Abbott Laboratories has kicked off a pivotal study to evaluate its catheter-based Triclip transcatheter tricuspid valve repair system in patients with severe tricuspid regurgitation (TR). The first enrollments in the U.S. FDA-approved Triluminate study were performed at Abbott Northwestern Hospital in Minneapolis by a cardiac team led by Paul Sorajja, director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute and co-primary investigator for the trial.
New med-tech investment firm Vensana Capital reported Wednesday that it has closed an inaugural fund, Vensana Capital I, with $225 million in committed capital. The venture capital and growth equity investment firm, launched earlier this year, aims to use the fund to invest in 10 to 12 companies, with commitment sizes ranging from $10 million to $30 million per company.
The fund, which was oversubscribed, will focus on companies across the med-tech sector, including medical devices, diagnostics and information systems, digital health, drug delivery and technology-enabled services. Vensana does not plan to invest in biopharma ventures.
The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.
Concussion and traumatic brain injury (TBI) are serious public health problems, but they can be tricky to diagnose, with symptoms sometimes not presenting for days or weeks following a head injury. Abnormal eye movement can indicate a TBI, but traditional "follow my finger" screenings won't pick up more subtle changes in vision. Artificial intelligence (AI) could improve diagnosis by measuring deficits in certain eye movements that occur with a TBI. In a study published online July 25, 2019, in the journal Concussion, Bethesda, Md.-based Righteye Inc.'s FDA eye-tracking technology not only identified but scaled the severity of TBIs by measuring horizontal and vertical saccades, rapid eye movements between fixed points.
Surmodics Inc. reported that it has completed enrollment in the pivotal TRANSCEND clinical trial to evaluate its Surveil drug-coated balloon (DCB), hitting the first in a series of product development milestones tied to an exclusive licensing agreement with Abbott Laboratories. The Eden Prairie, Minn.-based company will receive $10 million for reaching this goal. The randomized, controlled study enrolled 446 patients at 65 sites in the U.S. and abroad and aims to assess the Surveil DCB in treating peripheral artery disease (PAD) in the upper leg.
Sunnyvale, Calif.-based EBR Systems Inc. scooped up $30 million in an undisclosed round that was led by Australian private equity firms Brandon Capital Partners and M.H. Carnegie & Co. The money will be used to complete enrollment in the company's pivotal SOLVE CRT clinical trial and prepare for commercialization of the Wireless Stimulation Endocardially (WiSE) cardiac resynchronization therapy (CRT) system. The funding boost comes as John McCutcheon has joined EBR Systems as president and CEO.
By streamlining processes, cutting costs and improving data quality, artificial intelligence (AI) and machine learning can reduce clinical trial spend and speed time to market. The technology is showing up in a number of applications, from guiding recruitment to developing biomarkers to determine who will respond to certain treatments and driving cost efficiencies.
