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BHI Therapeutic Sciences, Inc.

BHI Therapeutic Sciences, Inc.

Global stem cell research and innovation company pioneering ethical, effective, and safe cord blood therapies.

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Deal Type

Equity

Funding Goal

$25,000,000

Current Reservations

$0

Minimum Reservation

$25,000

Maximum Reservation

$2,500,000

Deal Stage

Other

Pre-money Valuation

$25,000,000

Open Date

12/11/2017

Closing Date

06/15/2020

Elevator Pitch

BHI Therapeutic Sciences is pioneering ethical, effective, safe and affordable stem cell therapies utilizing human umbilical cord blood and tissue derived technologies.

Company Overview

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

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.

Traction

  • Approval of an investigator-led FDA-approved cell therapy for the treatment of acute ischemic stroke.

    June, 2018
  • Brian Mehling, MD and Marina Manvelyan, Ph.D. accepted as members of the prestigious International Society for Stem Cell Research.

    December, 2019

Pitch Deck

Press Mentions

Key Customers & Partners

Blue Horizon International AG

Testimonials

Marina Manvelyan
Marina Manvelyan
Clinical Research Scientist
"Research in regenerative medicine is bringing huge advances in science, technology, health and medicine. Stem cell therapies in clinical trials are showing great promise in the fields of orthopedics, skin and wound healing, and in treating diseases including spinal cord injury, traumatic brain injury, diabetes, myocardial infarction and much more. Stem cell therapies and regenerative medicine are becoming the preferred substitutes for many surgical, pharmacological, and rehabilitative medical services. "
Yesenia Torres
Yesenia Torres
Patient
"I was injured 20 years ago in a car accident, my injury is C4 C5 incomplete, which means there's no movement from the chest down. After several stem cell therapy treatments I have felt some movement. I am very happy to be a patient, it is clear they are interested in helping people get better. I do believe stem cells are going to make a big change in the way illnesses and injuries are managed."
Kirk Barton
Kirk Barton
Retired NFL Player and Patient
"I am a retired NFL player and spent my college days playing for Ohio State University sustaining many injuries over the years. My knee gave me the most trouble, but I didn't want surgery. After researching alternatives, I learned stem cell therapy was cutting-edge stuff, something that could potentially change the world.I didn't know how to get there, how to get it done...until I was introduced to Dr. Mehling. My knee has never felt better. "
Arlene Santiago
Arlene Santiago
Patient
"I am Arlene and I am a fighter, cancer survivor, mother, sister, wife, friend, and lover of God. I definitely believe that stem cells are capable of fixing a lot of medical problems. I'm extremely grateful for Brian and I know he is always trying to help people who are in need, experiencing an illness, or trying to improve their quality of life. I just want to say thank you for giving me the opportunity to experience stem cells. The therapy helped me a lot."

Frequently Asked Questions

What are stem cells?

Stem cells are essentially “blank slate” cells that possess the remarkable potential to differentiate to any one of the billions of cells that form the diverse tissues of the human body. Stem cells have the power to divide virtually without limits and convert or develop into specialized cells that can replace injured or damaged tissue. Additionally, stem cells are known to secrete cytokines (small secreted proteins released by cells) that have immunomodulatory effects that have been demonstrated to exert a therapeutic effect. Stem cells have been shown to migrate to sites of injury and inflammation where they are believed to support the survival of damaged cell and inhibit the immune responses. Tissue-specific stem cells (adult stem cells), are already specialized and can produce different cell types for the specific tissue or organ in which they reside.

Why is stem cell therapy so exciting?

Stem cell research is the most exciting option in the field of regenerative medicine being tested for efficacy in treating a variety of health issues where the body’s own response to traditional treatment isn’t sufficient to restore health and optimum function. Cell-based therapy is a new investigational approach that holds promise to enhance recovery from broad spectrum of diseases. Hundreds of cellular therapies are currently under investigation in clinical trials for a wide-range of medical conditions. Stem cell application in clinical trials shows promising results in therapy of neurological, musculoskeletal, cardiovascular and metabolic diseases. Stem cell therapies and regenerative medicine are becoming the preferred substitutes for many surgical, pharmacological, and rehabilitative medical services.

Are there different types of stem cells?

BHI stem cell sources include allogenic (genetically similar, but not identical) Human Umbilical Cord Blood (hUCB), Wharton's Jelly (WJ), and autologous (obtained from the same individual) Adipose Tissue derived stem cells. hUCB is a rich source of hematopoietic stem cells (stem cells that give rise to other blood cells) and progenitor cells as well as non-hematopoietic stem cells such as: endothelial cells, mesenchymal stem cells (MSCs) and unrestricted somatic stem cells. Cells from UCB can be used directly after isolation without expansion. Umbilical Cord is collected from primiparous pregnant women receiving caesarean section in accordance with the sterile procedure guidelines in each hospital, and MSCs from WJ are expanded. Stromal vascular fraction of adipose tissue contains mesenchymal stem cells that have the capacity to differentiate into cartilage, bone, muscle, and adipose tissue.

