What PolyPid does

PolyPid Ltd. is an Israeli clinical-stage biopharmaceutical company founded in 2008 and listed on Nasdaq (PYPD) since June 26, 2020, headquartered in Petach Tikva, Israel with a U.S. subsidiary in Summit, NJ. The company develops long-acting, controlled-release medicines built on its proprietary Kynatrix™ technology (and the underlying PLEX, Polymer-Lipid Encapsulation matriX platform), which enables customizable, localized, linear drug delivery over periods ranging from days to weeks without burst effects, allowing high local concentration with negligible systemic exposure.

PolyPid's lead product candidate, D-PLEX100, is a first-in-class incisional prophylactic therapy that delivers sustained, localized doxycycline directly at the surgical incision for up to 30 days to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. The Phase 3 SHIELD II trial demonstrated a 60% relative risk reduction in SSI incidence (p=0.0013) and a 64% reduction in clinically significant wound infections per ASEPSIS scoring (p=0.0103). The product received FDA Breakthrough Therapy Designation, and the NDA was accepted with Priority Review, setting a PDUFA goal date of November 28, 2026. The pipeline extends the platform into oncology (OncoPLEX) and orthopedic infections (BonyPid, D-PLEX500), with the February 2026 Kynatrix launch positioning the company toward metabolic and adjacent therapeutic areas.

PolyPid's revenue model is currently pre-commercialization with $0 reported revenue across 2022–2025 and net losses of $34.2M in 2025 and $7.7M in Q1 2026. In July 2026, the company entered an exclusive U.S./Canada commercialization partnership with Azurity Pharmaceuticals valued at over $320 million, comprising $15M upfront, $15M upon FDA NDA acceptance, tiered royalties in the mid-teen to mid-twenties percent range, and up to approximately $300M in additional regulatory, development, and sales-based milestones; Azurity will commercialize the product while PolyPid manufactures and supplies it. Target customers are hospitals and surgical centers performing colorectal surgery, reached through Azurity's hospital-focused sales force, with U.S. commercial launch targeted for Q1 2027.

Name

PolyPid

Legal name

PolyPid Ltd.

Website

https://polypid.com

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

PolyPid is an Israeli clinical-stage biopharmaceutical company developing long-acting, localized drug delivery products using its proprietary Kynatrix/PLEX platform. Its lead candidate, D-PLEX100, delivers 30-day localized doxycycline to prevent surgical site infections in colorectal surgery, partnered with Azurity for U.S./Canada commercialization.

Ownership category

akta.pro rank

Headquarters

HQ city

Petah Tiqva

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Product Sales through Azurity Partnership: Upon FDA approval and commercialization, PolyPid will manufacture and supply D-PLEX100 to Azurity for a transfer price and receive tiered royalties ranging from mid-teen to mid-twenties percentages on future sales in U.S. and Canada.
2. Milestone Payments from Azurity: PolyPid will receive $15 million upon signing the agreement (July 2026) and an additional $15 million upon FDA acceptance of the NDA. Additional regulatory, development, and sales-based milestone payments up to approximately $300 million.
3. Warrant Exercises: PolyPid secured $26.7 million through warrant exercises following successful Phase 3 SHIELD II trial results, extending operational runway beyond FDA approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

PolyPid develops long-acting, controlled-release pharmaceutical products based on its proprietary Kynatrix (PLEX) technology, which enables customizable, localized, burst-free drug delivery over periods ranging from days to weeks. Its lead commercial-stage product, D-PLEX100, delivers sustained doxycycline release directly at the surgical incision for 30 days to prevent surgical site infections (SSIs) in abdominal colorectal surgery patients. Additional pipeline candidates extend the platform into oncology (OncoPLEX) and orthopedic (BonyPid, D-PLEX500) indications.

Product overview

PolyPid is an innovative biopharmaceutical company developing long-acting, controlled-release drugs using its proprietary PLEX and Kynatrix technology platforms. The company's lead product D-PLEX100 is a first-in-class incisional prophylactic therapy for preventing surgical site infections, delivering sustained localized antibiotic exposure directly at surgical incisions for 30 days. The pipeline spans surgical care (D-PLEX100), oncology (OncoPLEX), and orthopedic applications (BonyPid, D-PLEX500). In July 2026, PolyPid entered an exclusive $320M+ commercialization partnership with Azurity Pharmaceuticals for D-PLEX100 in the U.S. and Canada, with FDA NDA acceptance and Priority Review granted, targeting commercial launch in Q1 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• D-PLEX100 First-in-class incisional prophylactic therapy that uses the Kynatrix technology to deliver sustained, localized doxycycline release at the surgical incision for 30 days, designed to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. Demonstrated a 60% relative risk reduction in SSI incidence in the Phase 3 SHIELD II trial.
• Kynatrix Platform Next-generation drug delivery technology platform enabling customizable, localized, extended drug delivery over periods ranging from days to weeks without burst effects, ensuring linear, high-concentration exposure across a broad range of therapeutic agents.
• PLEX Technology Proprietary Polymer-Lipid Encapsulation matriX technology enabling controlled local delivery of drugs at predetermined release rates and durations over periods ranging from days to several months, designed to address shortcomings of systemic administration and existing localized delivery systems.
• OncoPLEX Pipeline product candidate applying the PLEX platform to deliver sustained docetaxel release, intended to overcome therapeutic barriers in post-resection solid tumors and glioblastoma.
• BonyPid Pipeline orthopedic product candidate using a polymer-lipid coating for antibiotic delivery to treat and prevent infections in bones, including osteomyelitis and Gustilo III infected open fractures.
• D-PLEX500 Pipeline product candidate for peri-implantitis treatment using a local, biodegradable, prolonged-release doxycycline-formulated bone graft.

