Cosmos Health Enters Final Development Phase of CCX0722 Weight Management Solution; Expected Product Launch in Q1 or Q2 2026, Gaining Access to Over $142 Billion Market
Cosmos Health (NASDAQ:COSM) announced entering the final development phase of CCX0722, its weight management solution. The company is finalizing scale-up production and engaging with Contract Research Organizations (CROs) to complete the technical dossier. Clinical trials are expected to complete between late 2025 and early 2026, with product launch targeted for Q1 or Q2 2026.
The product is seeking potential classification as a Class III medical device. The company aims to enter the global weight management market, valued at $142.58 billion in 2022 with an expected CAGR of 9.7% from 2023 to 2030. CCX0722 is described as a biocompatible hydrogel solution targeting the growing obesity epidemic.
Cosmos Health (NASDAQ:COSM) ha annunciato di essere entrato nella fase finale di sviluppo di CCX0722, la sua soluzione per la gestione del peso. L'azienda sta finalizzando la produzione su scala e collaborando con Organizzazioni di Ricerca sotto Contratto (CRO) per completare il dossier tecnico. Si prevede che gli studi clinici si concludano tra la fine del 2025 e l'inizio del 2026, con il lancio del prodotto previsto per il primo o il secondo trimestre del 2026.
Il prodotto sta cercando una possibile classificazione come Dispositivo Medico di Classe III. L'azienda mira a entrare nel mercato globale della gestione del peso, valutato 142,58 miliardi di dollari nel 2022 con un CAGR previsto del 9,7% dal 2023 al 2030. CCX0722 è descritto come una soluzione idrogel biocompatibile che affronta la crescente epidemia di obesità.
Cosmos Health (NASDAQ:COSM) anunció que ha entrado en la fase final de desarrollo de CCX0722, su solución para el manejo del peso. La compañía está finalizando la producción a gran escala y colaborando con Organizaciones de Investigación por Contrato (CRO) para completar el dossier técnico. Se espera que los ensayos clínicos finalicen entre finales de 2025 y principios de 2026, con el lanzamiento del producto programado para el primer o segundo trimestre de 2026.
El producto busca una posible clasificación como Dispositivo Médico de Clase III. La compañía tiene como objetivo entrar en el mercado global de manejo de peso, valorado en 142,58 mil millones de dólares en 2022 con un CAGR esperado del 9,7% desde 2023 hasta 2030. CCX0722 se describe como una solución de hidrogel biocompatible que aborda la creciente epidemia de obesidad.
코스모스 헬스 (NASDAQ:COSM)는 체중 관리 솔루션 CCX0722의 최종 개발 단계에 진입했다고 발표했습니다. 이 회사는 대규모 생산을 마무리하고 기술 문서를 완료하기 위해 계약 연구 기관(CRO)와 협력하고 있습니다. 임상 시험은 2025년 말과 2026년 초 사이에 완료될 것으로 예상됩니다, 제품 출시 목표는 2026년 1분기 또는 2분기입니다.
이 제품은 3등급 의료 기기로 분류될 가능성을 모색하고 있습니다. 이 회사는 2022년에 1,425억 8천만 달러로 평가된 글로벌 체중 관리 시장에 진입하는 것을 목표로 하고 있으며, 2023년부터 2030년까지 예상 CAGR은 9.7%입니다. CCX0722는 증가하는 비만 유행을 목표로 하는 생체 적합성 하이드로겔 솔루션으로 설명됩니다.
Cosmos Health (NASDAQ:COSM) a annoncé être entré dans la phase finale de développement de CCX0722, sa solution de gestion du poids. L'entreprise finalise la production à grande échelle et collabore avec des organisations de recherche sous contrat (CRO) pour compléter le dossier technique. Les essais cliniques devraient se terminer entre fin 2025 et début 2026, avec un lancement du produit prévu pour le premier ou le deuxième trimestre de 2026.
Le produit cherche à obtenir une classification potentielle en tant que dispositif médical de classe III. L'entreprise vise à entrer sur le marché mondial de la gestion du poids, évalué à 142,58 milliards de dollars en 2022 avec un taux de croissance annuel composé (CAGR) prévu de 9,7% de 2023 à 2030. CCX0722 est décrit comme une solution d'hydrogèle biocompatible ciblant l'épidémie croissante d'obésité.
