Vytala, a healthcare-focused food technology company, announced significant advancements for its medical food, Seracal, which is designed to address fat malabsorption. The company revealed new clinical data and received Institutional Review Board (IRB) approval for a study at Broward Health, underscoring the growing adoption and impact of Seracal in clinical settings.
Throughout 2025, Seracal has demonstrated impressive sales growth, exceeding 30% monthly. This surge is attributed to heightened clinician demand, patient needs, and extensive coverage by U.S. insurance providers. As part of its outreach, Seracal will be showcased at two prominent medical conferences this fall.
At the FNCE 2025 conference in Nashville on October 12, Carol Ireton-Jones, PhD, RD, an expert in adult dietetics focusing on complex gastrointestinal disorders, will present findings from a study titled “Can Fat Absorption Be Enhanced with a Novel Medical Food?” This presentation will include two case studies illustrating Seracal’s clinical efficacy. One case involves a pediatric patient with VACTERL association and short bowel syndrome who gained weight and showed improvement in gastrointestinal symptoms after using Seracal. Another case highlights a patient with pancreatic cancer and cachexia who experienced significant weight gain, reduced gastrointestinal distress, and fewer acute pancreatitis episodes, leading to an enhanced quality of life.
Additionally, at the PIONEER Symposium in St. Louis on the same day, Sivan Kinberg, MD, a Pediatric Gastroenterologist and Director of the Pediatric Intestinal Rehabilitation Center at Columbia University Medical Center, will present a case report on a 5-year-old patient with short bowel syndrome. Following the introduction of Seracal, this patient achieved notable weight gain and a reduction in gastrointestinal symptoms within six weeks.
Vytala also announced a newly approved IRB study at Broward Health in South Florida, led by Debora Duro, MD, MS, the Program Director of Pediatric Gastroenterology, Hepatology and Nutrition. This retrospective analysis aims to evaluate outcomes in approximately 30 pediatric gastrointestinal patients treated with Seracal, with results expected in 2026. Dr. Duro remarked, “We are seeing wonderful outcomes across a wide range of patients. This analysis will help define Seracal’s role in clinical practice beyond exocrine pancreatic insufficiency.”
Seracal is built on the innovative science of Lym-X-Sorb, a pioneering fat absorption technology developed by Dr. David Yesair of BioMolecular Products, Inc. Supported by over $30 million in development funding, which includes a $7 million grant for a clinical trial from the National Institutes of Health, Lym-X-Sorb has shown statistically significant improvements in body mass index (BMI), fat-soluble vitamin absorption, and overall tolerance in subjects with conditions such as cystic fibrosis and exocrine pancreatic insufficiency.
Vytala has exclusive worldwide rights to the proprietary formulation and manufacturing trade secrets of Lym-X-Sorb, which has been further optimized for taste, palatability, and stability. Dr. Kinberg noted the critical role Seracal played for a severely malnourished child with short bowel syndrome, stating, “Seracal provided a critical breakthrough… It supported weight gain when other options had failed and helped this patient avoid parenteral nutrition.”
The company is also conducting a multi-center prospective study led by Dr. Ireton-Jones to assess Seracal’s outcomes across broader patient populations. This trial will track gastrointestinal symptoms, weight gain, and growth in patients aged one and older. Dr. Ireton-Jones emphasized the importance of further studies, stating, “While individual patient experiences are encouraging, further studies are essential to advance clinical care.”
Seracal is currently available nationwide and is covered by most major healthcare insurers. Vytala’s mission is to enhance nutrition and address the widespread issue of malabsorption, leveraging over 100 years of collective experience in clinical nutrition, food science, healthcare, and reimbursement. The company’s unique crystallized lipid technology has been validated in multiple clinical studies, and a new reimbursement code has been issued by the Centers for Medicare & Medicaid Services (CMS) for the product. Vytala is committed to developing a suite of precision nutrient products to tackle a broad spectrum of diseases affecting both humans and animals, aiming to eliminate nutrient deficiencies.