Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics
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- Annabella Morton
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1 Dear VPEG Limited Partner, We hope this investor update finds you well. We're pleased to share with you an important update below on the following: Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics MEDITE Cancer Diagnostics, Inc. specializes in the marketing and selling of MEDITE core products (instruments and consumables), manufacturing, development of new solutions in histology and cytology and marketing of molecular biomarkers. These premium medical devices and consumables are for detection, risk assessment and diagnosis of cancerous and precancerous conditions and related diseases. Depending upon the type of cancer, segments within the current target market of approximately $5.8 billion are growing at annual rates between 10% and 30%. The wellestablished brand of MEDITE Cancer Diagnostics is well received and a foundational cornerstone of the Company s business. The Company is publicly traded under the symbol MDIT, and the VPEG investment secures significant value added through warrant coverage and strategic affiliations. In 2016 and 2017 MEDITE focused on implementation of several growth opportunities including enhanced distribution of core products through focused sales and distribution channel(s), newly developed and patent pending assays, new laboratory devices and several marketing projects like the Chinese standardization projects for histology and cytology. The Company is optimistic about recent marketing efforts focusing on larger
2 laboratory chains and other important strategic relationships. The Company has approximately 74 employees in four countries, a distribution network to about 80 countries and a wide range of products for anatomic pathology, histology and cytology laboratories available for sale. MEDITE acts as a hub for histology (also known as anatomic pathology) laboratories either as part of a hospital, as part of a chain of laboratories or individually. It is one out of only four companies offering all equipment and consumables for these laboratories worldwide. The MEDITE brand stands for innovative and high quality products and competitive pricing. For the cytology market, MEDITE offers a wide range of consumable products and equipment; in particular for liquid -based cytology which is an important tool in cancer screening and detection in the field of cervical, bladder, breast, lung and other cancer types. It also developed an innovative, easy to use standardized staining solutions, and a very innovative and effective early cancer detection marker -based assays. These new developments are cost effective solutions able to replace more expensive competitive products, and therefore are also becoming the first choice for the growing demand in emerging countries. The above technologies have the ability to change the competitive landscape within the industry. China is one of the top strategic initiatives for MEDITE in 2017 & The Chinese market is growing quickly, and the Company expects it will be one of two largest markets for its products. By working with its Chinese distributor, UNIC Medical, the Company has successfully received China Food and Drug Administration ( CFDA ) approval for all MEDITE histology laboratory devices at the end of 2014, and for the Cytology device in The Company is working with UNIC and are anticipating increased sales in China in the third and fourth quarter of Also, together with UNIC, MEDITE is part of a government supported project to standardize the histology laboratory process in China. UNIC Medical is using MEDITE equipment and consumables for processing and launching new assays. UNIC has taken an active role in branding MEDITE Cancer Diagnostics in China.
3 On May 31, 2016, UNIC received CFDA approval as a Class I in vitro diagnostic reagent for MEDITE's "SureThin" cell preservation solution. As China adopts Cytopathology standards across the country, the Company expects 'Liquid Based Cytology Tests (LBC)' will be used for the majority of Pap collections for cervical cancer screening. MEDITE is prepared to sell the complete SureThin product line, including the already approved Processor to this potential market of 485 million women between the ages of 16 and 64 years of age. Management anticipates launching the product in China by the third quarter of 2017 and in the US by the fourth quarter of On May 31, 2016, UNIC received CFDA approval as a Class I in vitro diagnostic reagent for MEDITE's "SureThin" cell preservation solution. As China adopts Cytopathology standards across the country, the Company expects 'Liquid Based Cytology Tests (LBC)' will be used for the majority of Pap collections for cervical cancer screening. The Company is in the process of moving forward the submission of an application to the US Food and Drug Administration ( FDA ) for SureThin Gyn applications. Once approved, MEDITE can compete with some of the dominant suppliers in this $600 million market and target major strategic lab partners. The impact of the gynecology segment SureThin solution in the US and China market will drive significant new revenue and gross margin improvement opportunities in the later part of The product is attracting the interest of larger labs that will use both the SureThin non gyn and gyn applications. The gyn clearance with the sale of the SureThin processor will encourage market growth Management believes will provide sources for improved sales channels. MEDITE will launch SureThin in the US to independent labs using the LDT (Laboratory Directed Tests) protocol in CLIA approved sites as early as third quarter 2017 while continuing to work through the FDA path. The developed and US patented self collection device SoftKit is targeting the growing POC & POP (point of care or point of people care) market. Growth in this area is due to consumer driven health care requirements and the necessity to support and address incremental patient population needs for screening and on going diagnostic tests. SoftKit serves as just such a product, addressing this market requirement. SoftKit is planned to be sold through various marketing channels that serve the gynecology physician consumer health and emerging post -acute care as the influence of clinical
