DyeVert™ PLUS System

Osprey Medical Receives US FDA Clearance for DyeVert™ Plus

Osprey Medical today announced that it has received US FDA 510(k) clearance for its advanced DyeVert™ PLUS Contrast Reduction System. This new platform augments Osprey’s current technology with the capability to actively manage dye administration during coronary interventions.

DyeVert PLUS received European CE Mark in 4Q 2016. The company further validated its dye savings capabilities through initial market testing with multiple physicians in Germany and Italy, which showed a 44% contrast reduction. The product received strong positive feedback on the utility of real-time contrast monitoring and ease-of-use.

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DyeVert™ PLUS System

Osprey Introduces DyeVert PLUS at TCT

Osprey Medical is pleased to announce the expansion of its portfolio with introduction of the DyeVert™ PLUS Contrast Modulation/Monitoring System. This new platform integrates the current DyeVert technology with substantial patient management and monitoring capabilities. The system has received European CE Mark and FDA clearance is pending. The Company anticipates US availability Q1 2017.

Highlighted at the Transcatheter Cardiovascular Therapeutics (“TCT”) Conference, held October 29 – November 2 in Washington DC, the DyeVert PLUS received publicity via both podium presence and considerable booth exposure. As one of the world’s largest gatherings of heart specialists, TCT hosts over 6,000 medical professionals in the fields of interventional cardiology and vascular medicine.

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DyeVert™ PLUS System

Osprey to present at TCT 2016

Osprey Medical is pleased to announce the Company’s scheduled presentations for the upcoming Transcatheter Cardiovascular Therapeutics (“TCT”) Conference, which is being held October 29 to November 2 in Washington, DC.

The TC is a leading international cardiovascular conference and one of the world’s largest gathering of heart specialists. The meeting hosts around 11,000 attendees with over 6,000 international medical professionals in the fields of interventional cardiology and vascular medicine.

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EuroPCR 2016

DyeVert Pilot Trial Results Presented at EuroPCR

Osprey Medical Inc. is pleased to announce the results of the DyeVert Pilot Trial as presented at the European Association of Percutaneous Cardiovascular Intervention’s annual conference (EuroPCR) during May 19th in Paris, France. The results from the clinical trial were presented to one of the world’s largest international conferences in the area of cardiovascular medicine with over 12,000 attendees.

Professor Steffen Desch presented the results of the DyeVert pilot trial that was performed at the Heart Centre in Lübeck, Germany and Monash Medical Centre in Melbourne, Australia. Monash’s Dr. James Sapontis was the principal investigator of the study. This prospective, non-randomized, single arm trial found that the DyeVert™ System saved 47.4% contrast dye on average in all patients, 50.3% in PCI/Stenting and 46.6% in diagnostic procedures.

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