A Revolution in Surgical Care Awaits!

New York, May 30, 2025 – It's a pivotal moment in surgical infection prevention as PolyPid Ltd. gears up to unveil its crucial SHIELD II Phase 3 trial results for D-PLEX100 by the end of Q2 2025. This innovative biopharmaceutical company is poised to transform surgical care practices with its cutting-edge localized drug delivery technology.

Why Surgical Site Infections are a Major Concern

Surgical site infections (SSIs) are a critical hurdle in modern healthcare, representing a staggering 20% of all hospital-related infections in the US. They plague high-risk surgeries, such as colorectal procedures, with infection rates soaring to 30%. This not only leads to prolonged hospital stays—averaging an additional 7 to 11 days—but also significantly increases mortality risk and healthcare costs, totaling around $10 billion annually in the US and Europe.

The Shortcomings of Current Prevention Methods

Current anti-infection strategies largely rely on intravenous antibiotics administered shortly before surgery. However, these systemic doses often fall short—surgical incisions hinder local blood flow, making it difficult for antibiotics to reach the surgery site effectively. This inept method also brings potential risks, such as higher toxicity and the looming threat of antibiotic resistance.

Introducing PLEX Technology: A Game Changer!

PolyPid’s revolutionary PLEX technology is reshaping the landscape of drug delivery. This system features layers of biocompatible polymers and lipids that protect and gradually release antibiotics right at the surgical site over an extended period.

D-PLEX100 utilizes doxycycline, renowned for its efficacy against a range of bacteria, including antibiotic-resistant strains like MRSA. The localized delivery system achieves antibiotic concentrations 10-115 times greater than traditional intravenous approaches, all while reducing drug exposure and side effects.

Impressive Clinical Progress Shines a Light on D-PLEX100

Recent clinical trials showcase D-PLEX100's impressive performance. In Phase 2 studies involving abdominal surgeries, the combination of D-PLEX100 and standard care resulted in a significant 59% reduction in SSIs compared to the standard treatment alone. For context, the treatment group reported zero deaths within 60 days post-surgery, while five patients in the control group did not survive.

SHIELD II: The Defining Clinical Trial

The SHIELD II Phase 3 trial is designed to build on previous learnings from the SHIELD I study. Following a positive interim review from a Data Safety Monitoring Board, the trial is now set to include 800 patients. This multinational study spans about 60 centers across the US, Europe, and Israel, aiming to evaluate D-PLEX100's effectiveness in diverse medical environments.

Broader Implications for Healthcare

The successful deployment of D-PLEX100 could inspire wider adoption of localized drug delivery methods in surgical practices. Beyond infection prevention, this technology may soon be utilized for localized chemotherapy applications through PolyPid’s OncoPLEX program, currently in development.

With around 12 million surgical procedures annually in the US alone, the potential impact on healthcare is monumental. PolyPid has already secured European commercialization rights through a partnership valued at $115 million, with ongoing discussions for US market access.

The Future Looks Bright!

As the pharmaceutical landscape navigates the challenges of antibiotic resistance, D-PLEX100's impending data readout represents a hopeful milestone. With compelling clinical data, regulatory recognitions, and a significant unmet need, all eyes will be on PolyPid as it approaches this critical turning point in surgical infection prevention.