Brian Mehling, MD and Dongcheng Wu, MD, Ph.D., chief scientific officer and chair of the BHITS Scientific Advisory Board are partnering on stem cell research for the therapy of COVID-19.
The 2019 novel coronavirus pneumonia first emerged in Wuhan, Hubei, China, in December 2019. The disease spread quickly to 26 countries worldwide representing a serious global public health threat. Common signs of infection include respiratory symptoms, fever, dry cough, shortness of breath and breathing difficulties. In more severe cases, the infection can cause pneumonia, severe acute respiratory system injury with overwhelming inflammation in the lung. To date, there are no anti-viral therapeutics that specifically target human coronaviruses, so treatments are only supportive. The present clinical trial is aimed to evaluate the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for the therapy of novel coronavirus pneumonia patients.BHI Therapeutic Sciences Inc. (BHITS) is a Delaware corporation offering this investment opportunity and shall be referred to herein as “BHITS.” Our sister company, Blue Horizon International AG, is a Swiss holding company and shall be referred to herein as “BHIAG.” Generically, when discussing the family of interrelated companies that includes BHITS and BHIAG, the term “Blue Horizon” will denote the entire family of for-profit and non-profit companies, both domestically and internationally.
BHITS is a Delaware Corporation formed on August 16, 2017 for the general purpose of providing regenerative medical services and performing research and development of related products and services. This is a new entity, with limited assets and significant liabilities, whose ongoing operations will be funded primarily by the proceeds of this and future offerings, after having been funded to date by its founders and initial investors.
BHITS was formed to perform research regarding, and to monetize, stem cell technology and associated regenerative medicine. Stem cells are a special type of human cell that can be used to regenerate the human body, in some cases, without drugs or surgery. Regenerative medicine professionals will soon seek to use stem cells to treat various diseases, to extend lifespans and improve the quality of life for certain patients.
BHITS and BHIAG do not use fetal or embryonic stem cells, but rather use only ethically harvested placental cord blood stem cells that are ethically harvested without any injury to the baby or mother. BHIAG has also become one of the pioneers of the use of stem cells cultured from ethically harvested placental cord material, and from a patients’ own fat or bone marrow.
The Business of BHI Therapeutic Sciences Inc.
Stem cell therapy has successfully proven to regenerate the human body without the need for medicine and surgery. Patients suffering from chronic, often debilitating diseases, can benefit, including those diagnosed with Alzheimer ’s disease, strokes, diabetes, arthritis, heart disease, infertility, erectile dysfunction and chronic traumatic encephalopathy, the neurodegenerative disease found in people with multiple head injuries. BHITS is led by an accomplished science and medical team and draws on its relationship with international partners who have successfully treated thousands of patients with stem cell therapy.
Results from our clinical studies show our cellular products are safe and effective in the improvement of symptoms related to chronic inflammation, spinal cord injury, stroke, musculoskeletal disorders, and other medical conditions. We have taken every precaution to ensure the safety and viability of the stem cells administered providing high-quality cellular therapies in both international and domestic operations.
Dr. Brian Mehling is the founder of BHITS and BHIAG and is a globally recognized presence in the regenerative medicine research community. Dr. Mehling has previously founded BHI companies in Germany, Slovakia, Belize, Brazil, Jamaica, Seychelles and Israel. With BHITS, Dr. Mehling and his team are bringing their global experience to the United States. BHITS is the only Blue Horizon company licensed in the U.S. to utilize the broad swath of intellectual property created by BHIAG, as all intellectual property generated by BHIAG’s overseas entities is exclusively licensed to BHITS for domestic operations.
BHITS will be conducting all United States business related to the Blue Horizon family of businesses, research and monetization of stem cell technology and associated regenerative medicine. BHITS will also be the sole conduit for the U.S. for all internationally developed Blue Horizon intellectual property. BHITS is also the sole U.S. distributor of the Alpha Blu cosmetic line, a line of products developed in Germany because of Blue Horizon’s stem cell research.
Our Revenue Model
BHITS will be conducting clinical research, including FDA studies in all 50 states. FDA has given us the approval to proceed with our Investigational New Drug (IND) application allowing for the initiation of a clinical study of an FDA-approved cell therapy (HCP, cord blood) for treatment of acute ischemic stroke. The study is registered at the ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT03735277). Our studies have been conducted following approval by an Investigational Research Board (IRB) and in accordance with Good Clinical Practice. IRB approved protocols necessary for obtaining stem cells from FDA approved sources, which helps standardize quality control. All revenues and expenses for anything related to any Blue Horizon business in the U.S. will be the property of BHITS.
BHITS expects to collect revenue from study subjects in our IRB and FDA endorsed protocols. There are currently nine IRB-approved protocols and one FDA-endorsed protocol, yet – in process, however there are over a dozen ready to commence once approval is granted. Once approved, enrolled study subjects pay BHITS a fee - often $5,000 per injection – with a substantial profit to BHITS at that price point. BHITS also believes that many of the costs associated with research and development will be substantially reduced by the exclusive relationship created between BHITS and BHIAG.
Treatments We Are Researching
BHITS received FDA endorsement of Investigator-led IND application for initiation of a clinical study of an FDA-approved cord blood cell therapy for treatment of acute ischemic stroke. The study is further approved by IRB and registered on clinicaltrials.gov database. There are 800,000 strokes yearly, killing 120,000 people in the U.S alone. Factoring in all the people in America who have had strokes and are dealing with chronic stroke issues, the number of potential patients jumps up from 800,000 to 7,000,000.
BHITS plans to submit second Investigator-led IND application for initiation of a clinical study of an FDA-approved cell therapy (HPC, cord blood) for treatment of knee osteoarthritis associated pain. BHITS has conducted several clinical investigations to evaluate the safety and efficacy of umbilical cord blood stem cells in the treatment of chronic inflammation, musculoskeletal conditions, stroke, and spinal cord injury.The studies have been conducted following approval by IRB and in accordance with Good Clinical Practice.
Alpha Blu is a safe and effective, German-produced cosmetic skin care line that contains more than 32 cytokines and growth factors derived from BHIAG’s human stem cell cultures. BHIAG has conducted research studies that show a stimulation of the natural skin production of elastin and collagen, and a dramatic reduction in oxidative stress, through the use of Alpha Blu. Alpha Blu has also developed a line of sunscreen that does not contain any potentially cancer-causing or toxic chemical blocks. BHITS believes the market for Alpha Blu extends beyond consumer cosmetics and could include a post-surgical balm to reduce scarring, help with stretch marks, and to be used on sensitive skin and psoriasis. All revenues and expenses of the Alpha Blu cosmetic line in the U.S. will be property of BHITS.
Approval of an investigator-led FDA-approved cell therapy for the treatment of acute ischemic stroke.June, 2018