Dive Brief:

• Boston Scientific is set to acquire Veniti for its device to treat venous obstructive disease.

• The deal will see Boston Scientific pay $108 million in cash upfront and commit to up to $52 million in near-term regulatory milestones for the 75% of Veniti it does not already own.

• Veniti is seeking FDA approval for a self-expanding, nitinol device that could become the first stent cleared for use in the peripheral venous system in the U.S.

Dive Insight:

Boston Scientific’s business development team has been busy. In 2018, the device manufacturer has struck seven acquisition agreements worth more than $1 billion upfront to strengthen its presence in the cardiovascular sector and other fields. Boston Scientific owned a stake in several of the acquired companies before deciding to buy them outright.

The latest takeover will give Boston Scientific control of one of the leading products in an emerging field. Surgeons have been using stents to treat vein obstructions caused by conditions such a deep vein thrombosis for more than 20 years. Yet, for most of this time no companies made specialized devices, forcing surgeons to use stents designed for use in arteries. These arterial stents are ill-suited to the size, force and flexibility of the venous system.

Seeing an opportunity, Veniti, Cook Medical and OptiMed independently developed devices tailored to the venous system. These stents came to market in Europe several years ago and have been put through multiple trials, generating impressive short-term data that caught the attention of Boston Scientific.

Following its business development blueprint, Boston Scientific bought a 25% stake in Veniti for $25 million in 2016, enabling it to keep a close eye on the progress of venous obstructive disease specialist. The companies tightened their ties 11 months ago when Veniti gave Boston Scientific the right to distribute its Vici Venous Stent under a limited global agreement.

Veniti's stent was already CE marked and on the market in Europe when Boston Scientific invested in the company but was yet to gain FDA approval. The company took a big step toward entering the U.S. market in June when it filed for pre-market approval from the FDA on the strength of clinical data from a recently-completed pivotal study. With the device closing in on that key regulatory decision, Boston Scientific has decided now is the time to make its move.

If the FDA clears the device, Boston Scientific will access an as-yet-untapped market. Boston Scientific says venous obstructive disease affects 1.1 million people a year in the U.S and Western Europe. The U.S. portion of this patient population currently lacks access to venous stents, although Cook finished a U.S. clinical trial of its device late last year, two weeks before Veniti wrapped up its pivotal study.