Name: HYPOXIC BLOOD STORAGE
Uploaded: 2022-09-21
Duration: 5 min 35 s
Description: HYPOXIC BLOOD STORAGE. June 2022 Laurel Omert MD.

HYPOXIC BLOOD STORAGE. June 2022 Laurel Omert MD. 

Scene 1

I am an employee of Hemanext. This presentation contains forward-looking statements, which provide our current expectations, beliefs or forecasts of future events. Forward-looking statements include, without limitation, for example, statements regarding the clinical development of our products and potential attributes and benefits of such products.. 

Scene 2

The  Hemanext  ONE® System has not been authorized, cleared or approved by FDA and is pending FDA De Novo review.  It received CE mark certiﬁcation in April 2021.

This presentation contains forward-looking statements, which provide our current expectations, beliefs or forecasts of future events. Forward-looking statements include, without limitation, for example, statements regarding the clinical development of our products and potential attributes and benefits of such products.

We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results could differ materially from those anticipated in the forward-looking statements for many reasons.

You should not unduly rely on these forward-looking statements, which are made as of the date of this document. We undertake no obligation to update any such statements to reflect circumstances or the occurrence of unanticipated events after the date of this document.

22% SO 2. 27% SO 2. DONATED UNITS ILLUSTRATE THE NATURAL RANGE AND VARIABILITY IN SO 2. 

Scene 3

DONATED UNITS ILLUSTRATE THE NATURAL RANGE AND VARIABILITY IN SO 2

Current Storage Method D" of St.. Landry P, Ducas E, De Grandmont MJ, et al. Poster presented at: 35th International Congress of the ISBT; 2018 June 2-6; Toronto, Canada.. 

Scene 4

HYPOXIC BLOOD REDUCES DONOR VARIABILITY  AND CONTROLS OXYGEN DURING STORAGE

Landry P,  Ducas  E, De  Grandmont  MJ, et al. Poster presented at: 35th International Congress of the ISBT; 2018 June 2-6; Toronto, Canada.

ATP (pmol/gHb). Kea Kea 088 eu!lesea uuv Kpms. FDA Clinical Trial 001 Results: ATP. 

Scene 5

ATP was tested at Baseline, 21 days and 42 days of storage Both Control and  Hemanext  were also able to be rejuvenated at the end of storage

* 12 hours vs. 8 hours of processing time **  p < 0.0001 ***  p < 0.003

Brought to you by  Hemanext Clinical Trial 001

ControllAS3*
(e 8 hours)
4.6
eme)
3.4

(qH6/10Wd) Oda e'z @. Study Arm Baseline Day 21" Day 42. 

Scene 6

2,3 DPG was tested at Baseline, 21 days and 42 days of storage Both Control and  Hemanext  were also able to be rejuvenated at the end of storage.

* 12 hours vs. 8 hours of processing time ** p < 0.0001

FDA Clinical Trial 001 Results: Morphology. Morphology was tested at Baseline, 21 days and 42 days of storage Wet-prep slides fixed with 1% glutaraldehyde in PBS 100 RBCs scored per system below and given weighted score. 

Scene 7

FDA Clinical Trial 001 Results: Morphology

Morphology was tested at Baseline, 21 days and 42 days of storage Wet-prep slides fixed with 1% glutaraldehyde in PBS 100 RBCs scored per system below and given weighted score

Clinical Trial 001 John D. Bauer, ed., Clinical Laboratory Methods, 9th Ed. (St. Louis, MO: C.V. Mosby Co.) 1982. Meryman  HT,  Homblower  M, Storage of Washed Red Cells. Vox Sang 1991;60(2):88-98

(001-0 euoos) K6010qdJ0bAd 08B. Study Ann Baseline Day 21" Day 42". 

Scene 8

* 12 hours vs. 8 hours of processing time **  p < 0.0001

Hypoxic Blood*
12 hours)
82.1
n=96
74.5
n=95

Adverse Event. a Study Arm Mild Moderate Inli Severe. 

