Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain
Creative Medical Technology Holdings (NASDAQ: CELZ) has received FDA Fast Track designation for CELZ-201-DDT, its lead therapy targeting degenerative disc disease (DDD) and chronic lower back pain. The designation enables accelerated FDA interactions, rolling BLA submissions, and priority review eligibility.
CELZ-201-DDT, part of the AlloStem® platform, is an allogeneic perinatal cell therapy administered through minimally invasive intramuscular injections. The therapy has shown promising safety data and early efficacy signs in clinical trials. The global spinal disorders treatment market is projected to exceed $20 billion by 2030.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha ottenuto la designazione Fast Track dalla FDA per CELZ-201-DDT, la sua terapia di punta destinata alla malattia degenerativa del disco (DDD) e al dolore lombare cronico. La designazione consente interazioni accelerate con la FDA, sottomissioni BLA in modalità rolling e l'idoneità alla revisione prioritaria.
CELZ-201-DDT, parte della piattaforma AlloStem®, è una terapia cellulare perinatale allogenica somministrata tramite iniezioni intramuscolari minimamente invasive. Nei trial clinici ha mostrato dati di sicurezza promettenti e segnali precoci di efficacia. Il mercato globale dei trattamenti per i disturbi della colonna vertebrale è previsto superare $20 miliardi entro il 2030.
Creative Medical Technology Holdings (NASDAQ: CELZ) ha recibido la designación Fast Track de la FDA para CELZ-201-DDT, su terapia principal dirigida a la enfermedad degenerativa del disco (DDD) y al dolor lumbar crónico. La designación permite interacciones aceleradas con la FDA, presentaciones BLA en formato rolling y la posibilidad de revisión prioritaria.
CELZ-201-DDT, parte de la plataforma AlloStem®, es una terapia celular perinatal alogénica administrada mediante inyecciones intramusculares mínimamente invasivas. En ensayos clínicos ha mostrado datos de seguridad prometedores y señales tempranas de eficacia. Se espera que el mercado global de tratamientos para los trastornos de la columna vertebral supere los $20 mil millones para 2030.
Creative Medical Technology Holdings (NASDAQ: CELZ)가 퇴행성 추간판 질환(DDD) 및 만성 요통을 표적으로 하는 주력 치료제 CELZ-201-DDT에 대해 미국 FDA의 패스트트랙(Fast Track) 지정을 받았습니다. 이 지정으로 FDA와의 신속한 소통, 롤링 방식의 BLA 제출 및 우선심사 대상 자격이 가능해집니다.
CELZ-201-DDT는 AlloStem® 플랫폼의 일부로, 최소침습적 근육내(근육주사) 방식으로 투여되는 동종 주산기 세포치료법입니다. 임상시험에서 유망한 안전성 데이터와 초기 효능 신호를 보였습니다. 글로벌 척추 질환 치료 시장은 2030년까지 200억 달러를 초과할 것으로 전망됩니다.
Creative Medical Technology Holdings (NASDAQ: CELZ) a obtenu la désignation Fast Track de la FDA pour CELZ-201-DDT, sa thérapie principale ciblant la maladie dégénérative des disques (DDD) et la lombalgie chronique. Cette désignation permet des échanges accélérés avec la FDA, des soumissions BLA en rolling et l'éligibilité à un examen prioritaire.
CELZ-201-DDT, qui fait partie de la plateforme AlloStem®, est une thérapie cellulaire périnatale allogénique administrée par injections intramusculaires peu invasives. La thérapie a montré des données de sécurité prometteuses et des signes précoces d'efficacité dans les essais cliniques. Le marché mondial des traitements des affections rachidiennes devrait dépasser 20 milliards de dollars d'ici 2030.
Creative Medical Technology Holdings (NASDAQ: CELZ) hat für CELZ-201-DDT, seine führende Therapie gegen degenerative Bandscheibenerkrankungen (DDD) und chronische Rückenschmerzen, die Fast-Track-Zulassung der FDA erhalten. Diese Einstufung ermöglicht beschleunigte Abstimmungen mit der FDA, Rolling-BLA-Einreichungen und die Berechtigung für eine vorrangige Prüfung.
CELZ-201-DDT, Teil der AlloStem®-Plattform, ist eine allogene perinatale Zelltherapie, die durch minimalinvasive intramuskuläre Injektionen verabreicht wird. In klinischen Studien wurden vielversprechende Sicherheitsdaten und frühe Anzeichen von Wirksamkeit beobachtet. Der globale Markt für Wirbelsäulenbehandlungen dürfte mehr als 20 Milliarden US-Dollar bis 2030 erreichen.
