Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product

This study will be an open label, single-dose study to gain experience with first clinical use and to evaluate the suitability of the methods and procedures for evaluation of product performance of a to-be-marketed drug-device combination product (sc2WearTM Furosemide Combination Product) in a minimum of 20 adult male and female subjects previously diagnosed with mild to advanced heart failure (NYHA class II-IV). The study will enroll up to 30 Subjects to ensure a minimum of 20 evaluable Subjects. Methodology: Each Subject will complete Screening, Treatment, and Follow-Up Phases on an outpatient basis. During the Screening Phase, all Subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the trial. Drug administration may start on the day of enrollment or be scheduled within 3 days of completion of Screening procedures. However, if the treatment visit doesn't occur within 3 days of initial screening, subjects may be rescreened and treated within 3 days of rescreening. The Treatment Phase comprises a preprogrammed bi-phasic 5 hour drug administration. Treatment Day observations will commence with pre-placement procedures and continue until one hour after device removal. Device preparation, placement and removal will be performed by study staff in accordance with product instructions for use. Removal will occur within

3 hours of completion of drug delivery (8 hours of start of administration). Subjects will return 5-7 days after the Treatment Day for a post treatment follow-up and photography. After preparation of the skin, the device will be placed on the upper abdominal area by clinical study staff. Subjects are advised to avoid strenuous physical activity or activities that could expose the device to moisture such as swimming, bathing or showering. Participants will be informed that marked diuresis may ensue after activation, and that they should avoid travel, operating a vehicle or other situations without immediate access to bathroom facilities. For each Subject, a reusable components (Activator) and a single-use unit (Cartridge) will be used. Following removal from the skin, the assembled device will be inspected and photographed by the site staff. The used device (assembled Cartridge and Activator) will be placed in a sealed container and returned for further inspection and measurement of residual volume in the device reservoir.

Inclusion criteria

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female Subjects ≥18 years of age
• New York Heart Association (NYHA) Class II-IV Heart Failure.
• In the opinion of the Investigator, able to participate in the study.
• If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not recommended)
• If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment.
• Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.

Exclusion criteria

• Contraindication to furosemide.
• History of chronic skin conditions requiring medical therapy.
• Skin reaction to medical adhesives or history of poor skin adherence of adhesives.
• Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
• Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.
• Clinically significant abnormalities at Screening in safety laboratory tests.
• Hypokalemia - Potassium of < 3.6 mmol/L.
• Systolic BP (SBP) < 90 mm Hg.
• Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
• History of major abdominal surgery affecting the site of device placement.
• Participation in another trial, within 30 days prior to Screening.
• History of hepatitis B, hepatitis C, or HIV
• History of current or recent alcohol abuse.
• Female subject who is pregnant or lactating.
• Any surgical or medical condition that in the opinion of the Investigator may interfere with participation in the study or that may affect the outcome of the study.