1. Healthcare Innovation & Commercialization October 8th 2014
Getting a Company off the Ground

2. My Story… Currently CEO of SevenOaks Biosystems previously..
Co-Founded with Dr Rox Anderson (MGH/HMS)
previously..
Immunology undergrad, life sciences investment banker ( )
Harvard-MIT Biomedical Enterprise Program ( )
Started MoMelan Technologies with Dr Rox Anderson (Professor of Dermatology, HMS) in June 2009
Raised $5m in Venture Capital, acquired in Nov 2012
MoMelan - 1st Venture-backed company
Novel enabling medical device technology for automated epidermal expansion and transplant
1 full-time employee, 1 Rockstar scientific founder, 4 board-members, 4 inactive founders, 5 consultants

3. General points about start-ups & people
When starting out, keep it lean
Business vs Science Project
Capital efficiency is key
Impact on fundraising
Companies are continuously evolving at the beginning

4. Starting a company – key stakeholders
‘Working’ Scientists
Entrepreneur
‘Rockstar’ scientist
Stakeholder can be one, or more of each
Different motivations and desired outcomes
Advisors

5. Motivation - Points to consider
Assess risk profiles and weigh against contributions
Rockstar scientist is probably going to bring in the $$
The ‘Entrepreneur’ (could be MBA, post-doc leaving to join company, etc) bears significant risk
Scientists remaining in their job – less risk but should be compensated for job well-done
Advisors – low risk profile but can be critical to success
Stock is your primary currency
Utilize vesting
How to break up the pie…
Without

6. People, Evolution & Hiring
Companies evolve quickly…
Sometimes month to month - Rapidly changing
For Example…
First 12 months
Early science
‘Rangefinding work’
Next 12 Months
Critical path science
Company-building
Be mindful of personalities
Passion
Negotiate in good faith – be honest about aims and expectations
Use Consultants
Hire – internalize talent

7. People, Evolution & Firing
Obvious reasons to fire someone
Fraud
Assault
Corporate espionage
Less obvious reasons to fire someone
Companys needs change
Not as good as you thought they were
Consultants with expectations
You are attracting higher-quality talent
Be honest, set aims and expectations, and don’t sugar coat bad news

8. Back to breaking up the pie
Deciding how to break-up equity can lead to..

9. Class Exercise Break up into groups of 5
Quickly choose a ‘company name’
Allocate roles
1 rockstar scientist
1 Entrepreneur type
3 post-doc types
1 is leaving to join the company
2 are staying

10. Class Exercise Scenario
Your Rockstar scientist has invented a new medical device
3 of his post-docs have been working on this technology for 2 years as part of their job
1 post-doc is leaving to head the scientific effort at the company, the other two are remaining in the lab
Your Rockstar has found an ‘MBA type’ to spearhead the business effort
10 Minutes to decide how much each person gets!

11. MoMelan Technologies
The Company
MoMelan Technologies developed EpigraftTM (now called CellutomeTM)
Technology invented at the Wellman Center for Medicine, MGH, licensed from Partners Healthcare
Scientific Founder is R.Rox Anderson, MD – Professor of Dermatology, Harvard Medical School
Sameer Sabir – Co-Founder (& Student of Prof. Anderson)
designed to make epidermal skin grafting minimally invasive, simple and automated
Started the company with a concept, raised 2 rounds of investment capital, developed a commercial product, ran some clinical trials, cleared the FDA and sold the company….all in 2.5 years

12. 2012 2011 2010 2009 Timeline File with FDA – September
ACQUIRED by KCI, Inc - November
2010
Series A Financing 0f $3.6m – June
First patient treated – November
Awarded $750k MA state award
2009
Could have all the years visible at the outset and only have the bullets dissolve on. – RD
Try that as alternative for consideration.
That’s basically RD
First financing of $1.1m – March
First prototype complete – October
Co-Founded MoMelan with Prof Rox Anderson - Sept

14. MoMelan Technologies - Overview
The Company
MoMelan Technologies is developing EpigraftTM
unique medical device platform that enables optimized mechanical autologous epidermal transplant
designed to make epidermal skin grafting minimally invasive, simple and automated
Point of care, few meaningful competitive approaches
$1.1m Seed round in February 2010
$750k Massachusetts Award
Simple & Rapid Regulatory Pathway
FDA 510k class 1 – exempt from pre- market notification
The opportunity
Large potential market applications for unmet needs
Wound-Healing, including complicated wounds ($3bn)
Synergies with existing wound- dressings, NPWT
Dermatology, including Medical ($500m) and Aesthetic ($820m)
Attractive economic dynamics
85%+ projected gross margins
Reimbursement
Patient pay or existing reimbursement, depending on application
Office or outpatient procedure
<1 hour procedure time in total

