TVA Medical pulled in $9.5 million in new venture funding to advance its kidney failure treatment device through the clinical trial process, demonstrating that medical device venture investment still has some life in it.
The 5-year-old Austin, TX, startup's claim to fame is a device that enables hemodialysis for patients dealing with end-stage renal disease. It is a minimally invasive catheter-based system that lets physicians join an artery to a vein (a procedure known as an arteriovenous fistula) without surgery, a departure from the typical practice. With that procedure complete, physicians can deliver dialysis treatments for end-stage renal disease. Plans call for pursuing FDA clearance at some point, though international studies are the focus right now.
TVA says the new funding will help it pursue additional clinical testing for its endovascular technology to help it pursue global regulatory approvals.
Kidney dialysis offers a major opportunity for device companies. TVA said it sees a $1 billion-plus market opportunity. And, as TVA Medical CEO Adam Berman notes in a statement, the U.S. healthcare system spends more than $47 billion annually to treat end-stage renal disease, with just over half of patients still alive three years after treatment. A device that could improve the standard of care for these patients would be in high demand (though reimbursement issues are another battle to be fought after gaining approval).
Somewhere down the line, TVA may also catch the eye of some of the global medical device companies in the kidney dialysis space. Among them: Baxter ($BAX), the world's second largest kidney dialysis device maker, which is in the process of spending $4 billion to acquire Gambro AB, the third largest company in the space. Fresenius and smaller competitor NxStage Medical are also worth watching.
Berman and serial medical device entrepreneur/cardiovascular surgeon William E. Cohn co-founded TVA in 2008. S3 Ventures led the round, which also included TriStar Technology Ventures and founding investor Santé Ventures.
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