Medical Device News Magazine

Intravascular Imaging Incorporated (“i3”) Announces Launch of Its 3-French NIRF-IVUS Imaging Catheter

Intended for Human Coronary Imaging, with Favorable Tests in Ex-Vivo Human Coronaries, and Launch of Series A Financing

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I3 today announced the launch of its proprietary 3-French NIRF-IVUS Catheter designed in collaboration with the Massachusetts General Hospital.

The device was tested in ex-vivo human coronary arteries and in vivo in preclinical studies, using its proprietary NIRF-IVUS intravascular imaging system. I3’s imaging system combines intravascular ultrasound (“IVUS”), the dominant imaging approach used for coronary stent optimization during percutaneous coronary intervention (PCI), with near-infrared fluorescence imaging (“NIRF”). Combined into a single catheter, NIRF-IVUS enables visualization of the molecular and cellular details that underline pathophysiologic progression of coronary lesions, arterial dissections, coronary transplant vasculopathy, and fibrin production in unhealed stents.

Farouc Jaffer, MD PhD, interventional cardiologist at Massachusetts General commented; “Through the use of molecular and pathophysiologic imaging we can now visualize plaque inflammation in living subjects simultaneously with IVUS-detected plaque anatomy. Plaque inflammation is a critical driver of coronary and stent events, particularly among patients with high residual plaque inflammation on maximal statin therapy. Thus, it’s important to explore new molecular imaging approaches to personalize therapies aimed at preventing a serious, life-threatening cardiac events.”

I3, previously funded via federal and foundational grants and industry sponsorship from a leading imaging manufacturer, is now raising its first equity round. “With these extraordinary early preclinical and ex vivo human results, i3 will raise its first equity round, advance its GMP manufacturing and position its device for a pivotal human study and eventual FDA submission,” said R. Scott Jones, CEO of i3. “We will market our product as an upgrade to the fast-growing international IVUS marketplace,” Jones continued.

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