Creative Medical Technology Holdings Applauds Presidential Initiative to Expand IVF Access, Showcasing OvaStem® Program's Success and Growth Potential
Creative Medical Technology Holdings (NASDAQ: CELZ) supports President Donald J. Trump’s executive order to expand access to in vitro fertilization (IVF). This aligns with their OvaStem® program, which has shown an 85% improvement in hormonal function and a 70% success rate in delivering healthy babies using a patient’s own eggs, with no safety concerns up to five years post-treatment. OvaStem® offers a novel alternative to traditional IVF by using a patient’s own cells, particularly benefiting those with Primary Ovarian Insufficiency (POI), who typically face a 5-10% chance of spontaneous pregnancy.
OvaStem® integrates the company's AlloStem® platform, already in two FDA-cleared U.S. clinical trials. Creative Medical Technology Holdings has also filed for Orphan Drug Designation for POI. The executive order, signed on February 18, 2025, mandates recommendations within 90 days to lower IVF costs, currently ranging from $12,000 to $25,000 per cycle. This initiative aims to make advanced fertility technologies more accessible.
CEO Timothy Warbington and Clinical Operations Director Courtney Bartlett emphasized the company’s commitment to providing safe, effective, and affordable infertility solutions. The company continues to advance its portfolio of regenerative medicine technologies to empower families and drive shareholder value.
Creative Medical Technology Holdings (NASDAQ: CELZ) sostiene l'ordine esecutivo del Presidente Donald J. Trump per ampliare l'accesso alla fertilizzazione in vitro (IVF). Questo è in linea con il loro programma OvaStem®, che ha mostrato un miglioramento dell'85% nella funzione ormonale e un tasso di successo del 70% nel fornire bambini sani utilizzando gli ovuli della paziente, senza preoccupazioni di sicurezza fino a cinque anni dopo il trattamento. OvaStem® offre un'alternativa innovativa alla IVF tradizionale utilizzando le cellule della paziente, beneficiando particolarmente coloro che soffrono di Insufficienza Ovarica Primaria (POI), che tipicamente affrontano una probabilità del 5-10% di gravidanza spontanea.
OvaStem® integra la piattaforma AlloStem® dell'azienda, già presente in due studi clinici approvati dalla FDA negli Stati Uniti. Creative Medical Technology Holdings ha anche presentato richiesta per la Designazione di Farmaco Orfano per la POI. L'ordine esecutivo, firmato il 18 febbraio 2025, richiede raccomandazioni entro 90 giorni per ridurre i costi della IVF, attualmente compresi tra $12.000 e $25.000 per ciclo. Questa iniziativa mira a rendere le tecnologie avanzate per la fertilità più accessibili.
Il CEO Timothy Warbington e il Direttore delle Operazioni Cliniche Courtney Bartlett hanno sottolineato l'impegno dell'azienda a fornire soluzioni per l'infertilità sicure, efficaci e convenienti. L'azienda continua a far progredire il suo portafoglio di tecnologie di medicina rigenerativa per potenziare le famiglie e aumentare il valore per gli azionisti.
Creative Medical Technology Holdings (NASDAQ: CELZ) apoya la orden ejecutiva del Presidente Donald J. Trump para ampliar el acceso a la fertilización in vitro (IVF). Esto está alineado con su programa OvaStem®, que ha mostrado una mejora del 85% en la función hormonal y una tasa de éxito del 70% en el nacimiento de bebés sanos utilizando los óvulos de la paciente, sin preocupaciones de seguridad hasta cinco años después del tratamiento. OvaStem® ofrece una alternativa novedosa a la IVF tradicional al usar las propias células de la paciente, beneficiando especialmente a aquellos con Insuficiencia Ovárica Primaria (POI), que típicamente enfrentan una probabilidad del 5-10% de embarazo espontáneo.
OvaStem® integra la plataforma AlloStem® de la compañía, que ya está en dos ensayos clínicos autorizados por la FDA en EE. UU. Creative Medical Technology Holdings también ha solicitado la Designación de Medicamento Huérfano para la POI. La orden ejecutiva, firmada el 18 de febrero de 2025, exige recomendaciones dentro de 90 días para reducir los costos de la IVF, que actualmente oscilan entre $12,000 y $25,000 por ciclo. Esta iniciativa tiene como objetivo hacer que las tecnologías avanzadas de fertilidad sean más accesibles.