What makes you different than your competitors?

Hundreds of allogeneic stem cell therapies are underway in humans for a wide-range of medical conditions. However, these studies are not always following regulatory compliances; accordingly they have not been proven to be safe. BHI Therapeutic Sciences has unique advantages over its competitors. We are in regulatory compliance in each country we conduct clinical trials to ensure the lab and clinical procedures are lawfully approved by their federal agencies. FDA endorsed our Investigator-led IND (Investigational New Drug) application to allow for initiation of a clinical study of an FDA-approved cell therapy (HCP, cord blood) for treatment of acute ischemic stroke. BHI Stem Cells believes it is uniquely positioned to become a leader in providing the highest quality cellular therapies through centers it intends to locate throughout the world.

Risks & Disclosures

Risks Relating to the Company and Its Business

The Company Has Limited Operating History

The Company has a limited operating history and there can be no assurance that the Company's proposed plan of business can be realized in the manner contemplated and, if it cannot be, shareholders may lose all or a substantial part of their investment. There is no guarantee that it will ever realize any significant operating revenues or that its operations will ever be profitable.

The Company Is Dependent Upon Its Management, Founders, Key Personnel and Consultants to Execute the Business Plan, And Many Of Them Will Have Concurrent Responsibilities At Other Companies

The Company's success is heavily dependent upon the continued active participation of the Company's current executive officers as well as other key personnel and consultants. Many of them will have concurrent responsibilities at other entities. Some of the advisors, scientists, consultants and others to whom the Company’s ultimate success may be reliant have not signed contracts with the Company and may not ever do so. Loss of the services of one or more of these individuals could have a material adverse effect upon the Company's business, financial condition or results of operations. Further, the Company's success and achievement of the Company's growth plans depend on the Company's ability to recruit, hire, train and retain other highly qualified scientific, technical and managerial personnel. Competition for qualified employees and consultants among companies in the applicable industries is intense, and the loss of any of such persons, or an inability to attract, retain and motivate any additional highly skilled employees and consultants required for the initiation and expansion of the Company's activities, could have a materially adverse effect on it. The inability to attract and retain the necessary personnel, consultants and advisors could have a material adverse effect on the Company's business, financial condition or results of operations.


The Company Is Attempting To Break New Ground In Regenerative Medicine Involving Stem Cell Treatment, Some Or All Of Which May Fail.

The Company's success is dependent upon the ability of the Company to continue to develop new treatments and protocols for the use of stem cell treatment and regenerative medicine. Should the Company be unable to develop treatments and protocols that are successful at providing treatment, or should a competitor be able to do so prior to the Company being able to do so, your investment may be significantly affected and the Company may fail.

The Company’s Treatment and Protocols May Fail Causing Serious Injury or Death to The

Patients, Leading to Lawsuits and Bad Publicity For the Company

The Company's success is dependent upon the ability of the Company to successfully create treatments and treatment protocols using stem cells. There are risks that a patient may have adverse effects from the Company’s efforts. For example, a patient may suffer significant health issues as a result of the Company’s treatments or treatment protocols and a patient may die or suffer complications or adverse reactions. Any or all of these occurrences could lead to the Company being subject to lawsuits, bad publicity, and other effects which could have a detrimental effect on the Company and on your investment.

Although Dependent Upon Certain Key Personnel, The Company Does Not Have Any Key Man Life Insurance Policies On Any Such People At The Time Of This Offering.

The Company is dependent upon management in order to conduct its operations and execute its business plan, however, the Company has not purchased any insurance policies with respect to those individuals in the event of their death or disability. Therefore, should any of these key personnel, management or founders die or become disabled, the Company will not receive any compensation that would assist with such person's absence. The loss of such person could negatively affect the Company and its operations.

The Company Is Or Will Be Subject To Income Taxes As Well As Non-Income Based Taxes, Such As Payroll, Sales, Use, Value-Added, Net Worth, Property And Goods And Services Taxes.

Significant judgment is required in determining our provision for income taxes and other tax liabilities. In the ordinary course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain. Although the Company believes that our tax estimates will be reasonable: (i) there is no assurance that the final determination of tax audits or tax disputes will not be different from what is reflected in our income tax provisions, expense amounts for non- income based taxes and accruals and (ii) any material differences could have an adverse effect on our financial position and results of operations in the period or periods for which determination is made.

The Company Is Not Subject To Sarbanes-Oxley Regulations And Lack The Financial Controls And Safeguards Required Of Public Companies.


