About · Ethics & Safety
Ethics, Safety & Regulatory Disclosures
Furnetics operates at the frontier of gene therapy and whole-body genetic transformation. Work at that frontier carries real risk to patients, to communities, and to the broader integrity of medical practice — and it demands oversight that is genuinely independent, technically competent, and answerable. This page documents the bodies, systems, and disclosures that govern every procedure we perform.
Nothing on this page is aspirational. Every structure described here is in place today, and its outputs — charters, annual safety reports, redacted board minutes, and audit summaries — are available to institutional partners, regulators, and prospective clients on request.
Oversight
Three bodies review our work
Furnetics separates scientific advice, clinical protocol approval, and independent ethical review into three distinct bodies with distinct mandates. No single body — and no executive — can approve a procedure class on its own.
Independent Ethics Board (IEB)
The IEB is the corporation's senior review body and the one with binding authority. It is composed of seven members: four external ethicists and clinicians, one external patient advocate, one external regulatory-affairs specialist, and one non-voting internal medical liaison (the Chief Medical Officer). External members serve staggered three-year terms and are compensated at a flat honorarium unrelated to procedure volume or revenue. Every member files an annual conflict-of-interest disclosure that is published in the annual safety report.
The IEB meets in person quarterly and by secure video monthly. Emergency reviews carry a 72-hour service level. The IEB has binding veto power over any procedure class and can, by two-thirds vote, suspend an active protocol pending investigation. It reports to the Board of Directors, not to the Chief Executive. Redacted minutes are made available quarterly.
Clinical Review Board (CRB)
The CRB is an internal body chaired by the Chief Medical Officer and staffed by the clinicians, geneticists, and counselors responsible for delivering patient-facing services. The CRB reviews and approves individual patient protocols against the procedure classes the IEB has authorized. Its scope is operational: given an approved procedure class, is this the right intervention for this patient, and are all safety and psychological prerequisites met? A CRB decision is required before any Furnetics service can be scheduled.
Scientific Advisory Board (SAB)
The SAB is our external panel of researchers from the Karolinska Institute, the Kyoto Institute of Life Sciences, the University of Cape Town, and Universidad de Buenos Aires. Its remit is advisory: sequencing techniques, vector safety, publication review, and the ethical framework the IEB draws on when writing charter language. The SAB does not approve or veto procedures. See Scientific Advisory Board for members and affiliations.
Quality system
Modeled on ISO 13485, adapted for gene therapy
Our quality management system is modeled on ISO 13485:2016 — the international standard for medical device quality management — and adapted for the advanced-therapy medicinal product (ATMP) context in which Furnetics operates. We are not currently certified to ISO 13485; we operate to its structure and audit against its clauses.
| Discipline | How Furnetics applies it |
|---|---|
| Document control | Every procedure, protocol, and standard operating procedure is version-controlled in the Furnetics QMS platform. Changes require dual-body approval (CRB and, for procedure-class changes, IEB) and are audited quarterly. |
| Design controls | Every service line has a written design history file covering inputs, outputs, verification, validation, and post-market data. Design changes reset the file and re-trigger review. |
| Risk management | Modeled on ISO 14971. Each procedure class carries a documented risk register reviewed at each IEB meeting and updated on any adverse event. |
| CAPA | Corrective and Preventive Action program with a five-business-day acknowledgement SLA and mandatory root-cause analysis for any Grade 3 event or above. |
| Post-market surveillance | Mandatory five-year structured follow-up for every patient. Aggregated safety data feeds the annual safety report and the risk registers above. |
| Internal audit | Quarterly internal audits by an independent quality function reporting to the Board Audit Committee, not to operations leadership. |
| External audit | Annual audit by an independent third-party quality auditor. Summary findings are included in the annual safety report. |
Manufacturing
GMP-aligned manufacturing at Ulaanbaatar
Vector preparation, sequencing, and cell-line work are performed in Furnetics' Ulaanbaatar facility to Good Manufacturing Practice standards aligned with EU GMP Annex 1 (sterile products) and Annex 2A (ATMPs).
