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Long-Term Safety and Toxicity Animal studies have not consistently shown major toxicity signals, which is one reason interest in BPC 157 has continued

Maintaining adequate vitamin B12 serum levels may help improve mental health by decreasing the risk of depression and anxiety

Monitoring Recommendations For extended use protocols, periodic laboratory monitoring provides additional safety assurance

Cold shock proteins represent another dimension of cryotherapys benefits

EBioMedicine 95 , 104773 (2023)

In support of these claims, the applicant provided two retrospective reviews (Lee et al., 2022 and Muscarella, 2022) of medical device reports (MDRs) from the FDA Manufacturer and User Facility Device Experience (MAUDE) database, an FDA News Release (2021, April 1) concerning infection and contamination risks associated with reusable urological endoscopes, and an FDA Update (2025, January 31) communicating the recall of endoscope accessories from Olympus reusable urological endoscopes as supporting evidence