The Company does not have the internal infrastructure necessary, and is not required, to complete an attestation about our financial controls that would be required under Section 404 of the Sarbanes- Oxley Act of 2002. There can be no assurances that there are no significant deficiencies or material weaknesses in the quality of our financial controls. The Company expects to incur additional expenses and diversion of management's time if and when it becomes necessary to perform the system and process evaluation, testing and remediation required in order to comply with the management certification and auditor attestation requirements.

Changes In Laws Or Regulations Could Harm The Company’s Performance.

Various federal and state laws, including labor laws, govern the Company’s relationship with our employees and affect operating costs. These laws may include minimum wage requirements, overtime pay, healthcare reform and the implementation of various federal and state healthcare laws, unemployment tax rates, workers' compensation rates, citizenship requirements, union membership and sales taxes. A number of factors could adversely affect our operating results, including additional government-imposed increases in minimum wages, overtime pay, paid leaves of absence and mandated health benefits, mandated training for employees, changing regulations from the National Labor Relations Board and increased employee litigation including claims relating to the Fair Labor Standards Act.

The Company’s Bank Accounts Will Not Be Fully Insured

The Company’s regular bank accounts and the escrow account for this Offering each have federal insurance that is limited to a certain amount of coverage. It is anticipated that the account balances in each account may exceed those limits at times. In the event that any of Company’s banks should fail, the Company may not be able to recover all amounts deposited in these bank accounts.

The Company’s Business Plan Is Speculative

The Company’s present business and planned business are speculative and subject to numerous risks and uncertainties. There is no assurance that the Company will generate significant revenues or profits.

The Company Faces Significant Competition in the United States and Elsewhere

The Company will face significant competition in the United States and elsewhere which could adversely affect your investment.

The Company Will Likely Incur Debt

The Company will likely incur debt (including secured debt) in the future and in the continuing operations of its business. Complying with obligations under such indebtedness may have a material adverse effect on the Company and on your investment.


The Company’s Expenses Could Increase Without a Corresponding Increase in Revenues

The Company’s operating and other expenses could increase without a corresponding increase in revenues, which could have a material adverse effect on the Company’s financial results and on your investment. Factors which could increase operating and other expenses include, but are not limited to (1) increases in the rate of inflation, (2) increases in taxes and other statutory charges, (3) changes in laws, regulations or government policies which increase the costs of compliance with such laws, regulations or policies, (4) significant increases in insurance premiums, (5) increases in borrowing costs, and (5) unexpected increases in costs of supplies, goods, materials, construction, equipment or distribution.

An Inability to Maintain and Enhance Product Image Could Affect Your Investment

It is important that the Company maintains and enhances the image of any new products. The image and reputation of the Company’s products may be impacted for various reasons including, but not limited to, bad publicity, litigation, and complaints from regulatory bodies. Such problems, even when unsubstantiated, could be harmful to the Company’s image and the reputation of its products. These claims may not be covered by the Company’s insurance policies. Any resulting litigation could be costly for the Company, divert management attention, and could result in increased costs of doing business, or otherwise have a material adverse effect on the Company’s business, results of operations, and financial condition. Any negative publicity generated could damage the Company’s reputation and diminish the value of the Company’s brand, which could have a material adverse effect on the Company’s business, results of operations, and financial condition, as well as your investment. Deterioration in the Company’s brand equity (brand image, reputation and product quality) may have a material adverse effect on its financial results as well as your investment.

If We Are Unable To Effectively Protect Our Intellectual Property, It May Impair Our Ability To Compete

Our success will depend on our ability to obtain and maintain meaningful intellectual property protection for any such intellectual property. The names and/or logos of Company brands may be challenged by holders of trademarks who file opposition notices, or otherwise contest, trademark applications by the Company for its brands. Similarly, domains owned and used by the Company may be challenged by others who contest the ability of the Company to use the domain name or URL. Our business depends on proprietary technology that may be infringed. Some or all of our products depend or will depend on our proprietary technology for their success. We rely on a combination of trade secrets, copyrights and trademarks, together with non-disclosure agreements, confidentiality provisions in sales, procurement, employment and other agreements and technical measures to establish and protect proprietary rights in our products. While we may seek patents for some or all of our products and technology, there is no guarantee that such patents will be granted. Our ability to successfully protect our technology may be limited because intellectual property laws in certain jurisdictions may be relatively ineffective, detecting infringements and enforcing proprietary rights may divert management’s attention and company resources, contractual measures


such as non-disclosure agreements and confidentiality provisions may afford only limited protection, any patents we may receive will expire, thus providing competitors access to the applicable technology, competitors may independently develop products that are substantially equivalent or superior to our products or circumvent our intellectual property rights; and competitors may register patents in technologies relevant to our business areas. In addition, various parties may assert infringement claims against us. The cost of defending against infringement claims could be significant, regardless of whether the claims are valid. If we are not successful in defending such claims, we may be prevented from the use or sale of certain of our products, or liable for damages and required to obtain licenses, which may not be available on reasonable terms, any of which may have a material adverse impact on our business, results of operation or financial condition.