El CEO Timothy Warbington y la Directora de Operaciones Clínicas Courtney Bartlett enfatizaron el compromiso de la empresa de proporcionar soluciones de infertilidad seguras, efectivas y asequibles. La empresa continúa avanzando su cartera de tecnologías de medicina regenerativa para empoderar a las familias y aumentar el valor para los accionistas.
Creative Medical Technology Holdings (NASDAQ: CELZ)는 도널드 J. 트럼프 대통령의 체외 수정 (IVF) 접근성 확대를 위한 행정 명령을 지지합니다. 이는 환자의 자체 난자를 사용하여 건강한 아기를 출산하는 데 70%의 성공률과 호르몬 기능 개선에서 85%의 향상을 보여준 OvaStem® 프로그램과 일치합니다. 치료 후 5년까지 안전성 문제는 없습니다. OvaStem®은 환자의 세포를 사용하여 전통적인 IVF에 대한 새로운 대안을 제공하며, 일반적으로 5-10%의 자발적인 임신 가능성을 가진 1차 난소 기능 부전 (POI) 환자에게 특히 유익합니다.
OvaStem®은 이미 두 개의 FDA 승인 미국 임상 시험에 있는 회사의 AlloStem® 플랫폼을 통합합니다. Creative Medical Technology Holdings는 POI에 대한 고아약 지정을 신청하기도 했습니다. 2025년 2월 18일 서명된 행정 명령은 IVF 비용을 줄이기 위한 권장 사항을 90일 이내에 요구하며, 현재 IVF 비용은 사이클당 $12,000에서 $25,000 사이입니다. 이 이니셔티브는 고급 생식 기술을 더 접근 가능하게 만드는 것을 목표로 합니다.
CEO인 Timothy Warbington과 임상 운영 이사인 Courtney Bartlett는 안전하고 효과적이며 저렴한 불임 솔루션을 제공하겠다는 회사의 의지를 강조했습니다. 회사는 가족을 지원하고 주주 가치를 높이기 위해 재생 의학 기술 포트폴리오를 계속 발전시키고 있습니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) soutient l'ordre exécutif du Président Donald J. Trump visant à élargir l'accès à la fécondation in vitro (IVF). Cela s'aligne avec leur programme OvaStem®, qui a montré une amélioration de 85% de la fonction hormonale et un taux de réussite de 70% dans la délivrance de bébés en bonne santé en utilisant les ovules de la patiente, sans problèmes de sécurité jusqu'à cinq ans après le traitement. OvaStem® offre une alternative novatrice à l'IVF traditionnelle en utilisant les propres cellules de la patiente, bénéficiant particulièrement à celles qui souffrent d'Insuffisance Ovarienne Primaire (POI), qui ont généralement une chance de 5 à 10% de grossesse spontanée.
OvaStem® intègre la plateforme AlloStem® de l'entreprise, déjà présente dans deux essais cliniques approuvés par la FDA aux États-Unis. Creative Medical Technology Holdings a également déposé une demande de désignation de médicament orphelin pour la POI. L'ordre exécutif, signé le 18 février 2025, exige des recommandations dans les 90 jours pour réduire les coûts de l'IVF, qui varient actuellement de 12 000 à 25 000 USD par cycle. Cette initiative vise à rendre les technologies avancées de fertilité plus accessibles.
Le PDG Timothy Warbington et la Directrice des opérations cliniques Courtney Bartlett ont souligné l'engagement de l'entreprise à fournir des solutions d'infertilité sûres, efficaces et abordables. L'entreprise continue d'avancer son portefeuille de technologies de médecine régénérative pour autonomiser les familles et accroître la valeur pour les actionnaires.
Creative Medical Technology Holdings (NASDAQ: CELZ) unterstützt die Exekutive Anordnung von Präsident Donald J. Trump zur Erweiterung des Zugangs zu In-vitro-Fertilisation (IVF). Dies steht im Einklang mit ihrem OvaStem®-Programm, das eine Verbesserung der hormonellen Funktion um 85% und eine Erfolgsquote von 70% bei der Geburt gesunder Babys unter Verwendung der eigenen Eizellen der Patientin zeigt, ohne Sicherheitsbedenken bis zu fünf Jahre nach der Behandlung. OvaStem® bietet eine neuartige Alternative zur traditionellen IVF, indem die eigenen Zellen der Patientin verwendet werden, was besonders für Patientinnen mit primärer Ovarialinsuffizienz (POI) von Vorteil ist, die typischerweise eine Chance von 5-10% auf eine spontane Schwangerschaft haben.
