VANCOUVER, BC / ACCESSWIRE / May 25, 2020 / Ovation Science Inc. (CSE:OVAT) ("Ovation" or the "Company"), is providing an update to its previous disclosures regarding its DermSafe® hand sanitizer product. This release provides updates to regulatory status, sales, manufacturing, and the science which supports DermSafe.
DermSafe hand sanitizing lotion provides a protective solution that is unique from other products on the market due to its patented polymer skin delivery technology Invisicare® and its use of chlorhexidine gluconate (CHG) as the active ingredient versus alcohol. DermSafe helps prevent the cross-contamination of bacteria and viruses between people and from contact with hard surfaces. CHG is a well established active ingredient as it has been used in hospitals worldwide for over 60 years in pre-surgical soaps as well as dental applications.
DermSafe Regulatory Approval
- DermSafe has two drug identification numbers (DIN) issued by Health Canada: DIN#02310589 and DIN#02355558 (personal use and personal commercial use). Both of these DINS are exclusively licensed worldwide by Ovation Science Inc. from Skinvisible Pharmaceuticals Inc. DermSafe has also been accepted by Health Canada under its list of "Disinfectants and hand sanitizers accepted under COVID-19 interim measure". On May 1st, DermSafe received clearance from Health Canada for importation into Canada from the USA under their "Notification & Request for Importation Clearance Number" COVID19 program. Under this clearance, on May 5th, the Company commenced importation of DermSafe into its warehouse in Toronto, Canada from the United States.
DermSafe Sales and Manufacturing
- In April, the Company announced sales of DermSafe to China, the United Kingdom and Canada. Sales to these countries totaled approximately CDN$233,000 in the initial three month introduction period for the product which began February 3, 2020. Other enquiries about DermSafe have come from potential distributors in S. Korea, Japan, Brazil, Columbia, Mexico, Kuwait and Greece. Ovation has signed confidentiality agreements with the potential representatives for some of these territories and is awaiting the results of their investigation into obtaining regulatory approval to import DermSafe into those countries. On April 22, Ovation announced it had signed a distribution agreement for its DermSafe hand sanitizer with Gad Medical Equipment Ltd. (Gad Medical) for Israel. They import and market healthcare and medical equipment as well as pharmaceuticals and consumables for hospitals and clinics. Gad Medical has filed with the Ministry of Health (MOH) in Israel to receive approval for the importation of DermSafe.
- Ovation has submitted a purchase order to begin its manufacturing at a contract manufacturer located in Ontario, Canada and anticipates a delivery date in early July. There are many advantages to having Canadian production including pricing and proximity to potential customers. DermSafe's approved by Health Canada, allows for easier exportation to some countries.
DermSafe has undergone many independent studies on its effectiveness and other benefits. Although the Company has not tested DermSafe against the COVID19 virus, an envelope virus, several viral tests were carried out by an internationally recognized, independent laboratory plus US FDA compliant laboratories on other envelope viruses including H1N1, H5N1 and H3N2. Additionally, the Invisicare polymer was tested to show its ability to remain bound to the skin for extended periods of time. A list of these studies, all conducted at independent laboratories, are summarized below:
1. Tests conducted by independent lab, Retroscreen Virology Ltd., Center for Infectious Diseases Bart's & The London Queen Mary's School of Medicine and Dentistry, London, United Kingdom:
Evaluation of Antiviral Properties of a Product Using a Virucidal Suspension Assay:
- REDUCTION IN INFLUENZA VIRUSES (PCS-003 July/06): The virucidal activity of DermSafe was assessed against A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Guangdong/120/00 viruses. The viruses were placed for a 60 second contact time on 96-well plates which contained DermSafe. The virus titre was then measured by titration on MDCK cells and virus was detected by Haemagglutination assay. Untreated virus was used as control. The results show a >99.9968% reduction in the virus H1N1 (swine flu), >99.9998% reduction in H3N2 (influenza virus) and a >99.9684% reduction in Guangdong virus (Influenza B).
- REDUCTION IN H5N1 AVIAN FLU VIRUS AT VARIOUS TIME POINTS (PCF-001 Dec/05): The virucidal activity of DermSafe was assessed against H5N1 (avian flu virus) at 15 and 30 seconds as well as 1, 5 and 10 minute contact times. The viruses were placed the various contact times on 96-well plates which contained DermSafe. The results showed a 99.00% to 99.90% reduction in virus from DermSafe over the various time points.
Evaluation of Antiviral Properties of a Product Testing Virucidal Activity on Skin Tissue:
- REDUCTION IN H5N1 BIRD FLU VIRUS / Ex-VIVO STUDY (Pig Skin) (PCF-002 June/06): The virucidal activity of DermSafe was assessed using an ex-vivo (pig skin) study at both short-term and long term time points. The virus was placed on sections of pig skin which had been treated with DermSafe. The results showed that DermSafe killed the H5N1 virus by 99.44% at 5 minutes and 99.9% at 10 minutes. The longer term durations resulted in a 98.22% reduction in the H5N1 virus at both 2 hours and 4 hours (without reapplication).
