Tactile Medical Announces Positive Clinical Trial Results in Lymphedema Patients Using Advanced Pneumatic Compression Device Therapy

Rhea-AI Summary

Tactile Medical (Nasdaq: TCMD) announced positive results from a clinical study on their Flexitouch advanced pneumatic compression device (APCD) for lower extremity lymphedema. The 52-week study, published in the Journal of Vascular Surgery, Venous and Lymphatic Disorders, is the largest U.S. prospective clinical trial on PCDs and lymphedema. Key findings include:

- 92% patient compliance at 8 weeks, 72% at 52 weeks
- 1.4 cm decrease in limb girth
- Cellulitis events reduced from 21.4% to 6.1%
- Skin hyperpigmentation decreased from 75% to 40% of patients
- 6% limb girth reduction at 12 weeks in moderate and severe cases

The study involved 179 Veterans across four VA medical centers, with chronic venous insufficiency being the most common cause of lymphedema (63% of participants). The results demonstrate significant improvements in quality of life, clinical outcomes, and therapy adherence.

Positive

• Largest U.S. prospective clinical trial on PCDs and lymphedema
• High patient compliance: 92% at 8 weeks, 72% at 52 weeks
• Significant reduction in cellulitis events from 21.4% to 6.1%
• Decrease in skin hyperpigmentation from 75% to 40% of patients
• 6% limb girth reduction at 12 weeks in moderate and severe cases
• Improved compression garment compliance from 64% to 74%

Negative

• None.

Insights

Medical Research Analyst

This study represents a significant advancement in lymphedema treatment research, particularly for the Flexitouch system. The large sample size of 179 Veterans and 52-week duration provide robust evidence of the device's efficacy. Key findings include:

• 92% patient compliance at 8 weeks, dropping to 72% at 52 weeks, indicating strong initial adoption and sustained use.
• Significant reductions in limb girth (1.4 cm), cellulitis events (from 21.4% to 6.1%) and skin hyperpigmentation (from 75% to 40% of patients).
• 6% limb girth reduction at 12 weeks for moderate to severe lymphedema cases.

These results demonstrate meaningful clinical improvements and high patient adherence, which could translate to reduced healthcare costs and improved quality of life for lymphedema patients. For Tactile Medical, this data strengthens their market position and may lead to increased adoption of the Flexitouch system.

Financial Analyst

This clinical trial data is likely to have a positive impact on Tactile Medical's financial outlook. Key financial implications include:

• Potential market expansion: Strong efficacy data may lead to increased adoption among healthcare providers and patients, potentially driving revenue growth.
• Reimbursement support: Robust clinical evidence can strengthen the case for insurance coverage, potentially improving accessibility and sales.
• Competitive advantage: As the largest U.S. prospective trial in this field, the study results may differentiate Flexitouch from competitors, potentially increasing market share.
• Long-term revenue potential: High compliance rates (72% at 52 weeks) suggest strong potential for recurring revenue from long-term users.

While specific financial projections aren't provided, these results could positively impact Tactile Medical's top-line growth and market position in the lymphedema treatment space. Investors should monitor for potential increases in prescription rates and sales in upcoming quarterly reports.

Largest U.S. Prospective Clinical Trial Ever Conducted Demonstrated High Compliance with the Flexitouch® System and Significant Improvements Across Study Endpoints

MINNEAPOLIS, Sept. 25, 2024 (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 publication of a new clinical study in the Journal of Vascular Surgery, Venous and Lymphatic Disorders. This study assessed outcomes associated with use of the Company’s Flexitouch advanced pneumatic compression device (APCD) in Veterans with lower extremity lymphedema. Notably, this 52-week study represents the largest peer-reviewed, prospective, clinical trial investigating PCDs and lymphedema ever published in the United States.

The prospective, longitudinal, pragmatic study publication, titled “Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema”, was authored by Padberg et al. and included 179 Veterans across four participating VA medical centers. The primary outcome measures included disease-specific health-related quality of life (QoL) endpoints obtained at baseline and again at each of 12, 24, and 52 weeks. The secondary outcome measures assessed limb circumference, cellulitis events, skin quality, and therapy compliance over the course of 52 weeks. Among the patients included in the study, chronic venous insufficiency was the most common etiology of lymphedema (phlebolymphedema), presenting in approximately 63% of study participants. Further, mild lymphedema was the most common disease stage, presenting in 68% of patients.

The secondary endpoint results demonstrated several statistically significant improvements, baseline to 52 weeks, with reductions in limb girth, cellulitis events, and skin hyperpigmentation. Among these results, the following were observed:

• Limb girth decreased by 1.4 cm
• Cellulitis events decreased from 21.4% to 6.1%
• Skin hyperpigmentation decreased from 75% of patients to 40% 
  

There were additional improvements also noted in compliance and limb girth reduction which included:

• 92% patient compliance (defined as used for 5 to 7 days per week) with Flexitouch at 8 weeks and 72% patient compliance at 52 weeks
• 74% patient compliance with compression garments at 52 weeks, compared to 64% at baseline
• 6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema.
  

“We sincerely thank the clinical researchers, patients, and VA Medical Centers for advancing peer-reviewed evidence that supports clinical and patient benefits of our Flexitouch therapy,” said Sheri Dodd, President and Chief Executive Officer of Tactile Medical. “Achieving these impressive study results, including outstanding compliance over a 1-year timeframe, validates the importance of APCD therapy outcomes and demonstrates a patient experience that supports strong adherence to therapy. We are proud to provide Veterans the at-home tools they need to improve their clinical symptoms and quality of life.”

Full text of the study may be found online at: https://www.jvsvenous.org/article/S2213-333X(24)00208-7/fulltext.

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

FAQ

What were the key results of Tactile Medical's Flexitouch APCD clinical trial for lymphedema?

The clinical trial showed high patient compliance (92% at 8 weeks, 72% at 52 weeks), a 1.4 cm decrease in limb girth, reduction in cellulitis events from 21.4% to 6.1%, and decreased skin hyperpigmentation from 75% to 40% of patients. Additionally, there was a 6% limb girth reduction at 12 weeks in moderate and severe cases.

How long did Tactile Medical's Flexitouch APCD clinical trial for lymphedema last?

The clinical trial lasted for 52 weeks, making it the largest peer-reviewed, prospective clinical trial investigating PCDs and lymphedema ever published in the United States.

What was the most common cause of lymphedema in Tactile Medical's TCMD Flexitouch study?

The most common cause of lymphedema in the study was chronic venous insufficiency (phlebolymphedema), presenting in approximately 63% of study participants.

How many patients were involved in Tactile Medical's TCMD Flexitouch clinical trial?

The clinical trial included 179 Veterans across four participating VA medical centers.