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This model allows us to engage directly with patients and clinicians, which are both critical audiences to which we can provide clinical evidence and education.
−Removed: For our respiratory therapy products, we have a durable medical equipment (“DME”) distribution model, utilizing mature comprehensive respiratory DME provider representatives to service patients.
−Removed: We sell the AffloVest product to accredited DME providers, whose representatives gather and submit documentation for payer reimbursement, train patients on use of the device, and provide ongoing patient support.
+Added: For our respiratory therapy product, we have a durable medical equipment (“DME”) distribution model, through which we sell the AffloVest product to accredited DME providers, whose representatives gather and submit documentation for payer reimbursement, train patients on use of the device, and provide ongoing patient support.
For the year ended December 31, 2025, we generated revenue of $329.5 million and had net income of $19.1 million.
Our revenue increased 12% during the year ended December 31, 2025, compared to the year ended December 31, 2024.
−Removed: Lymphedema is a type of chronic swelling, or edema, which occurs in the arms, legs, neck, trunk or other body parts when the lymphatic vessels are unable to adequately drain protein-rich lymph fluid from these regions.
+Added: Lymphedema is a type of chronic swelling, or edema, which occurs in the arms, legs, neck, trunk, chest or other body parts when the lymphatic vessels are unable to adequately drain protein-rich lymph fluid from these regions.
Lymphedema is progressive in nature, worsens over time, and has no known cure.
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Our proprietary Flexitouch, Entre and Nimbl systems are clinically proven at-home solutions for patients with vascular disorders such as lymphedema.
−Removed: Patients with lymphedema or chronic venous insufficiency are typically treated by vascular surgeons, vascular medicine physicians, oncology care teams, wound physicians, nurses and therapists.
+Added: Patients with lymphedema are typically treated by vascular surgeons, vascular medicine physicians, oncology care teams, wound physicians, nurses and therapists.
Our current lymphedema products are the Flexitouch Plus, Entre Plus and Nimbl systems.
1 unchanged sentence
Food and Drug Administration (the “FDA”) in July 2002, and we introduced the system to address the many limitations of self-administered home-based manual lymphatic drainage therapy.
−Removed: We began selling our more advanced Flexitouch system after
−Removed: receiving 510(k) clearance from the FDA in October 2006.
+Added: We began selling our more advanced Flexitouch system after receiving 510(k) clearance from the FDA in October 2006.
In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck.
−Removed: In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system.
+Added: In June 2017, we
+Added: announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system.
In December 2020, we received 510(k) clearance for two new indications for our Flexitouch Plus system:
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The Entre Plus system is sold or rented to patients who need a simple pump or who do not yet qualify for insurance reimbursement for an advanced compression device such as our Flexitouch Plus system.
−Removed: Nimbl, our next generation pneumatic compression platform, received 510(k) clearance in June 2024 and, beginning in October 2024, is commercially available throughout the United States for treatment of upper extremity lymphedema.
+Added: Nimbl, our next generation pneumatic compression platform, received 510(k) clearance in June 2024 and, beginning in October 2024, is commercially available throughout the United States for treatment of upper extremity lymphedema, and subsequently was commercially launched for lower extremity lymphedema in February 2025.
Sales and rentals of our lymphedema products generated $278.4 million, or 84%, of our revenue in 2025, and $259.4 million, or 89%, of our revenue in 2024.
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Overview of Lymphedema and Chronic Venous Insufficiency
−Removed: The lymphatic system, a fundamental part of the cardiovascular system, consists of lymph vessels and lymph organs that protect the body against harmful bacteria and transport lymph fluid from the body’s tissues
−Removed: back to the cardiovascular system.
−Removed: Lymph vessels are thin-walled capillaries that absorb fluids, bacteria and proteins, and propel them to lymph nodes, small lymph organs that filter and process the lymph fluid by eliminating waste and bacteria.
+Added: The lymphatic system, a fundamental part of the cardiovascular system, consists of lymph vessels and lymph organs that protect the body against harmful bacteria and transport lymph fluid from the body’s tissues back to the cardiovascular system.
+Added: Lymph vessels are thin-walled capillaries that absorb fluids, bacteria and
+Added: proteins, and propel them to lymph nodes, small lymph organs that filter and process the lymph fluid by eliminating waste and bacteria.
Lymph nodes are located in several areas of the body, including superficial and deep lymph nodes under each arm, at the hip, in the groin, above the collar bones in the neck, in the abdomen, tonsils and spleen, and in bone marrow.
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Symptoms related to lymphedema can present anywhere in the body, including the head, neck, arms, legs, trunk and genitals.
−Removed: For most patients with lymphedema, it has a negative impact on their quality of life.
−Removed: Performing daily activities of cooking, shopping, cleaning and yard work can often become difficult, if not impossible, for patients who suffer from lymphedema.
+Added: For most patients with lymphedema, the negative impact on their quality of life extends far beyond the swelling and heaviness and can include physical limitations, skin changes and recurrent infections, depression, anxiety and social isolation, and the financial burden of care.
For patients with head and neck lymphedema, critical functions such as swallowing, breathing and range of motion can be negatively impacted.
Over time, the accumulation of lymph fluid can result in significant changes in the structure of the tissues, causing thickening and hardening of the skin, referred to as fibrosis.
−Removed: Recurrent skin infections such as erysipelas and cellulitis, a more serious skin infection, are common complications of lymphedema.
+Added: Recurrent skin infections such as cellulitis, a serious skin infection, are common complications of lymphedema.
+Added: For people with cancer, the build-up of lymph fluid can be caused by surgery, especially when lymph nodes are removed, radiation therapy that can damage lymph nodes and vessels, infections that damage surrounding tissue or cause scarring, and other conditions.
+Added: In 2024, a study was published that showed the striking disparity in care between non-cancer-related lymphedema (“NCRL”) and cancer-related lymphedema (“CRL”) patients.
+Added: On average from the study, 39% of NCRL patients had a diagnosis after two doctor consultations compared to 75% of CRL patients, and 63% of NCRL patients experienced more than twelve months between symptom onset and lymphedema diagnosis compared to 16% of CRL patients.
+Added: Consequently, the study found that NCRL patients perceive physician disinterest in their condition and ultimately feel dissatisfied with their healthcare experience related to lymphedema.
Lymphedema worsens over time if not properly treated, and currently has no known cure.
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Ulcers develop in areas with edema as swelling interferes with the movement of oxygen and nutrients through tissues, and if left untreated, these ulcers can quickly become infected or even gangrenous.
−Removed: Physicians diagnose chronic venous insufficiency based on appearance, symptoms and imaging techniques and classify it based upon a scale endorsed by the Society for Vascular Surgery.
+Added: diagnose chronic venous insufficiency based on appearance, symptoms and imaging techniques and classify it based upon a scale endorsed by the Society for Vascular Surgery.
Market Opportunity
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Based on a study published in 2020 by Dr.
