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Details:
Initiated pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch (sirolimus) coated balloon for the treatment of complex obstructive coronary disease like Coronary Artery Disease.
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 April 19, 2024
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
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
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
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
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
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
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