Tactile Medical Launches Next-Generation Nimbl™ Lymphedema Platform

Rhea-AI Summary

Tactile Medical (Nasdaq: TCMD) has launched Nimbl, its next-generation pneumatic compression platform, for treating upper extremity lymphedema across the United States. Nimbl, which received FDA 510(k) clearance in June 2024 and CMS PDAC approval in September 2024, is 68% lighter, 40% smaller, and uses 33% less hosing than the company's current basic pneumatic compression device.

The device is indicated for treating both upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing. Nimbl offers connectivity to the free Kylee digital application for tracking usage and symptoms. The company plans to expand Nimbl's availability for lower extremity conditions in the coming months.

Positive

• Launch of next-generation Nimbl platform for lymphedema treatment
• FDA 510(k) clearance and CMS PDAC approval obtained for Nimbl
• Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than previous device
• Connectivity to free Kylee digital application for tracking usage and symptoms
• Planned expansion to lower extremity conditions in coming months

Negative

• None.

Insights

Medical Device Expert

The launch of Nimbl represents a significant advancement in lymphedema treatment technology. Its 68% lighter and 40% smaller design addresses key patient concerns about device portability and ease of use. This could potentially lead to improved patient adherence and better clinical outcomes, especially for breast cancer survivors who make up a large portion of upper extremity lymphedema patients.

The FDA clearance and CMS PDAC approval are important regulatory milestones that pave the way for widespread adoption and insurance coverage. The planned expansion to lower extremity treatments in the coming months suggests a strong product pipeline and potential for market share growth.

The integration with the Kylee™ digital app adds value through patient engagement and data tracking, which could lead to improved patient outcomes and potentially valuable real-world data for the company. However, the impact on revenue and market share will depend on successful commercialization and adoption rates among clinicians and patients.

Financial Analyst

While the Nimbl launch is a positive development for Tactile Medical, its immediate financial impact may be The initial focus on upper extremity lymphedema targets a specific subset of the market. The real financial potential lies in the upcoming expansion to lower extremity conditions, which could significantly broaden the addressable market.

Investors should monitor key performance indicators in the coming quarters, including:

• Adoption rates among clinicians
• Revenue growth in the lymphedema segment
• Gross margins, as the new product may have different cost structures
• Impact on operating expenses, particularly in sales and marketing

With a market cap of $342,724,496, Tactile Medical is a small-cap company where product launches can have a material impact. However, the full financial benefits of Nimbl may not be realized until the lower extremity version is launched and gains traction in the market.

Initial Launch Focused on Treating Patients Suffering from Upper Extremity Lymphedema

MINNEAPOLIS, Oct. 02, 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 that Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the United States for the treatment of upper extremity lymphedema. Nimbl, which is significantly smaller and lighter than previous device iterations, is indicated as a treatment option for patients with both upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing. Nimbl received U.S Food & Drug Administration (FDA) 510(k) clearance in June 2024 and Pricing, Data Analysis, and Coding (PDAC) approval from the Centers for Medicare & Medicaid Services (CMS) in September 2024. The Company expects to make Nimbl commercially available for patients with lower extremity conditions in the coming months.  

“We are excited to announce the commercial launch of Nimbl, an important addition to our leading portfolio of patient-focused, clinically proven lymphedema therapy solutions,” said Sheri Dodd, Chief Executive Officer at Tactile Medical. “This first phase of Nimbl’s introduction, targeted specifically for upper extremity treatment, is well-timed as we recognize Breast Cancer Awareness Month and the many thousands of patients in need of better treatment solutions. Up to 40% of breast cancer survivors are affected by lifelong, debilitating lymphedema symptoms through swelling and discomfort in the breast, trunk, arms, and hands, and we are proud to provide a highly effective and convenient treatment option. We look forward to expanding Nimbl’s launch to include patients with lower extremity conditions, and we remain committed to advancing solutions that increase patient access to therapy with a differentiated user experience.”

Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than the Company’s current generation basic pneumatic compression device (PCD). Its compact design is the smallest PCD of its kind, making it an ideal therapy for daily use at home or on the go. In addition to the patient centric feature enhancements, Nimbl also offers connectivity to the Company’s free Kylee™ digital application, providing patients a simple way to track their usage and change in symptoms, and to share results with their care team. Convenient accessories are available for purchase including a rechargeable battery and custom-designed travel bag.

“Patients and clinicians alike will appreciate the introduction of Nimbl as a compelling treatment option designed to increase adherence and improve clinical outcomes”, said Tony Gasparis, MD, Chief Medical Officer at Tactile Medical. “Patients can now more easily fit therapy into their daily routine resulting in long-term relief and increased confidence for clinicians.”

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 is Tactile Medical's new product for lymphedema treatment?

Tactile Medical has launched Nimbl, a next-generation pneumatic compression platform for treating upper extremity lymphedema.

When did Tactile Medical (TCMD) receive FDA clearance for Nimbl?

Tactile Medical received FDA 510(k) clearance for Nimbl in June 2024.

How does Nimbl compare to Tactile Medical's previous compression devices?

Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than Tactile Medical's current generation basic pneumatic compression device.

What conditions can Tactile Medical's Nimbl device treat?

Nimbl is indicated for treating upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing.

Does Tactile Medical's Nimbl device offer any digital connectivity features?

Yes, Nimbl offers connectivity to Tactile Medical's free Kylee digital application for tracking usage, symptoms, and sharing results with care teams.