−Removed: Steven Dean of Ohio State Medical Center et al., it is estimated that more than 16 million people in the United States are living with lymphedema due to CVI.
+Added: Steven Dean of Ohio State Medical Center et al., it is estimated that more than 16 million people in the United States were living with lymphedema due to CVI.
This, in addition to the estimated five million individuals living in the U.S.
−Removed: with cancer-related and primary
−Removed: lymphedema, increases the prevalence estimates to over 20 million individuals.
−Removed: For people with cancer, the build-up of lymph fluid can be caused by surgery, especially when lymph nodes are removed, radiation therapy that can damage lymph nodes and vessels, infections that damage surrounding tissue or cause scarring, and other conditions.
−Removed: In the fourth quarter of 2016 we expanded the indications for use of the Flexitouch system.
−Removed: We received U.S.
−Removed: FDA clearance to market a first-of-its-kind system to treat patients suffering from lymphedema of the head and neck, a frequent consequence of head and neck cancer and its treatment.
−Removed: Patient symptoms often include significant skin changes, pain and discomfort, as well as difficulty breathing and swallowing.
−Removed: The American Cancer Society estimates that there are 430,000 survivors of head and neck cancers in the United States, and more than 65,000 new patients are diagnosed each year.
−Removed: In a 2016 clinical publication, researchers at Vanderbilt University School of Medicine estimated that more than 75% of patients with head and neck cancer develop lymphedema requiring treatment.
+Added: with cancer-related and primary lymphedema, increases the prevalence estimates to over 20 million individuals.
+Added: Lymphedema and Cancer Treatment
+Added: Cancer treatment can cause damage to the lymphatic system in several ways.
+Added: Cancer surgery often removes lymph nodes, radiation therapy can cause scar tissue to form around the lymph nodes and vessels, the cancer tumor itself can block or put pressure on lymph nodes and vessels, and chemotherapy and immunotherapy can increase the risk of lymphedema.
+Added: Cancer related lymphedema can present months or years after cancer has been treated.
+Added: Unfortunately, studies show that many patients who develop lymphedema after cancer treatment have to consult with more than one doctor to get a diagnosis and often endure four months or longer before first treatment is rendered.
+Added: Breast cancer related lymphedema has more published evidence, clinician understanding and patient awareness than any other cancer type.
+Added: Patients treated for breast cancer face a lifetime risk of developing lymphedema.
+Added: The National Accreditation Program for Breast Centers, the National Comprehensive Cancer Network, the Commission on Cancer Guidelines and the Oncology Nursing Society have evidence-based guidelines on cancer survivorship that feature lymphedema early detection, monitoring and treatment.
+Added: While lymphedema is identified as one of the top medical issues reported by breast cancer survivors, access to care remains a challenge.
+Added: The consequences of head and neck cancer treatment are significant, with 90% of patients experiencing lymphedema and 47% having moderate to severe fibrosis.
+Added: Patient symptoms of lymphedema of the head and neck include significant skin changes, pain, difficulty breathing, speaking and swallowing.
+Added: In 2016, Tactile received U.S.
+Added: FDA clearance to market a first-of-its-kind system to treat patients suffering from lymphedema of the head and neck, The American Cancer Society estimates that there are 430,000 survivors of head and neck cancers in the United States, and more than 65,000 new patients are diagnosed each year.
Our Flexitouch head and neck system is the only pneumatic compression device with an indication to treat patients suffering from debilitating head and neck lymphedema and our therapy is protected with several patents issued in 2022.
We estimate the market opportunity for our Flexitouch head and neck system is approximately $1 billion in the United States, which is based on 75% of the total number of patients suffering from cancers of the head and neck and our average selling price per device.
−Removed: In June 2020, a study published in Supportive Care in Cancer recognized the effectiveness of Flexitouch in treating patients with head and neck related lymphedema.
−Removed: The study, led by Vanderbilt University was a pilot randomized clinical trial reflecting statistically significant reductions in swelling, pain and improvements in the ability to swallow.
−Removed: In addition, in September 2021, we initiated a randomized, controlled clinical trial evaluating the effectiveness of our Flexitouch Plus system for the treatment of head and neck lymphedema.
−Removed: We believe this study will represent the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema.
−Removed: Ten clinical sites participated in the trial that completed in 2024.
−Removed: Traditional Treatment and Limitations
−Removed: A traditional treatment for lymphedema is complete decongestive therapy consisting of manual lymphatic drainage, which is a specialized application of gentle pressure to the skin applied by a trained therapist that encourages drainage of lymph fluid, as well as decongestive exercises, skin care and compression with multilayered bandages, compression garments or pumps.
−Removed: Typically, this therapy begins with clinic visits three to five times per week for four to eight weeks, which is costly, inconvenient for the patient, and time consuming.
−Removed: Access to therapy clinics can also be limited, leading to many patients not completing their prescribed in-clinic treatments.
−Removed: Following the in-clinic visits, typically clinical improvement plateaus or reimbursement for the therapy ends, and patients transition to self-administered home-based care.
−Removed: Manual lymphatic drainage is difficult for patients to self-administer due to limited range of motion and treatment techniques that are difficult to replicate, and pump-based compression using simple pumps can be uncomfortable and has not demonstrated the clinical and economic benefits of our Flexitouch advanced pneumatic pump.
−Removed: To address these limitations, our at-home Flexitouch Plus system was developed to provide automated lymphatic drainage therapy through an advanced, easy-to-use, self-applied at-home system.
−Removed: Peer-reviewed, published studies have shown that our Flexitouch Plus system provides improved quality of life and clinical outcomes and delivers significant cost savings to payers and patients.
−Removed: The standard of care treatment for CVI is compression therapy.
−Removed: Compression stockings and wraps are used to provide added pressure, increasing the effectiveness of the calf-muscle pump in returning blood to the heart.
−Removed: As the disease progresses, patients may develop a venous leg ulcer, which is commonly treated using multilayered bandages to minimize swelling and enhance blood flow.
−Removed: A clinician applies these typically non-removable bandages to patients at a precise pressure and patients wear the bandages between weekly visits to the wound clinic during which they are then removed and reapplied.
−Removed: Enhancing standard of care treatments for CVI with our pneumatic compression systems has been proven to reduce the recurrence of ulcer formations as well as recurrent skin infections (cellulitis) leading to better patient quality of life and lower overall cost of clinical care.
+Added: In June 2020, a pilot study demonstrated the effectiveness of Flexitouch in treating patients with head and neck related lymphedema.
+Added: In 2025, we announced the results of our landmark randomized controlled trial demonstrating sustained clinical benefits of Flexitouch Plus as a first-line therapy for treating head and neck cancer-related lymphedema.
+Added: Care Pathway & Limitations
+Added: Treatment for lymphedema depends on the extent and severity of the condition upon diagnosis.
