Neuravi

CEO: Eamon Brady
Based: Galway, Ireland
Founded: 2009
Company website

The scoop: Neuravi aims to capitalize on 5 large and randomized studies in the New England Journal of Medicine, which conclusively proved the benefit of using devices for the physical removal of blood clots to treat ischemic stroke instead of just drugs. The benefits of the devices were so clear that some of the trials had to be stopped early for ethical reasons out of consideration for those randomized into the drug-only early group. As a result, so-called stent thrombectomy devices are likely to vault from being underutilized to being the standard of care. Neuravi aims to catch up to market leaders Medtronic ($MDT) and Covidien with its CE-marked EmboTrap Revascularization Device. CEO Eamon Brady told FierceMedicalDevices that the device's technical features and unique mechanism of action give it an edge over those competitors.

What Makes Neuravi Fierce: The company aims to be the latest and greatest entrant in the burgeoning market due to the EmboTrap's technical differentiation. It has a bevy of different features: The blood clot is trapped within the device itself, and it facilitates the resumption of blood flow following removal and reduces the risk of blood clot fragment escaping during retrieval.

"The EmboTrap has a micro stent inside the cage that re-establishes blood flow on deployment. This cage expands to about 1mm and provides a tiny channel for blood flow to the brain immediately on deployment. Even with the clot on the inside of the device, flow is still able to get distal beyond the trapped clot through the inner channel," the company explained in an email.

In a European clinical trial of 42 patients, the device successfully restored blood flow, or achieved revascularization, in 36 (86%) of the patients, with most of them recovering the ability to function independently.

The results led financiers to invest €19 million ($21 million) in the company in a Series B round, led by European private equity firm LSP (Life Sciences Partners), following a $6.5 million Series A in 2012. And remember that funding for med tech startups is much tighter in Europe than the U.S. In addition, Brady said the medical device bigwig Abbott ($ABT) is a strategic investor in the company.

Ischemic strokes strike 1.7 million Europeans and Americans per year, at a cost of $65 billion in the U.S.

What to look for: In a word, expansion. Brady said the company has an 8-person sales team with a direct presence in the Nordics, Germany and France, as well as distributorship agreements in southern Europe and the Netherlands. Those are countries where penetration of thrombectomy is quite high, Brady said.

In other European countries, like the U.K. and Belgium, the procedural approach to treating stroke still has room for adoption. Brady expects hospital demand and reimbursement to improve in those countries soon, once federal institutions like the U.K.'s National Institute for Health and Care Excellence (NICE) recommend use of the devices.

"Until agencies like NICE provide guidance which backs the use of thrombectomy, penetration in the U.K market will remain modest. However, the available evidence has changed dramatically in the last year with the recent trials and so we expect NICE to back thrombectomy in its upcoming guidance on acute stroke management," Brady said.

Neuravi is aiming to be the market leader in the U.K. and Belgium because market leaders Medtronic and Stryker ($SYK) don't possess a first-mover advantage in those countries, Brady said. He expects reimbursement for thrombectomy to improve in those markets once important institutions like NICE make their recommendation.

The two industry bigwigs have established first-mover advantage in the U.S., but the market is closer to U.K. than Germany in terms of the penetration of the new treatment paradigm; by one estimate about 13,000 procedures were performed in the country out of a potential 695,000 based on patient eligibility criteria.

Neuravi aims to secure FDA clearance for the EmboTrap via the Arise II pivotal trial of patients in the U.S. and Europe. The agency has given the company its blessing to commence enrollment for a clinical trial in Q4 2015. Premarket trials for devices going down the 510(k) clearance pathway are generally shorter than those for devices being reviewed via the more stringent PMA pathway. On the reimbursement side, Brady said payments to U.S. hospitals for thrombectomy are very strong, but reimbursement to physicians could be improved upon.

Another factor that will impact growth at Neuravi, as well other companies that sell thrombectomy devices, is the emergence of the needed infrastructure at specialized and general centers to support the emerging standard of care.

Brady said there is a long-term need to develop additional comprehensive stroke centers in the U.S. and Europe. But he also said that "there's a lot of room for growth within the existing infrastructure," explaining that many centers which currently accept 100 cases a year can easily ramp up to a workload that is three times as high.

The new approach calls for hospitals to transport ischemic stroke patients with large vessel occlusions to comprehensive stroke centers. And in a previous interview, Dr. Jeffrey Saver of the UCLA Stroke Center said that general hospitals will need to use contrast agents during CT scanning and offer 24-hour imaging for the purposes of diagnosis and patient stratification, or else they will have to forgo accepting stroke patients altogether under new standards. Neuravi says 87% of all strokes are ischemic. About a third of such stroke sufferers are eligible for thrombectomy devices.

Brady said he's confident about his ability to secure an "exit" via a sale of the company or an IPO, saying Neuravi is among the only available assets that's 100% focused on the fast-growing device arena of ischemic stroke.

-- Varun Saxena (email | Twitter)

For more:
American Heart Association guidelines encourage use of stent retrievers to treat stroke
Irish startup Neuravi raises $21M to get stroke stent retrieval device through pivotal trial
New studies show that devices, not just drugs, can help treat strokes
Experts: Stent retrieval devices to play larger role in treatment of stroke
Covidien, Stryker tout stroke study that used their stents

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