|Trivascular's Ovation--Courtesy of Trivascular|
TriVascular Technologies ($TRIV) has managed to raise $10 million in debt--despite a market cap of only about $90 million. Shareholders weren't too pleased--sending the stock down 15% in early trading on the news. That puts it off about 65% for the year so far.
At the same time, the company also has started a post-market, registry study that's aimed at improving sales of its Ovation Abdominal Stent Graft platform, particularly among women. The FDA approved the next-gen Ovation iX to treat abdominal aortic aneurysms in July.
The study is intended to support the use of Ovation in endovascular aortic repair (EVAR). The system is "the lowest profile FDA-approved EVAR device," according to the company. Its sheath is designed to minimize vessel trauma and reduce procedural steps. This is expected to be an advantage among female patients--whose vasculature is often too small to accommodate EVAR. The study, known as LUCY, is slated to be in 225 women patient and 45 U.S. sites.
"There is a lot of enthusiasm for this study. Women are historically an underserved patient population with respect to EVAR due to the smaller access vessels, shorter average aortic necks and other unique anatomical complications, all of which are fully addressed by conventional aortic stent graft technology," said TriVascular President and CEO Christopher Chavez on an early August earnings call.
He added, "35% of men and 60% of women remain ineligible for EVAR, principally because of inadequate aortic neck link or limitations based on neuro access vessels. The Ovation platform is uniquely suited to address these issues and safely expand the EVAR option to more women."
The Ovation platform has been used to treat more than 7,000 patients; the company already has a European Post-Market registry of more than 500 patients.
Last quarter, TriVascular reported $9.7 million in revenue, an increase of about 25% over the same period a year earlier. It had an operating loss of $12.8 million last quarter, with $52.7 million in cash at June 30. At that time, the company said CRG had provided it with a debt facility of up to $30 million--this $10 million of that funded during the third quarter.
TriVascular went public in an April 2014 IPO with a $12 share price--that's now below $5.
- here is the SEC filing
- here is the latest quarterly transcript
- and here is the statement on the LUCY study
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