+Added: Treatment options include complete decongestive therapy consisting of manual lymphatic drainage (“MLD”), which is a specialized application of gentle pressure to the skin applied by a trained therapist that encourages drainage of lymph fluid, as well as decongestive exercises, skin care and compression with multilayered bandages, compression garments or pumps.
+Added: The manual lymph drainage can be self-administered at home or in a clinic if lymphedema therapists are available.
+Added: If administered in-clinic, visits typically are three to five times per week for four to eight weeks.
+Added: This is costly, a significant commitment for the patient, inconvenient and time-consuming.
+Added: Access to lymphedema therapists can be limited, and a reason that many patients do not access or complete their prescribed in-clinic treatments.
+Added: Following the in-clinic visits, patients typically transition to self-administered home-based MLD and daily use of compression garments.
+Added: Manual lymphatic drainage is difficult for patients to self-administer due to limited range of motion and treatment techniques
+Added: that are difficult to replicate.
+Added: To address these limitations, our at-home Flexitouch Plus and Nimbl systems were developed to provide automated pneumatic compression that mimics manual lymphatic drainage through an advanced, easy-to-use, consistent, self-applied at-home system.
In 2022, three independent societies’ consensus endorsements were published in Phlebology:
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Experts from the American Venous Forum, American Venous and Lymphatic Society and Society for Vascular Medicine provided the consensus guidance on diagnosis and patient treatment pathways for lymphedema.
−Removed: Over a majority of the panel (92%) agreed with the statement that sequential
−Removed: pneumatic compression should be recommended for lymphedema patients, with 34% strongly agreeing.
+Added: A large majority of the panel (92%) agreed with the statement that sequential pneumatic compression should be recommended for lymphedema patients, with 34% strongly agreeing.
In addition, 72% of the panel agreed with the statement that all patients with CVI (stages C3-C6) should be considered as lymphedema patients, with 38% strongly agreeing.
Overview of Bronchiectasis
−Removed: Bronchiectasis is a COPD-associated condition where the lung’s bronchi become inflamed, widened, permanently damaged and scarred.
+Added: Bronchiectasis is often a COPD-associated condition where the lung’s bronchi become inflamed, widened, permanently damaged and scarred.
As more of the bronchial wall thickens, mucus gets trapped, creating a breeding ground for infection.
−Removed: The inability to fully clear mucus and pathogens from the lungs can result in a chronic cycle of infections and inflammation.
−Removed: Airway clearance therapies help break this vicious cycle and need to be used regularly to maintain a healthy respiratory system.
+Added: The inability to fully clear mucus and pathogens from the lungs can result in a progressive, chronic process of infections, inflammation, and permanent lung damage, often referred to as a ‘vicious vortex’.
+Added: Airway clearance therapies help interrupt the vicious vortex and need to be used regularly to maintain a healthy respiratory system in these patients.
Market Opportunity
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High frequency chest wall oscillation is used to treat bronchiectasis and over 70 other International Classification of Disease (“ICD”)-10 diagnosis codes.
+Added: Awareness of bronchiectasis is rising, bolstered by the emergence in 2025 of the first FDA-approved pharmaceutical, which is regarded as complementary to airway clearance therapy in the multi-modal treatment approach.
+Added: This pharmaceutical provides a targeted, anti-inflammatory oral medication approach and HFCWO therapy vests physically help clear the mucus.
Traditional Treatment and Limitations
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We intend to continue to educate physicians, nurses, therapists, patients, payers and DME provider representatives to raise awareness of these diseases, the associated health burdens of such diseases on patients and society, and the clinical and economic benefits of using our products.
−Removed: Further, we intend to continue promoting this awareness through training and educating clinicians, advertising campaigns, exhibiting at tradeshows and physician meetings and publishing additional clinical and economic outcome data demonstrating the benefits of our solutions.
+Added: Further, we intend to continue promoting this awareness through training and educating clinicians, advertising campaigns, exhibiting at tradeshows and physician
+Added: meetings and publishing additional clinical and economic outcome data demonstrating the benefits of our solutions.
Our ongoing marketing initiatives focus on increasing referrals from physicians trained in the diagnosis and treatment of venous and lymphatic diseases, oncology and chronic respiratory conditions.
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We also intend to expand and support our respiratory DME channels, in an effort to help demonstrate HFCWO as a staple among the host of treatments they bring to chronic respiratory patients.
−Removed: We intend to strengthen our distribution network by continuing to recruit, train and
−Removed: retain talented sales representatives.
+Added: We intend to strengthen our distribution network by continuing to recruit, train and retain talented sales representatives.
With an expanded sales force, our goal is to expand the existing prescriber base.
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We market Flexitouch Plus, Entre Plus and Nimbl systems as at-home therapies for the treatment of lymphedema and chronic venous insufficiency.
−Removed: We market AffloVest as an at-home therapy intended to promote airway clearance.
+Added: We market AffloVest as an at-home therapy to mobilize lung secretions through high frequency chest wall oscillation.
These products have received 510(k) clearance from the FDA to be marketed in the United States.
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Flexitouch Plus System
−Removed: Our Flexitouch Plus system is a fully automated, programmable, advanced pneumatic compression device, or APCD, designed for treatment of lymphedema in the home setting.
−Removed: Our Flexitouch Plus system has received 510(k) clearance for the treatment of lymphedema, phlebolymphedema, lipedema, certain types of other edema, venous insufficiencies and certain types of leg ulcers.
+Added: Our Flexitouch Plus system is a programmable advanced pneumatic compression device designed to stimulate the lymphatic system.
+Added: It is indicated for the treatment of lymphedema, phlebolymphedema, lipedema, certain types of other edema, venous insufficiencies and certain types of leg ulcers.
We introduced our first-generation Flexitouch system in the United States in 2003, our second-generation Flexitouch system in 2006, and our third-generation Flexitouch system, the Flexitouch Plus, in 2018.
−Removed: The mechanism of action of our patented Flexitouch Plus system is designed to stimulate the lymphatic system similar to manual lymphatic drainage therapy, the current standard of care in patient treatment.
−Removed: By automating this technique, we believe our system offers an effective, cost-efficient, convenient and accessible at-home treatment for patients.
+Added: The patented mechanism of action of the Flexitouch Plus system works by sequentially inflating and deflating its chambers to create a gentle, wave-like motion that directs lymph fluid from the impaired areas toward healthy regions of the body.
+Added: By automating
+Added: this technique, we believe our system offers an effective, cost-efficient, convenient and accessible at-home treatment for patients.
Our Flexitouch Plus system consists of an electronic controller unit that offers 17 treatment settings and multiple contoured garment configurations for the trunk, chest, head, neck and the arm or leg.
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Each connector has eight outflow ports into which the garment hoses are connected.
−Removed: Our unique garments contain up to 32 air chambers, are made of a soft, pliable fabric and are designed with zippers and hook-and-loop fasteners to fit snugly around affected areas for maximum comfort and optimum pressure delivery.
