1. Inspired by Science, Driven to Improve Patient Outcomes
Monitored & Fueled by MDflux
Our innovative nutritional diagnostic allows
dietitians and physicians to provide precise
nutritional support to patients, resulting in
faster recovery from injury and critical
illness, and reduced hospital stay.
Team Dx4
# of interviews: 6+8/82
George Brooks | Christine Chu | Mike Horning | Robert Lee | Collin Williams

2. Today’s Hospitalization Standard of
Care
Overfed
?
Here’s the Overlooked Problem
Nourished
ICUS lack accurate
diagnostics to
assess a patient’s
nutritional state
Starvation

3. Makes Diagnosis
Overfed
Possible
Allowing for a body energy
state supportive of healing
and improved patient
outcomes
Nourished
Actionable events with products already available
Standard of Hospital Care
Our study shows near starvation state as
maintained by standard of care for
Traumatic Brain Injured Patients
Starvation

5. Product Market Fit – What we
Thought
Traumatic
Brain Injury
(TBI)
Neurologist

6. Product Market Fit – What we
learned
TBI
Preterm
Infants
Dietician
Surgeries
Oncology
Short Gut
Etc….
• Dietitians work across specialties
• Dietitians will find Indications for Use
• Dietitian will create demand for our products

7. Customer Archetype
•Jill Redgate, Critical Dietitian, VA Hospital – West LA
•Certified Clinician – Manages critical care
•Orders nutritional support directly or consults with
physician
“[MDflux] could revolutionize nutrition and change standard of care”
Current Standard of Hospital Care
Time Honored equations based on height/weight/age
Personalized
measurement of
nutritional needs
Actionable
data around
the needs of
each patient
Continuous
monitoring of
progress

8. “This could replace the finger prick
glucose test”
Dr. Neil Martin
Chair of Neurosurgery at Ronald Reagan UCLA Medical Center
“Nutrition is the ticket out of
there.”
Dr. Elizabeth Thilo, M.D.
Clinical Neonatologist, University of Colorado, Denver 10/28/13
Referring to premies leaving the NICU
“You have to do this!”
Susan Moore
Director of Strategy and Business Development,
Children's Hospital & Research Center Oakland

9. What We Learned - Where to Start
Current Channel: In-Hospital
LDT
$185
per test
Hospital
Reimbursement
Sales & Marketing
CMS / Insurance
Using inpatient
DRG code
Dietitian &
Physician order
test
Pathologist
LDT
Submits code:
CPT 82544
*LDT = Laboratory Developed Test

10. What We Learned – Way Forward
Future Strategic
Partnership
$ TBD
Reimbursement
CMS / Insurance
Using New
CPT/DRG Code
Sales & Market
Scale CPT 82544
Pathologist
Submits
Using
New MDflux
Code
Resources
Assistance with
Regulatory
Approvals

11. Overfed
Nourished
6 Demo
Starvation

12. What We Learned
1. Dietitian key stakeholder
2. Indication for use in
neonatal care
3. Partnering with a multinational partner to scale
and achieve FDA and
international approvals.

13. Appendix

14. Clinical Trials – UCLA &
Others
1. 14 TBI patients & 6 Controls, dual tracer
Two JCI articles
Completed
currently under review
2. 40 TBI patients, dual tracer
Confirms the results of (1)
Will submit multiple
publications
3. Started trial for TBI with single tracer
plus Alternative Fuels
Discussing Surgery Application
Ongoing contract
discussions and
future publications
4. Ongoing animal studies and research & development, Rutgers Univ.
5. Pursuing Neonatologist KOL for Preterm Infant Care Application

15. What We Learned from the Course
Pricing Based on CPT Code
82544
Net Sales (at $150 or $200 per)
Gross Margin at ~ 63% of Net Sales
Operating Margin ~ 50% of Gross Margin
(Depending on R&D expense and
co-marketing expenses).
EBITDA at 17-33% of Total
(Depending on Operational Expenses)

16. What We Learned from the Course
Total Addressable Market
• Equals
(TAM) all US hospital patients
•
•
•
36M US inpatient hospitalizations per year
Average length of stay equals 5 days
Assuming $250 per patient yields $9B TAM
Target Market
•ICU cases
•4M cases per year @$250 each = $1B
•Because ICU stays are much more expensive (>$10K per
day) value-based pricing may yield higher revenue
$ = The power to do good

17. What we
Learned Financial /
2012
Operations2013
Q1 Q2
Q3 Q4
Proof of Concept
Q1
Q2
Q3 Q4
Q2
Q3
Q4 Q1
Q2
Q3
Q4
Q1
Q2
FDA Submission & Clearance
Strategy
2018
Q3 Q4
Q1
Q2
Safety
Trials
Pilot Studies
PUBS
CLIA
LDT
Provision
al Patent
Pivotal
Trials
PUBS
Pre-IDE  IVD- Partnership  PMA submission &
approval
8 US Patents &
PCT counterpart
Self funding
Seed funding
Series A funding
Series B funding
$15M
$10M
$5M
Q3
Post market activities
Minimal Viable
Product
Continue
System
$20M
Q1
2017
Product Launch
Laboratory
Prototype
Regulatory/ IP
Milestones
Cash Reserve
Q3 Q4
2016
2015
Timeline
Clinical
Milestones
Milestones
Start
Q1 Q2
2014
17
12/4/2009

20. Company Reimbursement
CMS & Private
Insurance
CMS/Insurance
pays the hospital
based on
condition-specific
DRG
Actual $ amount
varies by hospital
Hospital
Hospital pays
MDflux based on
procedure-specific
CPT code
CPT 82544 =$185
$185
% of total per test

21. Pathway through FDA Regulations
Pre-Market Approval
CONFIRM Source: FDA.gov
Pursuing pre-market approval (PMA) by:
FDA Office of In Vitro Diagnostics (IVD) and Radiological Health (OIR)