PneumoniaCheck by ARC Medical, The link between diagnosis and treatment of Pneumonia

Glossary
• Aerosol – a suspension of fine solid particles or liquid
droplets in a gas
• BronchoAlveolar Lavage (BAL) – a medical procedure
in which a bronchoscope is passed through the mouth
or nose into the lungs and fluid is squirted into a small
part of the lung and then recollected for examination
4
Distributed By ARC Medical

Glossary
• Bronchoscopy – a technique of visualizing the inside of
the airways for diagnostic and therapeutic purposes
• Diagnostic related groups (DRGs) - A payment system
in which benefit payments are based on the individual
diagnosis of a patient instead of the actual medical
service received
5

Glossary
• Nasopharyngeal swab – a sample of secretions from
the uppermost part of the throat, behind the nose, to
detect organisms that can cause disease
• PneumoniaCheck – a device that non-invasively
collects uncontaminated lower lung aerosols
• Pathogen – a specific causative agent (as a bacterium
or virus) of disease
6

Glossary
• Pneumonia – a disease of the lungs characterized
especially by inflammation and consolidation of lung
tissue followed by fever, chills, cough, and difficulty in
breathing
• Polymerase Chain Reaction (PCR) – an in vitro
technique for rapidly synthesizing large quantities of a
given DNA segment
• Reactive airway disease – a general term for
conditions involving wheezing and allergic reactions
7

Glossary
• Separates airflow – the upper airway aerosols are
segregated from the lower lung aerosols
• Specificity – measures the proportion of negatives
which are correctly identified (e.g. the percentage of
healthy people who are correctly identified as not
having the condition)
• Sensitivity – measures the proportion of actual
positives which are correctly identified as such
8

Glossary
• Disruptive technology – Introducing new technology
to current technology which will change the way
things are done
9

Pneumonia
10
What is pneumonia?

Pneumonia
11
• Pneumonia is an infection of one or both lungs
which is usually caused by bacteria, viruses, or
fungi.
• Currently, over 5.6 million people develop
pneumonia each year in the United States.

Bacteria spores traveling with a sneeze

Pneumonia
13
• Once organisms enter the lungs, they usually
settle in the air sacs and passages of the lung
where they rapidly grow in number.
• This area of the lung then becomes filled with
fluid and pus (the body's inflammatory cells) as
the body attempts to fight off the infection.

Pneumonia
14
• Over 1.1 million of these people are admitted
to a hospital for treatment. Although most of
these people recover, approximately 50,000
people will die from pneumonia.
• Pneumonia is the sixth leading cause of death
in the United States.

Pneumonia
15

Pneumonia
16
• Antibiotics will not
help patients with
viral pneumonia
• Antibiotics only
work on bacterial
pneumonia

Pneumonia - “CAP”
17
Community-Acquired Pneumonia
• Pneumonia in people who have not
recently been in the hospital or another
health care facility (nursing
home, rehabilitation facility)

Pneumonia - “HAP”
18
Hospital-Acquired Pneumonia
• An infection of the lungs contracted during a
hospital stay (not on a ventilator)
• HAP tends to be more serious, because a
patient's defense mechanisms against infection
are often impaired during a hospital stay.

Pneumonia - “HAP”
19
Hospital-Acquired Pneumonia
• In addition, the types of germs present in a
hospital are often more dangerous than those
encountered in the community

Cystic Fibrosis
20
• Cystic fibrosis is an inherited disease that
causes thick, sticky mucus to build up in the
lungs and digestive tract.
• It is one of the most common chronic lung
diseases in children and young adults, and may
result in early death.

http://www.cdc.gov/nchs/fastats/pneumonia.htm
21

Pathogen Cases
Streptococcus pneumoniae 20-60%
Haemophilus influenza 3-10%
Staphylococcus aureus 3-5%
Gram-negative bacilli 3-10%
Legionella species 2-8%
Mycoplasma pneumoniae 1-6%
Chlamydia pneumoniae 4-6%
Viruses 2-15%
Aspiration 6-10%
Others 3-5%
Adapted from Mandell LA, Bartlett JG, Dowell SF, et al: Update of practice guidelines for the management of community-acquired
pneumonia in immunocompetent adults. Clin Infect Dis 2003;37:1405-1433.
Many pathogens: Which to treat?
22