4 labs are expanded. Initially the SoftKit is targeted at the uterine cancer/hpv screening market. The next phase of testing will include cervical screening. MEDITE is currently developing a study plan with a major research center in the Midwest, with the goal of submitting for FDA approval during Management believes that 2017 developments, allows them to more fully leverage the products and biomarker solutions from the CytoCore component of MEDITE. The first entry will be the introduction of the SureCyte+ C1 (fluorogenic) instant stain, offering tremendous opportunities for lab efficiencies and enhanced patient care, C1 is the first of many new offering under the SureCyte brand. MEDITE is currently conducting informal studies with several labs in the USA and preparing a formal study with a hospital in China with our partner, UNIC. Cancers and precancerous conditions are defined in terms of structural abnormalities in cells. For this reason cytology is widely used for the detection of such conditions while histology is typically used for the confirmation, identification and characterization of the cellular abnormalities detected by cytology. Other diagnostics methods such as marker based assays provide additional information that can supplement, but which cannot replace cytology and histology. The trend towards more personalized treatment of cancer increases the need for cytology, histology and assays for identifying and testing the best treatment alternatives. MEDITE believes that this segment will therefore be increasingly important for future development of strategies to fight the cancer epidemic (World Health Organization: World Cancer Report 2014) which expects about a 50% increase in cancer cases worldwide within the next 20 years. This segment sees a trend toward, and demand for, higher automation for more throughput in bigger laboratories, process standardization, digitalization of cell and tissue slides and computer aided diagnostic systems, while also looking for cost effective solutions. In the US the Patient Protection and Affordable Care Act is a national example for the industry. More people have health insurance and therefore can afford early cancer screening, while at the same time the payers for health care continue looking for cost reductions. VPEG Chairman, Dr. Ron Zamber, summarized the opportunity: "MEDITE
5 represents an extremely scalable, globally recognizable entry for VPEG into the rapidly growing and critically important global cancer detection vertical. Their established customer base and revenue streams, and the unique deal structure allows us to mitigate down-side risk while preserving all upside potential for our investors. Their leadership team has shown exceptional competence and has demonstrated a well conceived and disciplined approach to optimize their growth strategy. In addition, VPEG's vast network of relationships in health care domestically and internationally will afford VPEG GP the opportunity to help accelerate value creation for MEDITE and VPEG's Limited Partners, while helping save countless lives through earlier, more cost effective cancer detection." Your VPEG Investor Relations team is here to answer your questions. Please be aware that future correspondences will be sent from info@vpeg.net; add this account to your contact list to avoid any future s being labeled as spam. This update contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of All statements, other than statements of historical facts, included in this update that address activities, events or developments that Visionary Private Equity Group I, LP ("VPEG") and the companies or ventures that it has invested (or target as an investment) (collectively, the Companies") expect, believe or anticipates will or may occur in the future are forward-looking statements. Without limiting the generality of the foregoing, forward-looking statements contained in this update specifically include the expectations of management of VPEG and the Companies regarding plans, strategies, objectives, anticipated financial and operating results of VPEG and the Companies, and production and operating expenses guidance included in the update. These statements are based on certain assumptions made by VPEG and the Companies based on management's experience, technical analyses, current conditions, anticipated future developments and other factors believed to be appropriate and believed to be reasonable by management. When used in this update, the words will, potential, believe, intend, expect, may,
6 should, anticipate, could, estimate, plan, predict, project, target, profile, model or their negatives, other similar expressions or the statements that include those words, are intended to identify forwardlooking statements, although not all forward-looking statements contain such identifying words. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of VPEG and the Companies, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the Risk Factors disclosed in VPEG's private placement memorandum. Any forward-looking statement speaks only as of the date on which such statement is made and VEPG and the Companies undertake no obligation to correct or update any forwardlooking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. An investment in VPEG involves a high degree of risk and other considerations and, therefore, should be undertaken only by investors capable of evaluating the risks of making such an investment and bearing the risks, it represents. As an investor in VPEG you have carefully consider the information provided in this update; however, as a sophisticated investor you acknowledge that you have relied upon your own examination of and ability to understand the nature of this update, and your investment in VPEG, including the risks involved, in making a decision to invest in VPEG. There can be no assurance that VPEG will be able to achieve its investment objective or that investors will receive any return on or of their capital.
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