Slide 1: D-PLEX100 for the Prevention of Surgical Site Infections
D-PLEX100 FOR THE PREVENTION OF SURGICAL SITE INFECTIONS December 15, 2020
Slide 2: Disclaimer
Disclaimer This presentation of PolyPid Ltd. (the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar ex
Slide 3: Agenda
Agenda 01 The Burden of Surgical Site Infections – Dr. Anthony Senagore 02 The Impact of Prevention of SSI in Heart Surgery – Dr. Hartzell Schaff 03 Surgical Site Infections in Colorectal Surgery – Dr. Oded Zmora 04 Results From D-PLEX100 Phase 2 Trials - Dr. Anthony Senagore 05 The Future of D-PLEX
Slide 4: Today's Moderator: Anthony Senagore, MD
Today’s Moderator: Anthony Senagore, MD Anthony J. Senagore, MD, is a colorectal surgeon with a long track record of academic surgery practice. He has served as Professor of Surgery at a number of prestigious academic medical centers including most recently UTMB at Galveston. He has served as Chair
Slide 5: Today's Presenters
Today’s Presenters Hartzell V. Schaff, MD Dr. Schaff is the Stuart W. Harrington Professor of Surgery and a consultant in the Division of Cardiovascular Surgery at Mayo Clinic, Rochester, Minnesota. He is a member of major international societies, including the American Association for Thoracic Surg
Slide 6: The Burden of SSI
The Burden of SSI Anthony Senagore, MD
Slide 7: SSI is Globally Recognized as a Problem With Human and Financial Cost
SSI is Globally Recognized as a Problem With Human and Financial Cost Up to 30% 7-11 days Estimated SSI rate of patients Additional post-operative hospital days undergoing colorectal surgery1,2 for patients with SSIs3 “The human and financial costs of treating surgical site infections (SSIs) are inc
Slide 8: The Financial Impact of SSI is Felt in Hospitals Big and Small
The Financial Impact of SSI is Felt in Hospitals Big and Small In 2019, Medicare cash penalties for 7 of the 21 hospitals on the U.S. News Best Hospitals Honor Roll1 Hospital Hospital-acquired condition penalty 2 Readmission penalty 2 UPMC Shadyside in Pittsburgh $2,720,780 $977,439 Ronald Reagan UC
Slide 9: The Impact of Prevention of SSI in Heart Surgery
The Impact of Prevention of SSI in Heart Surgery Hartzell V. Schaff, MD Professor of Surgery, Division of Cardiovascular Surgery Mayo Clinic
Slide 10: Eliminating the risk of infection can have a profound change on how CABG surgery is performed
Eliminating the risk of infection can have a profound change on how CABG surgery is performed • Current SSI rate of about 6-8%1 in high-risk cardiac surgery patients • One of the most devastating complications following cardiac surgery is Deep Sternal Wound infection (DSWI) ‒ Mortality rates of up t
Slide 11: Bilateral internal mammary artery (BITA) has shown better outcomes than single internal mammary artery
Bilateral internal mammary artery (BITA) has shown better outcomes than single internal mammary artery (SITA) but usage is low • Use of BITA has been associated with improved long- term survival and freedom from repeat revascularization1 • Surgeons continue to avoid using BITA grafting because of pr
Slide 12: D-PLEX100 could be a game changer in the CABG world
D-PLEX100 could be a game changer in the CABG world The Society of Thoracic Surgeons: “Although graft patency and survival appears superior with BITA grafting, the main concern for surgeons is the potential increased risk of sternal wound infections compared with SITA” 1 Apply D-PLEX100 in high-risk
Slide 13: Surgical Site Infections In Colorectal Surgery
Surgical Site Infections In Colorectal Surgery Oded Zmora, MD Chair, Department of Surgery Associate Professor of Surgery Shamir Medical Center Israel
Slide 14: Common Indications for Colorectal Surgery
Common Indications for Colorectal Surgery Colon / rectal cancer Colon and rectal polyps Inflammatory bowel diseases (IBD) Diverticular disease 13
Slide 15: Approaches to Colorectal Surgery: Open Surgery
Approaches to Colorectal Surgery: Open Surgery 14
Slide 16: Approaches to Colorectal Surgery: Endoscopic Surgery (Laparoscopy/ Robot)
Approaches to Colorectal Surgery: Endoscopic Surgery (Laparoscopy/ Robot) 15
Slide 17: Approaches to Colorectal Surgery: Laparoscopic Colectomy
Approaches to Colorectal Surgery: Laparoscopic Colectomy One wound needs to be extended to allow removal or the resected bowel 16
Slide 18: Approaches to Colorectal Surgery: Robotic Colectomy
Approaches to Colorectal Surgery: Robotic Colectomy 17
Slide 19: Following Resection the Proximal And Distal Stumps Need To Be Joined (Anastomosis)
Following Resection the Proximal And Distal Stumps Need To Be Joined (Anastomosis) Anastomosis can be performed in two ways: Hand sewn Stapled 18
Slide 20: At the Conclusion of Surgery, the Abdominal Wall and the Skin Are Closed
At the Conclusion of Surgery, the Abdominal Wall and the Skin Are Closed The layers that need to be closed depends on type and site of the incision: Abdominal wall: muscles, facia External to the abdominal wall: subcutaneous fat, skin 19
Slide 21: Postoperative Complications Occur in Close to One-third of Patients Undergoing Colorectal Procedures