Computer, Website or Information System Breakdown Could Affect The Company’s Business

Computer, website and/or information system breakdowns as well as cyber security attacks could impair the Company’s ability to service its customers leading to reduced revenue from sales and/or reputational damage, which could have a material adverse effect on the Company’s financial results as well as your investment.

Changes In The Economy Could Have a Detrimental Impact On The Company

Changes in the general economic climate could have a detrimental impact on the Company’s revenue. It is possible that recessionary pressures and other economic factors (such as declining incomes, future potential rising interest rates, higher unemployment and tax increases) may adversely affect the Company. Any of such events or occurrences could have a material adverse effect on the Company’s financial results and on your investment.

The Amount Of Capital The Company Is Attempting To Raise In This Offering May Not Be Enough To Sustain The Company's Current Business Plan

In order to achieve the Company's near and long-term goals, the Company may need to procure funds in addition to the amount raised in the Offering. There is no guarantee the Company will be able to raise such funds on acceptable terms or at all. If we are not able to raise sufficient capital in the future, we will not be able to execute our business plan, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer all or substantially all of our remaining assets, which could cause you to lose all or a portion of your investment.

We May Not Be Able To Obtain Adequate Financing To Continue Our Operations

The Company may require additional debt and/or equity financing to pursue our growth and business strategies. These include, but are not limited to enhancing our operating infrastructure and otherwise respond to competitive pressures. Given our limited operating history and existing losses, there can be no assurance that additional financing will be available, or, if available, that the terms will be acceptable to us. Lack of additional funding could force us to curtail substantially our


growth plans. Furthermore, the issuance by us of any additional securities pursuant to any future fundraising activities undertaken by us would dilute the ownership of existing shareholders and may reduce the price of our Shares.

Terms Of Subsequent Financing, If Any, May Adversely Impact Your Investment

We may have to engage in common equity, debt, or preferred stock financings in the future. Your rights and the value of your investment in the Non-Voting Common Stock could be reduced by the dilution caused by future equity issuances. Interest on debt securities could increase costs and negatively impact operating results. In the event we are permitted to issue preferred stock pursuant to the terms of our Company documents, preferred stock could be issued in series from time to time with such designation, rights, preferences, and limitations as needed to raise capital. The terms of preferred stock would be more advantageous to those investors than to the holders of Non-Voting Common Stock. In addition, if we need to raise more equity capital from the sale of common stock, institutional or other investors may negotiate terms at least as, and possibly more, favorable than the terms of your investment. Shares of common stock which we sell could be sold into any market that develops, which could adversely affect the market price.

Our Employees, Executive Officers, Directors And Insider Shareholders Beneficially Own Or Control A Substantial Portion Of Our Outstanding Shares

Our employees, executive officers, directors and insider shareholders beneficially own or control a substantial portion of our outstanding type of stock which may limit your ability and the ability of our other shareholders, whether acting alone or together, to propose or direct the management or overall direction of our company. Additionally, this concentration of ownership could discourage or prevent a potential takeover of our Company that might otherwise result in an investor receiving a premium over the market price for its Shares. The majority of our currently outstanding Shares of stock are beneficially owned and controlled by a group of insiders, including our employees, directors, executive officers and inside shareholders. Accordingly, our employees, directors, executive officers and insider shareholders may have the power to control the election of our directors and the approval of actions for which the approval of our shareholders is required. If you acquire our Shares, you will have no effective voice in the management of our Company. Such concentrated control of our Company may adversely affect the price of our Shares. Our principal shareholders may be able to control matters requiring approval by our shareholders, including the election of directors, mergers or other business combinations. Such concentrated control may also make it difficult for our shareholders to receive a premium for their Shares in the event that we merge with a third party or enter into different transactions which require shareholder approval. These provisions could also limit the price that investors might be willing to pay in the future for our Shares.

