychische Gesundheit auf wichtige Meilensteine der klinischen Entwicklung und Wertschöpfung zusteuert, einschließlich der voraussichtlichen Veröffentlichung von Phase-II-Daten zu HLP004 in diesem Quartal und von Phase-III-Topline-Daten zu HLP003 im vierten Quartal 2026. Parallel dazu baut Helus weiterhin sein breit gefächertes und rechtlich geschütztes geistiges Eigentumsportfolio aus, das eine Pipeline mit mehreren Vermögenswerten umfasst, darunter über 350 global eingereichte Patentanträge und über 100 Patenterteilungen. Das Unternehmen bringt herausragende Programme für die Bewältigung schwerer psychischer Erkrankungen voran. In Anbetracht des Übergangs von der klinischen Entwicklung zur späteren Durchführung richtet das Unternehmen seinen Fokus zunehmend auf weltweite Zulassungsmaßnahmen und die langfristige kommerzielle Planung. Diese Entwicklung untermauert die Wichtigkeit von bewährter Führungskompetenz in der Arzneimittelentdeckung, Vermögensbildung und globalen Skalierung.

„Herr Cola bringt eine seltene Kombination aus profunder neurowissenschaftlicher Expertise, globaler Kommerzialisierungserfahrung und bewährter Führungskompetenz auf Kapitalmärkten mit“, so Eric So, Mitbegründer und Vorstandsvorsitzender des Unternehmens. „Da Helus sein herausragendes Portfolio im Bereich der psychischen Gesundheit voranbringt, macht ihn seine Erfolgsbilanz beim Aufbau erstklassiger ZNS-Franchiseunternehmen und bei der Skalierung globaler Unternehmen zur idealen Besetzung, um Helus bei der Umsetzung unserer wissenschaftlichen Erkenntnisse in bedeutende Therapien für die Patienten und eine langfristige Wertschöpfung für unsere Aktionäre anzuleiten.“

Mit mehr als 30 Jahren Erfahrung auf dem Gebiet von Neurowissenschaft, seltener Erkrankungen und Spezialpharmazeutika steuert Cola tiefgreifende Fachkenntnisse in Bezug auf die Entwicklung innovativer ZNS-Assets und die Expansion auf globale Märkte, den Aufbau hochleistungsfähiger Unternehmen und die Schaffung eines langfristigen Shareholder Value bei. Seine berufliche Laufbahn umspannt Führungspositionen in den Bereichen F&E, Kommerzialisierung, Unternehmensstrategie und Vermögensbildung, so dass er ideal geeignet ist, um Helus durch seine nächste Wachstumsphase zu führen.

„Es ehrt mich, in diesem entscheidenden und spannenden Moment Teil von Helus zu werden“, erklärte Cola. „In Anbetracht der bereits vorliegenden überaus differenzierten klinischen Daten zu HLP003 und einer robusten Pipeline von entwickelten innovativen Wirkstoffen ist Helus einzigartig positioniert, um ein Paradigmenwechsel bei der Behandlung schwerer psychischer Erkrankungen einzuläuten. Ich freue mich auf die Zusammenarbeit mit dem Vorstand und dem Helus-Team, um auf diesem Fundament aufzubauen und wissenschaftliche Fortschritte in den langfristigen Erfolg für die Patienten und Aktionäre zu verwandeln.“

Als President des Spezialpharmazeutika-Geschäftsbereichs von Shire trug Cola dazu bei, das Unternehmen zu einem global führenden ZNS-Akteur zu machen, der wegweisende Therapien lancierte und skalierte, darunter Vyvanse, das in ein mehrere Milliarden Dollar schweres Franchiseunternehmen verwandelt werden konnte, und das Wachstum von Shire von 5 Mrd. USD auf eine Marktkapitalisierung von 20 Mrd. USD zu steigern, was dabei half, das Unternehmen für die nachfolgende 62 Mrd. USD schwere Übernahme durch Takeda, eine der größten Übernahmen in der Arzneimittelbranche, aufzustellen. Zu Beginn seiner Karriere war Cola einer der ersten Angestellten bei Merck, der an der Schaffung von Astra-Merck mitwirken sollte. Hierbei handelt es sich um eines der erfolgreichsten Spin-out-Unternehmen im Arzneimittelsektor, das zur Kommerzialisierung von Prilosec, ein Franchiseunternehmen mit einem Jahresumsatz von damals bis zu 6 Mrd. USD, gebildet wurde. Er bekleidete später Führungsrollen bei AstraZeneca PLC hinsichtlich der Lebenszykluserweiterung von Prilosec und des Übergangs zu Nexium.

In jüngerer Vergangenheit fungierte Cola als President und CEO von Avalo Therapeutics, Inc., wo er die Ausrichtung auf seltene Erkrankung und genomische Medizin leitete, klinische First-in-Class-Assets lizenzierte und beträchtliche Finanzmittel mobilisierte. Er diente zudem als Führungskraft in verschiedenen Vorstandsfunktionen, unter anderem als Vorsitzender von Phathom Pharmaceuticals, Inc., und ist ehemaliges Mitglied des Vorstands von Sage Therapeutics, Inc., wo er für Inflektionspunkte und Marktveröffentlichungen zuständig war.

Cola hält einen B.A. in Biologie vom Ursinus College, einen M.S. in Biomedizinwissenschaften und -technik von der Drexel University und er studierte Bioengineering an der University of Pennsylvania, bei dem angeschlossenen Universitätsklinikum war er außerdem als biomedizinischer Techniker tätig.

