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Minovia Therapeutics Mitochondrial Augmentation Technology to be Featured in Presentation and Workshop at the 67th ASH Annual Meeting and Exposition

HAIFA, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that data collected by research teams at Memorial Sloan Kettering Cancer Center (MSK) and Shaare Zedek Medical Center (SZMC) featuring the Company’s mitochondrial augmentation technology in myelodysplastic syndrome (MDS) will be presented at the 67th American Society of Hematology’s (ASH) Annual Meeting and Exposition on December 6–9, 2025 in Orlando, FL. The data will be featured in an oral presentation to be held on Saturday, Dec 6, 2PM ET (abs25–9123_abstract), as well as part of a workshop called, “Mitochondria and metabolism – clinical trials,” to be held Friday, Dec 5, 5:10PM ET.

The oral presentation, to be presented by principal investigator Dr. Omar Abdel–Wahab, will outline the MSK team’s progress with Minovia’s mitochondrial augmentation technology in pre–clinical studies using an MDS animal model, as well as the SZMC team’s work studying the lead product, MNV–201, in low risk MDS patients treated in a Phase 1b clinical trial.1 To date, MNV–201 has demonstrated a high safety and tolerability profile in the seven patients receiving treatment, with no anti–mitochondrial antibodies nor drug–related adverse events. One patient experienced transfusion independence with rising hemoglobin levels that have since been sustained for more than 10 months. The same patient also demonstrated improvement in blood–based biomarkers of mitochondrial function.

“The data we continue to see with our lead product, MNV–201, is encouraging, and we are grateful to the MSK nonclinical and SZMC clinical teams for spearheading the research to demonstrate its utility in this indication. We are excited by the possibility suggested by preclinical studies that mitochondrial augmentation of hematopoietic stem and progenitor cells may enable delay in disease progression to Acute Myeloid Leukemia (AML), and by the positive preliminary clinical response. We believe this continues to demonstrate the great potential of mitochondrial augmentation, first highlighted at ASH in a presentation by Dr. Elad Jacoby selected as ‘Best of ASH’ in 2018. We will continue to develop our program to facilitate the introduction of this treatment modality into the MDS context,” said Minovia Co–founder and CEO, Natalie Yivgi–Ohana, Ph.D.

MNV–201 has been granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for MDS, and both Fast Track and Rare Pediatric Disease Designation for Pearson Syndrome.

The Company also announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for early 2026, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About MDS

MDS is defined by ineffective hematopoiesis resulting in blood cytopenia, and clonal instability with a risk of evolution to AML. Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenia and AML. The goals of therapy for patients with MDS are to improve cytopenia, reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both quality of life and lifespan. The median age at diagnosis of MDS is ~70 years, but surprisingly some of the Pearson Syndrome patients develop MDS in a much higher prevalence relative to the disease population. About 15% of the MDS patients will present with Sideroblastic Anemia, the most common symptom in Pearson Syndrome. Minovia developed novel blood biomarkers to measure mitochondrial health and has been able to demonstrate for the first time that MDS is presumably an age–related mitochondrial disease. As such, Minovia is currently conducting a Phase Ib study of MNV–201 in low–risk MDS patients. Six out of the nine expected patients in the study have been dosed so far.

About MNV–201

MNV–201 is a first–in–class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy–producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. In early–stage clinical studies, MAT has demonstrated a strong safety profile and signs of multi–system benefit in patients with Pearson Syndrome, including improvements in growth, muscle function, hematologic stability, and improved quality of life.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Minovia’s main treatment, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand operations to the U.S. For more information, visit www.minoviatx.com.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination . Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.

