DuraSealTM Dural Sealant System PMA P040034

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DuraSealTMDural Sealant System PMA P040034
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Presenters

• Eric 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

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Presentation 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.

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Company 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

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DuraSeal Dural Sealant System
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Pre-Clinical Summary

• DuraSeal 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

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Water Tight Closure Remains Elusive

• 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

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CSF Leak Causes Postoperative Morbidity

• Meningitis may lead to delayed neurologic
  complications
• Prolonged hospitalization and increased patient
  cost
• Interference with wound healing (dehiscence)
• Abscess formation
• Additional surgical intervention often required

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Methods For Sealing Sutured Dural Closure
Current Methods Current Methods
FDA-Approved Devices Products Used Off Label
None
NO STANDARD OF CARE Fibrin Sealant (e.g.
Tisseel) Absorbable gelatin (e.g.
Gelfoam) Collagen hemostatic agents (e.g.
Surgicel) Other bioadhesives (e.g. BioGlue)
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US Pivotal Study Objective

• 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

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Study Design

• Prospective
• Multi-center
• Non-randomized, single arm study
• 11 participating sites
• 10 United States
• 1 Europe

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Follow-up Compliance
Patients Enrolled n132
Intra-operativeScreen Failures n21
Patients Treated with DuraSeal n111
Immediate Post-operative Visit (within 7 days of
surgery) n111 100 of patients evaluated
Patient Death n1 at 27 days Post-op
6 Week Visit n110 99 of patients evaluated
Patient Death n1 at 85 days Post-op
Lost to Follow-up n2
3 Month Visit n107 98 of patients evaluated
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Primary Efficacy Analysis-Intraoperative Sealing
Success
Analysis Results
Intent 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
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Summary

• Primary efficacy endpoint was met
• Adverse events consistent in nature, frequency
  and severity for patients undergoing cranial
  surgery

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Conclusion

• 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