Creative Medical Achieves Second International Nonproprietary Name Milestone
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
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Should l Buy CELZ?
Source: Newsfilter
- Regulatory Progress: Creative Medical has achieved the proposed International Nonproprietary Name (INN) 'etaroleucel' for its autologous Treg immunotherapy CELZ-101 from the WHO, marking significant regulatory advancement in its clinical pipeline and enhancing its international reputation in regenerative medicine.
- Technology Validation: CELZ-101 is designed to induce immune tolerance in complex autoimmune settings, particularly for Type 1 diabetes in pancreatic islet transplantation, showcasing its potential to address significant unmet medical needs and provide new treatment options for patients.
- Multi-Platform Development: Following the approval of 'olastrocel' for CELZ-201, Creative Medical demonstrates its capability to advance multiple cell therapy programs through internationally recognized regulatory frameworks, further solidifying its leadership position in the regenerative medicine sector.
- Strategic Value: CEO Timothy Warbington emphasizes that INN recognition is foundational for global clinical development and commercialization, indicating that Creative Medical is building a scalable, internationally credible platform aimed at long-term value creation.
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Analyst Views on CELZ
About CELZ
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. The Company conducts substantially all of its commercial operations through its subsidiary, Creative Medical Technologies, Inc. Its products include AlloStem (CELZ-201-DDT) - allogenic human perinatal tissue derived cell program (clinical phase), ImmCelz (CELZ-100) - personalized supercharged immune therapy platform (pre-clinical trials), Type I Diabetes (CELZ-201 CREATE-1) - type I diabetes, Allostemspine Chronic Lower Back Pain (CELZ 201 ADAPT), Alova, CaverStem - erectile dysfunction treatment, FemCelz - female sexual function treatment, StemSpine - regenerative stem cell procedure for the treatment of degenerative disc disease (clinical trials), and OvaStem - stem cell therapy for premature ovarian failure.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Creative Medical Achieves Second International Nonproprietary Name Milestone
- Regulatory Progress: Creative Medical has achieved the proposed International Nonproprietary Name (INN) 'etaroleucel' for its autologous Treg immunotherapy CELZ-101 from the WHO, marking significant regulatory advancement in its clinical pipeline and enhancing its international reputation in regenerative medicine.
- Technology Validation: CELZ-101 is designed to induce immune tolerance in complex autoimmune settings, particularly for Type 1 diabetes in pancreatic islet transplantation, showcasing its potential to address significant unmet medical needs and provide new treatment options for patients.
- Multi-Platform Development: Following the approval of 'olastrocel' for CELZ-201, Creative Medical demonstrates its capability to advance multiple cell therapy programs through internationally recognized regulatory frameworks, further solidifying its leadership position in the regenerative medicine sector.
- Strategic Value: CEO Timothy Warbington emphasizes that INN recognition is foundational for global clinical development and commercialization, indicating that Creative Medical is building a scalable, internationally credible platform aimed at long-term value creation.
See More
Sanofi Secures EU Approval for Teizeild, Demonstrating Significant Efficacy in Type 1 Diabetes
- New Drug Approval: Sanofi's Teizeild receives EU approval as the first disease-modifying therapy for Stage 2 Type 1 Diabetes, demonstrating a median delay of 48.4 months to Stage 3 T1D, significantly enhancing patient quality of life and strengthening the company's competitive position in diabetes treatment.
- FDA Approval: Fortress Biotech's ZYCUBO gains FDA approval as the first treatment for Menkes Disease, showing nearly an 80% reduction in mortality risk when used early, laying a solid foundation for future market expansion and revenue growth.
- Acquisition Deal: Boston Scientific's $14.5 billion acquisition of Penumbra reflects its strategic expansion in interventional therapies, expected to enhance its leadership in vascular treatments and drive future revenue growth.
- Clinical Trial Progress: Creative Medical's CELZ-201 shows significant improvement in 79% of patients in the ADAPT trial for chronic lower back pain, indicating the therapy's clinical potential and likely attracting further investment and partnership opportunities.
See More
Creative Medical Technologies Reports Positive CELZ-201 Interim Data, Significant Pain Relief Achieved
- Clinical Trial Progress: Creative Medical Technologies released positive 180-day interim data from its FDA-cleared ADAPT trial, showing a mean 15.3 percentage point improvement in functional disability with approximately 79% of patients achieving clinically meaningful benefits, marking a transition from early clinical execution to regulatory engagement and strategic value creation.
- Pain Relief Effectiveness: In the ADAPT trial, pain scores declined by an average of 3.9 points on a 10-point scale, highlighting CELZ-201's potential as a scalable, non-surgical, disease-modifying therapy for chronic lower back pain, a condition affecting over 16 million Americans.
