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.
Preparation and submission of a Phase 1-2 Clinical Trial Application (CTA) to the European Medicines Agency and relevant national competent authorities, to support initiation of clinical trials in the European Union, in full compliance with EU Good Clinical Practice (GCP) requirements, current Good Manufacturing Practice (cGMP) standards, and applicable data integrity and regulatory guidelines.
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).
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.