• Specimens are very often contaminated from
the upper respiratory resulting in many false
positives.
• This leads to broad antibiotic treatment
because the actual pathogen causing the
pneumonia is usually never identified.
Current sampling data
is not reliable or accurate
23

• Medical history
• Physical exam
• Chest x-rays
• Blood tests
• Blood culture
• Sputum collection
• CT – chest computed tomography scan
Methods to determine
if patients have pneumonia
24

• Thoracentesis - Pleural fluid culture
• Pulse oximetry
• Nasal swab
• Throat swab
• Urine antigen
• Bronchoscopy - BAL
Methods to determine
if patients have pneumonia
25

• Chest x-rays can reveal areas of opacity (seen as white)
which represent consolidation.
• Pneumonia is not always seen on x-rays, either
because the disease is only in its initial stages, or
because it involves a part of the lung not easily seen by
x-ray.
• X-rays cannot identify pathogens.
Routine chest x-rays
26

27
A chest x-ray showing a very prominent wedge-
shaped bacterial pneumonia in the right lung

Routine sputum sample
28

Thoracenteses procedure
30

Routine nasal swab sample
31

Routine throat swab sample
32

• Invasive method
to get a lung
sample
• Very
uncomfortable
for the patient
• Procedure may
cause pneumonia
Bronchoalveolar Lavage - BAL
34

Problem: Sampling
35

Solution?
36

• Pneumonia kills more children than any other disease.
Unfortunately, the pathogen cannot be identified in
most patients.
• Thepathogens causing pneumonia are difficult to
identify because a high quality specimen from the
lower lung is difficult to obtain due to contamination
of the sample.
• Overuse of broad-spectrum antibiotics leads to
antibiotic resistance.
Development of PneumoniaCheck
37

• PneumoniaCheck was developed and designed to
collect aerosolspecimens selectively from the lower
lung generated during deep cough.
• This technology allows PneumoniaCheck to effectively
separate the upper respiratory tract from the aerosols
in the lung by >90%.
• PneumoniaCheck utilizes a separation reservoir and
specially designed mouthpiece to segregate contents
from the upper airway and the lower lungs.
38

• PneumoniaCheck includes several specially designed
features to exclude oralcontaminants from the sample
and a filter to collect the aerosolized pathogens from
the lower lungs.
• The filter can collect >99.97% of virus and bacteria
sized particles from the sampled lower lung aerosols.
39

• PC saves time and money diagnosing pneumonia;
however, it is NOT a diagnostic device.
40

Solution:
41

• To use PneumoniaCheck, a patient simply coughs
deeply into the mouthpiece and expels the remaining
air in his or her lungs.
• This action can be repeated as many times as
necessary to collect a sufficient sample of lower
respiratory aerosolized pathogens.
• Recommend collecting 10 coughs
Solution:
42

• The air from the upper respiratory is collected in a
reservoir, and aerosols from the lower respiratory are
captured on a microbial filter.
• The filter can then be sent to a laboratory to be tested
for the presence of various pathogens.
Solution:
43

• PneumoniaCheck uses fluid mechanics to isolate lung
pathogens onto the filter.
• Fluid mechanics is the branch of physics that studies
fluids (liquids, gases, and plasmas) and the forces on
them.
Solution:
44

Solution:
45

Solution:
46

Solution:
47

• Method
Collect sample from normal (healthy) subjects who drank alcohol
Breathalyzers in upper airway reservoir and in lower airway filter
• Results from upper airway different from lower airway
Upper airway reservoir: Negative
Lower airway filter: Positive
• Conclusion
PneumoniaCheck collects alcohol released from the lungs while
separating out the air from the mouth
Verification and validation tests
48