- Safety Confirmation: An independent Data Safety Monitoring Board confirmed CELZ-201's favorable safety profile with no significant adverse events, supporting the program's continued advancement and laying the groundwork for late-stage discussions with regulators and potential partners.
- Broad Market Outlook: The chronic lower back pain market represents a multi-billion-dollar opportunity, with current treatments often relying on opioids, steroid injections, or invasive spine surgery; Creative Medical's cell therapy aims to provide a durable, minimally invasive alternative, expected to drive progress in commercialization planning.
See More
Creative Medical Reports Positive Interim Data for CELZ-201 in Chronic Back Pain Trial
- Clinical Trial Results: Creative Medical's CELZ-201 (Olastrocel) shows a mean improvement of 15.3 percentage points in functional disability (ODI%) at 180 days in the FDA-cleared ADAPT trial, with 79% of patients achieving significant functional improvement, confirming the therapy's durable efficacy and excellent safety profile.
- Pain Relief Effectiveness: The same trial reports an average pain reduction of 3.9 points on a 0-10 scale, with 79% of patients experiencing at least a 2-point decrease in pain, indicating CELZ-201's potential advantages in treating chronic lower back pain.
- Market Opportunity: Chronic lower back pain affects over 16 million Americans, representing a multi-billion-dollar market, and CELZ-201 is positioned as an off-the-shelf, non-surgical regenerative cell therapy designed to provide durable disease-modifying benefits, addressing gaps in current treatment options.
- Strategic Transition: With de-risked safety and confirmed human efficacy signals, CELZ-201 is moving from execution risk to a data-driven value creation phase, as the company advances toward late-stage regulatory engagement and commercialization planning, awaiting final data release.
See More
Creative Medical Receives Approval to Advance Veterans' Burn Pit Initiative
- Regulatory Approval: Creative Medical's BioDefense Inc. Burn Pit Initiative has received regulatory approval, marking a significant milestone in addressing long-term health issues faced by U.S. veterans exposed to burn pits.
- Capital Efficiency: The initiative will be executed without the need for additional fundraising, leveraging existing strategic partnerships and infrastructure to achieve meaningful cost efficiencies, reflecting the company's disciplined financial stewardship.
- Expanded Data Collection: The new approval allows BioDefense Inc. to initiate expanded data collection, AI-driven molecular modeling, and regenerative countermeasure development using its proprietary induced pluripotent stem cell platform, directly benefiting affected veterans.
- Strategic Differentiation: Creative Medical emphasizes that its existing collaboration agreements and internal intellectual property will prevent additional balance sheet pressure, creating a distinct competitive advantage among emerging biotech firms.
See More
Creative Medical Completes Enrollment for ADAPT Trial on Chronic Lower Back Pain
Clinical Trial Completion: Creative Medical Technology Holdings, Inc. has completed patient enrollment in its FDA-cleared ADAPT clinical trial for CELZ-201, a cell therapy aimed at treating chronic lower back pain due to degenerative disc disease.
Safety Review Success: The trial has received a positive safety review from an independent Data Safety Monitoring Board, confirming a favorable safety profile for CELZ-201 with no significant adverse events.
Market Potential: Chronic back pain affects over 16 million Americans, representing a multi-billion-dollar market with few effective non-surgical treatments available.
Future Developments: The company plans to transition the ADAPT program into its next phase, with topline results expected in the first half of 2026, focusing on safety, efficacy, and commercialization strategies.
See More
Creative Medical Achieves Second International Nonproprietary Name Milestone
- Regulatory Progress: Creative Medical has achieved the proposed International Nonproprietary Name (INN) 'etaroleucel' for its autologous Treg immunotherapy CELZ-101 from the WHO, marking significant regulatory advancement in its clinical pipeline and enhancing its international reputation in regenerative medicine.
- Technology Validation: CELZ-101 is designed to induce immune tolerance in complex autoimmune settings, particularly for Type 1 diabetes in pancreatic islet transplantation, showcasing its potential to address significant unmet medical needs and provide new treatment options for patients.
- Multi-Platform Development: Following the approval of 'olastrocel' for CELZ-201, Creative Medical demonstrates its capability to advance multiple cell therapy programs through internationally recognized regulatory frameworks, further solidifying its leadership position in the regenerative medicine sector.
- Strategic Value: CEO Timothy Warbington emphasizes that INN recognition is foundational for global clinical development and commercialization, indicating that Creative Medical is building a scalable, internationally credible platform aimed at long-term value creation.
See More
Sanofi Secures EU Approval for Teizeild, Demonstrating Significant Efficacy in Type 1 Diabetes
- New Drug Approval: Sanofi's Teizeild receives EU approval as the first disease-modifying therapy for Stage 2 Type 1 Diabetes, demonstrating a median delay of 48.4 months to Stage 3 T1D, significantly enhancing patient quality of life and strengthening the company's competitive position in diabetes treatment.