Über Helus Pharma

Helus Pharma™, der kommerzielle Markenname von Cybin Inc., gegründet im Jahr 2019 (das „Unternehmen“), ist ein klinisches Arzneimittelunternehmen, das sich der Heilung psychischer Erkrankungen durch die Entwicklung von proprietären NSAs verschrieben hat – neuartige serotonerge Agonisten: synthetische Moleküle, welche voraussichtlich die neuroplastizitätsförderlichen Serotoninsignalwege aktivieren. Die proprietären NSAs des Unternehmens sind dafür bestimmt, den immensen unerfüllten Bedarf von Menschen mit Depressionen, Angststörungen und sonstigen psychischen Erkrankungen zu adressieren.

Dank führender Daten möchte Helus Pharma die Behandlungslandschaft durch die Einführung von NSAs für nachhaltige psychische Gesundheitsverbesserungen bereichern. Helus Pharma entwickelt derzeit HLP003, einen proprietären NSA in Phase III für die adjunktive Behandlung bedeutender Depressionserkrankungen, der von der U.S. Food and Drug Administration als wegweisende Therapie (Breakthrough Therapy Designation) bestimmt wurde, und HLP004, ebenfalls ein proprietärer NSA in Phase II für allgemeine Angststörungen. Darüber hinaus verfügt Helus Pharma über ein umfangreiches Forschungsportfolio an klinisch geprüften NSAs.

Das Unternehmen ist in Kanada, den Vereinigten Staaten, dem Vereinigten Königreich und Irland tätig. Neuigkeiten über das Unternehmen und weitere Informationen über Helus Pharma finden Sie auf www.helus.com oder folgen Sie dem Team bei X, LinkedIn, YouTube und Instagram. Helus PharmaTM ist eine Marke von Cybin Corp.

Hinweise zu zukunftsgerichteten Aussagen

Bestimmte Aussagen in dieser Pressemitteilung über das Unternehmen beziehen sich auf zukunftsgerichtete Aussagen und zukunftsgerichtete Informationen im Sinne der geltenden Wertpapiergesetze (zusammenfassend als „zukunftsgerichtete Aussagen“ bezeichnet). Zukunftsgerichtete Aussagen beruhen auf keinen historischen Tatsachen, sondern vielmehr auf den aktuellen Erwartungen und Prognosen des Unternehmens in Bezug auf zukünftige Ereignisse, und beinhalten demnach Risiken und Ungewissheiten, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich von den in diesen zukunftsgerichteten Aussagen ausgedrückten oder implizierten Ergebnissen abweichen. Solche Aussagen sind im Allgemeinen an der Verwendung von zukunftsgerichteten Wörtern wie „können“, „sollten“, „könnten“, „potenziell“, „möglich“, „beabsichtigen“, „schätzen“, „planen“, „antizipieren“, „erwarten“, „glauben“ oder „fortsetzen“ oder an der Verwendung solcher Wörter in der Verneinung oder in anderen Variationen zu erkennen. Zukunftsgerichtete Aussagen in dieser Pressemitteilung beinhalten Aussagen in Bezug auf die Erwartungen des Unternehmens hinsichtlich bedeutender Fortschritte in der Behandlung schwerer psychischer Erkrankungen; die Fähigkeit der NSAs des Unternehmens, den immensen unerfüllten Bedarf von Menschen mit Depressionen, Angststörungen und sonstigen psychischen Erkrankungen zu adressieren; die Veröffentlichung der Phase-II-Daten für HLP004 im ersten Quartal 2026 und der Phase-III-Topline-Daten für HLP003 im vierten Quartal 2026; und die Vorhaben des Unternehmens hinsichtlich der Entwicklung unternehmenseigener Arzneimittelentdeckungsplattformen, innovativer Arzneimittelverabreichungssysteme, neuartiger Formulierungsansätze und Behandlungsschemas für psychische Erkrankungen.

Zukunftsgerichtete Aussagen beruhen auf angemessenen Annahmen und Einschätzungen von der Geschäftsleitung des Unternehmens zum Zeitpunkt der Mitteilung solcher Aussagen. Zukunftsgerichtete Aussagen können erhebliche Abweichungen umfassen, da sie bekannte und unbekannte Risiken, Ungewissheiten und sonstige Faktoren beinhalten, die dazu führen können, dass die tatsächlichen Ergebnisse, Leistungen oder Errungenschaften des Unternehmens erheblich von den in den zukunftsgerichteten Aussagen ausgedrückten oder implizierten zukünftigen Ergebnissen, Leistungen oder Errungenschaften abweichen. Zu solchen Faktoren zählen unter anderem: Schwankungen bei allgemeinen makroökonomischen Bedingungen; Schwankungen auf Wertpapiermärkten; Erwartungen in Bezug auf die Größe des NSA-Marktes; die Fähigkeit des Unternehmens zum erfolgreichen Erreichen seiner Geschäftsvorhaben; Wachstumspläne; politische, soziale und ökologische Unsicherheiten; Arbeitnehmerbeziehungen; die Existenz von Gesetzen und Vorschriften, die auf den Märkten, in denen das Unternehmen tätig ist, Einschränkungen einführen; Auswirkungen von Krankheitsausbrüchen auf die Betriebstätigkeiten des Unternehmens; und die Risikofaktoren, die in der Erörterung und Analyse der Geschäftsleitung des Unternehmens für die drei und sechs Monate bis zum 30. September 2025 dargelegt sind, und das jährliche Formblatt des Unternehmens für den Jahresabschluss vom 31. März 2025, abrufbar über das Unternehmensprofil bei SEDAR+ unter www.sedarplus.ca und über die US-amerikanische Börsenaufsichtsbehörde (U.S. Securities and Exchange Commission) bei EDGAR unter www.sec.gov/edgar. Obwohl die in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen auf Annahmen beruhen, die von der Unternehmensleitung für angemessen erachtet werden oder zum Zeitpunkt der Veröffentlichung erachtet wurden, kann das Unternehmen Investoren gegenüber nicht garantieren, dass die tatsächlichen Ergebnisse mit diesen zukunftsgerichteten Aussagen übereinstimmen werden, da andere Faktoren ggf. zu nicht erwarteten, prognostizierten oder beabsichtigten Ergebnissen führen können. Die Leser sollten sich nicht ungebührlich auf die in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen verlassen. Das Unternehmen übernimmt keine Verpflichtung dafür, zukunftsgerichtete Aussagen in Bezug auf Annahmen, Meinungen, Prognosen oder sonstige Faktoren im Falle einer Änderung zu aktualisieren, sofern dies nicht gesetzlich vorgeschrieben.

