Oct 2019

PolyPid Announces Positive Top-line Results from Phase 2 Clinical Trial of D-PLEX100 for the Prevention of Surgical Site Infections in Abdominal Surgery

D-PLEX100 Administration into the Surgical Site Led to Statistically Significant Reduction in Infections Compared to Standard of Care Alone  Company Intends to Hold End of Phase 2 Meeting with FDA and Subsequently Submit an IND to Conduct a Phase 3 Clinical Trial in Abdominal Surgery Petah Tikva, Israel, October 16, 2019 — PolyPid Ltd., an emerging clinical-stage  biopharmaceutical company…

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Sep 2019

PolyPid Announces Completion of $50 Million Series E-1 Financing

Petah Tikva, Israel, September 4, 2019 -- PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies, announced today the closing of its $50M Series E-1 preferred shares financing round. The financing was led by existing institutional shareholders and included US-based high-net worth investors. National Securities Corporation acted as the…

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May 2019

PolyPid Receives a Second QIDP Designation for D-PLEX100 in Abdominal Surgery

QIDP designation provides additional five years of market exclusivity and eligibility for FDA priority review and Fast Track designation.   A Phase II clinical study in abdominal surgery is currently ongoing with more than 140 patients already enrolled, top-line results are expected in the second half of 2019. Petah Tikva, Israel — May 21th, 2019 – – PolyPid Ltd.,…

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Nov 2018

PolyPid Announces FDA Clearance of Investigational New Drug Application (IND) to Commence Pivotal Phase 3 Clinical Trial of D-PLEX100 for the Prevention of Sternal Wound Infection Post-Cardiac Surgery

Multinational Phase 3 study expected to start in the first half of 2019 Petah Tikva, Israel — November 12, 2018 – – PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies for post-surgical complications, announced today that the United States Food and Drug Administration (FDA) has completed its review of the IND and…

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Oct 2018

PolyPid Begins Phase 2 Study to Assess Safety and Efficacy of D-PLEX100 in Prevention of Abdominal surgical site infections

Study to enroll up to 300 patients; with top-line results expected in the second half of 2019 Petah Tikva, Israel -- October 15, 2018 - - PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing new innovative therapies for post-surgical complications, announced today that the first patient has been enrolled in a Phase 2…

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Jul 2018

PolyPid has received Certificate of GMP Compliance of a manufacturer

During July 2018, PolyPid has received Certificate of Good Manufacturing Practice (GMP) Compliance of a manufacturer. Manufacturer's / Importer's Authorization (MIA)  was issued following an inspections in accordance with the requirements of GMP, of the Israeli laws and regulations, and issued under the provision of the Conformity Assessment and Acceptance of Industrial Products (CAA) Agreement…

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Dec 2017

PolyPid Appoints Jacob Harel as Chairman of the Board of Directors

PETAH TIKVA, Israel – December 21, 2017 -- PolyPid Ltd., a clinical-stage pharmaceutical company with an initial focus on the prevention and treatment of post-surgical site infections, today announced that Jacob Harel, a seasoned business development executive with more than 30 years of experience in the global pharmaceutical industry, has been appointed as Chairman of…

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Aug 2017

PolyPid Ltd. Completes Enrollment in Phase Ib/II Study of D-PLEX100 in Post-Cardiac Surgery Sternal Infection

Data Readout from Phase Ib/II Study Expected by End of 2017 Company Intends to Seek Regulatory Approvals in U.S. and Europe in 2018 to Conduct a Phase III Clinical Trial of D-PLEX™ Petah Tikva, Israel, August 16, 2017 -- PolyPid Ltd., a clinical-stage biopharmaceutical company with an initial focus  on the prevention and treatment of…

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Mar 2017

PolyPid Announces Positive Interim Data from Company’s Confirmatory Clinical Trial for D-PLEX1000 Antibiotic Eluting Bone Substitute

Performance and Safety Endpoints Met for First Patients Having Reached Six-Month Follow-up Period. Petah Tikva, Israel, March 9, 2017 -- PolyPid Ltd., an emerging clinical-stage specialty pharmaceutical company focused primarily on the development of post-surgical anti-infective pipeline, announced today interim results from the first group of patients having reached the six-month follow-up period in the Company's confirmatory…

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Mar 2017

PolyPid Announces Receipt of Qualified Infectious Disease Product (QIDP) Designation from FDA for D-PLEX100 in Post-Cardiac Surgery Sternal Infection

QIDP Designation Allows for FDA Priority Review and Adds Five Years of Market Exclusivity for  D-PLEX™. D-PLEX™ Currently Subject of On-going Phase Ib/II Study in Israel. Company Intends to Seek Regulatory Approvals in U.S. and Europe in Coming Year to Conduct Phase III Clinical Trial of D-PLEX™. Petah Tikva, Israel, March 08, 2017 -- PolyPid…

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Technology

PolyPid’s PLEX targeted drug delivery platform enables localized, controlled, continuous release of medication over prolonged periods of time for better patient outcomes.

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D-PLEX100

Provides safe and effective local antibiotic protection against SSI (surgical Site Infection) at the needed tissues or organs by administration during surgical procedures.

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D-PLEX1000

Comprised of antibiotic eluting ß tri-calcium phosphate (ßTCP) granules, designed for bone related infections applications.

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