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Vytala achieves a milestone with successful launch of Seracal and initiates IRB-approved study to expand its use across broader patient population

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Vytala

Mar 18, 2025, 11:58 ET

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Seracal™, based on Lym-X-Sorb®, contains a proprietary lipid technology invented by David Yesair Ph.D. and exclusively licensed by Vytala      

DOWNINGTON, Pa., March 18, 2025 /PRNewswire/ -- Vytala, a healthcare-focused food technology company, today announced a series of key achievements signifying commercial momentum and early market leadership. Following the launch of Seracal in November, monthly sales growth has exceeded 50%, driven by strong clinician interest, patient need, and broad coverage by US healthcare insurers.

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Seracal Logo (PRNewsfoto/Vytala)
Seracal Logo (PRNewsfoto/Vytala)

Dr. Debora Duro, Program Director, Pediatric Gastroenterology, Hepatology and Nutrition at Broward Health, has prescribed Seracal to multiple patients and shares: "Seracal is amazing. I have patients with diagnoses ranging from intestinal failure to faltering weight, and most have experienced weight gain within the first month. Parents are overjoyed, the product is easy to use, and children are gaining weight after months of struggle."

Market demand for Seracal has surpassed initial forecasts with a 90% reorder rate – further confirming strong patient acceptance and sustained clinical adoption. Seracal was recently approved by 3 HealthWell Foundation disease funds within Vitamins and Supplements*. This partnership expands access and provides support for patients starting on their Seracal journey.

Seracal is an improved formulation that contains the underlying technology of Lym-X-Sorb, a pioneering nutritional therapy invented by Dr. David Yesair of BioMolecular Products, Inc. that addresses fat malabsorption.  Seracal/Lym-X-Sorb was proven to be efficacious and well-tolerated in patients with exocrine pancreatic insufficiency and cystic fibrosis in a large $7 million National Institutes of Health sponsored clinical study.  Subjects randomized to Seracal/Lym-X-Sorb experienced improved BMI, as demonstrated by increases in both weight and height velocity.  The therapy also improved absorption of essential fatty acids, fat-soluble vitamins and choline.

Vytala signed an exclusive worldwide licensing agreement with BioMolecular Products (BMP), gaining rights to Lym-X-Sorb's proprietary formulation and extensive manufacturing trade secrets. Over $30 million dollars has funded development of the Lym-X-Sorb technology to date.  Vytala has made further formulation enhancements, incorporating key taste, texture and stability improvements into Seracal.

A patient with pancreatic cancer describes his experience with Seracal: "I have gained between 8-10 pounds since starting Seracal 6 weeks ago.  I believe it has also helped with my chronic pancreatitis, lessening the symptoms of belly pain and back pain.  This has allowed me to widen my diet to include foods that I couldn't eat previously."

Vytala is actively enrolling subjects into an IRB approved study designed to assess Seracal's acceptance and clinical outcomes across a broader patient populations. Led by Dr. Carol Ireton-Jones PhD, RDN, CNSC, FASPEN, FAND, an esteemed expert in gastrointestinal nutrition with numerous publications - the multi-center study will measure GI symptoms, weight gain and nutrient absorption in at least 30 patients aged one and older. 

Swapna, a healthcare advocate, researcher and adult living with Short Bowel Syndrome, conveyed her excitement about being one of the first patients to enroll in the study: "Living a fulfilling life with tube feeding due to congenital Short Bowel Syndrome, I have always had to be at the mercy of innovation. Participating in Vytala's early experience program, I can finally be at the forefront of science. I hope Seracal will be the easy and accessible answer to my reduced ability to absorb fat and fat-soluble nutrients, a barrier I have had for 35 years. Maybe I can even live to eat and enjoy nourishing myself with food without all the complications!  A goal I have only dreamed of."

Dr. Ireton-Jones commented, "Anecdotal data provides insight into patient experiences, but in the scientific community, research is essential to generate evidence.  That is why we're conducting this study. We are confident that Seracal's unique technology will improve fat absorption in patients with a variety of GI conditions, which is why this study is so important."  

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

*Approved for Alagille Syndrome, Cystic Fibrosis, and Inborn Errors and Genetic Bile Acid Deficiency

About Vytala

Vytala is advancing nutrition with a mission to help people achieve their best health through the power of nutrition. Our founding team is committed to addressing the widespread problem of malabsorption and brings over 100 years of experience in clinical nutrition, food science, healthcare and in reimbursement. Vytala's unique crystalized lipid technology has been proven in multiple clinical studies, and CMS has issued a new reimbursement code for the product. Vytala is developing a suite of precision nutrient products to address a broad spectrum of diseases in humans and animals. The company will not rest until it has eliminated nutrient deficiencies.

SOURCE Vytala

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

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

Vytala, a healthcare-focused food technology company, today announced important milestones for Seracal™, its novel medical food designed to address...

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