Evolutionary Biologics Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your products are unapproved new drugs and are also unlicensed biological products. The introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Passage 2

your umbilical cord derived product, EVO JEL™, fails to meet the criterion in 21 CFR 1271.10(a)(2) that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.” This product is not intended solely to perform the same basic function or functions of the umbilical cord in the recipient as in the donor, such as serving as a conduit. Rather, using this product for the treatment of diseases or conditions, such as inflammation, joint tears, tendon tears, muscle tears, cartilage tears, osteoarthritis, plantar fasciitis, and bone spurs is not homologous use as defined in 21 CFR 1271.3(c).

Passage 3

your umbilical cord derived product, EVO JEL™, fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1) because the umbilical cord undergoes processing that alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. Information available to the Agency indicates that EVO JEL is offered in a “flowable” form. The processing of the umbilical cord from the form of a tube into a flowable form is more than minimal manipulation because such processing alters the original relevant characteristics of the umbilical cord relating to the tissue’s utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.

Passage 4

EVO HYBRID™ fails to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1) because the umbilical cord and amniotic membrane undergo processing that alters the original relevant characteristics of those tissues related to their utility for reconstruction, repair, or replacement. For example, the processing of umbilical cord from the form of a tube into a flowable form is more than minimal manipulation because the processing alters the original relevant characteristics of the umbilical cord relating to the tissue’s utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form, and the processing of amniotic membrane from the form of a sheet into a flowable form alters the original relevant characteristics of the amniotic membrane relating to its utility to serve as a barrier by effectively eliminating its physical integrity, tensile strength and elasticity.

Passage 5

your product derived from umbilical cord, “placental tissue,” and amniotic membrane, EVO HYBRID™, fails to meet the criterion in 21 CFR 1271.10(a)(2) because this product is not intended solely to perform the same basic function or functions of umbilical cord and amniotic membrane in the recipient as in the donor, such as serving as a conduit (for umbilical cord) or serving as a selective barrier for the movement of nutrients between the external and in utero environment, protecting the fetus from the surrounding maternal environment, and serving as a covering to enclose the fetus and retain fluid in utero (for amniotic membrane). Rather, use of this product for reducing inflammation, tissue regeneration, organ regeneration, bone growth, tissue growth, cartilage repair, and wound healing, for example, is not homologous use as defined in 21 CFR 1271.3(c).

Passage 6

Your exosome product, EXO RNA™, also meets the definition of a drug and biological product under section 201(g)(1) of the FD&C Act and section 351(i) of the PHS Act, as discussed above, and is subject to premarket review and approval requirements.

Passage 7

Your products are not the subject of an approved biologics license application (BLA) or an approved application under section 505 of the FD&C Act. Based on our review, your products are both unapproved new drugs and unlicensed biological products, and you cause their introduction or delivery for introduction into interstate commerce in violation of section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Passage 8

FDA has not identified approved BLAs in effect for your EXO RX™, EXO ELIXIR™ and **EXO PERIO™** products. In your response, please explain the basis of your determination regarding whether these products require FDA premarket review.