Concept Medical Announces First Patient Enrollment in the MAGICAL BTK IDE Trial, Launching its PAD Clinical Program in the United States

TAMPA, Fla., Jan. 16, 2025 /PRNewswire/ -- Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrolment of the first patient in the "MAGICAL BTK" (Randomized Controlled Trial of MagicTouch PTA – Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in the Treatment of Below The Knee arterial disease) U.S. Investigational Device Exemption (IDE) pivotal trial. The first patient was enrolled by Dr. Prakash Krishnan, MD, and his team at the Icahn School of Medicine at Mount Sinai, marking a crucial milestone in the advancement of treatment options for patients suffering from peripheral artery disease (PAD) below the knee.

Following the recent IDE Approval by the U.S. Food and Drug Administration (FDA) for MagicTouch PTA, this enrolment heralds the beginning of Concept Medical's peripheral clinical trial program in the United States. With the ongoing IDE study for MagicTouch SCB in coronary artery disease, Concept Medical is now actively enrolling in two U.S. clinical trials in both coronary and peripheral interventions—an unprecedented achievement aimed at improving patient outcomes and expanding therapeutic choices.

     "The enrolment of the first patient in the MAGICAL BTK trial represents an important stride toward improving the standard of care for below-the-knee disease in patients with peripheral artery disease," said Dr. Prakash Krishnan, MD, Icahn School of Medicine at Mount Sinai. "Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and patient quality of life. I am honored to be part of this landmark study and look forward to the meaningful clinical evidence it will generate."

The MAGICAL BTK pivotal trial is designed to evaluate the safety and effectiveness of MagicTouch PTA Sirolimus Coated Balloon compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of below-the-knee arterial disease. The primary endpoint, measured at 12 months, is primary patency, ensuring that the trial's findings focus on meaningful clinical outcomes. This global, multi-center study is led by Prof. Sahil Parikh (Chairperson), with a distinguished panel of Principal Investigators including Dr. Eric Secemsky (Beth Israel Deaconess Hospital and Harvard Medical School), Prof. Brian DeRubertis (NY Presbyterian Weill Cornell Medical Center and Cornell University Medical College), Prof. Edward Choke (Northern Heart Hospital), and Prof. Osamu Iida (Osaka Keisatsu Hospital).

     "The initiation of the MAGICAL BTK Trial heralds a new era in the treatment of patients with chronic limb-threatening ischemia and offers hope to the millions of patients with this condition who are at risk for limb loss because of insufficient arterial circulation in their legs," stated Prof. Sahil Parikh.

Sirolimus-coated balloon technology has already reshaped coronary and peripheral artery disease management, with MagicTouch achieving positive results in large-scale trials across Asia and Europe.. Now, with the MAGICAL BTK trial, U.S. patients have the opportunity to benefit from this breakthrough approach. Concurrently, patient enrolment from Asia will broaden the global patient cohort, offering a more comprehensive understanding of the therapy's benefits across diverse populations.

     "At Concept Medical, our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions," said Dr. Manish Doshi (Founder & Managing Director). "The start of MAGICAL BTK further validates our dedication to bringing next-generation, evidence-based solutions to clinicians and patients worldwide. Our goal is to redefine current standards, ensuring better outcomes and improved quality of life for those affected by PAD."

With the MAGICAL BTK trial and the MAGICAL SFA IDE trial for superficial femoral artery (SFA) treatment set to begin, Concept Medical is poised to revolutionise endovascular care. The company's distinctive technology platform has already elevated the management of coronary artery disease, and now, by expanding its reach into peripheral interventions, Concept Medical reinforces its leading position in advancing patient-focused, drug-delivery solutions.

About Concept Medical

Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus Coated Balloons (SCBs)—the world's first and most utilized SCB technology—well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy.

For more information, please visit www.conceptmedical.com.

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