EDEN PRAIRIE, MN / ACCESSWIRE / September 20, 2018 / From shaving cuts to emergency trauma, uncontrolled bleeding is a every-day problem. Protégé Biomedical in Eden Prairie, MN, started by husband and wife Michael and Susan Wuollett, has been working on a solution for several years that can stop bleeding in a few short seconds. Today they announced Protégé Biomedical received FDA clearance on their Ionic Hemostatic Mineral (IHM) BandageTM. This newly-cleared product is a gauze pad impregnated with their patented hemostatic (blood-stopping) technology.
While this first FDA clearance is indicated for surface bleeding, their technology has demonstrated in pre-clinical testing that it can stop major trauma bleeding in a femoral artery in less than 3 minutes.
"Were thrilled to receive our first FDA clearance after years of testing and trials and working with the FDA. This is a big milestone for us, but our work is only beginning." said Michael Wuollett, CEO and co-founder of Protégé Biomedical. "This is the first of many indications for which we plan to gain clearance. The next indication we will likely pursue is emergency trauma."
The company is working on a launch strategy to get the product to market. "We have several launch strategies and opportunities we are exploring, and we plan to take the time needed to get it right, but you can expect to see it on the market soon" says co-founder and COO, Susan Wuollett. This initial product is a natural fit in convenient and drug stores for nuisance bleeding, especially amongst people on blood thinners, but could also be marketed to clinics and dermatologists.
For more information about the company, contact susan.wuollett@protgebiomedical.com.
About Protégé Biomedical
Protégé Biomedical is a medical device company with a unique and patented line of hemostatic products developed to stop bleeding fast and keep it stopped, in animals and humans. Protégé Biomedical has a line of hemostatic products for animals, under the brand name ClotIt® and ClotIt® VET, and received its first FDA clearance for humans in September 2018. For more information visit www.protegebiomedical.com
SOURCE: Protégé Biomedical
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https://www.accesswire.com/512334/Protege-Biomedical-Receives-FDA-Clearance-for-Bandage-to-Stop-Bleeding