Das Unternehmen macht in Bezug auf die vorgeschlagenen Produkte des Unternehmens keine Aussagen über medizinische, behandlungsbezogene oder gesundheitliche Nutzen. Die U.S. Food and Drug Administration, Health Canada oder ähnliche Zulassungsstellen haben keine Aussagen in Bezug auf NSAs oder HLP003, HLP004 und sonstige Programme des Unternehmens geprüft. Die Wirksamkeit solcher Produkte ist nicht durch zugelassene Forschung bestätigt. Es gibt keine Garantie dafür, dass NSAs, HLP003, HLP004 oder sonstige Programme des Unternehmens zur Diagnostizierung, Behandlung, Heilung oder Prävention jeglicher Erkrankungen oder Störungen fähig sind. Es sind umfassende wissenschaftliche Forschungsarbeiten und klinische Studien erforderlich. Wenn Helus Pharma die für die Kommerzialisierung seines Geschäfts erforderlichen Zulassungen oder Forschungsarbeiten nicht umsetzen kann, kann dies die Leistung und Betriebstätigkeit des Unternehmens wesentlich beeinträchtigen.

Weder die Wertpapierbörse Cboe Canada noch die Wertpapierbörse Nasdaq Global Market haben die Inhalte dieser Pressemitteilung gebilligt oder missbilligt, und sie sind nicht für die Angemessenheit und Richtigkeit der hierin dargelegten Inhalte verantwortlich.

Anlegerkontakt:
Josh Barer
astr partners
Managing Director
(908) 578-6478
[email protected]

George Tziras
Chief Business Officer
Helus Pharma
1-866-292-4601
[email protected] – oder – [email protected]

Medienkontakt:
Johnny Tokarczyk
RXMD
Public Relations Director
[email protected]
(914) 772-7562


GLOBENEWSWIRE (Distribution ID 9652878)

Helus Pharma Appoints Michael Cola as Chief Executive Officer to Lead Next Phase of Scale and Execution

  • Former President of Shire PLC’s (“Shire”) Specialty Pharmaceutical business, with more than 30 years of experience across neuroscience, rare disease, and specialty pharmaceuticals, including senior leadership roles at Astra-Merck and AstraZeneca PLC
  • Proven leader in late-stage clinical development, global commercialization, and capital formation across central nervous system (“CNS”) programs
  • Appointed as Helus Pharma advances its pipeline toward key clinical milestones, including expected Phase 2 data for HLP004 this quarter and Phase 3 topline data for HLP003 later this year

This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025.

BOSTON and TORONTO, Feb. 10, 2026 (GLOBE NEWSWIRE) —  Helus PharmaTM (“Helus”) (Nasdaq: HELP) (Cboe CA: HELP), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists (“NSAs”), today announced the appointment of Michael Cola as Chief Executive Officer, effective immediately.

Mr. Cola’s appointment comes at a pivotal moment as Helus advances its pipeline of next-generation mental health therapies toward key clinical and corporate value-inflection milestones, including the expected release of Phase 2 data for HLP004 this quarter and Phase 3 topline data for HLP003 in Q4 2026. In parallel, Helus continues to build a broad and defensible intellectual property estate spanning its multi-asset pipeline, with more than 350 patent applications filed globally and over 100 patents granted. The Company is advancing differentiated programs designed to address serious mental health disorders. With the transition from early clinical development to later-stage execution underway, the Company is increasingly focused on global regulatory engagement and long-term commercial planning. This evolution underscores the importance of experienced leadership across drug development, capital formation, and global scale-up.

“Michael brings a rare combination of deep neuroscience expertise, global commercialization experience, and proven capital markets leadership,” said co-founder and Executive Chairman Eric So. “As Helus advances its differentiated mental health pipeline, his track record of building first-in-class CNS franchises and scaling global organizations makes him uniquely suited to lead Helus as we work to translate our science into meaningful therapies for patients and long-term value for shareholders.”

With more than 30 years of experience across neuroscience, rare disease, and specialty pharmaceuticals, Mr. Cola brings deep expertise in guiding innovative CNS assets through development and into global markets, building high-performance organizations, and creating long-term shareholder value. His career spans senior leadership roles across R&D, commercialization, corporate strategy, and capital formation, positioning him to lead Helus through its next phase of growth.