Our Operating Plan Relies In Large Part Upon Assumptions And Analyses Developed By The Company. If These Assumptions Or Analyses Prove To Be Incorrect, The Company’s Actual Operating Results May Be Materially Different From Our Forecasted Results


Whether actual operating results and business developments will be consistent with the Company’s expectations and assumptions as reflected in its forecast depends on a number of factors, many of which are outside the Company’s control, including, but not limited to:

  • whether the Company can obtain sufficient capital to sustain and grow its business
  • our ability to manage the Company’s growth
  • whether the Company can manage relationships with key vendors and advertisers
  • demand for the Company’s products and services
  • the timing and costs of new and existing marketing and promotional efforts
  • competition
  • the Company’s ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel
  • the overall strength and stability of domestic and international economies
  • the results of clinical trials, if any are required, may not meet the level of statistical significance required by the FDA, other regulatory body or comparable foreign regulatory authorities for approval;
  • we may be unable to demonstrate that a product or service’s clinical and other benefits
  • the FDA, other regulatory body or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, if any are required;
  • the approval policies or regulations of the FDA, other regulatory body or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
  • regulatory authorities may withdraw approvals of such products or services;
  • we could be sued and held liable for harm caused to patients; and
  • the efficacy and safety as demonstrated in clinical trials, if required;
  • the timing of market introduction of such product or service as well as competitive products;
  • the clinical indications for which the product or service is approved;
  • acceptance by physicians, hospitals and patients of the product or service as a safe and effective treatment;
  • the potential and perceived advantages of such product or service over alternative treatments, especially with respect to patient subsets that we are targeting with such product or service;
  • the safety of such product or service seen in a broader patient group, including its use outside the approved indications;
  • the cost of treatment in relation to alternative treatments;
  • the availability of adequate reimbursement and pricing by third-party payors and government authorities;
  • the prevalence and severity of adverse side effects; and
  • the effectiveness of our sales and marketing efforts.
  • a covered benefit under its health plan;
  • safe, effective and medically necessary;
  • appropriate for the specific patient;
  • cost-effective; and
  • neither experimental nor investigational.
  • the demand for any products or services for which we may market and/or obtain regulatory approval, if required;
  • our ability to set a price that we believe is fair for our products and services;
  • our ability to generate revenues and achieve or maintain profitability;
  • the level of taxes that we are required to pay; and
  • the availability of capital.
  • injury to our reputation;
  • withdrawal of clinical trial participants, if required;
  • initiation of investigations by regulators;
  • costs to defend the related litigation;
  • a diversion of management’s time and our resources;
  • substantial monetary awards to patients or others;
  • product recalls, withdrawals, marketing or promotional restrictions;
  • loss of revenues from product sales; and
  • the inability to commercialize our products and services.
  • whether the Company can obtain sufficient capital to sustain and grow its business
  • our ability to manage the Company’s growth
  • whether the Company can manage relationships with key vendors and advertisers
  • demand for the Company’s products and services
  • the timing and costs of new and existing marketing and promotional efforts
  • competition
  • the Company’s ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel
  • the overall strength and stability of domestic and international economies
  • the results of clinical trials, if any are required, may not meet the level of statistical significance required by the FDA, other regulatory body or comparable foreign regulatory authorities for approval;
  • we may be unable to demonstrate that a product or service’s clinical and other benefits
  • the FDA, other regulatory body or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, if any are required;
  • the approval policies or regulations of the FDA, other regulatory body or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
  • regulatory authorities may withdraw approvals of such products or services;
  • we could be sued and held liable for harm caused to patients; and
  • the efficacy and safety as demonstrated in clinical trials, if required;
  • the timing of market introduction of such product or service as well as competitive products;
  • the clinical indications for which the product or service is approved;
  • acceptance by physicians, hospitals and patients of the product or service as a safe and effective treatment;
  • the potential and perceived advantages of such product or service over alternative treatments, especially with respect to patient subsets that we are targeting with such product or service;
  • the safety of such product or service seen in a broader patient group, including its use outside the approved indications;
  • the cost of treatment in relation to alternative treatments;
  • the availability of adequate reimbursement and pricing by third-party payors and government authorities;
  • the prevalence and severity of adverse side effects; and
  • the effectiveness of our sales and marketing efforts.
  • a covered benefit under its health plan;
  • safe, effective and medically necessary;
  • appropriate for the specific patient;
  • cost-effective; and
  • neither experimental nor investigational.
  • the demand for any products or services for which we may market and/or obtain regulatory approval, if required;
  • our ability to set a price that we believe is fair for our products and services;
  • our ability to generate revenues and achieve or maintain profitability;
  • the level of taxes that we are required to pay; and
  • the availability of capital.
  • injury to our reputation;
  • withdrawal of clinical trial participants, if required;
  • initiation of investigations by regulators;
  • costs to defend the related litigation;
  • a diversion of management’s time and our resources;
