FDA
CBER
OPDP
FTC
DOJ
SEC
STATE AG
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BioIntelScan
BioIntelScan
Scan a URL
The Bloomberg Terminal for Regenerative Medicine

Every enforcement action. Every company. Every warning letter. One terminal.

BioIntelScan is the regenerative medicine intelligence terminal for clinic owners, doctors, ad agencies, and investors. Live FDA, CBER, OPDP, FTC, DOJ, SEC, and state-AG enforcement — scored against the 21 CFR 1271 four-prong test the moment guidance changes.

Start at $49/mo →Reserve founding seat
Enforcement actions tracked
0+
CBER biologics actions
0
HCT/P & stem-cell letters
0
Regen-med companies cited
0

FDA · CBER · OPDP · FTC · DOJ · SEC · State AGs — seven sources, synced daily.

● Live feed
2026-09-11CBERNexCell Scientific Inchigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-08-14CBERR3 Medical Companieshigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-05-26CBERBlue Horizon International, LLChigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-05-07State AGAttorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Companyhigh— Iowa Attorney General (official press release): Attorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Company.
2026-02-11CBERDynamic Stem Cell Therapyhigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-01-29CBERCentral Coast Multispecialty Medical Group, Inc.high— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2026-01-27CBERConceive Fertility Centerhigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2026-01-23CBERLouisville Reproductive Centerhigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-12-03CBERGreen Valley Fertility Partnershigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-12-02State AGAttorney General Brenna Bird Secures Victory Against Scam Stem Cell Treatment Companyhigh— Iowa Attorney General (official press release): Attorney General Brenna Bird Secures Victory Against Scam Stem Cell Treatment Company.
2025-12-01CBERCelularity, Inchigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-12-01CBERBioXtek LLChigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-11-25CBERLux Therapeutics LLC dba Ponya Therapeutics LLChigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-09-12CBERCellebration LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-09-04CBERNuVida Medical LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-08-15CBERPlatinum Biologics LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-08-15CBERInnate Healthcare Institutehigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-06-13CBERInVia Fertility Specialists, PLLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-03-04State AGArizona AG sues umbilical cord blood registry over alleged scamhigh— Arizona attorney general action as reported by AZ Family: Arizona AG sues umbilical cord blood registry over alleged scam.
2025-02-14CBERSperm Bank, Inc. dba Fertility Center of Californiahigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2026-09-11CBERNexCell Scientific Inchigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-08-14CBERR3 Medical Companieshigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-05-26CBERBlue Horizon International, LLChigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-05-07State AGAttorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Companyhigh— Iowa Attorney General (official press release): Attorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Company.
2026-02-11CBERDynamic Stem Cell Therapyhigh— FDA warning letter (CBER): Unapproved New Drugs/Unlicensed Biological Product Violations.
2026-01-29CBERCentral Coast Multispecialty Medical Group, Inc.high— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2026-01-27CBERConceive Fertility Centerhigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2026-01-23CBERLouisville Reproductive Centerhigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-12-03CBERGreen Valley Fertility Partnershigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-12-02State AGAttorney General Brenna Bird Secures Victory Against Scam Stem Cell Treatment Companyhigh— Iowa Attorney General (official press release): Attorney General Brenna Bird Secures Victory Against Scam Stem Cell Treatment Company.
2025-12-01CBERCelularity, Inchigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-12-01CBERBioXtek LLChigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-11-25CBERLux Therapeutics LLC dba Ponya Therapeutics LLChigh— FDA warning letter (CBER): Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA).
2025-09-12CBERCellebration LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-09-04CBERNuVida Medical LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-08-15CBERPlatinum Biologics LLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-08-15CBERInnate Healthcare Institutehigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-06-13CBERInVia Fertility Specialists, PLLChigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).
2025-03-04State AGArizona AG sues umbilical cord blood registry over alleged scamhigh— Arizona attorney general action as reported by AZ Family: Arizona AG sues umbilical cord blood registry over alleged scam.
2025-02-14CBERSperm Bank, Inc. dba Fertility Center of Californiahigh— FDA warning letter (CBER): Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps).

One terminal · four workflows

Built for the four people who live in this market.

Same enforcement graph underneath. Different surface for each role.

