Creative Medical Technology Announces Positive Top-Line Results for OvaStem® Pilot Study

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) announced positive results from a three-year follow-up study of its OvaStem® procedure, aimed at treating Primary Ovarian Insufficiency (POI). The study revealed a **90% efficacy** in improving hormonal function and a **70% success rate** in delivering healthy babies using the patients' own eggs. Importantly, there were **no serious adverse effects** reported. This innovative procedure, utilizing the patient's own bone marrow aspirate, represents a potential advancement in fertility treatment for women with POI, who typically face low chances of conception.

Positive

• 90% efficacy in improving hormonal function for POI patients.
• 70% success rate in delivering healthy babies using patients' own eggs.
• No serious adverse effects reported over three years.

Negative

• None.

Three-Year Follow Up Results Confirm Significant Efficacy and No Serious Adverse Effects in Patients receiving OvaStem® Procedure for Treating Primary Ovarian Insufficiency

PHOENIX, July 28, 2022 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a leading commercial stage biotechnology company focused on a regenerative approach to immunotherapy, urology, neurology, and orthopedics, today announced positive three-year follow up data for the Company's OvaStem® pilot study.  The data shows significant efficacy of the OvaStem® procedure for the treatment of medical refractory Primary Ovarian Insufficiency (POI) without any serious adverse effects and the successful birth of healthy babies.

OvaStem® is a patented outpatient clinic procedure that utilizes a patient's own bone marrow aspirate for treatment of medical refractory POI. Below is a summary of the study's three-year follow up data:

There were no safety related concerns at up to three years and the OvaStem® procedure resulted in an efficacy of 90% in the treated patients in terms of improvement in hormonal function and 70% in terms of delivery of healthy babies using their own eggs. Patients with POI usually only have a 5% to 10% chance of spontaneous pregnancy and must rely on donor eggs for conception via in vitro fertilization therapy. The company plans to submit a manuscript for publication in a peer reviewed journal and present the data at future fertility medicine conferences. 

"The positive three-year data from our OvaStem® pilot study is very encouraging, and we are excited to engage with practitioners on further development and translation," said Timothy Warbington, President and CEO of the company.  "To our knowledge, this pilot study is one of the first to demonstrate the clinical efficacy of injecting bone marrow aspirate into the ovaries using a minimally invasive outpatient procedure, thereby repairing, remodeling and improving the function.  We believe as we further develop the OvaStem® program there is great potential to help patients with POI to conceive and deliver babies using eggs from their own ovaries without having to use surrogacy or donor eggs. Despite all on-going research, there is no FDA approved treatment for POI."

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of immunotherapy, urology, neurology, and orthopedics. 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.

 

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SOURCE Creative Medical Technology Holdings, Inc.

FAQ

What are the results of the OvaStem procedure study by CELZ?

The OvaStem procedure study showed a 90% efficacy in hormonal function improvement and a 70% success rate in delivering healthy babies.

Is there any FDA-approved treatment for Primary Ovarian Insufficiency?

Currently, there is no FDA-approved treatment for Primary Ovarian Insufficiency.

What is the significance of the OvaStem study results for patients?

The results indicate a potential new option for POI patients to conceive using their own eggs, which is a significant improvement over current methods that often rely on donor eggs.

When were the OvaStem study results released?

The results were announced on July 28, 2022.