United Health Products Provides Regulatory Status Update
The timing to resolve the FDA Warning Letter is uncertain. Since the April notice of disapproval of its IDE application, UHP has engaged with the FDA's IDE review team (which functions separately from the group that issued the Warning Letter) to seek a path to timely approval of a new IDE and commencement of the clinical study irrespective of the Warning Letter status. UHP has retained a regulatory attorney to support its efforts in this regard and is discussing with the FDA various solutions including, among other options, identifying an alternative sponsor acceptable to the FDA to oversee the new clinical study on the Company's behalf. In such an arrangement, UHP would retain full and exclusive rights to the data and analysis contained in a Clinical Trial Report and incorporate these into a revised PMA application. The Company will make further announcements as FDA discussions progress.
About United Health Products -- UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. UHP is seeking approval to access the human surgical market.
For more information on UHP visit the company's new website: www.uhpcorp.com or contact the company at [email protected].
The company can also be reached by phone or text message at 475.755.1005.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words 'believes,' 'expects,' 'anticipates' or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
View the original release on www.newmediawire.com
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