“I am honored to join Helus at this pivotal and energizing moment,” said Mr. Cola. “With highly differentiated HLP003 clinical data already in hand and a robust pipeline of novel compounds in development, Helus is uniquely positioned to advance a new paradigm in the treatment of serious mental health disorders. I’m excited to work alongside the Board and the Helus team to build on this foundation and translate scientific progress into lasting patient and shareholder impact.”

As President of Shire’s Specialty Pharmaceutical business, Mr. Cola helped transform the company into a global CNS leader, launching and scaling breakthrough therapies, including building Vyvanse into a multi-billion-dollar franchise, and contributing to Shire’s growth from a $5 billion to a $20 billion market-capitalization, helping position the company for its subsequent $62 billion acquisition by Takeda, one of the largest pharmaceutical acquisitions in the industry. Earlier in his career, Mr. Cola was one of the founding hires at Merck selected to help create Astra-Merck, one of the most successful pharmaceutical spinouts, formed to commercialize Prilosec, a franchise that at one point generated more than $6 billion in annual revenue. He later held senior leadership roles at AstraZeneca PLC supporting the lifecycle expansion of Prilosec and the transition to Nexium.

More recently, Mr. Cola served as President and CEO of Avalo Therapeutics, Inc., where he led the transition to a rare disease and genomic medicine focus, licensed first-in-class clinical-stage assets, and raised significant funding. He has also served in senior board leadership roles, including as Chairman of Phathom Pharmaceuticals, Inc. and as a former board member of Sage Therapeutics, Inc., supporting organizations through clinical inflection points and commercial launches.

Mr. Cola holds a B.A. in Biology from Ursinus College, an M.S. in Biomedical Science and Engineering from Drexel University and studied Bioengineering at the University of Pennsylvania, where he also worked as a biomedical engineer at its affiliated hospital.

About Helus Pharma

Helus Pharma™, the commercial operating name of Cybin Inc., founded in 2019 (the “Company”), is a clinical stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs – novel serotonergic agonists: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The Company’s proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.

With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.

The Company operates in Canada, the United States, the United Kingdom and Ireland. For Company updates and to learn more about Helus Pharma, visit www.helus.com or follow the team on X, LinkedIn, YouTube and Instagram. Helus PharmaTM is a trademark of Cybin Corp.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, “forward-looking statements”) and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “potential”, “possible”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s expectation to meaningfully advance the treatment of serious mental health disorders; the ability of the Company’s NSAs to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions; the release Phase 2 data for HLP004 in the first quarter of 2026 and Phase 3 topline data for HLP003 in the fourth quarter of 2026; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the NSA market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three and six month periods ended September 30, 2025, and the Company’s annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding NSAs or HLP003, HLP004 and other programs of the Company. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of NSAs, HLP003, HLP004 or other programs of the Company can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Helus Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

Neither Cboe Canada, nor the Nasdaq Global Market stock exchange, have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor Contact:
Josh Barer
astr partners
Managing Director
(908) 578-6478
[email protected]

George Tziras
Chief Business Officer
Helus Pharma
1-866-292-4601
[email protected] – or – [email protected]

Media Contact:
Johnny Tokarczyk
RXMD
Public Relations Director
[email protected]
(914) 772-7562


GLOBENEWSWIRE (Distribution ID 9651746)

شركة Profound Medical توقع اتفاقية توزيع حصرية لمنتجات TULSA-PRO®وSonalleve® مع شركة Al Faisaliah Medical Systems في المملكة العربية السعودية

الاتفاقية تفتح المجال أمام علاجات Profound التي لا تستلزم أي جراحة أو إشعاع لاستئصال الأنسجة المريضة، لتخترق بذلك أكبر سوق للرعاية الصحية في الشرق الأوسط

تم الحصول بالفعل على جميع الموافقات التنظيمية اللازمة لاستيراد وبيع تقنيتي الاستئصال المتقدمتين من شركة Profound في المملكة العربية السعودية

تورنتو والرياض، المملكة العربية السعودية, Nov. 13, 2025 (GLOBE NEWSWIRE) —

يسر شركة Profound Medical (NASDAQ:PROF; TSX:PRN) (“Profound” أو “الشركة”)، وهي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة، أن تُعلن أنها أبرمت اتفاقية توزيع وتوريد حصرية لتقنيتي TULSA–PRO® و Sonalleve®في المملكة العربية السعودية مع شركة Al Faisaliah Medical Systems (“FMS”)، وهي شركة تابعة لإحدى أبرز تكتلات الأعمال في المملكة، مجموعة Al Faisaliah Group (“AFG”).

وتعد Profound الشركة الوحيدة التي تجمع بين قدرات التصوير في الوقت الحقيقي والتصوير الحراري للرنين المغناطيسي (“MR”) مع تصميمات العلاج التي تعتمد على الذكاء الاصطناعي للسماح للأطباء بمعالجة الأنسجة المريضة بدقة ولطف دون أي جراحة أو غلي أو كي الأنسجة المرتبطة أو فقدان الدم أو الألم الشديد/ المُطوَّل أو الحاجة إلى الإقامة في المستشفى لليلة واحدة.