OvaStem® integriert die AlloStem®-Plattform des Unternehmens, die bereits in zwei von der FDA genehmigten klinischen Studien in den USA getestet wird. Creative Medical Technology Holdings hat auch einen Antrag auf Orphan Drug Designation für POI eingereicht. Die am 18. Februar 2025 unterzeichnete Exekutive Anordnung verlangt Empfehlungen innerhalb von 90 Tagen zur Senkung der IVF-Kosten, die derzeit zwischen 12.000 und 25.000 USD pro Zyklus liegen. Diese Initiative zielt darauf ab, fortschrittliche Fertilitätstechnologien zugänglicher zu machen.
CEO Timothy Warbington und die Direktorin für klinische Operationen Courtney Bartlett betonten das Engagement des Unternehmens, sichere, effektive und erschwingliche Lösungen für Unfruchtbarkeit anzubieten. Das Unternehmen setzt seine Fortschritte im Portfolio regenerativer Medizintechnologien fort, um Familien zu stärken und den Shareholder-Wert zu steigern.
- OvaStem® program shows 85% improvement in hormonal function and 70% success rate in delivering healthy babies.
- No safety concerns reported up to five years post-treatment for OvaStem®.
- Integration of AlloStem® platform in FDA-cleared clinical trials.
- Filing for Orphan Drug Designation for POI.
- Support for executive order to lower IVF costs, potentially increasing market adoption.
- Current IVF costs range from $12,000 to $25,000 per cycle, making it inaccessible for many families.
OvaStem® Demonstrates Strong Long-Term Efficacy with No Safety Concerns, Backed by Pending Orphan Drug Designation for AlloStem®
PHOENIX, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a leading biotechnology innovator in regenerative medicine, enthusiastically supports President Donald J. Trump’s executive order expanding access to in vitro fertilization (IVF). This initiative directly aligns with the company’s vision to transform reproductive health through its groundbreaking OvaStem® program, which has demonstrated an
Patients with Primary Ovarian Insufficiency (POI) typically face only a 5
The executive order, signed on February 18, 2025, mandates the Domestic Policy Council to deliver recommendations within 90 days to lower out-of-pocket IVF costs, which currently range from
"The President’s executive order is a historic step toward expanding fertility care, and we are thrilled to contribute to this movement with our patented cutting-edge OvaStem® program," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "With our unmatched expertise in regenerative medicine and a growing pipeline of innovative treatments, we are uniquely positioned to redefine reproductive health and provide new hope to millions of families."
"Our goal is to provide women with the safest, most effective, and affordable infertility solutions possible," added Courtney Bartlett, DNP, Director of Clinical Operations. "The President’s commitment to reducing financial hurdles will allow more families to access fertility treatments, and OvaStem® stands at the forefront of this revolution."
Creative Medical Technology Holdings continues to lead the charge in regenerative medicine, with a robust portfolio of proprietary technologies and clinical programs aimed at addressing some of the most pressing medical challenges. As federal efforts to expand fertility care progress, the company remains fully committed to advancing innovative solutions that empower families and drive shareholder value.
For more information about the OvaStem® program and other regenerative therapies, please visit www.creativemedicaltechnology.com. *whitehouse.gov
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology, and orthopedics and is traded on NASDAQ under the ticker symbol CELZ. For further information about the Company, please visit www.creativemedicaltechnology.com.
Forward Looking Statements
This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov.
Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
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FAQ
What is the success rate of the OvaStem® program by CELZ?
What does the CELZ OvaStem® program offer for patients with Primary Ovarian Insufficiency (POI)?
How does the executive order signed on February 18, 2025, affect IVF costs?
What are the safety concerns associated with the OvaStem® program by CELZ?
What is the potential impact of the executive order on CELZ's business?
What is the significance of the Orphan Drug Designation filed by CELZ for POI?
How does CELZ's AlloStem® platform integrate with the OvaStem® program?