  • substantial monetary awards to patients or others;
  • product recalls, withdrawals, marketing or promotional restrictions;
  • loss of revenues from product sales; and
  • the inability to commercialize our products and services.
  • whether the Company can obtain sufficient capital to sustain and grow its business
  • our ability to manage the Company’s growth
  • whether the Company can manage relationships with key vendors and advertisers
  • demand for the Company’s products and services
  • the timing and costs of new and existing marketing and promotional efforts
  • competition
  • the Company’s ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel
  • the overall strength and stability of domestic and international economies
  • the results of clinical trials, if any are required, may not meet the level of statistical significance required by the FDA, other regulatory body or comparable foreign regulatory authorities for approval;
  • we may be unable to demonstrate that a product or service’s clinical and other benefits
  • the FDA, other regulatory body or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, if any are required;
  • the approval policies or regulations of the FDA, other regulatory body or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
  • regulatory authorities may withdraw approvals of such products or services;
  • we could be sued and held liable for harm caused to patients; and
  • the efficacy and safety as demonstrated in clinical trials, if required;
  • the timing of market introduction of such product or service as well as competitive products;
  • the clinical indications for which the product or service is approved;
  • acceptance by physicians, hospitals and patients of the product or service as a safe and effective treatment;
  • the potential and perceived advantages of such product or service over alternative treatments, especially with respect to patient subsets that we are targeting with such product or service;
  • the safety of such product or service seen in a broader patient group, including its use outside the approved indications;
  • the cost of treatment in relation to alternative treatments;
  • the availability of adequate reimbursement and pricing by third-party payors and government authorities;
  • the prevalence and severity of adverse side effects; and
  • the effectiveness of our sales and marketing efforts.
  • a covered benefit under its health plan;
  • safe, effective and medically necessary;
  • appropriate for the specific patient;
  • cost-effective; and
  • neither experimental nor investigational.
  • the demand for any products or services for which we may market and/or obtain regulatory approval, if required;
  • our ability to set a price that we believe is fair for our products and services;
  • our ability to generate revenues and achieve or maintain profitability;
  • the level of taxes that we are required to pay; and
  • the availability of capital.
  • injury to our reputation;
  • withdrawal of clinical trial participants, if required;
  • initiation of investigations by regulators;
  • costs to defend the related litigation;
  • a diversion of management’s time and our resources;
  • substantial monetary awards to patients or others;
  • product recalls, withdrawals, marketing or promotional restrictions;
  • loss of revenues from product sales; and
  • the inability to commercialize our products and services.
  • whether the Company can obtain sufficient capital to sustain and grow its business
  • our ability to manage the Company’s growth
  • whether the Company can manage relationships with key vendors and advertisers
  • demand for the Company’s products and services
  • the timing and costs of new and existing marketing and promotional efforts
  • competition
  • the Company’s ability to retain existing key management, to integrate recent hires and to attract, retain and motivate qualified personnel
  • the overall strength and stability of domestic and international economies
  • the results of clinical trials, if any are required, may not meet the level of statistical significance required by the FDA, other regulatory body or comparable foreign regulatory authorities for approval;
  • we may be unable to demonstrate that a product or service’s clinical and other benefits
  • the FDA, other regulatory body or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, if any are required;
  • the approval policies or regulations of the FDA, other regulatory body orcomparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
  • regulatory authorities may withdraw approvals of such products or services;
  • we could be sued and held liable for harm caused to patients; and
  • the efficacy and safety as demonstrated in clinical trials, if required;
  • the timing of market introduction of such product or service as well as competitive products;
  • the clinical indications for which the product or service is approved;
  • acceptance by physicians, hospitals and patients of the product or service as a safe and effective treatment;
  • the potential and perceived advantages of such product or service over alternative treatments, especially with respect to patient subsets that we are targeting with such product or service;
  • the safety of such product or service seen in a broader patient group, including its use outside the approved indications;
  • the cost of treatment in relation to alternative treatments;
  • the availability of adequate reimbursement and pricing by third-party payors and government authorities;
  • the prevalence and severity of adverse side effects; and
  • the effectiveness of our sales and marketing efforts.
  • a covered benefit under its health plan;
  • safe, effective and medically necessary;
  • appropriate for the specific patient;
  • cost-effective; and
  • neither experimental nor investigational.
  • the demand for any products or services for which we may market and/or obtain regulatory approval, if required;
  • our ability to set a price that we believe is fair for our products and services;
  • our ability to generate revenues and achieve or maintain profitability;
  • the level of taxes that we are required to pay; and
  • the availability of capital.
  • injury to our reputation;
  • withdrawal of clinical trial participants, if required;
  • initiation of investigations by regulators;
  • costs to defend the related litigation;
  • a diversion of management’s time and our resources;
  • substantial monetary awards to patients or others;
  • product recalls, withdrawals, marketing or promotional restrictions;
  • loss of revenues from product sales; and
  • the inability to commercialize our products and services.

