BioIntel Scan @biointelscan
I founded BioIntelScan. I saw a biologics firm die from one FDA warning letter in 90 days. Now I help clinic owners catch compliance risks before they bite. BioIntelScan.com Global Joined May 2026-
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361 exempt - or does it need an IND? The test: 21 CFR 1271.10(a) - minimal manipulation + homologous use. Our Four-Prong Scanner screens products against the rule. Not legal advice. -> biointelscan.com
The Ninth Circuit reversed for the FDA in the California Stem Cell Treatment Center case (2023). The four-prong precedent just got teeth. Track rulings live. → biointelscan.com
Seven agencies. One timeline. FDA warning letters. FTC complaints. CBER notices. OPDP letters. SEC actions. State-AG orders. DOJ injunctions — all filtered to regen med and the four-prong case law that shapes it. The Bloomberg Terminal for regen med → biointelscan.com
Counsel gives advice. BioIntelScan creates the record. Track every FDA, FTC & DOJ action against regenerative-medicine operators, scored against 21 CFR 1271 in real time. Run the Four-Prong Scanner before you commit. biointelscan.com Not legal advice. #regmed #FDA
R3 Stem Cell settled with the FTC ($5M) over unsupported stem-cell claims. Marketing is not evidence. Our Claim Clearance flags unsubstantiated language before it becomes a liability. Not legal advice. -> biointelscan.com
Friday gut-check for regen-med marketers: Every claim you shipped this week — would it survive a four-prong scan? Batch-review them in Claim Clearance™ and get a counsel-ready memo before Monday → biointelscan.com/claim-clearance
Investors: regulatory risk is deal risk. Liveyon recalled product after patient hospitalizations. Deal-Flow Signals surface enforcement exposure before you wire. → biointelscan.com/pricing
Regen-med deal flow, filtered for risk: Organogenesis M&A talks. Celularity restructuring. StimLabs strategic review. New INDs opening CBER review windows. Deal-flow signals + enforcement risk in one terminal → biointelscan.com
Stop guessing which claims go "too far." Claim Clearance scores each one against the four-prong test and flags the warning-letter language before you publish. → biointelscan.com/claim-clearance
Guidance changes your risk score the moment it drops. CBER's draft on sepsis risk + donor screening for HCT/Ps is open for comment now. New rules re-run every 361 registration against tighter criteria. Track drafts → finals in one place → biointelscan.com
Kimera Labs (amniotic/exosome) drew an FDA warning letter. The Enforcement Risk Score shows who fits the pattern next — and why. → biointelscan.com
Agencies: you write the copy, you can own the FTC liability. R3 Stem Cell ended in a $5M FTC judgment. Clear every client claim before it ships. → biointelscan.com/claim-clearance
60 seconds. One claim. Four prongs. Minimal manipulation. Homologous use. No combination. No systemic effect. Paste your product or indication into the free Four-Prong Scanner and see exactly which prong puts you at risk → biointelscan.com
"Am I one warning letter away from shutting down?" The question every regen-med clinic owner asks at 2am. BioIntelScan answers it: score every product you offer on the four-prong test, get alerts when peers in your segment catch action. biointelscan.com
Free Four-Prong Scanner: drop in your product and get an instant read on minimal manipulation, homologous use, combination, and systemic effect. → biointelscan.com
The Bloomberg Terminal for regenerative medicine. BioIntelScan tracks every FDA, FTC & DOJ enforcement action, scored against 21 CFR 1271, in real time. Know who's regulated before your capital does. biointelscan.com Not legal advice. #regmed #FDA
The FDA has issued warning letters to exosome marketers (New Life, Chara, Lux). No exosome product is FDA-approved to treat disease. Know the regulatory status before you buy in - we track every warning letter. Not legal advice. -> biointelscan.com
The four-prong test isn't theoretical. It's been litigated. US Stem Cell Clinic: federal injunction barring SVF for unapproved uses. California Stem Cell: Ninth Circuit reversed for the FDA in 2023. The case law that shapes your risk → biointelscan.com
The 2024-25 exosome sweep: New Life Medical, Chara Biologics and Lux Therapeutics all hit with FDA warning letters. Is exosome therapy on your menu? → biointelscan.com
Agencies: you're liable for the claims you put in market. Claim Clearance™ lets you paste 50 headlines, CTAs, and disclaimers and get 50 verdicts — each scored against CFR + case law, with a counsel-ready memo per campaign. Clear it before it ships → biointelscan.com
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