AIROS Medical Launches At-Home Device for PAD Crisis

AUDUBON, PA – February 04, 2026 – AIROS Medical, a Pennsylvania-based medical technology firm, today announced the launch of its FDA 510(k)-cleared ARTAIRA® Arterial Compression Device, introducing a new, non-invasive option for patients to manage symptoms of Peripheral Arterial Disease (PAD) from the comfort of their homes. The launch comes as global health organizations grapple with alarming projections for the disease's prevalence.

A Looming Public Health Challenge

Peripheral Arterial Disease is a serious circulatory condition characterized by narrowed arteries that reduce blood flow to the limbs, most commonly the legs. This reduction in circulation can lead to debilitating symptoms, including severe leg pain during exercise (claudication), pain even at rest, slow-healing or non-healing ulcers on the feet and legs, and tissue death. In its most severe form, known as critical limb ischemia, PAD can lead to infection and amputation.

The scale of the problem is staggering and set to expand dramatically. Current estimates place the number of people living with PAD at over 200 million worldwide. However, a landmark 2025 global study cited by the American Limb Preservation Society projects a startling 220% increase in cases by 2050, pushing the total number of affected individuals to more than 360 million.

This projected surge is driven by an aging global population and the rising prevalence of key risk factors such as diabetes, hypertension, and smoking. Despite its widespread impact, PAD often remains underdiagnosed and undertreated. In the United States alone, where 7 to 12 million people are affected, studies show a significant rise in prevalence, with certain demographics, such as Black American men over 50, facing a disproportionately higher burden. The growing crisis highlights an urgent need for accessible and effective treatment options that can improve patient outcomes and quality of life.

Bringing Advanced Compression Therapy Home

The newly launched ARTAIRA device aims to directly address this need. It is an intermittent pneumatic compression (IPC) system designed specifically to increase blood flow and circulation in the lower extremities. The prescription-only device consists of a portable control unit and two-chamber garments worn on the legs.

The system works by delivering rapid, high-pressure compression cycles to the calf and foot. One chamber inflates behind the calf while the other inflates under the foot, delivering 120mmHg of pressure in a timed sequence before deflating and repeating the cycle. This process effectively “squeezes” the limbs to propel oxygenated blood through the narrowed arteries to the feet and toes, which are often the most affected areas.

"Millions of aging Americans, including many diabetics, experience pain in their legs, have trouble healing foot ulcers, and are at risk of other serious health complications including amputation as a result of poor blood flow to the lower extremities," said Darren M. Behuniak, Chief Operating Officer of AIROS Medical, in a statement. "ARTAIRA increases circulation to treat these conditions and help patients return to regular activities and lifestyles."

The company has emphasized user-friendliness in the device's design. Weighing just seven pounds, the control unit features a simple two-button interface and a large color LCD screen that clearly displays pressure levels and remaining treatment time, making it suitable for at-home use by a wide range of patients, including the elderly.

Reshaping the PAD Treatment Landscape

The introduction of an at-home IPC device like ARTAIRA represents a significant shift in the management of chronic PAD. The current treatment paradigm for PAD is multi-faceted, ranging from lifestyle modifications and supervised exercise programs to medications like antiplatelets and statins. For more advanced disease, patients often face invasive procedures such as angioplasty, stenting, atherectomy (plaque removal), or bypass surgery.

ARTAIRA offers a non-invasive alternative that can be used alongside these other therapies. By enabling patients to perform treatment sessions at home, it removes the logistical barriers and costs associated with frequent clinic visits. This convenience can improve patient adherence, a critical factor in managing chronic conditions. The broader healthcare system also stands to benefit, as the shift towards home-based care can alleviate the burden on hospitals and specialized vascular clinics.

Crucially, AIROS Medical has secured reimbursement for ARTAIRA from Medicare and some commercial health insurers, a key step in ensuring broad patient access. While specific coverage criteria will apply, this reimbursement pathway is vital for integrating the new technology into standard patient care protocols for those who qualify.

A Strategic Expansion into a Growing Market

For AIROS Medical, the launch of ARTAIRA marks a pivotal strategic expansion. Founded in 2016, the company built its reputation on developing compression therapy systems for lymphedema and chronic venous insufficiency. With ARTAIRA, it is now leveraging its core technological expertise to enter the sizable and rapidly growing PAD treatment market.

The global market for PAD devices was valued at nearly $4.9 billion in 2024 and is projected to exceed $7.1 billion by 2032. By targeting this market with a user-friendly, non-invasive, and reimbursable at-home solution, AIROS Medical is positioning itself to capture a significant share of this growth.

"Our company has focused on treating patients with lymphedema and chronic venous insufficiency and we are thrilled to apply our user-friendly pneumatic compression technology to this adjacent patient population with vascular disorders," Behuniak stated. "We view ARTAIRA as a natural progression of our product line and look forward to enhancing the quality of life for even more patients in the United States and abroad."

To support the launch, the company plans to roll out extensive clinical education programs, professional workshops, and live demonstrations at major podiatric, vascular, and wound care conferences. This educational push aims to familiarize healthcare providers with the device's clinical applications and benefits, paving the way for its adoption as a new tool in the fight against the debilitating effects of Peripheral Arterial Disease.