Biostage selects IQVIA as CRO for FDA-approved esophageal implant trial

Harvard Apparatus Regenerative Technology, Inc.

IQVIA, a global CRO with GI and cell-therapy trial experience, to manage Biostage's first clinical trial.
Trial is FDA-approved open-label study for up to 10 patients requiring removal of up to 6cm esophagus (cancer, trauma, birth defects).
Primary endpoint: continuous biological conduit at 3 months; first human use met endpoint by 1 month (JTO CRR, Aug 2021).
Preliminary contract covers first stage; second comprehensive contract expected. Trial duration 4-6 years with staggered enrollment and 2-year follow-up.
CEO: current 5-year survival for esophageal cancer only 20%; >600k new cases annually worldwide.

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