يظل التسويق التجاري لدواء TULSA–PRO، المُصمم خصيصًا لعلاج أمراض البروستاتا (سرطان البروستاتا وتضخم البروستاتا الحميد “BPH” أو أيٍ منهما) في الولايات المتحدة هو الأولوية القصوى لفريق المبيعات المباشرة للشركة. يمثل TULSA Procedure™، الذي يتم إجراؤه باستخدام نظام TULSA–PRO من Profound، تقدمًا كبيرًا في علاج البروستاتا. بدلاً من الجراحة أو الإشعاع، يتم تطبيق إجراء TULSA داخل جناح التصوير بالرنين المغناطيسي لتسخين أنسجة البروستاتا بدقة ولطف “وصولًا لدرجة الحرارة اللازمة للقضاء على الأنسجة المريضة” (55–57 درجة مئوية) باستخدام الموجات فوق الصوتية الاتجاهية، مع حماية الأعصاب المحيطة والبنية التشريحية. من حيث نية العلاج، في حين أن TULSA–PRO يتمتع بالمرونة التي تمكننا من استخدامه في جميع عمليات الاستئصال، بما في ذلك الاستئصال البؤري واستئصال نصف الغدة، فإن غالبية إجراءات TULSA هي إما استئصال الغدة بالكامل أو استئصال الغدة بالكامل تقريبًا. في أواخر عام 2024، أصدرت مراكز الرعاية الطبية والخدمات الطبية (CMS) في الولايات المتحدة القاعدة النهائية لنظام الدفع المستقبلي للمرضى الخارجيين (OPPS) (“القاعدة النهائية”) لرموز الفئة 1 الجديدة CPT® وأوصافها التي تغطي إجراء TULSA، والتي دخلت حيز التنفيذ في 1 يناير 2025. بموجب القاعدة النهائية، تم وضع سداد تكاليف TULSA في تصنيف الدفع الخارجي لمستوى 7 في طب المسالك البولية (APC). حتى الآن، خضع أكثر من 4000 رجل لإجراء TULSA، واعتبارًا من آخر تقرير (أكتوبر 2025)، بلغ عدد أنظمة TULSA–PRO المثبتة لدى Profound 67 نظامًا.

ويحظى المنتج الثاني لشركة Profound، وهو Sonalleve، والذي يُقدّم يتم في المقام الأول كعملية بيع رأسمالية لمرة واحدة، باهتمام تجاري متزايد، وخاصة خارج الولايات المتحدة. يستخدم Sonalleve نفس تقنية التصوير بالرنين المغناطيسي والتصوير الحراري مثل TULSA–PRO، ويجمع ذلك مع الموجات فوق الصوتية المركزة من خارج الجسم لعلاج الأمراض. توجد حاليًا عشرة أجهزة Sonalleve عاملة في أجزاء من أوروبا والصين وجنوب شرق آسيا – حيث تم بالفعل علاج أكثر من 4000 امرأة باستخدام هذه التكنولوجيا لعلاج الانتباذ البطاني الرحمي والأورام الليفية الرحمية، وهي أمراض تصيب الرحم ويمكن أن تسبب آلامًا مزمنة وحيضًا ثقيلًا وطويلًا أو أيًا منهما. وقد أثبت العلاج باستخدام Sonalleve تخفيف الألم والأعراض دون التأثير على احتياطي المبيض، كما تشير تقارير إلى محافظة النساء على خصوبتهن بعد العلاج. ويُستخدم Sonalleve الآن أيضًا في الأبحاث والتجارب السريرية في أوروبا لاستئصال أنسجة سرطان البنكرياس وأمراض الأورام الأخرى. على مدى السنوات الخمس الماضية، قدمت منظمات الأبحاث في أوروبا وكندا ما يقرب من 10 مليون دولار أمريكي لإجراء المزيد من الأبحاث السريرية باستخدام Sonalleve لعلاج أمراض متعددة تهدد الحياة في كثيرٍ من الأحيان.

مع استمرار تزايد اهتمام المستخدمين بتقنيات Profound، تنشر الشركة فريق المبيعات المباشرة الخاص بها في أمريكا الشمالية، في حين تتعاون مع شركاء توزيع استراتيجيين مختارين لدعم إمكانات الأعمال وقاعدة العملاء في أجزاء أخرى من العالم.

وصرح Arun Menawat، الرئيس التنفيذي ورئيس مجلس إدارة شركة Profound، قائلاً: “يشرفنا أن نتعاون مع شركة FMS، إحدى شركات توزيع الأجهزة الطبية الرائدة في المملكة العربية السعودية، لتوزيع كل من TULSA–PRO وSonalleve”. “إن التسويق والتوزيع الناجحين لعلاجاتنا الخالية التي لا تستلزم جراحة لاستئصال الأنسجة المريضة يتطلب فهمًا عميقًا لديناميكيات السوق الإقليمية والاحتياجات المحددة للأطباء والمرضى المحليين. وبفضل سجلها الحافل في تقديم إجراءات الأورام المتقدمة وغيرها من التقنيات الطبية في المملكة، فإننا على ثقة بأن شركة FMS هي الشريك المثالي لنا”.

قال المدير العام لشركة FMS، السيد Abdullah Al Melik: “مع توجه المملكة العربية السعودية نحو التنوع الاقتصادي في إطار رؤية 2030، تلتزم كل من FMS وشركتنا الأم، AFG، بالقيام بدور حاسم في تشكيل مستقبل البلاد. وتعد المجموعة من أهم مُقدمي المعدات والخدمات للمستشفيات القائمة، كما تمتلك وتدير مرافقها الطبية المتخصصة بفعاليةٍ. بفضل شراكتنا مع شركة Profound، نحن متحمسون للغاية لتقديم تقنياتها الفريدة التي لا تستلزم الجراحة أو الإشعاع إلى المستشفيات ومراكز العلاج السعودية التي تهدف إلى أن تكون رائدة عالميًا في نتائج المرضى. نتطلع إلى العمل بشكل وثيق مع فريق Profound.”

