Development & testing of a novel therapeutic device for improving mobility in patients with lower-extremity peripheral artery disease - the objective of this proposal is to develop a novel device to…

The National Heart, Lung, and Blood Institute awarded Aquilo Sports L.L.C. $1.111 million on August 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop and test a novel home-based lower-extremity heat therapy device for patients with symptomatic peripheral arterial disease.

Aquilo is developing a wearable lower-body garment that pneumatically compresses polyurethane water-circulating channels against the leg to deliver efficient heat transfer, addressing a gap in non-invasive PAD treatment. The current standard of care—12-week supervised exercise therapy—is often painful and logistically inaccessible for older adults, leading many untreated patients to pursue invasive revascularization procedures that carry elevated risks of limb ischemia and amputation. A pilot study of six PAD patients using Aquilo's device demonstrated clinically meaningful improvements: average 32-meter gain in 6-minute walk distance, 14 percent increase in calf muscle strength, 22 percent reduction in chair stand time, and 5 millimeters of mercury systolic blood pressure reduction in five of six participants. The device was supported by a prior Phase I SBIR award and represents the only commercial system intended for lower-extremity heat therapy delivery.

Work is performed in Jeffersontown, Kentucky, with a period of performance through July 31, 2029. This is a Phase II SBIR award, classified as a project grant with $1.111 million obligated.

Development & testing of a novel therapeutic device for improving mobility in patients with lower-extremity peripheral artery disease - the objective of this proposal is to develop a novel device to deliver lower-extremity heat therapy (leht) for individuals with symptomatic peripheral arterial disease (pad). The current non-invasive standard of care for pad is a 12-week program of supervised exercise therapy (set). However, this approach is often painful, as patients are exercised to the point of claudication, and many older adults face logistical barriers to attending regular in-person sessions. As a result, a significant proportion of patients go untreated. Due to the lack of accessible and practical treatment options, many patients ultimately OPT for invasive revascularization procedures. However, these procedures can disrupt the natural progression of claudication, often leading to multiple interventions, increased incidence of acute and chronic limb ischemia, and a heightened risk of amputation. To address this GAP, aquilo™ has developed a patented, home-based leg HT system with support from a phase i sbir award. The system consists of a lower-body garment that pneumatically compresses polyurethane, water-circulating channels against the leg to enable efficient heat transfer. The feasibility and safety of this device were evaluated in a pilot study involving six patients with pad (pmid: 39760021). Participants demonstrated a clinically meaningful average improvement of 32 meters in 6-minute walk distance, along with a 14% increase in calf muscle strength and a 22% reduction in chair stand time. Additionally, five of six participants showed a 5 mmhg reduction in systolic blood pressure. Currently, no commercial system exists for delivering leht, despite its potential as a comfortable, home-based, non-pharmacologic treatment for pad. The multidisciplinary aquilo development team has the expertise and track record to translate this promising technology into a commercially viable therapy that could transform pad management. The proprietary aquilo leht system (U.S. Patent US11779508) is composed of two main components: a wearable garment and a control console. The garment is a lower-body wrap with a zippered outer shell that contains six pneumatic chambers. Inside, a water-circulating pad is compressed against the limb to deliver heat therapy. ECG sensors connect via bluetooth to monitor treatment compliance. The second component is a user- friendly console that houses a heating element and two pumps-one to circulate heated water through the pad and another to inflate the pneumatic chambers, ensuring consistent and gentle contact with the leg. The console also receives and remotely stores compliance data from the ECG sensors. With a single TAP on the touchscreen interface, users can initiate a full treatment cycle. The system includes several built-in safety features, such as audible and visual alarms and automatic shutoff in cases of excessive temperature, pressure, or low water level. The system's design was informed by rigorous prototyping and proof-of-concept testing to refine technical specifications, assess performance, and resolve engineering challenges. These efforts culminated in the successful completion of a 12-week feasibility study on six patients with pad, demonstrating the system's functional reliability and safety for home-based use. In this phase II project, we aim to (1) finalize the fabrication of the aquilo HT system and confirm that all design specifications have been met (aim 1), and (2) evaluate the system's efficacy, safety, and usability in a 12-week randomized controlled trial involving 40 patients with pad (aim 2). Feasibility will be demonstrated through the successful achievement of design and performance benchmarks (aim 1), along with evidence of safety (no skin injuries or burns), device reliability, and clinically meaningful improvements in functional outcomes (aim 2). Following the successful completion of these milestones, we will initiate a design freeze and conduct verification and validation (v & v) testing in accordance