Unfavorable changes in any of these or other factors, most of which are beyond the Company’s control, could materially and adversely affect its business, results of operations and financial condition.

To Date, The Company Has Had Operating Losses And Does Not Expect To Be Initially Profitable For At Least The Foreseeable Future, And Cannot Accurately Predict When It Might Become Profitable

The Company has been operating at a loss since the Company's inception, and the Company expects to continue to incur losses for the foreseeable future. Further, the Company may not be able to generate significant revenues in the future. In addition, the Company expects to incur substantial operating expenses in order to fund the expansion of the Company's business. As a result, The Company expects to continue to experience substantial negative cash flow for at least the foreseeable future and cannot predict when, or even if, the Company might become profitable.

The Company May Be Unable To Manage Their Growth Or Implement Their Expansion Strategy

The Company may not be able to expand the Company's product and service offerings, the Company's markets, or implement the other features of the Company's business strategy at the rate or to the extent presently planned. The Company's projected growth will place a significant strain on the Company's administrative, operational and financial resources. If the Company is unable to successfully manage the Company's future growth, establish and continue to upgrade the Company's operating and financial control systems, recruit and hire necessary personnel or effectively manage unexpected expansion difficulties, the Company's financial condition and results of operations could be materially and adversely affected.

The Company Relies Upon Trade Secret Protection To Protect Its Intellectual Property; It May Be Difficult And Costly To Protect The Company's Proprietary Rights And The Company May Not Be Able To Ensure Their Protection


The Company currently relies on trade secrets. While the Company uses reasonable efforts to protect these trade secrets, the Company cannot assure that its employees, consultants, contractors or advisors will not, unintentionally or willfully, disclose the Company's trade secrets to competitors or other third parties. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, the Company's competitors may independently develop equivalent knowledge, methods and know-how. If the Company is unable to defend the Company's trade secrets from others use, or if the Company's competitors develop equivalent knowledge, it could have a material adverse effect on the Company's business. Any infringement of the Company's proprietary rights could result in significant litigation costs, and any failure to adequately protect the Company's proprietary rights could result in the Company's competitors offering similar products, potentially resulting in loss of a competitive advantage and decreased revenue. Existing patent, copyright, trademark and trade secret laws afford only limited protection. In addition, the laws of some foreign countries do not protect the Company's proprietary rights to the same extent as do the laws of the United States. Therefore, the Company may not be able to protect the Company's proprietary rights against unauthorized third-party use. Enforcing a claim that a third party illegally obtained and is using the Company's trade secrets could be expensive and time consuming, and the outcome of such a claim is unpredictable. Litigation may be necessary in the future to enforce the Company's intellectual property rights, to protect the Company's trade secrets or to determine the validity and scope of the proprietary rights of others. This litigation could result in substantial costs and diversion of resources and could materially adversely affect the Company's future operating results.

The Company's Business Model Is Evolving

The Company's business model is unproven and is likely to continue to evolve. Accordingly, the Company's initial business model may not be successful and may need to be changed. The Company's ability to generate significant revenues will depend, in large part, on the Company's ability to successfully market the Company's products to potential users who may not be convinced of the need for the Company's products and services or who may be reluctant to rely upon third parties to develop and provide these products. The Company intends to continue to develop the Company's business model as the Company's market continues to evolve.

If The Company Fails To Maintain And Enhance Awareness Of The Company's Brand, The Company's Business And Financial Results Could Be Adversely Affected

The Company believes that maintaining and enhancing awareness of the Company's brand is critical to achieving widespread acceptance and success of the Company's business. The Company also believes that the importance of brand recognition will increase due to the relatively low barriers to entry in the Company's market. Maintaining and enhancing the Company's brand awareness may require the Company to spend increasing amounts of money on, and devote greater resources to, advertising, marketing and other brand-building efforts, and these investments may not be successful. Further, even if these efforts are successful, they may not be cost-effective. If the Company is unable to continuously maintain and enhance the Company's media presence, the


Company's market may decrease and the Company may fail to attract advertisers and subscribers, which could in turn result in lost revenues and adversely affect the Company's business and financial results.

The Company Needs to Increase Brand Awareness

Due to a variety of factors, the Company's opportunity to achieve and maintain a significant market share may be limited. Developing and maintaining awareness of the Company's brand name, among other factors, is critical. Further, the importance of brand recognition will increase as competition in the Company's market increases. Successfully promoting and positioning the Company's brand, products and services will depend largely on the effectiveness of the Company's marketing efforts. Therefore, the Company may need to increase the Company's financial commitment to creating and maintaining brand awareness. If the Company fails to successfully promote the Company's brand name or if the Company incurs significant expenses promoting and maintaining the Company's brand name, it would have a material adverse effect on the Company's results of operations.

The Company Faces Competition In The Company's Markets From Various Large And Small Companies, Some Of Which Have Greater Financial, Research And Development, Production And Other Resources Than Does The Company

In many cases, the Company’s competitors have longer operating histories, established ties to the market and consumers, greater brand awareness, and greater financial, technical and marketing resources. The Company's ability to compete depends, in part, upon a number of factors outside the Company's control, including the ability of the Company's competitors to develop alternatives that are superior. If the Company fails to successfully compete in its markets, or if the Company incurs significant expenses in order to compete, it could have a material adverse effect on the Company's results of operations.

