TriVascular Technologies Announces First Patient Enrolled in the LUCY Study
Aug 24 15
TriVascular Technologies, Inc. announced the first patient enrolled and treated in the LUCY Study (TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair). The LUCY study is a prospective, consecutively enrolling, non-randomized multi-center post-market registry designed to evaluate the ultra-low profile (14F) Ovation platform when used in the endovascular treatment of abdominal aortic aneurysms (AAA) in female as compared to male patients. The lack of adequate treatment options, principally due to suboptimal, large bore, conventional EVAR systems, is a persistent issue for female AAA patients. Clinical literature shows that women diagnosed with AAA experience aortic expansion at a rate that is 40-80% faster than men, which can result in aortic rupture at smaller diameters. On average, women with abdominal aortic aneurysms have challenging access vessel anatomy and, often, hostile aortic neck anatomy. This fact, when combined with the technical limitations of conventional stent graft systems, results in significantly decreased access to on-label EVAR treatment for most women. The primary objective of the LUCY Study is to demonstrate the clinical outcomes and benefits associated with using the Ovation Abdominal Stent Graft platform in both female and male patients, including low access-related vascular complications, low mortality rates, and high eligibility rates even in patients who tend to have small
access vessel diameters and challenging aortic neck anatomy. The study will enroll up to 225 subjects (75 females in the Treatment Group and 150 males in the Control Group) in up to 45 sites in the United States. Study results will provide a comparison of female and male patient outcomes. The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial procedure.
TriVascular Technologies, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Provides Earnings Guidance for the Year 2015
Aug 4 15
TriVascular Technologies, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported revenue of $9,733,000 against $7,798,000 a year ago. Loss from operations was $12,813,000 against $12,739,000 a year ago. Loss before income tax expense was $14,791,000 against $14,495,000 a year ago. Net loss was $14,856,000 against $14,572,000 a year ago. Net loss per share, basic and diluted was $0.73 against $0.87 a year ago. Pro forma net loss was $14,856,000 against $15,275,000 a year ago. Pro forma net loss per share, basic and diluted was $0.73 against $0.82 a year ago. LBITDA was $12,758,000 against $11,909,000 a year ago. Adjusted LBITDA was $11,500,000 against $11,939,000 a year ago. The increase revenue was primarily attributable to the growth of the U.S. business as the U.S. field sales organization gained traction and customer utilization increased. The increase in operating expenses was driven primarily by an increase in selling, marketing and general and administrative expenses.
For the six months, the company reported revenue of $17,758,000 against $14,832,000 a year ago. Loss from operations was $26,360,000 against $25,368,000 a year ago. Loss before income tax expense was $30,361,000 against $28,895,000 a year ago. Net loss was $30,493,000 against $28,995,000 a year ago. Net loss per share, basic and diluted was $1.50 against $3.30 a year ago. Pro forma net loss was $30,493,000 against $29,628,000 a year ago. Pro forma net loss per share, basic and diluted was $1.50 against $1.91 a year ago. LBITDA was $26,332,000 against $24,479,000 a year ago. Adjusted LBITDA was $24,027,000 against $23,977,000 a year ago.
The company maintained its previously issued financial guidance which anticipates revenue for full-year 2015 to be in the range of $36 million to $39 million, reflecting year-over-year growth of approximately 13% to 23% over 2014 on a reported basis and 17% to 27% on a constant currency basis. Gross margin is expected to be between 60% and 62%.
TriVascular Technologies, Inc. and CRG Modify Term Loan Agreement
Aug 4 15
TriVascular Technologies, Inc. and Capital Royalty Partners II L.P. and its affiliate funds announced that they have amended the existing term loan agreement under which TriVascular previously borrowed $50 million. The transaction primarily amends the terms of the existing term loan agreement with CRG to increase the borrowing amount up to $95.0 million, net of financing fees. The company continues to have the option to access up to $15.0 million on or before December 31, 2015, subject to achievement of certain revenue milestones. The newly available borrowings of $30.0 million are dividend amongst two tranches. The first new tranche, consisting of $10.0 million in convertible notes with an interest rate of 8% and convertible into the company's common stock at a price of $8.00 per share, is scheduled to be funded at the closing on August 18, 2015, subject to customary closing conditions. The second new tranche consists of $20.0 million of borrowings that may be available to draw, upon achievement of certain revenue milestones, with the same interest, payment and other material terms as the existing borrowings under the loan. In connection with the transaction, the company plans to seek an amendment of its loan agreement with Century Medical, Inc. primarily to obtain consent to subordination of the additional borrowings.