Monday, September 09, 2019 4:12:52 PM
Phoenix, AZ September 4, 2019 Creative Medical Technology Holdings (OTC-CELZ) reported today completion of data analysis and submission of a research paper describing a total of 140 patients treated with the CaverStem® procedure. The patients suffered from erectile dysfunction for whom standard drug interventions such as Cialis, Levitra, and Viagra (PDE-5) were ineffective.
The data analysis demonstrated that primary end-point of the study was met.
“It is very exciting to see the patented cell based intervention that we first described in peer reviewed literature in our 2013 publication1 has now grown to become a commercialized procedure, available through qualified physicians, after completing a clinical trial with independent monitoring and oversight for safety and efficacy,” said Amit Patel, MD, MS, Board Member of the Company.
In the submitted paper, a total of 40 patients were treated in the primary trial and 100 in the clinical registry. This signifies one of the largest clinical studies of a non-drug treatment for erectile dysfunction.
“The current data is derived from cells that are extracted from the same patient that they are to be used on, and that the cells are not chemically or biologically manipulated. The devices used for extraction and concentration of the cells are FDA cleared. This approach is completely different from unethical and potentially dangerous approaches other groups are using including non-matched stem cells or fat derived stem cells using “home-made” isolation protocols.”
“Since founding the company and acquisition of the technology, through patent prosecution to engaging in the clinical trials and now in the treatment of patients in multiple locations, we have maintained an ongoing positive outlook for our CaverStem® technology. The results which will be published in a peer-reviewed journal as well as reflected on clinicaltrials.gov substantiate our long term belief in the potential safety and efficacy of our technology,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings, Inc. “We are glad to be offering this breakthrough treatment to patients with erectile dysfunction who currently have no other options as part of the ongoing clinical registry.”
To learn more, please visit www.caverstem.com
About Erectile Dysfunction
Erectile dysfunction (ED) is characterized by the lack of ability to achieve and maintain penile erection for intercourse. Methods used to quantify ED include the Erectile Function Visual Analog Scale (EF-VAS) and the International Index of Erectile Function (IIEF-5), however clinically it is primarily diagnosed based on symptomology. In our aging society, ED is becoming an increasing problem. According to one study 39% of men at age 40 experience symptoms of ED, whereas by age 70 the incidence rises to 67%. In this latter age group, it is believed that 50-85% of ED cases are associated with hypertension, diabetes, cardiovascular disease and dyslipidemia. Overall, it is estimated that 10-30 million Americans suffer from this condition.
Recent CELZ News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/05/2024 08:05:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/17/2024 08:02:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 08:45:39 PM
- Creative Medical Technology Holdings Provides Corporate Update • Business Wire • 03/27/2024 01:00:00 PM
- Creative Medical Technology Holdings Inc. Announces FDA Authorization for Groundbreaking Type 1 Diabetes Prevention Therapy Under Expanded Access • Business Wire • 03/07/2024 02:15:00 PM
- Biotech Finds Mid-Week Success Following FDA Announcement • AllPennyStocks.com • 03/06/2024 09:10:00 PM
- Creative Medical Technology Holdings, Inc. Receives FDA Orphan Drug Designation for CELZ-101 in Key Transplantation Therapy • Business Wire • 03/06/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/20/2023 09:05:37 PM
- Creative Medical Technology Holdings Provides Corporate Update • PR Newswire (US) • 11/15/2023 01:00:00 PM
- Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain • PR Newswire (US) • 10/10/2023 12:00:00 PM
- Creative Medical Technology Holdings Receives FDA Clearance to Initiate a Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ (CELZ-201-DDT) for the Treatment of Chronic Lower Back Pain • PR Newswire (US) • 09/19/2023 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/11/2023 08:45:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/29/2023 09:37:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/28/2023 01:00:18 PM
- Creative Medical Technology Holdings Regains Compliance With Nasdaq Listing Requirements • PR Newswire (US) • 06/28/2023 12:00:00 PM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM