Detailed Narrative
Lymphedema Business Performance and Medicare Prior Authorization
The lymphedema business demonstrated strong momentum with 12% year-over-year revenue growth in Q2 FY26, driven by healthy referral trends, improved territory productivity, and NCD-driven Flexitouch adoption. The April 13th Medicare prior authorization requirement introduced administrative steps, causing near-term moderation in Medicare order volumes. However, the company prepared for these requirements, and initial impacts are expected to moderate📎 as operational efficiency improves and MACs gain familiarity with the new process.
Airway Clearance Segment Headwinds and Next-Gen AffloVest Launch
Sales of AffloVest declined 7% year-over-year in Q2 FY26, primarily due to temporary inventory management dynamics among several large DME partners. This was associated with the launch of the next-generation AffloVest system, which prompted DMEs to assess existing inventory. The company expects these dynamics to continue influencing ordering patterns through Q3, with normalization anticipated in Q4. Despite this, underlying business fundamentals, patient demand, and the competitive position of AffloVest remain strong.
LymphaTech Acquisition and Strategic Expansion
The LymphaTech acquisition aims to address unmet needs in lymphedema diagnosis and monitoring. Its FDA-cleared platform provides objective, quantitative assessment of limb volume and circumference, generating 3D models for disease progression tracking. The company has submitted for an expanded indication as a diagnostic aid for lymphedema, with FDA approval expected in 2027, and is pursuing a Category III CPT code to establish a reimbursement pathway and support broader adoption. This initiative targets the 20 million undiagnosed lymphedema patients in the U.S.
Clinical Evidence and Market Access Initiatives
Tactile Medical published the 6-month manuscript for its head and neck clinical evidence program in a peer-reviewed journal, demonstrating Flexitouch's efficacy in treatment-naive patients. This study supports expanding awareness and improving access to care for head and neck lymphedema patients, particularly by engaging commercial payors to remove restrictive experimental and investigational designations. The Medicare NCD policy already allows coverage for these patients, and the publication is expected to drive clinician awareness.
New Treatment Option: MyoSleeve Distribution Agreement
The company announced an exclusive U.S. distribution agreement with ElastiMed for MyoSleeve, a discreet, wearable, non-pneumatic compression device for lower leg lymphedema. This product is specifically targeted at veterans, active duty service members, and other beneficiaries through the VA channel, where Tactile Medical has established relationships. MyoSleeve expands the company's portfolio of lymphatic care solutions, offering an additional treatment option for earlier-stage patients and complementing existing pneumatic compression therapies.