scPharmaceuticals Inc. announces recent progress on Furoscix a proposed treatment for heart failure.

scPharmaceuticals Inc. announced a progress update on Furoscix including progress on both the drug and device validation, and the successful completion of the human factors program. Furoscix is the Company�s lead program for the treatment of congestion in patients with heart failure and the Company remains on track to resubmit the Furoscix New Drug Application (NDA) under the current 505(b)(2) approval pathway with the FDA by mid-year 2020.

The Company has successfully completed their human factors validation study of the Furoscix On-body Infusor. The validation study included 60 participants including congestive heart failure patients, healthcare providers, and caregivers, who collectively represent the intended users of Furoscix. The study was designed to measure eight observational use metrics and included 900 tasks to assess whether the Furoscix On-body Infusor can be safely and effectively used. Results from the study demonstrated a user success rate of 99 percent and support the Furoscix On-body Infusor�s use within the intended population.

The Company has also progressed the device validation and drug stability testing, which are key components of the Furoscix NDA resubmission. The initial phase of the drug stability study was successfully completed with analytical testing of the drug product batches finalized for the initial timepoints. The Company also accomplished a key aspect of the device validation in which 100 percent of patients met all pre-defined end points in a five-hour simulated wear study. Final testing for both the device and drug stability remains on schedule and will be completed prior to the refiling of the Furoscix NDA by mid-year 2020.