Governance
Ex Tenebris Lucem Recuperare
Fibro-Resolve, Inc. operates under a rigorous framework of ethical leadership, clinical integrity, and regulatory excellence.
The Ethical Foundation
Our clinical and research activities are strictly guided by the principles established in the Belmont Report. We believe that medical innovation is only as valuable as the ethical framework upon which it is built.
- Respect for Persons We honor the autonomy of every individual. Our protocols prioritize informed consent and the protection of those with diminished autonomy, ensuring that participation in our science is always a choice made with full transparency.
- Beneficence Our "Primary Directive" is to do no harm while maximizing potential benefits. We apply rigorous risk-benefit analyses to every stage of the FM-TTFields development lifecycle.
- Justice We are committed to the equitable distribution of the fruits of our research. Our mission is to alleviate human suffering across all populations, ensuring that advancements in bioelectric medicine are accessible to as many as possible.
Clinical & Institutional Oversight
Led by a Board-Certified Radiation Oncologist with extensive experience in institutional review, Fibro-Resolve maintains a "Regulatory First" posture.
- IRB Compliance All research involving human subjects is submitted to and overseen by an independent Institutional Review Board (IRB) to ensure the highest standard of safety and ethics.
- Scientific Rigor Our Phase 0 design and subsequent clinical pathways are engineered to meet and exceed FDA Class II/III regulatory standards for medical devices.
- Data Integrity We maintain strict protocols for data collection, storage, and analysis, ensuring that our clinical evidence is both verifiable and reproducible.
"Governance is not merely a regulatory requirement; it is the tactical expression of our commitment to the patients we serve and the science we advance."