TRM Health (Translational Regen Medicine, LLC) operates as a U.S.-licensed telemedicine and care coordination platform. These disclaimers describe the investigational nature of services, the regulatory frameworks under which they are delivered, and your rights as a patient or research subject.
WJ Exosome, TOL Protocol, Home IV, and TRM Topicals are investigational. They are not approved by the U.S. Food and Drug Administration (FDA) to diagnose, treat, cure, or prevent any specific disease or condition. No clinical outcome is promised, implied, or guaranteed. Participation in investigational care carries risks that your physician will review with you in writing before any treatment begins.
Biologic products distributed through TRM Health are characterized under the U.S. Public Health Service Act, Section 351(a), and FDA HCT/P regulations at 21 CFR Part 1271 where applicable. Lots are released by a U.S.-based cGMP manufacturer with a 16-year operating record. Each shipment includes a lot Certificate of Analysis and a chain of custody record. Any product not accompanied by a verified CoA is not eligible for physician approval on this platform.
For Texas-based encounters that involve investigational therapies, TRM Health uses an informed consent instrument designed to satisfy 22 TAC 171.2(b). The consent records the investigational nature of the therapy, the alternatives available, the foreseeable risks and benefits, the patient's right to refuse, and the requirement of physician supervision. Consents are version pinned, IP stamped, and retained for a minimum of 7 years.
Research and investigational protocols delivered through TRM Health are subject to oversight by an Institutional Review Board (IRB). Adverse events are documented in the patient chart and forwarded to the IRB and, where required, to FDA MedWatch. Patients and clinicians can report adverse events through their dashboard at any time.
TRM Health handles Protected Health Information consistent with HIPAA Privacy and Security Rules. PHI is encrypted in transit and AES-256 encrypted at rest. Access is role scoped (Patient, Physician or NP, Sales Rep, Nurse, Admin, IRB Coordinator) with least-privilege defaults. A complete PHI access ledger is maintained and exportable on demand. Documents (consents, invoices, lab results, visit notes, IRB forms, tax summaries, shipping artifacts) are retained for 7 years.
TRM Health does not pay for referrals. Sales representatives are compensated on documented services and not on physician referral patterns. Discounts are reviewed and audited with an immutable hash chain. There are no physician self-referral pathways for designated health services on this platform.
The TOL Protocol involves the consented research and investigational use of oleander-derived material under physician supervision. Oleander material is biologically active and may cause cardiac glycoside toxicity if dosed or administered improperly, or in patients on contraindicated medications such as digoxin. The TOL informed consent details these risks. Do not begin or alter treatment without an evaluation by a physician credentialed on the TRM Health platform.
TRM Health does not bill insurance. Patients pay directly using credit card, Stripe, attorney lien arrangements, or third-party financing (CareCredit, Klarna, Capital One). Itemized receipts are issued and, where eligible, a Letter of Medical Necessity is generated to support HSA, HRA, or FSA reimbursement. Coverage decisions are made by your plan administrator. Tax summaries are provided annually.
TRM Health is not a substitute for emergency care. If you are experiencing chest pain, shortness of breath, signs of stroke, severe bleeding, suicidal thoughts, or any other medical emergency, call 911 or go to the nearest emergency department.
Translational Regen Medicine, LLC. For privacy or compliance inquiries, contact compliance through the Help center inside your dashboard. For PHI access requests, you (or a personal representative authorized under HIPAA) may request a complete copy of your record.