1. Chest pain and it’s consequences Khaled R Hassan, MD AMED LLC

2. Chest pain  Chest pain accounts for approximately six million annual visits to emergency departments (ED) in the United States, making chest pain the second most common complaint.

3. Are all chest pain cardiac ? Typical angina ( definite ) Typical angina ( definite ) 1) Substernal chest discomfort with a characteristic quality and duration that is 2)provoked by exertion and 3) relieved by rest or NTG. 1) Substernal chest discomfort with a characteristic quality and duration that is 2)provoked by exertion and 3) relieved by rest or NTG. Atypical Chest pain ( probable ) Atypical Chest pain ( probable ) Meets two of the above criterias. Meets two of the above criterias. Noncardiac chest pain Noncardiac chest pain Meets one or none of the criteria Meets one or none of the criteria ACC/AHA Guidelines for chronic stable angina

4. Noncardiac chest pain The mean annual prevalence of NCCP in 6 population-based studies was approximately 25%. However, these studies differ in many aspects such as NCCP definition, geography, sample size, sampling order and ethnic disparities. 16 A population-based survey in the United States assessed the prevalence of GERD in Olmsted County, Minnesota and reported an overall NCCP prevalence of 23% The mean annual prevalence of NCCP in 6 population-based studies was approximately 25%. However, these studies differ in many aspects such as NCCP definition, geography, sample size, sampling order and ethnic disparities. 16 A population-based survey in the United States assessed the prevalence of GERD in Olmsted County, Minnesota and reported an overall NCCP prevalence of 23% 16

5. Noncardiac chest pain costs Approximately $8 billion dollars for the initial care of patients suspected to have an acute coronary syndrome,but who are subsequently found negative for CAD. Approximately $8 billion dollars for the initial care of patients suspected to have an acute coronary syndrome,but who are subsequently found negative for CAD. This high cost is driven by the high incidence of missed myocardial infarction, the associated litigation. This high cost is driven by the high incidence of missed myocardial infarction, the associated litigation.

6. Noncardiac chest pain costs No studies have specifically assessed the indirect costs(e.g. work days lost, value of unpaid work of non-cardiac chest pain. However, based on studies of functional gastrointestinal disorders, such as irritablebowel syndrome and non-ulcer dyspepcia the indirect costs are likely to be sbstantial. No studies have specifically assessed the indirect costs(e.g. work days lost, value of unpaid work of non-cardiac chest pain. However, based on studies of functional gastrointestinal disorders, such as irritablebowel syndrome and non-ulcer dyspepcia the indirect costs are likely to be sbstantial. Indirect costs may also accrue annually because of the chronicity of symptoms. Indirect costs may also accrue annually because of the chronicity of symptoms. No studies have specifically assessed the indirect costs(e.g. work days lost, value ofÔunpaidÕwork) of non-cardiac chest pain. However, based on studies infunctional gastrointestinal disorders, such as irritable bowel syndrome and non-ulcer dyspepsia, the indirect costs are likely to be very substantial. 36, 37 Indirectcosts may also accrue annually because of the chroni- city of symptoms. No studies have specifically assessed the indirect costs(e.g. work days lost, value ofÔunpaidÕwork) of non-cardiac chest pain. However, based on studies infunctional gastrointestinal disorders, such as irritable bowel syndrome and non-ulcer dyspepsia, the indirect costs are likely to be very substantial. 36, 37 Indirectcosts may also accrue annually because of the chroni- city of symptoms.

7. Initial screening of chest pain History and physical History and physical EKG EKG Labs including cardiac markers. Labs including cardiac markers.

8. Conventional EKG Willem Einthoven was a Dutch doctor and a physiologist. He invented the first practical EKG in 1903 and received Noble for it in 1924.

9. EKG

10. Etiology of noncardiac chest pain  GERD  Esophageal motility disorder  Esophageal hypersensitivity  Musculoskeletal  Pulmonary diseases  Stress

11. A day of Dr. H in nursing home Dr. H is a busy internist. Every morning he rounds to his nursing homes before going to his office. He just completed his round to a nursing home and is heading towards his office. He is already late. He got a page from a Nursing home about a pt. complaining of CP. Nurse was not ready with vitals. He asked the nurse to get vitals and the chart and ordered a sta EKG.

12. A day of Dr. H in nursing home Dr. H arrived at the office. Nurse told him that 5 patients have been roomed, one has left after some heated argument with the front desk for his delay. There are few narcotics script from hospice to sign. He started seeing pt. right away and forgot about the pt. with chest pain, no one called from nursing home either. Dr. H arrived at the office. Nurse told him that 5 patients have been roomed, one has left after some heated argument with the front desk for his delay. There are few narcotics script from hospice to sign. He started seeing pt. right away and forgot about the pt. with chest pain, no one called from nursing home either.