2. Test conducted by ATS Labs., Eagan, Minnesota (US FDA compliant / independent lab):
Evaluation of Antiviral Properties of a Product Using a Virucidal Suspension Assay:
- REDUCTION IN H3N2 INFLUENZA A VIRUS AT VARIOUS TIME POINTS (AO3812 March/06): The virucidal activity of DermSafe was assessed against H3N2 (influenza virus) for a 15, 30 and 60 second contact times. DermSafe was placed in a tube and then the virus was added for the contact times. The results respectively showed a 99.00% at 15 seconds, 99.94% at 30 seconds and 99.98% at 60 seconds reduction in virus from DermSafe over the various time points.
3. Test conducted by Bioscience Laboratories, Inc., Bozeman, Montana (US FDA compliant / independent lab):
Evaluation of the Persistent Antimicrobial Efficacy on E.coli (Anti-Bacterial) of DermSafe at 2 and 4 Hours after Application (#90864-150 Oct/09):
- The persistent antimicrobial properties of DermSafe was tested against Escherichia coli (e-Coli) (ATCC #43888). The hands of 13 subjects were contaminated with a suspension of e-Coli and measured. The subjects then applied DermSafe and measurements of e-Coli were taken at 2 and 4 hours following product application. This evaluation is based on ASTM 2752-10 Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. The results at 2 hours post-application showed a 99.12% kill of e-Coli and at 4 hours post-application a 99.38% kill.
4. Test conducted by California Skin Research Institute, San Diego, CA (US FDA compliant / independent lab):
Invisicare Persistence Study (#98-065 September/98):
- Study to demonstrate the ability of a hand sanitizer made with Invisicare polymers to adhere to skin under conditions that simulate normal working conditions (i.e. multiple hand washings in a hospital setting). The sanitizer was applied to the forearms of 30 subjects, followed by a scrub for 2 minutes with gauze saturated with 5% Ammonium Hydroxide at 3 time intervals being, 10 minutes, 2 hours and 4 hours.
- Results revealed the sanitizer made with Invisicare polymer was bound to skin for greater than 4 hours, even after 6 minutes of scrubbing. At 4 hours the sanitizer product began to exfoliate from the skin. These results show that the sanitizer made with Invisicare polymer has the ability to persist on skin throughout multiple hand washes and exposure to detergents, chemicals and solvents for a minimum of 4 hours.
For information about Ovation Science products visit https://ovationscience.com/products/.
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About Ovation Science Inc.
Ovation Science Inc. is a research and development company that develops topical and transdermal consumer products including DermSafe, all made with patented Invisicare® skin delivery technology. The technology enhances the delivery of ingredients to and through the skin and is protected by patents in eleven countries. With over twenty years of topical and transdermal drug delivery experience in the pharmaceutical market, Ovation's management and science team have created a unique pipeline of over twenty-five patent-protected medical / wellness topical and transdermal products along with a line of anti-aging / beauty formulas. Ovation earns revenues from licensing and development fees, royalties, the sale of Invisicare to its licensees and now revenue from its own product sales. Ovation has offices in Vancouver, BC Canada and Las Vegas, Nevada, USA. Ovation trades on the CSE under the symbol OVAT. Visit our website www.ovationscience.com.
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular there is no assurance that the Company's DermSafe product will be licensed or approved for sale in Israel, Japan, Brazil, Columbia, Mexico, Kuwait or Greece and that if approval is obtained that it will result in sales in those countries. Although DermSafe has been tested against other envelope viruses there is no assurance that it will kill or be as effective against COVID-19. In addition there is no assurance the Company's level of sales will continue or will not be negatively impacted by increased competition and recovery from the coronavirus pandemic. Other examples of the assumptions underlying the forward-looking statements contained herein include, but are not limited to those related to: strategies, potential sales, distribution and manufacturing of the Company's product as well as its effectiveness against COVID-19, the Company's ability to receive regulatory approval outside of Canada. There are no guarantees of future performance. Ovation Science Inc. cautions that all forward looking statements are inherently uncertain and that actual results may be affected by a number of material factors, many of which are beyond Ovation Science Inc.'s control. Accordingly, readers should not place undue reliance on the forward-looking information. Ovation disclaims any obligation to revise or update any such forward-looking information to reflect future results, events or circumstances, except as required by law.
Statements have not been evaluated by the Food and Drug Administration or Health Canada. These products are not intended to diagnose, treat, cure, or prevent any disease. Ovation does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA).
Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.
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SOURCE: Ovation Science Inc.
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