Md flux dx4 week 10
 

Md flux dx4 week 10

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  • Changed color of MDflux <br />
  • Physician Consults Nutritionist, Orders Tests <br />
  • Physician Consults Nutritionist, Orders Tests <br /> Next Channel: Instrument Manufacturer, FDA-IVD, indications for use <br />
  • Simplify <br />
  • From week 6 ppt <br />
  • From week 6 ppt <br />
  • RAMIN <br />
  • Wanted to, but couldn’t change color of Mdflux under the hospital. <br />
  • Simplfy <br />

Md flux dx4 week 10 Md flux dx4 week 10 Presentation Transcript

  • 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
  • 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
  • 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
  • Product Market Fit – What we Thought Traumatic Brain Injury (TBI) Neurologist
  • 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
  • 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 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
  • 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
  • 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
  • Overfed Nourished 6 Demo Starvation
  • 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.
  • Appendix
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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)