Vytala™ Announces New Clinical Data and IRB Approval for Seracal™

Two abstracts to be presented at leading medical conferences highlight broadening clinical use of Seracal™ and a new IRB approval

DOWNINGTON, PA, UNITED STATES, October 9, 2025 /EINPresswire.com/ -- Vytala, a healthcare-focused food technology company, today announced important milestones for Seracal™, its novel medical food designed to address fat malabsorption. Throughout the year Seracal continues to see rapid adoption, with monthly sales growth exceeding 30%, supported by strong clinician demand, patient need, and broad U.S. insurance coverage.

This fall, Seracal will be featured at two major medical conferences:
• FNCE 2025 (Nashville, October 12): Carol Ireton-Jones, PhD, RD, an expert adult dietitian with expertise in complex GI disorders, and colleagues will present ‘Can Fat Absorption Be Enhanced with a Novel Medical Food?’ The poster highlights Seracal’s clinical impact through two case studies: a pediatric patient with VACTERL and short bowel syndrome reliant upon G-tube feeding that gained weight and experienced GI symptom improvement, and a patient with pancreatic cancer and cachexia who experienced significant weight gain, reduced GI distress and fewer episodes of acute pancreatitis, with improved quality of life.
• PIONEER Symposium (St. Louis, October 12): Sivan Kinberg, MD, Pediatric Gastroenterologist and Director of the Pediatric Intestinal Rehabilitation Center at Columbia University Medical Center in New York, will present a case report on a 5-year-old patient with short bowel syndrome. After initiating Seracal, the patient achieved meaningful weight gain and a reduction in GI symptoms within six weeks.

In addition, Vytala announced a newly approved IRB study at Broward Health in South Florida, led by Dr. Debora Duro, MD, MS, the Program Director of Pediatric Gastroenterology, Hepatology and Nutrition at Salah Foundation Children’s Hospital at Broward Health Medical center in Ft Lauderdale, FL. The retrospective analysis will evaluate outcomes in approximately ~30 pediatric GI patients treated with Seracal, with results expected in 2026. “We are seeing wonderful outcomes across a wide range of patients,” said Dr. Duro. “This analysis will help define Seracal’s role in clinical practice beyond exocrine pancreatic insufficiency.”

Seracal builds on the breakthrough science of Lym-X-Sorb^®, a pioneering fat absorption technology developed by Dr. David Yesair of BioMolecular Products, Inc. Backed by over $30 million in development funding, including a $7 million NIH clinical trial, Lym-X-Sorb generated statistically significant improvements in BMI, fat-soluble vitamin absorption, and overall tolerance in subjects with cystic fibrosis and exocrine pancreatic insufficiency. Vytala licensed exclusive worldwide rights to the proprietary formulation and manufacturing trade secrets of Lym-X-Sorb, and has further optimized it for improved taste, palatability, and stability.

“For a child with short bowel syndrome who was severely malnourished and facing a return to parenteral nutrition, Seracal provided a critical breakthrough,” said Dr. Kinberg. “It supported weight gain when other options had failed and helped this patient avoid parenteral nutrition. This case highlights the broader potential of Seracal to improve outcomes and quality of life for children with short bowel syndrome.”

Vytala is also conducting a multi-center prospective study, led by Dr. Ireton-Jones, to assess Seracal’s outcomes across broader patient populations. The trial is tracking GI symptoms, weight gain and growth in patients age one and older.

“While individual patient experiences are encouraging, further studies are essential to advance clinical care,” said Dr. Ireton-Jones. “We believe Seracal’s unique mechanism will benefit patients with a wide range of GI conditions, and early data is demonstrating positive outcomes as well as some great insights.”

Seracal is available nationwide and covered by most major healthcare insurers.

Tracy Ruvolo
Vytala
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