(Updates)
** Shares of Fractyl Health GUTS.O decline ~22% to $5.80
premarket
** Co reports Q4 net loss of $19.2 mln, or $11.18 per
share, compared to a loss of $10.9 mln, or $7.39 per share last
year
** Revenue from sales and leasing of its weight-loss
maintenance device Revita was "insignificant", came in at $0.1
mln for 2023 - GUTS
** Revita is approved in Europe and GUTS had initiated a
limited commercial pilot for the device in Germany last year
** Says U.S. health regulator has approved request to begin
clinical study of Revita, which is designed to surgically
remodel the duodenal lining that receives food from the stomach
and begins nutrient absorption
** Co plans to begin study in H2 2024 and will test Revita
versus a sham treatment in patients who have lost at least 15%
total body weight on tirzepatide, a GLP-1 drug sold as Mounjaro
for type 2 diabetes by Eli Lilly LLY.N
** As of last close, GUTS down 46.2% since market debut on
Feb. 2
(Reporting by Bhanvi Satija in Bengaluru)
((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))