- FDA Approval: Fortress Biotech's ZYCUBO gains FDA approval as the first treatment for Menkes Disease, showing nearly an 80% reduction in mortality risk when used early, laying a solid foundation for future market expansion and revenue growth.
- Acquisition Deal: Boston Scientific's $14.5 billion acquisition of Penumbra reflects its strategic expansion in interventional therapies, expected to enhance its leadership in vascular treatments and drive future revenue growth.
- Clinical Trial Progress: Creative Medical's CELZ-201 shows significant improvement in 79% of patients in the ADAPT trial for chronic lower back pain, indicating the therapy's clinical potential and likely attracting further investment and partnership opportunities.
See More
Creative Medical Technologies Reports Positive CELZ-201 Interim Data, Significant Pain Relief Achieved
- Clinical Trial Progress: Creative Medical Technologies released positive 180-day interim data from its FDA-cleared ADAPT trial, showing a mean 15.3 percentage point improvement in functional disability with approximately 79% of patients achieving clinically meaningful benefits, marking a transition from early clinical execution to regulatory engagement and strategic value creation.
- Pain Relief Effectiveness: In the ADAPT trial, pain scores declined by an average of 3.9 points on a 10-point scale, highlighting CELZ-201's potential as a scalable, non-surgical, disease-modifying therapy for chronic lower back pain, a condition affecting over 16 million Americans.
- Safety Confirmation: An independent Data Safety Monitoring Board confirmed CELZ-201's favorable safety profile with no significant adverse events, supporting the program's continued advancement and laying the groundwork for late-stage discussions with regulators and potential partners.
- Broad Market Outlook: The chronic lower back pain market represents a multi-billion-dollar opportunity, with current treatments often relying on opioids, steroid injections, or invasive spine surgery; Creative Medical's cell therapy aims to provide a durable, minimally invasive alternative, expected to drive progress in commercialization planning.
See More
Creative Medical Reports Positive Interim Data for CELZ-201 in Chronic Back Pain Trial
- Clinical Trial Results: Creative Medical's CELZ-201 (Olastrocel) shows a mean improvement of 15.3 percentage points in functional disability (ODI%) at 180 days in the FDA-cleared ADAPT trial, with 79% of patients achieving significant functional improvement, confirming the therapy's durable efficacy and excellent safety profile.
- Pain Relief Effectiveness: The same trial reports an average pain reduction of 3.9 points on a 0-10 scale, with 79% of patients experiencing at least a 2-point decrease in pain, indicating CELZ-201's potential advantages in treating chronic lower back pain.
- Market Opportunity: Chronic lower back pain affects over 16 million Americans, representing a multi-billion-dollar market, and CELZ-201 is positioned as an off-the-shelf, non-surgical regenerative cell therapy designed to provide durable disease-modifying benefits, addressing gaps in current treatment options.
- Strategic Transition: With de-risked safety and confirmed human efficacy signals, CELZ-201 is moving from execution risk to a data-driven value creation phase, as the company advances toward late-stage regulatory engagement and commercialization planning, awaiting final data release.
See More
Creative Medical Receives Approval to Advance Veterans' Burn Pit Initiative
- Regulatory Approval: Creative Medical's BioDefense Inc. Burn Pit Initiative has received regulatory approval, marking a significant milestone in addressing long-term health issues faced by U.S. veterans exposed to burn pits.
- Capital Efficiency: The initiative will be executed without the need for additional fundraising, leveraging existing strategic partnerships and infrastructure to achieve meaningful cost efficiencies, reflecting the company's disciplined financial stewardship.
- Expanded Data Collection: The new approval allows BioDefense Inc. to initiate expanded data collection, AI-driven molecular modeling, and regenerative countermeasure development using its proprietary induced pluripotent stem cell platform, directly benefiting affected veterans.
- Strategic Differentiation: Creative Medical emphasizes that its existing collaboration agreements and internal intellectual property will prevent additional balance sheet pressure, creating a distinct competitive advantage among emerging biotech firms.
See More
Creative Medical Completes Enrollment for ADAPT Trial on Chronic Lower Back Pain
Clinical Trial Completion: Creative Medical Technology Holdings, Inc. has completed patient enrollment in its FDA-cleared ADAPT clinical trial for CELZ-201, a cell therapy aimed at treating chronic lower back pain due to degenerative disc disease.
Safety Review Success: The trial has received a positive safety review from an independent Data Safety Monitoring Board, confirming a favorable safety profile for CELZ-201 with no significant adverse events.
Market Potential: Chronic back pain affects over 16 million Americans, representing a multi-billion-dollar market with few effective non-surgical treatments available.
Future Developments: The company plans to transition the ADAPT program into its next phase, with topline results expected in the first half of 2026, focusing on safety, efficacy, and commercialization strategies.
See More
