A hair restoration clinic adding exosomes has a small but measurable literature to work from: a 2025 systematic review found 11 clinical studies, every one reporting improvement in at least one hair parameter, with density gains of 9.5 to 35 hairs per square centimeter and no serious adverse events [1]. The comparators the clinic already knows are larger, with 27 controlled PRP trials covering 1,117 subjects in the 2023 meta-analysis by Cruciani and colleagues [4] and 13 randomized microneedling trials covering 696 patients in the 2024 meta-analysis by Pei and colleagues [5].
The physician owner or clinical director of a hair clinic, medical or surgical, is usually deciding how a topical exosome step after scalp microneedling fits a workflow that already includes trichoscopy, standardized photography and hair counts. Each of eight questions names why it matters and what a documented answer looks like. ExaVeyra Sciences supplies exosome material for topical aesthetic use by licensed practitioners, and every clinical decision described here belongs to the practitioner.
Regulatory status
The FDA stated in its 2019 public safety notification that there are currently no FDA-approved exosome products [19]. ExaVeyra supplies exosome material for topical aesthetic use by licensed practitioners, described by its available formats, with the lot number on every vial and a certificate of analysis for every lot; the certificate, characterization panel and cold-chain records are available on request. The FDA microneedling page states that the devices are not approved for delivering topical products into the skin [20], and whether and how any material is used in a given clinic is the practitioner’s decision.
1. Which licensed practitioner owns the scalp protocol, and which steps are delegated?
A hair clinic’s protocol usually already names who performs scalp microneedling, who applies topical preparations and who reads the trichoscopy. The exosome step attaches to that existing document, and the supervising physician signs the revision.
The studies describe the step in physician-led settings. Koumprentziotis and colleagues reported a prospective series of 20 patients in a dermatology setting, with microneedling radiofrequency followed by topical application and trichoscopy at 3, 6 and 9 months [8], and Ablon reported a 30-subject study with four sessions a month apart and trichoscopy on day 120 [9].
A documented answer names the physician who owns the protocol, the nurse or technician who performs the microneedling and the topical step, the supervision level under the state practice act, and who performs and reads the measurements. The state guides linked below summarize the practice-act questions, and the state board remains the authority.
2. Which published scalp studies describe the sequence, and which route did they use?
The scalp literature divides by route, and a clinic’s protocol has to state which one it follows. Wan and colleagues reported a prospective open-label study of 16 men in 2025 in which scalp microneedling was followed by topical application, with a mean density gain of 35 hairs per square centimeter at 12 months and tenderness that resolved within 48 hours [7].
Ersan and colleagues reported a prospective study of 30 men in 2024 in which the exosomes, characterized by nanoparticle tracking at a mean of 139.7 nanometers, were delivered by scalp injection, with higher density by digital imaging at weeks 4 and 12 [10]. That route sits outside topical labeling, and Park KY described four women with persistent erythema, nodules and granulomatous inflammation after intradermal injection of products sold for topical use [18].
Gupta, Wang and Rapaport found a single clinical study among 16 in their 2023 systematic review, a topical series in 39 adults [2], and Queen and Avram counted nine clinical hair studies with 125 patients in 2025, with rare side effects in the hair studies and at least 10 serious adverse events in the broader dermatology field [3]. A documented answer cites the topical study the protocol follows and states that the route stays topical.
3. How does the clinic’s existing measurement workflow capture the add-on?
Hair clinics hold an advantage over most aesthetic settings because they already measure. Dhurat and Saraogi wrote in their methods review that global photography forms an important part of any hair clinic and that phototrichogram analysis is usually possible only in a trial setting [15], and Oh and colleagues used standardized global scalp photography as the reference in their 2025 study of whether patients perceive density change [14].
The published scalp studies used trichoscopy-based counts: terminal and vellus hair counts, follicular units per square centimeter and inter-follicular distance on day 120 in the Ablon study [9], and density and diameter at fixed scalp points in the Koumprentziotis series [8]. Sindhusen and colleagues noted in their 2025 review that none of the three PRP transplant studies used standardized tools or trichoscopy [11], which is the gap a clinic’s own records can close.