Contact

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]

___________________________
1 Dr. Abdel–Wahab has financial interests related to Minovia Therapeutics.


GLOBENEWSWIRE (Distribution ID 9579259)

عرض أول نموذج لغوي ضخم متعدد المجالات الحيوية يفك شفرة لغة علم الأحياء البشري في المعرض العالمي للصحة في الرياض

دبي، الإمارات العربية المتحدة،, Oct. 28, 2025 (GLOBE NEWSWIRE) — أصبحنا ولأول مرة نستطيع فهم البيانات الأعقد في جسم الإنسان وهي الحديث الدقيق بين الجينات والبروتينات والمستقلبات كلغة موحدة وليس إشارات معزولة. فقد أعلنت اليوم شركة. BioAro Inc إنجازها التاريخي في مجال الذكاء الاصطناعي حيث أطلقت أول نموذج لغوي ضخم (LLM) متعدد المجالات الحيوية في العالم تم تدريبه على بيانات موحدة ومتعددة المجالات الحيوية. إنه النموذج The BioIntelligence™والذي يمثل المحرك المُشغل لمنصته الرائدة PanOmiQ™ ستُعرض في المعرض العالمي للصحة في الرياض، ما يقدم إنه نموذج جديد يقدم فهمًا عميقًا لعلم الأحياء ولا يقتصر على القياس فقط.

تشرذم المعرفة بالطب الحديث خلل جوهري. تغمرنا البيانات من كل جانب، من ملفات الجينومات والبروتينات ونتائج تحاليل التمثيل الغذائي – لكننا نفتقر إلى المترجم القادر على ربط كل تلك البيانات. فهذا الأسلوب الانعزالي في تفسير البيانات يجعل جذور الأمراض المعقدة كالسرطان والسكري غامضة، ويؤخر علاجها، ويقلل الرعاية الصحية المخصصة لكل حالة.

لكن PanOmiQ™ تكسر هذه الحواجز. فبفضل نموذجها اللغوي الضخم متعدد المجالات الحيوية المدرب على المعرفة الكاملة لعلم الأحياء البشري، تستطيع المنصة فك شفرة التفاعلات الدقيقة المتشابكة التي تحدد الصحة والمرض. وهي لا تكتفي بتحليل نقاط البيانات الحيوية فحسب بل تفسرها وتربط بينها، وبذلك تكشف الأسباب الجذرية والرؤى التنبؤية بسرعة ودقة غير مسبوقتين.

يقول الدكتور Anmol Kapoor، المؤسس والرئيس التنفيذي لـ BioAro: “انتقلنا من عدّ الكلمات إلى فهم الشعر، لكنه الشعر الذي تنظمه خلايانا”. “جوهر النظام الصحي الجديد هو The BioIntelligence™. فهو يحول البيانات المبعثرة إلى حوار متناغم بين الإنسان وطريقة عمل جسمه، ليجعل الصحة واقعًا وقائيًا”.

حصن سيادي لحماية البيانات الأكثر خصوصية

تدرك BioAro حساسية البيانات الجينية وضرورة حمايتها القصوى ومن أجل ذلك صممت منصة PanOmiQ™ لتعمل داخل المؤسسات الطبية والمختبرات في الموقع. تعتمد المنصة على مزيج قوي من تسريع FPGA وحوسبة وحدات المعالجة الرسومية GPU، ما يمكنها من أن تكون وحدة ذكاء مستقلة داخل بيئة آمنة كمستشفى أو معمل.

  • بياناتك لا تغادرنا أبدًا: تزيد مخاطر الحوسبة السحابية في عصرنا، لكن PanOmiQ™ تضمن السيادة الكاملة على البيانات، والامتثال الكامل لمعايير GDPR (النظام الأوروبي العام لحماية البيانات) وHIPAA (قانون قابلية نقل التأمين الصحي والمسؤولية) وغيرها من الأنظمة المحلية، مما يحافظ على المعلومات الأكثر خصوصية بأمان داخل الموقع.
  • السرعة حيث تهم: تعالج المنصة البيانات محليًا مما يزيل أي تأخير بسبب انتظار رفع البيانات إلى السحابة. فما كان يستغرق أسابيع بالأدوات التقليدية المنعزلة، تُنجزه PanOmiQ™ في ساعات، وهذا يسرع العلاج والاكتشاف الطبيين.
  • دقة حقيقية ومعتمدة: حققت المنصة دقة 100% في اختبار الكفاءة من كلية علماء الأمراض الأمريكية CAP، مما يؤكد أن سرعتها الثورية تترافق مع موثوقية لا مثيل لها.

