Tactile Medical reports positive clinical data on Flexitouch Plus for managing lymphedema in head and neck cancer survivors.
Quiver AI Summary
Tactile Systems Technology, Inc. announced at the ASCO 2025 Annual Meeting new clinical data showing that its Flexitouch Plus device significantly improves clinical outcomes and quality of life for patients with head and neck cancer-related lymphedema compared to usual care. The study, which is the largest prospective, randomized controlled trial in this patient group in the U.S., involved 236 participants and demonstrated that the Flexitouch Plus reduces the time to initial therapy and improves symptom management more effectively than traditional treatment options. Key findings included quicker access to the therapy for patients using the Flexitouch Plus, higher rates of treatment initiation, significant swelling reduction, and notable improvements in health-related quality of life. Tactile Medical's CEO emphasized the potential for these findings to enhance reimbursement coverage, inform clinical guidelines, and increase access to care for lymphedema patients.
Potential Positives
- Presentation of new clinical data at ASCO highlights significant clinical and quality-of-life benefits of the Flexitouch Plus device for patients with head and neck cancer-related lymphedema.
- The study represents the largest prospective, randomized controlled trial in the United States focused on this patient group, indicating robust research backing for the product.
- Flexitouch Plus demonstrated faster initiation of therapy and higher rates of effective treatment compared to usual care, thereby enhancing patient access to essential care.
- Positive results are expected to support broader reimbursement coverage and clinical guideline updates, potentially increasing market adoption and sales opportunities for the company.
Potential Negatives
- The press release highlights that usual care and the advanced pneumatic compression device (APCD) are similarly effective, which could raise concerns about the market differentiation and unique value proposition of Tactile Medical's product.
- While the APCD group showed significant benefits, the statement about usual care participants achieving only marginal improvements may indicate that the existing treatment options are inadequate, putting pressure on the company to demonstrate the superiority of its product in future results.
- The press release underscores that only 71% of usual care participants received the needed therapy, suggesting systemic issues in access and patient management that may reflect poorly on the effectiveness of conventional treatments and potentially impact Tactile Medical’s reputation in the broader healthcare context.
FAQ
What is Flexitouch Plus?
Flexitouch Plus is an FDA-cleared advanced pneumatic compression device for at-home treatment of lymphedema and related conditions.
What were the results of the recent study on Flexitouch Plus?
The study showed Flexitouch Plus significantly reduced swelling and improved quality of life compared to usual care for head and neck cancer-related lymphedema.
How long does it take for patients to start treatment with Flexitouch Plus?
Patients using Flexitouch Plus received their device in an average of 17.9 days, compared to 29.8 days for usual care.
What percentage of patients received therapy with Flexitouch Plus?
A total of 94.9% of participants using Flexitouch Plus received therapy, compared to 71% of those in the usual care group.
What is Tactile Medical's commitment to patient care?
Tactile Medical is committed to elevating lymphedema therapy through evidence generation and improving access to care for chronic condition patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$TCMD Insider Trading Activity
$TCMD insiders have traded $TCMD stock on the open market 9 times in the past 6 months. Of those trades, 0 have been purchases and 9 have been sales.
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- DANIEL L. REUVERS has made 0 purchases and 2 sales selling 39,276 shares for an estimated $560,996.
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- WILLIAM W BURKE sold 3,300 shares for an estimated $31,911
- SHERI LOUISE DODD (Chief Executive Officer) sold 3,149 shares for an estimated $30,954
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Full Release
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