platform technology of in situ polymerized biomaterials and delivery devices targeting large...

• Platform technology of “in situ polymerized” biomaterials and delivery devices

• Targeting large potential markets in biosurgery, specifically:

Adhesion Barriers and Sealants

• First to market products

• Products commercially available

• Initial targets in Neuro/Spine and broad applicability beyond initial targets

Confluent’s vision is to be the leading developer of products for unmet needs associated with surgical sealing and adhesion prevention

Confluent’s vision is to be the leading developer of products for unmet needs associated with surgical sealing and adhesion prevention

Company Overview

Proprietary "Reversible" Hydrogel Technology

Confluent Hydrogel Technology

Technology• Synthetic origin, very biocompatible• Strong tissue adherence• Products stored at room temperature• Quick polymerization• Ideal for minimally invasive surgery applications• Strong IP and barrier to entry

Business Model• No separate reimbursement typically needed for products• Leverages outsourcing• High margins• Minimal capital investment• Easily scaled

Confluent’s Differentiation

• Neuro and Spine SurgeryCSF leaks can lead to neural compression, postural headaches, infection, meningitis, and death

• Vascular, Cardiac, and Orthopedic SurgeryBleeding can prolong surgery, transfusions create risk of disease transmission

• Thoracic and General SurgeryProlonged hospital stays, risk of infection, and morbidity

The Need for Surgical Sealing

• GynecologicalInfertility and pelvic pain due to adhesions

• General SurgeryBowel obstruction, pain, complicated re-operations

• Spine Surgery Failed back syndrome, re-do surgery may result in dural tears

• Cardiac SurgeryComplicated re-do surgery, danger of myocardial incision

The Need for Adhesion Prevention

DuraSeal Surgical Sealant Target Market

Large need for surgical sealants (neuro, spine, general, vascular, thoracic, and plastic)

$$ initial target opportunity for Confluent

DuraSeal will be first dural sealant in U.S.

Additional markets can be accessed with technology platform

Cardiac$$

Vascular$$ Thoracic

$$

Neuro$$

DuraSeal – Mechanism of Action

Intended Use:• Duraseal is intended for

use as an adjunct to sutured cranial dural repair to provide watertight closure.

When applied, DuraSeal:

• Rapidly diffuses into tissue crevices and crosslinks

• Interlocks within tissue crevices resulting in excellent tissue adherence

• Blue colorant allows for visualization of gel coverage and thickness

DuraSeal – Mechanism of Action

DuraSeal can withstand elevated CSF pressures due to:• Strong tissue adherence

• High cohesive strength

• Biomimetic elasticity

DuraSeal – Mechanism of Action

Post operative attributes:• Separates dura from the

bone flap preserving the tissue plane

• May facilitate subsequent re-operation

DuraSeal – Mechanism of Action

Biocompatible absorption:• Water soluble linkages

hydrolyze over # weeks

• Water soluble PEG molecules are liberated and cleared via the kidneys

DuraSeal – Mechanism of Action

DuraSeal Benefits for cranial surgeries:• Creates an immediate

watertight seal

• Blue colorant allows for visualization of gel coverage and thickness

• Reduces postoperative CSF leaks

• Safely absorbs after the body has naturally healed

• Easily prepared in # minutes

*Expected rate of postoperative CSF leakage is about ##% and cost of a single CSF leak is estimated to be around $$$

DuraSeal - Clinical Data*

Pilot Study (Reference)

• Single arm study in patients for intradural cranial and spinal procedures

• 100% intraoperative sealing of the dura was observed

• ##% post-operative leak rate and ##% pseudomeningocele rate observed

Pivotal Study (Reference)

• Single arm study in ## patients for intradural cranial procedures

• ##% intraoperative sealing of the dura was observed

• #% post-operative leak rate and #% pseudomeningocele rate observed

DuraSeal - MicroMyst Applicator

• Cleared in U.S.• CE Mark in EU• For use in Spine and

transsphenoidal procedures

Durotomy Sealant application

“Zero Swelling” Version of DuraSeal

DuraSeal Spine Sealing

Status• OUS: CE Mark• US: Clinical trials

Large clinical need for post-surgical adhesion prevention (gynecological, abdominal and pelvic surgery)

Initial target opportunity for Confluent

SprayGel is the world’s first sprayable local adhesion barrier

Pilot trial in Gynecology has shown 70% reduction in incidence and extent of adhesions

Trial in General Surgery underway and pivotal trial in Laparoscopy planned

SprayGel Adhesion Barrier

SprayGel Air-assisted Applicator

Worldwide Adhesion Barrier Market

Abdominal$

Gynecologic$

Product Pipeline

Time

Ove

rall

Mar

ket

Op

po

rtu

nit

y S

ize

Product Roadmap and Strategy

DuraSeal - Drug Delivery

Controlled release demonstrated with:• Antibiotics• Analgesics• Antiproliferatives• Anti-inflammatories

% A

nalg

esic

Rel

ease

d

% A

ntib

iotic

Re

leas

ed

Days at 37°CDays at 37°C

• 13 issued patents• Additional 12 patents pending• Broad coverage of fundamentals

▫ Creates substantial barrier-to-entry▫ Composition of matter, method of use, delivery device

technology

Intellectual Property Position

DuraSeal – None for craniotomy. Other indications include: Cryolife and Baxter

Preparation Time

Competitive Environment

Strength

CoSeal DuraSeal HemaSeel

Bur

st (

amou

nt /

amou

nt)

HemaSeel

CoSeal

DuraSeal

Time

Financial Overview

Products commercially available

Exceeded forecast this past year 25%

Profitability expected bylate year

Year Year Year Year(Expected)

Year(Expected)

Planned / Actual

Rev

enu

e

Year(Expected)

2005 Revenue by MonthYear End Totals

To

tal S

ales

Month

DuraSealUS Launch

Management Team

• Amar Sawhney (Co-founder and CEO)

• Jim Fortune (COO)24 years experience (17 with JNJ in orthopedic, neurosurgical businesses)

• Eric Ankerud (VP Clinical, Regulatory, Quality)23 years experience▫ Headed regulatory at Boston Scientific, Summit, CR Bard

• Patrick Campbell (VP R&D)22 years experience (ACS, Focal)

• Fred Khosravi (Co-founder and Chairman)Co-Founder and President, Access Closure (current), Embolic Protection, Inc., EndoTex, Inc.

• Sandra PanemPartner, Cross Atlantic Partners

• Mark WanFounding Partner, Three Arch Partners

• Martin SutterManaging Director, Essex Woodlands

• William TidmoreFormer President, Chairman Acromed

• Charles WardenVersant Ventures

Board of Directors

DuraSeal : Broad applicability and dual benefit

Sealant > Cranial, Spine, Vascular, ThoracicAdhesion Barrier > Cranial, Spine, Cardiac

Significant revenue opportunity

Market Opportunity

Spine$$

Neuro$$

Thoracic$$

Vascular$$

Cardiac$$

Confluent’s Products: Addressing Emerging Trends in Surgery

• Enable Minimally Invasive Surgery

• Provide multiple benefits: sealing, faster surgery, easier re-operations, decreased pain etc…

• Favorable Healthcare Economics▫ Decrease LOS▫ Improve Outcomes by reducing post-op complications

• Significant new products in emerging fields of “Biosurgery” and “Orthobiologics”

• Ideally suited for “combination products” that include added bioactive agents