Vytala Unveils Groundbreaking Clinical Advancements for Seracal Medical Food

Vytala, a pioneering company focusing on healthcare and food technology, has made significant announcements concerning Seracal™, its innovative medical food aimed at addressing fat malabsorption conditions. In recent updates, Vytala highlighted substantial sales growth, with monthly increases exceeding 30%, driven by high clinician demand and widespread insurance coverage across the United States.

This upcoming fall, Seracal will be presented at two key medical conferences. On October 12, during FNCE 2025 in Nashville, renowned dietitian Carol Ireton-Jones, PhD, RD, will showcase the clinical effectiveness of Seracal in a presentation titled "Can Fat Absorption Be Enhanced with a Novel Medical Food?" This presentation will underline the profound impact of Seracal through two compelling case studies. One case involves a pediatric patient afflicted by VACTERL association and short bowel syndrome who, after relying on G-tube feeding, experienced weight gain and alleviation of gastrointestinal (GI) symptoms with Seracal. Another case centers on a patient battling pancreatic cancer and cachexia who observed dramatic weight gain, reduced GI distress, and an overall enhancement in their quality of life.

In parallel, the PIONEER Symposium in St. Louis, also on October 12, will feature Dr. Sivan Kinberg, a Pediatric Gastroenterologist from Columbia University Medical Center. His case report will focus on a 5-year-old with short bowel syndrome who demonstrated notable weight gain and a decrease in GI symptoms within just six weeks of initiating treatment with Seracal.

Additionally, Vytala has initiated a newly approved Institutional Review Board (IRB) study at Broward Health in South Florida, led by Dr. Debora Duro, MD, MS. This retrospective analysis aims to evaluate outcomes among approximately 30 pediatric GI patients treated with Seracal, with results anticipated in 2026. Dr. Duro remarked, "We are witnessing incredible outcomes across a diverse range of patients." She emphasized that the study will help clarify Seracal's clinical role beyond just treating exocrine pancreatic insufficiency.

Seracal is founded on the advanced technology of Lym-X-Sorb®, a unique fat absorption innovation developed by Dr. David Yesair of BioMolecular Products, Inc. With over $30 million in development funding—of which $7 million came from NIH clinical trials—Lym-X-Sorb has demonstrated statistically significant enhancements in body mass index (BMI), fat-soluble vitamin absorption, and overall tolerance in individuals with cystic fibrosis and exocrine pancreatic insufficiency. Vytala secured exclusive global rights to this proprietary formulation and further improved it for taste, palatability, and stability.

Dr. Kinberg noted a specific case where Seracal was a crucial breakthrough for a severely malnourished child facing return to parenteral nutrition. Thanks to Seracal, the child's weight gain was achieved when other interventions had failed, thereby preventing the need for parenteral nutrition. This individual case illustrates the broader potential of Seracal to enhance outcomes and life quality for children suffering from short bowel syndrome.

Moreover, Vytala is embarking on a multi-center prospective study led by Dr. Ireton-Jones to evaluate Seracal's impact across a larger demographic of patients. This comprehensive trial is set to monitor GI symptoms alongside weight gain and growth metrics in patients aged one year and older.

Dr. Ireton-Jones commented, "While patient experiences thus far are promising, additional studies are crucial for advancing clinical care." She anticipates that Seracal's distinctive mechanism could benefit patients with various GI disorders, supported by early data showing positive outcomes and insightful revelations. Seracal is currently available nationwide and is covered by most major healthcare insurance providers.

Vytala's mission centers on advancing nutritional innovations to promote optimal health through nutrition. With their founding team bringing in over a century of experience in clinical nutrition, food science, and healthcare reimbursement, they aim to effectively address malabsorption—an issue affecting countless individuals. Vytala’s unique crystallized lipid technology has been validated in multiple clinical evaluations, leading to the establishment of a new reimbursement code for their product by Medicare Services.

As they continue to develop a suite of precision nutrient offerings aimed at a broad array of diseases impacting both humans and animals, Vytala remains steadfast in its goal: the elimination of nutrient deficiencies globally.