First sirolimus device for peripheral arterial disease enters European market

MagicTouch AVF Concept Medical has received the CE mark for its MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) catheter, making the catheter the first commercially available sirolimus device for peripheral arterial disease. The MagicTouch catheter has also been approved for treating erectile dysfunction (MagicTouch ED) and for managing arteriovenous fistula complications (MagicTouch AVF). [...]

FDA Breakthrough Device Designation for Virtue sirolimus-eluting balloon

Virtue AVF Orchestra BioMed, in partnership with Terumo, has secured Breakthrough Device Designation by the FDA for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee peripheral arterial disease. A press release reports that currently approved therapeutic options for peripheral arterial disease are limited and have been shown to be marginally [...]

2019-09-17T15:58:59+00:00September 17th, 2019|Tags: , |

CE mark for BackBeat Cardiac Neuromodulation Therapy for hypertension

BackBeat CNT Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat [...]

2019-09-06T17:40:53+00:00September 6th, 2019|Tags: , , |

Orchestra BioMed completes US $34 million financing to accelerate product pipeline development and advance partnerships

Orchestra BioMed has completed a US$34 million Series B-1 Preferred Stock financing—led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation and existing investors from SternAegis Ventures. Additionally, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on [...]

2019-07-15T13:30:55+00:00July 15th, 2019|Tags: , , |