About MYOS RENS Technology

MYOS RENS Technology Inc. focuses on the discovery, development, and commercialization of nutritional ingredients, functional foods, and other technologies aimed at maintaining or improving the health and performance of muscle tissue. Fortetropin is the company’s proprietary food ingredient clinically shown to improve muscle size, lean body mass, and strength as part of resistance training in humans. Fortetropin has also been shown to reduce muscle atrophy in dogs following orthopedic surgery. Fortetropin is made from fertilized chicken egg yolks using a proprietary process that retains the biological integrity and bioactivity of the product. Research and Development As a nutrition company, the company is dedicated to basic and clinical research that supports its existing and future product portfolio. The company focuses on the following areas of research: Basic Research Biochemical characterization of Fortetropin, including proteomic and lipidomic approaches; and identification and isolation of proteins, peptides, and lipids in Fortetropin responsible for pro-myogenic activity. Canine Clinical Research Effect of Fortetropin to reverse disuse atrophy in dogs after an orthopedic surgery procedure to repair the cranial cruciate ligament; effect of Fortetropin on quality of life and activity in geriatric dogs; and effect of Fortetropinon serum myostatin levels in healthy dogs. Human Clinical Research Effect of Fortetropinon skeletal muscle protein fractional synthetic rate in older men and women; and effect of Fortetropin on muscle function and recovery after orthopedic procedures. Clinical Studies and Basic Research Programs The company’s research program is actively evaluating various active proteins, lipids, and peptides in Fortetropin, primarily as a reversible and temporary modulator of the regulatory protein myostatin, and to leverage this knowledge to improve and build its intellectual property. The company invests in research and development activities externally through academic and industry collaborations aimed at enhancing its products, improving manufacturing and broadening the product portfolio. The company has developed the following collaborations with various academic centers: In August 2019, the company entered into a research agreement with the Department of Kinesiology at McMaster University in Hamilton, Canada to evaluate the impact of Fortetropin on reducing muscle disuse atrophy in young men. In order to assess the impact of Fortetropin on muscle atrophy, a series of body composition measurements would be performed during each phase of the study. In addition, muscle biopsy samples would be collected during each phase and in-depth biochemical analyses would be performed. The company anticipates that the study would be concluded in the first quarter of 2022. No work has started on this study as of March 24, 2020. In February 2019, the company entered into an agreement with the College of Veterinary Medicine at Kansas State University to study the impact of Fortetropin on quality of life and activity in geriatric dogs. The company anticipates that the study would be concluded in the first half of 2020. In March 2018, the company entered into a research agreement with Rutgers University, The State University of New Jersey, to work with Rutgers researchers in a program focused on discovering compounds and products for improving muscle health and performance. The company anticipates that the study would be concluded in the second half of 2020. Product Marketing and Distribution The sales channels through which the company sells its products are evolving. The first product the company introduced was MYO-T12, a proprietary formula containing Fortetropin and other ingredients. In February 2014, the company expanded its commercial operations into the age management market through a distribution agreement with Cenegenics Product and Lab Services, LLC (Cenegenics), under which Cenegenics distributed and promoted a proprietary formulation containing Fortetropin through its age management centers and its community of physicians focused on treating a growing population of patients focused on proactively addressing age-related health and wellness concerns. The distribution agreement with Cenegenics expired in December 2016. There were no sales to Cenegenics in 2018. The company received a new purchase order in April 2019 and recorded $202 of sales to Cenegenics in 2019. In May 2016, the company launched Physician Muscle Health Formula, a proprietary formulation containing Fortetropin and sold the product directly to physicians to distribute to their patients who are focused on wellness. The company relaunched the product as part of its longevity marketing strategy in December 2019. In March 2017, the company launched Qurr, a Fortetropin-powered product line formulated to support the vital role of muscle in overall well-being, as well as in fitness. The company’s Qurr line of muscle-focused over-the-counter products are available through a direct-to-consumer e-commerce platform at www.qurr.com. In March 2018, the company launched Yolked, a Fortetropin-powered product, which is NSF Certified for Sports, and developed and marketed to collegiate and professional athletes who want to improve their muscle size and performance with a nutrition product. In June 2018, the company launched its Fortetropin based pet product Myos Canine Muscle Formula (MCMF). In July 2019, the company launched a version of MCMF called VET Strength to focus on veterinarians and their dog patients. In November 2019, the company launched its white label business, working with manufacturers to create new brands and products using Fortetropin as the foundation. Strategy The company’s strategy is to understand the complex genetic and molecular pathways regulating muscle mass and function. The company seeks to gain market share for its core branded products in the sports and fitness nutrition, rehabilitation and restorative health, and domestic pet muscle health verticals by formulating and developing new and complementary product lines, expanding the U.S. distribution by increasing the channels of sale, expanding distribution geography beyond the U.S., and seeking strategic relationships with other distributors. Research and Development Expenses During the years ended December 31, 2019, the company incurred research and development expenses of $145. Intellectual Property In January 2019, the United States Patent and Trademark Office (USPTO) issued the company a new patent (United States Patent No. 10,165,785) titled, ‘Process for Producing Composition for Increasing Muscle Mass’. The new patent covers the manufacturing process for a fertilized, egg yolk-derived composition that helps to maintain the natural bioactivity of egg yolk without compromising its safety. It was developed by researchers at the German Institute of Food Technologies/DIL (DIL), including Dr. Volker Heinz, Director of DIL and a co-inventor on the patent. DIL has assigned the rights of this patent to the company. The processes covered by these patents are used to manufacture the company’s nutrition products. In August 2014, the USPTO, issued the U.S. Patent No. 8,815,320 B2 to the company covering its proprietary methods of manufacturing Fortetropin. The patent entitled ‘Process for Producing a Composition Containing Active Follistatin’ provides intellectual property protection for manufacturing Fortetropin, the major ingredient in the company’s core commercial muscle health products, and carries a patent term through early 2033. Regulations The Food and Drug Administration (FDA), has primary jurisdiction over the company’s products pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the Dietary Supplement and Health Education Act (DSHEA), and the regulations promulgated thereunder. The DSHEA provides the regulatory framework for the safety and labeling of dietary supplements, foods and medical foods. In particular, the FDA regulates the safety, manufacturing, labeling and distribution of dietary supplements. In addition, the Animal Plant Health and Inspection Service, regulates the importation of the company’s primary product from Germany. The Federal Trade Commission, and the FDA share jurisdiction over the promotion and advertising of dietary supplements and nutrition products. The company’s products are required to be prepared in compliance with the FDA’s Good Manufacturing Practices, as set forth in 21 CFR Part 111. Fortetropin, the active ingredient in the company’s products, must be imported into the United States in conformance with United States Department of Agriculture requirements for egg products. Other statutory obligations include reporting various serious adverse events on a Medwatch Form 3500A. History MYOS RENS Technology Inc. was founded in 2007. The company was incorporated in the state of Nevada in 2007.