Medera Appoints Three Cardiopulmonary Experts to SAB as HFpEF Gene Therapy Program Nears Next Milestone

As Medera Inc. moves its AAV-based HFpEF gene therapy program closer to a defined clinical inflection point, the composition of its Scientific Advisory Board now signals where the program's evidentiary burden will fall: cardiac hemodynamics, exercise physiology, and objective functional endpoints. The Boston-based clinical-stage company announced on 8 June 2026 the appointment of three specialists — Gregory Lewis, MD (Massachusetts General Hospital / Harvard Medical School), Marat Fudim, MD, MHS (Duke University School of Medicine), and Rajeev Malhotra, MD, MS (MGH / Harvard Medical School) — to its SAB.

The appointments are directly indexed to the clinical development strategy for SRD-002, Medera's lead candidate, which targets cardiac calcium handling via intracoronary AAV delivery. That delivery architecture — designed to maximise localised cardiac transduction while limiting systemic vector exposure — places specific demands on the physiological endpoints used to demonstrate efficacy and safety. Lewis brings foundational work on right ventricular-pulmonary vascular interactions and peripheral oxygen utilisation in heart failure; Fudim contributes expertise in invasive hemodynamic assessment and catheter-based therapeutic strategies; Malhotra integrates translational vascular biology and metabolism research with human clinical study design.

For clinical development and regulatory affairs teams tracking the HFpEF space, the SAB expansion reflects a broader methodological challenge: HFpEF lacks the clear ejection-fraction-based endpoints that anchor HFrEF trials, making the selection of physiological surrogates a material regulatory consideration. Medera's CEO Ronald Li, PhD, noted that the program has generated "consistent and clinically meaningful signals across cardiac hemodynamics and functional measures" and indicated that additional clinical updates are expected in the near term.

The company has not disclosed a specific timeline for its next development stage, but the framing around "key upcoming milestones" and the targeted SAB build-out suggests a data readout or IND-enabling activity is within the current planning horizon. Gene therapy programs of this class carry substantial CMC and manufacturing scrutiny under 21 CFR Part 211 and evolving FDA guidance on AAV vector characterisation, meaning that clinical momentum will need to be matched by commensurate process validation and sterility assurance documentation as the program scales.

The measurable outcome to track is the next clinical data disclosure, which Medera has indicated is forthcoming and which will test whether the hemodynamic and functional improvements observed to date hold across a broader patient cohort.

Source: Medera Inc. via GlobeNewswire, 8 June 2026.