Clinics

Clinic owners & operators

Defensive monitoring

"Am I one warning letter away from shutting down?"

  • Live enforcement feed for your sub-vertical
  • Score every product on the four-prong test
  • Alerts when peers in your segment catch action
Doctors

Practicing physicians

Claim & news research

"Can I say this in my marketing? What's actually happening in my space?"

  • Research mode: search any claim against CFR + case law
  • Daily clinical-relevance digest
  • Personal watchlist of products + companies you use
Agencies

Advertisers & marketing agencies

Claim Clearance™

"Clear this campaign before it ships. Every headline, every CTA, every disclaimer."

  • Batch claim review (paste 50 claims, get 50 verdicts)
  • Per-client workspaces with audit trail
  • Counsel-ready approval memo on every campaign
Investors

Investors & analysts

Portfolio risk + deal flow

"Which of my bets has FDA / FTC exposure? Who's about to catch a 483?"

  • Company Risk Board across the regen med universe
  • Deal-flow signals (M&A, fundings, IND filings)
  • Portfolio watchlists with auto-alerts

Company coverage

Every regen med operator, on the record.

Public companies, mid-market tissue processors, clinic networks, and CGT sponsors — ranked by their actual FDA warning letters, CBER and OPDP untitled letters, and FTC and SEC actions, each linked to the official letter.

Free tier: Top-10. Full universe + screener on Terminal.
CompanyActions on recordWarning lettersMost recent actionCategory
Dynamic Stem Cell Therapy21Warning letter · Feb 11, 2026Stem Cell / Exosome Products
NexCell Scientific Inc11Warning letter · Sep 11, 2026Unapproved Biologic
R3 Medical Companies11Warning letter · Aug 14, 2026Unapproved Biologic
Blue Horizon International, LLC11Warning letter · May 26, 2026Unapproved Biologic
Attorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Company10Action · May 7, 2026Stem Cell / Exosome Products
Central Coast Multispecialty Medical Group, Inc.11Warning letter · Jan 29, 2026Regenerative Medicine
Conceive Fertility Center11Warning letter · Jan 27, 2026Regenerative Medicine
Louisville Reproductive Center11Warning letter · Jan 23, 2026Regenerative Medicine
Green Valley Fertility Partners11Warning letter · Dec 3, 2025Regenerative Medicine
Attorney General Brenna Bird Secures Victory Against Scam Stem Cell Treatment Company10Action · Dec 2, 2025Stem Cell / Exosome Products
Celularity, Inc11Warning letter · Dec 1, 2025Unapproved Biologic
BioXtek LLC11Warning letter · Dec 1, 2025Unapproved Biologic
Lux Therapeutics LLC dba Ponya Therapeutics LLC11Warning letter · Nov 25, 2025Unapproved Biologic
Cellebration LLC11Warning letter · Sep 12, 2025Regenerative Medicine
NuVida Medical LLC11Warning letter · Sep 4, 2025Regenerative Medicine

Showing the 15 companies with the most regenerative-medicine and biologics enforcement actions on the public record, out of94 actions in total. Sources: FDA warning letter index, CBER and OPDP untitled letters, FTC, SEC. Updated daily.

Live enforcement feed

Seven sources. One timeline.

FDA warning letters, CBER and OPDP untitled letters, FTC health-claim actions, DOJ prosecutions, SEC litigation releases, and state attorney-general actions, synced daily — filtered to regenerative medicine and the four-prong case law that shapes it.

Guidance Tracker
FDA / CBER / OPDP / FTC drafts + finals
Last sync 12 min ago
  • 2025-09-12
    CBER
    Sepsis Risk in HCT/Ps — Donor Screening (Draft)
    Comment open

    Tightens donor screening requirements for tissue processors. Comment period closes Q1 2026.

  • 2025-08-04
    CBER
    Tuberculosis Risk in HCT/Ps — Updated Donor Eligibility
    Draft

    Re-runs all 361 HCT/P registrations against updated TB risk criteria.

  • 2025-06-21
    FDA
    Bacterial Infection Risk in HCT/Ps — Final Guidance
    Final

    Effective immediately. Adds testing + record-keeping for tissue intended for non-skin uses.