13. A day of Dr. H in nursing home After few hours a nurse brought a faxed EKG to Dr. H saying that it was at the bottom of faxed papers. Now he remembered about the pt. in nursing home with chest pain. The EKG was very poor quality with lots of electrical interference due not proper placement of leads and blackened from fax ink. Unable to read the EKG he called the nursing home to send the pt. out by calling 911!!!!!

14. Newer Technology The IneedMdEKG Glove The IneedMdEKG Glove Paradigm shift in the practice of clinical ele ctrocardiography Paradigm shift in the practice of clinical ele ctrocardiography The EKG ‐ Glove is a mitten ‐ like biomedica l device that utilizes a “peel and stick” print ed circuit to place electrodes on the chest or back of a patient in under 60 sec. The EKG ‐ Glove is a mitten ‐ like biomedica l device that utilizes a “peel and stick” print ed circuit to place electrodes on the chest or back of a patient in under 60 sec.

15. IneedMDEKG gloves The EKG Glove produces a full 12 lead EkG that is equivalent to traditional electrod e placement method. The EKG Glove produces a full 12 lead EkG that is equivalent to traditional electrod e placement method. The glove embeds all of the abdominal/ches t wired leads into a glove like sheath The glove embeds all of the abdominal/ches t wired leads into a glove like sheath FDA 510 approved device for non ‐ technician use. European CE approved FDA 510 approved device for non ‐ technician use. European CE approved

16. IneedMD EKG Gloves The glove is a single us e, disposable apparat us. Designed to obtain a 12 lead electrocardiogram /EKG) using pre ‐ posi tioned electrodes. The EKG Glove comes in 2 sizes Adult Medium: Greater than 97 ‐ 104cm Adult Large: Greater th an 104 cm The glove can wirelessl y transmit information with a different reader.

17. IneedMD EKG Gloves The IneedMDEKG Glove retails for $19.99. Two Sizes –Chest Girth 97 ‐ 104 cm Chest Girth greater than 104 cm. The IneedMDEKG Glove retails for $19.99. Two Sizes –Chest Girth 97 ‐ 104 cm Chest Girth greater than 104 cm. FDA Approved FDA Approved European CE Approved CPT Code: 930XXXXX European CE Approved CPT Code: 930XXXXX Made in the USA. Additional products include adaptor, wireles s readersoftware and mobile applications. Made in the USA. Additional products include adaptor, wireles s readersoftware and mobile applications.

18. Additional products Box and Connecting Cable ‐ This is required to convert 10pin to 15pin Wireless reader with Bluetooth Mobile Application to read EKG Available forApple iOS and Android. Adaptor for current EKG Readers – 10/15 port converter Analytical Software for monitoring EKG

19. Problem with EKG machine and wire Average time is 10 minutes to setup and test “Spaghetti” wires are cumbersome, unsanita ry, and confusing. Average time is 10 minutes to setup and test “Spaghetti” wires are cumbersome, unsanita ry, and confusing. Broken EKG Cables with high replacement Broken EKG Cables with high replacement cost. cost. Upto30% chance of an erroneous reading due to misplacement of leads and wires. Uncomfortable to patients. Upto30% chance of an erroneous reading due to misplacement of leads and wires. Uncomfortable to patients. 77% of EKG Wires were found to have. MRSA. 77% of EKG Wires were found to have. MRSA.

20. Comparison of EKG Glove vs. Current ECG

21. Benefits of EKG gloves Less than 60 seconds or less to do and read EKG. Less than 60 seconds or less to do and read EKG. The lowest error rate. The lowest error rate. Minimized risk of infection. Minimized risk of infection. Compact size. Compact size. Bluetooth connectivity and mobile applicatio n allows seamless use anywhere. Bluetooth connectivity and mobile applicatio n allows seamless use anywhere. Decrease overall hospital costs. Decrease overall hospital costs.

22. Market Use Institutional health care market –hospitals. Institutional health care market –hospitals. Long term care facility. Long term care facility. Home Healthcare Home Healthcare Emergency Emergency Doctor’s office. Doctor’s office.

23. Competitive Analysis

24. At a glance

25. Integration with existing infrastructures Wireless connectivity. Wireless connectivity. Connects with a growing number of EMRs. Currently Epiphany, Microsoft Health Vault –Coming Soon: EPIC, GE, etc. Mobile Applications available (OSApple, A ndroid). Connects with a growing number of EMRs. Currently Epiphany, Microsoft Health Vault –Coming Soon: EPIC, GE, etc. Mobile Applications available (OSApple, A ndroid). Windows 7 and Apple desktop software available. Windows 7 and Apple desktop software available.

