Aphex BioCleanse Systems Enters Agreement with Now Biopharma for Hand Sanitizer Clinical Trial

Rhea-AI Summary

Aphex BioCleanse Systems (OTC: SNST) has announced a collaboration with Now Biopharma to conduct a clinical trial for its hand sanitizer, HydrAphex®. This trial will include 300 human subjects and will compare HydrAphex® with an approved alcohol-based product and a saline control. The product claims to inactivate a wide range of pathogens, including the SARS-CoV-2 virus. Aphex is seeking FDA approval for its non-toxic, non-alcohol formula, which utilizes Hy-IQ™ Water. This trial aims to gather data to support the product's safety and efficacy.

Positive

• Collaboration with Now Biopharma for clinical trial.
• Trial involves 300 subjects, enhancing credibility.
• HydrAphex® shown effective against the SARS-CoV-2 virus.
• Seeking FDA approval for non-toxic, non-alcohol formula.

Negative

• None.

PITTSFORD, N.Y., Aug. 31, 2020 /PRNewswire/ -- Aphex BioCleanse Systems, Inc. (OTC: SNST) ("Aphex" or "the Company"), a sanitization solutions company focused on the development and distribution of chemical-free, water-based sanitization and disinfection products, announced today that the Company has entered into an agreement with Now Biopharma to conduct a hand sanitizer clinical trial in accordance with Federal Register Document No. RIN0910, Safety and Efficacy of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Final Rule (Dec. 20, 2017).

The clinical protocol for this study will include 300 human subjects and compare the Aphex hand sanitizer HydrAphex® to an approved alcohol based product and a saline control.

HydrAphex® is a hand sanitizer that can be used without water and includes Hy-IQ™ Water. When used as directed, Hy-IQ™ quickly drips off, evaporates, or otherwise leaves no significant chemical residue. The product has been shown to inactivate vegetative bacteria and fungi, bacterial spores, and viruses. It has also been shown in testing to be effective against the 229E Strain (SARS-CoV-2) of the human coronavirus. The safety of this product is based upon the fact that the finished product is water with an increased concentration of hydrogen ions and trace levels of residual sulfates.

"We are confident that our non-alcohol, non-toxic Hy-IQ™ formula is far superior to countless formulas being used in other hand sanitizers sold on the market today," said Aphex President and CEO David J. Weaver. "This clinical trial will give us the empirical data needed to support our hypothesis of the safety and superiority of our product, and further our goal of seeking regulatory approval and gaining customer confidence."

In addition to the active ingredient Hy-IQ™ Water being used in this clinical trial, it has also been reviewed and submitted to the FDA as a GRAS (Generally Regarded as Safe) active ingredient for use with food products. The Company is currently seeking FDA final review and approval.

About Aphex BioCleanse Systems, Inc.
Aphex has developed a proprietary broad-based germ-killing formula trademarked as Hy-IQ ™ Water. The Non-Toxic, Non-Alcohol, Hydrogen Based Trade Secret formulation has a unique method of action that uses hydrogen ions traveling at the speed of light that results in lysing(death) of germ cells. Significant prior testing has proven the formula's ability to effectively kill a broad base of pathogens. "Hy-IQ™ Water, may be the most significant discovery in disinfecting since the discovery of chlorine in 1774," says Aphex CEO, David Weaver. www.aphexus.com 

FDA Statement
The statements in this document have not been evaluated or approved by the FDA. The products and statements referenced in this document are not intended to diagnose, treat, cure, or prevent any disease. 

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and expectations, as well as future results of operations and financial condition. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

ShareholderInfo@aphexus.com
www.aphexus.com
Phone: 1-585-386-0990

Address:
Aphex BioCleanse Systems Inc.
15 Fishers Rd, #111
Pittsford, NY  14534

For media inquiries, please contact:

Kathryn Reinhardt
aphex@cmwmedia.com
858-264-6600

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SOURCE Aphex BioCleanse Systems, Inc.

FAQ

What is the purpose of the clinical trial involving SNST?

The clinical trial aims to evaluate the safety and efficacy of HydrAphex® compared to an alcohol-based sanitizer and a saline control.

How many participants are included in the SNST clinical trial?

The clinical trial will include 300 human subjects.

What are the key ingredients in HydrAphex®?

HydrAphex® contains Hy-IQ™ Water, a proprietary non-toxic, non-alcohol formulation.

What are the expected outcomes of the SNST clinical trial?

The trial aims to provide empirical data to support the hypothesis of HydrAphex®'s safety and superiority over traditional hand sanitizers.

When did Aphex BioCleanse Systems announce the clinical trial agreement?

The announcement was made on August 31, 2020.