WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced that an abstract presenting groundbreaking data on the prevalence and annual incidence of lymphatic malformations (LMs) in the U.S. has been accepted for a poster presentation at the Society for Investigative Dermatology (SID) Annual Meeting, scheduled for May 7-10, 2025, in San Diego, California.
The research, based on a medical claims analysis conducted over a seven-year period using Komodo Health data, estimates that between 44,553 and 92,967 U.S. patients are diagnosed with lymphatic malformations involving the skin. The analysis included contributions from a multidisciplinary team, including Dr. Ionela Iacobas, M.D., Medical Director of the Vascular Anomalies Center at Texas Children’s Hospital, and rare disease epidemiology expert David Lapidus, Founder and President of LapidusData.
“This study is the first to quantify the U.S. LM population based on a rigorous, quantitative analysis of medical claims data,” noted Dr. Iacobas. “The findings reinforce what we are seeing in clinical practice, which is growing demand for multidisciplinary care of patients with complex vascular anomalies.”
The abstract elaborates on two distinct cohorts of patients diagnosed with cutaneous lymphatic malformations. Analysis revealed an estimated 44,553 patients with high probabilities of LM involvement based on stringent diagnostic criteria. A secondary group of approximately 48,414 patients identified through broader diagnostic claims brings the total to as many as 92,967 LMs cases involving the skin. The poster will also highlight annual incidence rates of these cases.
The presentation, titled “Incidence, prevalence, and care for patients with lymphatic malformations (LMs) in the U.S.: A claims-based analysis,” will occur during the SID Annual Meeting on Thursday, May 8, 2025, from 4:30 to 6:00 p.m. PT in the Indigo Ballroom/Foyer of the Hilton San Diego Bayfront.
Microcystic LMs are a rare and debilitating genetic condition caused by dysregulation of the PI3K/mTOR pathway. This chronic disease is characterized by malformed lymphatic vessels that leak, bleed, and lead to severe complications, including recurring infections. Despite its significant impact, there are currently no FDA-approved treatments for microcystic LMs, which affect over 30,000 diagnosed individuals in the U.S.
Palvella’s contributions to this research mark a significant step toward advancing awareness and strategies for addressing this complex condition. The full abstract will be published in the August 2025 supplement of the Journal of Investigative Dermatology, with findings expected to influence future clinical and therapeutic approaches.
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