- Cleanroom classification. Viral vector preparation is performed in an ISO 5 (EU GMP Grade A) unidirectional-flow environment, surrounded by ISO 7 (Grade B) background. Contamination monitoring is continuous.
- Chain of custody. Every patient's biological material carries a unique identifier from consultation biopsy through sequencing, vector preparation, administration, and five-year follow-up. Chain-of-custody records are retained for the lifetime of the patient and made available on subpoena.
- Batch records. Full batch records — raw materials, environmental conditions, personnel, quality-control results — are retained for a minimum of thirty years for every therapeutic product administered.
- Cold chain. Cross-border delivery of therapeutic products to our Brussels and Nairobi client-services offices uses validated cold-chain packaging with continuous temperature and location logging. Any excursion invalidates the shipment.
- Personnel qualification. Every clinician and technician participating in a Furnetics procedure holds current qualification for that procedure class, refreshed annually, with practical re-certification every three years.
Jurisdictional availability
Where each service is offered
Furnetics services are offered only in jurisdictions where the applicable regulatory framework permits them. The matrix below reflects the current position as of the last review; it is updated at each IEB quarterly meeting. Where a service is not offered in a client's home jurisdiction, Furnetics does not accept referrals for that service in that jurisdiction (including via medical-tourism arrangements) and clients are directed to their local regulatory authority. Prospective clients who elect to travel to our Ulaanbaatar campus do so as private individuals, under their own passport and legal responsibility. Furnetics does not sponsor, arrange, or subsidize such travel.
| Jurisdiction | Maintain™ | Phenotype™ | Genotype™ | Select™ |
|---|---|---|---|---|
| Mongolia (headquarters) | Offered | Offered | Offered | Offered |
| European Union — via Brussels office | Offered | Consultation only | Not offered | Consultation only |
| Kenya — via Nairobi office | Offered | Offered | Case-by-case | Offered |
| United Kingdom | Consultation only | Not offered | Not offered | Not offered |
| United States of America | Ulaanbaatar campus only | Not offered | Not offered | Not offered |
| Elsewhere | By arrangement — contact learnmore@furnetics.com for a jurisdictional review | |||
Consultation only means Furnetics will meet with prospective clients and discuss options, but will not administer the procedure in that jurisdiction. Case-by-case means each individual protocol requires additional IEB review. Not offered means Furnetics declines to accept the client in that jurisdiction.
Safety record
Adverse-event disclosures
The figures below cover every Furnetics therapeutic procedure administered between the launch of the Phenotype Renovations line in October 2002 and the most recent quarterly close (31 March 2026). They are drawn directly from the safety register and match the corresponding line in the 2025 Annual Safety Report.
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14,238
Procedures administered
Across all four service lines, since October 2002.
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238
Reported adverse events
187 mild (Grade 1), 42 moderate (Grade 2), 9 severe (Grade 3 or higher). Rate: 1.67%.
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4
Procedure-associated deaths
Each investigated, disclosed to next of kin, and published (redacted) in the annual safety report for the relevant year.
Adverse-event reporting is not optional. Every patient signs an ongoing consent to five-year structured follow-up, and Furnetics clinicians are contractually required to log any event that meets the CTCAE (Common Terminology Criteria for Adverse Events) reporting threshold. Patients, families, and treating clinicians may also report events directly by writing to learnmore@furnetics.com; every report is acknowledged within five business days.
Documentation
Available on request
The following documents are available to institutional partners, regulators, prospective clients, and qualified researchers on request. Request access by writing to learnmore@furnetics.com and specifying your affiliation and the intended use.
- Annual Safety Report — 2025
- Annual Safety Report — 2024
- Annual Safety Report — 2023
- Independent Ethics Board Charter
- Clinical Review Board Standard Operating Procedures
- Quality Manual (ISO 13485–modeled)
- External Quality Audit — 2025 Summary Findings
- Redacted Independent Ethics Board Minutes — Q1 2026