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. BHITS is opening a treatment and trial clinic in Houston, Texas in 2018 to expand its stem cell therapy research into the U.S.
Blue Horizon has successfully and safely treated 100 research subjects with chronic inflammation, 90 subjects with spinal cord injury and 90stroke patients with the application of ethically harvested human umbilical cord blood derived stem cells. Also, 207 research subjects with musculoskeletal disorders were successfully treated with the application of human adipose tissue derived stem cells.1 BHITS plans to bring that experience to America.
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.2With 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.3
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 all research, including eventual FDA studies in all 50 states, as well as IRB approved protocols in and Texas. IRB approved protocols are research protocols that are reviewed for patient safety by a U.S. government-registered group of science professionals. They are the first steps to eventual FDA-approved protocols and are a requirement for research publication in peer review journals. They are also 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 approved protocols. There is currently one IRB-approved protocol – and no FDA-approved protocols, 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 $10,000 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
While BHITS will begin clinical trials on a multitude of different conditions, BHITS believes one of the most promising is treatment of Chronic Traumatic Encephalopathy This traumatic brain injury and condition was exemplified by the movie Concussion with Will Smith. More than 80 NFL players have committed suicide due to this tragic condition.
BHITS also plans to roll out IRB and eventual FDA approved protocols for stroke treatment. 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.
Our Clinic To Be Opened in Texas
BHITS projects that the IRB approved protocols will allow for 600 patients in the next 12 months- 200 IV infusions for peripheral diseases, 200 IV plus intra-articular for joint diseases, and 200 IV plus Intrathecal for central nervous system diseases. Once BHITS commences FDA studies, the number of paying study subjects could increase as BHITS anticipates no FDA limitations on the number of study subjects.
BHITS anticipates using a portion of the funds raised in this offering and a planned Regulation A offering to open a clinic in Houston, Texas to administer stem cell treatments that will be IRB approved and approved by the Texas medical board. Texas recently legalized clinical trials using stem cells, becoming the first state in the U.S. to do so. BHITS plans to open a facility in in Houston in 2018 and to roll out a large swath of clinical trials for treatment protocols related to serious chronic diseases and terminal illnesses.
BHITS anticipates that the Texas clinic could increase the total revenue of BHITS as more patients could be treated, as it is anticipated that it will not be impeded by the FDA limits. BHITS anticipates that other states will follow Texas’ lead in the stem cell treatment realm – much like recent acceptance of medical marijuana in most states – allowing BHITS to grow across the U.S. as states follow what Texas has started.
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.