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PolyPid Hosts KOL Call to Discuss Significant Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on its Ongoing SHIELD II Phase 3 Trial
After a Reduction in Surgical Site Infection (SSI) Rates During COVID, Rates are Now Increasing, Signaling a Return to Pre-COVID Levels Known Procedure and
About this update from Polypid Ltd.
[{"type":"text","content":"After a Reduction in Surgical Site Infection (SSI) Rates During COVID, Rates are Now Increasing, Signaling a Return to Pre-COVID Levels Known Procedure and Patient Risk-Factors Significantly Increase the Risk of SSIs and Impact Payer Costs Approximately 250 Patients of a Planned Total of 600 Subjects Currently Enrolled in SHIELD II Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up; Top-line Results Expected in the First Quarter of 2025 PETACH TIKVA, Israel, June 18, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100. Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs. Key takeaways include: The return to higher pre-COVID SSI rates due to the increase in the number of elective surgeries conducted and the surgical environment normalizing to levels found prior to 2020.SSIs are under-reported, and up to 30-35% of colorectal infections are missed due to sub-optimal surveillance strategies.Procedural and patient-related risk factors such as smoking, alcohol abuse, type 2 diabetes and a high BMI have a significant negative impact on the risk of developing a SSI, and this increase in risk is compounded when patients have multiple risk factors.Long term cost to commercial payers of a single colorectal SSI event over a period of 24 months can range from $44,000 (superficial SSI) to $64,000 (deep SSI), with the cost for Medicare ranging from $20,000 to $45,000, respectively.Surgical care bundles in patients undergoing colorectal surgery significantly reduce the risk of SSIs. The 30-day high concentration release of antibiotics achieved with D-PLEX100 has the potential to add additional benefit to infection prevention bundles. “Studies show traditional evidence-based interventions have maximum benefit within the perioperative and immediate postoperative period. Building upon this, D-PLEX100 supports prolonged doxycycline concentrations withi...