نبذة عن شركة Al Faisaliah Medical Systems

تأسست شركة FMS في عام 1973، وكانت في البداية قسم الرعاية الصحية التابع لشركة AFG، حتى تأسيسها كشركة مستقلة في عام 1993. بفضل سابقة أعمالها الضخمة التي تضم العديد من الشركاء والمنتجات، تتمكن الشركة من تقديم حلول متكاملة ومعقدة لمعدات الرعاية الصحية من مصدر واحد لأكبر مقدمي الرعاية الصحية في المنطقة. تعد شركة FMS مزودًا رئيسيًا لحلول الرعاية الصحية المتنوعة، وذلك من خلال انتشار عملياتها في جميع أنحاء المملكة العربية السعودية، حيث توفر أحدث المعدات والحلول لمختلف الاستخدامات مثل الأورام والعمليات والملاحظة والرعاية الحرجة وأمراض القلب والأوعية الدموية وغيرها. لمزيد من المعلومات، يُرجى زيارة www.tibbiyah.com/fms.

نبذة عن Al Faisaliah Group

AFG هي شركة قابضة مملوكة للقطاع الخاص يقع مقرها الرئيسي في الرياض، المملكة العربية السعودية، وتعمل في جميع أنحاء الشرق الأوسط. وقد اشتق اسم الشركة من اسم مؤسسها عبدالله الفيصل الابن الأكبر للملك الراحل فيصل بن عبد العزيز. تأسست المجموعة في عام 1971، وتلعب أدوارًا قياديةً في العديد من الصناعات بما في ذلك منتجات الألبان والإلكترونيات والرعاية الصحية وخدمات الطعام. وتدير AFG أيضًا ذراع رأس المال الاستثماري لشركات (Al Faisaliah Ventures) التي تستثمر في الشركات الرائدة عالميًا وإقليميًا. وتحظى المجموعة بتقدير كبير في مختلف أنحاء المنطقة بفضل قيمها الراسخة وإدارتها المحترفة وشراكاتها الاستراتيجية التي تمتد لعقود من الزمن مع شركات محلية وعالمية رائدة بما في ذلك Sony وDanone وPhilips. لمزيد من المعلومات، يُرجى زيارة www.alfaisaliah.com.

نبذة عن شركة Profound Medical

Profound هي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة.

تعمل شركة Profound على تسويق TULSA–PRO® وهي تقنية تجمع بين التصوير بالرنين المغناطيسي في الوقت الفعلي والتخطيط المعزز بالذكاء الاصطناعي والموجات فوق الصوتية عبر مجرى البول التي يتم تشغيلها آليًا والتحكم في درجة الحرارة ذات الحلقة المغلقة. إن إجراء TULSA Procedure™‎، الذي يتم إجراؤه باستخدام نظام TULSA–PRO، لديه القدرة على أن يصبح طريقة علاج رئيسية في جميع أنوع أمراض البروستاتا؛ بدءًا من سرطان البروستاتا منخفض أو متوسط أو عالي الخطورة؛ إلى المرضى الهجينين الذين يعانون من سرطان البروستاتا وفرط تنسج البروستاتا الحميد (“BPH”)؛ إلى الرجال المصابين بتضخم البروستاتا الحميد فقط؛ وأيضًا، إلى المرضى الذين يحتاجون إلى علاج إنقاذي لسرطان البروستاتا الموضعي المتكرر بالإشعاع. يستخدم إجراء TULSA توجيهات التصوير بالرنين المغناطيسي في الوقت الفعلي لضمان الدقة في الحفاظ على القدرة على التحكم في البول والوظيفة الجنسية لدى المرضى، مع قتل أنسجة البروستاتا المستهدفة من خلال تقنية امتصاص الصوت الدقيقة التي تسخنها بلطف حتى تصل إلى 55–57 درجة مئوية. إجراء TULSA هو إجراء جراحي لا يستلزم جراحة أو إشعاع ويتم إجراؤه في جلسة واحدة تستغرق بضع ساعات. يمكن علاج جميع أشكال وأحجام البروستاتا تقريبًا بأمان وفعالية وكفاءة باستخدام إجراء TULSA. لا ينطوي الإجراء على نزيف؛ ولا يتطلب الأمر البقاء في المستشفى؛ ويبلغ معظم مرضى TULSA عن تعافيهم السريع وعودتهم إلى روتينهم الطبيعي. تم وضع علامة CE على منتج TULSA–PRO، وتمت الموافقة عليه من قبل وزارة الصحة الكندية، وتمت الموافقة عليه بموجب 510(k) من قبل Food and Drug Administration (“FDA”).

تقوم شركة  Profoundبتسويق Sonalleve®، وهي منصة علاجية مبتكرة حاصلة على علامة CE لعلاج الأورام الليفية الرحمية، والانتباذ العضلي الليفي، وتخفيف آلام نقائل العظام، والأورام الليفية العضلية، وأورام العظام العظمية. كما تمت الموافقة على Sonalleve من قبل إدارة المنتجات الطبية الوطنية الصينية لعلاج الأورام الليفية الرحمية غير الجراحية، وحصل على موافقة FDA بموجب الإعفاء الإنساني للجهاز لعلاج ورم العظم العظمي. وتجري شركة Profound حالياً المراحل الأولى من استكشاف أسواق علاجية محتملة إضافية لجهاز Sonalleve حيث ثبت أن هذه التقنية لها تطبيقات سريرية، مثل الاستئصال غير الجراحي لسرطانات البطن والحرارة العالية لعلاج السرطان.