+Added: Our unique ComfortEase garments contain up to 32 air chambers, are made of a soft, pliable fabric and are designed with zippers and hook-and-loop fasteners to fit snugly around affected areas for maximum comfort and optimum pressure delivery.
The garments come in a variety of sizes that can be easily adjusted to patients of all sizes.
−Removed: When our system is activated, air passes through the hoses, delivering sequential inflation and deflation to the
−Removed: garments and applying gentle pressure to the skin.
−Removed: The inflation sequence is designed to stimulate the lymphatic system, moving lymph fluid from the impaired areas toward healthy regions of the body.
+Added: When our system is activated, air passes through the hoses, delivering sequential inflation and deflation to the garments and applying gentle pressure to the skin.
The electronic controller unit adjusts the amount of pressure and the timing of the pressure and release cycles.
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Entre Plus System
−Removed: We introduced our Entre system in the United States in February 2013 to offer a lightweight, portable pneumatic compression solution for patients with cognitive or dexterity issues who need a basic (simple) pump or for patients who do not yet qualify for insurance coverage of an advanced compression device such as our Flexitouch Plus system.
−Removed: Our Entre system is a basic pneumatic compression device used for the at-home treatment of venous disorders including lymphedema and chronic venous insufficiency, including venous leg ulcers.
−Removed: Our Entre system is a pump with garments covering the arm or leg with eight chambers that inflate in sequence and remain inflated for a preset time period.
+Added: Our Entre system, introduced in 2013, is a basic pneumatic compression device used for the at-home treatment of lymphedema, chronic edema, venous insufficiency, and chronic wounds.
+Added: Our Entre system is a pump with garments covering the arm or leg with eight chambers that inflate in sequence.
In 2023, our second-generation system, Entre Plus, was introduced.
−Removed: Nimbl, our next generation pneumatic compression platform, received 510(k) clearance in June 2024, and beginning in October 2024, is commercially available throughout the United States for the treatment of upper extremity lymphedema.
+Added: In February 2025, we launched Nimbl for lower extremity lymphedema, which has replaced most orders for our Entre system and we expect to continue to do so.
+Added: Nimbl, our next generation basic pneumatic compression system, received 510(k) clearance in June 2024.
+Added: Nimbl was commercially launched for upper extremity lymphedema in October 2024 and was commercially launched for lower extremity lymphedema in February 2025.
Improving on the Entre Plus garments, the Nimbl system has reduced hose and harnesses while maintaining the eight chambers that inflate in sequence for treatment.
1 unchanged sentence
In 2022, we introduced Kylee™, a free mobile application to help patients learn about lymphedema, track their symptoms and treatment, and share their progress with their doctor.
−Removed: The purpose behind Kylee is to help support and encourage patients to embrace self-care and become more educated about their condition.
+Added: Kylee helps to support and encourage patients to embrace self-care and become more educated about their condition.
Our customers can use Kylee to track their orders for our devices and view onboarding tutorials for using the device.
−Removed: Once a patient starts using the device, they can use Kylee to record their treatments and symptoms, and capture photos of their condition for sharing with their healthcare team.
−Removed: Flexitouch Plus and Nimbl controllers include Bluetooth technology, which is viewable using Kylee.
+Added: Once a patient starts using a Tactile device, they can use Kylee to view their device usage, track their symptoms, and capture photos of their condition for sharing with their healthcare team.
+Added: Flexitouch Plus and Nimbl controllers include Bluetooth technology to enable data transfer to the Kylee application.
We acquired the AffloVest business in September 2021.
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A key part of our success is our ability to demonstrate the effectiveness of our products by funding studies that generate clinical and economic outcome data supporting our products.
−Removed: We have developed a
−Removed: significant body of clinical data supporting the efficacy and safety of our products.
−Removed: We intend to continue to invest in additional studies to support peer-reviewed, published articles that evidence the clinical and economic benefits of our solutions as compared to traditional treatments.
+Added: We have developed a significant body of clinical data supporting the efficacy and safety of our products.
+Added: We intend to continue to invest in studies to support peer-reviewed, published articles that demonstrate the clinical and economic benefits of our solutions as compared to traditional treatments.
To date, more than 26 studies regarding the safety and efficacy of our products have been completed, in which over 2,300 subjects have been included.
−Removed: Economic Impact of our Flexitouch System in Patients with Phlebolymphedema
+Added: Impact of our Flexitouch System in Patients with Phlebolymphedema
+Added: In 2024, the largest U.S.
+Added: prospective clinical trial ever conducted investigating pneumatic compression and lymphedema was published in the Journal of Vascular Surgery - Venous and Lymphatic Disorders, which demonstrated high compliance and significant improvements across study endpoints for patients treated with Flexitouch.
+Added: The 52-week study included 179 veterans across four participating VA medical centers.
+Added: Among the patients included in the study, chronic venous insufficiency was the most common etiology of lymphedema (phlebolymphedema), present in approximately 63% of study participants.
+Added: Further, mild lymphedema was the most common disease stage, presenting in 68% of patients.
+Added: The study demonstrated statistically significant improvements in its primary endpoint of health-related and general quality of life measures.
+Added: Specifically, Lymphedema Quality of Life (QoL) increased from 6.2 to 6.9, which includes improvements in function, appearance, symptoms, and emotion.
+Added: The secondary endpoint results demonstrated several statistically significant improvements, baseline to 52 weeks, with reductions in limb girth, cellulitis events, and skin hyperpigmentation.
+Added: Among these results, the following were observed at 52 weeks:
+Added: limb girth decreased by 1.4 cm;
+Added: cellulitis events decreased from 21.4% to 6.1%;
+Added: and skin hyperpigmentation decreased from 75% of patients to 40% of patients.
+Added: There were additional improvements also noted in compliance and limb girth reduction, which included:
+Added: 92% patient compliance (defined as used for five to seven days per week) with Flexitouch at 8 weeks and 72% patient compliance at 52 weeks;
+Added: 74% patient compliance with compression garments at 52 weeks, compared to 64% at baseline;
+Added: and 6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema.
A retrospective longitudinal matched case-control analysis of de-identified private insurance claims published by the Journal of Vascular Surgery in 2018 indicated significant benefits attributable to our Flexitouch system as compared to alternative compression therapies currently employed to help reduce the notable economic burden of phlebolymphedema (chronic venous insufficiency-related lymphedema).
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P=0.020), and 85% lower other outpatient-related costs ($353 vs $2,313;
−Removed: Compared with other APCDs, Flexitouch was associated with 53% lower total costs ($3,973 vs $8,436;
+Added: Compared with other APCDs, Flexitouch was associated with 53%
+Added: lower total costs ($3,973 vs $8,436;
P=0.032) because of lower outpatient costs and lower rates of cellulitis infections (22.4% vs 44.9% of patients;
Impact on Clinical Outcomes and Healthcare Costs with Use of our Flexitouch System
−Removed: A retrospective study published by the American Medical Association in JAMA Dermatology demonstrated significant improvement in key clinical endpoints and immediate cost reductions for individuals with lymphedema following receipt of our Flexitouch system.
