THE BEGINNING OF THE END OF BOTTLED OXYGEN – AN EVALUATION OF THE 02MAX™ FACE MASK USING AN OXYGEN CONCENTRATOR

INTRODUCTION – Traditional oxygen face masks have been around since the 1950’s, with minimal updates in design and virtually identical masks from one manufacturer to another related to product shape and functionality. Sharp Medical Products, LLC (“Sharp Medical”) has developed a new oxygen face mask (02MAX™) that has a number of design features that appear to improve the delivery of oxygen compared to standard face masks on the market. Three prior research studies have demonstrated virtually identical results showing that the 02MAX™ delivers up to 50% improvement in oxygen delivery compared to industry standard such as the

AirLife® face mask ; in other words, with a flow rate of 5L 02MAX™ delivers virtually identical oxygen delivery 1,2,3 compared as the AirLife® at 10L, and 02MAX™ at 10L is the same as AirLife® at 15L. There are obvious advantages (financial as well as operational) with a much more efficient face mask in the 02MAX™; however, one new advantage is not so obvious and that is the possibly of reducing or eliminating a traditional oxygen supply method - bottled oxygen. Bottled oxygen is used in numerous locations such as hospitals, clinics, homes and the pre-hospital environment (civilian and military).

One area in particular that uses virtually only bottled oxygen is the civilian ambulance service; in the USA alone, there is an estimated 48,0004 ambulances that provide 16 million5 EMS runs per year; of those 34%6, or 5.6 million runs, receive oxygen during transport. Virtually every ambulance in the world uses bottled oxygen and their protocols are very similar – when needed, use either a nasal cannula or a face mask with a non-rebreather at 12-15L of oxygen flow per minute. A device that could eliminate bottled oxygen on essentially all of these ambulances would be the usage of an oxygen concentrator. An oxygen concentrator does not “generate” oxygen, but instead takes ambient air, compresses it and then filters out nitrogen resulting in 100% oxygen. Such devices not only eliminate the need for bottled oxygen but are significantly safer than bottled oxygen that can result in a fire or explosion of the tank is ruptured. Oxygen concentrators are a fairly recent invention (1970s) and are usually used in the 2-5L/02/min rate; only in the last 10 years have a few commercial concentrators been in use that allow up to 10L/02/min. There is no known commercial concentrator available that would allow a flow of 15L/02/min to use existing commercial oxygen face masks; however, an existing commercial concentrator on an ambulance flowing at 10L/02/min in conjunction with the 02MAX™ may achieve the same delivery of oxygen levels within the mask as a market leading oxygen mask using bottled oxygen at 15L/02/min. 1,2,3 In fact, the first studies on the 02MAX™ would support this assumption.

GOAL – To validate the hypothesis that 02MAX™ using an oxygen concentrator with a flow rate of 10L/min can deliver the same oxygen levels within the mask as the market leader AirLife® with and without a non-rebreather bag at 15L/min from bottled oxygen.

TYPE OF TEST – An internal pilot study using healthy adult volunteers.

DATE/LOCATION OF TESTING – Testing was performed on March 22-24, 2018 in Scottsdale Arizona.

BIAS ELIMINATION – A number of factors were in place to prevent bias by Sharp Medical Products, LLC as well as the subjects:

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1. The subjects were not informed as to the goal of the project besides testing face masks in general, and had no basis to create a preconceived opinion on outcome 2. The subjects were blinded to the real time collection of oxygen levels measured in the mask

MATERIALS/SUBJECTS – GENERAL

1 2 Oxygen Face Masks were tested.

a. 02MAX™ by Sharp Medical Products, LLC, which incorporates a number of revolutionary design features. Commercial articles, not prototypes, were used. b. Airlife® face mask by Carefusion, Incorporated. Standard, off the shelf, oxygen face masks are manufactured by an estimated > 35 companies in the United States and numerous more world-wide. They all appear to be virtually identical and use the same geometry and materials (polyvinyl chloride). For this evaluation a commercially available face mask (AirLife® Adult Oxygen Mask, Reference 001201 from Carefusion, Incorporated) was used to

test against 02MAX™, as AirLife® is considered to be the industry leading face mask in the

