WAYNE, Pa., Oct. 20, 2020 /PRNewswire/ -- Envara Health, a venture backed company focused on advanced nutrition, has launched a new, clinically proven medical food Encala® , formulated to address fat malabsorption in patients with cystic fibrosis (CF) and other exocrine pancreatic diseases. The product is unique in its ability to provide both easily absorbable fat calories and improve the absorption of fat and nutrients in accompanying meals and beverages.
An estimated 86% of patients with CF must take pancreatic enzyme replacement therapy (PERT) to facilitate fat absorption. While PERT helps, it does not fully correct the problem. Insufficient caloric absorption causes developmental issues in children, chronic malnutrition in adults, and accelerates progression of the lung disease by which cystic fibrosis is characterized. The structured lipid within Encala does not require PERT or digestion to be absorbed.
Encala's unique mechanism of action leads to improved absorption of the healthy calories in Encala as well as other fat and fat-soluble vitamins in the accompanying meal. [View the product video.] The therapy was proven to be efficacious, safe, and well-tolerated in patients with CF and exocrine pancreatic insufficiency in a National Institutes of Health sponsored study. The 12-month study included 110 subjects and was placebo controlled and double-blinded in 10 accredited CF centers. Subjects randomized to Encala with more severe fat absorption and higher clinical need experienced a statistically significant BMI z-score over 3 months compared to those randomized to an active placebo that had the same caloric composition. The improved BMI was the result of an increase in both weight and height velocity, indicating catch-up growth. The therapy also improved absorption and values of other important nutrients, including essential fatty acids, fat-soluble vitamins, and choline.
"The field of medical nutrition needs innovative solutions to help improve quality of life for patients with malabsorption," said Virginia A. Stallings, MD, founder and medical advisor to Envara Heath. "Encala is the only therapy that has been clinically proven to add healthy calories and provide additional fat absorption beyond the use of PERT. This will help both children and young adults reach their growth and nutritional goals."
Encala is a taste-neutral, gluten-free, non-GMO, plant-based powder. It is a source of highly absorbable long-chain fats, including essential fatty acids, and an alternative to medium-chain triglycerides typically derived from palm, coconut or vegetable oil found in most nutritional supplements.
The therapy is recommended for use under medical supervision in adults and children over one year of age who have transitioned to toddler or family table food. Encala is available in 15-serving pouches or on-the-go single-serving sticks.
"Envara Health is committed to putting our unique structured lipid platform to work to improve how patients manage their malabsorption issues," said Jim O'Connell, CEO & co-founder, Envara Health. "There is tremendous potential for this new technology to revolutionize clinical nutrition across a broad range of diseases."
Patients and caregivers can visit www.Encala.com to learn more about Encala and to order online. Nutrition professionals can also contact Envara Health to have free samples shipped directly to their patients. The product is available for order beginning October 29, 2020.
Encala may be eligible for reimbursement under certain insurance plans. Find reimbursement resources, including support and forms, at www.Encala.com.
About Envara Health:
Envara Health is bringing breakthrough science, clinical evidence and meaningful health improvements to the field of nutrition. The company is led by a team of life science and clinical nutrition veterans committed to addressing the widespread problem of malabsorption, and the resulting weight, growth and nutritional deficiencies it causes. Our first product, Encala®, is a medical food that provides a source of needed, healthy calories, including the essential fatty acids, in an easily absorbable structure. Encala has been tested in multiple clinical studies, and has also been shown to improve the absorption of other fat and nutrients from corresponding meals. Envara Health's validated structured lipid platform is enabling the development of a suite of precision nutrient products that will address a broad spectrum of disease states, in both humans and animals. To learn more about Envara Health, visit https://envarahealth.com. For more information about Encala, visit www.Encala.com.
SOURCE Envara Health