MEDITE Cancer Diagnostics, Inc. Reports 2014 Year End Results along with Expectations for 2015

ORLANDO, Fla., May 11, 2015 /PRNewswire/ -- MEDITE Cancer Diagnostics, Inc., (MDIT) specializing in the development, manufacturing and marketing of molecular biomarkers and premium medical devices for detection, risk assessment and diagnosis of cancer and precancerous conditions announces 2014 results and expectations for 2015.

In 2014, MEDITE Enterprise, Inc., with its subsidiaries in Germany, Austria and Poland, transformed through its purchase by CytoCore, Inc.  from a privately owned company into a public company with a well know brand, 76 employees and an existing distribution network into about 70 countries.  

MEDITE is now recognized as an up and coming competitor in the multibillion dollar anatomical pathology and cytology global market. MEDITE's products improve the process and quality of cytology and histology methods and tools used for risk assessment and the diagnosis of cancer or precancerous conditions. The company is focused on becoming a global manufacturer of total histology and cytology solutions. The synergies resulting from the combined extensive research, knowledge, experience and developments of CytoCore Inc., with the engineering and marketing capabilities of MEDITE, should significantly expand product offerings and addressable markets for the new MEDITE.

"We are pleased MEDITE's core business increased revenue, and remained operationally profitable, while obtaining very promising research and development technology from CytoCore, which should be an integral factor as MEDITE becomes an innovative force in cancer diagnostics.  While reducing CytoCore's operational losses by 50%, we made significant investments and achievements in the following new markets, products and developments," commented Michaela Ott, CEO of MEDITE Cancer Diagnostics, Inc.

• Chinese Market Collaboration
  We achieved another major goal in 2014 with our market entrance into China. In our opinion, China is the fastest growing and, by 2016, one of the largest market places for our products. With our Chinese distributor, UNIC Medical, we successfully received Chinese Food and Drug Administration ("CFDA") approval for all MEDITE histology laboratory devices. The CFDA application for the cytology product line currently is in preparation, and approval is expected in 2015. The UNIC sales team has already successfully started selling the MEDITE histology products in China. During the first quarter we've already received purchase orders for approximately $500,000. Furthermore, we are planning with UNIC, as part of a government initiative, to standardize the histology laboratory process using MEDITE equipment, consumables, immuno-assays, along with the approved UNIC scanning technology for digitalization and computer aided diagnostics utilizing the latest cloud technology. UNIC Medical is a subsidiary of UNIC Group, a high tech company focused on automated digital optical quality assurance technology.
  
  
• Cancer Risk Assessment Immuno-Assays and Special Stains
  MEDITE has developed an innovative cytology stain and immuno-assays to be used for the detection of cancer and precancerous cells. Conventional tests, such as those used in the standard PAP test for cervical cancer, don't utilize special stains; therefore abnormal cells can blend with normal cells and may potentially avert detection. In addition, our test significantly reduces the time for processing a Pap to under a minute from over 30 minutes, and reduces or eliminates the use of hazardous reagents. Our cancer risk assessment immuno-assays developed over the last few years are showing excellent results in internal studies, but have not been tested yet in formal clinical trials. This new immuno-assay, with our new special stain applied with our proprietary image recognition software, "highlight" specific cells to appropriately identify abnormal cells. Among others, we believe healthcare practitioners can utilize MEDITE's solution to supplement existing PAP test methods. In our opinion, one of the tests based upon our immuno-assays has the potential for displacing the expensive Human Papilloma Virus (HPV) testing methods. MEDITE's enhanced test potentially improves the accuracy of patient diagnosis and reduces costs associated with unnecessary testing. We aim to start marketing this test globally outside the United States in 2015, and in the United States by 2017.
  
  
• CytoTape – Coverfilm
  MEDITE becomes the third participant in an approximate $60 million market dominated currently by one supplier. This product replaces glass as the protective cover of microscopic slides and allows for far quicker slide processing.
  
  
• Twister – Film-Coverslipper
  This highly demanded new type of instrument is able to coverslip microscopic slides at speeds of up to 1,200 slides per hour. The current average glass-coverslipper on the market can only coverslip an average of 200 slides per hour. Our Twister perfectly complements our own CytoTape and could increase market share globally.
  
  
• Microtomes and Cryostats
  New manufacturing methods will enable MEDITE to increase its product gross margin while keeping the highest level of precision. These machines, which address approximately a $90 million market, are used to section human tissue into a few micron thin slices for optical microscope cancer screening. The new specially designed manual microtome specifically targets emerging countries, while the new Cryostat is designed to set new standards in compact size and low energy consumption.
  