U.S. All subjects (10) were tested with the 02MAX™ vs AirLife® face mask (both the non- rebreather and rebreather (no bag) versions were used). 2 Medical grade bottled oxygen was used as well as an oxygen concentrator (Millennium M10 from Respironics). 3 An oxygen-measuring device (GOX 100 from Greisinger Electronic) was used to measure oxygen percentages (AOP) within the masks. A form fitted hole was created in the lateral aspect of the masks on the right and the GOX 100 sensor placed within this airtight opening. For each subject, the sensor was placed within 0.5 cm of the right naris (nostril) of the nose to measure AOP. The sensor was electronically connected to the processor, which displays a digital real time read out of the ambient oxygen levels at the sensor. 4 10 Human adult, healthy volunteers over the age of 18 were used – both males and females. Those with excessive facial hair were excluded. The subjects were blinded to the results of the oxygen levels being recorded and were not informed to the purpose of the test beyond evaluating oxygen face masks. The subjects were instructed to breathe only through their nose and to breathe in a normal calm regular rhythm. 5 Prior studies1,2,3 had demonstrated that a steady state is achieved within 1-2 minutes; therefore, the duration “run” was 3 minutes for each test cycle; for example, volunteer #5 wore the AirLife® mask at 10L/min for 3 minutes. Oxygen levels were measured every 10 seconds; which is 18 samples per 3 minutes MATRIX OF DATA COLLECTION – As below for each of the 10 subjects.

TYPE OF OXYGEN CONCENTRATOR CONCENTRATOR BOTTLED BOTTLED OXYGEN FLOW (L/MIN) 10 10 15 15 MASK BRAND 02MAX™ AirLife® AirLife® AirLife® NON REBREATHER BAG SIMPLE SIMPLE SIMPLE NON-REBREATHER OR SIMPLE MASK

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METHODS

1 MASK AMBIENT OXYGEN PERCENTAGE (AOP) – The AOP was measured by using a high quality oxygen-measuring device as described previously (GOX 100) that collected continuous air samples from a sensor within the mask within 0.5 cm of the right naris for each subject. Face masks were placed onto each subject for comfort and the subjects were asked to breathe normally through their nose. Oxygen flow into the mask was started at 10 or 15 liters/minute (as per the matrix above) and AOP recorded at 10 second intervals until 3 minutes (18 readings). Subjects were asked to breath normally throughout the test period and were given time to get acclimated to the masks. The order of mask measurements alternated from one subject to the next.

RESULTS (Table 1)

Demographics. 60% of the subjects were female with the following averages – 66.8 inches in height, 152.0 pounds in weight and 40 years in age.

Results are divided into key groups:

I STEADY STATE (GRAPH 1)

Time to reach a steady state of ambient oxygen is fairly quick and appears happen within 1-2 minutes for all 4 mask/oxygen delivery types tested; change is not noted after 2 minutes.

10 HUMAN SUBJECTS TIME TO REACH STEADY STATE OF AMBIENT OXYGEN -

02MAX CONCENTRATOR 10L VS AIRLIFE CONCENTRATOR 10L VS AIRLIFE

70 BOTTLED OXYGEN 15L VS AIRLIFE NON-REBREATHER BOTTLED 15L

) 2 60

50 02MAX 10L CONCENTRATOR 40 AIRLIFE 10L 30 CONCENTRATOR AIRLIFE 15L 20 BOTTLED O2

Ambient Oxygen Ambient Oxygen Levels (%0 AIRLIFE NON 10 REBREATHER 15L BOTTLED O2 0 AVE MIN 1 AVE MIN 2 AVE MIN 3

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2 OXYGEN CONCENTRATOR AND 02MAX™ (GRAPH 2)

Graph 2 shows an average of AOP over 3 minutes for all 4 mask/oxygen delivery methods.

10 HUMAN SUBJECTS AVERAGE AMBIENT OXYGEN LEVELS OVER 3

MINUTES AT STEADY STATE

51% 49% 51%

50

45 39% 02MAX CONCENTRATOR 02 10L 40

35 AIRLIFE CONCENTRATOR 02 10L 30 AIRLIFE BOTTLED O2 15L 25

20 AIRLIFE NON-REBREATHER BOTTLED O2 15L 15 10

Ambient oxygenlevels inmask (%) 5 0

Key points from this graph:

 Primary – 02MAX™ using an oxygen concentrator at 10 liters/02 flow per minute had the same AOP as the market leader, AirLife® (both simple as well as non-rebreather bag), using bottled oxygen at 15 liters/02 flow per minute.  Secondary – 1,2,3 o As seen prior , 02MAX™ delivers significantly more oxygen at 10/liters per minute flow than AirLife® - 51% compared to 39%; a 30.7% difference. o As seen prior3, there appears to be no increase in oxygen delivery with a non-rebreather bag.