• Method
Collected samples from normal (healthy) subjects
• Results contaminated with bacteria
Oral swabs: 40%
PneumoniaCheck: 0%
• Conclusion
PneumoniaCheck increases Specificity from 60% to 100% with
no false positives
Clinical Study – reducing false positives
49

• Method
Sampled cystic fibrosis lungs
(chronic lung infections)
• Results
67% were positive with bacteria using
PneumoniaCheck
Same pathogens and proportion as
BAL results from literature
• Conclusion
PneumoniaCheck collects pathogens from the lungs from diseased
patients
Clinical Study – Cystic Fibrosis
50

CF Patients BAL PneumoniaCheck™
Pseudomonas aeruginosa 12-61%1-4  47%
Staphylococcus aureus 19-36%2-4  13%
Klebsiella species 21%1  13%
Overall bacteria 41-71%2-4  67%
BAL vs. PneumoniaCheck
51

• Fewer antibiotics with better outcomes
• Less antibiotic resistant bacteria
• Shorter hospital stays
• Reduced healthcare costs-
Diagnosis, additional procedures, complications, antibiotic
resistance and more
Benefits for hospitals
52

Diatherix Laboratories sample lab report
53

Diatherix Laboratories sample lab report
54

ARC Medical & PneumoniaCheck
55

Current Methods PC
including analysis with PCR analysis
Work-up including analysis costs
Chest x-ray $180
Sputum $90
Nasopharyngeal swab $130
Blood (x3) $270
Urine $130
PneumoniaCheck™
PneumoniaCheck™
Culture
PCR (Bacteria + Viruses, next day results)
Total diagnosis cost per individual pneumonia patient $800
Savings using PneumoniaCheck
Treatment - empirical, within 4 hours of admission
Penicillin (ß-lactam) $85
Macrolide $80
Treatment - Focused antibiotics
1 day broad spectrum antibiotics (penicillin + macrolide)
+ 13 days of narrow spectrum antibiotics (erythromycin)
Total treatment cost per individual pneumonia patient $165
Savings using PneumoniaCheck with focused antibiotics
Diagnosis + total antibiotics $965
Total savings "without complications"
ESTIMATED PNEUMONIA ECONOMIC ANALYSIS USING PNEUMONIACHECK
Diagnosis
Antibiotics

IV antibiotics $0
3 additional hospital days $6,000
Repeat diagnosis workup $800
Bronchoalveolar Lavage (BAL) $2,100
Respiratory therapy tests $1,000
Cost of complication $9,900
Total savings "with complications"
Antibiotic resistance § $476
Savings antibiotic resistance
Total Cost $11,341
Total Savings
With Complications
Antibiotic Resistance

Work-up including analysis costs
Chest x-ray $180 $180
Sputum $90
Nasopharyngeal swab $130
Blood (x3) $270
Urine $130
PneumoniaCheck™
PneumoniaCheck™ $150
Culture
PCR (Bacteria + Viruses, next day results) $300
Total diagnosis cost per individual pneumonia patient $800 $630
Savings using PneumoniaCheck $170
Treatment - empirical, within 4 hours of admission
Penicillin (ß-lactam) $85
Macrolide $80
Treatment - Focused antibiotics
1 day broad spectrum antibiotics (penicillin + macrolide) $33
+ 13 days of narrow spectrum antibiotics (erythromycin) $35
Total treatment cost per individual pneumonia patient $165 $68
Savings using PneumoniaCheck with focused antibiotics $97
Diagnosis + total antibiotics $965 $698
Total savings "without complications" $267
Diagnosis
Antibiotics

IV antibiotics $2,610 $1,305
3 additional hospital days $6,000 $6,000
Repeat diagnosis workup $800
Bronchoalveolar Lavage (BAL) $2,100
Respiratory therapy tests $1,000
Cost of complication $12,510 $7,305
Total savings "with complications" $5,205
Antibiotic resistance § $476 $95
Savings antibiotic resistance $381
Total Cost $13,951 $8,098
Total Savings $5,853
With Complications
Antibiotic Resistance

