1.2 Distributed By ARC Medical

2. Distributed By ARC Medical 3 3. 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 4. 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 8. Glossary Disruptive technology Introducing new technology to current technology which will change the way things are done 9 Distributed By ARC Medical 9. Pneumonia 10 Distributed By ARC Medical What is pneumonia? 10. Pneumonia 11 Distributed By ARC Medical 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. 11. Bacteria spores traveling with a sneeze 12. Pneumonia 13 Distributed By ARC Medical 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. 13. Pneumonia 14 Distributed By ARC Medical 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. 14. Pneumonia 15 Distributed By ARC Medical 15. Pneumonia 16 Distributed By ARC Medical Antibiotics will not help patients with viral pneumonia Antibiotics only work on bacterial pneumonia 16. Pneumonia - CAP 17 Distributed By ARC Medical Community-Acquired Pneumonia Pneumonia in people who have not recently been in the hospital or another health care facility (nursing home, rehabilitation facility) 17. Pneumonia - HAP 18 Distributed By ARC Medical 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. 18. Pneumonia - HAP 19 Distributed By ARC Medical Hospital-Acquired Pneumonia In addition, the types of germs present in a hospital are often more dangerous than those encountered in the community 19. Cystic Fibrosis 20 Distributed By ARC Medical 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. 20. http://www.cdc.gov/nchs/fastats/pneumonia.htm 21 Distributed By ARC Medical 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 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 Distributed By ARC Medical 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 Distributed By ARC Medical 24. Thoracentesis - Pleural fluid culture Pulse oximetry Nasal swab Throat swab Urine antigen Bronchoscopy - BAL Methods to determine if patients have pneumonia 25 Distributed By ARC Medical 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 Distributed By ARC Medical 26. 27 Distributed By ARC Medical A chest x-ray showing a very prominent wedge- shaped bacterial pneumonia in the right lung 27. Routine sputum sample 28 Distributed By ARC Medical 28. 29 Distributed By ARC Medical 29. Thoracenteses procedure 30 Distributed By ARC Medical 30. Routine nasal swab sample 31 Distributed By ARC Medical 31. Routine throat swab sample 32 Distributed By ARC Medical 32. 33 Distributed By ARC Medical 33. Invasive method to get a lung sample Very uncomfortable for the patient Procedure may cause pneumonia Bronchoalveolar Lavage - BAL 34 Distributed By ARC Medical 34. Problem: Sampling 35 Distributed By ARC Medical 35. Solution? 36 Distributed By ARC Medical 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 Distributed By ARC Medical 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. Development of PneumoniaCheck 38 Distributed By ARC Medical 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. Development of PneumoniaCheck 39 Distributed By ARC Medical 39. PC saves time and money diagnosing pneumonia; however, it is NOT a diagnostic device. Development of PneumoniaCheck 40 Distributed By ARC Medical 40. Solution: 41 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 44. Solution: 45 Distributed By ARC Medical 45. Solution: 46 Distributed By ARC Medical 46. Solution: 47 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 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 Distributed By ARC Medical 52. Diatherix Laboratories sample lab report Distributed By ARC Medical 53 53. Diatherix Laboratories sample lab report Distributed By ARC Medical 54 54. ARC Medical & PneumoniaCheck 55 Distributed By ARC Medical 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 (-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 56. Current Methods PC including analysis with PCR analysis 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 ESTIMATED PNEUMONIA ECONOMIC ANALYSIS USING PNEUMONIACHECK With Complications Antibiotic Resistance 57. Current Methods PC including analysis with PCR analysis 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 (-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 ESTIMATED PNEUMONIA ECONOMIC ANALYSIS USING PNEUMONIACHECK Diagnosis Antibiotics 58. Current Methods PC including analysis with PCR analysis 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 ESTIMATED PNEUMONIA ECONOMIC ANALYSIS USING PNEUMONIACHECK With Complications Antibiotic Resistance 59. 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 Distributed By ARC Medical 60. Current treatment is a blind guess All receive broad-spectrum antibiotics 20% patients get worse 5% die Current medicine 61 Distributed By ARC Medical 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 Distributed By ARC Medical 62. Taking a relaxing 30 minute break, quiz is next 63. Extra credit? 