TriVascular Technologies to Launch $100 Million IPO

Santa Rosa, CA-based TriVascular Technologies Inc. announced on March 10 that it has filed with the Securities and Exchange Commission (SEC) to launch an initial public offering of common stock and intends to be listed on the NASDAQ exchange under the symbol TRIV.

Although the company's SEC filing does not state the number or price range of shares to be offered, Ron Leuty, writing for the San Francisco Business Times, has reported that the company is seeking $100 million. Leuty says the firm hopes to expand its sales and marketing, fund additional research, and pay off a $4.5 million loan from Boston Scientific Corp.

TriVascular specializes in minimally invasive treatment of abdominal aortic aneurysms (AAA). The company's Ovation and the subsequent Ovation Prime abdominal stent graft systems are intended for endovascular aneurysm repair (EVAR).

One of TriVascular's claims to fame stems from its offering of the Ovation Prime series in sizes down to 14Fr. It says this offers enhanced deliverability for the AAA endograft system, even through narrow and tortuous anatomies. TriVascular says this minimally invasive system expands the pool of patients eligible for EVAR with these smaller available sizes.

The company was formed in 1998. From 2005 it was owned by Boston Scientific, which sold it to its current owners in March 2008. According to Leuty, Trivascular lost $50.3 million last year on revenue of $19.5 million. He says the company had an accumulated deficit through last year of $238.5 million. Cash and equivalents are said to be $38.1 million.

The company received CE Mark approval for its Ovation system in September 2010. FDA approval followed in October 2012. TriVascular's newest product, the Ovation Prime system, was approved by FDA in January 2013.

On January 27 of this year, TriVascular announced that it had completed enrollment for a 500-patient European study with 30 medical centers participating. The multicenter prospective post-market registry is designed to evaluate the safety and performance of the company's Ovation and Ovation Prime abdominal stent graft systems, with patient follow-up out to five years.

The study is said to be evaluating the treatment of AAA in the real-world setting of routine clinical practice. Its primary endpoint is treatment success. This is defined as a composite of technical and clinical success at 12 months. Technical success includes successful delivery and deployment of the stent graft, while clinical success includes freedom from aneurysm expansion, aneurysm rupture, Type I and III endoleaks, conversion to open repair, stent graft migration, and stent graft occlusion.

Stephen Levy is a contributor to Qmed and MPMN.