26. Government focus on Medicare US Government Reallocating 1% of Medicare/Medicaid Paymentsgoes to hospit als that offer best care within Criteria – Allocation percentage rises incrementally annually. Criteria include Patients who may have had a heart attack receive care within 90min. Reducing length of stay (LOS) and preventi ng readmits. US Government Reallocating 1% of Medicare/Medicaid Paymentsgoes to hospit als that offer best care within Criteria – Allocation percentage rises incrementally annually. Criteria include Patients who may have had a heart attack receive care within 90min. Reducing length of stay (LOS) and preventi ng readmits.

27. FDA 510K Approval FDA 510k approval based on study at Ben Gurion University in TelAviv, Israel. FDA 510k approval based on study at Ben Gurion University in TelAviv, Israel. 50 Patients at NYU Medical Center Study. 50 Patients at NYU Medical Center Study. 100 Patients at Mt.Sinai Hospital, 100 Patients at Mt.Sinai Hospital, Department of Interventional Cardiology – Compared to the “gold standard” GE manufactured ECG machine. Department of Interventional Cardiology – Compared to the “gold standard” GE manufactured ECG machine. 120 Patients PeconicBay Medical Center in Long Island, NY. 120 Patients PeconicBay Medical Center in Long Island, NY.

28. Clinical study in Mt. Sinai First ‐ in ‐ man study of the ‘EKG ‐ glove’ – a novel tool for surface electrocardiographic tracings. Purpose: Evaluation of EKG Glove. Method: 200 EKGs were analyzed in a blin ded, randomized, non ‐ sequential fashion by two independent observers across a range of EKG properties. Conclusion: High agreement between the E KG Glove and standard EKG tracings. First ‐ in ‐ man study of the ‘EKG ‐ glove’ – a novel tool for surface electrocardiographic tracings. Purpose: Evaluation of EKG Glove. Method: 200 EKGs were analyzed in a blin ded, randomized, non ‐ sequential fashion by two independent observers across a range of EKG properties. Conclusion: High agreement between the E KG Glove and standard EKG tracings.

29. Study in Mt. Sinai

30. FDA 510K summary Class II Medical Device 510k Number: K033559 Device Name: 12 Lead Glove unit. Indications for Use: Single unit using conv entional ECG Electrode configuration for the purpose of conducting an electrocardio gram. Class II Medical Device 510k Number: K033559 Device Name: 12 Lead Glove unit. Indications for Use: Single unit using conv entional ECG Electrode configuration for the purpose of conducting an electrocardio gram. All 4 key components were individually FD A approved – Shell, Electrodes, Preprinted conductive fle x circuit, connector cable All 4 key components were individually FD A approved – Shell, Electrodes, Preprinted conductive fle x circuit, connector cable

31. INeedMDEKG Marketing Video Introduction Video and Directions on how t o use the glove – http://www.youtube.com/watch?v=OIX6qH Gfy_Y –8:51 minutes Introduction Video and Directions on how t o use the glove – http://www.youtube.com/watch?v=OIX6qH Gfy_Y –8:51 minutes http://www.youtube.com/watch?v=OIX6qH Gfy_Y –8:51 minutes http://www.youtube.com/watch?v=OIX6qH Gfy_Y –8:51 minutes Instruction on how to use glove, connect wi th software and how to use software – http://www.youtube.com/watch?v=LoEu1 ‐ 8 s1 Instruction on how to use glove, connect wi th software and how to use software – http://www.youtube.com/watch?v=LoEu1 ‐ 8 s1 http://www.youtube.com/watch?v=LoEu1 ‐ 8 s1 http://www.youtube.com/watch?v=LoEu1 ‐ 8 s1

32. Marketing Videos Today in America Video 2011 with Terry Bradshaw –Interviews with Dr.Gopinathan and Dr.Tilford – http://www.youtube.com/watch?v=X877K 9UQcTU –5:00 minutes Today in America Video 2011 with Terry Bradshaw –Interviews with Dr.Gopinathan and Dr.Tilford – http://www.youtube.com/watch?v=X877K 9UQcTU –5:00 minutes Instructions on how to use Glove from Paragon National – http://www.youtube.com/watch?v=pMhtzc 2oeMM –2:43 minutes Instructions on how to use Glove from Paragon National – http://www.youtube.com/watch?v=pMhtzc 2oeMM –2:43 minutes

33. Marketing Videos 5. Telemedicine demonstration with EKG Glove – http://www.youtube.com/watch?v=q5hVe4 Yrj7Q –5:01 minutes 5. Telemedicine demonstration with EKG Glove – http://www.youtube.com/watch?v=q5hVe4 Yrj7Q –5:01 minutes

34. Time comparison

35. Time Comparison

36. End of conventional EKG Let’s welcome the new technology…….. Few slides were the courtesy of INEEDMD and Dr. Gopinathan.