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First US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical’s SensePatch Drug Delivery Technology

This represents the first regulatory submission in the United States for Sensile Medical’s SensePatch technology as a combination product with scPharmaceuticals’ Furosemide for use in the United States.

Per the company, the NDA for the combination product of a novel furosemide formulation and sc2Wear Infusor™ based on the SenseCore micro pump technology was submitted in August and has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date of June 23, 2018.

On the NDA submission and FDA acceptance, Derek Brandt, CEO of Sensile Medical comments, “The NDA submission and FDA acceptance of the filing of this large-volume innovative drug-device product represents an important milestone for Sensile Medical and for the emerging market of wearable drug delivery devices.”  He concluded, “The lessons learned during the design and development process position us well to pursue this platform across a broad range of therapeutic segments and uses.”

The Company Describred the Advantages of Subcutaneous Drug Delivery Using Sense Core Technology:  Slow and controlled subcutaneous drug delivery is often therapeutically equivalent to intravenous (IV) or intramuscular (IM) drug administration. Contrary to IV or IM drug administration, subcutaneous delivery is something patients or lay caregivers can usually do in the comfort of their home. This enables novel, hospital-strength treatment options for home use.

Sensile’s unique SenseCore micro-pump technology powers a new generation of large volume devices as well as pumps for very exact small volume delivery. The SenseCore allows for a first of its kind device design that uses a reusable motorized component and disposable cartridges. This design minimizes waste and creates cost-effective treatment options unattainable by other device technologies.

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