البيانات التطلعية

يتضمن هذا البيان الصحفي بيانات تطلعية بشأن شركة Profound وأعمالها والتي قد تشمل، على سبيل المثال لا الحصر، التوقعات المتعلقة بفعالية تقنية Profound في علاج سرطان البروستاتا، وتضخم البروستاتا الحميد، والأورام الليفية الرحمية، وعلاج الألم التلطيفي، وورم العظام العظمي؛ ومدى وتوقيت استكمال Profound لمبيعات نظام TULSA–PRO® من قنوات المبيعات المؤهلة؛ وتوقعات Profound للإيرادات المستقبلية؛ ونجاح إستراتيجية Profound التجارية وأنشطتها فيما يتعلق بـ TULSA–PRO. في كثير من الأحيان، ولكن ليس دائمًا، يمكن التعرف على البيانات التطلعية من خلال استخدام كلمات مثل “يخطط”، “من المتوقع”، “يتوقع”، “مجدول”، “ينوي”، “يتأمل”، “يتوقع”، “يعتقد”، “يقترح” أو الاختلافات (بما في ذلك الاختلافات السلبية) لهذه الكلمات والعبارات، أو تنص على أن بعض الإجراءات أو الأحداث أو النتائج “قد” أو “يمكن” أو “سوف” يتم اتخاذها أو حدوثها أو تحقيقها. وتستند مثل هذه البيانات إلى التوقعات الحالية لإدارة شركة Profound. قد لا تقع الأحداث والظروف التطلعية التي تمت مناقشتها في هذا البيان الصحفي بحلول تواريخ محددة أو قد لا تقع على الإطلاق وقد تختلف ماديًا نتيجة لعوامل الخطر المعروفة وغير المعروفة وعدم اليقين الذي يؤثر على الشركة، بما في ذلك المخاطر المتعلقة بصناعة الأجهزة الطبية، والموافقات التنظيمية، والسداد، والعوامل الاقتصادية، وأسواق الأسهم بوجهٍ عامٍ والمخاطر المرتبطة بالنمو والمنافسة. على الرغم من أن Profound حاولت تحديد العوامل المهمة التي قد تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج الفعلية بشكل مادي عن تلك الموصوفة في البيانات التطلعية، إلا أنه قد تكون هناك عوامل أخرى تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج عن تلك المتوقعة أو المقدرة أو المقصودة. لا يمكن ضمان أي بيان تطلعي. تم وصف العوامل والمخاطر الأخرى التي قد تؤدي إلى اختلاف النتائج الفعلية بشكل مادي عن تلك المنصوص عليها في البيانات التطلعية في التقرير السنوي لشركة Profound على النموذج 10–K والملفات الأخرى المقدمة إلى هيئات تنظيم الأوراق المالية الأمريكية والكندية، والمتاحة على www.sedarplus.ca وwww.sec.gov. باستثناء ما تقتضيه قوانين الأوراق المالية المعمول بها، فإن البيانات التطلعية تتحدث فقط اعتبارًا من تاريخ إصدارها، ولا تتعهد Profound بأي التزام بتحديث أو مراجعة أي بيان تطلعي علنًا، سواء نتيجة لمعلومات جديدة أو أحداث مستقبلية أو غير ذلك، بخلاف ما يقتضيه القانون.

لمزيد من المعلومات، يرجى التواصل مع:

Stephen Kilmer
علاقات المستثمرين
[email protected]
هاتف: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9575020)

Profound Medical Inks Exclusive Distribution Agreement for TULSA-PRO® and Sonalleve® with Al Faisaliah Medical Systems in Saudi Arabia

Agreement creates runway for Profound’s incision–free and radiation–free therapies for the ablation of diseased tissue, to penetrate the largest healthcare market in the Middle East

All required regulatory approvals to import and sell Profound’s two advanced ablative technologies in Saudi Arabia are already in place

TORONTO and RIYADH, Saudi Arabia, Nov. 11, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial–stage medical device company that develops and markets artificial intelligence (“AI”)–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into an exclusive distribution and supply agreement for its TULSA–PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. (“FMS”), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (“AFG”).

Profound is the only company that combines the real–time imaging and thermography capabilities of magnetic resonance (“MR”) with AI–driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay.

U.S. commercialization of TULSA–PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, “BPH”), remains the top priority for the Company’s direct sales team. The TULSA Procedure, performed using Profound’s TULSA–PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55–57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention–to–treat, while TULSA–PRO has the flexibility to be used for all ablations, including focal and hemi–gland, the majority of TULSA Procedures are either whole–gland or near–whole–gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (“Final Rule”) for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To–date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (October 2025), Profound’s TULSA–PRO installed base stood at 67 systems.

Profound’s second product, Sonalleve, which is offered primarily as a one–time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA–PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life–threatening, diseases.

As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.

“We’re honored to partner for the distribution of both TULSA–PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia,” commented Profound’s CEO and Chairman, Arun Menawat. “Successfully marketing and distributing our incision–free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients. With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we’re confident that FMS is the ideal partner for us.”