A documented answer names the measurement set (global photographs at fixed positions, trichoscopy at marked scalp points, and the counts the device reports), the visits at which each is taken, and the person who takes and reads them, so the new service produces the same record as the clinic’s existing ones.
4. Where does the add-on sit relative to the surgical workflow, if transplants are performed?
For a surgical clinic the distinction is between a topical aftercare step on an intact or microneedled scalp and anything applied to grafts or the recipient site during surgery. The transplant adjunct literature is a PRP literature: Pathania and colleagues randomized 20 patients to grafts held in PRP or chilled Ringer’s lactate and reported faster recovery from post-transplant shedding and higher density at 6 months [12], and Sindhusen and colleagues found three controlled studies with 217 participants [11].
Balwi and Koldas reviewed adjunctive therapies in hair transplantation in 2026 and wrote that exosome approaches lack robust clinical validation and standardized characterization in that setting [13]. No controlled study of exosome material applied during transplant surgery was located, and an intraoperative use would be a study question under an IND, outside the aftercare protocol.
A documented answer keeps the topical step in the post-procedure protocol, states that nothing is applied to grafts or wounds during surgery, and points any investigator interested in a surgical study to the IND route described in the clinic-launch resources linked below.
| Question | Why it matters | What a documented answer looks like |
|---|---|---|
| Who owns the protocol, and who performs each step? | The published series were physician-led with trichoscopy read by clinicians [8, 9] | A signed protocol naming the physician, each operator, the supervision level and who reads the measurements |
| Which published sequence and route does the protocol follow? | The scalp studies divide between topical application after microneedling and injection [7, 10] | The study citation, the stated topical route and the interval between sessions |
| How is the add-on measured? | Global photography and trichoscopy are the clinic’s existing instruments [14, 15] | A measurement set with visits, positions and the reader named |
| Where does it sit relative to surgery? | The transplant adjunct evidence is a PRP literature; exosome evidence in that setting is absent [11, 13] | A post-procedure step only, with intraoperative use reserved for an IND study |
| What do the lot documents show? | Manufacturing standards were called for across the hair studies [3] | The certificate of analysis, characterization panel and cold-chain records, read against MISEV2023 [16] |
| How is the material stored and consent written? | Storage conditions changed vesicle recovery [17]; the FDA notification shapes the wording [19] | A freezer log, an excursion plan and a consent form that matches the website |
| How is an adverse event reported? | MedWatch accepts voluntary reports from health professionals [21] | A named reporter, the lot number in the report and the supplier notified |
5. Which questions does the published evidence leave open?
A clinic that explains the service against its PRP and microneedling comparators is on firmer ground when the gaps are stated with the literature. The points below set out what the published evidence does not yet show.
- Controlled data are few: Al Ameer and colleagues found two randomized trials among 11 clinical studies, and heterogeneity of design and outcome limited comparison [1].
- Samples are small: the prospective topical series enrolled 16, 20 and 30 participants [7, 8, 9], against 1,117 subjects across the PRP trials [4].
- Follow-up is short: the longest topical series reported 12 months [7], and no study reports maintenance after the last session.
- The microneedling step carries its own effect: Pei and colleagues reported that combined microneedling improved density over monotherapy in 13 randomized trials [5], and Ahmed and colleagues found that needle depth and device type did not change hair count in subgroup analyses of 11 randomized trials [6], so the contribution of the topical material is not separated in single-arm series.
- Products differ: Queen and Avram called for consistent manufacturing standards and regulatory oversight [3], and a result for one product may not transfer to another.
- Transplant data are absent: no controlled study of exosome material during hair transplant surgery was located, and the adjunct literature is PRP [11, 13].
- No society position was located: a PubMed search on the audit date found no International Society of Hair Restoration Surgery position on exosome products.
6. What does the supplier’s documentation show, and how does the topical labeling read?
Queen and Avram ended their 2025 review with a call for consistent manufacturing standards and regulatory oversight [3], and a clinic answers that call for itself by reading the documents for each lot. The MISEV2023 guideline sets out reporting headings for separation method, particle size and concentration, marker proteins and morphology, a neutral checklist for a certificate of analysis [16].
