Vytala Launches Seracal™: Improving Nutrient Absorption and Providing Essential Fatty Acids to Patients with Malabsorption

Pioneering Nutrition Science Within a Plant-Based Medical Food Solution

Seracal™ accelerates healthy weight gain in patients that have digestive disorders and malabsorption as a result of increased nutrient uptake.

DOWNINGTOWN, Pa., Oct. 1, 2024 /PRNewswire/ -- Vytala, a food technology company working to advance nutrition, today announces the launch of Seracal™, the first and only non-enzymatic treatment clinically proven to improve absorption of fatty acids and fat-soluble nutrients in patients that have exocrine pancreatic insufficiency.  The medical food is plant-based, gluten-free, formulated to address fat malabsorption has been scientifically validated to promote healthy weight gain. 

Shelby Birdwell, MS, RD, LS a Cystic Fibrosis Dietitian in Dallas, TX, expressed her enthusiasm: "There is nothing currently on the market like Seracal.  Many of my patients struggle with malabsorption, and the unique lipid technology offers a needed new option for supporting fat and vitamin absorption, improving weight maintenance and reducing GI symptoms.  I am excited about the launch of Seracal and will recommend it for pancreatic insufficient patients that need additional support."

Malabsorption impacts 1 in 5 people with a digestive disease.  It causes developmental issues in children, chronic malnutrition in adults, and increases both direct and indirect costs of care.  Until now, limited options food-based solutions like MCT oil (which does not contain essential fatty acids) have been available. Seracal is unique in providing easily absorbable, unsaturated fat calories, while improving absorption of other fat and nutrients in the accompanying meal.

Carol Ireton-Jones PhD, RDN, LD, CNSC, FASPEN, FAND, the founder and CEO of Good Nutrition for Good Living, commented: "The potential of an easily added oral food product that enhances absorption without requiring additional digestive enzymes has multiple applications. Addition of calories and nutrient absorption orally can be the difference in meeting nutrient needs for patients with a malabsorption diagnosis." 

Nutrient Absorption
The culmination of decades of research and development, Seracal blends pioneering food science with plant-based healthy fats, creating a crystalized lipid that delivers essential fatty acids in a highly absorbable form. No lipase or bile acid required. The taste neutral powder was designed to be mixed into a variety of foods and snacks.  "The way these three ingredients naturally fit together into our proprietary crystal shape is elegant.   This configuration allows Seracal to create pockets, that carry fat soluble nutrients across the intestinal barrier," says Megan Fisklements, PhD, Chief Food Science Officer at Vytala. 

Supporting Research

In a large clinical study funded by the National Institutes of Health, Seracal [Lym-X-Sorb]^® was proven to be safe and effective compared with an active placebo containing the same caloric content over a 12-month period^.1 The study included 110 subjects that had exocrine pancreatic insufficiency and cystic fibrosis. Subjects randomized to Seracal with moderate to severe malabsorption experienced a BMI z-score improvement, the result of an increase in both weight and height velocity.  The therapy also improved values of additional important nutrients, including essential fatty acids, mono and poly unsaturated fatty acids, fat soluble vitamins and choline.

Carol Ireton-Jones, PhD, RD noted, "With evidence supporting the effectiveness in people with cystic fibrosis, practitioners can trial application with other malabsorption-related diagnoses, as a next step."

Where to Find Seracal
Seracal is a medical food for use under medical supervision and is covered by most commercial insurers and state Medicaid plans. Prescribers and patients can initiate a Seracal order and access reimbursement information and support through tools available on the Vytala website's Products page.  All orders require a prescriber's signature.

For those interested in learning more about Seracal please contact Vytala. Seracal is expected to begin shipments in mid-October, with pre-orders starting September 26, 2024.

Product Specs:

• 1 stand-up pouch contains 7.1 oz (202 grams), including 15 servings at 70 kcals per serving
• Serving recommendations: 2 servings per day for children (age 11 and under); 3 servings per day for adults

Relevant Links
To learn more about Seracal and the clinical publications visit www.MySeracal.com.
To find out more about Vytala visit www.VytalaHealth.com.

About Vytala
Vytala is advancing nutrition, with a mission to help people achieve their best health through the power of nutrition.  Led by a team of executives with over 80 years of combined experience in clinical nutrition, food science, life sciences, commercial leadership, and reimbursement, Vytala is dedicated to tackling the pervasive issue of malabsorption. Our breakthrough crystalized lipid technology has been proven in multiple clinical studies, and CMS issued a new reimbursement code for the medical food category.  Vytala's unique platform enables a suite of precision nutrient products, which can address a broad spectrum of diseases in humans and in mammals.

¹Stallings VA, Tindall AM, Mascarenhas MR, Maqbool A, Schall JI (2020) Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial. PLoS ONE 15(5): e0232685. https://doi.org/10.1371/journal.pone.0232685

SOURCE Vytala