At Performance Medical Technologies (PMT), we are thoughtfully advancing the research and development of a promising therapeutic approach, guided by a transparent and compliant regulatory process, with the goal of supporting physicians treating patients with 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 industry partners are focused on validating safety, exploring mechanisms of action, and determining optimal therapeutic dosing. These studies are supported by a network of research institutions and contract development organizations with expertise in preclinical and pharmaceutical development.
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 planned both in U.S. and Italy, leveraging FVG and Virginia’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.