+Added: A retrospective study published in JAMA Dermatology demonstrated significant improvement in key clinical endpoints and immediate cost reductions for individuals with lymphedema following receipt of our Flexitouch system.
The study was conducted in the United States and included 718 patients with a lymphedema diagnosis who had continuous insurance coverage during the 12 months prior to and the 12 months after receiving our Flexitouch system from 2007 through 2013.
The study evaluated a broad, clinically relevant set of healthcare use outcomes for each patient for the 12 months before and the 12 months after receipt of our Flexitouch system, including cellulitis infections, inpatient hospitalizations, physical therapy and outpatient hospital visits.
−Removed: Receipt of our Flexitouch system was associated with a significant decline in the rate of cellulitis diagnosis in the cancer-related lymphedema patients of 79% (from 21.1% to 4.5%;
−Removed: p<0.001) and in the non-cancer-related lymphedema patients of 75% (from 28.8% to 7.3%;
−Removed: The inpatient hospitalization rate declined 22% in the cancer-related group (from 2.7% to 2.1%;
−Removed: p=0.63) and declined 54% in the non-cancer-related group (from 7.0% to 3.2%;
−Removed: The manual therapy rate decreased 30% in the cancer-related lymphedema patients (from 35.6% to 24.9%;
−Removed: p=0.001) and decreased 34% in the non-cancer-related lymphedema patients (from 32.3% to 21.2%;
−Removed: In addition, outpatient hospital visits declined 29% in the cancer-related patients (from 58.6% to 41.4%;
−Removed: p<0.001) and 40% in the non-cancer-related patients (from 52.6% to 31.4%;
+Added: Receipt of our Flexitouch system was associated with a significant decline in the rate of cellulitis diagnosis in the cancer-related lymphedema patients of 79% and in the non-cancer-related lymphedema patients of 75%.
+Added: The inpatient hospitalization rate declined 22% in the cancer-related group and declined 54% in the non-cancer-related group.
+Added: Outpatient hospital visits declined 29% in the cancer-related patients and 40% in the non-cancer-related patients.
The study also reviewed lymphedema-related healthcare costs for each patient in the study for the 12 months before and the 12 months after receipt of our Flexitouch system.
−Removed: Among the cancer-related lymphedema patients, total costs per patient, excluding durable medical equipment costs, were reduced by 37%, from $2,597 to $1,642 (p=0.002) following receipt of our Flexitouch system.
−Removed: The greatest contributor to this change was a 54% reduction in outpatient hospital costs from $1,517 to $694 (p<0.001).
−Removed: Total costs per
−Removed: non-cancer-related lymphedema patient, excluding durable medical equipment costs, were reduced by 36% from $2,937 to $1,883 (p=0.007).
−Removed: Outpatient hospital costs for the non-cancer patients declined by 65% from $1,726 to $606 (p<0.001).
+Added: Among the cancer-related lymphedema patients, total costs per patient, excluding durable medical equipment costs, were reduced by 37%.
Flexitouch System Impact on Limb Volume and Patient-Reported Outcomes
1 unchanged sentence
The study was conducted in the United States and collected data from a patient registry required by a third-party payer for 196 patients with lower extremity lymphedema who were prescribed our Flexitouch system from January 2009 to May 2012.
−Removed: The primary objective of the study was to examine the effectiveness of our Flexitouch system in reducing lower extremity limb volume, with a secondary objective of evaluating clinician-assessed and patient-reported outcomes.
Use of our Flexitouch system was associated with a statistically significant reduction in limb volume with 88% of patients experiencing a reduction in limb volume and with 35% enjoying a substantial reduction in limb volume of greater than 10%.
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Comparison of our Flexitouch System with Simple Pneumatic Compression Devices
−Removed: A prospective, randomized controlled trial published in Supportive Care in Cancer demonstrated that our Flexitouch system provides better clinical outcomes as compared to those achieved with a simple pneumatic compression device for home-based treatment of breast cancer-related lymphedema.
+Added: A prospective, randomized controlled trial published in Supportive Care in Cancer in 2012 demonstrated that our Flexitouch system provides better clinical outcomes as compared to those achieved with a simple pneumatic compression device for home-based treatment of breast cancer-related lymphedema.
The study was conducted in the United States and involved 36 patients.
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The patients were randomized to our Flexitouch system or a simple pneumatic compression device used for home treatment of one-hour per day for 12 weeks.
−Removed: The simple pneumatic compression device used in the study was a Bio Compression 2004 Sequential Circulator pneumatic compression device.
−Removed: The primary objective of the study was to determine whether our Flexitouch system provides better outcomes, as measured by arm edema and tissue water reductions, compared to a simple pneumatic compression device in patients with arm lymphedema.
The study does not reflect a comparison of our Flexitouch system to a product that is billed under the same Healthcare Common Procedure Coding System, or HCPCS, Code as our Flexitouch system.
−Removed: Thirty-six patients with unilateral upper extremity lymphedema with at least 5% arm edema volume at the time of enrollment completed treatments over the 12-week period, with 26 patients being evaluated for edema volume change and 28 patients being evaluated for changes in arm tissue water content.
−Removed: Arm edema volumes were determined from arm girth measurements and suitable model calculations, and tissue water was determined based on measurements of the arm tissue.
−Removed: The patients were randomized into two groups of 18 patients each, with one group receiving treatment with our Flexitouch system and the other group receiving treatment using a simple pneumatic compression device.
−Removed: The group using our Flexitouch system experienced an average reduction in edema of 29% compared to a 16% increase in the group using a simple pneumatic compression device.
+Added: The group using our
+Added: Flexitouch system experienced an average reduction in edema of 29% compared to a 16% increase in the group using a simple pneumatic compression device.
Study of Patient-Reported Satisfaction with Use of our Flexitouch System
−Removed: A retrospective study published in the Oncology Nursing Forum demonstrated that patients using our Flexitouch system were satisfied with the device and perceived it to be beneficial in managing their lymphedema.
−Removed: The study was conducted in the United States and involved 155 patients with lymphedema whose treatment was initiated from March 2004 to May 2006.
−Removed: The primary objective of the study was to compare treatment protocol adherence, satisfaction and perceived changes in emotional and functional status between patients with cancer-related lymphedema and non-cancer-related lymphedema using our Flexitouch system.
+Added: A retrospective study published in the Oncology Nursing Forum in 2008 demonstrated that patients using our Flexitouch system were satisfied with the device and perceived it to be beneficial in managing their lymphedema.
+Added: The study was conducted in the United States and involved 155 patients with lymphedema.
Ninety percent of the 155 study patients reported being "satisfied" with our Flexitouch system.
