Sensile Medical's SensePatch Drug Delivery Technology on its way to the US

Based in Olten, Switzerland, Sensil Meidical is applying micro pump technology to develop a broad range of customer-specific delivery and dosing solutions. These pumps are ideally suited for large-volume subcutaneous delivery of modern pharmaceutical and biotech products for self-administration by patients. Its latest on- and off-body liquid drug delivery devices offer various opportunities to inject a drug without the need of changing the primary packaging.

At the beginning of November the startup announced that the US based scPharmaceuticals submitted Furosemide for s.c. administration together with Sensile's patch pump delivery system for approval with the U.S. Food and Drug Administration (FDA). scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that, through our proprietary platform, are designed to enable the subcutaneous administration of therapies previously limited to intravenous (IV) delivery.

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. 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.

"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," said Derek Brandt, CEO of Sensile Medical. "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."

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.

Winner of InnoPrix SoBa 2017
The InnoPrix SoBa award is given once a year and comes with a monetary prize of CHF 25'000 to support innovative product and service ideas in the Canton of Solothurn. This year, the award ceremony of the competition was held at the end of November and the winner was Sensile Medical. Sensile Medical owes this success to its employees. "We are very proud and continue working on innovative ideas building bridges from drugs to patients", said representative from Sensile.

(ran)