DuraSealTM

Dural Sealant System

PMA P040034

DuraSealTM

Dural Sealant System

PMA P040034

PresentersPresentersEric Ankerud, J.D. – Confluent Surgical, Inc.

Vice President, Clinical, Regulatory, and Quality

Patrick Campbell, Ph.D. – Confluent Surgical, Inc.

Vice President, Research & Development

John Tew, M.D. – Mayfield Clinic

Professor, Department of Neurosurgery, University of Cincinnati

G. Rees Cosgrove, M.D. – Massachusetts General Hospital

Associate Professor of Surgery, Harvard Medical School

Harry van Loveren, M.D. –Tampa General Hospital

Professor and Chairman, Director of Skull Base and Cerebrovascular Surgery, University of South Florida

Presentation OverviewPresentation Overview

Project Overview – Eric Ankerud, J.D.

Technology Overview – Pat Campbell, Ph.D.

Project Rationale – John Tew, M.D.

US Pivotal Trial Results – G. Rees Cosgrove, M.D.

Safety Evaluation – Harry van Loveren, M.D.

Company OverviewCompany Overview

Mission: Development of in-situ polymerized biomaterials to address the unmet needs of surgical wound healing including surgical tissue sealing, post surgical adhesion prevention, and hemostasis

Founded: 1998

People: 30 employees

Facility: Waltham, Massachusetts

Products: Commercially available OUS

DuraSeal Dural Sealant SystemDuraSeal Dural Sealant System

Thumb piece

Syringes (2)

SprayerComponents

Powder Vial

Pre-Clinical SummaryPre-Clinical SummaryDuraSeal is non-toxic and safe, up to 40X human dose

DuraSeal is not neurotoxic, and allows complete neodura formation

Intraoperative and postoperative sealing efficacy demonstrated in relevant canine model

Ability to image DuraSeal has been demonstrated, and has complete absorption over 8 weeks

Achieving “water tight” closure is basic tenet of neurosurgical practice

Controlling intraoperative leakage is important to prevent CSF leakage and development of postoperative complications:

Suture pinholes and space between sutures act as “one-way” valve for CSF leakage

Subdural collections of CSF fluid may develop into pseudomeningoceles and overt incisional leaks with potential for serious post-operative sequelae

“Water Tight” Closure Remains Elusive“Water Tight” Closure Remains Elusive

Meningitis – may lead to delayed neurologic complicationsProlonged hospitalization and increased patient cost Interference with wound healing (dehiscence)Abscess formationAdditional surgical intervention often required

CSF Leak Causes Postoperative Morbidity

CSF Leak Causes Postoperative Morbidity

Methods For Sealing Sutured Dural ClosureMethods For Sealing Sutured Dural Closure

Current MethodsFDA-Approved Devices Products Used Off Label

None NO STANDARD OF CAREFibrin Sealant (e.g. Tisseel)

Absorbable gelatin (e.g. Gelfoam)Collagen hemostatic agents (e.g.

Surgicel)Other bioadhesives (e.g. BioGlue)

To evaluate the safety and effectiveness of the DuraSeal Dural Sealant System as an adjunct to sutured dural repair during cranial surgery to provide watertight closure

US Pivotal Study ObjectiveUS Pivotal Study Objective

ProspectiveMulti-centerNon-randomized, single arm study11 participating sites

10 United States 1 Europe

Study DesignStudy Design

Follow-up ComplianceFollow-up CompliancePatients Enrolled

n=132

Intra-operativeScreen Failures

n=21

Patients Treated with DuraSealn=111

Immediate Post-operative Visit

(within 7 days of surgery)n=111

100% of patients evaluated

Patient Deathn=1 at 27 days

Post-op

6 Week Visitn=110

99% of patients evaluated

Patient Deathn=1 at 85 days

Post-op

3 Month Visitn=107

98% of patients evaluated

Lost toFollow-up

n=2

Primary Efficacy Analysis-Intraoperative Sealing Success

Primary Efficacy Analysis-Intraoperative Sealing Success

Analysis ResultsIntent To Treat*(includes 2 non-evaluable patients)

98.2% (109*/111)

[95% CI: 93.6-99.8]

Per Protocol(includes all evaluable patients)

100% (109/109) [95% CI: 96.7-100]

* Two patients had no leak after Valsalva maneuver, but pressure reached was only to 10 cm H2O and, therefore, were not evaluable

SummarySummary

Primary efficacy endpoint was met

Adverse events consistent in nature, frequency and severity for patients undergoing cranial surgery

ConclusionConclusion

In the patient population evaluated, the benefits

associated with the use of the DuraSeal Sealant outweigh any potential risks associated with

the use of the device