−Removed: Of these patients, more than 65% reported being "extremely satisfied." Further, 95% of patients reported a positive limb volume outcome, which was defined as a patient perceiving that limb volume had been maintained or reduced with device use.
−Removed: Of these patients, 42% reported limb volume decreases as much as 20%, and an additional 20% reported decreases of less than 20%.
−Removed: In addition, clinically and statistically significant improvements occurred in all areas of physical and emotional health (p<0.006).
+Added: Of these patients, more than 65% reported being "extremely satisfied."
Flexitouch System Impact on Patient-Reported Improved Quality-of-Life
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The study was conducted in the United States and collected data from patients presenting for treatment of lower-extremity lymphedema from March 2011 to September 2014.
−Removed: A total of 100 consecutive patients with lower-extremity lymphedema met inclusion criteria and were included in the study.
−Removed: The primary objective of the study was to demonstrate improved quality-of-life in patients with lower-extremity lymphedema with Flexitouch system treatment.
−Removed: The secondary objective was to demonstrate reduced infectious complications of lymphedema with Flexitouch system treatment, and to determine the incidence of concomitant venous insufficiency in patients with lymphedema.
−Removed: Use of our Flexitouch system was associated with overall improvement in lower extremity-related symptoms, with 54% of patients reporting greatly improved symptom control after use of our Flexitouch system, 35% moderately improved and 11% mildly improved.
+Added: The study reported that 54% of patients reported greatly improved symptom control after use of our Flexitouch system, 35% moderately improved and 11% mildly improved.
In the year before use of our Flexitouch system, 15% of the patients reported 26 episodes of cellulitis, which decreased to five episodes after initiation of the Flexitouch system (P=0.002) in subsequent median follow-up of 12.7 months.
−Removed: Eight percent of patients reported skin ulceration of the affected extremity in the year before presentation for treatment.
−Removed: The number of lower-extremity ulcers pre- and post-Flexitouch system use decreased from seven to two ( P =0.007).
−Removed: Overall, 46% of the patients had complete limb girth measurements at the ankle and calf, and there was a statistically significant decreased overall limb girth after Flexitouch system treatment in pre- and post-ankle (28.3 cm vs.
−Removed: 27.5 cm, P =0.01), and calf mean girths (44.7 cm vs.
−Removed: 43.8 cm, P =0.018).
−Removed: In addition, venous reflux was present in 18% of patients, 14% and 4% within the superficial and deep venous system respectively.
−Removed: In patients with venous reflux, moderate to great improvement in symptoms was reported in 7% and 11%, respectively compared with 28% and 43% in patients without venous reflux ( P =0.257).
+Added: 8% of patients reported skin ulceration of the affected extremity in the year before presentation for treatment.
Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck
−Removed: An open label, randomized wait-list controlled trial published in the Supportive Care in Cancer journal supported the safety and feasibility of the Flexitouch system APCD for the treatment of secondary lymphedema in head and neck cancer, or HNC, patients.
−Removed: This study was conducted in the United States and included 49 head and neck cancer patients.
−Removed: Eligible patients had completed treatment for HNC, were disease free, and had lymphedema at enrollment.
−Removed: Participants were randomized to wait-list lymphedema self-management (standard of care) or lymphedema self-management plus the use of the APCD bib.
−Removed: Safety (CTCAE V4.0) and feasibility were primary endpoints;
−Removed: secondary endpoints included efficacy measure by objective examination and patient reported outcomes (symptoms, quality of life, function) adherence barriers, and satisfaction.
−Removed: Assessments were conducted at baseline and weeks 4 and 8.
−Removed: No device-related serious adverse events were reported.
−Removed: Most patients used the APCD once per day, instead of the prescribed twice per day, citing time related factors as barriers to use.
−Removed: Patients in the intervention group reported improvement in perceived ability to control lymphedema (baseline:
−Removed: 5/19, 26% good or excellent;
−Removed: 16/19, 84% good or excellent, p=0.003) and visible external swelling (front view p<0.001, right view p=0.004, left p=0.005), as well as less reported pain.
−Removed: Relative to patients in the control group, at 8-weeks patients using the Flexitouch system had statistically significant reductions in the reported severity of soft tissue (p=0.008, d =−0.86) and neurological symptoms (p=0.047, d=−0.60) clusters on the Lymphedema Symptom Intensity and Distress Survey-Head and Neck.
−Removed: Relative to patients in the control group, patients using the Flexitouch system had statistically significant improvement in swallowing solids (p=0.016) and mucous related symptoms (p=0.050, d=−0.80 and −0.57 respectively) on the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey.
+Added: A landmark randomized control study of 236 patients with head and neck cancer related lymphedema demonstrated short term and sustained clinical and quality of life benefits of Flexitouch Plus as a first-line therapy in treating head and neck cancer-related lymphedema.
+Added: The study assessed clinical and quality of life outcomes at 2, 4 and 6 months for patients randomized to either usual care (therapist-guided multi modal treatment) or Flexitouch Plus.
+Added: In October 2025, the 4 and 6 month results were presented as a late breaking research poster at the ACRM 2025 102nd Annual Conference.
+Added: Highlights include:
+Added: ● Flexitouch Plus demonstrated reduced internal swelling at the majority of anatomical sites (13 of 19), with statistically significant improvement achieved in the base of tongue (p=0.008) and arytenoids (p=0.023);
+Added: ● Improvements in both internal (Endoscopy Modified Patterson Scale) and external soft tissue swelling (clinical observation) favored Flexitouch Plus over usual care;
+Added: ● Statistically significant improvement in epiglottic thickness and prevertebral soft tissue thickness at C3 in both groups at six months;
+Added: ● Both groups demonstrated sustained improvement in patient-reported symptom burden.
+Added: In June 2025, the two-month data publication of this same study demonstrated significant clinical and quality-of-life benefits in Flexitouch Plus treated patients.
+Added: Specific areas that showed differentiation between usual care and Flexitouch Plus treated patients include:
+Added: ● Participants in the usual care arm took an average of 29.8 days to begin therapist guided lymphedema treatment, compared to 17.9 days for therapy initiation for patients randomized to Flexitouch;
+Added: ● Only 71% of participants randomized to usual care actually received their assigned usual care treatment.
+Added: 94.9% of those that were randomized to Flexitouch received treatment;
+Added: ● Flexitouch participants had statistically 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;
+Added: ● Self-reported symptom improvement occurred in both groups, with Flexitouch demonstrating statistically significant improvement on three of the six health-related quality-of-life sub scales.
AffloVest Clinical Evidence
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Sales and Marketing
−Removed: Unlike many of our competitors, we generally utilize a direct-to-patient and -provider model to market our lymphedema products directly to patients and clinics, providing high-quality customer service and capturing both the manufacturer and distributor margins for the majority of this business.
−Removed: The direct channel allows us to focus on three of our primary call points, vascular, therapy and oncology.