64 Distributed By ARC Medical 64. PneumoniaCheck quiz 65. 1. What is PneumoniaCheck? 66 66. 2a. Explain how PneumoniaCheck functions - generally 67 67. 2b. Explain how PneumoniaCheck works - detailed 68 68. 3. How does PneumoniaCheck compare to BAL? 69 69. 4. What is the approximate cost to treat hospitalized pneumonia with current medicine? 70 70. 5. Does Medicare penalize a hospital for readmission of pneumonia? 71 71. 6. What is BronchoAlveolar Lavage (BAL) 72 72. 7. Are antibiotics effective for bacteria, viruses, or both? 73 73. 8. What is the major design goal of PneumoniaCheck? 74 74. 9. The PneumoniaCheck incidence results were compared to published incidence studies of BALs from what type of patients? 75 75. 10. How soon must treatment begin after a patient is admitted for pneumonia? 76 76. 11. What is the definition of a false positive and an example? 77 77. 12. What are some current methods for initially diagnosing pneumonia? 78 78. 13. With PneumoniaCheck, patients are not required to produce sputum or mucus. True or false? 79 79. 14. What is the difference between specificity and sensitivity? 80 80. 15. Pneumonia is not always seen on x-rays, why? 81 81. 16. What does the PneumoniaCheck filter collect? 82 82. 17. How many people are affected by pneumonia in the United States annually? 83 83. 18. How many people are hospitalized with pneumonia in the United States annually? 84 84. 19. How many people die from pneumonia in the United States annually? 85 85. 20. What institutions helped invent PneumoniaCheck? 86 86. 21. What is the number one killer of children worldwide? 87 87. 22. How many coughs are recommended to capture an ideal sample? 88 88. 23. Is PneumoniaCheck a diagnostic device, a collection device, or both? 89 89. 24. What is a general difference between pneumonia without complications and pneumonia with complications? 90 90. 25. Has the FDA has cleared PneumoniaCheck for sale in the U.S.? 91 91. 26. How does PneumoniaCheck collect pathogens from the lungs? 92 92. 27. How is a PneumoniaCheck specimen analyzed? 93 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 94. 29. What is our primary reason to sell PneumoniaCheck? 95 95. 30. What are my PneumoniaCheck commissions based upon a 350-bed hospital sale? 96 96. 1. What is PneumoniaCheck? PneumoniaCheck is a specimen transport container designed to collect uncontaminated lower lung samples noninvasively. 97 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 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 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 100 100. 4. What is the Approximate cost to treat hospitalized Pneumonia with current medicine? With complications: $14,000 Without complications: $1,000 101 101. 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. 102 102. 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. 103 103. 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. 104 104. 8. What is the major design goal of PneumoniaCheck? To reduce the amount of oral contamination in collected lower lung samples. 105 105. 9. PneumoniaCheck incidence results were compared To published incidence studies of BALs from what type of patients? Cystic Fibrosis (CF) patients 106 106. 10. How soon must treatment begin after a patient is admitted for pneumonia? 4 hours, also called the DTN or door to needle time. 107 107. 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) 108 108. 12. What are some current methods for initially diagnosing pneumonia? Chest x-ray Sputum sample Oral swab Nasopharyngeal swab Blood sample Urine sample 109 109. 13. With PneumoniaCheck, patients are not required to produce sputum or mucus. True or false? True 110 110. 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*** 111 111. 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. 112 112. 16. What does the PneumoniaCheck filter collect? Specimens / aerosols from the lower lungs 113 113. 17. How many people are affected by pneumonia in the United States annually? 5.6 million 114 114. 18. How many people are hospitalized with pneumonia in the United States annually? 1.1 million 115 115. 19. How many people die from pneumonia in the United States annually? 50,000 116 116. 20. What institutions helped invent PneumoniaCheck? US Centers for Disease Control and Prevention Georgia Institute of Technology 117 117. 21. What is the number one killer of children worldwide? 118 118. 22. How many coughs are recommended to capture an ideal sample? 10 coughs 119 119. 23. Is PneumoniaCheck a diagnostic device, a collection device, or both? A collection device ONLY NOT a diagnostic device 120 120. 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 121 121. 25. Has the FDA cleared PneumoniaCheck for sale in the U.S.? Yes 122 122. 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. 123 123. 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. 124 124. 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