SOURCE: Golden Valley Development, Inc.

June 03, 2015 09:17 ET

Golden Valley Development, Inc. Enters Into Agreement, Receives Initial Purchase Order to Commercialize XytoTest Breakthrough Cervical Cancer Device

Groundbreaking Cervical Cancer Detection Device Establishes Commercialization, Investment and Production Agreement to Capitalize on a $7 Billion Global Market Opportunity

FORT LAUDERDALE, FL--(Marketwired - Jun 3, 2015) - Golden Valley Development, Inc. (OTC PINK: GVDI) (the "Company"), a developer and marketer of patented and patentable technologies, is pleased to announce a purchase order agreement and strategic partnership with Mel-Mont Medical, LLC, ("Mel-Mont") to commercialize XytoTest™ worldwide. ( 

The cervical cancer diagnostic test market will reach $9 billion by 2020 with an annual growth rate (CAGR) of 6.1%, according to Transparency Market Research. Over half a million cases are detected every year. Over 275,000 women die every year from cervical cancer, of which 85% of these deaths are in developing countries.

"No woman should die from cervical cancer. The real tragedy of cervical cancer is that it is easily preventable if detected early enough," stated Liliana Montes, Mel-Mont Medical CEO. "What is exciting with XytoTest™ is that now women can self-sample and actually receive more accurate, detailed results, so they can either get early care or avoid the disease completely. We are very excited about the opportunity to partner with Golden Valley Development because of their unique desire to work with patented medical devices for large scale commercialization."

The purchase order agreement entails the initial purchase by Mel-Mont of 100,000 XytoTest™ units from GVDI valued at $440,000 and to be delivered in 4 equal phases with larger commercial orders to follow. The product is being clinically tested in Spain, Columbia, and has a clear path for commercialization in 31 countries in Europe through the CE registration. XytoTest™ is in the process of obtaining the necessary approvals from Mexico and US FDA. It is covered by a US Patent PTO number 62045844.

XytoTest™ is a self-sampling kit of cervical specimens for the analysis of DNA for the 14 high-risk strains of HPV (Human Papilloma Virus). The medical device is comprised of a hollow sheath made of special resin that meets US FDA 21 CFR 181.32 requirements. The device is user-friendly and is less than 8 millimeters in diameter. There is a cell collector of USP medical grade IV elastomer fully tested to guarantee no skin or mucous membrane irritation in accordance to ISO 10993-5 and ISO 10993-10.

"XytoTest™ is easy to use by any woman and was designed so that any woman, in minutes, anywhere can now self-sample and receive a DNA analysis of the results. This can avoid many unnecessary deaths and improve the quality of women's lives," stated Frank Melendez, COO of Mel-Mont.

Mel-Mont Medical, LLC, a Florida corporation, is a US medical device firm focused on comprehensive health care programs for vulnerable female populations located in rural areas of developing countries, has launched a unique patentable self-sampling device, XytoTest™, that enables women anywhere in the world to either test themselves for the presence of cervical cancer or help them determine the likelihood they will develop this deadly cancer. Over half a million new cases of Cervical Cancer are detected every year.

"GVDI is thrilled with this strategic commercial partnership and initial purchase order with Mel-Mont. It furthers our medical division and its development and commercial deployment of groundbreaking, patented and patentable life-saving medical technological devices. We cannot overemphasize the quality of the people behind this great company and its extraordinary products," stated Kevin Sorrels, CEO of GVDI.

Ms. Montes, CEO of Mel-Mont Medical, is an experienced operations and global logistics manager for pharmaceutical/medical devices field with vast experience in the regulatory and compliance field, especially Europe, Latin America and the Middle East. She is also an authority in preventive cervical cancer sampling medical devices. Mr. Melendez is an experienced developer and inventor of medical devices and OTC formulations for the professional, retail, and medical product markets.

"Liliana and Frank and the Mel-Mont team bring a wealth of expertise; we are enormously appreciative to be commercialization partners with them," said Kevin Sorrels, CEO of GVDI.

Through its unique approach to product development, Mel-Mont Medical has developed a one-of-a-kind medical device kit that empowers women to test for cervical cancer. Unlike traditional screening using Pap smear, woman can now use XytoTest™ in a private setting to avoid the embarrassment, anxiety, or fear caused by the regular cytology. The key drivers of the Company's product development approach include: Private setting; No qualified personnel required; FDA approved DNA technology; 94% sensitivity reducing false negatives; Higher population coverage; and Cost-effectiveness. XytoTest™ is a self-sampling kit of cervical specimens for the analysis of DNA for the 14 high-risk strains of Human Papilloma Virus (HPV). Mel-Mont currently operates in the USA and emerging countries including in Latin and South America with a focus in Colombia, where the company has offices, and Mexico.

Screening for high risk Human Papilloma Virus (Hr-HPV) infection is more effective in reducing the incidence of cervical cancer than screening using regular cytology (Pelvic Examination). Moreover, Hr-HPV testing can be done on a vaginal sample self-taken by a woman herself with XytoTest™, which offers an opportunity to improve screening coverage and high sensibility when done via DNA analysis.

According to a research funded by The 7th Framework Programme of the European Commission, the Belgian Foundation against Cancer, the International Agency for Research on Cancer, and the German Guideline Program in Oncology, there have been 36 studies conducted involving 154,556 women to establish the accuracy of human papilloma virus testing on self-collected specimens with medical devices such as XytoTest™. The results demonstrate that the DNA analysis via Polymerase Chain Reaction (PCR) on self-collected samples with a medical device such as XytoTest™ to identify Hr-HPV have similar sensitivity to clinician-collected samples, but it is cost-effective and increases population coverage.

About Golden Valley Development, Inc.
Golden Valley Development, Inc. ("GVDI" or "Company") is a holding company and developer and marketer of patented and patentable technologies. As a holding company, GVDI is focused in technology and financial services, engaging in several business activities, the most significant being as a technology provider to third party logistic providers and as a financial service company for small-to-medium sized businesses (SMEs) worldwide.

About Mel-Mont Medical LLC
Mel-Mont Medical (MMM) researches, develops and markets comprehensive health care programs for the vulnerable and female population using proprietary medical devices. Founded in 2014, Mel-Mont Medical develops educational and self- sampling campaigns to reduce the spread of HPV infections. Also it provides information and education about Human Papilloma Virus (HPV) as a precursor of cervical cancer within the female population sexually active. Our health programs are directed to the vulnerable, female population located in rural areas of developing countries around the globe, where traditional health care systems are difficult and complex to implement. The company operates in the USA and emerging countries including Latin and South America with a focus in Colombia, where the company has offices, and Mexico.

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