Investor Connect 882: TEN Connect May 2026 - Part 2
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In this episode of Investor Connect, we hear from Dr. Swarna Balasubramaniam, a surgeon-turned-founder, who presents Noleus Leaf, a perioperative therapeutic device designed to restart bowel function and shorten the long, complication-prone recovery after major abdominal surgery, where patients often remain hospitalized 2 to 14 days waiting for intestines to "wake up."
She explains how excess IV fluids swell the intestines, contributing to ileus, and how Noleus Leaf uses negative pressure (vacuum) therapy placed at the end of surgery for six hours and then removed at the bedside to remove fluid and help patients eat and drink sooner, supporting healing. Dr. Balasubramaniam shares first-in-human study results conducted outside the US showing patients tolerated internal negative pressure therapy and bedside removal, and recovered bowel function two days earlier than supportive care. She outlines the market opportunity, citing about 2.9 million patients affected, additional use cases in inflammatory or infectious GI conditions, and economics including a device cost under $300 at scale and potential pricing tied to saving roughly two hospital days.
The discussion also covers regulatory and commercialization plans, including pursuing a 510(k) pathway leveraging negative pressure wound therapy predicates rather than a De Novo approach, targeting large tertiary and quaternary surgical centers first, and building a sales motion that requires both surgeon champions and hospital value analysis approval. Dr. Balas notes the company has been capital efficient (under $4 million to date), is raising $1.4 million to support a 10–15 patient trial and verification/validation work for FDA clearance, and anticipates commercialization in about two and a half years, with potential exit paths to large medical device or wound care companies.
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