نظام :The BioIntelligence™ جبهة موحدة للرعاية الصحية

تشمل The BioIntelligence™، بفضل نموذجها اللغوي الضخم متعدد المجالات الحيوية، مجموعة متكاملة من الأدوات المتخصصة:

  • Genelio™: هنا تتحول قوة النماذج اللغوية الضخمة إلى تجربة شخصية. يتيح Genelio™ للأفراد إجراء حوار طبيعي تفاعلي مع بياناتهم الجينية والصحية. فمثلًا يستطيع المستخدم أن يسأل: “لماذا ترتفع نسبة إصابتي بأمراض القلب مقارنة بغيري؟” أو “ما تأثير هذا التغير الجيني على أطفالي؟”، ليحصل على إجابات واضحة ومباشرة مستمدة من ملفه البيولوجي، وهذا يُسهِّل العلم المعقد ويُمكِّننا منه.
  • PanAUM™: بيئة رقمية مدعومة بالذكاء الاصطناعي لاكتشاف الأدوية تتنبأ بالتفاعلات الجزيئية وتسرّع تحديد العلاج.
  • BioLIMS™: نظام مختبر متكامل من الجيل المستقبلي يقوم بإدخال البيانات المنظمة مباشرة في محرك التحليل.
  • BioELR™: يربط الأجهزة القابلة للارتداء وأجهزة الاستشعار وتطبيقات الصحة، وهذا يقدم رؤى فورية بالذكاء الاصطناعي لعلاج الأمراض المزمنة والوقاية منها.

نبذة عن Axion™– من سلسلة The BioIntelligence

للتوسع في تشغيل هذا النظام، تم تطوير سلسلة Axion™ وهي مجموعة من الأنظمة الذكية المخصصة لتوفير قدرات حوسبة سيادية وسريعة بتقنية FPGA في بيئات الرعاية الصحية والبحث العلمي.

يُمكّن خط Axion™ بمستوياته الثلاثة “الجوهر”، و”الفائق”، و”المتقدم”، المستشفيات والمؤسسات البحثية والبرامج الصحية الوطنية من نشر التكنولوجيا بسلاسة، وفقًا لاحتياجاتها التشغيلية وحجم بياناتها.

إن Axion™ و PanOmiQ™معًا يقدمان سرعة وسيادة وقابلية للتوسع غير مسبوقين – لتضمن توافر مستقبل الطب في أي مكان، بأمان وذكاء.

يقول Bader Al–Marzooqi، المستثمر الإماراتي البارز في مجال التكنولوجيا الصحية: “بالنسبة لدولة الإمارات والخليج بكامله، وهما يضعان القيادة التكنولوجية والسيادة على البيانات في صميم أولوياتهما، فإن BioAro ابتكار تحويلي، حيث لا يقدم تكنولوجيا فحسب، بل قدرة سيادية تتماشى مع رؤيتنا الوطنية لنظام صحي آمن ومبتكر ووقائي. وهي تمكن أطبائنا وتحمي بيانات مواطنينا أيضًا”.

العرض في المعرض العالمي للصحة – الرياض

ستعرض BioAro منظومتها المتكاملة في المعرض العالمي للصحة بالرياض، وسيشمل ذلك عرض قوة النظام بإجراء حوار مباشر مع Genelio™ وتحليل فوري متعدد المجالات الحيوية عبر PanOmiQ™.

ويضيف الدكتور Kapoor: “نحن لا نطلق منتجًا فحسب، بل نشعل حركة تقودنا من تخمين العلاج بعد الإصابة إلى الصحة الذكية الوقائية. إن مستقبل الطب يتحدث بلغة الحياة ذاتها، ونحن فخورون بأن نمنحه صوته في الرياض”.

