Femasys Gets FDA Exemption for Permanent Birth Control
By Dean Seal
Femasys said U.S. regulators have granted it an investigational device exemption to evaluate the safety and efficacy of its first-of-its-kind non-surgical permanent birth control in a clinical trial.
The biomedical company said Monday that the U.S. Food and Drug Administration approved of the exemption for FemBloc, a permanent birth control that eliminates the need for anesthesia, incisions or permanent implants.
Femasys plans to launch a pivotal trial for FemBloc in the third quarter.
Shares nearly tripled to a high of $1.76 in premarket trading before retreating. With an hour left to go before market open, shares have more than doubled to $1.24.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 26, 2023 08:44 ET (12:44 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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