Longeveron Inc. announced that extended long-term follow-up data from the Company?s ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) is being presented as a poster at the annual Scientific Sessions of the American Heart Association (AHA), being held in Philadelphia, PA on November 11-13, 2023. The poster, titled Long-term Transplant-free Survival Is Improved in Hypoplastic Left Heart Syndrome with Cell-based Therapy (Sunjay Kaushal, et al), showed that 100% of the 10 patients who participated in the ELPIS I trial survived and remained heart transplant-free for up to 5 years of age after receiving Lomecel-BTM during their Stage II surgery. The extended follow-up data on all patients enrolled in the study now includes monitoring for up to 5 years following treatment with Lomecel-BTM.

The average age at the time of the last follow-up visit was 4.5 years, with 2 patients being 5 years of age. Additional long-term follow-up is ongoing in the ELPIS I participants. Historical results from outside studies have shown that children with HLHS have approximately 20% mortality by 5 years.

Lomecel-BTM has received Rare Pediatric Disease Designation, Fast Track Designation, and Orphan Drug Designation by the US Food and Drug Administration (FDA) for the HLHS indication. The ELPIS I trial (NCT03525418) was an open-label, Phase 1b study designed to evaluate the safety of Lomecel-BTM in patients with HLHS. Patients underwent the Glenn Procedure (an open-heart surgery) at approximately 4-5 months of age.

The results from the ELPIS I trial, which were previously reported, showed that the study met its primary safety endpoint and that all patients were alive, transplant-free, and maintained their expected rate of growth one year after treatment.