At Performance Medical Technologies (PMT), we are rigorously advancing the research and validation of a therapeutic solution through a transparent and compliant regulatory process aimed at delivering…, early-stage Parkinson’s Disease and related neurodegenerative conditions.
PMT is pursuing a dual-entity regulatory strategy, securing approvals in both the United States and European Union, aligned with FDA and EMA standards. Our approach includes:
Ongoing collaborations with academic and biotech partners to validate safety, mechanism of action, and therapeutic dosing. Studies conducted in partnership with institutions such as the University of Trieste, Virginia Tech University, and the University of Virginia, and supported by contract research organizations including Serichim and Curia Global
Application for IND status to initiate clinical trials in the U.S. Compliance with FDA Good Clinical Practice (GCP), cGMP manufacturing, and data integrity standards
Phase 1 and 2 trials to assess safety, dosing, and efficacy. Pilot and phased trials coordinated in Italy, leveraging FVG’s clinical research infrastructure and patient recruitment ecosystem
Engagement with the European Medicines Agency (EMA) for early scientific advice and pathway selection (e.g., centralized procedure). GMP certification and compliance with EU pharmacovigilance and data protection standards (GDPR)
Regulatory approval is more than a milestone—it’s a commitment to scientific accountability, patient safety, and long-term therapeutic impact. PMT’s data platform supports:
This ensures that every aspect of development—preclinical, clinical, and post-market—is aligned with global regulatory expectations and prepared for review.
PMT is currently advancing through:
We are also in active dialogue with global regulatory and funding bodies, to support trial initiation and data dissemination.
By adhering to the highest regulatory standards, PMT is helping to move an effective therapy from anecdotal use into an approved, evidence-based treatment for millions of patients worldwide. Together with our clinical partners, we’re turning scientific insight into regulated impact.
