QualiMed
Localized Drug Delivery

The enormous growth of nanotechnology has paved the way for the development of advanced drug delivery systems, which have ultra-precision and control over the release kinetics of various drugs. Different strategies such as encapsulation, biomarkers, and artificial nanocarriers have been adopted by companies to ensure targeted and controlled drug delivery. However, they have not been able to develop a better delivery vehicle to improve the outcomes of these newly developed drugs and therapies.

Enter QualiMed Innovative Medizinprodukte GmbH, a wholly owned subsidiary of Q3 Medical Devices Ltd, Dublin, Ireland, a leader in the design, development, production, and sales of innovative medical devices for cardiology, peripheral vascular, non-vascular, and surgical intervention, and the patients they treat. Q3 Medical Devices Ltd. and its owned companies— QualiMed, AMG, Qsan China, and QualiMed USA—are continually focused on enhancing its team of medical device professionals who are interested in working in this fast- paced ever-changing environment. QualiMed is differentiating itself by developing an intraluminal localized delivery tool intended to combat the current inability to achieve safe local therapeutic concentrations at target sites due to the negative systemic impact. "Treatments and therapies delivered locally—localized drug delivery or localized therapy delivery—represents the best opportunity for increasing efficacy while minimizing the impacts of systemic toxicity or complications associated with many treatments using cytotoxic drugs or controlled therapies. This is where we will excel," says Eric K. Mangiardi, the CEO of Q3 Medical Devices Ltd.

The Company is focused on three areas of intervention: Interventional Cardiology, Peripheral Vascular, and Non-Vascular solutions. These clinical focus areas represent a significant amount of market opportunity while also highlighting the increasing need for more cost-effective, efficacious treatments that improve outcomes and reduce costs for patients.

To continually innovate, QualiMed augments its team with talented individuals who are aligned with the evolutionary change that the company is bringing to the market from its biodegradable, micro-invasive, and localized drug delivery technologies. “Our people are our drivers, and we are constantly identifying employees who want to work in the fast-paced technology revolution we are a part of,” states Mangiardi.

QualiMed’s people, coupled with the clinicians and patients, deserve a better standard of care and have that opportunity to deliver this through its innovative platforms. “We have assessed that localization of the drug or other therapies could potentially be a critical factor for allowing patients to have better outcomes through higher localized delivery while minimizing

The systemic toxic effect,” mentions Mangiardi. By being able to deliver the drug through the local delivery device intraluminally, QualiMed ensures the therapy is placed directly in the area of need, potentially limiting systemic toxicity, increasing therapeutic concentrations at the target sites, and improving overall therapeutic efficacy. The Company’s mechanism is designed to use pressure to increase the uptake of a non-specific drug or therapeutic agent into the tissue structure, potentially promoting better results.

As of today, the QualiMed’s Localized Drug Delivery Device is not commercially available; Mangiardi expects to launch it in 2020. “With our technology, we will soon be able to provide surgeons and interventionists with new treatment modalities to help their patients while reducing the cost of care through improved efficacy and reduced side effects. For example, the recent prophylactic use of the Company’s ARCHIMEDES biodegradable implant potentially reduces the complication rates associated with modified anatomy surgical procedures live whipples or transplants as evaluations are ongoing,” says Mangiardi. The ARCHIMEDES device was designed as a replacement for the nearly two million plastic hepato-biliary stents used annually that also require a second procedure for implant removal and is only one of a number of advanced products in the companies emerging protfolio.

Q3 Medical, through its wholly owned subsidiaries continues to develop technologies in three product verticals: Biodegradable, Micro Invasive Technologies, and Localized Drug Delivery with the focus to commercialize the products internationally. “As we expand into the US and build our China-based manufacturing facility, we expect to enhance our global footprint for the doctors we support and the patients they treat," concludes Mangiardi.