Quantifiable outcome

• 60% relative risk reduction in SSI incidence (p=0.0013)
• +3 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Azurity PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 21 July 2026PolyPid entered an exclusive commercial partnership with Azurity Pharmaceuticals for D-PLEX100 in the U.S. and Canada. PolyPid will receive $15M upfront, $15M upon FDA NDA acceptance, and up to ~$300M in additional milestones, plus tiered royalties (mid-teen to mid-twenties percentages). Azurity will commercialize the product while PolyPid manufactures and supplies it. Azurity will also fund clinical development for potential label expansion beyond abdominal surgery SSI indications.

Scale indicators7 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Stryker Corporation: Stryker's surgical and infection-prevention segments provide a wide array of surgical devices and hospital consumables. While Stryker does not have a direct D-PLEX100 equivalent, it competes for hospital SSI-prevention budgets and formulary space via adjacent product categories.
• Johnson & Johnson (J&J MedTech): Johnson & Johnson's MedTech division, including Ethicon and DePuy Synthes, holds dominant positions in surgical wound closure, orthopedics, and infection prevention. J&J is a broad incumbent whose hospital channel and SSI-adjacent product lines compete for the same surgeon mindshare as D-PLEX100.
• Medtronic: Medtronic's Surgical Solutions division offers a broad portfolio of surgical instruments, hemostats, and infection-related products used in operating rooms globally. As a broad incumbent with scale hospital sales coverage, Medtronic is the primary existing-relationship competitor PolyPid must displace for surgical SSI adoption.
• Becton Dickinson (BD): BD's Surgery business (previously led by new PolyPid Chairman Brooke Story) is the dominant provider of surgical infection prevention products, skin antiseptics, and surgical devices in U.S. hospitals. BD is a broad incumbent that competes with D-PLEX100 through established SSI-prevention product portfolios and deep hospital relationships.

Emerging players

• Iterum Therapeutics: Iterum develops oral and IV antibiotics (sulopenem) targeting resistant infections treated in hospital and community settings. Comparable to PolyPid as an emerging anti-infective player with a focus on reducing surgical and hospital-acquired infections, though its delivery modality is conventional rather than localized sustained-release.
• Citius Pharmaceuticals: Citius is a clinical-stage specialty pharma developing oncology and anti-infective products including Mino-Lok (a catheter-lock solution for catheter-related bloodstream infections). Comparable to PolyPid as an emerging player in hospital-administered anti-infective therapies addressing high-acuity infection indications.

Direct peers

• Eagle Pharmaceuticals: Eagle Pharmaceuticals develops improved formulations and sustained-release injectables (e.g., vasopressin, PEMFEXY) that compete on pharmacokinetic and dosing advantages over standard hospital drugs. Eagle is a comparable specialty pharma whose value proposition is reformulating existing molecules for hospital use via proprietary delivery technology.
• Pacira BioSciences: Pacira commercializes EXPAREL, a long-acting injectable local anesthetic using a multivesicular liposomal platform for sustained drug release. Pacira is the closest public-market peer to PolyPid: a specialty biopharma whose value is anchored by a single sustained-release technology deployed in surgical care settings.
• Heron Therapeutics: Heron develops sustained-release polymer-based drug delivery products (ZYNRELEF, APONVIE, CINVANTI) using a bioerodible polymer platform that targets the surgical and postoperative care setting. The shared thesis - proprietary extended-release technology deployed in hospitals to displace standard of care - is directly analogous to PolyPid's D-PLEX100/Kynatrix.
• DURECT Corporation: DURECT is a clinical-stage specialty pharma built around its DUR-928 and SABER/SUCROVEST sustained-release drug delivery platforms, with applications in acute organ injury and postoperative pain. Comparable to PolyPid as a small-cap, technology-platform-driven biopharma targeting localized or controlled-release drug delivery for medical indications.

Market position

Strengths5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/PolyPidLtd
• YouTubevimeo.com/user134795947
• LinkedInlinkedin.com/company/polypid
• Facebookfacebook.com/profile.php

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds10 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PolyPid