platform technology of in situ polymerized biomaterials and delivery devices targeting large...
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• 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
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Proprietary "Reversible" Hydrogel Technology
Confluent Hydrogel Technology
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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
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• 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
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• 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
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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$$
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DuraSeal – Mechanism of Action
Intended Use:• Duraseal is intended for
use as an adjunct to sutured cranial dural repair to provide watertight closure.
When applied, DuraSeal:
• Rapidly diffuses into tissue crevices and crosslinks
• Interlocks within tissue crevices resulting in excellent tissue adherence
• Blue colorant allows for visualization of gel coverage and thickness
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DuraSeal – Mechanism of Action
DuraSeal can withstand elevated CSF pressures due to:• Strong tissue adherence
• High cohesive strength
• Biomimetic elasticity
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DuraSeal – Mechanism of Action
Post operative attributes:• Separates dura from the
bone flap preserving the tissue plane
• May facilitate subsequent re-operation
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DuraSeal – Mechanism of Action
Biocompatible absorption:• Water soluble linkages
hydrolyze over # weeks
• Water soluble PEG molecules are liberated and cleared via the kidneys
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DuraSeal – Mechanism of Action
DuraSeal Benefits for cranial surgeries:• Creates an immediate
watertight seal
• Blue colorant allows for visualization of gel coverage and thickness
• Reduces postoperative CSF leaks
• Safely absorbs after the body has naturally healed
• Easily prepared in # minutes
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*Expected rate of postoperative CSF leakage is about ##% and cost of a single CSF leak is estimated to be around $$$
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
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DuraSeal - MicroMyst Applicator
• Cleared in U.S.• CE Mark in EU• For use in Spine and
transsphenoidal procedures
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Durotomy Sealant application
“Zero Swelling” Version of DuraSeal
DuraSeal Spine Sealing
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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$
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Product Pipeline
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Time
Ove
rall
Mar
ket
Op
po
rtu
nit
y S
ize
Product Roadmap and Strategy
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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
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• 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
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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
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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)
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2005 Revenue by MonthYear End Totals
To
tal S
ales
Month
DuraSealUS Launch
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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)
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• 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
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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$$
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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
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