Eric K Mangiardi
President & C.E.O.
Prior to this role, Mangiardi held Board positions and or was an investor in QualiMed , AMG, and Alveolus where he served as the CEO and founder before the company was acquired by Merit Medical and now forms that foundation of their Merit Endotek Division. He has 25 years of experience and a number of patents and patent applications in his name for various novel medical devices. Mangiardi holds an MSc in International Marketing, from the University of Strathclyde, Glasgow, Scotland and a Bachelors of Science in Finance and Marketing from the University of Dayton, USA.
Chief Risk Officer
Prior to this role, Gülcher was Founder and Co-Managing Director at QualiMed where he held numerous position as the Head of Regulatory, Quality, Drug Device Combination Technologies, and oversaw the legal functions within the business. Gülcher is a graduate in Electronic Engineering and previously worked as manager for quality and regulatory affairs at Devon Medical GmbH, Hamburg, and as Head of medical devices approval at DEKRA GmbH.
QUALIMED INNOVATIVE MEDIZINPRODUKTE GMBH
QualiMed Innovative Medizinprodukte GmbH (QualiMed), a Q3 Medical Limited Holding, is a German based manufacture and developer of high end, implantable medical devices for the Interventional Cardiology, Peripheral Vascular, and Non-Vascular specialties. QualiMed was found in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory approval of coronary stents and their respective delivery devices. As an OEM they designed and manufactured implantable stent devices for some of the most well know global medical device companies. Later the business was expanded to peripheral vascular and non-vascular implants that included the world’s first removable pulmonary, esophageal, and biliary stents. In the last years QualiMed has focused on the development of various Micro Invasive, Bioresorbable and Drug Delivery platform technologies, as part of its global commercialization strategy for its own branded products. The company has CE approvals to sell its core technology products including mechanical implants, catheter-based technologies including delivery devices, balloons, aspiration devices, drug device combination technology (Drug Eluting Stents and Balloons), and biodegradable / bio-absorbable technologies.
Manufacturing is organized in an owned facility outside of Hamburg Germany in the town of Winsen where QualiMed runs two Class 10,000 Clean rooms according to EEC GMP standards. The Company has production capabilities for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications and holds more than 70 patents and utility models worldwide.
AMG INTERNATIONAL GMBH
amg International GmbH (AMG), a Q3 Medical Limited Holding, a German based developer, manufacturer, and seller of high-end Cardiology and Peripheral Vascular devices in Europe, South America, Middle East, and Asia. AMG was founded in 1997 as a manufacturer and distributor for implantable medical devices with a focus on the development and regulatory approval of coronary and peripheral vascular devices. AMG is currently commercializing its technology in over 30 countries and has recently completed its clinical studies for an advanced coronary stent with a fast absorbing biodegradable polymer that may limit the time required for post implant dual anti-platelet therapy with 5-year follow up.
AMG GI: In 2017 the interventional coronary and peripheral vascular core customers were transferred to QualiMed own branded products and AMG will serve as the channel and brand for the company’s new Non-Vascular product lines including ARCHIMEDES Bioresorbable replacement for the 1.5 Million plastic stents that are used annually. Plastic stents have the distinct disadvantage of requiring a removal procedure and a high complication. In addition, its UNITY-B Bioresorbable Balloon Expandable Biliary technology, (a hybrid platform of magnesium and polymer) is currently undergoing clinical studies and is expected to be launched in the 1st half of 2019.
Numerous other Bioresorbable developments are ongoing from the Bioresorbable covered version of the UNITY-B platform, to a Bioresorbable esophageal, and pseudocyst drainage system. All products built for the AMG GI product line will be Bioresorbable. The distribution channel has already begun to form in Europe, Asia, South America, and the Middle East with approximately 20 distributors contracted or in contract discussions and the first orders shipped to the distribution partners for ARCHIMEDES, its 1st CE approved Bioresorbable replacement for plastic biliary stents.
Q3 Medical Devices (Shanghai) Co. Ltd. (Q-San) a Q3 Medical Limited Holding, is a Baoshan, China (Shanghai Region) based wholly owned foreign subsidiary focused on the development, manufacturer, registration, and commercialization of products for the Chinese market as well as to support the manufacturing needs of Q3 Holdings combined companies to further enhance competitiveness and optimize supply and distribution channels. The Baoshan facility will have the same capabilities as the German manufacturing (QualiMed) facility with the added benefit of 4x the capacity and an optimized production flow.
The combined manufacturing entities give the Company capacities and redundancies it needs as it continues to execute on its global growth initiatives while providing risk reduction through the multiple production facility locations. The 45,000 sq/ft (4500 sq/m) facility is expected to be operational in the second half of 2019 with the ability to provide products to the Q3 companies at that time. Q3 is working very closely with the local Baoshan and regional Shanghai governments to ensure that the project meets all local registration requirements. Q3 Holding along with its local construction partner and most recent investor, “Boil Holding Group” are in active works to complete the facility as planned. The facility is an owned facility.
307, Building 5, No. 99, Fulian 2nd Road, Baoshan District, Shanghai
QUALIMED USA, LLC
QualiMed USA, LLc (QualiMed USA), a Q3 Medical Limited Holding, is a Charlotte North Carolina based wholly owned subsidiary focused on the development, manufacturer, registration, and commercialization of products for the North American market. It is currently in the process of registering an IDE with the USA FDA to gain approval to trial its ARCHIMEDES Bioresorbable replacement for plastic biliary stents. The US market alone represents an annual usage of approximately 500,000 stents. As mentioned previously the ability of ARCHIMEDES to eliminate the cost and complications associated with the traditional removal procedures required for plastic stents at a maximum of 90 days post implant represents a significant opportunity for the Company, patients, doctors, and insurance providers to deliver a better quality of care at a substantially lower cost. With US facility fees alone for removals ranging from $5,000-$10,000 the Company believes there is a significant opportunity to supplant the traditional plastic stents with ARCHIMEDES.
QualiMed USA, LLc
1800 Camden Rd, Suite 107, (P.O Box 252), Charlotte, North Carolina 28203