Supporting Research

Supporting Research
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Reduced Plasma Corticosterone for
Serial Blood Collection
GentleSharp 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
Corticosterone (ng/mL)
Summary
1000
* p < 0.05
OFF
ON
*
800
*
600
400
200
0
WEEK 1
Reduction:
9.7%
WEEK 2
49.2%
WEEK 3
65.2%
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Reduced Animal Movement and
Vocalization for Serial Blood Collection
GentleSharp 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
Average Rating (1 - 5 Scale)
Summary
3.0
* p < 0.05
** p < 0.005
**
**
2.5
OFF
ON
*
*
2.0
1.5
1.0
0.5
0.0
0
VOCAL
MOVE
WEEK 1
VOCAL
MOVE
WEEK 2
VOCAL
MOVE
WEEK 3
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Reduced Peak Insertion Force During
Rat Tail Penetration
Summary
GentleSharp reduces the peak
insertion force required for needle
insertions into cadaver rat tails.
16
12
8
4
0 (cm)
Difference = 67.5%
** p < 0.001
1.4
1.2
1.4
1.2
Peak Force (n)
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).
Peak Force (n)
Results
1.8
1.6
1.0
0.8
0.6
0.4
0.2
0.0
OFF
ON
0.08
0.06
**
0.04
0.02
1
Student’s t-test, statistical
significance of mean difference:
** p < 0.001
1.0
2
3
Tail Section
> INDIVIDUAL TRIALS <
4
0.0
OFF
ON
> AVERAGE MEANS OF ALL TRIALS <
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Decreased Needle Insertions for Serial
Blood Collection
Summary
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
** p < 0.01
2.5
Needle Insertions
GentleSharp reduces the average
number of needle insertions required
to obtain a successful blood sample
from mice tail arteries during serial
blood collections.
**
2.0
1.5
1.0
0.5
0.0
OFF
ON
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Increased Collection Success for Serial
Blood Collection
90
GentleSharp increases the average
success rate for serial blood collection
from mice tail arteries.
85
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 ≥ 0.01
g total blood mass (~10 µl blood) per
trial; individual success rate based on
9 collection trials per animal (e.g. 9:9 =
100%).
Success (%)
Summary
** p < 0.005
**
80
75
70
65
60
55
50
OFF
ON
Average Success Rate
64.7 ± 3.4%
80.1 ± 3.5%
Proportion with
100% Success
0/23 = 0%
6/24 = 25%
Experimental Design
Student’s t-test, statistical significance
of mean difference:
** p < 0.005
> 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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Decreased Needle Insertions for Serial Blood
Collection - Repeated Sampling On Same Day
Summary
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
OFF
ON
* p < 0.05
Needle Insertions
GentleSharp reduces the average
number of needle insertions required
for successful blood collection from
mice tail arteries during serial blood
collections within same collection day.
2.6
2.4
2.2
2
1.8
1.6
*
1.4
1.2
1
Collection 1
Collection 2
Collection 3
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
Summary
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.
Experiment 2
Experiment 1
OFF
ON
OFF
ON
100
Success (%)
GentleSharp 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.
100
Success (%)
A More Humane Blood Sampling System
Increased Collection Success for
Novice Collectors
80
60
40
20
0
Novice
Trained
80
60
40
20
0
Novice
Trained
Month 1 (M1)
Novice
Trained
OFF
5/11
10/12
M1 OFF
ON
12/12
11/12
Novice
Trained
Month 2 (M2)
Novice
Trained
3/7
101/113
M1 ON
8/8
107/113
M2 OFF
10/15
117/129
M2 ON
16/16
122/129
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
Increased Blood Mass for Serial Blood
Collection
Summary
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).
0.045
0.040
Blood Mass (g)
GentleSharp increased the average
blood mass collected per trial during
serial blood collections from mice
tail arteries.
Difference = 26.7%
* p = 0.05
*
0.035
0.030
0.025
0.020
0.015
0.010
0.005
0.000
OFF
Repeated Measures Analysis of
Variance, statistical significance of
mean difference:
* p = 0.05
ON
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip
A More Humane Blood Sampling System
No Significant Change in Mice Handling
Time for Serial Blood Collection
Summary
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
105
Handling Time (s)
GentleSharp does not alter the animal
handling time required for blood
collections during serial blood
collections from mice tail arteries.
100
95
90
85
80
OFF
ON
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.
Learn more at
GentleSharp.com
CONTACT SALES
+01 (814) 355-0003 x117
[email protected]
ART-5022-3 Rev04 / ECO #4097
Pat. ActuatedMedical.com/ip