Sorin Group (BIT:SRN) CEO André-Michel Ballester said he expects the Perceval sutureless aortic valve to help accelerate revenue growth in the 2015 2nd half, beyond flat Q1 results impacted by foreign exchange rates and "operational challenges" in the heart valve division.
"Although 1st-quarter revenues came below expectations, primarily due operational challenges in the heart valves segment, I am encouraged by the current level of business activity and expect an acceleration in the second half of the year," Ballester said in prepared remarks.
Sorin also touted results from 3 studies showing its next-generation Perceval device worked better in European patients with severe aortic stenosis than transcatheter aortic valve implants.
The Italian cardiac device maker booked adjusted net profits of $8.7 million (€7.7 million) during the quarter, down from $12.7 million (€11.2 million) in the 2014 first quarter. That included a $2.15 million (€1.9 million) impact from its New Ventures investment arm and a $3.86 million (€3.4 million) unfavorable foreign exchange impact.
Revenue for the quarter reached $215 million (€189.4 million), an increase of just 0.6% at comparable foreign exchange rates, and 7.4% as reported, versus the 2014 first quarter.
Sorin said revenues from its cardiac surgery and cardiac rhythm management business units each grew less than 1% during the quarter. Revenue increased for heart-lung machines and autotransfusion machines and devices, but declined for tissue and mechanical heart valves.
Sorin issued guidance for the 2nd quarter that predicts revenue growth of 2% to 3%. The Milan-based company also expects an acceleration of top-line growth in the 2nd half of 2015, driven in part by an expected FDA approval for Perceval, as well as the launch of Sorin’s Platinum system for cardiac rhythm management devices in Europe, the company said.
Results from a trio of studies presented last week at the American Assn. of Thoracic Surgeons meeting in Seattle, showed the Perceval device’s safety & effectiveness in treating aortic stenosis, with 2 studies comparing Perceval to TAVI.
The 1st set of findings, based on a study of 991 patients, found Perceval had much higher rates of short- and mid-term survival versus TAVI, with a 5.8% mortality rate for the Perceval arm compared to 9.8% for the TAVI cohort. Conventional surgery produced a 3.4% mortality rate. Sutureless valves matched conventional surgery results in terms of post-operative complications (0%) but came out significantly better than TAVI, which posted a 9.8% complication rate.
A 2nd study looked at 2,175 patients from a pair of multicenter registries, finding Perceval valves had better device success and a lower rate of mild paravalvular leakage versus TAVI in patients with severe symptomatic stenosis.
The 3rd study involved 1-year results from the 628-patient Cavalier trial. Even with 40% of the patients being octogenarians, there were low rates of cardiac mortality, stroke, major paravalvular leaks and valve removals and no incidents of valve migration, valve thrombosis or structural valve deterioration, according to the study.