Cost savings from several categories:
• Diagnosis • Antibiotics • Complications • Antibiotic resistance
Lower costs for hospitals and patients
$0
$500
$1,000
$1,500
$2,000
$2,500
PneumoniaCheck™
Bronchoscopy
Urine
Blood
Nasopharyngeal Swab
Sputum
Chest X-Ray
Cost of Diagnosis (including laboratory analysis costs)
$2,100
$800
$630
60

• Current treatment is a blind guess
• All receive broad-spectrum antibiotics
• 20% patients get worse
• 5% die
Current medicine
61

• PneumoniaCheck selectively collects from lungs
allowing better identification of the offending bacteria
• Patient gets targeted antibiotic with better outcomes
• Hospital stay shortened, less complications
• Less mortality
• Less resistant bacteria
Better medicine
62

Taking a relaxing 30 minute
break, quiz is next

Extra credit?
64

2a. Explain how PneumoniaCheck functions - generally
67

2b. Explain how PneumoniaCheck works - detailed
68

3. How does PneumoniaCheck compare to BAL?
69

4. What is the approximate cost to treat hospitalized
pneumonia with current medicine?
70

5. Does Medicare penalize a hospital for
readmission of pneumonia?
71

6. What is BronchoAlveolar Lavage (BAL)
72

7. Are antibiotics effective for bacteria,
viruses, or both?
73

8. What is the major design goal of
PneumoniaCheck?
74

9. The PneumoniaCheck incidence results were
compared to published incidence
studies of BALs from what type of patients?
75

10. How soon must treatment begin after a
patient is admitted for pneumonia?
76

11. What is the definition of a false positive
and an example?
77

12. What are some current methods for
initially diagnosing pneumonia?
78

13. With PneumoniaCheck, patients are not required to
produce sputum or mucus. True or false?
79

14. What is the difference between
specificity and sensitivity?
80

15. Pneumonia is not always seen
on x-rays, why?
81

16. What does the PneumoniaCheck filter collect?
82

17. How many people are affected by pneumonia
in the United States annually?
83

18. How many people are hospitalized with
pneumonia in the United States annually?
84

19. How many people die from pneumonia
85

20. What institutions helped invent
PneumoniaCheck?
86

21. What is the number one killer
of children worldwide?
87

22. How many coughs are recommended to
capture an ideal sample?
88

23. Is PneumoniaCheck a diagnostic device, a
collection device, or both?
89

24. What is a general difference between pneumonia
without complications and pneumonia with
complications?
90

25. Has the FDA has cleared PneumoniaCheck
for sale in the U.S.?
91

26. How does PneumoniaCheck
collect pathogens from the lungs?
92

27. How is a PneumoniaCheck specimen analyzed?
93

28. Patients should produce at least 10 coughs very
rapidly to produce sputum to utilize the full benefits of
the reservoir bag. True or false?
94

29. What is our primary reason to sell
PneumoniaCheck?
95

30. What are my PneumoniaCheck commissions
based upon a 350-bed hospital sale?
96

1. What is PneumoniaCheck?
PneumoniaCheck is a specimen transport container
designed to collect uncontaminated lower lung samples
noninvasively.
97

2a. Explain How PneumoniaCheck Works, Generally
A patient coughs deeply into the mouthpiece and expels
the remaining air in his or her lungs.
This action can be repeated as many times as necessary
(recommended 10 coughs) to collect a sufficient sample
of lower respiratory aerosolized pathogens.
98

2b. Explain how PneumoniaCheck works, detailed
The air from the upper respiratory tract is collected in a
reservoir, and pathogens from the lower lungs are
trapped on a microbial filter due to resistance created by
back pressure from the inflated reservoir bag.
The entire device is then sent to a lab to be tested for the
presence of pathogens.
99

3. How does PneumoniaCheck compare to BAL?
PneumoniaCheck has similar/higher specificity (less
contamination) than BAL
PneumoniaCheck has similar sensitivity than BAL (CF
patient data)
***Note: BAL has limitations:
oral contamination, time of collection and
antibiotic contamination
100

