Santa Rosa, Calif.-based TriVascular said in a regulatory filing that it raised $10 million from 5 unnamed investors in a debt-and-warrants offering. The company, which won pre-market approval from the FDA this month for its Ovation iX device, raised $78 million in April 2014 with an initial public offering.
TriVascular also said today that it launched the Lucy study, which aims to enroll up to 225 subjects (75 women in the treatment cohort and 150 men in the control group), to compare use of the Ovation system between the genders.
Women are an underserved population in EVAR because of generally smaller access vessels and often-challenging aortic neck anatomies, TriVascular said. The study, a prospective, consecutively enrolling, non-randomized multi-center post-market registry, has a primary endpoint of major adverse events within 30 days, the company said.
“We are excited to participate in this important study,” Dr. Krishna Mannava, who treated the 1st patient in the study at Fairfield Medical Center in Lancaster, Ohio, said in prepared remarks. “The Ovation system is ideally suited for patients with small-diameter access vessels and diseased aortic necks, which is often characteristic of female patients. Our first Lucy case went well and we are excited to continue enrolling and, ultimately, see the results from this landmark study.”
“We are focused on developing products and providing clinical evidence to help expand EVAR access to more patients, and improve EVAR outcomes for all patients,” added chairman, president & CEO Christopher Chavez. “The goal of the LUCY Study is to answer very important questions and ensure that gender does not limit access to life-saving technology. We are excited to begin enrollment and are grateful to all of the study investigators who put their trust in our technology when caring for their patients.”
Earlier this month TriVascular reported slightly wider 2nd-quarter losses on sales growth that approached 25%. The company posted losses of -$14.9 million, or -73¢ per share, on sales of $9.7 million for the 3 months ended June 30. That a 1.9% increase in red ink, on sales growth of 24.8%.