FDA 510(k) Application Withdrawn for Angiodroid CO2 Injector for Angiography
NORTHVALE, N.J., Nov. 20, 2015 /PRNewswire/ -- ADM Tronics Unlimited, Inc. (OTCQB: ADMT) has announced that Angiodroid America, Inc. has withdrawn its Premarket Notification 510(k) application filed with the US Food and Drug Administration (“FDA”) for Angiodroid The CO2 Injector for Angiography (the “Angiodroid Injector”). The Angiodroid Injector is the first automatic injector for peripheral angiography using carbon dioxide gas (CO2), eliminating both the pathologies associated with iodine contrast medium that often is not tolerated by diabetic or nephropathy patients, and the risks and pain associated with the manual injection of CO2.
The decision to withdraw the 510(k) was unrelated to the Angiodroid Injector device but due to CO2 gas itself having not been previously approved by the FDA for this use. Angiodroid America is now reviewing what would be required for CO2 gas to be approved for this use. Angiodroid The CO2 Injector is already approved for sale by the European Regulatory Authorities and has been introduced in Europe, Middle East and Asian markets.
Angiodroid, Srl is a privately owned Italian entity. Angiodroid America, Inc., founded last year in affiliation with Triotech Ventures and ADMT, is a majority-owned subsidiary of Angiodroid, Srl. ADMT owns 20% of Angiodroid America, Inc. and provides it with engineering and regulatory services and will be the exclusive manufacturer of the device for the North American market.
The mission of Triotech is to support foreign medical technology companies with specialized services and finances to assist such companies to access the North American marketplace through a US-based subsidiary. For each accepted project, Triotech selects a team of partners, companies and professionals with specific expertise for a particular project. ADMT was selected to join the consortium to provide engineering, regulatory and manufacturing services for Triotech projects.
ADMT specializes in electronic medical device design, development and manufacturing for diagnostic and therapeutic medical technologies at its FDA-Registered Medical Device Manufacturing Facility. The Company is a one-stop source for complete design, engineering, regulatory and manufacturing services. ADMT has a number of proprietary medical devices. These proprietary devices, conceived, designed and produced in-house, include therapeutic and diagnostic medical technologies in fields as diverse as audiology, physical medicine, wound therapy, neurology and urology.
About ADMT
ADMT is a diversified, technology-based developer and manufacturer of innovative technologies and products. Its core competency is its ability to conceptualize a technology, bring it through development, into manufacturing and commercialization, all in-house. ADMT has three Business Segments: Proprietary Electronic Medical Devices; Eco-Friendly, Safe, Water-Based Formulations; and, Design, Engineering, Regulatory and Manufacturing Services. The Company’s headquarters, laboratories, medical device and manufacturing operations are located in Northvale, NJ. ADMT’s multi-disciplinary team of engineers, researchers and technologists employ advanced technology infrastructure, such as 3-D solid prototyping, precision instrumentation and specialized software and peripherals for the research, development and commercialization of diversified technologies. Additional information is available at the Company’s websites - admtronics.com and concepttoquantity.com.
Except for historical information contained herein, the matters set forth in this news release are “forward looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Although ADMT believes the expectations reflected in such forward looking statements are based upon reasonable assumptions, there can be no assurance that its expectations will be realized. Forward looking statements involve risks and uncertainties that could cause actual results to differ materially from expectations. Factors that could contribute to such differences include those described from time to time in ADMT’s filings with the SEC, news releases and other communications.
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SOURCE ADM Tronics Unlimited, Inc.
