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Creative Medical Technology Holdings Applauds Presidential Initiative to Expand IVF Access, Showcasing OvaStem® Program's Success and Growth Potential

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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.

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Positive

  • 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.

Negative

  • Current IVF costs range from $12,000 to $25,000 per cycle, making it inaccessible for many families.

News Market Reaction – CELZ

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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 85% improvement in hormonal function and a 70% success rate in delivering healthy babies using a patient’s own eggs—all with no safety concerns at up to five years post-treatment.

Patients with Primary Ovarian Insufficiency (POI) typically face only a 5-10% chance of spontaneous pregnancy and must rely on donor eggs for conception. OvaStem® changes this paradigm by leveraging the company’s rapid autologous therapy platform to harness the regenerative properties of a patient’s own cells, providing a novel, personalized alternative to traditional IVF. Further enhancing this breakthrough, the next-generation OvaStem® integrates the company’s AlloStem® platform, which is already being utilized in two FDA-cleared U.S. clinical trials. Additionally, Creative Medical Technology Holdings has filed for Orphan Drug Designation for POI, reinforcing its leadership in fertility innovation.

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 $12,000 to $25,000 per cycle, making treatment inaccessible for many families. By removing these financial barriers, the administration’s plan paves the way for greater adoption of advanced fertility technologies.

"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

Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com


FAQ

What is the success rate of the OvaStem® program by CELZ?

The OvaStem® program by CELZ has a 70% success rate in delivering healthy babies using a patient’s own eggs.

What does the CELZ OvaStem® program offer for patients with Primary Ovarian Insufficiency (POI)?

The CELZ OvaStem® program offers a novel, personalized alternative to traditional IVF, leveraging the patient's own cells to improve hormonal function and increase the chances of conception.

How does the executive order signed on February 18, 2025, affect IVF costs?

The executive order mandates recommendations within 90 days to lower out-of-pocket IVF costs, which currently range from $12,000 to $25,000 per cycle.

What are the safety concerns associated with the OvaStem® program by CELZ?

There are no safety concerns reported up to five years post-treatment for the OvaStem® program by CELZ.

What is the potential impact of the executive order on CELZ's business?

The executive order to lower IVF costs could increase the accessibility and adoption of CELZ's advanced fertility technologies, potentially driving business growth.

What is the significance of the Orphan Drug Designation filed by CELZ for POI?

The Orphan Drug Designation for POI reinforces CELZ's leadership in fertility innovation and could provide regulatory and financial benefits.

How does CELZ's AlloStem® platform integrate with the OvaStem® program?

CELZ's AlloStem® platform, already in two FDA-cleared clinical trials, is integrated into the next-generation OvaStem® to enhance its regenerative properties.