September 4, 2015

Pentagon Funds Silicon Valley Initiative

The Defense Department has awarded a $75 million contract to the San Jose, Calif.-based research consortium FlexTech Alliance to establish and manage a Manufacturing Innovation Institute for Flexible Hybrid Electronics. According to the alliance, FHE has the potential to affect the electronic wearable devices market and medical health monitoring systems. The contribution, according to Defense Secretary Ashton Carter, is part of an Obama administration effort to boost investment and innovation in emerging technologies, including 3-D printing, lightweight metals and digital manufacturing and design.

Edwards Acquires CardiAQ

Edwards Lifesciences has completed its acquisition of CardiAQ Valve Technologies in a deal that could be worth up to $400 million, giving it access to CardiAQ’s proprietary transcatheter mitral valve implant. Irvine, Calif.-based CardiAQ received the FDA’s go-ahead in April to conduct an early feasibility study of two of its systems in up to 20 patients. The company also plans to initiate a CE mark study in Europe. The acquisition builds on Edwards’ existing transcatheter mitral valve program.

FDA Clears MagVenture System

The FDA has cleared MagVenture’s MagVita TMS Therapy system for use in treating adults with major depressive disorder who have failed to improve with antidepressant medication. The noninvasive system works by stimulating neural tissue in the part of the brain implicated in patients suffering from the disorder. It was cleared for use in the EU in 2011. MagVenture specializes in noninvasive magnetic stimulation systems for depression, as well as research in the areas of neurophysiology, neurology, cognitive neuroscience, rehabilitation and psychiatry.

Valeant to Acquire Synergetics USA

Valeant Pharmaceuticals has reached an agreement to buy Synergetics USA, a supplier of precision surgical devices with a focus on ophthalmology and neurosurgery, for $6.50 per share. Synergetics stockholders also will receive additional payments of up to $1 per share if specified sales milestones are achieved following the closing. The transaction is expected to close in the fourth quarter of 2015. “The addition of Synergetics’ portfolio of instruments and devices will further enhance Bausch + Lomb’s presence around the world in the rapidly evolving field of vitreoretinal surgery,” says J. Michael Pearson, chairman and CEO of Valeant, which bought Bausch + Lomb in 2013.

Medtronic Acquires Medina

Medical device giant Medtronic has acquired Menlo Park, Calif., devicemaker Medina Medical for $150 million, plus future milestone payments. Medina focuses on developing treatments for vascular abnormalities of the brain, including an intrasaccular 3D mesh implant that fills the inside of a brain aneurysm. The device has CE mark approval, but is not available in the U.S.

Surefire Gets 510(k) Clearance

The FDA has granted clearance to Surefire Medical’s infusion system with an expandable tip that increases drug delivery directly to a tumor while protecting healthy tissue. A study found that, when compared with conventional end-hole catheters, the Surefire Precision enabled increased uptake of particles by an average of 68 percent, and up to 90 percent in treating primary liver cancer.