نبذة عن شركة BioAro Inc.
BioAro Inc. شركة كندية متخصصة في برمجيات وتكنولوجيا الأحياء، وهي تُشكّل مستقبل الصحة الذكية والسيادية. إن مهمتها هي توحيد علم الأحياء وعلوم البيانات من خلال The BioIntelligence™، لرأب الصدع بين المعلومات المعقدة عن الجزيئيات والرؤى الصحية القابلة للتطبيق والمخصصة للأفراد.

للتواصل الإعلامي:
Mohini
بريد إلكتروني: [email protected]
هاتف: +1–403–250–2221

لمزيد من المعلومات، تفضل بزيارة الموقعين: www.PanOmiQ.com | www.BioAro.com

الصور المرافقة لهذا البيان متاحة عبر الرابطين التاليين:
https://www.globenewswire.com/NewsRoom/AttachmentNg/83d816d2–5608–4ef8–a36f–bf9d55cda525
https://www.globenewswire.com/NewsRoom/AttachmentNg/18aa3fb2–b13e–4a25–a7cb–4557cba39e89


GLOBENEWSWIRE (Distribution ID 9563090)

Présentation du tout premier grand modèle de langage multiomique au monde au salon Global Health Exhibition de Riyad, ou la promesse d’un décodage du langage de la biologie humaine

DUBAÏ, Émirats arabes unis, 28 oct. 2025 (GLOBE NEWSWIRE) — Pour la première fois, les données les plus complexes du corps humain, à savoir les interactions complexes entre nos gènes, nos protéines et nos métabolites, peuvent s’entendre non pas comme des signaux isolés, mais comme un langage cohérent. Aujourd’hui, BioAro Inc. annonce une avancée historique dans le domaine de l’intelligence artificielle en inaugurant le tout premier grand modèle de langage (ou LLM, de l’anglais Large Language Model) au monde reposant sur des données multiomiques standardisées. Son noyau, intitulé « The BioIntelligence™ » alimente sa plateforme phare PanOmiQ™, qui sera présentée au salon Global Health Exhibition de Riyad. Il s’agit là d’un nouveau paradigme où la biologie n’est pas seulement mesurée, mais véritablement comprise.

La médecine moderne se heurte principalement aux enjeux de la fragmentation. Si nous croulons sous les données (instantanés génomiques, profils protéomiques, relevés métabolomiques), nous manquons de moyens pour donner un sens à leur histoire collective. Cette approche cloisonnée empêche de comprendre les origines de maladies complexes comme le cancer ou le diabète, et retarde d’autant les traitements et la personnalisation des soins.

PanOmiQ™ brise ces barrières. Formé depuis le lexique complet de la biologie humaine, son grand modèle de langue multiomique déchiffre les interactions subtiles et non linéaires qui définissent la santé et la maladie. Loin de se limiter à l’analyse des points de données, il interprète le contenu biologique pour révéler les causes profondes et les données prédictives avec une rapidité et une clarté jusqu’alors inimaginables.

« Nous passons de la notion d’un simple comptage de mots à celle de la compréhension de la poésie, et plus précisément la poésie écrite dans le langage de nos propres cellules » explique le Dr Anmol Kapoor, fondateur et PDG de BioAro. « Le cœur d’un nouvel écosystème de santé est né : ‘The BioIntelligence™’. Il transforme des données disparates en un dialogue cohérent entre les patients et leur propre biologie, faisant enfin de la santé proactive et prévisible une réalité pratique. »

Une forteresse souveraine pour les données les plus personnelles

Consciente que les données les plus sensibles, à savoir notre empreinte génétique, exigent le plus haut niveau de sécurité, BioAro a conçu PanOmiQ™ pour un déploiement sur site. En conjuguant l’accélération induite par les composants logiques programmables et les calculs réalisés par processeur graphique, la plateforme fonctionne comme une unité d’intelligence autonome au sein des murs d’un hôpital ou d’un laboratoire.

