EXECUTIVE SUMMARY

Our Mission Examera offers an innovative and user- friendly solution to tackle some of the most common women health issues. We envision Examera to become the name brand for women’s health and become a platform for women to control their health and receive health-related products. Our Product Examera is a state-of-the-art and easy-to-use device for vaginal health monitoring. It provides gynecologists with relevant parameters such as pH, color, and odor, essential for accurate vaginal infection diagnosis. With Examera, patients can eliminate the need for unnecessary doctor visits while still being able to monitor their vaginal health regularly. Our Competitive Advantages Key competitors in the vaginal health self- diagnosis test market are BD MAX, Natureland, Youcount, and VS-Sense. While BD MAX is restricted to clinic use and other competitors only measure one parameter, Examera is able to stay above the competition with its integrated technologies that make it an accurate, reliable, user- friendly, and affordable solution. Our Market The total addressable market in North America for Examera is worth $11 billion. Examera aims to target 5% of this market, making up a total of $15 million as the obtainable market. To generate revenue, Examera device and accessories will be sold to general practitioners, gynecologists, obstetrics, and clinics. The device is priced at $749. Other disposable components such as probes and plates will be offered at $8 and $1 each, respectively. Examera also comes with a monthly software subscription for all device users at $19.99. In the long term, Examera aims to reduce its production cost and expand to the general public health market. Our Marketing Strategy Marketing the product in North America, Examera first needs to obtain Class II medical device approval from Health Canada and the FDA. It will then partner with gynecologist and medical device distributors to sell the product. Other strategies such as cause marketing, social media advertisement, informative marketing will be implemented to raise brand awareness. Examera aims to capture 15% of market share by year 5. Challenges and Exit Strategies Being the new entrant, Examera will face some challenges such as limited consumer awareness, high competition, high product prices and high initial capital associated with acquiring regulatory approvals. These barriers can be alleviated with Examera’s comprehensive business model and innovative products. Several risks involved with the business have been identified, namely changes in medical regulations, device malfunction and misdiagnosis, data breach, competition threats, and brand- reputation damage. The following report points out some measures to take to mitigate and prevent these risks. Ideal exit options for Examera are company acquisition, management buyout, IP licensing, and IPO. Financial Considerations It is projected for Examera to sell $490,849 for the first year. This amount will grow steadily to reach $3,604,792 by the end of the fifth year. The company is required to sell at least 1005 units in order to reach its break- even-point. Examera starts making $111,392 profit in the third year, which reaches $1,162,502 by the end of the fifth year. This will create an average gross profit margin of 66% during the first five years. For the first year, Examera initiates the operation with six employees, including its four founders, with an average salary of $60,000 per staff. The number of employees is projected to double by the end of the fifth year. Start-up Financing Requirement The founders will bring in $200,000 to cover the startup costs for the first year. In addition, Examera seeks to raise $75,000 and $30,000 through Angel investment and the Canadian Scientific Research and Experimental Development (SRED), respectively

BUSINESS CONCEPT

Examera is a state-of-the-art technology that helps gynecologists monitor their patients’ vaginal health with accurate, easy-to-use, and inexpensive device assisted by IoT, ANN, and AI. Examera enables rapid vaginal infection diagnosis by simultaneous measurement of relevant and crucial parameters such as pH, color, and odor. The system can detect various vaginal diseases such as Gardnerella (BV) and Candida (Fungal Infection).

POTENTIAL CUSTOMERS AND BENEFICIARIES

Examera will enter the Canadian market through medical device distributors and direct outreach to the general practitioners, gynecologists, obstetrics, and gynecology clinics in Ontario, targeting women’s health. Examera will then expand its business to other provinces in Canada and general women’s health market.

4000 gynecologists in Canada¹        92,000  physicians in Canada¹

5,000,000  cases who can benefit from Examera in Canada          48,000,000 cases who can benefit from Examera in the U.S These physicians and clinics are the main source of revenue generation for Examera. Subsequently, Examera will be generating revenue from the general public section by selling directly to patients who self-monitor their key measurements’ levels to maintain their vaginal health. In addition, doctors can use Examera’s application to carefully monitor the patients’ state of health. This will be done through Examera’s preparatory software, which has a fixed monthly subscription fee. The followings are the potential customers and beneficiaries of Examera: Family doctors, gynecologists, and obstetrics Canadian Medical Association (CMA) Canadian Foundation for Women’s Health The Society of Obstetricians and Gynaecologists of Canada (SOGC)

