Kyle Winborne

Kyle Winborne, on behalf of Adam Maeder, asked for clarification on the OpEx plans for 2026, specifically if they are expected to be stable year-over-year compared to 2025, and sought qualitative color on investments in manufacturing and commercial team scaling. He also inquired about the opportunity in China for the year, including the expected portfolio and macro outlook.

Answer

David Fischel, Chairman and CEO, confirmed that operating expenses are expected to be flat year-over-year, with adjusted OpEx remaining under $30 million annually. He explained that reductions from completed large projects free up funds for manufacturing ramp and commercial activities, with more significant commercial team investments anticipated in 2027. For China, Mr. Fischel noted that partner MicroPort EP received approval for the Genesis system and a robotic ablation/mapping catheter a year ago, with first Genesis systems expected to be sold this year despite a difficult macro environment for capital. He also mentioned GenesisX and MAGiC regulatory submissions and a shift to MicroPort's catheter for royalties.

Kyle Winborne asked about Stereotaxis's OpEx plans for 2026, specifically if they are expected to remain stable year-over-year compared to 2025, and requested qualitative color on planned investments in manufacturing and commercial team scaling. He also inquired about the opportunity in China for 2026, including the expected portfolio and the macro outlook.

Answer

David Fischel, Chairman and CEO of Stereotaxis, confirmed expectations for overall flat operating expenses, noting that reductions from completed large projects free up funds for investments in manufacturing ramp and commercial activities. He anticipates more significant commercial team investments in 2027. For China, Mr. Fischel mentioned Genesis system approval with MicroPort EP a year ago and expects the first Genesis systems to be sold this year despite a difficult macro environment, alongside GenesisX and MAGiC regulatory submissions and a shift to MicroPort's catheter.

Kyle Winborne asked about the drivers behind the strong Q4 performance in the lymphedema business, specifically inquiring if the NCD interpretation fully became a tailwind and the impact of increased sales rep productivity. He also asked how Tactile Medical balanced the new Medicare prior authorization requirements with existing NCD tailwinds when formulating 2026 guidance.

Answer

CEO Sheri Dodd attributed the strong Q4 lymphedema performance to the culmination of investments in people, processes, and technology, including strong CRM adoption, increased sales rep productivity from recent hires, and a modest tailwind from Medicare patients directly accessing Flexitouch Advanced under new NCD criteria. Regarding 2026 guidance, Ms. Dodd explained that the outlook incorporates a balanced and thoughtful approach, acknowledging tailwinds like the NCD and a seasoned sales force, while prudently factoring in the short-term administrative impact of the new Medicare prior authorization requirement, for which Tactile Medical is well-prepared given its commercial experience.

Kyle Winborne asked about the drivers behind the strong Q4 2025 performance in the lymphedema business, specifically inquiring if the NCD interpretation fully became a tailwind and the impact of increased headcount productivity.

Answer

Sheri Dodd, Chief Executive Officer, explained that Q4 performance was a culmination of investments in people, processes, and technology, including strong CRM adoption, increased sales rep productivity from recent hires, and a modest tailwind from Medicare patients moving directly to Flexitouch Advanced under new NCD criteria. She also highlighted the strong performance of the airway clearance business.

Kyle Winborne of Piper Sandler Companies questioned why Tactile Medical's full-year guidance was not raised more significantly despite a strong Q2 revenue beat and inquired about the timeline for the six-month head and neck lymphedema data release and its potential impact on payer coverage and the P&L.

Answer

CEO Sheri Dodd explained that while Q2 performance provided confidence to raise the low end of guidance, the company remains cautious due to potential short-term disruptions from upcoming AI tool implementations, drawing on lessons learned from the Q1 CRM rollout. Regarding the head and neck data, Dodd confirmed a Q4 manuscript submission and clarified the goal is to influence commercial payer coverage, which currently deems the treatment experimental. She noted that while discussions are active, policy changes are on payer timelines, and a more significant financial impact is expected in 2026 and beyond.

Kyle Winborne of Piper Sandler Companies asked for an update on competitive dynamics in the MIGS market, specifically if headwinds were abating and if Sight Sciences was gaining share. He also requested clarification on the revenue cadence for Q3 and Q4 implied by the new annual guidance.

Answer

Chief Commercial Officer Matt Link stated that while the market remains competitive, Sight Sciences' team is executing better in a more stable environment, leveraging the OMNI and SION platforms. CFO Ali Bauerlein outlined the guidance cadence, projecting a mid-single-digit decline for surgical glaucoma in Q3 against a tough comparison, which implies a return to growth in Q4 against an easier year-over-year comparison.