ExaVeyra prints the lot number on every vial, generates a certificate of analysis for every lot with serology, and makes the certificate, characterization panel and cold-chain records available on request. The labeling reads topical aesthetic use by licensed practitioners, and the protocol, consent form and website use the same words.
A documented answer files the lot documents with the receiving record, names the person who read them, and records that the labeling and the protocol describe the same route. The clinic’s other scalp preparations follow the same logic: topical GHK-Cu is available as topical 503A preparations compounded to prescription, and the hair restoration formulary pages linked below describe each by its documentation.
7. How is consent written, and how is the material stored and logged?
The consent form names the procedure, the topical step as aftercare chosen by the physician, and the measurements the clinic will take, in the same words the website uses. The FDA notification states that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products [19], so consent language that describes appearance and the clinic’s own measurements, and names no condition, keeps the documents consistent.
Görgens and colleagues reported in 2022 that plain phosphate-buffered saline reduced vesicle recovery, while buffer with human albumin and trehalose preserved vesicles at minus 80 degrees and across freeze-thaw cycles [17]. ExaVeyra orders ship overnight frozen on dry ice and arrive in 1 to 3 business days, and the receiving procedure checks the dry ice, records the arrival time and lot number, and moves the vials to the freezer before anything else happens.
A documented answer names the freezer, the person who records its temperature on every working day, the excursion plan with affected lot numbers, and the consent version in use on each session date.
8. How is an adverse event recorded and reported?
The hair series reported scalp tenderness and slight irritation resolving within 48 hours [7] or no adverse events [8, 9], and the serious events in the wider literature followed injection [3, 18]. A clinic still writes down in advance who records a reaction and where the record goes.
The FDA’s MedWatch program accepts voluntary reports from health professionals covering biologics, devices and cosmetics [21]. A documented answer names the reporter, requires the lot number and the session date in every report, notifies the supplier so the lot can be traced, and files the report with the chart and the trichoscopy record.
A hair clinic already measures what most aesthetic settings estimate. Running the exosome step through the same photographs, the same trichoscopy points and the same chart is what turns a new service into a record the clinic can stand behind.
A verified account places the documents in the file before the first session
The checklist below gathers the eight questions into items a clinic manager can tick off. Each one has an owner in the table above.
- The signed protocol names the physician, each operator, the supervision level and who reads the measurements.
- The protocol cites the topical study it follows and states the interval and the route.
- The measurement set, with visits, photograph positions and trichoscopy points, is written and the baseline is taken before the first session.
- The surgical protocol, where one exists, keeps the topical step post-procedure and reserves any intraoperative use for an IND study.
- The certificate of analysis, characterization panel and cold-chain records for the current lot have been requested and read.
- The consent form and website describe the same service, and the chart has a discrete lot field.
- The freezer log is running and the excursion plan is written.
- The adverse event route names a reporter and requires the lot number and session date.
A hair clinic that applies for a verified account can have these documents on file before the first booking. Anyone may ask the scientific team a question or apply without an NPI, review takes 1 to 3 business days, and NPI verification gives access to the practitioner portal, product documentation and pricing for each available format.
Clinics that run the new step through the measurements they already trust are well placed to grow the service as the evidence matures, and their standardized records are the kind of data the scalp literature still needs.
Aviso Educativo: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
Referencias
- 1.Al Ameer MA, Alnajim AT, Al Ameer A, Alsalman Z, Al Ameer GA, Alnajim ST, et al. Exosomes and Hair Regeneration: A Systematic Review of Clinical Evidence Across Alopecia Types and Exosome Sources. Clin Cosmet Investig Dermatol. 2025;18:2215-2227. PMID 40955427. doi:10.2147/CCID.S543451Systematic review of clinical studies to May 2025 with OCEBM levels and RoB 2 or ROBINS-I; 11 studies (two randomized trials, three retrospective, three prospective single-arm, one case series, two case reports). Carries in this article: every study reported improvement in at least one hair parameter, density gains ranged from 9.5 to 35 hairs per square centimeter, no serious adverse events were noted, and heterogeneity of design and outcome limited comparison. Disclosure: none stated in the PubMed record.
