MERCATOR MEDSYSTEMS, INC.

Improved Sirolimus-Analog Adventitial Delivery to Enhance Outcomes in Below-the-Knee Peripheral Artery Disease

Operating in national heart lung and blood institute based in San Leandro, CA, MERCATOR MEDSYSTEMS, INC. operates.

Profile

PROJECT SUMMARY
Peripheral artery disease (PAD) affects 1 in 16 individuals over age 40 (approximately 10 million Americans) [2].
The end stage of lower-extremity PAD, critical limb-threatening ischemia (CLTI), is estimated to affect 1.3% of
those over age 40 (approximately 2 million Americans) [3]. Left untreated, up to 40% of patients with CLTI will
require major (above the ankle) amputation within 6 months [4].
CLTI is often associated with multivessel below-the-knee (BTK) arterial occlusion, necessitating surgical bypass
or endovascular intervention to restore blood flow. Endovascular (catheter-based) procedures, which are likely
to occur in approximately 220,000 cases in the U.S. in 2025 [5], are often preferred over surgery in CLTI patients
due to high-surgical-risk comorbidities, but they have historically produced suboptimal results. Failure of the first
intervention is typically 50% or greater in the first year. After that initial failure and over the 5-year period following
reintervention, patients often progress toward a need for multiple re-interventions, major amputation in more than
half of patients, and 5-year survival rates less than 40% (as in a recent study of 1,134 patients with average age
of 59 years) [6]. Drug-coated balloons and drug-eluting stents have invariably had negative clinical trial results
for reducing restenosis below the knee, possibly because

Within the national heart lung and blood institute space, the company focuses on its core offering rather than a broad product line.

The business is associated with San Leandro, CA.

Its current recorded stage is SBIR/STTR.

The company reports a headcount in the 11-50 range.

Public records show total funding of about $1M.

Website: mercatormed.com