4. What is the Approximate cost to treat hospitalized
Pneumonia with current medicine?
With complications: $14,000
Without complications: $1,000
101

5. Does Medicare penalize a hospital for
readmission of Pneumonia?
Yes, due to Diagnostic Related Charges (DRGs), the
hospital has captured its money and the readmission is
treated for free.
102

6. What is BronchoAlveolar Lavage (BAL)
A medical procedure in which a bronchoscope is passed
through the mouth or nose into the lungs.
Fluid is squirted into a small part of the lung and then
recollected for examination.
103

7. Are antibiotics effective for bacteria,
viruses or both?
Bacteria only
However, antibiotics are given broadly even when a
bacterium is never identified.
Many pneumonia cases are viral, in which case antibiotics
only create resistance.
104

8. What is the major design goal of
PneumoniaCheck?
To reduce the amount of oral contamination in collected
lower lung samples.
105

9. PneumoniaCheck incidence results were compared
To published incidence studies of BALs
from what type of patients?
Cystic Fibrosis (CF) patients
106

10. How soon must treatment begin after a
patient is admitted for pneumonia?
4 hours, also called the DTN or door to needle time.
107

11. What is the definition of a false positive
and an example?
A result that indicates that a given condition is present
when it is not.
An example of a false positive would be if a particular test
designed to detect pneumonia returns a positive result
but the person does not have pneumonia.
(Positive on normal, healthy controls)
108

12. What are some current methods for
initially diagnosing pneumonia?
Chest x-ray
Sputum sample
Oral swab
Nasopharyngeal swab
Blood sample
Urine sample
109

13. With PneumoniaCheck, patients are not required to
produce sputum or mucus. True or false?
True
110

14. What is the difference between
specificity and sensitivity?
Specificity – measures the proportion of negatives which
are correctly identified.
Sensitivity – measures the proportion of actual positives
which are correctly identified as such.
*** Difficult with no gold standard***
111

15. Pneumonia is not always seen
on x-rays, why?
The disease may be at a stage that is too early to be
detected.
The disease may involve a part of the lung not easily seen.
112

16. What does the PneumoniaCheck filter collect?
Specimens / aerosols from the lower lungs
113

17. How many people are affected by pneumonia
5.6 million
114

18. How many people are hospitalized with
pneumonia in the United States annually?
1.1 million
115

19. How many people die from pneumonia
50,000
116

20. What institutions helped
invent PneumoniaCheck?
US Centers for Disease Control and Prevention
Georgia Institute of Technology
117

21. What is the number one killer
of children worldwide?
118

22. How many coughs are recommended to
capture an ideal sample?
10 coughs
119

23. Is PneumoniaCheck a diagnostic device,
a collection device, or both?
A collection device ONLY
NOT a diagnostic device
120

24. What is a general difference between pneumonia
without complications and
pneumonia with complications?
Without complications:
A patient who gets better after broad-spectrum
antibiotics
With complications:
A patient who does not get better after broad-spectrum
antibiotics
121

25. Has the FDA cleared PneumoniaCheck
for sale in the U.S.?
Yes
122

26. How does PneumoniaCheck
collect pathogens from the lungs?
PneumoniaCheck utilizes a medical grade filter that has
been tested and shown to capture over 99% of bacteria
and viruses.
123

27. How is a PneumoniaCheck
specimen analyzed?
The PneumoniaCheck filter is designed to be analyzed
using PCR DNA analysis.
The PneumoniaCheck filter may be able to be analyzed
using traditional microbiology culturing, gram stains, and
immunoassays; however, these methods have not been
tested.
124

28. Patients should produce at least 10 coughs very
rapidly to produce sputum to utilize the full benefits
of the reservoir bag. True or false?
False
125

PneumoniaCheck by ARC Medical, The link between diagnosis and treatment of Pneumonia

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PneumoniaCheck by ARC Medical, The link between diagnosis and treatment of Pneumonia