- 2.Gupta AK, Wang T, Rapaport JA. Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions. J Cosmet Dermatol. 2023;22(9):2424-2433. PMID 37381168. doi:10.1111/jocd.15869PRISMA systematic review, searches January 2023; 16 studies, of which 15 were preclinical and one clinical. Carries in this article: the single clinical study then available reported topical adipose stem cell exosomes in 39 adults with androgenetic alopecia, and the authors concluded that clinical evidence was limited. Disclosure: two authors are affiliated with a contract research company and one with a hair restoration practice, as listed in the record.
- 3.Queen D, Avram MR. Exosomes for Treating Hair Loss: A Review of Clinical Studies. Dermatol Surg. 2025;51(4):409-415. PMID 39447204. doi:10.1097/DSS.0000000000004480Review of PubMed, EMBASE and Cochrane; 48 studies of exosomes in human subjects, of which nine were relevant to alopecia, with 125 patients receiving an exosome product for hair loss. Carries in this article: side effects in the hair studies were rare, while at least 10 serious adverse events had been reported in the broader dermatology field, and the authors called for consistent manufacturing standards and regulatory oversight. Disclosure: none stated in the PubMed record.
- 4.Cruciani M, Masiello F, Pati I, Marano G, Pupella S, De Angelis V. Platelet-rich plasma for the treatment of alopecia: a systematic review and meta-analysis. Blood Transfus. 2023;21(1):24-36. PMID 34967722. PMC9918380. doi:10.2450/2021.0216-21Systematic review and meta-analysis with GRADE by the Italian National Blood Center; 27 controlled trials, 1,117 subjects, 18 trials in androgenetic alopecia. Carries in this article: PRP against saline increased hair density by 25.6 hairs per square centimeter over medium-term follow-up, rated low quality for inconsistency and risk of bias, with no serious adverse events, the comparator a hair clinic already knows. Disclosure: the authors declared no conflicts of interest.
- 5.Pei D, Zeng L, Huang X, Wang B, Liu L, Zhang G. Efficacy and safety of combined microneedling therapy for androgenic alopecia: A systematic review and meta-analysis of randomized clinical trials. J Cosmet Dermatol. 2024;23(5):1560-1572. PMID 38239003. doi:10.1111/jocd.16186Systematic review and meta-analysis of randomized trials published 2012 to 2022; 13 trials, 696 patients. Carries in this article: microneedling combined with a topical agent improved hair density and diameter over either alone (density mean difference 13.36), with no difference in adverse reaction rates, the reason the microneedling step itself carries a measurable effect. Disclosure: none stated in the PubMed record.
- 6.Ahmed KMA, Kozaa YA, Abuawwad MT, Al-Najdawi AI, Mahmoud YW, Ahmed AM, et al. Evaluating the efficacy and safety of combined microneedling therapy versus topical Minoxidil in androgenetic alopecia: a systematic review and meta-analysis. Arch Dermatol Res. 2025;317(1):528. PMID 40056230. PMC11890238. doi:10.1007/s00403-025-04032-1PROSPERO-registered systematic review and meta-analysis, searches to September 2024; 12 randomized trials, 631 patients. Carries in this article: combined microneedling improved hair count over minoxidil alone (standardized mean difference 1.32) with high heterogeneity, needle depth and device type did not change the result in subgroup analyses of the 11 meta-analyzed trials, and adverse events were more frequent but mild. Disclosure: the authors declared no competing interests.
- 7.Wan J, Kim SB, Cartier H, Garson S, Frank K, Haykal D, et al. [A prospective study of exosome-based treatment for androgenetic alopecia]. Aesthetic Plast Surg. 2025;49(11):3151-3156. PMID 40146273. doi:10.1007/s00266-025-04817-9Prospective open-label study; 16 men aged 36 to 45, scalp microneedling followed by a topical exosome product, assessed at 1, 3, 6 and 12 months. Carries in this article: a mean density gain of 35 hairs per square centimeter at 12 months from baselines of 75 to 95, with scalp tenderness and slight irritation resolving within 48 hours. Disclosure: the first author is affiliated with a commercial research company and the product is named in the abstract.
