Needs Statement: A safe method of reducing hospitalizations for at-risk patients with heart failure in the outpatient setting. The device is a Biphasic furosemide transdermal patch, with coated microneedles. Microneedles are coated in a bolus dose of furosemide (in blue) for immediate release, followed by sustained release of maintenance dose (in green) over 5-7 days. Microneedles increase the bioavailability of furosemide, allowing treatment of exacerbations in the outpatient setting. The patch will be offered across a variety of dose ranges (20-80mg) depending on the patient’s medical needs. The patch will be prescribed and administered in the hospital setting.

Patients presenting to their provider with the primary complaint of a CHF exacerbation requiring diuresis and no additional interventions (such as antibiotics, echocardiography, etc. ) will be given the patch and monitored for 2-4 hrs. The patch should be worn over an area of high vascularity, such as the deltoid muscles. Upon application, the bolus dose of furosemide will be released over 2-4 hrs and the patient should be monitored in the clinical setting, such as the emergency department during this phase.

After demonstrating initial clinical stability through symptomatic relief and confirmation of intact renal function on labs, the patient can be discharged home on the patch. The sustained release component will then continue to provide additional diuresis over the span of 5-7 days. The purpose of the microneedles is to introduce the diuretic with increased bioavailability (greater than oral furosemide), though less than 100% so as to maintain a safety profile appropriate for the outpatient setting.