100

75

50

25

Proximal Tibia (91.38%)

Humeral Head(93.10%)

N I O ™ S U C C E S S R A T E ( % )

w w w . p s - m e d . c o m › 7 1 3 . 7 2 3 . 6 0 0 0 › i n f o @ p s - m e d . c o m

CLINICAL SUMMARY: HUMAN CADAVER STUDIES.Four major clinical evaluations were conducted on human cadavers in suppor t of FDA submission and approval for the NIO™. Two evaluations were conducted at the Central Morgue of Lima, Peru, one evaluation was conducted at the Georgia Health Sciences University cadaver lab, and another evaluation was conducted at the New York Institute of Technology College of Osteopathic Medicine under the super vision of Dr. Bennet t Fut terman. All four studies were submit ted to the FDA as par t of validation and verification testing on the NIO™. The highlights of these studies are discussed below.

F I R S T A T T E M P T S U C C E S S R A T E S A S H I G H A S 9 8 %› Initial testing demonstrated an overall average success rate of 91.3% for the proximal tibia, and 93.1% for the humeral head. The New York Institute of Osteopathic Medicine conducted a 4 th study which established a proximal tibia success rate of over 98%.

E A S I LY T O L E R A T E S C O M M O N U S E R E R R O R S› The study evaluated common user errors related to needle placement and found that even when placed up to 5cm from the correc t inser tion site, the NIO™ maintained an 85% success rate.

S A F E O N T H E B O N E› The NIO™ proved to be safe on the bone, and resulted in zero incidence of bone frac ture as obser ved by post-inser tion X-rays.

R A P I D R E S U L T S W I T H H I G H U S E R S A T I S F A C T I O N› The average time of placement for the NIO™ was 18.3 seconds with 10 second times achieved by trained personnel. Users repor ted a satisfac tion rate of 8.5 on a scale of 1 - 10.

CLINICAL SUMMARY: HUMAN CADAVER STUDIES.

NIO™

P e r S y s M e d i c a l › L i f e S a v i n g I n n o v a t i o n s

F I N A L L Y — A N E W C H O I C E I N I N T R A O S S E O U S

The NIO™ is an simple, automatic intraosseous device packaged for safe, quick, and easy vascular access. No drills, no batteries, no extra parts.

K E Y F E A T U R E S

THE NEW IO. VASCULAR ACCESS MADE SIMPLE.

› Sterile - zero chance of cross-contamination› Vascular access in as few as 10 seconds› Disposable and single-use

› No external power source or bat ter y needed› Pocket-sized and lightweight - 3.5oz› No maintenance required

› Patient-friendly, no exposed needle› Assembled ready to use in package › 5 year shelf life