  
• BreastPap
  Independent studies confirm the analysis of female breast nipple aspirant, or the detection of abnormal cells, can be a useful risk analysis procedure for further evaluation of breast cancer for women between the ages of 20 and 45, when in most cases mammography is not appropriate. For them, it is a simple and affordable way to receive information about their breast cancer risk based a noninvasive method. MEDITE will soon test a prototype of an inexpensive breast aspirant collection device. Collected cells drawn from this device or fluids from the breast aspirant needle procedure can therefore be tested with the MEDITE assays and quickly evaluated for the possibility of cancer or precancerous conditions. We believe a market of 300 million women currently exists for the application of MEDITE's assays for either the "breast pap" or fine needle aspirant procedures in countries where testing is currently affordable and reimbursed. First market entries are planned in Europe and Asia using MEDITE's CE mark.
  
  
• Standard Histology Staining Solution
  Our highly innovative newly developed staining solutions for histology and cytology are fulfilling modern needs for digitalization, computer aided diagnosis, and therefore can set a new standard in the industry around the world. It can replace the currently used Hematoxylin and Eosin stains, and in addition can reduce or eliminate laboratories' use of environmentally hazardous reagents like xylene or formalin.
  
  
• Histology Lab-in-One Patent
  Similar to the highly automated clinical laboratory industry, the anatomic pathology laboratory industry is about to undergo an automation transformation. This highly innovative patented method will serve the industry in transitioning towards automation. Biopsies could be automatically processed into microscopic slides for diagnosis and digitalization. This Lab-in–One-technology, has the ability to change the competitive landscape within the industry.

We believe these significant investments in marketing, research and development as indicated in our results of operations for 2014 shown below, provide the launch for an exciting growth company looking to significantly increasing participation and market share in a dynamic multibillion industry.   

Total revenues of $11 million for the fiscal year ended December 31, 2014 represented an increase of 10% from 2013. This increase was mainly a result of the growing sales of the recently launched cytology product lines to $1,852,000 (+38 %) and the growing revenue in the USA to $1,396,000 (+107%).

Cost of revenues represents the cost of the product sold, freight, and other costs of selling our products, totaled $7.16 million compared to $5.75 million for the year ended December 31, 2013. This mainly resulted from a higher percentage of distributor versus direct sales compared to the previous year.

Research and development expenses increased to $1.24 million compared to $934,000 for 2013. This increase of $309,000 or 33% is the result of the expenses associated with the former CytoCore, Inc. during 2014.  MEDITE's stand-alone funding for research and development, not including the contribution from CytoCore, Inc., increased $115,000 for year 2014 versus year 2013.

The operating loss of $394,000 of 2014, compared to the operating profit of $294,000 in 2013, resulted primarily from the inclusion of the $638,000 in operating expenses from the former CytoCore.

The net loss for the year ended December 31, 2014, totaled $699,000 as compared to net income of $54,000. As noted above, the primary reason for the loss was the inclusion of the results of operating expenses, including research and development associated with the former CytoCore's operations, and increased income tax expense resulting from expensing the $129.452 deferred tax asset previously capitalized at December 31, 2013.   

About MEDITE Cancer Diagnostics, Inc.
 MEDITE Cancer Diagnostics Inc., is a Delaware registered company consisting of wholly-own MEDITE GmbH a Germany-based Company, with its subsidiaries CytoGlobe GmbH (Cytology Products, Germany), MEDITE GmbH (Distributor, Austria), MEDITE Inc. (Distributor, Americas) and MEDITE sp. z o.o. (R&D Poland). Since 1978, the MEDITE® group of companies has specialized in the development, manufacture and distribution of medical laboratory automation equipment and supplies for pathology, histology and cytology. For these fields, MEDITE offers a complete range of devices and consumables.  MEDITE currently sells into 70 countries and is the market leader in Germany. Through CytoGlobe, a wholly owned subsidiary, MEDITE offers a full range of products for Cytology labs. Additional information on MEDITE's products and services can be found at www.medite-group.com. On April 3, 2014, MEDITE was purchased by CytoCore, Inc. a bimolecular diagnostics company engaged in the design, development, and commercialization of cost-effective cancer screening systems and Biomarkers to assist in the early detection of cancer. The name of the company changed from CytoCore, Inc. to MEDITE Cancer Diagnostics, Inc. in early December 2014.

Forward Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding future operating performance, events, trends and plans. All statements other than statements of historical fact contained herein, including, without limitation, statements regarding our future financial position, business strategy, budgets, projected revenues and costs, and plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may," "will," "expects," "intends," "plans," "projects," "estimates," "anticipates," or "believes" or the negative thereof or any variation thereon or similar terminology or expressions. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause our actual results to differ from our expectations, include but are not limited to, MEDITE's ability to maintain and grow its revenues, as well as those risk factors that apply to our operations as disclosed in Item 1A of our Report on Form 10-K for the year ended December 31, 2014 and other filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on our forward-looking statements, as they speak only as of the date made. Such statements are not guarantees of future performance or events and we undertake no obligation to disclose any revision to these forward-looking statements to reflect events or circumstances occurring after the date hereof.

For more information please visit: www.medite-group.com

SOURCE MEDITE Cancer Diagnostics, Inc.

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