BBioIntelScan
Free Four-Prong Scan
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, FTC, CBER, OPDP, SEC, and state-AG enforcement — scored against the 21 CFR 1271 four-prong test the moment guidance changes.

Run a Free Four-Prong Scan →Reserve founding seat
Actions tracked
50
Critical severity
13
Four-prong flags
10
Agencies covered
7
FDA · FTC · CBER · SEC · OPDP · State AGs · DOJ
● Live feed
2023-12-20FDAMiMedx Groupcritical— Warning Letter for marketing AmnioFix and EpiFix as 361 HCT/Ps despite failing the minimal-manipulation prong; products required pre-market approval as biologics.
2024-12-04FDAIntegra LifeScienceshigh— Second warning letter in 18 months citing QMS deficiencies across three facilities; "comprehensive compliance master plan" remediation underway.
2023-08-17FDAIntegra LifeSciences (Boston)high— Warning Letter for sterility assurance failures at Boston facility producing surgical reconstruction biologics; voluntary product recall followed.
2024-08-15FDACelularity Inc.critical— FDA Warning Letter targeting placental-derived products marketed as 361 HCT/Ps; agency cited failure of homologous-use and minimal-manipulation tests.
2025-09-24FDANew Life Medical Servicescritical— Warning Letter for marketing exosome products for unapproved therapeutic uses; products are unapproved biologics requiring BLA.
2024-11-12FDAChara Biologicscritical— FDA cited unapproved exosome therapies for orthopedic and cosmetic indications; firm marketing as 361 HCT/P.
2025-02-18FDALux Therapeutics (Ponya)high— Warning Letter targeting marketing claims for exosome injectables; firm cited for misbranding and failure to register as a drug manufacturer.
2025-04-09FDABioXTekhigh— Warning Letter for unapproved umbilical cord blood-derived products marketed as autologous regenerative therapies.
2018-12-14FDALiveyon LLCcritical— Voluntary recall + Warning Letter following hospitalizations from contaminated umbilical cord blood products distributed to clinics.
2019-06-25FDAUS Stem Cell Clinic LLCcritical— Federal court permanent injunction (S.D. Fla.) barring SVF preparation from adipose tissue marketed for unapproved indications. Landmark four-prong case.
2019-06-25FDACalifornia Stem Cell Treatment Centercritical— Federal court (C.D. Cal.) initially ruled for defendants, but Ninth Circuit reversed in 2023 — landmark precedent for SVF four-prong analysis.
2023-10-04FDAGenetech Inc.high— Warning Letter for marketing umbilical cord-derived products as 361 HCT/Ps for orthopedic indications; failed homologous-use prong.
2024-03-22FDALiveyon Labshigh— Second-round Warning Letter after firm reorganized; CBER cited failure to address prior 2018 deficiencies.
2023-02-08FDAKimera Labscritical— Warning Letter for amniotic fluid and exosome products marketed for therapeutic and cosmetic uses without FDA approval.
2023-09-14FDAOrganicell Regenerative Medicinehigh— Untitled Letter regarding promotional claims for Zofin (amniotic-derived product); unapproved for COVID-19 and inflammatory indications.
2022-10-19FDAPredictive Biotechhigh— Warning Letter for unapproved umbilical cord-derived products including AmnioWrap and CoreCyte marketed for orthopedic indications.
2022-08-30FDAUtah Cord Bankhigh— Warning Letter for processing umbilical cord tissue beyond minimal manipulation thresholds; marketed for non-homologous use.
2024-05-16FTCR3 Stem Cellcritical— FTC complaint for deceptive advertising of stem cell therapies for arthritis, MS, Parkinson's, autism; $5M judgment + permanent injunction.
2019-10-23SECMiMedx Groupcritical— $1.5M civil penalty + officer ban; SEC found channel-stuffing and revenue-recognition fraud over multiple quarters.
2019-12-06FTCStemGenexcritical— Class-action settlement and FTC scrutiny following claims of stem cell efficacy for chronic disease; clinic ceased operations.
2023-12-20FDAMiMedx Groupcritical— Warning Letter for marketing AmnioFix and EpiFix as 361 HCT/Ps despite failing the minimal-manipulation prong; products required pre-market approval as biologics.
2024-12-04FDAIntegra LifeScienceshigh— Second warning letter in 18 months citing QMS deficiencies across three facilities; "comprehensive compliance master plan" remediation underway.
2023-08-17FDAIntegra LifeSciences (Boston)high— Warning Letter for sterility assurance failures at Boston facility producing surgical reconstruction biologics; voluntary product recall followed.
2024-08-15FDACelularity Inc.critical— FDA Warning Letter targeting placental-derived products marketed as 361 HCT/Ps; agency cited failure of homologous-use and minimal-manipulation tests.
2025-09-24FDANew Life Medical Servicescritical— Warning Letter for marketing exosome products for unapproved therapeutic uses; products are unapproved biologics requiring BLA.
2024-11-12FDAChara Biologicscritical— FDA cited unapproved exosome therapies for orthopedic and cosmetic indications; firm marketing as 361 HCT/P.
2025-02-18FDALux Therapeutics (Ponya)high— Warning Letter targeting marketing claims for exosome injectables; firm cited for misbranding and failure to register as a drug manufacturer.
2025-04-09FDABioXTekhigh— Warning Letter for unapproved umbilical cord blood-derived products marketed as autologous regenerative therapies.
2018-12-14FDALiveyon LLCcritical— Voluntary recall + Warning Letter following hospitalizations from contaminated umbilical cord blood products distributed to clinics.
2019-06-25FDAUS Stem Cell Clinic LLCcritical— Federal court permanent injunction (S.D. Fla.) barring SVF preparation from adipose tissue marketed for unapproved indications. Landmark four-prong case.
2019-06-25FDACalifornia Stem Cell Treatment Centercritical— Federal court (C.D. Cal.) initially ruled for defendants, but Ninth Circuit reversed in 2023 — landmark precedent for SVF four-prong analysis.
2023-10-04FDAGenetech Inc.high— Warning Letter for marketing umbilical cord-derived products as 361 HCT/Ps for orthopedic indications; failed homologous-use prong.
2024-03-22FDALiveyon Labshigh— Second-round Warning Letter after firm reorganized; CBER cited failure to address prior 2018 deficiencies.
2023-02-08FDAKimera Labscritical— Warning Letter for amniotic fluid and exosome products marketed for therapeutic and cosmetic uses without FDA approval.
2023-09-14FDAOrganicell Regenerative Medicinehigh— Untitled Letter regarding promotional claims for Zofin (amniotic-derived product); unapproved for COVID-19 and inflammatory indications.
2022-10-19FDAPredictive Biotechhigh— Warning Letter for unapproved umbilical cord-derived products including AmnioWrap and CoreCyte marketed for orthopedic indications.
2022-08-30FDAUtah Cord Bankhigh— Warning Letter for processing umbilical cord tissue beyond minimal manipulation thresholds; marketed for non-homologous use.
2024-05-16FTCR3 Stem Cellcritical— FTC complaint for deceptive advertising of stem cell therapies for arthritis, MS, Parkinson's, autism; $5M judgment + permanent injunction.
2019-10-23SECMiMedx Groupcritical— $1.5M civil penalty + officer ban; SEC found channel-stuffing and revenue-recognition fraud over multiple quarters.
2019-12-06FTCStemGenexcritical— Class-action settlement and FTC scrutiny following claims of stem cell efficacy for chronic disease; clinic ceased operations.

