Landmark Study Demonstrates Sustained Clinical Benefits of Flexitouch® Plus as First-Line Therapy in Treating Head and Neck Cancer-Related Lymphedema
MINNEAPOLIS, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced the presentation of new six-month clinical data during the late-breaking poster session at the American Congress of Rehabilitation Medicine (ACRM) 102nd Annual Fall Conference demonstrating sustained clinical benefits of Flexitouch® Plus as a first-line therapy for treating patients with head and neck cancer-related lymphedema.
The six-month analysis, drawn from a large randomized controlled trial, showed improvement in lymphedema symptom burden for participants in both the advanced pneumatic compression device (APCD) study arm, consisting of treatment with Flexitouch Plus, and the usual care study arm, which included therapist-guided multimodal treatment. Symptom severity was based on scoring from disease-specific patient-reported symptom surveys. Swelling improvements were also observed in objective clinical assessments, including CT imaging. Highlights from the six-month results include:
- Flexitouch Plus demonstrated reduced internal swelling at the majority of anatomical sites (13 of 19), with statistically significant improvement achieved in the base of tongue (p=0.008) and arytenoids (p=0.023);
- Clinician-reported outcome measures of both internal (Endoscopy Modified Patterson Scale) and external soft tissue swelling favored Flexitouch Plus over usual care;
- Significant improvement in epiglottic thickness and prevertebral soft tissue thickness at C3 in both groups at six months;
- The initial patient benefit of Flexitouch Plus and usual care was maintained over the six-month study timeframe; and
- Both groups demonstrated sustained improvement in symptom burden over the six-month study timeframe.
“For the first time, we have reported long-term data supporting the use of advanced pneumatic compression technology, specifically the Flexitouch Plus, as a clinically effective alternative to usual care for treating lymphedema among head and neck cancer survivors,” said Principal Investigator Dr. Sheila Ridner, PhD, RN, Research Professor at Vanderbilt University School of Nursing. “This is especially meaningful for a patient population in which up to 90% develop lymphedema within one year following cancer treatment, and nearly half go on to experience moderate to severe fibrosis. While usual care modalities like therapist-guided treatment remain important methods of symptom management, our findings suggest that APCD therapy effectively delivers long-term clinical health benefits for patients, including differentiated reduction in internal swelling severity.”
The new long-term results follow two-month data released at ASCO in June 2025 and are drawn from the largest prospective, randomized controlled study ever conducted among head and neck cancer survivors in the United States, which enrolled 236 patients across 10 academic and community-based centers.
“The sustained patient benefits associated with Flexitouch Plus, as demonstrated in the six-month results, combined with the early improvements seen at two months, are clinically important for head and neck lymphedema patients and the providers who treat them,” said Sheri Dodd, Chief Executive Officer of Tactile Medical. “Not only is therapist-guided care limited in the U.S., but payer coverage policies have restricted access to Flexitouch Plus in this population. We look forward to the broader dissemination of the study results to inform clinical guidelines, support patient and provider education, and overturn restrictive payer policies that currently limit head and neck lymphedema patients from accessing clinically proven treatment options.”
Flexitouch Plus is an FDA-cleared therapy designed for at-home treatment of lymphedema, chronic edema, chronic venous insufficiency (CVI), and chronic wounds*.
About Tactile Systems Technology, Inc. (DBA Tactile Medical)
Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. Tactile Medical collaborates with clinicians to expand clinical evidence, raise awareness, increase access to care, reduce overall healthcare costs and improve the quality of life for tens of thousands of patients each year.
Investor Inquiries:
Sam Bentzinger
Gilmartin Group
investorrelations@tactilemedical.com
*Individual results may vary. For full prescribing information, including contraindications, warnings, and instructions for use, please visitwww.tactilemedical.com.
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