CONCLUSIONS

02MAX™ using an oxygen concentrator at 10 liters/02 flow per minute had the same AOP as the market leader,

AirLife® (both simple as well as non-rebreather bag), using bottled oxygen at 15 liters/02 flow per minute. Thus confirming the hypothesis as noted in the goal. With concentrators now able to deliver 10L/02/min flow used in conjunction with the 02MAX™ it may be soon possible to eliminate the usage of bottled oxygen in many areas of usage such as hospitals, clinics and ambulances. In the USA alone, more than 5.4 million ambulance runs utilize

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bottled oxygen and obviously this same paradigm shift can take place elsewhere throughout most of the world that also uses bottled oxygen. Switching to oxygen concentrators will result in less staff time (filing bottles), cheaper costs (tanks and filling fees) as well as improved safety (explosions and fires). Oxygen concentrators that flow at 10L per minute are presently large and would need weight and size reduction; however, with the size of the potential market for such a device commercialization of a smaller/lighter version should not be insurmountable.

02MAX™ has been proven to deliver significantly more oxygen and be more comfortable than the market leaders; the results of this study offer additional value by opening up massive brand new markets combining oxygen concentrators with 02MAX™ for further cost savings and safety improvements.

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ATTACHMENT 1

Oxygen % measuring device (GOX 100) from Greisinger Electronic) (Part 2 – the

sensor)

Oxygen % measuring device (GOX 100 from Greisinger Electronic) (Part 1 – the electronics)

Respironics Milennium M10 Oxygen

Concentrator. Dimension 27” x 19” x 13”. 53lb Version 032418

TABLE 1 (10 Adult Subjects)

02 MAX CONCENTRATOR 10L VS REGULAR 10L CONCENTRATOR, VS REGULAR 15L BOTTLE AND NON REBREATHER 15L BOTTLE 02 MAX 10L REGULAR 10 REGULAR 15L NON REB 15L % FEMALE HEIGHT (IN) WEIGHT (LB) AGE 60.0% 66.8 152.2 40.0 TIME 10 29.2 16.1 37.5 35.0 20 30.3 18.7 43.5 41.1 30 33.7 23.0 45.1 43.9 40 39.2 28.3 44.6 47.3 50 42.7 34.0 46.6 48.7 60 45.1 37.5 46.4 48.7 1:10 47.9 39.0 46.9 49.8 1:20 48.3 39.7 46.4 47.8 1:30 51.4 39.4 46.1 51.8 1:40 52.3 39.7 45.7 48.1 1:50 51.9 40.9 48.7 50.7 2:00 51.6 40.8 50.5 48.2 2:10 53.9 37.3 47.5 52.0 2:20 54.0 40.7 50.2 53.1 2:30 55.7 39.9 46.7 51.3 2:40 57.8 42.5 48.4 50.5 2:50 56.7 43.7 46.4 51.4 3:00 56.9 41.5 46.5 51.2 3:10 3:20 3:30 3:40 3:50 4:00 4:10 4:20 4:30 4:40 4:50 5:00 AVE ALL 51 39 49 51 AVE MIN 1 40 29 47 47 AVE MIN 2 54 43 50 52 AVE MIN 3 59 44 51 55 AVE MIN 4 0 0 0 0 AVE MIN 5 0 0 0 0

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REFERENCES

1. Evaluation of the Sharp Medical Products, LLC 02MAX™ Face Mask vs Airlife Commercial Face Mask – An Independent Prospective University Study. Accepted SAEM presentation May 2018 2. Evaluation of the Sharp Medical Products, LLC Face Mask vs 3 Commercial Face Masks – Standard (Airline), Oxymask and the Panoramic Face Mask. 2016

3. Internal Evaluation of Sharp Medical Products New Commercial Grade Face Mask - 02MAX™. 2016 4. Quora. https://www.quora.com/How-many-ambulances-and-firetrucks-are-there-in-the-US 5. National Study of Ambulance Transports to United States Emergency Departments. Prehospital and Disaster Medicine. 21 (2): 82-90, 2006 6. Emergency Oxygen Therapy: From Guideline to Implementation. Breathe 9:246-253, 2013

7. Comfort Evaluation Comparing Sharp Medical Products, LLC 02MAX™ Face Mask vs Airlife from Carefusion, 2016

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