Postoperative Complications Occur in Close to One-third of Patients Undergoing Colorectal Procedures1 Complications related to the surgical procedure include: Anastomotic leak Abdominal abscess Surgical Site Infection (SSI) 1. Longo W E, Virgo K S, Johnson F E. et al. Risk factors for morbidit
Slide 22: SSI is a Major Issue in Colorectal Surgery
SSI is a Major Issue in Colorectal Surgery The bowel is loaded with bacteria The risk for SSI increases due to endogenic bacteria (comes from the inside) May also be caused by skin bacteria 21
Slide 23: SSI Rate Differs by Surgery Type and Personal Risk Factors
SSI Rate Differs by Surgery Type and Personal Risk Factors Rate of SSI infection by surgery type: Open surgery: 10-30% Laparoscopic colectomy: <10% Personal risk factors include: Obesity Diabetes Smoking and COPD Immunosuppression Nutritional status 22
Slide 24: Prevention Measures Are a Part of the Standard of Care…
Prevention Measures Are a Part of the Standard of Care… Perioperative intravenous antibiotics Bowel mechanical cleansing Oral antibiotics Wound irrigation with water Closure technique … but the risk of SSI in colorectal surgery remains high 23
Slide 25: Symptoms, Signs and Treatment of SSI Can Vary Depending on the Severity of the Infection
Symptoms, Signs and Treatment of SSI Can Vary Depending on the Severity of the Infection Symptoms & Signs: Pain, fever, redness, purulent discharge, dehiscence Escalating Measures for treating SSI may include: Open the wound for drainage Frequent change of wound dressing Post-operative antibio
Slide 26: Video: Application of D-PLEX100 in Colorectal surgery
Video: Application of D-PLEX100 in Colorectal surgery PLEX candidate 1) Pour 2) Hydrate 3) Mix 25
Slide 27: My Experience with D-PLEX100 in Phases 2 and 3 Studies
My Experience with D-PLEX100 in Phases 2 and 3 Studies Easy to use Requires minimal training No patient’s discomfort 26
Slide 28: Results From D-PLEX100 Phase 2 Trials
Results From DPLEX100 Phase 2 Trials Anthony Senagore, MD
Slide 29: D-PLEX100 – Localized Drug Delivery System Optimized for the Prevention of SSI
D-PLEX100 – Localized Drug Delivery System Optimized for the Prevention of SSI D-PLEX for prophylaxis of SSI: Active Ingredient: Doxycycline; broad spectrum antibiotic Release Profile: Constant & linear release regardless the tissue: bone & soft tissues Release Rate: Generating the optimal loc
Slide 30: D-PLEX100 Phase 2 Study Design in Abdominal Surgeries (soft tissues)
D-PLEX100 Phase 2 Study Design in Abdominal Surgeries (soft tissues) Prospective, multicenter, randomized, controlled, two arm, single blind, study Assess safety and efficacy of D-PLEX administered prophylactically concomitantly with the standard of care (SoC) to prevention incisional surgical s
Slide 31: Demographics and Baseline Data Summary Statistics
Demographics and Baseline Data Summary Statistics • Elective abdominal colon surgery involving resection and ileocolonic, ileorectal, colocolonic or colorectal anastomosis or with a stoma. In laparoscopic or open surgery, an abdominal wall incision ≥ 5 cm. • Baseline demographic (Age, BMI, etc.) and
Slide 32: D-PLEX100 Effective in Reduction of SSI & Mortality in Soft Tissue Colorectal Surgical Model
D-PLEX100 Effective in Reduction of SSI & Mortality in Soft Tissue Colorectal Surgical Model within 30 days (Primary End-Point, ITT population) Laparoscopy & Open Laparotomy Open Laparotomy 24% 59% reduction 45% 74% reduction (P=0.0086) (P=0.0053) SoC SoC n=24 n=14 10% 11% D-PLEX100 D-PLEX100 n=10 n
Slide 33: Same Rate of Serious Treatment Emergent Adverse Events – With Significant Reduction in Mortality
Same Rate of Serious Treatment Emergent Adverse Events – With Significant Reduction in Mortality Injury, poisoning and procedural complications D-PLEX (N=99) CONTROL (N=100) Anastomotic hemorrhage 1 (1.0%) 0 (0.0%) Anastomotic leak 2 (2.0%) 3 (3.0%) No significant variance in Injury 0 (0.0%) 1 (1.0%
Slide 34: More than 70% of the infected bacteria within the surgical wounds were resistant to +2 antibiotics
More than 70% of the infected bacteria within the surgical wounds were resistant to +2 antibiotics D-PLEX100 demonstrated efficacy in surgeries were Multidrug-resistant bacteria (MDR) strains are very common Type of bacteria isolated from surgical wounds following the Ph2 abdominal study: • Staphylo
Slide 35: The Future of D-PLEX100
The Future of DPLEX100 Dr. Noam Emanuel Polypid Founder & CSO
Slide 36: We Imagine a World Without the Fear of SSIs…
We Imagine a World Without the Fear of SSIs… We believe that intraoperative use of D-PLEX100 can have a profound change in the way we operate and treat patients • Change the prophylactic Standard of Care, e.g., eliminate/reduce post - and even pre-surgery prophylactic antibiotics • Change the way we
Slide 37: Milestones for the Next Months
Milestones for the Next 12 Months Q4 ‘20 Q1 ‘21 Q2 ‘21 Q3 ‘21 Q4 ‘21 Breakthrough designation SHIELD 1 – 1st Soft Tissue Ph III trial Topline D-PLEX100 Blinded sample Open abdominal, 616 – 900 pts, 60 centers size re-estimation results SHIELD 2 - 2nd Soft Tissue Ph III trial Open abdominal and MIS,
Slide 38: Q&A
Q&A
Slide 39: PolyPid
POLY PID OPTIMIZED THERAPEUTICS