  • Vos données ne quittent jamais le site : à l’ère des vulnérabilités du cloud, PanOmiQ™ garantit une souveraineté absolue des données. Elle assure une conformité totale au règlement RGPD, à la loi fédérale américaine HIPAA et aux réglementations locales en stockant les données les plus personnelles au monde en toute sécurité sur site.
  • La vitesse là où elle est clé : en traitant les données à la périphérie, la plateforme élimine les retards critiques liés aux téléchargements vers le cloud. Grâce au traitement parallèle et à l’accélération du délai de traitement et de recherche, PanOmiQ™ réalise en quelques heures ce que les outils traditionnels et non intégrés mettent des semaines à accomplir.
  • Une précision absolument garantie : la plateforme a atteint une précision de 100 % lors des tests de compétence CAP, preuve que sa vitesse d’exécution révolutionnaire s’assortit d’une fiabilité à toute épreuve reposant sur des directives normalisées.

L’écosystème BioIntelligence™ : un front uni pour les soins de santé

Grâce au grand modèle de langue multiomique, The BioIntelligence™ alimente une suite d’outils spécialisés qui fonctionnent ensemble :

  • Genelio™ : c’est là où la magie du LLM se pare d’une dimension personnelle. Genelio™ permet aux individus d’échanger de manière naturelle, sous forme de chat, avec leurs propres données génomiques et de santé. Les utilisateurs peuvent ainsi poser des questions telles que « Pourquoi ai–je un risque plus élevé de maladie cardiaque ? » ou « Que signifie cette variante génétique pour mes enfants ? » et recevoir des réponses claires, sous forme de conversation et tirées directement de leur profil biologique unique, ce qui rend ainsi les données scientifiques complexes accessibles et permet à chacun de mieux maîtriser sa santé.
  • PanAUM™ : un environnement de découverte de médicaments par simulation informatique alimenté par l’IA prédisant les interactions moléculaires tout en accélérant l’identification des candidats thérapeutiques.
  • BioLIMS™ : un système de laboratoire de nouvelle génération qui alimente le moteur d’analyse en données structurées en toute transparence.
  • BioELR™ : un connecteur pour les appareils portables, les capteurs et les applications de santé visant à fournir des données en temps réel et basées sur l’IA, orientées sur la gestion des maladies chroniques et les soins préventifs.

Présentation de Axion™ – La série BioIntelligence

Pour alimenter cet écosystème à grande échelle, la série Axion™ se présente sous la forme d’une gamme exclusive de systèmes matériels intelligents conçus pour fournir des calculs IA sur site, accélérés par la technologie FPGA et souverains pour les environnements de soins de santé et de recherche.

La gamme Axion™ (Core, Ultra et Supreme) permet aux hôpitaux, aux instituts de recherche et aux programmes de santé nationaux de déployer la technologie sans interruption de service, chaque niveau étant adapté à différents besoins de fonctionnement et de traitement des données.

Ensemble, Axion™ et PanOmiQ™ redéfinissent les notions de vitesse, souveraineté et évolutivité pour garantir que l’avenir de la médecine puisse s’exercer partout de manière sécurisée et intelligente.

« Pour les Émirats arabes unis et la région du Golfe au sens large, qui accordent la priorité à la fois au leadership technologique et à la souveraineté des données, il s’agit d’une solution transformatrice » observe Bader Al–Marzooqi, un investisseur émirati de premier ordre spécialisé dans le domaine des technologies de la santé. « BioAro ne se contente pas d’importer des technologies. Elle propose une solution souveraine en phase avec notre vision nationale d’un avenir sécurisé, innovant et proactif dans le domaine des soins de santé. Elle donne à nos cliniciens les moyens d’agir tout en protégeant les données de nos citoyens. »

Présentation au salon Global Health Exhibition de Riyad

Au salon Global Health Exhibition de Riyad, BioAro démontrera le potentiel de son écosystème en activant une conversation en direct avec Genelio™ et en conduisant une analyse multiomique en temps réel via PanOmiQ™.