- FDA Fast Track designation received for CELZ-201-DDT, accelerating development timeline
- Promising clinical data showing favorable safety profile and early efficacy signs
- Addressing $20 billion global spinal disorders market by 2030
- Non-addictive alternative solution amid opioid crisis
- Minimally invasive treatment approach compared to surgical alternatives
- Final enrollment in clinical trial still pending
- Therapy still in clinical-stage, requiring further trials and approvals
Insights
FDA Fast Track designation for CELZ's back pain therapy accelerates development timeline and validates its potential to address a major unmet medical need.
The FDA's Fast Track designation for CELZ-201-DDT represents a significant regulatory milestone for Creative Medical Technology. This designation is granted to therapies that address serious conditions with high unmet medical needs, and it brings several tangible benefits to the development program. The company will now enjoy more frequent interactions with FDA reviewers, eligibility for rolling BLA submissions (allowing sections to be submitted and reviewed as they're completed rather than waiting for the entire application), and potential priority review which can reduce approval timelines from 10 months to 6 months.
What makes this particularly noteworthy is the therapeutic approach. CELZ-201-DDT is an allogeneic perinatal cell therapy administered via minimally invasive injections, targeting the underlying cellular degeneration in disc disease rather than just masking symptoms. The FDA's decision indicates the therapy has demonstrated both a favorable safety profile and preliminary efficacy signals - critical hurdles for regenerative medicine approaches.
The market opportunity here is substantial. Degenerative disc disease affects millions globally, with current treatments limited to pain management, anti-inflammatories, physical therapy, or invasive surgical procedures. A regenerative approach that could modify disease progression would represent a paradigm shift in treatment. With the global spinal disorders market projected to exceed
The company's mention of an expanded access policy suggests they're also preparing pathways for patients with serious conditions to access the treatment outside of clinical trials, which aligns with regulatory expectations for promising therapies addressing significant unmet needs.
PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.
This designation positions CELZ-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables the Company to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review—potentially expediting the path to market and patient access.
Transformative Regenerative Approach
CELZ-201-DDT, part of the Company’s proprietary AlloStem® platform, is an allogeneic perinatal cell therapy administered via minimally invasive, ultrasound-guided intramuscular injections. The Fast Track designation was awarded based on compelling clinical data demonstrating a favorable safety profile and early signs of efficacy, marking a potentially significant step forward in redefining treatment standards for patients suffering from chronic back pain due to DDD.
“Fast Track designation from the FDA is both a validation of our scientific approach and a catalyst for value creation,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “Lower back pain from degenerative disc disease remains a leading cause of disability worldwide, and the opioid crisis underscores the urgent need for new, non-addictive solutions. As we near final enrollment in our FDA cleared clinical trial, we believe CELZ-201-DDT has the potential to transform patient care while driving shareholder value through accelerated development timelines.”
Addressing a Large and Growing Market
DDD impacts millions of patients globally, with current options often limited to symptom management or invasive surgery. The Company’s approach targets the underlying cellular degeneration and inflammation, aiming to restore function and improve quality of life. The global spinal disorders treatment market is projected to surpass
Next Steps and Expanded Access
In alignment with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), Creative Medical Technology will publicly post its expanded access policy for CELZ-201-DDT within 15 days of this announcement, with details available on the Company’s website.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company advancing a pipeline of cell and immune therapies targeting unmet needs in neurology, urology, orthopedics, and autoimmune diseases. The Company leverages proprietary regenerative platforms and a robust regulatory strategy to accelerate development.
Forward Looking Statements
This press release contains forward-looking statements regarding regulatory milestones, clinical development, and the Company’s strategic plans. Actual results may differ due to a range of factors, including regulatory risks and clinical outcomes. Creative Medical Technology assumes no obligation to update these statements, except as required by law.
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| Creative Medical Technology Holdings, Inc. | ||
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FAQ
What is the significance of FDA Fast Track designation for CELZ-201-DDT?
How does CELZ-201-DDT treat degenerative disc disease?
What is the market potential for CELZ's degenerative disc disease treatment?
When will CELZ's expanded access policy for CELZ-201-DDT be available?
What clinical evidence supported CELZ-201-DDT's Fast Track designation?
