#USA #Tampa #Concept Medical #MagicTouch PTA #MAGICAL BTK

Concept Medical Achieves a Significant Milestone in Clinical Trials

Concept Medical Inc., a leader in innovative drug delivery technologies, recently announced a major achievement: the successful recruitment of the first patient in its pivotal MAGICAL BTK clinical trial. This trial, which operates under an Investigational Device Exemption (IDE) in the United States, focuses on the effectiveness of the MagicTouch PTA — a sirolimus-coated balloon designed for treating localized artery diseases below the knee.

The recruitment was conducted by Dr. Prakash Krishnan and his team from the Icahn School of Medicine at Mount Sinai, indicating a pivotal step in expanding treatment options for patients suffering from peripheral artery disease (PAD) below the knee. The occurrence of this recruitment was heralded as a significant leap forward, aimed at establishing a new standard of care in managing such conditions.

The recent approval of the IDE by the U.S. Food and Drug Administration (FDA) specifically for the MagicTouch PTA has paved the way for this trial, which marks the initiation of Concept Medical’s clinical programs for peripheral interventions in the U.S. This move is especially notable as the company is concurrently active in two clinical trials involving both coronary and peripheral treatment options. This unprecedented endeavor is directed towards improving patient outcomes and expanding therapeutic choices.

Dr. Krishnan expressed his enthusiasm, stating, “The enrollment of the first patient in the MAGICAL BTK trial represents a significant advancement towards enhancing care standards for patients affected by PAD below the knee. The technology involved has the potential to substantially improve limb recovery and patient quality of life. It is an honor to be part of this historic study, and I look forward to the meaningful clinical evidence it will generate.”

About the MAGICAL BTK Trial

The MAGICAL BTK trial is specially designed to evaluate the safety and efficacy of the MagicTouch PTA, comparing it against standard percutaneous transluminal angioplasty (PTA) procedures for treating localized artery diseases below the knee. The primary endpoint, measured after 12 months, is focused on primary patency, ensuring that the trial's conclusions prioritize clinically significant outcomes.

This global, multicenter trial is spearheaded by leading experts including Professor Sahil Parikh, alongside distinguished researchers such as Dr. Eric Secemsky from Harvard Medical School and Professor Brian DeRubertis from New York Presbyterian Weill Cornell Medical Center. Professor Parikh remarked, “The launch of the MAGICAL BTK trial ushers in a new era in treating patients suffering from chronic limb-threatening ischemia, offering hope to the millions who may face limb loss due to inadequate blood circulation in their legs.”

The sirolimus-coated balloon technology has transformed the management of coronary and peripheral artery diseases, with the MagicTouch technology already demonstrating positive outcomes in large-scale trials conducted throughout Asia and Europe. The initiation of the MAGICAL BTK trial now offers U.S. patients an opportunity to benefit from this innovative approach. Concurrently, patient recruitment in Asia will further enrich the global cohort, enhancing the understanding of treatment benefits across diverse populations.

Dr. Manish Doshi, founder and CEO of Concept Medical, emphasized the company’s commitment to patient-centered innovation. “Our unwavering dedication to pushing the boundaries of vascular interventions is encapsulated in the launch of MAGICAL BTK. We are determined to provide clinicians and patients globally with next-generation solutions grounded in evidence. Our goal is to redefine current standards, ensuring better outcomes and quality of life for those afflicted by PAD.”

With the MAGICAL BTK trial alongside the MAGICAL SFA trial targeting superfemoral artery treatments, Concept Medical positions itself at the forefront of endovascular care advancements. By extending its unique technology platform to peripheral interventions, Concept Medical further solidifies its status as a leader in developing patient-focused drug delivery solutions.

About Concept Medical

Headquartered in Tampa, Florida, Concept Medical is a global company dedicated to improving patient care through cutting-edge research and development in drug delivery technologies. Their proprietary platforms are engineered to precisely deliver pharmaceutical agents across the lumen surfaces of blood vessels. The company is known for developing the globally recognized MagicTouch sirolimus-coated balloon family, which has been utilized to treat over a million patients worldwide, establishing a new standard in vascular therapy.

For additional information, visit www.conceptmedical.com.