Wednesday, March 18, 2020 1:46:22 PM
I was initially interested in their HerbaSafe antimicrobial soaps and sanitizers that have tested to be more effective than alcohol-based hand sanitizers, but his last comment about their partner, N8 Meidical's Endotracheal Tube (ETT) actually struck me as even more compelling, considering how COVID-19 associated pneumonia is causing a spike in ventilator use, coupled with the CDC's recent prioritization of Ventilator Associated Events (VAE) within the framework of the National Action Plan to Prevent Health Care-Associated Infections.
As you can see from clinicaltrials.gov, N8 Medical's ETT was previously designated and FDA "breakthrough device" and should have completed their study by October 30, 2019.....I think they have a good case for expedited review here and hope a favorable decision could be coming soon!
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Hello Paul,
Good morning – hope you are well. I recall meeting you in person in one of the earlier board meetings.
Glad to receive your email inquiry about Hydromer’s HerbaSafe line.
Yes, we are aggressively marketing these products through Social Media while discussing with medical, hospital, retail and other channels of markets.
Please note that per FDA guidelines, only three ingredients - Benzalkonium Chloride, Ethyl Alcohol, and Isopropyl Alcohol (with alcohol content of a minimum of 60% over longer term use by a consumer)– are approved as OTC Hand Sanitizers for use by a consumer.
See details in this link:
https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers
We are actively working on a few large inquiries of hand sanitizers and they are all requiring alcohol based products. Based on the market need, our R&D/Manufacturing team is working to quickly put together an alcohol-based hand sanitizer formula to add to this line, so we can provide multiple options. We are also continuing to push the benefits of the non-alcohol line and have some opportunities lining up for selling this down the road – although, everyone is right now looking for an alcohol-based sanitizers.
We are also working on medical device coatings combining with antimicrobials, especially with our partner N8 Medical with their unique technology on ET tubes, through various government agencies for emergency approvals as an alternate solution for the Coronavirus outbreak. Will keep you posted on this development and how quickly we can see business growth.
Please let me know if you need any additional information.
Best regards,
Ravi
Ravi Rangarajan
VP Sales, Marketing & Biz Development
"Our houses are such unwieldy property that we are often imprisoned rather than housed in them." - Henry David Thoreau, Walden: Economy, 1854
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