PROBLEM

Vaginal diseases are some of the most common reasons women go to the doctor. These problems are usually accompanied by symptoms such as itching, burning, pain, abnormal bleeding, discharge, etc. One common vaginal disease is vaginitis, and inflammation of the vagina that can occur due to bacterial or yeast infection. Bacterial vaginosis (BV) is a common type of vaginitis caused by the overgrowth of natural bacteria in the vagina, which upsets the natural balance ². In order to shed light on the significance of the early detection of vaginal disease, some key facts have been presented below: 40% of women with vaginitis leave an initial medical visit undiagnosed Up to 75% of women experience at least one case of VVC, TV, BV in their lifetime3 40% – 45% will have 2 or 3 of this vaginal diseases3 These infections result in approximately 10 million office visit per year 3-7 Most women found to have BV (84%) have reported no symptoms3,8 Early diagnosis can lead to milder treatment, which is usually missed and costs more for the government of Canada to treat3 Multiple components increase test labor intensity and marginal cost Lack of electronic data capturing by existing solutions leads to no medical history for patients Existing at-home solutions measure only one parameter such as pH, which is not accurate enough for the proper detection of vaginal disease The early detection and diagnosis of vaginal problems are crucial in treating these issues. Examera offers a rapid and easy-to-use solution to screen bacterial vaginitis as well as other vaginal disease and provides early detection capability. Examera is a technology that aids women in monitoring their vaginal health with accurate, easy-to-use, and inexpensive device assisted by IoT, ANN, and AI. Using Examera, healthcare providers can receive timely updates on a patients’ test results for remote monitoring. Thus, the workload will be whittled down to in-practice testing. Women can regularly self-monitor their key measurements’ levels to maintain their vaginal health and build a personal medical history database. Additionally, they can record and compare these results and data with normal industry benchmarks and to carefully monitor their state of health while providing valuable information for the improvement of women health science. Currently, the test for diagnosis of vaginal disease is done by collecting vaginal discharge samples in clinics and measuring its pH, odor, and colour in clinics or through microscopy, gram stain, and DNA test in laboratories. These methods are suffering from low accuracy, long diagnosis time, or high costs. Examera is able to produce accurate results in a short time and with low costs eliminating the need for patients to have regular and unnecessary doctor visits.

TECHNOLOGY AND INNOVATION

Examera offers hardware and software solutions to health providers and women to rapidly get tested for various vaginal diseases, specifically with a focus on bacterial vaginosis (BV). The hardware device measures the collected sample’s color, pH, and odor. Additionally, it can determine the presence of Gardnerella Vaginalis (BV) and Candida (Yeast Infection) with a high level of accuracy. Examera Hardware Examera hardware incorporates multiple sensors that increase the efficacy of the diagnosis. The three main criteria for vaginal infection diagnosis, pH, the color of discharge, and odor are all measured with the Examera hardware device. After the sample is collected with a swab, it is placed in the sample holder. The device probes measure multiple variables, which are directly communicated with the software for diagnosis. In addition to the discharge’s physicochemical properties, the device also measures the biological activity in the discharge by providing information about the presence of bacteria or fungi. AI-Based Software Solution Upon registering with the Examera software, the physician will connect the device to the software through which the results will be analyzed. The AI-powered diagnosis platform will provide the diagnosis and will recommend treatment options to the physician. The patient will be able to separately connect their device to their profile, which will send updates to the physician. This feature will enable the tele women-health aspect of the Examera platform and reduces the need for an in-person visit.

INNOVATION OVERVIEW

The followings are the innovative ideas incorporated in Examera: High efficiency Examera provides healthcare providers with a seamless, uninterrupted, and user- friendly testing device that can quickly perform the test at a fraction of the cost of existing solutions. Innovative business model General practitioners, obstetrics, gynecologists, and other healthcare professionals are the channel partners introducing our device to patients. they can receive back- office support, and patients will be directly in control of their healthcare data. One-stop solution for accurate vaginal infection diagnosis. Due to each test’s limitations, physicians need to run multiple tests to distinguish between various vaginal infections. Examera provides multiple measurements through one sample and a software suite that analyzes the patient result and recommends management plans to increase care quality. AI-based software Examera currently has access to over 300 test results to train various recommendation engines to support healthcare professionals’ diagnostic and treatments

COMPETITIVE ADVANTAGES

The competitive analysis table illustrates Examera’s features in comparison to its key competitors. As demonstrated, Examera stays above the competition with its integrated technology, versatility, affordability, and test speed. As demonstrated above, Examera outperforms its competitors in all fields thanks to its sophisticated yet affordable state-of-the-art technologies. For example, Examera is the only device (except BD MAX) among its competitors with integrated pH, odor, and color tests for both home and clinic usage to produce the most accurate results while keeping its price lower than similar products. Examera’s competitive advantage over BD MAX is its affordability and faster test results using AI, which makes it suitable for both clinics and home users while BD MAX only targets the clinics.

MARKET

The total addressable market for Examera is estimated to worth $11 billion (including North American women affected with BV, clinics, gynecologists and general practitioners). From this potential market, $300 million is the serviceable available market (SAM), consisting of clinics, gynecologists and general practitioners (GP). Assuming we can target only 5% of this potential market, the serviceable obtainable market (SOM) is worth $15 million. It is also estimated that the market growth for this industry in North America is 2.4%, which demonstrates the growth potential of this lucrative business.

