QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon.
The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease.
The Singapore-based company is slated to enroll patients in the U.S., Europe and New Zealand to evaluate the efficacy of the Chocolate Touch DCB. The study is designed to compare that device with C.R. Bard’s (NYSE:BCR) Lutonix balloon to treat patients with peripheral vascular disease.
“We are thrilled to receive this conditional IDE approval from FDA,” CEO Eitan Konstantino said in prepared remarks. “This approval concludes a highly sophisticated research effort and marks a significant step towards joining the exclusive list of companies able to sell drug-coated balloons in the US.”
In February, a federal appeals court sent a possible $20 million loss for QT Vascular and its sister companies Quattro Vascular and TriReme Medical back to a lower court to reconsider whether founder Konstantino violated his duties to AngioScore when he founded QT Vascular.
AngioScore accused Konstantino of breaching his fiduciary duties to the company by developing the Chocolate balloon device, which competes with AngioScore’s AngioSculpt balloon. The lawsuit was filed in June 2012 in the U.S. District Court for Northern California.
The suit alleged that TriReme, Quatto and QT vascular abetted in Konstantino’s breaches.
In July 2015, Judge Yvonne Gonzalez Rogers sided with AngioScore and ordered Konstantino cough up his 15 million shares in QT Vascular, which were worth about $2 million at the time. He also had to disgorge the $250,000 he received for licensing the Chocolate rights and a 2.85% royalty on sales of the balloon.
Gonzales Rogers awarded AngioScore nearly $3.0 million in lost profits and another $17.1 million in future lost profits on sales from 2014 through the 2nd quarter of 2019.
The trio of firms appealed to the U.S. Court of Appeals for the Federal Circuit in October 2015, asking the court to stay the verdict pending its appeal and that it would likely go bankrupt if forced to pony up.
In July the Federal Circuit found that the lawsuit involves a California state law claim that never should have been heard in a federal court.
“Because we find that the district court improperly exercised supplemental jurisdiction over the state-law claims but did not err in denying attorneys’ fees, we reverse-in-part, affirm-in-part, vacate in-part, and remand with instructions to dismiss the state-law claims for lack of jurisdiction,” Judge Todd Hughes wrote for the Federal Circuit.