Response: Although we acknowledge the applicant's concerns regarding the descriptor for C1739, we do not agree that the device category code should be withdrawn and replaced with a new code effective January 1, 2026, for the following reasons: First, per the applicant's request prior to CY 2026 rulemaking, CMS revised the descriptor for C1739 to read, effective October 1, 2025: Tissue marker, uniquely detectable and identifiable with probe/sensor, any method (implantable), with delivery system
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Chemical Makeup (1)(2)(3) Molecular Formula: Tesamorelin: C 221 H 366 N 72 O 67 S CJC-1295 (Mod GRF 1-29): C 152 H 252 N 44 O 42 Ipamorelin: C 38 H 49 N 9 O 5 Molecular Weight: Tesamorelin: 5136 g/mol CJC-1295 (Mod GRF 1-29): 3367.9 g/mol Ipamorelin: 711.8 g/mol Sequence Tesamorelin: Unk-Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2 CJC-1295 (Mod GRF 1-29): L-tyrosyl-D-alanyl-L-alpha-aspartyl-L-alanyl-L-isoleucyl-L-phenylalanyl-L-threonyl-L-glutaminyl-L-seryl-L-tyrosyl-L-arginyl-L-lysyl-L-valyl-L-leucyl-L-alanyl-L-glutaminyl-L-leucyl-L-seryl-L-alanyl-L-arginyl-L-lysyl-L-leucyl-L-leucyl-L-glutaminyl-L-alpha-aspartyl-L-isoleucyl-L-leucyl-L-seryl-L-argininamide Ipamorelin: alpha-methyl-alanyl-L-histidyl-3-(2-naphthyl)-D-alanyl-D-phenylalanyl-L-lysinamide Other Known Titles CJC-1295 (Mod GRF 1-29): CJC 1295 with DAC Ipamorelin: Ipamorelin Acetate Research and Clinical Studies Tesamorelin & CJC-1295 (Mod GRF 1-29) & Ipamorelin Blend and the Pituitary Gland The Tesamorelin & CJC-1295 (Mod GRF 1-29) & Ipamorelin peptide blend appear to exhibit significant interactions with the pituitary gland, seemingly exerting potential impact through specific receptor binding and subsequent modulation of growth hormone (GH) release
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Inactive Ingredients and Their Role The solution for injection includes stabilizers and preservatives along with saline to maintain the product's stability and sterility and ensure safety during administration
