Delivery Method: Via UPS and EMAIL Reference #: CBER 25-707745 Product: Biologics Recipient:
Recipient Name
Park Thomas
Recipient Title
Chief Executive Officer and Owner
NuVida Medical LLC
5814 S 25th St
Phoenix, AZ 85040
United States
park.thomas@nuvidamed.com Issuing Office: Center for Biologics Evaluation and Research (CBER)
United States
WARNING LETTER
September 04, 2025
CBER 25-707745
Dear Mr. Thomas:
The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between February 10, 2025, and February 19, 2025. During the inspection, FDA documented that your company distributes two products derived from human amniotic membrane, Procenta and XCELLERATE; a product consisting of three layers of the placental membrane including amnion (amniotic membrane), chorion (chorionic membrane), and the intermediate layer, completeFT1; and a product derived from human dermal tissue, Coll-E-Derm, for allogeneic use (collectively, “your products”).
This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your 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).
Based on information and records reviewed by FDA, including your website https://nuvidamed.com/ and the website https://extremitycare.com/ linked to your website for more information about your products (last visited September 2025), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example,
- Procenta, XCELLERATE, and completeFT are each described on the website https://extremitycare.com, linked to on your https://nuvidamed.com website, as “a placental tissue allograft that may be used as a protective barrier in wound care applications. The natural properties of amniotic tissue provide mechanical protection and growth factors to support the management of acute and chronic wounds.”2
- Coll-e-Derm is described on the website https://extremitycare.com, linked to on your https://nuvidamed.com website, as “a prehydrated human acellular dermal matrix that retains angiogenin and collagen type IV. Angiogenin and collagen type IV may play a key role in supporting revascularization.”
Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).
Your Procenta, XCELLERATE, completeFT, and Coll-e-Derm products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d) and are subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Nuvida Medical LLC does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all criteria in 21 CFR 1271.10(a).
For example, your Procenta, XCELLERATE, completeFT, and Coll-e-Derm products fail to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). In the donor, amniotic membrane and placental membrane comprising all three layers (amnion, intermediate layer, and chorion) serve 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. The labeling, advertising, and other indications of your objective intent demonstrate that Procenta, XCELLERATE, and completeFT are intended to perform functions that are not considered the same basic function or functions in the recipient as in the donor. Rather, your Procenta, XCELLERATE, and completeFT products are intended for certain wound care applications, including by providing growth factors,3 that fall outside of the basic function of amniotic membrane and placental membrane comprising all three layers (amnion, intermediate layer, and chorion) in the donor. Therefore, Procenta, XCELLERATE, and completeFT fail to meet the criterion for homologous use (21 CFR 1271.10(a)(2)).
With respect to your Coll-e-Derm™ product, skin in the donor serves to provide covering, protecting the body from external force, and serving as a water-resistant barrier to pathogens or other damaging agents in the external environment. The labeling, advertising, and other indications of your objective intent demonstrate that your Coll-e-Derm™ product is intended to perform functions that are not considered the same basic function or functions in the recipient as in the donor. Rather, your Coll-e-Derm™product is intended for use in “supporting revascularization.” Supporting revascularization is not a basic function of dermal tissue in the donor. Supporting revascularization would require biochemical stimulation of a wound healing response in the body via cell signaling, which is not a basic function of dermal tissue in the donor. Therefore, your Coll-e-Derm™ product fails to meet the criterion for homologous use (21 CFR 1271.10(a)(2)).
Therefore, these HCT/Ps are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.4 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.
Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.
Response to the Form FDA-483
We have reviewed your response, dated March 12, 2025, to FDA’s Form FDA-483 in detail. We acknowledge your representation that you have corrected the deficiencies documented on the FDA-483. We also acknowledge that you removed certain claims regarding your products from your website based on discussions with the FDA investigator concerning the intended uses of your products. Your voluntary corrections were not sufficient to correct the violations noted in this letter, because your products continue to be intended for non-homologous uses.
Conclusion
This letter addresses certain issues regarding your products and is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.
Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Cc:
(b)(4)
Oliver Burckhardt
Chief Operating Officer and Owner
Extremity Care LLC
555 E North Ln
Ste 5000, Bldg D
Conshohocken, PA 19428
Leonard R. Duford
President and Chief Executive Officer
Lucina BioSciences, LLC
14707 E 2nd Ave GL150
Aurora, CO 80011
_______________________________
1 You also market completeFT as an “collagenous amnion/chorion memrane allograft…derived from placental tissue” and a “full thickness amniotic membrane.”
2 Your product provides growth factors but it is unclear how growth factors would support wound management (such as covering/protecting the wound or providing a moist wound environment) as opposed to wound healing.
3 As stated above, it is unclear how the growth factors in your products would support wound management as opposed to wound healing. Wound healing is not a basic function of amniotic membrane or placental membrane comprising all three layers (amnion, intermediate layer, and chorion).
4 Because your products fail to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).
