NFocus Neuromedical Inc. is developing a new treatment for brain aneurysms that could end up giving companies like Johnson & Johnson (NYSE:JNJ), Stryker (NYSE:SYK) and Covidien (NYSE:COV) a real headache.
But the Palo Alto, Calif.-based startup isn’t in a rush to get its product onto the U.S. market, despite receiving CE Mark approval recently for its single-deployment embolization treatment for brain aneurysms, the Luna Aneurysm Embolization System.
CEO Eric Milledge told MassDevice that NFocus plans to use the CE Mark to continue building clinical evidence for another year at least, pushing off U.S. market release to 2012.
“Our intent isn’t to go out to Europe and commercialize at this stage,” Milledge told us. “Our focus is on building solid clinical data with 90-day, six-month and 12-month follow-ups, to make sure the device is performing as well as we think it is.”
The Luna device has the potential to “be very disruptive” to catheter-placed wire coils, which currently dominate the aneurysm market, he said. The catheter-fed Luna device creates a scaffold to “encourage tissue growth across the aneurysm opening” and can be quickly re-sized during the procedure.
Current clinical procedures for treating aneurysms include brain surgery, which is curative but risky, and catheter-fed coils, which Milledge described as working well, but difficult to train surgeons on. He said the Luna procedure is less complicated and more effective.
Milledge, a J&J vet with more than 34 years at the healthcare and consumer products conglomerate conglomerate, joined NFocus in April 2009 as chairman before taking over the corner office from founder Martin Dieck, who assumed the COO role last year.
At Johson & Johnson, Milledge was group chairman of the 2,500-employee LifeScan division, which produces blood glucose meters, test strips and diabetes management software. During his tenure at LifeScan, Milledge led the company through two major M&A deals, buying out Animas Corp. and Inverness Medical Innovations, the latter a $1.3 billion deal.
At NFocus, he said, the focus is on building for the long haul rather than targeting an exit.
“Our intent is to build this company,” Milledge told us. “I really think this is a company you can sell too quickly. If this is a disruptive technology, there will be no shortage of acquirers.”
The plan, he said, is to build a global sales force of about 40 that can compete with the likes of his former employer along with Stryker, which recently built up its neuromodulation business, and ev3, acquired last year by Covidien.
The money the company spends today in boosting its cache of clinical data will pay off in the long run in developing a solid customer base, Milledge added.
“It’s easy to kill a start-up in the early stage by pushing [devices] into centers,” he explained. “We want to start at the top of the pyramid.”