New Data Demonstrates Significant Clinical and Quality-of-Life Benefits of Flexitouch® Plus in Treating Lymphedema Among Head and Neck Cancer Survivors

Rhea-AI Summary

Tactile Medical (NASDAQ: TCMD) presented new clinical data at ASCO 2025 demonstrating the effectiveness of their Flexitouch Plus device in treating lymphedema in head and neck cancer survivors. The study, involving 236 subjects across 10 sites, showed that Flexitouch Plus patients received treatment significantly faster (17.9 days vs 29.8 days for usual care) and had higher treatment initiation rates (94.9% vs 71%). The device demonstrated significant reduction in swelling and improved quality-of-life metrics in three of six sub-scales. The two-month analysis revealed that while both usual care and Flexitouch Plus (APCD) were similarly effective, APCD showed distinct advantages in treatment accessibility and swelling reduction. The company expects six-month results later this year, which could expand commercial payer coverage and improve care access.

Positive

• Higher treatment initiation rate with Flexitouch Plus (94.9%) compared to usual care (71%)
• Faster treatment initiation with Flexitouch Plus (17.9 days) versus usual care (29.8 days)
• Significant reduction in swelling demonstrated through digital photography and HN-LEFG scores
• Significant improvement in three of six health-related quality-of-life sub scales
• Large market potential with 90% of head and neck cancer survivors developing lymphedema

Negative

• None.

Insights

Medical Device Analyst

Tactile Medical's device shows faster treatment delivery and better outcomes for head/neck cancer lymphedema in major clinical trial.

The new clinical data for Tactile Medical's Flexitouch Plus represents a significant advancement in treating lymphedema among head and neck cancer survivors. The two-month results from this 236-patient randomized trial - the largest ever conducted in this population - demonstrate notable advantages over conventional therapy.

The most compelling findings show that patients using Flexitouch Plus received treatment 40% faster than those receiving usual care (17.9 days versus 29.8 days). Additionally, the treatment rate was substantially higher at 94.9% compared to just 71% for usual care - indicating significantly improved access to therapy.

Beyond accessibility, the device demonstrated clinical superiority with significant reductions in swelling (verified through digital photography and standardized assessment scores) and meaningful improvements in three of six quality-of-life metrics. These objective outcomes strongly validate the technology's effectiveness.

The market implications are substantial considering 90% of head and neck cancer survivors develop lymphedema. The comprehensive data collection across multiple academic and community sites strengthens the evidence quality, which will likely influence upcoming reimbursement decisions by commercial insurers.

While these two-month results are promising, the anticipated six-month data later this year will be crucial for potential inclusion in clinical guidelines and securing broader insurance coverage - the key factors that will ultimately determine widespread adoption of this technology in clinical practice.

Abstract Presented at ASCO 2025 Annual Meeting Features Two-Month Data from the Largest Randomized Trial Ever Conducted Among Head and Neck Cancer Survivors

MINNEAPOLIS, June 03, 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 clinical data at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting that demonstrates significant clinical and quality-of-life benefits associated with use of the Company’s Flexitouch Plus versus usual care in treating patients with head and neck cancer-related lymphedema.

“Current modalities for managing head and neck cancer-related lymphedema include therapist guided lymphedema treatment and lifelong home-based self-care. However, data shows that patients face substantial barriers to accessing these modalities, which limits the number of patients receiving treatment and delaying therapy initiation for those who do,” said Principal Investigator, Barbara Murphy, MD, Professor of Medicine, Director, Head and Neck Research Program, and Director, Pain and Symptom Management Program at Vanderbilt-Ingram Cancer Center. “Our study found that advanced pneumatic pump technology provides a feasible alternative that reduces swelling, increases speed to initial therapy, and generates strong quality-of-life outcomes.”

The two-month analysis featured data from the Company’s six-month clinical trial, which examines the effectiveness of Flexitouch Plus, an advanced pneumatic compression device (APCD), versus usual care in treating lymphedema among head and neck cancer survivors. The study includes 236 subjects across 10 academic and community sites, representing the largest prospective, randomized controlled study on this patient group ever conducted in the United States. Outcome measures include changes in disease-specific patient-reported symptom survey scores and objective clinical assessments, including CT imaging.

Two-month data demonstrated that usual care and APCD are similarly effective treatment modalities for head and neck lymphedema. Specific areas of differentiation showed:

• Usual care participants took an average of 29.8 days to begin therapist guided lymphedema treatment (TGLT), while APCD participants received their device in 17.9 days;
• Of participants randomized to usual care, only 71% received TGLT compared to 94.9% of those in the APCD group;
• APCD participants had significant reduction in swelling via digital photography and total Head and Neck Cancer Related Lymphedema and Fibrosis Grading (HN-LEFG) scores while usual care participants exhibited marginal improvements; and
• Self-reported symptom improvement occurred in both groups, with APCD demonstrating significant improvement on three of the six health-related quality-of-life sub scales.

“Tactile is committed to elevating lymphedema therapy with meaningful evidence generation, and these early results validate Flexitouch Plus as an effective option in treating head and neck cancer-related lymphedema,” said Sheri Dodd, Chief Executive Officer of Tactile Medical. “90% of head and neck cancer survivors will develop lymphedema, and we are pleased to provide a solution that supports the patient’s needs and timeline for effective symptom management. We look forward to the six-month results from this significant trial later this year. We expect this to support more expansive reimbursement coverage by commercial payers, inform clinical guidelines, and drive broader patient and provider awareness, ultimately improving access to care.”

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 are the key benefits of Tactile Medical's Flexitouch Plus for lymphedema treatment?

Flexitouch Plus demonstrates faster treatment initiation (17.9 vs 29.8 days), higher treatment rates (94.9% vs 71%), significant swelling reduction, and improved quality-of-life metrics compared to usual care.

How many patients were involved in TCMD's head and neck cancer lymphedema study?

The study included 236 subjects across 10 academic and community sites, making it the largest prospective, randomized controlled study of this patient group in the United States.

What is the market potential for TCMD's Flexitouch Plus in head and neck cancer survivors?

The market potential is significant as 90% of head and neck cancer survivors develop lymphedema, and Flexitouch Plus offers an FDA-cleared at-home treatment solution.

What regulatory clearances does TCMD's Flexitouch Plus have?

Flexitouch Plus is FDA-cleared for at-home treatment of lymphedema, chronic edema, chronic venous insufficiency (CVI), and chronic wounds.

When will TCMD release the complete six-month trial results for Flexitouch Plus?

The company expects to release the six-month results later in 2025, which could support expanded commercial payer coverage and inform clinical guidelines.