UEEC Hemostyp FDA approval moving forward! Unit
Post# of 591
(Total Views: 539)
Posted On: 10/10/2017 10:43:08 AM
UEEC Hemostyp FDA approval moving forward!
United Health Products Issues FDA Submission UpdateFont size: A | A | A
8:15 AM ET 10/10/17 | GlobeNewswire
United Health Products, Inc. (OTC:UEEC), a manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that its current Expanded Indication Submission Class II application for HemoStyp for internal usage with the U.S. FDA continues to progress, and is in an advanced stage of review. In addition, the company is pleased to announce that it has applied to the FDA's new and innovative CtQ Pilot Program premarket approval PMA (Class III internal usage) for HemoStyp.
The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body -as evidenced by years of prior product usage and studies--to be approved for Class III internal surgical use. The program's intent is to allow products that have demonstrated repeated safe interaction to enter the market in a more efficient manner. This application will run simultaneously with the company's prior Class II application for expanded indication. The market for 2017 for internal surgical hemostatic products is estimated to be more than seven billion, and is expected to grow at 7.1% over the next few years, to reach more than $8.3 billion by 2022. (http://industryarc.com/Report/15189/hemostats-market.html)
United Health Products Issues FDA Submission UpdateFont size: A | A | A
8:15 AM ET 10/10/17 | GlobeNewswire
United Health Products, Inc. (OTC:UEEC), a manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that its current Expanded Indication Submission Class II application for HemoStyp for internal usage with the U.S. FDA continues to progress, and is in an advanced stage of review. In addition, the company is pleased to announce that it has applied to the FDA's new and innovative CtQ Pilot Program premarket approval PMA (Class III internal usage) for HemoStyp.
The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body -as evidenced by years of prior product usage and studies--to be approved for Class III internal surgical use. The program's intent is to allow products that have demonstrated repeated safe interaction to enter the market in a more efficient manner. This application will run simultaneously with the company's prior Class II application for expanded indication. The market for 2017 for internal surgical hemostatic products is estimated to be more than seven billion, and is expected to grow at 7.1% over the next few years, to reach more than $8.3 billion by 2022. (http://industryarc.com/Report/15189/hemostats-market.html)
(0)
(0)