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Supporting Research CONTACT SALES +01 (814) 355-0003 x117 [email protected] ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip Learn more at GentleSharp.com These works are/were partially supported by the National Institutes of Health: National Institute on Aging SBIR grant No. AG037214. The views, opinions and/or findings contained in this work are those of Actuated Medical, Inc. and should not be construed as an official government position, policy or decision unless so designated by other documentation.
Transcript

Supporting Research

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

These works are/were partially supported by the National Institutes of Health: National Institute on Aging SBIR grant No. AG037214.

The views, opinions and/or findings contained in this work are those of Actuated Medical, Inc. and should not be construed as an

official government position, policy or decision unless so designated by other documentation.

0

200

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600

800

1000

WEEK 1 WEEK 2 WEEK 3

A More Humane Blood Sampling System

Reduced Plasma Corticosterone forSerial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> Sprague Dawley Rats (n =19).

> 9 total collection trials per subject - 3 sampling days (1 week apart) with

3 collections / day spaced 60 min apart.

> Week 1 - ON group: n = 19 trials with 10 rats; OFF group: n = 21 trials with 9 rats;

OFF vs ON groups, compared within week; Error bars = standard error of the mean.

SummaryGentleSharp reduces the average

plasma corticosterone concentration

obtained from rat tail vein samples

during serial blood collections.

Results With GentleSharp ON during needle

puncture (orange bar), the average

plasma corticosterone concentration

is reduced compared to GentleSharp

OFF during puncture (gray bar) on

week 2 (49.2% reduction) and 3

(65.2% reduction) of blood collections.

Repeated Measures Analysis of

Variance, statistical significance

of mean difference within week

of collection:

* p < 0.05

Co

rtic

oste

ron

e (

ng

/mL

)

* p < 0.05

Reduction: 9.7% 49.2% 65.2%

*

*

OFF

ON

A More Humane Blood Sampling System

Reduced Animal Movement and Vocalization for Serial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> Sprague Dawley Rats (n = 19).

> 9 total collection trials per subject - 3 sampling days (1 week apart)

with 3 collections / day spaced 60 min apart.

> Videos of collections viewed and graded (Likert Scale, 1 - 5) by blinded reviewers.

> ON group: n = 30 trials with 10 rats; OFF group: n = 27 trials with 9 rats;

OFF vs ON groups, compared within week; Error bars = standard error of the mean.

SummaryGentleSharp reduces the average

animal vocalization (VOCAL) and

movement (MOVE) during serial

blood sampling from rat tail veins.

Results With GentleSharp ON during needle

puncture (orange bars), the average

animal movement (MOVE) and

vocalization (VOCAL) is reduced

compared to GentleSharp OFF during

puncture (gray bars) on weeks 2 and

3 of blood collections.

Student’s t-test, statistical

significance of mean difference

within week of collection:

* p < 0.05 ** p < 0.005

00.0

0.5

1.0

1.5

2.0

2.5

3.0

WEEK 1

VOCAL MOVE VOCAL MOVE VOCAL MOVE

WEEK 2 WEEK 3

Ave

rag

e R

ati

ng

(1 -

5 S

ca

le)

* p < 0.05** p < 0.005

****

* *

OFF

ON

A More Humane Blood Sampling System

Reduced Peak Insertion Force During Rat Tail Penetration

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> Cadaver Sprague Dawley Rat Tails (n = 6) at 3 separate locations

along length of tail as shown.

> ON n = 18; OFF n = 18; Error bars = standard deviation.

SummaryGentleSharp reduces the peak

insertion force required for needle

insertions into cadaver rat tails.

Results With GentleSharp ON during needle

puncture (orange bar), the average

peak insertion force for needle

insertions into rat cadaver tails was

reduced by 67.5% compared to

GentleSharp OFF during puncture

(gray bar).

Student’s t-test, statistical

significance of mean difference:

** p < 0.001

0.0

0.02

0.04

0.06

0.08

1.0

1.2

1.4

OFF ON

1.8

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

0.0

1 2 3 4

16 12 8 4 0 (cm)Difference = 67.5%

** p < 0.001

OFF

ON

Pe

ak

Fo

rce

(n

)

Pe

ak

Fo

rce

(n

)

Tail Section

> INDIVIDUAL TRIALS < > AVERAGE MEANS OF ALL TRIALS <

**

A More Humane Blood Sampling System

Decreased Needle Insertions for Serial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice (n = 47), starting at ~11 wks of age.

> 9 total collection trials per subject - 3 sampling days (1 week apart) with

3 collections / day spaced 30 min apart; each trial limited to 3 insertion attempts.

> ON group: n = 216 trials with 24 mice; OFF group: n = 207 trials with 23 mice;

Error bars = standard error of the mean.

SummaryGentleSharp reduces the average

number of needle insertions required

to obtain a successful blood sample

from mice tail arteries during serial

blood collections.

Results With GentleSharp ON during needle

puncture (orange bar), the average

number of needle insertions required

to obtain a successful sample was

significantly reduced compared to

the GentleSharp OFF during puncture

(gray bar).

Repeated Measures Analysis of

Variance, statistical significance of

mean difference:

** p < 0.01

Ne

ed

le I

nse

rtio

ns

** p < 0.01

**2.5

2.0

1.5

1.0

0.5

0.0

OFF ON

A More Humane Blood Sampling System

Increased Collection Success for Serial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice (n = 47), starting at ~11 wks of age.

> 9 total collection trials per subject - 3 sampling days (1 week apart) with

3 collections / day spaced 30 min apart; each trial limited to 3 insertion attempts.

