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PolyPid Ltd. (Nasdaq: PYPD ) is a biopharma company focusing on developing targeted, locally administered, and prolonged-release therapeutics to improve surgical outcomes.

PolyPid’s lead product candidate, D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal and sternal surgical site infections (SSI).

PolyPid was founded in 2008 and is based in Petach Tikvah, Israel, and has a U.S. subsidiary in Summit, New Jersey.

PLEX Technology
PolyPid developed a proprietary drug delivery platform, Polymer-Lipid Encapsulation matriX (PLEX). PLEX is a drug delivery platform of alternating layers of polymers and lipids that can encapsulate a wide range of therapeutic molecules, small and large, including antibiotics, chemotherapeutics, antibodies, peptides, and siRNA, between its layers.

PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with drugs to locally deliver drugs over prolonged periods of time.

D-PLEX100
D-PLEX100 is a drug delivery candidate designed to provide local sustained and controlled anti-microbial activity directly at the surgical site, from the final stages of surgery and during the period of healing, to prevent surgical site infections (SSIs).

Following the administration of D-PLEX100 directly to the surgical site, PLEX technology releases the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs.

D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

Operating facilities
PolyPid’s 1,000m2 GMP manufacturing facility was completed in October of 2018 in Petach Tikvah, Israel. It was granted Manufacturer Authorization and Good Manufacturing Practice (GMP) certification by Israel’s Ministry of Health (IMOH) which is recognized by the European Medicines Agency (EMA) as part of its Mutual Recognition Agreements (MRA).