Our Company Could Face Several Regulatory Hurdles

Some or all of our products will need to comply with many governmental standards and regulations relating to the marketing, use and sale of our products in general. Compliance with all of these requirements may delay, or prohibit, commercialization in the Unites States and in various countries, thereby adversely affecting our business and financial condition.

A Data Security Breach Could Expose The Company To Liability And Protracted And Costly Litigation, And Could Adversely Affect The Company's Reputation And Operating Revenues

To the extent that the Company's activities involve the storage and transmission of confidential information, the Company and/or third-party processors will receive, transmit and store confidential customer and other information. Encryption software and the other technologies used to provide security for storage, processing and transmission of confidential customer and other information may not be effective to protect against data security breaches by third parties. The risk of unauthorized circumvention of such security measures has been heightened by advances in


computer capabilities and the increasing sophistication of hackers. Improper access to the Company's or these third parties' systems or databases could result in the theft, publication, deletion or modification of confidential customer and other information. A data security breach of the systems on which sensitive account information are stored could lead to fraudulent activity involving the Company's products and services, reputational damage, and claims or regulatory actions against us. If the Company is sued in connection with any data security breach, the Company could be involved in protracted and costly litigation. If unsuccessful in defending that litigation, the Company might be forced to pay damages and/or change the Company's business practices or pricing structure, any of which could have a material adverse effect on the Company's operating revenues and profitability. The Company would also likely have to pay fines, penalties and/or other assessments imposed as a result of any data security breach.

The Company Depends On Third-Party Providers For A Reliable Internet Infrastructure And The Failure Of These Third Parties, Or The Internet In General, For Any Reason Could Significantly Impair The Company's Ability To Conduct Its Business

The Company may outsource some or all of its online presence and data management to third parties who host the actual servers and provide power and security in multiple data centers in each geographic location. These third-party facilities could require uninterrupted access to the Internet. If the operation of the servers is interrupted for any reason, including natural disaster, financial insolvency of a third-party provider, or malicious electronic intrusion into the data center, its business could be significantly damaged. As has occurred with many Internet-based businesses, the Company may be subject to "denial-of-service" attacks in which unknown individuals bombard its computer servers with requests for data, thereby degrading the servers' performance. The Company cannot be certain it will be successful in quickly identifying and neutralizing these attacks. If either a third-party facility failed, or the Company's ability to access the Internet was interfered with because of the failure of Internet equipment in general or if the Company becomes subject to malicious attacks of computer intruders, its business and operating results will could be materially adversely affected.

Limitation On Director Liability

The Company may provide for the indemnification of directors to the fullest extent permitted by law and, to the extent permitted by such law, eliminate or limit the personal liability of directors to the Company and its shareholders for monetary damages for certain breaches of fiduciary duty. Such indemnification may be available for liabilities arising in connection with this Offering. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the Company pursuant to the foregoing provisions, the Company has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

The Company’s Expenses Could Increase Without a Corresponding Increase in Revenues


The Company’s operating and other expenses could increase without a corresponding increase in revenues, which could have a material adverse effect on the Company’s financial results and on your investment. Factors which could increase operating and other expenses include, but are not limited to (1) increases in the rate of inflation, (2) increases in taxes and other statutory charges, (3) changes in laws, regulations or government policies which increase the costs of compliance with such laws, regulations or policies, (4) significant increases in insurance premiums, (5) increases in borrowing costs, and (5) unexpected increases in costs of supplies, goods, materials, construction, equipment or distribution.

Changes In The Economy Could Have a Detrimental Impact

Changes in the general economic climate could have a detrimental impact on the Company’s revenue. It is possible that recessionary pressures and other economic factors (such as declining incomes, future potential rising interest rates, higher unemployment and tax increases) may decrease the disposable income that customers have available to spend on products and services like those of the Company and may adversely affect customers’ confidence and willingness to spend. Any of such events or occurrences could have a material adverse effect on the Company’s financial results and on your investment.

The Regulatory Approval Processes Of The FDA, Other Regulatory Bodies And Similar State and Foreign Authorities Is Lengthy, Time Consuming And Inherently Unpredictable

The Company believes its products and services will require FDA and/or other regulatory approval in the future for some or all of our products or services. The regulatory approval processes of the FDA, other regulatory bodies and similar foreign authorities could be lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our products and services, our business will be substantially harmed.

Our Revenues Will Be Dependent, In Part, Upon The Size Of The Markets In The Territories For Which We Gain Regulatory Approval And Have Commercial Rights

The Company believes its products and services will require FDA and/or other regulatory approval in the future and our revenues will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval.

Documents

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