GLOBAL MARKET

The global vaginitis therapeutic market is anticipated to expand at a CAGR of 8.4% (2.4% in North America) during the forecast period (2014-2025). North America leads the global market owning more than a third of market share. Established healthcare infrastructure in North America along with the high prevalence of disease and the presence of key manufacturers are the major factors responsible for such a large market share. Favorable government initiatives and growing target population are also among the factors that propel market growth⁹. It is predicted for the Asia Pacific to witness the fastest growth with a CAGR of around 9.6% during the forecast period (2014-2025). This rapid growth is associated with high unmet clinical needs, rising disposable income, increased awareness about early diagnosis, and availability of effective drugs in emerging countries, such as India and China⁹.

BUSINESS MODEL

To generate revenue, Examera can be sold directly to clinics for doctors to lend or rent out to patients or run tests on their facilities. They can receive timely updates on the patient’s test results for remote monitoring. So, the workload will be cut down on in-practice testing. Each device is planned to be sold for $749 to the clinics, GPs, and gynecologists; while it costs $240 to be manufactured. This will create a 70% gross profit margin. Additionally, some accessories are disposable and will be supplied by manufacturer, such as probes ($8 each) and plates ($1 each), which cost $2.5 and $0.1 each to manufacture. Examera software solution will provide a secure text messaging service that can be used to answer patients’ questions, allow patients to update their condition, and to remind patients to adhere to their treatment or to transfer referrals to specialized healthcare providers. The software’s subscription fee is $19.99 monthly, which can be accessible to all patients, clinics or doctors that use Examera device. Long-Term Features In the long term, Examera will reduce its production cost and will enter public health market. Women can get connected to registered nurses quickly, share their screening and get professional supports. The platform will allow quick and low-cost visits to gynecologists to further assist with the accessibility of these professionals in various communities. Ultimately, we envision Examera to become the name brand for women’s health and become a platform for women to control their health and receive health-related products.

MARKETING STRATEGY

Examera will implement a go-to-market strategy through the following channels: Get Class II approval from Health Canada, and file 510K with the FDA to get approval to be able to sell the product in North America. Partner with a gynecologist to collect clinical data for sales case studies. Approach medical device distributors and head positioning system providers to sell products in North America. Digital marketing Social media marketing, SEO, Search Engine Marketing (SEM), etc. Examera will have a strong online presence for the purposes of customer acquisition, raising awareness around the diseases, raising brand awareness, and sales. Cause marketing Raising awareness around women’s vaginal diseases. The company will inform women of related diseases, which will lead to increased sales indirectly. Print advertisement Health magazines and women’s magazines, such as Women’s Health Magazine, Canadian Woman Magazine, etc. Examera aims to reach its target customers through channels (such as magazines, weblogs, social media influencers’ channels) that have common target customers. Informative marketing Passing the medical information and the product’s benefits through medical practitioners. Onboarding medical practitioners such as gynecologists as representatives to promote the products by simply delivering the medical information and product’s benefits. Attending related seminars and conferences Having a strong presence in seminars and conferences to raise brand awareness among medical professionals. Target market share Goal is to capture 15% of the market for these devices by year 5.

BARRIERS TO ENTRY

Below, some of the entry barriers to market for Examera have been identified: Limited awareness of vaginal self-screening products Various cultural and social stigmas lead to many women shying away from visiting gynecology clinics. Due to the lack of awareness around at-home diagnostic solutions that can provide accurate results, there have been increasing cases of vaginal infection left undiagnosed and untreated. This fact creates a challenge by adversely affecting the demand for the new products in the market, such as Examera, simply because the consumers are unaware of the existence of the new products. Examera can overcome this barrier by offering informative advertisements and workshops to educate consumers on the benefits of accurate and insightful diagnostic ability of the self-screening products. High competition BD MAX is one of the key competitors of Examera that provides an integrated diagnostic system that deals with a variety of diseases outside of vaginal infection. The versatility proves BD MAX’s popularity among medical practitioners, making it a dominant player in North America’s women’s vaginal health-diagnostic market. However, BD MAX only offers an industrial solution that is not household friendly. Examera fills this gap with its self-screening device that can produce faster and more efficient results. Other competitors such as Natureland and VS-Sense provide a more consumer-friendly type of product in the form of a visually-read swab. These swabs can be easily found and purchased through Amazon or any drugstores at a very reasonable price for at-home use. The convenience and accessibility contribute to these competitor’s growing market share in the vaginal swab market. However, these swabs have limited diagnostic ability as they only test for the pH level of vaginal discharge. Whereas, Examera’s device has well-rounded features for pH, odor, and color test with AI-based software. High product price Exemera comes with a non-disposable device, disposable components such as plates and filters, and a subscription-based application. The cost of permanent ownership for the whole package can be quite high for low-income users. This issue can be addressed by giving clinics, gynecologists, and general practitioners the option to rent out Examera to their patients, reducing the affordability issue. Regulatory hurdles The Canadian vaginal health self-testing market is governed by Health Canada. In order to be licensed for sale, Examera must prove that its home-use medical device is safe, effective and of quality manufacture. This is achieved through a pre-market review of medical devices (such as clinical studies) and post-market surveillance of adverse effects. The process of getting regulatory approval can sometimes be time-consuming and quite expensive. Thus, entering such a market can be fairly challenging and require high initial capital.