August 12, 2020

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Durham medtech startup Deep Blue receives FDA clearance for hernia mesh product


Medtech startup Deep Blue Medical Advances can now begin selling a novel hernia mesh product with enhanced anchoring strength following receipt of FDA device (501 K) clearance, which the company announced it had received Tuesday.

The T-Line Hernia Mesh “provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation,” the Durham-based company says. It is designed to counter “mesh migration, contraction and eventual failure.”

Deep Blue has raised more than $800,000 in funding.

The company was founded in 2014 by Duke plastic surgeon Howard Levinson, MD.

Millions of hernia surgeries are done globally at billions in clinical costs and support a $1.1 billion hernia device market.

In separate efforts, Levinson is working on additional  projects including an anti-biofouling Foley catheter, a non-invasive light imaging technology to diagnose skin disorders, and tissue-engineered skin that resists contraction.

“Sewing a bit of each extension into the abdominal wall, in lieu of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair,” Levinson says of the T-Line. “We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice.”

The firm says it plans to launch the T-Line at “selected sites” in the near future.

 

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[Originally posted by WRALTechWire — Aug 11, 2020]