« Au–delà d’un simple lancement de produit, nous faisons naître un véritable mouvement, qui nous fera passer d’une approche réactive et empirique à une approche proactive et intelligente de la santé » indique le Dr Kapoor. « L’avenir de la médecine parle le langage de la vie elle–même, et nous sommes fiers de lui donner un écho à Riyad. »

À propos de BioAro Inc.
BioAro Inc. est une société canadienne de logiciels et de biotechnologie qui redessine les contours de la santé intelligente et souveraine de demain. Sa mission consiste à marier la biologie et la science des données grâce à The Bio Intelligence™ et à neutraliser les écarts entre les informations moléculaires complexes et les connaissances pratiques et personnalisées en matière de santé.

Contact médias :
Mohini
E–mail : [email protected]
Téléphone : +1–403–250–2221

Pour plus d’informations, veuillez consulter les pages : www.PanOmiQ.com et www.BioAro.com

Les photos annexées au présent communiqué sont disponibles aux adresses suivantes :
https://www.globenewswire.com/NewsRoom/AttachmentNg/83d816d2–5608–4ef8–a36f–bf9d55cda525
https://www.globenewswire.com/NewsRoom/AttachmentNg/18aa3fb2–b13e–4a25–a7cb–4557cba39e89


GLOBENEWSWIRE (Distribution ID 9563090)

Curia Invests $4 Million to Enhance Sterile API Manufacturing

ALBANY, N.Y., Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading global research, development and manufacturing organization, today announced the completion of a $4 million investment to upgrade its two API aseptic suites in Valladolid, Spain. The investment aligns with the latest EU GMP Annex 1 standards and reinforces Curia’s longstanding commitment to regulatory excellence and product quality. Annex 1 provides general guidance for the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products, applying the principles of Quality Risk Management (QRM) to prevent microbial, particulate and endotoxin contamination in the final product.

The enhancements support upgrades to Valladolid’s infrastructure and technology. Curia used innovative tools to take advantage of new possibilities derived from the application of an enhanced process understanding. The bulk of the investment was dedicated to updating the site’s equipment, including the installation of new isolators, along with modernizations to HVAC, pharmaceutical panels, automation, sterilization in place and general utilities. Transitioning to a fully closed system was the primary driver of these upgrades, with the goal of supporting process and product safety and preventing microbiological contamination at every step of production. Additionally, ergonomic improvements for operators were key to increasing operational safety, along with the implementation of additional automatic controls in line with stricter data integrity policies, as described in 21 CFR Part 11.    

“Quality and compliance are integral to how we operate,” said Philip Macnabb, CEO of Curia. “The new Annex 1 requirements align with our proactive approach to quality control. We always strive to offer our customers the highest level of assurance when it comes to compliance and our ability to deliver high–quality sterile APIs at scale. Customers depend on us for reliability, precision and trust. With these improvements at Valladolid, they can feel confident that we will continue to invest ahead of industry trends as we partner with them to bring their products to market.”

The updates at Valladolid followed a company–wide evaluation across Curia’s global network to identify opportunities for improvement related to new Annex 1 requirements. The assessment examined procedures, equipment, utilities, qualifications, and validations to create solutions tailored to each site and to address any areas for optimization.

Curia’s global API aseptic processing manufacturing network has served a broad portfolio of customers worldwide for more than 20 years. This investment positions the company to support increasingly complex manufacturing projects, while strengthening its commitment to delivering life–changing medicines with uncompromising quality and reliability.