- 8.Koumprentziotis IA, Kroumpouzos E, Delavar S, Kroumpouzos G. Microneedling radiofrequency followed by topical exosome application therapy for pattern hair loss: A scoping review and prospective study. Clin Dermatol. 2025;43(5):742-751. PMID 40744280. doi:10.1016/j.clindermatol.2025.07.006Scoping review (two microneedling radiofrequency and nine exosome studies) plus a prospective series; 20 patients, 16 men and four women, assessed with macroscopic photographs and trichoscopy at 3, 6 and 9 months, median follow-up 10 months. Carries in this article: increases in mean hair density and diameter with no adverse events reported, and the authors’ call for randomized trials to set parameters. Disclosure: the authors declared no competing interests; one author is employed by a biologics company.
- 9.Ablon G. An Exosome Regenerative Complex Plus Microneedling Promotes Hair Growth in Subjects With Self-Perceived Thinning Hair. J Drugs Dermatol. 2025;24(10):988-994. PMID 41037530. doi:10.36849/JDD.9244. ClinicalTrials.gov NCT06571799Single-arm clinical study; 15 men and 15 women, mean age 50.2, four sessions on days 0, 30, 60 and 90 with assessment on day 120. Carries in this article: trichoscopy showed increased terminal and vellus hair counts, more follicular units per square centimeter and reduced shedding, with no adverse events reported, an example of a trichoscopy-based measurement set. Disclosure: the product and its manufacturer are named in the abstract; no funding statement in the PubMed record.
- 10.Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plast Surg. 2024;48(21):4262-4271. PMID 39174804. PMC11588828. doi:10.1007/s00266-024-04332-3Prospective study; 30 men aged 22 to 65, Norwood III to VI, exosomes characterized by nanoparticle tracking (mean 139.7 nm) and delivered by scalp injection. Carries in this article: hair density by digital imaging increased at weeks 4 and 12 with no complications reported, and the route was scalp injection, outside topical labeling, the distinction a protocol has to state. Disclosure: the authors declared no conflict of interest; institutional ethics approval is recorded.
- 11.Sindhusen S, Tawanwongsri W, Eden C. Efficacy of Platelet-Rich Plasma as an Adjunct to Hair Transplantation: A Systematic Review. Cureus. 2025;17(10):e94116. PMID 41069573. PMC12506585. doi:10.7759/cureus.94116Systematic review of controlled prospective trials to June 2025; three studies, 217 participants. Carries in this article: PRP alongside transplantation was associated with higher density, follicle survival and earlier growth, while none of the studies used standardized evaluation tools or trichoscopy, the measurement gap a hair clinic can close in its own records. Disclosure: the authors declared no financial relationships.
- 12.Pathania V, Sood A, Beniwal N, Baveja S, Shankar P, Patrikar S. Randomized control trial to study the efficacy and safety of platelet-rich plasma as intraoperative holding solution in hair restoration surgery: A pilot study. Med J Armed Forces India. 2023;79(1):46-53. PMID 36605335. PMC9807676. doi:10.1016/j.mjafi.2021.04.015Randomized pilot trial; 20 patients, grafts held in PRP or chilled Ringer’s lactate, followed to 6 months with clinical and folliculoscopic images. Carries in this article: an example of a surgical-stage adjunct studied under trial conditions, with faster recovery from post-transplant shedding and higher graft density reported in the PRP group. Disclosure: none stated in the PubMed record.
- 13.Balwi A, Koldas T. Adjunctive regenerative therapies in hair transplantation: a comprehensive review of platelet-rich plasma, exosomes, and emerging methods. Front Med (Lausanne). 2026;13:1820122. PMID 42465074. doi:10.3389/fmed.2026.1820122Structured narrative review, searches to February 2025. Carries in this article: PRP density gains of roughly 10 to 30 hairs per square centimeter in randomized trials with limited transplant-specific evidence, and the authors’ statement that exosome approaches lack robust clinical validation and standardized characterization in the transplant setting. Disclosure: none stated in the PubMed record.