  • 2025-05-09
    OPDP
    Promotional Communications for Cellular & Gene Therapies
    Final

    Sets new standards for risk disclosure in CGT promotional materials.

  • 2024-11-30
    FTC
    Endorsement Guides (Health Claims Edition)
    Final

    Higher bar for testimonial-based stem cell + exosome marketing claims.

Deal-Flow Signals
M&A · funding · INDs · restructuring
Investor tier
  • 2026-04-09
    M&A
    Organogenesis

    Reported acquisition discussions with strategic buyer; due-diligence focus on 361 HCT/P exposure.

  • 2026-03-22
    IND
    Vertex Cell + Gene

    New IND filed for autologous T-cell therapy; opens 12-mo CBER review window.

  • 2026-03-12
    Funding
    AlloVir

    Series D extension; $90M for allogeneic cell-therapy commercialization.

  • 2026-02-18
    Layoffs
    Celularity

    20% workforce reduction; restructuring around CBER-aligned product set.

  • 2026-02-04
    M&A
    StimLabs

    Strategic review announced; rumored interest from two public wound-care firms.

Four-Prong Scanner

Score any product, claim, or indication in 60 seconds.

Paste a product description, a marketing claim, or a procedure indication. We score it against the 21 CFR 1271.10(a) four-prong test, cite the CFR sections, and flag the exact enforcement actions that set the precedent.

Four-Prong Scanner
Score any product, claim, or indication against 21 CFR 1271.10(a)
Demo · Counsel-ready output on subscription
Enforcement Risk Score
—
Awaiting scan
Range
0 · 100
Minimal Manipulation
—
21 CFR 1271.10(a)(1)
Homologous Use
—
21 CFR 1271.10(a)(2)
No Combination
—
21 CFR 1271.10(a)(3)
No Systemic Effect
—
21 CFR 1271.10(a)(4)
Demo output · Not legal advice. Terminal tier returns counsel-ready memo + CFR citations.21 CFR 1271.10(a) · Four-Prong Test

One terminal. Four audiences. Four ways to pay for it.

Pricing scales with seats, scan volume, and API access. Founding-member rates locked through 2026.

Solo
$49/month

For a single MD or clinic owner tracking their own exposure.

Solo doctors · clinic owners · peptide companies

  • 15 Peptide Claim Checks / mo
  • Full enforcement feed + filters
  • Unlimited Four-Prong Scans
  • 20 Claim Clearance checks / mo
  • Save 10 companies to watchlist
  • Email + weekly PDF report
Most common for ops teams
Practice + Agency
$299/month

Multi-provider practices and regen med marketing agencies. The sweet spot.

Multi-provider clinics · ad agencies · in-house marketing

  • 50 Peptide Claim Checks / mo
  • 5 seats (add more at $49/seat)
  • Unlimited Claim Clearance
  • Client workspaces (agencies)
  • Batch claim review (upload CSV)
  • Counsel-ready approval memos
  • API access (rate-limited)
  • Slack alerts
Terminal
$999/month

The full Bloomberg-style terminal. For investors, analysts, and multi-clinic networks.

Investors · analysts · multi-site networks

  • 150 Peptide Claim Checks / mo
  • 20 seats
  • Full company universe + risk screener
  • Portfolio watchlists + alerts
  • Deal-flow signals (M&A, fundings, INDs)
  • Data exports + full API
  • Research reports: 10-Case Canon, guidance recaps
  • Dedicated onboarding
Enterprise
Contact

Funds, large clinic networks, pharma marketing teams.

Funds · tissue processors · pharma MLR teams

  • Custom Peptide Claim Check volume
  • Unlimited seats
  • SSO + audit log + DPA
  • Custom data feeds + bespoke research
  • Upgrade path to BioIntel.io enterprise
  • MSA, BAA, E&O coverage
Talk to the team →

Prices are introductory for founding members. Annual discount available at Practice tier and above. Checkout is secured by Stripe.

Founding members

First 50 seats get 50% off Terminal for 12 months.

Clinic owners, doctors, agencies, and investors. Tell us which you are — we'll send onboarding tailored to your workflow.

First 50 founding-member seats lock in 50% off Terminal for 12 months and direct onboarding with the team.