No approved products
FDA's 2019 safety notice says there are no FDA-approved exosome products. Read the notice ↗
FDA says there are no approved exosome products. We help clinics say so plainly and book the services they do offer.
A 30-minute call with Anatolie. You leave with the gaps we found and a proposed first scope.

Four public FDA documents set the limits for what a clinic page can say.
FDA's 2019 safety notice says there are no FDA-approved exosome products. Read the notice ↗
FDA says exosomes used to treat disease are drugs and biological products. They need FDA approval first. Read the consumer alert ↗
An August 2026 warning letter says two exosome products needed an approved biologics license. FDA also cited the missing IND. Read the letter ↗
FDA's tissue rule names labeling and advertising as evidence of intended use. We treat clinic copy as part of that record. Read 21 CFR 1271.10 ↗
Sources checked October 27, 2026. We are marketers, not lawyers. Your counsel confirms what applies to your clinic.
Patients and business buyers never share a page, a form or a follow-up sequence.
Patients read exosome claims online, then ask your team. We build clinician-reviewed education and a route to the services you offer.
Your buyer is a clinic owner or medical director, not a patient. We scope that work under healthtech go-to-market.
Honest research education, plus a booking route for the services you already provide.
We find exosome claims on your site, ads, business profiles and phone scripts.
You receive a claim register with source, owner and a recommended fix.
We explain what exosomes are and what FDA has said, with links. Your clinician reviews it.
You receive page copy, cited sources and a review date.
We build it around services your clinicians can offer today, with fees and coverage you confirm.
You receive page copy, the agreed build and tested booking steps.
Staff get approved answers for calls and messages that mention exosomes. Medical questions go to a clinician.
You receive call and message scripts plus an escalation rule.
We assign calls and forms to a named owner. Reminders cover booked consultations.
You receive the routing plan, CRM stages and message templates.
We track inquiries, bookings and attendance by source, with written definitions.
You receive a baseline and a reporting plan.
Runs inside the health & longevity 90-day pilot.
We turn these down, whatever the budget.
Marketing work stops where medical and legal judgment starts.
| Work | LeadsACE | Your clinic team |
|---|---|---|
| Claim register | Finds and logs every claim | Decides each fix with counsel |
| Research education page | Drafts it with linked FDA sources | A clinician reviews and approves it |
| Consultation page | Writes and builds it | Confirms services, fees and credentials |
| Front-desk scripts | Writes answers and escalation rules | Staff use them. Clinicians take medical questions. |
| Inquiry routing | Sets up stages and reminders | A named owner responds |
| Eligibility and care | No role | Clinicians decide, with the patient |
That is a business sale with a different buyer. We scope positioning, partner materials and outbound under healthtech go-to-market.
Your counsel confirms the product's regulatory status first. Your claims to clinics have to match that status.
Explore healthtech go-to-market ↗Research, recruitment, clinic consultations and supply each follow different rules.
| Communication | What it needs | Source |
|---|---|---|
| Research education | Describe the actual study and its limits. Early findings are not treatment promises. | FTC health claims guidance ↗ |
| Trial recruitment | IRB approval first. Say the product is investigational. No "free treatment" lines. | FDA, Recruiting Study Subjects ↗ |
| Clinic consultation | Describe the assessment and the services you offer. Keep exosome treatment out of the offer. | FDA exosome notice ↗ |
| Business supply | Match every claim to the product's regulatory status. No consumer treatment claims. | Healthtech go-to-market |
Claims about TBI, CTE or neuron regeneration need evidence for that exact claim.
FTC expects competent and reliable scientific evidence for health claims. Usually that means randomized human trials. Read the FTC guidance ↗
Brain-health assessments are a separate service. See the brain-health clinic guide.
A nonprofit research site and a clinic site need different names, contact routes and forms. Each form should say what it is for.
Keep medical history out of marketing forms and analytics. It belongs in your approved clinical intake.
Peptide services follow different rules again. See the peptide clinic guide.
Bring your website, service menu and current scripts. Here is what happens next.
Straight answers before we talk.
No. FDA says no exosome products are approved. Google Ads bans promotion of experimental treatments. We build education and a consultation route for services you can offer.
Yes, as research education. It can explain what exosomes are and what FDA has said. Your clinician and counsel approve the wording. It should not invite patients to book exosome treatment.
FDA guidance says the IRB reviews and approves recruitment ads first. We can format and place IRB-approved materials. We do not write new treatment claims.
That is a business sale, handled under our healthtech go-to-market service. Your counsel confirms the product's status and claims before any outreach.
Your clinical and legal reviewers. We log each claim, its source and who approved it. We are marketers, not lawyers.
A 30-minute call with Anatolie. We review your offer, website, inquiry sources and follow-up. You leave with the gaps we found and a proposed first scope.