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20 global sites and 3,200 employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecule, generic APIs, sterile drug product and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts, along with our regulatory–compliant facilities, provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9552034)

Curia Investe US $4 Milhões para Aprimorar a Fabricação de APIs Estéreis

ALBANY, N.Y., Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), uma organização líder global em pesquisa, desenvolvimento e fabricação, anunciou hoje a conclusão de um investimento de US $4 milhões para atualizar suas duas suítes assépticas de API em Valladolid, Espanha. O investimento está alinhado com os mais recentes padrões do Anexo 1 de BPF da UE e confirma o compromisso de longa data da Curia com a excelência regulatória e a qualidade do produto. O Anexo 1 fornece orientações gerais para o projeto e controle de instalações, equipamentos, sistemas e procedimentos utilizados para a fabricação de todos os produtos estéreis, aplicando os princípios de Gerenciamento de Risco da Qualidade (QRM) para prevenir a contaminação microbiana, particulada e de endotoxina no produto final.

Estes aprimoramentos são compatíveis com as atualizações da infraestrutura e tecnologia da Valladolid. A Curia usou ferramentas inovadoras para aproveitar novas possibilidades derivadas da aplicação de uma compreensão aprimorada do processo. A maior parte do investimento foi dedicada à atualização dos equipamentos do local, incluindo a instalação de novos isoladores, juntamente com modernizações de HVAC, painéis farmacêuticos, automação, esterilização no local e utilidades gerais. A transição para um sistema totalmente fechado foi o principal impulsionador dessas atualizações, com o objetivo de apoiar a segurança do processo e do produto e prevenir a contaminação microbiológica em cada etapa da produção. Além disso, os aprimoramentos ergonômicos para os operadores foram fundamentais para aumentar a segurança operacional, juntamente com a implementação de controles automáticos adicionais de acordo com políticas de integridade de dados mais rigorosas, de acordo com 21 CFR Parte 11.    

“A qualidade e a conformidade são essenciais para a nossa operação”, disse Philip Macnabb, CEO da Curia. “Os novos requisitos do Anexo 1 se alinham com nossa abordagem proativa ao controle de qualidade. Sempre nos esforçamos para oferecer aos nossos clientes o mais alto nível de garantia quando se trata de conformidade e da nossa capacidade de fornecer APIs estéreis de alta qualidade em escala. Os clientes dependem de nós para confiabilidade, precisão e confiança. Com essas melhorias em Valladolid tem a confiança de que continuaremos a investir à frente das tendências do setor à medida que nos associamos a eles para levar seus produtos ao mercado.”

As atualizações em Valladolid seguiram uma avaliação de toda a empresa em toda a rede global da Curia para identificar oportunidades de melhoria relacionadas aos novos requisitos do Anexo 1. A avaliação analisou procedimentos, equipamentos, utilidades, qualificações e validações para criar soluções adaptadas a cada local e abordar quaisquer áreas para otimização.

A rede global de fabricação de processamento asséptico de API da Curia atende a um amplo portfólio de clientes em todo o mundo há mais de 20 anos. Esse investimento posiciona a empresa a apoiar projetos de fabricação cada vez mais complexos, ao mesmo tempo em que fortalece seu compromisso de fornecer medicamentos com qualidade e confiabilidade intransigentes que mudam a vida.

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de 20 locais em todo o mundo e 3.200 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos, produtos de medicamentos estéreis e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e processamento final estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias, oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 (518) 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)

Curia investiert 4 Mio. US-Dollar in die Optimierung der Herstellung steriler Wirkstoffe

ALBANY, New York, Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein weltweit führendes Forschungs–, Entwicklungs– und Produktionsunternehmen, gab heute den Abschluss einer 4 Millionen US–Dollar schweren Investition zur Modernisierung seiner beiden aseptischen API–Anlagen in Valladolid, Spanien, bekannt. Die Investition entspricht den neuesten Standards des EU–GMP–Anhangs 1 und unterstreicht das langjährige Engagement von Curia für regulatorische Exzellenz und Produktqualität. Anhang 1 enthält allgemeine Leitlinien für die Gestaltung und Kontrolle von Anlagen, Ausrüstung, Systemen und Verfahren, die für die Herstellung aller sterilen Produkte verwendet werden. Dabei werden die Grundsätze des Qualitätsrisikomanagements (QRM) angewendet, um eine Kontamination des Endprodukts mit Mikroorganismen, Partikeln und Endotoxinen zu verhindern.