15. Vice President of Market Development
The Momelan Team
Management
Sameer A Sabir
Chief Executive Officer
10 years experience in life sciences
JPMorgan, Commerzbank Securities,
Cinnabar Consulting
Robert LaRoche
Vice President of Market Development
26 years experience in medical device sales and marketing
CR Bard, Cambridge Heart, Candela
Andrew Ziegler
Lead Engineer
25 years experience in mechanical engineering design and prototyping
Design Continuum, iRobot
Jeff Cerier
Project Manager
30 years experience in device project management
Co-Founder, TDC
Board of Directors
Review blurbs
Robert Forrester
(Chairman) – COO, Verastem
Sameer A Sabir
Chief Executive Officer, MoMelan Technologies
Sridhar Prathikanti
Member, Life Science Angels
Josh Tolkoff
Managing Director, Ironwood Equity
Bill McCullen
General Partner, Launch Capital

16. The Momelan Team – Scientific Advisory Board
Professor Rox Anderson, MD
Professor of Dermatology, Harvard Medical School
Director, Wellman Center for Photomedicine
Massachusetts General Hospital
Boston, MA
Roy Geronemus MD
Director, Laser & Skin Surgery Center of New York
Clinical Professor of Dermatology
New York University Medical Center
New York, NY 
Rebat Halder MD
Professor and Chairman
Department of Dermatology
Howard University College of Medicine
Washington, D.C. 
David Armstrong DPM, MD, PhD
Professor of Surgery and Director
Southern Arizona Limb Salvage Alliance (SALSA)
University of Arizona College of Medicine
Tucson, AZ
Thomas Serena MD, FACS
Co-Founder & CEO, Serena Group
Vice-President, American College for Hyperbaric Medicine

17. Meeting a Significant Need
Problem
Innovation
Solution
Epidermal skin grafting is effective for many skin disorders, but is rarely utilized
-imprecise
-inefficient
-invasive
MoMelan’s automated device can precisely and reproducibly generate an optimized epidermal skin graft
A fast, minimally invasive, cost-effective solution for repigmentation & wound healing
Enabling epidermal skin grafting
Minimally Invasive
Repeatable & Reliable
Biomechanically Precise

18. EpiGraftTM – How it Works

19. Large US Market Opportunities
Medical Dermatology ($500 million)
Vitiligo (3-6m pts)
Skin cancer wound repair (800k cases/yr)
Aesthetic Dermatology ($820 million)
Post Laser Treatment Hypopigmentation (500k cases/yr)
Scar Revision – Including hypopigmented scars (1.6 M cosmetic surgeries/yr)
Wound Care ($2-3 billion)
Diabetic foot and venous leg ulcers (3.4m cases/yr)
Pressure sores (1.9m/yr)
Burns & Trauma (600k cases/yr)
Perfect as is

20. Low Regulatory Hurdle – Class 1 FDA Device
Product
Concept
Prototype
Clinical Testing
Notification
Path
Autologous tissue
Purely Mechanical
No Chemicals, Biologics, Enzymes
“Non-Significant Risk” Designation by multiple IRBs for case studies
No IDE from the FDA Required
Conclusion is That Device is FDA Class 1
Predicate: Electric Skin-Graft Mesher
Needs Only General Quality Controls, Not Marketing Release by FDA
MoMelan does not need FDA 510K Concurrence before selling a Class 1 Device

21. Financial Incentive to Adopt EpiGraftTM System
Differentiated disposables will separate self-pay/out of pocket markets
Patient Insured
For acute and chronic wounds
Existing epidermal grafting CPT codes
Facility fee where applicable
Patient Pay Out of Pocket
For aesthetic applications
Vitiligo, hypopigmentation, scar revision
Patients willing to pay to look better
Physician
Gross Profit
EpiGraft Disposable Price
In Office
EpiGraft Disposable Price
Physician
Gross Profit
EpiGraft Disposable Price
Physician Fee/Gross Profit
In Facility
$145
$200
Facility Fee
Gross Profit

22. Intellectual Property
Exclusive Worldwide License to MGH IP & 9 additional ‘MoMelan’ patent applications
Device Patents
4 Patent Applications
Protects key features of EpiGraft Device
Method Patents
4 Patent Applications
Protects key processes encompassed in EpiGraft Approach
BARRIER TO ENTRY
Broad series of 10 commercially relevant patent applications
Design
1 Patent Applications
Protects key design features including interface between control unit and disposable
Manufacturing Patents
1 Patent Application
Protects key disposable production process

23. Class Exercise Break up into groups of 5
Quickly choose a ‘company name’
Allocate roles
1 rockstar scientist
1 Entrepreneur type
3 post-doc types
1 is leaving to join the company
2 are staying

24. Class Exercise Scenario
Your Rockstar scientist has invented a new medical device
3 of his post-docs have been working on this technology for 2 years as part of their job
1 post-doc is leaving to head the scientific effort at the company, the other two are remaining in the lab
Your Rockstar has found an ‘MBA type’ to spearhead the business effort
10 Minutes to decide how much each person gets!

25. Find your niche, find what you are good at, and focus on that
Find your niche, find what you are good at, and focus on that. And be a good person along the way - if you try to take shortcuts it will just come back and haunt you…
Thomas Flohr
Aviation Entrepreneur