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, scored.

Public companies, mid-market tissue processors, clinic networks, and CGT sponsors — each with an Enforcement Risk Score™ built on warning letters, four-prong flags, and sub-segment peer pressure.

Free tier: Top-10. Full universe + screener on Terminal.
Enforcement Risk Board
Regen med operators ranked by exposure
#CompanySegmentWLs4-ProngScoreRisk tier
01
Liveyon LLC
Private · Mid-market
Umbilical cord stem cells2092critical
02
MiMedx Group
MDXG · Public
Amniotic & placental wound biologics1386critical
03
Kimera Labs
Private · Mid-market
Exosome + amniotic fluid products1182critical
04
Celularity Inc.
CELU · Public
Placental-derived cell therapy + HCT/P1281critical
05
Integra LifeSciences
IART · Public
Surgical biologics, tissue matrices2078high
06
Predictive Biotech
Private · Mid-market
Umbilical cord-derived biologics1171high
07
Organicell Regenerative Medicine
BRTX · Public
Amniotic fluid + exosome biologics0067high
08
StimLabs
Private · Mid-market
Amniotic + placental HCT/P0164high
09
Russell Health
Private · Mid-market
Amniotic + tissue processing0158elevated
10
Organogenesis Holdings
ORGO · Public
Advanced wound care + surgical biologics0052elevated
11
Artivion (fmr CryoLife)
AORT · Public
Cardiac tissue + vascular biologics0041moderate
12
Smith+Nephew Bioactives
SNN · Public
Regenerative wound + orthopedic biologics0038moderate
Showing 12 of 12. Full universe on Terminal tier.Methodology · Enforcement Risk Score™

Live enforcement feed

Seven agencies. One timeline.

FDA warning letters, FTC complaints, CBER safety notifications, OPDP untitled letters, SEC enforcement, state-AG consent orders, and DOJ injunctions — 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)
Free · Unlimited on waitlist
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. Five ways to pay for it.

Free tier is deliberately useful. Upgrade when your workflow needs volume, seats, or API access.

Free
$0forever

Everyone starts here. Read the market; try the scanner.

Clinic owners · doctors · investors · anyone kicking tires

  • Live enforcement ticker (7-day window)
  • Top-10 Company Risk Board
  • 3 Four-Prong Scans per month
  • Weekly enforcement digest email
Start free →
Solo
$49/month

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

Solo doctors · clinic owners

  • Full enforcement feed + filters
  • Unlimited Four-Prong Scans
  • 20 Claim Clearance checks / mo
  • Save 10 companies to watchlist
  • Email + weekly PDF report
Go Solo →
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

  • 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
Start Practice trial →
Terminal
$999/month

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

Investors · analysts · multi-site networks

  • 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
Book Terminal demo →
Enterprise
Contact

Funds, large clinic networks, pharma marketing teams.

Funds · tissue processors · pharma MLR teams

  • 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.

Founding members

First 500 seats get Terminal free for 90 days.

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

Founding-member seats include 90 days of Terminal access and direct onboarding with the team.