- 14.Oh CS, Anyanwu N, Buontempo MG, Desai D, Nohria A, Shapiro J, et al. Evaluating patient’s ability to detect changes in hair density using standardized global scalp photography: A cross-sectional study. J Am Acad Dermatol. 2025;93(1):265-266. PMID 40064375. doi:10.1016/j.jaad.2025.03.010Cross-sectional study published as a research letter. Carries in this article: standardized global scalp photography as the reference against which patient perception of density change was tested, the same photography a hair clinic runs for any new service. Disclosure: two senior authors list consulting and investigator relationships, declared in the record.
- 15.Dhurat R, Saraogi P. Hair evaluation methods: merits and demerits. Int J Trichology. 2009;1(2):108-119. PMID 20927232. PMC2938572. doi:10.4103/0974-7753.58553Narrative review of noninvasive, semi-invasive and invasive hair evaluation methods. Carries in this article: the authors’ statement that global photography forms an important part of any hair clinic and that phototrichogram analysis is usually possible only in a trial setting, the frame for choosing which measurements a clinic records routinely. Disclosure: none stated in the PubMed record. Cited in addition to the 2011-onward sources as the standard methods review.
- 16.Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, Blenkiron C, Bussolati B, et al; MISEV Consortium; Théry C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024;13(2):e12404. PMID 38326288. PMC10850029. doi:10.1002/jev2.12404International Society for Extracellular Vesicles reporting guideline, compiled with ISEV task forces and more than 1,000 researchers. Carries in this article: the reporting headings (separation, particle size and concentration, marker proteins, morphology) a clinic reads a certificate of analysis against. Disclosure: many consortium authors list EV company affiliations, declared in full in the article.
- 17.Görgens A, Corso G, Hagey DW, Jawad Wiklander R, Gustafsson MO, Felldin U, et al. Identification of storage conditions stabilizing extracellular vesicles preparations. J Extracell Vesicles. 2022;11(6):e12238. PMID 35716060. PMC9206228. doi:10.1002/jev2.12238In vitro stability study over up to 2 years across buffers and temperatures, EVs from several cell sources. Carries in this article: plain phosphate-buffered saline reduced vesicle recovery while buffer with human albumin and trehalose preserved vesicles at minus 80 degrees and across freeze-thaw cycles, the reason the freezer log and handling instructions matter. Disclosure: several authors list affiliation with an EV therapeutics company.
- 18.Park KY. Adverse Reactions Following Intradermal Injection of Exosome-Based Formulations: A Case Series. J Cosmet Dermatol. 2025;24(10):e70520. PMID 41097876. PMC12528963. doi:10.1111/jocd.70520Case series; adult women after intradermal injection of exosome-containing cosmetic products in nonclinical settings (South Korea); n = 4. Carries in this article: persistent erythema, nodules and granulomatous inflammation reported when products sold for topical use were used by another route, the reason the written protocol keeps to the labeled topical use. Disclosure: the author declared no conflicts of interest.
- 19.U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019 (content current as of 12/06/2019; verified 4 November 2026). https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-productsAgency safety notification (CBER). Carries in this article: the agency statement that there are currently no FDA-approved exosome products, and that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, the reason clinic copy describes the service and names no condition.
- 20.U.S. Food and Drug Administration. Microneedling Devices. Content current as of 10/15/2025; verified 4 November 2026. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devicesAgency device information page (CDRH). Carries in this article: the FDA has legally authorized microneedling devices to improve the appearance of facial acne scars, facial wrinkles and abdominal scars in patients aged 22 or older, that the agency may not have reviewed every device for every body location, and that the devices are not approved for delivery of topical products into the skin.
- 21.U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of 11/03/2026; verified 4 November 2026. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-programAgency reporting program page. Carries in this article: the voluntary reporting route for health professionals, patients and consumers covering biologics, medical devices and cosmetics, the route a clinic documents for any adverse event recorded with its lot number.