NEOSAFE: An Innovative Diagnostic Devicefor Assessment of Feeding Maturity for Newborns

Nur Benli, MSc.COOnur.benli@kuartismed.com

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Preterms

Births before 37th gestational week

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Early Moderate Late

<32 weeks 32 to 34 wks 34 to 366/7 wks

Premature Birth Rates† 3

11%

6%

12%

9%

8% 6%

15 Million births/year

12%

Premature Birth Rates† 4

1 Million deaths/year

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Feeding Ability = Feeding

Maturity

Suck-swallow-breathe and their coordination

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Feeding Ability = Feeding

Maturity

Suck-swallow-breathe and their coordination

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Same Preterm

@ 32nd wk (PMA)

No Feeding Maturity

@ 39th wk (PMA)

Feeding Maturity

Feeding Ability = Feeding

Maturity

Suck-swallow-breathe and their coordination

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Normal Swallow Pattern Abnormal Swallow Pattern

Lack of Feeding Maturity

Health Problems

Short and Long Term Complications

Prolong Hospitalization

Average Time @ NICU → 10-14 days

↓ the avg. time in the hospital by 3 days, saves $2 Billion in the USA.

Re-Admissions (due to feeding problems)

41% of newborns that are readmitted within 28 days of discharge.

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NeoSAFE 10

Acquire

Bio-Signals

Extract Bio-Events

Compute Temporal Statistics

Report Maturity Metric

NeoSAFE

Informed Clinical Decisions

Feeding Method and Schedule

NICU Period Decision

Safe Discharge Decision

Healthy Newborns

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2012 2020Today

2012 2013 2014 2015 2016 2017 2018 2019 2020

Kick-Off (w. Local Funding)6/12

H2020 SME Phase-1 Kick-Off10/14

New Prototype Design6/16 H2020 SME

Phase-2 Kick-Off3/17

International Clinical Research Kick-Off9/18

MEDICA Launch11/18

CE Application4/19

Proof-of-Concept

12/13

2nd Iteration Kick-Off (w. Local Funding)

7/15

Clinical Research Kick-Off

8/18

Out-Patient Development Kick-Off

12/19

So Far 12

2012 2020Today

2012 2013 2014 2015 2016 2017 2018 2019 2020

Kick-Off (w. Local

Funding)6/12

H2020 SME

Phase-1 Kick-Off10/14

New Prototype Design6/16 H2020 SME

Phase-2 Kick-Off3/17

International Clinical Research Kick-Off9/18

MEDICA Launch11/18

CE Application4/19

Proof-of-Concept

12/13

2nd Iteration Kick-Off (w. Local Funding)

7/15

Clinical Research

Kick-Off

8/18

Out-Patient Development Kick-Off

12/19

So Far

12

Competition

NeoSAFE VFSS ☢ Cervical

auscultation

Ultrasonographi

c imaging

Non-Invasive ✓ ✓ ✓

Objective Criterion ✓

Automatic ✓

Portable ✓ ✓ ✓

Painless ✓ ✓ ✓ ✓

Respiration ✓

User Friendly ✓

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Team 14

Prof. Dr. Aylin Tarcan, MDChief Medical Officer

Prof. Dr. Ayse Ecevit, MDChief Clinical Researcher

Balkar Erdogan, MSc.Lead Biomedical Engineer

Nur Benli, MSc.COO

Eren GupgupogluMarketing Director

Ercan KapucuLead Hardware Engineer

Onur KoyuncuMachine Learning Engineer

Cagri UsluEmbedded Software Engineer

Ahmet Saracoglu, PhDCEO

Ugur AcikgozHardware Engineer

Advisory and Ethics Board 15

Saadet Arsan , MDProf. of Pediatrics and Neonatology

Esin Koc, MDProf. of Pediatrics and Neonatology

President of Neonatology Assoc.

Omer Erdeve, MDProf. of Pediatrics and Neonatology

Help the Neonatologists to Decide The Optimum Time to Feed Orally &to Discharge Safely…

Nur Benli, MSc.COOnur.benli@kuartismed.com

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