+Added: Unlike many of our competitors, we generally utilize a direct-to-patient and -provider model to market our lymphedema products directly to patients and clinics, providing high-quality customer service and capturing both the manufacturer and distributor margins for most of this business.
+Added: The direct channel allows us to focus on our primary call points, which include vascular, therapy, oncology, and the Veterans Affairs hospital markets.
For AffloVest, we utilize the respiratory DME channel as our go-to-market method.
3 unchanged sentences
The below chart reflects these models:
−Removed: Our direct-to-patient and -provider lymphedema business is composed of a direct sales force, patient training and support, reimbursement capabilities and clinical expertise to educate, expand awareness, coordinate referrals and obtain payment for our products.
+Added: Our direct-to-patient and -provider lymphedema business is composed of a direct sales force, patient training and support, reimbursement capabilities and clinical expertise.
+Added: These functions focus on patient and provider education, expanding awareness, coordinating referrals, and obtaining payment for our products.
The chart below describes our U.S.
7 unchanged sentences
The chart below describes our DME model.
−Removed: As of December 31, 2024, we employed 298 account managers and specialists who provide support throughout the United States for our lymphedema and respiratory therapies compared to 270 account managers and specialists as of December 31, 2023.
+Added: As of December 31, 2025, we employed 166 account managers and 166 specialists for our lymphedema products and a team of 19 specialists supporting our airway clearance products.
+Added: This compares to 169 account managers and 111 specialists for our lymphedema products and a team of 18 specialists supporting our airway clearance products as of December 31, 2024.
Our marketing team leads our efforts in brand development, product messaging, tradeshow attendance, medical educational forums, website development, social media and advertising.
10 unchanged sentences
Based on our estimates, we are contracted or enrolled as an in-network provider with payers covering nearly 278 million lives.
−Removed: These contracts allow us to be an in-network provider for patients, enabling them to access our systems at a competitive rate and copay comparable to other suppliers and easing our administrative burden in processing authorizations and claims.
−Removed: For the last several years we have enjoyed an
−Removed: 80% or greater approval rate on commercial payers and 90% or greater approval rate on Medicare claims submitted (across all our products).
+Added: These contracts allow us to be an in-network provider for patients, enabling them to access our systems at a competitive rate and copay comparable to other suppliers and easing our
+Added: administrative burden in processing authorizations and claims.
+Added: For the last several years we have enjoyed an 80% or greater approval rate on commercial payers and 90% or greater approval rate on Medicare claims submitted (across all our products).
We began doing business with Medicare in 2007.
10 unchanged sentences
The AffloVest is reimbursed under HCPCS code E0483, high frequency chest wall oscillation for bronchiectasis, and over 70 other ICD-10 diagnosis codes.
−Removed: Research and Clinical Operations
−Removed: We are committed to ongoing research and development as part of our efforts to be at the forefront of physician and patient preference in the area of chronic disease, especially lymphedema, cancer-related lymphedema, chronic venous insufficiency, bronchiectasis and other chronic respiratory conditions.
−Removed: Our research and development and clinical operations functions include scientists, clinical monitors and project managers with expertise in pneumatics, electronics, garment design, embedded software, mechanical design, sensors, manufacturing technologies and clinical trial management.
−Removed: Our current research and development efforts are focused primarily on improving design for ease-of-use, enhancing clinical functionality and reducing production costs of our solutions.
−Removed: Our clinical development efforts are focused on further differentiating our products from our competitors.
−Removed: We coordinate our development efforts with our intellectual property strategies in order to enhance our ability to obtain patent and other intellectual property protection.
+Added: Our research scope includes engineering, scientific and clinical research in the areas of our therapies for the treatment of lymphedema, cancer-related lymphedema, chronic venous insufficiency, bronchiectasis and other chronic respiratory conditions.
+Added: Our expertise includes pneumatics, electronics, garment design, embedded software, mechanical design, sensors, manufacturing technologies and clinical trial management.
+Added: Our current research and development efforts are focused on improving design for ease-of-use, reducing production costs of our solutions and further differentiating our products from our competitors.
+Added: We coordinate our development efforts with external advisors and our intellectual property strategies in order to enhance our ability to obtain patent and other intellectual property protection.
Our research and development expenses, including spending on our clinical evidence development efforts, totaled $8.5 million and $8.8 million for the years ended December 31, 2025 and 2024, respectively.
14 unchanged sentences
We have implemented a quality management system designed to comply with FDA regulations and International Standards Organization, or ISO, standards governing medical device products.
−Removed: In the United States, we and some of our manufacturers are required to manufacture our products in compliance with the FDA's Quality System Regulation, which covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping for our products.
+Added: In the United States, we and some of our manufacturers are required to manufacture our products in compliance with the FDA's Quality Management System Regulation, as updated to take effect on February 2, 2026, which covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping for our products.
We maintain a quality management system to control compliance with such requirements and have procedures in place designed to ensure that all products and materials purchased by us conform to our requirements and FDA regulations.
56 unchanged sentences
● establishment registration and device listing;
−Removed: ● quality system regulation, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, current good manufacturing practice, as applicable, and other quality assurance procedures during all aspects of the manufacturing process;
+Added: ● quality management system regulation, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, current good manufacturing practice, as applicable, and other quality assurance procedures during all aspects of the manufacturing process;
● labeling regulations and the FDA prohibitions against the promotion of products for un-cleared, unapproved or "off-label" uses, and other requirements related to promotional activities;
6 unchanged sentences
This means the device cannot be cleared through the 510(k) process and will require marketing authorization through the premarket approval pathway.
−Removed: In September 2023 the FDA released additional draft guidance around best practices for selecting a predicate device to support a premarket notification submission.
A premarket approval application must be submitted to the FDA if the device cannot be cleared through the 510(k) process.
4 unchanged sentences
We are also subject to announced and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities or other sites of our subcontractors to audit any part of our quality system.
−Removed: We were inspected three times since January 2010 by the FDA and found to be in compliance with the Quality System Regulation.
+Added: We were inspected three times since January 2010 by the FDA and found to be in compliance with the Quality System Regulation requirements in effect at that time.
We cannot assure you that we can maintain a comparable level of regulatory compliance in the future at our facilities.
FTC Regulation
−Removed: Device advertising and promotional activity in certain circumstances is also subject to scrutiny by the Federal Trade Commission, as well as similar state consumer protection agencies, which enforce laws related
−Removed: to false and deceptive trade practices.
+Added: Device advertising and promotional activity in certain circumstances is also subject to scrutiny by the Federal Trade Commission (the “FTC”), as well as similar state consumer protection agencies, which enforce
+Added: laws related to false and deceptive trade practices.
A company that is found to have advertised its product in violation of these laws may be subject to liability, including monetary penalties.
89 unchanged sentences
The costs of complying with privacy and security related legal and regulatory requirements are burdensome and could have a material adverse effect on our business, financial condition and results of operations.
