New Data Demonstrates Significant Clinical and Quality-of-Life Benefits of Flexitouch® Plus in Treating Lymphedema 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
[email protected]
*Individual results may vary. For full prescribing information, including contraindications, warnings and instructions for use, please visit www.tactilemedical.com
