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Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

Mar 26, 2015

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Blake Ross
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Page 1: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.
Page 2: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

• 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

Page 3: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

Proprietary "Reversible" Hydrogel Technology

Confluent Hydrogel Technology

Page 4: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 5: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

• 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

Page 6: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

• 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

Page 7: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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$$

Page 8: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 9: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

DuraSeal – Mechanism of Action

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

• High cohesive strength

• Biomimetic elasticity

Page 10: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

DuraSeal – Mechanism of Action

Post operative attributes:• Separates dura from the

bone flap preserving the tissue plane

• May facilitate subsequent re-operation

Page 11: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

DuraSeal – Mechanism of Action

Biocompatible absorption:• Water soluble linkages

hydrolyze over # weeks

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

Page 12: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 13: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

*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

Page 14: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

DuraSeal - MicroMyst Applicator

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

transsphenoidal procedures

Page 15: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

Durotomy Sealant application

“Zero Swelling” Version of DuraSeal

DuraSeal Spine Sealing

Page 16: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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$

Page 17: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

Product Pipeline

Page 18: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

Time

Ove

rall

Mar

ket

Op

po

rtu

nit

y S

ize

Product Roadmap and Strategy

Page 19: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 20: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

• 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

Page 21: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 22: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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)

Page 23: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

2005 Revenue by MonthYear End Totals

To

tal S

ales

Month

DuraSealUS Launch

Page 24: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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)

Page 25: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

• 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

Page 26: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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$$

Page 27: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.

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

Page 28: Platform technology of in situ polymerized biomaterials and delivery devices Targeting large potential markets in biosurgery, specifically: Adhesion Barriers.