Innovative Nitric Oxide Delivery Device Company Announces Addition of FDA Advisor
SALT LAKE CITY, June 18, 2019 (GLOBE NEWSWIRE) — Nu-Med Plus, Inc. (NUMD),
a medical device leader developing new nitric oxide delivery technology
along with innovative applications in the medical field, announces the
engagement of Christina Thomas as a strategic regulatory service
partner. The announcement comes in anticipation of near-term FDA 510(k)
fillings for Nu-Med Plus nitric oxide delivery devices.
“We welcome Ms. Thomas to our company and we are certain she will provide highly valued insight and assistance navigating our company thru the FDA processes for new technologies. Christina’s proven track record of successful interactions with industry and her regulatory expertise make her an excellent addition to the Nu-Med team,” says Jeff Robins, CEO of Nu-Med Plus, Inc. “Christina’s appointment reflects our ongoing commitment to utilize experience and expertise, to advance our unique medical technology through the ever changing global regulatory approval process.”
Ms. Thomas has worked in regulatory affairs for 20+ years in the medical device industry while working with the FDA for many years on various device submissions and served as a subject matter expert for the FDA in medical software and instrumentation classification. Her auditing experience includes training by the FDA on medical manufacturing inspections, as well as domestic and international inspections. In addition, she is an expert in global product licensing, product registrations and notifications with international government agencies as well as sanctioned countries. Her experience has led her to develop regulatory strategy, product submission process and strategy and she has obtained multiple certifications for medical corporations as well as startup businesses.
The current administration recently published regulatory reform plans that harmonize FDA regulations with international standards. This will make medical devices approved in the U.S. easier to approve in other countries. Nu-Med Plus management has recognized the significance of these changes and is proactively taking steps to make Nu-Med Plus devices available for the international market in the future.
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About Nu-Med Plus, Inc.: Nu-Med Plus, Inc. founded in 2011 is a medical device development company created to explore medical applications of newly developed nitric oxide technologies. The strategy is to focus on high growth potential markets where there is a clearly defined need recognized by the medical community that can be addressed by Nu-Med Plus and its technical expertise. Initial research and product development have been in the delivery of inhaled nitric oxide gas for therapeutic use. For more information please visit www.nu-medplus.com.
Forward-Looking Statements: Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s ability to complete proposed private placement financing. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.