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    Concept Medical
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    5600 Mariner ST, STE 200, Tampa, FL 33609
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    +1(813)955-8855
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    enquiries@pharmacompass.com
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    https://www.conceptmedical.com/
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    Concept Medical Receives US FDA IDE Approval for Magictouch AVF Indication, Their Fifth Us Clinical Study Approval for the Magictouch Portfolio

    Details:

    FDA gave IDE approval for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula in the Haemodialysis management of Chronic Renal Failure.


    Lead Product(s): Sirolimus

    Therapeutic Area: Nephrology Product Name: MagicTouch AVF

    Highest Development Status: IND EnablingProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 02, 2024

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    Concept Medical's Fourth IDE Approval for the MagicTouch Sirolimus Coated Balloon is Granted for the Treatment of Superficial Femoral Artery Disease (SF...

    Details:

    The IDE approval will allow Concept Medical to initiate pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch PTA Sirolimus coated balloon in femoral and popliteal segments for the treatment of Superficial Femoral Arteries.


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch PTA

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 29, 2023

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    Concept Medical Received IDE Approval to Investigate Safety and Efficacy of Its MagicTouch Sirolimus Coated Balloon Catheter for The Treatment of Small ...

    Details:

    MagicTouch SCB is the world’s first Sirolimus-coated Balloon with extensive commercial usage or for the treatment of Small Vessels (SV) in coronary arteries, in Europe, major markets of Asia and the Mid-Eastern markets.


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch SCB

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 28, 2023

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    SIRONA Completes Enrollment - A Leap in the DCB Treatment of Femoropopliteal Arterial Disease

    Details:

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


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 21, 2022

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    Well Begun And Half Done! - SIRONA Randomized Trial Achieves Fifty Percent Enrollment

    Details:

    Magic Touch PTA is a marketed sirolimus coated balloon, 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.


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch PTA

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Jena University Hospital

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 09, 2022

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    Concept Medical Announces Enrolment of Index Patient in the Crucial Transform -1 RCT Using Magic Touch Sirolimus Coated Balloon for Small Coronary Vesse...

    Details:

    Concept Medical Inc. focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch sirolimus coated balloon).


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 02, 2020

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    Enrolment Initiated in World's First Rct with Sirolimus Coated Balloon for the Treatment of Below-the-Knee (btk) Peripheral Artery Disease

    Details:

    FUTURE BTK is a randomized, double blind, placebo-controlled, multi-center trial aimed at determining the effectiveness of MagicTouch PTA sirolimus coated balloon vs standard balloon angioplasty to treat below the knee arterial disease in critical limb ischemia patients.


    Lead Product(s): Sirolimus

    Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch – PTA

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 27, 2020

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