Medical Device Daily
Xtent (Menlo Park, California) – A developer of stent systems for delivering multiple stents and drug-eluting stent (DES) devices of customizable length with a single catheter – has reported closing on a new $25 million round of financing.
The funding, Xtent said, comes from previous investors at a valuation of more than twice that of a previous financing round, closed in 2003.
Xtent said that its system is designed to enable cardiologists to treat the largest, fastest growing portion of the market – long, diffuse lesions, multiple lesions and multiple vessel disease – with a single delivery strategy which minimizes catheter exchanges. The Xtent System customizes stent length for each lesion treated and is designed to enable the cardiologist to treat complex lesions "rapidly, efficiently and with a high degree of accuracy," it said.
Gregory Casciaro, president and CEO of Xtent, said that the company's key goal has been to differentiate itself from other stent and DES manufacturers in order to carve out a significant portion of this market, which he put at $6 billion by year-end 2006.
The bare stent/DES sector, he told Medical Device Daily, is increasingly seeing placement of multiple stents in each patient. Xtent is focusing, instead, on a "one-catheter procedure" that at the same time provides for "multiple stent placements."
He added: "The advantages here are many: the opportunity to save time for patients on the [surgical] table, reducing the amount of contrast dye necessary in treatment, [avoiding] the physician having to guess ahead of time the length of the lesion." The need to "guess" the lesion length and thus the particular stent to use has resulted in treatment failures ranging up to 40%, he said.
Explaining the Xtent approach, he said: "What we have come up with is the opportunity of delivering a stent train – up to 60 mm of stent – and divide it up according to the length of the lesions you are treating." After one length of stent is placed, the surgeon will then be able to deploy additional portions of this stent train to treat other lesions, but without using an additional catheter procedure.
These multiple placements are carried out with the aid of real-time fluoroscopy that Casciaro said takes the "guessing game" out of selecting the proper stents that he put at up to "26 variations for each of the manufacturers." This may result in "estimation errors" that can require additional, and expensive, stenting, he noted.
Brian Walsh, vice president, sales and marketing for Xtent, said that the price of the company's single catheter-multiple stenting procedure will be more than one stent placement but less than two stent placements. The result, he told MDD, would be savings on stent costs ranging from $300,000 yearly for smaller facility on up to $3 million yearly in a large teaching institution.
Casciaro said that the company expects to move forward with "in-man" clinical studies of the system in Europe "sooner vs. later," and definitely before the end of this year, in order to pursue the CE mark, and commercialization there to begin revenue flow during 2006.
"In the process, we'll do a pivotal trial in Europe, mirroring what the FDA is going to require, to start building a clinical body of evidence to bring [the system] to the U.S.," he said.
The company hopes to gain commercial approval and begin sales in the U.S. by 2008.
The new $25 million equity funding offers "more than two-[times] step-up in valuation by the investors who know us best as a strong vote of confidence in Xtent's progress," said Casciaro. "All our clinical and preclinical results so far indicate that Xtent is on its way to providing interventional cardiologists with tools that will greatly enhance their ability to treat much more complex coronary disease."
Robin Bellas, general partner at Morgenthaler Ventures (Menlo Park, California), the lead venture capital investor in Xtent, noted the transformational value of stenting, but added: "[W]e have always believed that the current generation of stents was just scratching the surface of potential treatment. Xtent is showing where the next generation of technology will lead."
Morgenthaler has made previous investments in Cardiothoracic Systems (Cupertino, California), Emphasys Medical (Redwood City, California), The Foundry, (Redwood City), Perclose (Redwood City), Satiety (Palo Alto, California) and Thermage (Hayward, California). It reports a total of $2 million under management.
Morgenthaler's most recent fund, capitalized at $850 million, was raised in July 2001.
Other investors in the latest Xtent round include Advanced Technology Ventures, Latterell Venture Partners and Split Rock Partners, co-manager of St. Paul Venture Capital.