> ON group: n = 24 mice; OFF group: n = 23 mice;

Error bars = standard error of the mean.

SummaryGentleSharp increases the average

success rate for serial blood collection

from mice tail arteries.

Results For the group with GentleSharp ON

(orange bar) during needle puncture,

there was a significantly higher success

rate compared to the group punctured

with GentleSharp OFF (gray bar).

Success is defined as obtaining

sufficient blood for performance of

Radio-Immuno Assay (RIA) for plasma

corticosterone; individual success rate

based on 9 collection trials per animal

(e.g., 9:9 = 100%).

Student’s t-test, statistical significance

of mean difference:

* p < 0.05

Su

cc

ess (

%)

Difference = 10%

* p < 0.0590

85

80

75

70

65

OFF ON

*

A More Humane Blood Sampling System

Decreased Needle Insertions for Serial Blood Collection - Repeated Sampling On Same Day

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice (n = 47), starting at ~11 wks of age.

> 9 total collection trials per subject - sampling days (1 week apart) with

3 collections / day spaced 30 min apart; each trial limited to 3 insertion attempts.

> ON group: n = 72 trials with 24 mice; OFF group: n = 69 trials with 23 mice; OFF vs

ON groups, compared within each collection separately; Error bars = standard

error of the mean.

SummaryGentleSharp reduces the average

number of needle insertions required

for successful blood collection from

mice tail arteries during serial blood

collections within same collection day.

Results With GentleSharp ON during needle

puncture (orange bars), the average

number of needle insertions required

to successfully obtain sample was

significantly reduced compared to

the GentleSharp OFF during puncture

(gray bars).

Repeated Measures Analysis of

Variance, statistical significance

of mean difference within collection:

* p < 0.05

Ne

ed

le I

nse

rtio

ns

OFF

ON

Collection 1 Collection 2 Collection 3

*

* p < 0.052.6

2.4

2.2

2

1.8

1.6

1.4

1.2

1

A More Humane Blood Sampling System

Increased Collection Success for Novice Collectors

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice, starting at ~11 wks of age; Target: Tail Artery.

> Success is defined as obtaining sufficient blood for performance of RIA for plasma

corticosterone; success rate based on successful collections / total collections attempted.

Sample Sizes for Collections represented below each graph (successful trial / total trials).

> Experiment 1 was completed within a single collection day.

> Experiment 2 was completed over two months:

M1= Month 1 totals; M2 = Month 2 cumulative totals.

SummaryGentleSharp increases the average

success rate for novice collectors to

successfully obtain blood samples

from mice tail arteries, enabling them

to achieve the performance of a

trained collector quicker.

Results Novice collectors exhibited greater

differences in success rates between

collections completed with GentleSharp

ON (orange bars) vs OFF (gray bars)

during needle puncture compared to

Trained collectors.

Where procedures performed with

GentleSharp ON, the gap in success

rate between Novice and Trained was

essentially eliminated.

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80

60

40

20

0

100

80

60

40

20

0

Su

cc

ess (

%)

Su

cc

ess (

%)

Experiment 1 Experiment 2

OFF

ON

OFF

ON

Novice Trained Novice Trained Novice Trained

Month 1 (M1) Month 2 (M2)

Novice Trained

M1 OFF 3/7 101/113

M1 ON 8/8 107/113

M2 OFF 10/15 117/129

M2 ON 16/16 122/129

Novice Trained

OFF 5/11 10/12

ON 12/12 11/12

A More Humane Blood Sampling System

Increased Blood Mass for Serial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice (n = 47), starting at ~11 weeks of age.

> 9 total collection trials per subject - 3 sampling days (1 week apart)

with 3 collections / day spaced 30 min apart.

> ON group: n = 215 trials with 24 mice; OFF group: n = 205 trials with 23 mice;

Error bars = standard error of the mean.

SummaryGentleSharp increased the average

blood mass collected per trial during

serial blood collections from mice

tail arteries.

Results With GentleSharp ON during needle

puncture (orange bar), the average

blood mass was 26.7% greater

compared to GentleSharp OFF

during puncture (gray bar).

Repeated Measures Analysis of

Variance, statistical significance of

mean difference:

* p = 0.05

Blo

od

Ma

ss (

g)

Difference = 26.7%

* p = 0.05 *0.045

0.040

0.035

0.030

0.025

0.020

0.015

0.010

0.005

0.000

OFF ON

A More Humane Blood Sampling System

No Significant Change in Mice Handling Time for Serial Blood Collection

CONTACT SALES+01 (814) 355-0003 [email protected]

ART-5022-3 Rev03 / ECO #3938 Pat. ActuatedMedical.com/ip

Learn more atGentleSharp.com

Experimental Design> C57BL/6J mice (n = 47), starting at ~11 weeks of age.

> 9 total collection trials per subject - 3 sampling days (1 week apart)

with 3 collections / day spaced 30 min apart.

> ON group: n = 212 trials with 24 mice; OFF group: n = 203 trials with 23 mice;

Error bars = standard error of the mean.

SummaryGentleSharp does not alter the animal

handling time required for blood

collections during serial blood

collections from mice tail arteries.

Results With GentleSharp ON (orange bar)

during needle puncture, the mean

handling time for collection trended

to be reduced compared to the

GentleSharp OFF during puncture

(gray bar).

Repeated Measures Analysis of

Variance, statistical significance

of mean difference:

p = 0.19

Ha

nd

lin

g T

ime

(s)

105

100

95

90

85

80

OFF ON


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