FMS’ GM, Mr. Abdullah Al Melik, said, “As Saudi Arabia moves toward economic diversification under Vision 2030, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country’s future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities. With our partnership with Profound, we're extremely excited to bring its unique, incision– and radiation–free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team.”

About with Al Faisaliah Medical Systems Co.

Founded in 1973, FMS was initially the healthcare division of AFG, until its establishment as an independent company in 1993. Its broad portfolio of partners and products enables it to deliver complex, integrated, single–source healthcare equipment solutions to the largest healthcare providers in the region. With operations across the Kingdom of Saudi Arabia, FMS is a major provider of diversified healthcare solutions, supplying state–of–the–art equipment and solutions for various uses such as oncology, operations, monitoring and critical care, cardiovascular and others. For further information, visit www.tibbiyah.com/fms.

About Al Faisaliah Group

AFG is a privately held holding company headquartered in Riyadh, Saudi Arabia, operating across the wider Middle East. Its name is derived from the name of its founder, Abdullah Al Faisal, eldest son of the late King Faisal. Founded in 1971, the Group holds leading positions in multiple industries including Dairy, Electronics, Healthcare and Food Service. AFG also operates a corporate venture capital arm (Al Faisaliah Ventures) that invests in global and regional disruptive players. The Group is recognized across the region for its strongly–held values, professional management and decades–long strategic partnerships with leading local and global firms including notably Sony, Danone and Philips. For further information, visit www.alfaisaliah.com.

About Profound Medical Corp.

Profound is a commercial–stage medical device company that develops and markets AI–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA–PRO®, a technology that combines real–time MRI, AI–enhanced planning, robotically–driven transurethral ultrasound and closed–loop temperature feedback control. The TULSA Procedure, performed using the TULSA–PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low–, intermediate–, or high–risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio–recurrent localized prostate cancer. The TULSA Procedure employs real–time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55–57°C. The TULSA Procedure is an incision– and radiation–free “one–and–done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA–PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non–invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non–invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward–Looking Statements

This release includes forward–looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; the extent and timing of Profound’s completion of TULSA–PRO® system sales from its qualified sales pipeline; Profound’s expectations for future revenues; and the success of Profound’s commercialization strategy and activities for TULSA–PRO. Often, but not always, forward–looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward–looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward–looking statements are described in Profound's Annual Report on Form 10–K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward–looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward–looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9573632)

PharmaJet® Signs Distribution Agreement with EVA Pharma to Provide Needle-free Injection Systems to Support Routine Polio Immunization in Egypt

GOLDEN, Colo. and CAIRO, Oct. 31, 2025 (GLOBE NEWSWIRE) — PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle–free injection technology, today announced that it has signed a Distribution Agreement with ATR, an affiliate to EVA Pharma, the leading pharmaceutical company driving healthcare innovation and access across the Middle East and Africa. The agreement, signed in Frankfurt at the CPHI meeting on October 30, 2025, includes provisions for Tropis distribution, technology transfer, and manufacturing.

The aim of the collaboration is to increase needle–free access within Egypt and regionally while broadening Egypt’s manufacturing capabilities. PharmaJet’s Tropis® intradermal needle–free delivery offers several strategic advantages for Egypt including substantial polio immunization cost savings1, reduced vaccine hesitancy2,3, increased coverage3, and the potential for medical technology regional manufacturing. The signing follows the July 2025 Memo of Understanding (MOU) that was signed between PharmaJet, Egypt’s Unified Procurement Agency (UPA) and EVA Pharma, which outlined plans for how UPA could incorporate Tropis into its portfolio.

The introduction of Tropis into immunization programs supports Egypt’s “1000 Golden Days” initiative which was launched to support the health and development of families during the critical period from conception to a child's second birthday. The collaboration will enable total immunization cost reduction and improved acceptability of polio vaccinations. Longer–term, the Tropis manufacturing and other needle–free product development initiatives may expand the benefits to vaccination against other infectious agents and improved pandemic preparedness.

EVA Pharma is a leading pharmaceutical and medical appliances manufacturing company that has vast experience in manufacturing, registering, marketing, distributing, and promoting pharmaceutical products. “This collaboration puts children first,” said Riad Armanious, CEO of EVA Pharma. “We’re reimagining vaccination through local innovation that improves every child’s experience while empowering healthcare professionals. By localizing manufacturing, we expand access and use existing budgets to reach many more children in Africa sustainably.”

“We are proud to collaborate with ATR and EVA Pharma to localize needle–free manufacturing and delivery,” said Paul LaBarre, Senior Vice President of Business Development for PharmaJet. “This partnership represents a strategic step forward for PharmaJet in the Middle East and Northern Africa region. Working with these innovative teams will accelerate integration of needle–free intradermal vaccine delivery into routine immunization programs in Egypt and beyond.”

Refer to Instructions for Use to ensure safe injections and to review risks.

1 Data on file
2 Soonawala, D et al, Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults, Vaccine, Volume 31, Issue 36, 12 August 2013, Pages 3688–3694
3 Mohan, D et al, Evaluating the impact of needle–free delivery of inactivated polio vaccine on Nigeria’s routine immunization program: An implementation hybrid trial , Vaccines,16 May 2025, 13(5), p.533

Media Contacts:
Nancy Lillie
[email protected]
1–888–900–4321 Option 3
Marina Faltas
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a68cea50–6f2b–4c9d–80af–cf4a85632192


GLOBENEWSWIRE (Distribution ID 1001136225)