Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

TAMPA,Fla.,Feb. 13,2023 --Concept Medical Inc.(CMI),on 9th February 2023,received the Investigational Device Exemption (IDE) from the US FDA,for its Magic Touch Sirolimus Coated Balloon.

Magic Touch PTA has received US FDA IDE approval for its BTK indication

The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease. CMI received their first IDE approval for their Magic Touch Sirolimus Coated Balloon for the Coronary ISR indication earlier in September 2022. The Magic Touch PTA Sirolimus Coated Balloon Catheter has also been granted with a breakthrough device designation in BTK by the US FDA.

Currently,Plain Old Balloon Angioplasty (POBA) is the standard of care for the treatment of the BTK arterial occlusion disease,along with few recently approved Paclitaxel Coated Balloons as well as stents. The IDE approval will allow Concept Medical to gather safety and effectiveness data for the Magic Touch PTA Sirolimus Coated Balloon to support a future Premarket Approval (PMA) in the USA,providing patients and physicians with an alternate product for the treatment of BTK arterial disease.

The CE marked Magic Touch PTA Sirolimus Coated Balloon Catheter has already been widely studied in multiple clinical trials outside the United States (OUS) and has shown promising safety and efficacy results. The product is currently being investigated in Europe in two randomized controlled trials (RCTs) for the BTK indication. The LIMES RCT is a study designed to compare the Magic Touch PTA Sirolimus Coated Balloon Catheter against POBA,while the Debate BTK Duell is a study against Paclitaxel coated balloon catheter.

Prof. Sahil Parikh (Columbia University Irving Medical Center,USA) who has been encouraging innovative technologies in Peripheral Intervention in the USA,stated that,"Concept Medical's proposed clinical trial studying the Magic Touch PTA in BTK indication,will collect significant data on safety and efficacy of the device,thus paving its way to treat patients in US. With Sirolimus Coated Balloon already receiving an IDE approval in coronary arteries,and breakthrough device designations for multiple indications,along with the vast OUS clinical data,it will surely be looked up to by the US physicians and patients with PAD."

Prof. Edward Choke (Sengkang General Hospital,Singapore),one of the early investigators of the Magic Touch PTA Balloon and who possibly has the widest experience with the device,and is also conducting a RCT against POBA – FUTURE BTK adds,"The field of BTK angioplasty needs effective solutions to its problem of poor patency rates. This is an exciting phase III trial that will determine whether the novel Magic Touch PTA Sirolimus coated balloon can maintain the patency of BTK arteries for a longer period of time,compared with our current gold standard of plain balloon angioplasty. This is a key goal in our efforts to reduce the number of repeated interventions and to save the legs of our patients with the severest form of peripheral arterial disease. If successful,this has the potential to be a game changer."

About Magic Touch PTA

Magic Touch PTAis a CE approved and commercially marketed Sirolimus DCB,developed using proprietary Nanolute Technology– the drug delivery technology platform of Magic Touch PTA balloon,is designed to deliver sub-micron particles of Sirolimus to reach the deepest layers of the vessel walls.

About Concept Medical Inc.

CMIis headquartered in Tampa,Florida and has operational offices in The Netherlands,Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.