Cosmos Health (NASDAQ:COSM) gab bekannt, dass es in die finale Entwicklungsphase von CCX0722, seiner Lösung zur Gewichtsreduzierung, eingetreten ist. Das Unternehmen finalisiert die Hochlaufproduktion und arbeitet mit Vertragsforschungsorganisationen (CROs) zusammen, um das technische Dossier zu vervollständigen. Die klinischen Studien sollen zwischen Ende 2025 und Anfang 2026 abgeschlossen werden, mit einem angestrebten Produktlaunch im ersten oder zweiten Quartal 2026.
Das Produkt strebt eine mögliche Klassifizierung als Medizinprodukt der Klasse III an. Das Unternehmen beabsichtigt, in den globalen Markt für Gewichtsmanagement einzutreten, der im Jahr 2022 mit 142,58 Milliarden US-Dollar bewertet wurde und von 2023 bis 2030 eine erwartete CAGR von 9,7% aufweist. CCX0722 wird als biokompatible Hydrogel-Lösung beschrieben, die der zunehmenden Fettleibigkeitsepidemie entgegenwirkt.
- Entering final development phase of weight management product CCX0722
- Targeting large market opportunity valued at $142.58 billion
- Market shows strong growth potential with 9.7% CAGR through 2030
- Product launch not expected until Q1-Q2 2026
- Clinical trials yet to begin
- Final regulatory approval as Class III medical device still pending
Insights
The development of CCX0722 marks a strategic entry into the burgeoning weight management market, with several noteworthy technical and market implications. The pursuit of Class III medical device classification is particularly significant, as this category typically requires the highest level of regulatory scrutiny and clinical evidence. This classification, while demanding more rigorous testing and validation, could provide substantial market advantages through stronger IP protection and potential insurance coverage.
The biocompatible hydrogel technology represents an innovative approach in the weight management space. Hydrogels, known for their ability to expand in the stomach and create a feeling of satiety, offer a mechanical rather than pharmacological solution to weight management. This characteristic could potentially provide a more favorable safety profile compared to pharmaceutical alternatives, though the upcoming clinical trials will be important in validating this hypothesis.
The market timing appears strategic, with the
While the company's progress is promising, investors should monitor several key metrics in upcoming updates: clinical trial enrollment rates, preliminary safety data and any regulatory interactions that could impact the timeline to market. The success of CCX0722 could significantly impact Cosmos Health's market position, particularly given its current market capitalization of
Finalizing scale-up production phase
Engaging with Contract Research Organizations to complete the technical dossier
Clinical trials expected to complete in late 2025 or early 2026
Potential classification as a Class III medical device
Product launch expected in the first or second quarter of 2026
Further updates on progress to follow in the coming months
CHICAGO, IL / ACCESS Newswire / February 11, 2025 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it is entering the final stage of development for CCX0722, its innovative weight management solution. The Company is currently finalizing the scale-up production phase, paving the way for human clinical trials and targeting a market launch in the first or second quarter of 2026.
Building on the successful completion of pilot production and previous development milestones, Cosmos Health is now actively engaging with Contract Research Organizations (CROs) to complete the technical dossier, and clinical trials are set to be completed between the end of 2025 and the beginning of 2026. This strategic progress marks a critical step in positioning CCX0722 for regulatory submission and potential classification as a Class III medical device.
According to Grand View Research, the global weight management market was valued at
As the Company nears regulatory submission and clinical validation, further updates on the progress of CCX0722 will be provided in the coming months.
Greg Siokas, CEO of Cosmos Health, stated: "CCX0722 has demonstrated exceptional characteristics throughout its development, and we are now moving forward with clinical validation. We believe CCX0722 has the potential to be a transformative solution in tackling the growing obesity epidemic. Our team is fully committed to bringing this innovative biocompatible hydrogel to market, offering a safe and effective option for weight management. At Cosmos Health, we remain dedicated to delivering science-backed, high-impact solutions that address critical global health challenges."
About Cosmos Health Inc.
Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X.
Forward-Looking Statements
With the exception of the historical information contained in this news release, the matters described herein, may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by, or that otherwise, include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could", are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements, involve unknown risks and uncertainties that may individually or materially impact the matters discussed, herein for a variety of reasons that are outside the control of the Company, including, but not limited to, the Company's ability to raise sufficient financing to implement its business plan, the impact of the COVID-19 pandemic and the war in Ukraine, on the Company's business, operations and the economy in general, and the Company's ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward- looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's filings with the SEC, which are available at the SEC's website (www.sec.gov). The Company disclaims any intention or obligation to update, or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
BDG Communications
cosm@bdgcommunications.com
+44 207 0971 653
SOURCE: Cosmos Health Inc.
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