SOURCE: iNeedMD Holdings, Inc.

September 29, 2015 06:00 ET

iNeedMD Receives CFDA Registration in China

NEW YORK, NY--(Marketwired - Sep 29, 2015) - iNeedMD Holdings, Inc. (OTCQB: NEMD) ("iNeedMD" or the "Company"), a medical device development company, is pleased to announce that it has received its China Food and Drug Administration ("CFDA ") registration certificate for The EKG Glove™. The CFDA is the main administrative authority charged with the regulation and control of medical devices in China. With CFDA approval, iNeedMD can solidify relationships with local Chinese distribution and sales organizations to promote The EKG Glove™, especially in the rapidly emerging telemedicine market. We believe China's primary care system is underfunded with basic medical services often absent outside of highly taxed public hospitals located in Tier 1 cities like Beijing or Shanghai. As a result, telemedicine may offer China an opportunity to create an easily accessible point-of-care healthcare system in the other Tier 2 through Tier 7 cities that make up 98% of China's aggregate population.

According to the World Health Organization (WHO), cardiovascular disease impacts approximately 230 million Chinese citizens which equates to one-in-five Chinese adults. In addition, the WHO estimates that between 2010 and 2030, annual cardiovascular events are projected to "increase by 50% based on population aging and growth alone." As a result, we believe the widespread availability of diagnostic 12-lead electrocardiograms ("EKGs"), the mainstay of universal cardiac care, will be integral to the diagnosis or rule-out of cardiac events or conditions in any comprehensive telemedicine system.

EKGs assess the electrical activity of an individual's heart and traditionally require a trained professional to place a complicated system of ten electrodes and ten corresponding lead wires in a specific configuration on an individual's chest to obtain an EKG tracing. The EKG Glove™ integrates a standardized system of electrodes and lead wire circuitry into a one-piece, disposable glove-like sheath that can be easily positioned on an individual's chest to acquire a diagnostic, 12-lead EKG. Its peel-and-stick format can be deployed in less than 60 seconds with minimal instruction making it appropriate for use in clinic, pre-hospital, and remote testing environments where access to highly-skilled technicians may be a challenge. A single cable connects The EKG Glove™ to a variety of portable Bluetooth-enabled EKG acquisition devices or more stationary EKG machines offering users a flexible and convenient testing platform.

iNeedMD's President and CEO, Thomas Nicolette commented, "The Company has been tracking the various guidance documents issued by the National Health and Family Planning Commission of the People's Republic of China ("NHFPC"). In early 2015, the NHFPC outlined a plan to build a uniform national telemedicine service network throughout the country's vast geography given the shortage of primary care providers and facilities. We believe remote electrocardiograms are built into the framework of China's evolving healthcare system. As a result of the CFDA's approval of The EKG Glove™ and the device's ability to be paired with a variety of portable EKG acquisition devices, iNeedMD is now able to begin forging partnerships with well-established distributors within the Chinese medical device market. We anticipate further announcements as to these agreements within the fourth quarter of this year."

About iNeedMD Holdings, Inc.

iNeedMD Holdings, Inc., headquartered in New York City, develops and markets medical device solutions that enable individuals and their healthcare partners to easily acquire, store and export health- and wellness-related data in convenient, portable platforms. Please visit www.ineedmd.com for additional information.

Forward Looking Statements

This press release may contain "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. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and other filings made by the Company with the U.S. Securities and Exchange Commission.

Contact Information

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    iNeedMD Holdings, Inc.
    Phone: 212.256.9669
    Email: ir@ineedmd.com