Regulatory Momentum ALIGN-AR IDE completion positions the Trilogy system for PMA submission, creating US market potential and a need for proactive training, clinical education, and evidence generation to accelerate adoption at leading centers.

Competitive Edge The Trilogy system is the first and only device approved in the EU for symptomatic aortic regurgitation, with US AR opportunity contingent on PMA. Use this differentiator to target high volume hospitals and cardiovascular surgeons with clear value propositions and clinical data.

Global Footprint A US HQ with offices in the UK and Germany and EU CE Mark enables regional go to market plans, regulatory alignment, and partner networks across Europe and North America.

Leadership Capacity New leadership across technology, finance, quality, regulatory, and clinical affairs signals readiness to scale manufacturing, compliance, and clinical programs, supporting partner engagements, payer discussions, and faster deal execution.

Clinical Adoption Opportunity With the Trilogy system's regulatory approvals, there is strong demand for clinician education, training programs, case support, and participation in registries to drive early adoption and evidence generation in AR treatment.