Scene 9

9 subjects experienced 15 adverse events (AEs*) 13 AEs occurred during blood donation phase; 2 occurred during  in vivo  phase Nausea and bruising at blood draw site reported during infusion in same subject

*AEs included dizziness, light-headedness, bruising and hematoma at blood draw sites **Appendicitis deemed unrelated to IP

a
Study Arm
Mild
Moderate
Inli
Severe

10. TRANSFUSION OF ANAEROBICALLY OR CONVENTIONALLY STORED BLOOD AFTER HEMORRHAGIC SHOCK Alexander T. Williams, • Vivek P. Jani, • Travis Nemkov,t Alfredo Lucas, • Tatsuro Yoshida,t Andrew Dunham, $ Angelo D'Alessandro, t and Pedro Cabrales• •Departrnent Of Biænginæring. University Of California San Diep, La Jolla, California; and Mola;ular Genetics. University of Coloraå' Denver. Aurora, Cdorac±; and 'Hemanext. Lexington, Massachuætts. 

Scene 10

TRANSFUSION OF ANAEROBICALLY OR CONVENTIONALLY STORED
BLOOD AFTER HEMORRHAGIC SHOCK
Alexander T. Williams, • Vivek P. Jani, • Travis Nemkov,t Alfredo Lucas, •
Tatsuro Yoshida,t Andrew Dunham, $ Angelo D'Alessandro, t
and Pedro Cabrales•
•Departrnent Of Biænginæring. University Of California San Diep, La Jolla, California;
and Mola;ular Genetics. University of Coloraå' Denver. Aurora, Cdorac±; and 'Hemanext.
Lexington, Massachuætts

SHOCK, Vol. 53, No. 3, pp. 352–362, 2020

Developed pre-clinical model to measure differences in RBC quality. 

Scene 11

30 min 50% blood  vol Hypovolemic Shock Hemorrhage Baseline Measurement LV catheter  calibration

Developed pre-clinical model to measure differences in RBC quality

Oxygen delivery & vascular management – resuscitation of blood pressure

Oxygen delivery – lactate reduction after shock

Marker of blood integrity – post-transfusion intravascular hemolysis

Markers of organ inflammation – kidneys, liver, lungs, spleen

Hypoxically stored blood reduced time to achieve resuscitation after hemorrhagic shock in Rat model. 

Scene 12

Hypoxically stored blood reduced time to achieve resuscitation after hemorrhagic shock in Rat model

Blood volume  required to maintain 90% MAP (mL) Conventional Hypoxic Resuscitation Time (min) Blood Volume Could not resuscitate Resuscitation Time =45 min

Hypoxically stored blood reduced volume needed to achieve resuscitation after hemorrhagic shock by ~50%. 

Scene 13

Hypoxically stored blood reduced volume needed to achieve resuscitation after hemorrhagic shock by ~50%

Hypoxic storage dramatically improved resuscitation efficacy and reduced the volume capable of achieving resuscitation.

Blood volume  required to maintain 90% MAP (mL) 2 4 6 8 10 Hypoxic Conventional Resuscitated ALL animals in shock Could not resuscitate animals in shock 4.7mL 8.8mL Blood Volume 80% 24hr  Recovery in Healthy Animals 83% 24hr Recovery in Healthy Animals

Hemolysis was greater in conventionally stored RBC compared to hypoxic RBC in Rat model. 

Scene 14

Hemolysis was greater in conventionally stored RBC compared to hypoxic RBC  in Rat model

Lactate was cleared faster by resuscitation with hypoxically stored blood: A Rat model. 

Scene 15

Lactate was cleared faster by resuscitation with hypoxically stored blood: A Rat model

After 60 minutes of resuscitation, the hypoxic stored blood is almost back  to baseline lactate level  * Includes ± standard deviation

Markers of kidney damage were reduced with hypoxically stored blood. 

Scene 16

Markers of kidney damage were reduced with hypoxically stored blood

Elevated amount of blood urea nitrogen (BUN) may be a sign that the animal’s kidneys aren’t working efficiently u-NGAL is a marker for the detection of acute kidney injury  * Includes ± standard deviation Neutrophil gelatinase-associated lipocalin

HYPOXIC BLOOD STORAGE

Scene 1 (0s)

Scene 2 (7s)

Scene 3 (1m 2s)

Scene 4 (1m 16s)

Scene 5 (1m 35s)

Scene 6 (1m 58s)

Scene 7 (2m 21s)

Scene 8 (2m 51s)

Scene 9 (3m 5s)

Scene 10 (3m 27s)

Scene 11 (3m 51s)

Scene 12 (4m 17s)

Scene 13 (4m 32s)

Scene 14 (4m 56s)

Scene 15 (5m 8s)

Scene 16 (5m 20s)