+Added: Telephone Consumer Protection Act.
+Added: The Telephone Consumer Protection Act of 1991 (“TCPA”) restricts telemarketing and the use of automated telephone equipment.
+Added: The TCPA limits the use of automatic dialing systems, artificial or prerecorded voice messages, SMS text messages and fax machines.
+Added: It also applies to unsolicited text messages advertising the commercial availability of goods or services.
+Added: Additionally, a number of states have enacted statutes that address telemarketing.
+Added: For example, some states, such as California, Illinois and New York, have created do-not-call lists.
+Added: Other states, such as Oregon and Washington, have enacted “no rebuttal statutes” that require the telemarketer to end the call when the consumer indicates that he or she is not interested in the product being sold.
+Added: Restrictions on telephone marketing, including calls and text messages, are enforced by the FTC, the Federal Communications Commission, states and through the availability of statutory damages and class action lawsuits for violations of the TCPA.
Environmental Regulation
Our research and development and manufacturing processes and operations may involve the controlled use of hazardous materials, including flammables, toxics and corrosives and produce hazardous chemical waste products.
−Removed: We are subject to numerous foreign, federal, state, and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship and end-of-life handling or disposition of products, and environmental protection, including those governing the generation, storage, handling, use, transportation and disposal of hazardous or potentially hazardous materials.
+Added: We are subject to numerous foreign, federal, state, and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship and end-of-life handling or disposition of products, and environmental protection, including those governing the
+Added: generation, storage, handling, use, transportation and disposal of hazardous or potentially hazardous materials.
Some of these laws and regulations require us to obtain licenses or permits to conduct our operations.
3 unchanged sentences
The time required to obtain clearance or approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may be different.
−Removed: Many countries also impose product standards, packaging requirements, environmental
−Removed: requirements, labeling requirements, and import restrictions on medical devices.
+Added: Many countries also impose product standards, packaging requirements, environmental requirements, labeling requirements, and import restrictions on medical devices.
Each country has its own tariff regulations, duties and tax requirements.
18 unchanged sentences
A LCD, administered by the two Medicare Administrative Contractors responsible for processing durable medical equipment claims, and which had set forth additional coverage criteria impacting Medicare coverage for our products was retired on November 14, 2024.
−Removed: The validity of the coverage criteria in the LCD remains under dispute in the District Court of the District of Columbia.
+Added: The validity of the coverage criteria in the LCD remains
+Added: under dispute in the District Court of the District of Columbia.
Our Medicare business was 24% of revenue in 2025 compared to 18% in 2024.
2 unchanged sentences
We also continue to closely monitor our Medicare business to identify trends that could have a negative impact on certain Medicare patients' access to our products, which in turn could have an adverse effect on our business and results of operations.
+Added: The One Big Beautiful Bill Act (“OBBBA”) was enacted in July 2025.
+Added: The OBBBA contains provisions that may reduce future Medicare reimbursement rates due to deficit-driven sequestration provisions.
+Added: Similarly, certain provisions contained in the OBBBA may have the effect of reducing participation in Medicaid on a national basis.
+Added: Changes to Medicaid eligibility or enrollment procedures could reduce the number of covered lives, decrease demand for our products, and increase uncompensated care.
Commercial payers that reimburse for our products do so in a variety of ways, depending on the insurance plan's policies, employer and benefit manager input, and contracts with their provider network.
12 unchanged sentences
Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our systems or to obtain and use information that we regard as proprietary.
−Removed: Our patent portfolio consists of four sets of patents, including patents relating to our Flexitouch system, our AffloVest system and other related technologies.
+Added: Our patent portfolio consists of a few sets of patents, including patents relating to our Flexitouch system, our AffloVest system and other related technologies.
As of December 31, 2025, we owned about 172 issued patents globally, of which 61 were issued U.S.
7 unchanged sentences
Human Capital Resources
−Removed: As a company, our focus is on developing and selling solutions that help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions by treating them at home.
−Removed: We believe the strength of our employees is the cornerstone to achieving these goals.
As of December 31, 2025, we had 1,086 employees.
−Removed: We have 613 employees who are based throughout the United States, as well as 424 employees who are primarily based in our corporate/manufacturing locations in the Minneapolis metropolitan area.
+Added: We had 651 employees based throughout the United States, as well as 435 employees primarily based in our corporate/manufacturing locations in the Minneapolis metropolitan area.
Our employees are our most important resource, and they set the foundation for our ability to achieve our strategic objectives.
20 unchanged sentences
The Company’s intranet facilitates employee inclusion, provides resources, and advances transparent communication efforts.
−Removed: We also introduced a number of new learning and development options for our team members in 2023.
+Added: We also have a number of learning and development options for our team members.
We continue to be diligent and remain focused on our employee engagement strategies, including through exit interview analyses, talent management and retention risk analyses and periodic employee engagement surveys.
33 unchanged sentences
Burns served as Vice President of Solutions Marketing, ResMed Americas of ResMed Inc.
−Removed: RMD), a global leader in digital health and cloud-connected medical devices focused on sleep apnea and other chronic diseases, from December 2003 to February 2016.
+Added: RMD), a global leader in digital health and cloud-connected medical devices focused on
+Added: sleep apnea and other chronic diseases, from December 2003 to February 2016.
Burns held various marketing and leadership roles of increasing responsibility with ResMed Inc.
2 unchanged sentences
Burns previously served in consulting and business development roles of increasing responsibility at a privately-held cardiology consulting practice that was subsequently acquired by GE Medical Systems, from 1994 to 1999.
−Removed: Ferstler , age 55, has served as our Senior Vice President of Sales since joining the company in July 2023.
−Removed: As described further in Part II, Item 9B.
−Removed: Other Information, Ms.
−Removed: Ferstler will cease to be an executive officer of the Company on February 18, 2025.
−Removed: Prior to joining Tactile Medical, Ms.
−Removed: Ferstler served as Vice President Sales, North America for Johnson & Johnson Vision since 2016 (NYSE:
−Removed: In this position, Ms.
−Removed: Ferstler led the field & inside sales teams, strategic accounts & training functions selling Acuvue brand contact lenses across multiple channels.
−Removed: Ferstler began her career in 1992 with Parke-Davis Pharmaceuticals where she served in a variety of sales, sales management and training and development roles.
−Removed: She joined Pfizer in 2000, serving as a district sales manager for all branded pharmaceutical products until 2003, then as Director of Division Operations and as a regional manager for Pfizer’s Urology and
−Removed: Respiratory product portfolios.
−Removed: From 2007 to 2016, Ms.
−Removed: Ferstler led regional and national sales teams for Endo Pharmaceuticals, Bayer Diabetes Care and Mylan Pharmaceuticals.
−Removed: Ferstler holds Bachelor of Arts in Psychology from the State University of New York College at Buffalo.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.