Monitored & Fueled by MDflux

Inspired by Science, Driven to Improve Patient Outcomes

Team Dx4 # of interviews: 6+8/82

George Brooks | Christine Chu | Mike Horning | Robert Lee | Collin Williams

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. 

ICUS lack accurate diagnostics to assess a patient’s nutritional state?

Here’s the Overlooked Problem

Overfed

Nourished

Starvation

Today’s Hospitalization Standard of Care

Standard of Hospital CareOur study shows near starvation state as maintained by standard of care for Traumatic Brain Injured Patients

Allowing for a body energy state supportive of healing and improved patient outcomes

Makes Diagnosis Possible Overfed

Nourished

Starvation

Actionable events with products already available

Traumatic Brain Injury

(TBI)

Product Market Fit – What we Thought

Neurologist

TBI

Etc….

OncologySurgeries

Short Gut

Preterm Infants

Product Market Fit – What we learned

Dietician

• Dietitians work across specialties• Dietitians will find Indications for Use• Dietitian will create demand for our products

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

“This could replace the finger prick glucose test”Dr. Neil MartinChair of Neurosurgery at Ronald Reagan UCLA Medical Center

“You have to do this!”Susan MooreDirector of Strategy and Business Development, Children's Hospital & Research Center Oakland

“Nutrition is the ticket out of there.”Dr. Elizabeth Thilo, M.D.Clinical Neonatologist, University of Colorado, Denver 10/28/13Referring to premies leaving the NICU

PathologistLDT

Submits code:CPT 82544

Current Channel: In-Hospital LDT

Hospital Reimbursement

CMS / InsuranceUsing inpatient

DRG code

$185per test

*LDT = Laboratory Developed Test

Sales & Marketing

Dietitian & Physician order

test

What We Learned - Where to Start

Future Strategic Partnership

ReimbursementCMS / Insurance

Using New CPT/DRG Code

PathologistSubmits

UsingNew MDflux

Code

Sales & MarketScale CPT 82544

ResourcesAssistance with

Regulatory Approvals

What We Learned – Way Forward

$TBD

Overfed

Nourished

Starvation

6 Demo

What We Learned

1. Dietitian key stakeholder2. Indication for use in neonatal care3. Partnering with a multi-

national partner to scale and achieve FDA and international approvals.

Appendix

1. 14 TBI patients & 6 Controls, dual tracer Completed

Two JCI articles currently under review

2. 40 TBI patients, dual tracerConfirms the results of (1)

Will submit multiple publications

3. Started trial for TBI with single tracer plus Alternative FuelsDiscussing Surgery Application

Ongoing contract discussions and future publications

5. Pursuing Neonatologist KOL for Preterm Infant Care Application

4. Ongoing animal studies and research & development, Rutgers Univ.

Clinical Trials – UCLA & Others

Pricing Based on CPT Code 82544

What We Learned from the Course

Net Sales (at $150 or $200 per)Gross Margin at ~ 63% of Net SalesOperating Margin ~ 50% of Gross Margin

(Depending on R&D expense and co-marketing expenses).

EBITDA at 17-33% of Total (Depending on Operational Expenses)

• Equals all US hospital patients• 36M US inpatient hospitalizations per year• Average length of stay equals 5 days• Assuming $250 per patient yields $9B TAM

Total Addressable Market (TAM)

•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

Target Market

What We Learned from the Course

$ = The power to do good

Pro

duct

Lau

nch

2012

Clin

ical

M

ilest

ones

Start

Mile

ston

esR

egul

ator

y/ IP

M

ilest

ones

Q1 Q2 Q3 Q4

2013Q1 Q2 Q3 Q4

2014Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2015 2016

SystemSystem

2017Q1 Q2Q1 Q2 Q3 Q4

2018Q3

17 12/4/2009

Proof of Concept

Provisional Patent

Minimal Viable Product

Laboratory Prototype

Strategy

Continue Pilot Studies

FDA Submission & Clearance Post market activities

PUBS

SafetyTrials

PivotalTrials

Timeline

What we Learned Financial / Operations

$10M

$15M

Cas

h R

eser

ve

$5M

$20M Self funding Seed funding Series A funding Series B funding

8 US Patents & PCT counterpart

PUBS

CLIALDT

Pre-IDE IVD- Partnership PMA submission & approval

HospitalHospital pays MDflux based on procedure-specific CPT codeCPT 82544 =$185

Company Reimbursement

CMS & Private InsuranceCMS/Insurance pays the hospital based on condition-specific DRGActual $ amount varies by hospital

$185% of total per test

CONFIRM Source: FDA.gov

Pursuing pre-market approval (PMA) by:FDA Office of In Vitro Diagnostics (IVD) and Radiological Health (OIR)

Pathway through FDA RegulationsPre-Market Approval