Driving the Medical Device Industry

Driving the Medical Device Industry

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Description: Around ½ of our Colorado Bioscience companies are Medical Device companies. Medical Device companies are favorably viewed by investors, even in today’s economy. Shorter, more predictable R&D cycle times.

More predictable therapeutic outcomes. Typically shorter, more predictable regulatory approval. Margins – depends on the device.

Can be 80% GM for high risk, life-support implantable devices (like heart valves). Also discussed: A New Paradigm for the Treatment of Heart Valve Disease.

Author: Larry Blankenship (Fellow) | Visits: 3039 | Page Views: 3050
Domain:  Medicine Category: Equipment Subcategory: Cardiology 
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Bioscience Business B i Roundtable

Larry Blankenship Chairman & CEO

Two Words o o ds

Medical Devices
�2009 ValveXchange, Inc. August 2009 2



Around � of our Colorado Bioscience companies are Medical Device companies Medical Device companies are favorably viewed by investors even in today s economy investors, today's

� Shorter, more predictable R&D cycle times � More predictable therapeutic outcomes � Typically shorter, more predictable regulatory approval � Margins? � depends on the device.
� Can be 80% GM for high risk, life-support implantable devices (like heart valves).
�2009 ValveXchange, Inc. August 2009 3

The Key to Success: Innovation


But innovation of what? What's the key to a good marriage? CHOOSING WISELY! "The secret to successful invention is g knowing what to invent"

- - Bill Bailey, IVAC Corporation, 1978

�2009 ValveXchange, Inc.

August 2009


Formulate an Innovation Strategy INNOVATING FOR IMPACT


1. Choose the right product

� "Who cares?!"

� Does it remove warts or does it save lives? �K Know your industry segment: Is it fundable? i d I i f d bl ?

2. Choose the right partners

� Advisors and Directors should be a "who's who" list � Team should be the best at what they do � Investors are partners ( after the money's gone ) (...after money s gone...) � One the will foster innovation and success
August 2009 5

3. Choose the right place

�2009 ValveXchange, Inc.

Why Colorado for Medical Devices?


Computer hardware companies Software companies Aerospace companies Medical research Animal testing Other bioscience companies

Machine shops, plastic molders, prototyping services, engineers Software services, software engineers Advanced test services Advice, counsel, testing Animal labs � CSU, CU, others Regulatory consultants, savvy employee base

Few other places have such an infrastructure And nowhere else is COLORADO!
�2009 ValveXchange, Inc. August 2009 6

A New Paradigm for the Treatment of Heart Valve Disease
Larry Blankenship Chairman & CEO 303-648-4077 lblankenship@valvexchange.com lblankenship@valvexchange com

Patients Face A Difficult Choice
Mechanical Heart Valves:

Will last the patient's lifetime But requires lifetime anticoagulation forcing sedentary lifestyle with significant side effects

Tissue Heart Valves:

No long term anticoagulants g g Full & active lifestyle But requires open-heart surgery every 10-15 years q p g y y y Generally offered to older patients
August 2009 8

�2009 ValveXchange, Inc.


The ValveXchange VitalityTM Valve Vitality

Rapidly exchangeable

Tissue Leaflet Set

Permanent surgically implanted

Docking Station,

�2009 ValveXchange, Inc.

August 2009


The ValveXchange Procedure
Minimally Invasive � Small incision in the ribcage

�2009 ValveXchange, Inc.

August 2009


Product Advantages


� Full active lifestyle (no anticoagulant) � MIS leaflet exchanges � No repeat open-heart surgeries


� Faster, less demanding implant � Much faster, easier replacement


� Significant lifetime reduction in costs �
�2009 ValveXchange, Inc.

from implant through every exchange No ER visits from anticoagulants

August 2009


A $1.2 Billion/Yr Growing Market g
>350,000 Heart Valve Procedures Worldwide in 2007

Aortic USA CAGR 2007� 2012 7.8% by value 7.0% by volume y
(Frost & Sullivan)

Source: C d Suisse S Credit S

Aortic Implants (000's)
�2009 ValveXchange, Inc. August 2009 12


Larry Blankenship � Chairman & CEO � Over 30 years experience: Serial medical device entrepreneur � Multiple successful VC funding rounds and M&A exits � Assisted St. Jude Medical to develop, qualify and launch #1 selling
valve in 1995

Ivan Vesely, PhD � Founder, CSO � 25 years experience: Heart Valve research and design � F d d world's best funded Heart V l Lab at Cleveland Clinic Founded ld' b t f d d H t Valve L b t Cl l d Cli i Todd Campbell � Manufacturing � Over 30 years experience in heart valves & tissue implants y p p � R&D, Engineering, Manufacturing, Quality Assurance � Edwards, St. Jude Medical, Medtronic

�2009 ValveXchange, Inc.

August 2009


Medical Advisors
Joseph Sabik, MD � Chairman of the VXi
Medical Advisory Board, Chief of Cardiac Surgery, The Cleveland Clinic Toronto General Hospital, inventor of the "David Methods" for aortic root reconstruction

Michael Mack, MD � Director,
Cardiothoracic surgery, Baylor; Chairman, The Heart Hospital, Baylor; President Elect, Society B l P id t El t S i t of Thoracic Surgeons

Tirone David, MD � Chief of Cardiac Surgery,

Antonio Calafiore, MD �

W. Randolph Chitwood, MD - Chief of

Surgery, East Carolina Heart Institute; Ex-President of the STS, inventor of the "Chitwood techniques" for minimally invasive and robotic heart surgery - Vice Chair of Medicine, Baylor; author AHA Valvular Disease guidelines; former President, Society for Heart Valve Disease Chief of Cardiac Surgery, The Christiana Healthcare System

Chief of the Prince Sultan Cardiac Center, Riyadh, Saudi Arabia; Former Chief of Cardiac Surgery at the Univ. of Chieti, Italy and Univ. of Catania, Italy

Blase Carabello, MD

Gerard Guiraudon, MD
Special Advisor for Minimally Invasive Surgical Techniques Pioneer in cardiac surgery, inventor of the Guiraudon Universal Cardiac Introducer (GUCI)
August 2009 14

Michael B b Mi h l Banbury, MD -

Richard "Pat" Cochran, MD � Director,

Cardio vascular Cardio-vascular and Thoracic Surgery, Maui Surgery Memorial Medical Center, former Chair of Cardiac Surgery, University of Wisconsin

�2009 ValveXchange, Inc.


�2009 ValveXchange, Inc.

August 2009



Disruptive technology, for the majority of the $1.2B/yr $1 2B/yr growing heart valve market Animal testing underway, concept proven Predictable regulatory pathway Reachable market (3 000 Drs in