Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough time to secure FDA clearance for the first and second generation of its endovascular guidewire prototype, he said.
TSSC has raised $3.725 million so far, starting with a friends and family round in 2020 and the first institutional round in early 2023. The company already has one device developer as a strategic investor, though DeBoer asked that the company not be publicly identified.
“We overcame our major technical barriers in the end of December. That was proving through some further developments that we can get our accuracy to where we needed to be,” DeBoer said. “Going forward, we have some straightforward engineering to do, which just requires money”TSSC has cost-reduction projects scoped out and ready to go as soon as the cash is available, he said, estimating about 18 months worth of engineering projects that will continue to improve the product’s performance.
“Even today, with the demos that we’re putting forward, the accuracy is sufficient for at least the early applications we’re pursuing in the endovascular space,” DeBoer said.
“We need to formally productize our platform, which means all the design history file and the documentation and everything to prepare for validation and verification, which will begin next year,” he continued. “… Once we have the funds in the bank, we can actually move pretty fast.”DeBoer anticipates needing a small team or — more likely — a third-party company to help in this next stage as the company tries to submit its first product to the FDA for review by mid-2025. After that first 510(k) clearance using a fiber optic sensing predicate, TSSC anticipates full commercialization in 2027 of a more polished second version that would include touchscreen controls.
TSSC currently has seven employees, and DeBoer expects the Series B round would double that number.
TSSC is working on fiber optic sensor technology that could have medtech applications in a wide range of areas, including robotic surgery, catheter procedures, cardiology, structural heart, electrophysiology, gastrointestinal and orthopedics.
The technology is similar to what Luna Innovations Inc. developed in partnership with Intuitive Surgical for its Ion endoluminal system for robotic bronchoscopy. Philips also uses the Luna fiber optic technology for its LumiGuide 3D device guidance system.Beyond developing its own guidewire device, TSSC is working with other device developers to find new uses for its technology, selling R&D equipment and offering varying levels of support.