Die Verbesserungen unterstützen die Modernisierung der Infrastruktur und Technologie in Valladolid. Curia nutzte innovative Tools, um neue Möglichkeiten zu erschließen, die sich aus einem verbesserten Prozessverständnis ergaben. Der Großteil der Investitionen floss in die Modernisierung der Anlagen am Standort. Dazu gehörten die Installation neuer Isolatoren, die Modernisierung der Klimaanlagen, der pharmazeutischen Schalttafeln, der Automatisierung, der Sterilisation vor Ort sowie der allgemeinen Versorgungsanlagen. Der Hauptgrund für diese Modernisierungen war der Übergang zu einem vollständig geschlossenen System. Damit sollten die Prozess– und Produktsicherheit gewährleistet und mikrobiologische Kontaminationen in jeder Phase der Produktion verhindert werden. Ergonomische Verbesserungen waren darüber hinaus für die Erhöhung der Betriebssicherheit von entscheidender Bedeutung. Ebenso wichtig war die Implementierung zusätzlicher automatischer Kontrollen gemäß den strengeren Richtlinien zur Datenintegrität, wie in 21 CFR Part 11 beschrieben.    

„Qualität und Compliance sind wesentliche Bestandteile unserer Geschäftstätigkeit“, sagte Philip Macnabb, CEO von Curia. „Die neuen Anforderungen in Anhang 1 sind mit unserem proaktiven Ansatz zur Qualitätskontrolle vereinbar. Wir sind stets bestrebt, unseren Kunden ein Höchstmaß an Sicherheit in Bezug auf die Einhaltung von Vorschriften sowie unsere Fähigkeit zur Lieferung hochwertiger, steriler Wirkstoffe in großem Maßstab zu bieten. Unsere Kunden verlassen sich auf unsere Zuverlässigkeit, Präzision und Vertrauenswürdigkeit. Mit diesen Verbesserungen in Valladolid können sie darauf vertrauen, dass wir weiterhin vor den Branchentrends investieren werden, um gemeinsam mit ihnen ihre Produkte auf den Markt zu bringen.

Die Aktualisierungen in Valladolid erfolgten auf Basis einer unternehmensweiten Bewertung des globalen Curia–Netzwerks, mit der Verbesserungsmöglichkeiten im Zusammenhang mit den neuen Anforderungen des Anhangs 1 identifiziert wurden. Die Bewertung umfasste Verfahren, Ausrüstung, Versorgungsanlagen, Qualifikationen und Validierungen, um maßgeschneiderte Lösungen für jeden Standort zu entwickeln und Optimierungsmöglichkeiten zu ermitteln.

Seit mehr als 20 Jahren bedient das globale Netzwerk von Curia für die aseptische Verarbeitung von APIs ein breites Spektrum von Kunden weltweit. Dank dieser Investition ist das Unternehmen nun in der Lage, immer komplexere Fertigungsprojekte zu realisieren und gleichzeitig sein Engagement für die Bereitstellung lebensverändernder Medikamente in kompromissloser Qualität und Zuverlässigkeit zu verstärken.

Über Curia
Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von 20 Standorten weltweit und 3.200 Mitarbeitern, das mit Kunden aus der Biopharmazie zusammenarbeitet, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen Wirkstoffen, generischen Wirkstoffen, sterilen Arzneimitteln und Biologika deckt den gesamten Prozess von der Entdeckung bis zur Vermarktung ab. Dazu gehören auch integrierte Kompetenzen in den Bereichen Zulassung, Analytik und sterile Abfüllung. Unsere Wissenschafts– und Prozessexperten sowie unsere Einrichtungen, die den behördlichen Vorschriften entsprechen, bieten erstklassige Kompetenz bei der Herstellung von Arzneimittelwirkstoffen und –produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Kontakt zum Unternehmen:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)