Osprey Medical (ASX:OSP) has received FDA clearance for expanded marketing claims of dye savings, image quality and reflux reduction for its DyeVert System.
The new claims allow the company to commercialise the DyeVert and AVERT Systems as the only products to have received FDA claims for contrast savings without compromise in image quality through a randomised controlled multi-centre trial.
The new expanded claims enable physicians to comply with cardiology and radiology society guidelines that encourage physicians to use dye sparing approaches in patients at-risk of Contrast Induced Acute Kidney Injury (CI-AKI).
Osprey says the DyeVert System offers performance improvements of increased dye savings and ease of use advantages over the first generation AVERT System.
The company’s core technologies originated from research conducted by Dr David Kaye at Melbourne’s Baker IDI Heart and Diabetes Institute.
Clinical use of the DyeVert System in over 100 patients from three different hospitals have shown an average of greater than 45 per cent dye savings without compromised image quality. This compares with typical dye savings of 30-35 per cent for the AVERT System, as seen in clinical use, and is a result of DyeVert saving dye even on puff injections.
Commercialisation of the DyeVert System commenced late last year, following FDA clearance.
According to the company, in the first 3 months of commercial release, 24 hospitals evaluated the system with 11 placing initial orders and 13 working through the approval process to purchase the DyeVert System.
"This initial evaluation and order rate is significantly faster than previous experience with AVERT and is reflective of the ease of use of the DyeVert System," said the company, which added that its expanded sales force will sell DyeVert as the lead product in 2016.
“FDA clearance of claims on our DyeVert System provides our sales reps with stronger marketing collateral when selling our products," said Osprey President and CEO, Mike McCormick.
"Osprey is dedicated to supporting the efficacy of our products with Tier 1 clinical evidence and as a result, we are now the only Company with FDA clearance for products that reduce dye without compromising image quality.
"These are unique and powerful claims that will allow our reps to present the DyeVert System as a product that can assist physicians in complying with Cardiology Society Guidelines that stress the need for dye reduction in patients with compromised kidneys. We are encouraged by our early commercial success and continue to scale up our sales force to drive adoption of the DyeVert System in 2016,” added Mr McCormick.