Landmark Study Demonstrates Sustained Clinical Benefits of Flexitouch® Plus as First-Line Therapy in Treating Head and Neck Cancer-Related Lymphedema

Rhea-AI Summary

Tactile Medical (Nasdaq: TCMD) presented six-month results from a large randomized controlled trial showing sustained clinical benefits of Flexitouch Plus as first-line therapy for head and neck cancer–related lymphedema.

Key findings: sustained symptom improvement in both study arms, objective swelling reductions at 13 of 19 internal sites with statistically significant decreases at the base of tongue (p=0.008) and arytenoids (p=0.023), and clinician-reported measures favoring Flexitouch Plus. The trial enrolled 236 patients across 10 centers and confirms durability of benefit through six months following earlier two-month data.

Positive

• 236-patient randomized study across 10 academic and community centers
• 13 of 19 anatomical sites showed reduced internal swelling with Flexitouch Plus
• Statistically significant improvement at base of tongue (p=0.008)
• Statistically significant improvement at arytenoids (p=0.023)
• Sustained symptom improvement maintained through six months

Negative

• Both study arms showed sustained symptom improvement, limiting universal superiority claims
• Significant reductions reported at only select internal sites (2 sites cited)
• Company cites restricted payer coverage limiting patient access in the U.S.

Insights

Clinical Evidence Strategist

Six-month randomized data show sustained symptom and objective swelling improvements with Flexitouch Plus versus usual care in head and neck lymphedema.

The trial enrolled 236 patients across 10 centers and reports maintained patient-reported symptom relief and objective swelling reductions at six months for both arms, with several anatomical sites (13 of 19) favoring Flexitouch Plus and statistically significant internal-swelling improvement at the base of tongue (p=0.008) and arytenoids (p=0.023). Clinician-scored internal and external swelling scales also favored the device, and targeted measures such as epiglottic thickness and prevertebral soft tissue at C3 improved significantly in both arms, supporting a durable clinical effect beyond the initial two-month signal.

Key dependencies and risks remain payer coverage and access, which the company highlights as limiting in the U.S., and the comparative data show benefit but not universal superiority across all anatomical sites. The findings strengthen the evidence base for guideline inclusion and reimbursement discussions because the data derive from the largest prospective randomized study in this population; relevant near-term items to watch include dissemination to guideline committees, payer policy updates, and presentation or publication dates for full datasets within the next 6–12 months.

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) 102^nd 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 visit www.tactilemedical.com.

FAQ

What did Tactile Medical (TCMD) report in the six-month Flexitouch Plus head and neck lymphedema study?

A 236-patient randomized trial showed sustained symptom improvement at six months and reduced internal swelling at 13 of 19 sites, with significant changes at the base of tongue (p=0.008) and arytenoids (p=0.023).

How many patients and centers were included in the TCMD head and neck lymphedema trial?

The study enrolled 236 patients across 10 academic and community centers in the United States.

Does Flexitouch Plus show lasting benefit for head and neck lymphedema at six months (TCMD)?

Yes; the six-month analysis reports that initial patient benefit was maintained and symptom burden improvements were sustained in both the Flexitouch Plus and usual care groups.

Which anatomical sites showed statistically significant improvement with Flexitouch Plus in the TCMD study?

Statistically significant internal swelling reduction was observed at the base of tongue (p=0.008) and arytenoids (p=0.023).

Will the TCMD results affect payer coverage for Flexitouch Plus in head and neck lymphedema?

The company said it expects broader dissemination of results to inform guidelines and help overturn restrictive payer policies that currently limit access, but no coverage changes were announced.

How do clinician-reported measures compare between Flexitouch Plus and usual care in the TCMD trial?

Clinician-reported outcomes for both internal (Endoscopy Modified Patterson Scale) and external soft tissue swelling favored Flexitouch Plus over usual care according to the six-month data.