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A R T ' s P r opri e t a r y H e m o - P r o t ec t i v e Flow Technology Features Bloo d p r o t e ct io n 1 - 1.5 liters of blood are being enriched with oxygen, rebalance patient's oxygen saturation levels in minutes A R T ' s d es i g n e d f e a t u r e s Hemolysis reduction Thrombosis reduction A unique (Low) flow - velocity ratio maintained throughout blood passage in disposable set V V A low - volume oxygenator V Pump head design for low flow V V Short dual lumen cannula design V Entire disposable set is coated with anticoagulants V 1. In August 2020, animal studies were performed in swine model at LAHAV CRO in Israel. 2 - 3. www.Britannica.com Copyright 2018 - 2 C 0 op 2 y 2 rig I h n t s pi 2 r 0 a 18 T - e 20 c 2 h 1 n In o s l p o ir g a i T e e s ch O no X l Y og B ie . s H O . X N Y . B L .H T .N D . . L , T A D l ., l A r l i l g r h ig t h s ts r r e es s e e rv r e v d ed 9 Hemolysis - breakdown or destruction of red blood cells so that the contained oxygen carrying pigment hemoglobin is freed into the surrounding medium Thrombosis - formation of a blood clot in the hart or in a blood vessel
What Proprietary Components Are We Developing?
What Differentiates ART From ECMO?
ART Vs. ECMO Patient population Cannulation Mechanical design of device and cannula Patient sedative state Ventilator induced lung injury Hospital's prior experience with ECMO Market size
ART System Vs. ECMO: Hospital's Prior Experience With ECMO ECM O * ECMO treatment is limited to hospitals with relevant know how and accumulated experience: ICU physicians, perfusionist and trained ICU nurses must operate and monitor a patient treated with ECMO. ECMO cannot be operated in the absence of a perfusionist ART design will may potentially eliminate the need for a perfusionist and facilitate its everyday use. 1. Innovative automatic auto - priming system, eliminates the need for perfusionists, and prevents air embolism 2. Disposable Cartridge is a one unit, no need to connect the different disposable element prior to use 3. Disposable cartridge is entered into the device in a plug - and - play easy to use manner ART would potentially be used in any ICU, with or without prior ECMO experience. For that reason, the device commercial potential is significantly larger than ECMO's * https:/ /ww w .elso.org/Portals/0/ELSO%20Guidelines%20General%20All%20ECLS%20Version%201_4.pdf (Accessed on July 23, 2018) ART System Perfusionist - operates a heart - lung machine (extracorporeal respiratory system), which is an artificial blood pump, which propels oxygenated blood to the patient's tissues
The Unmet Need Who Can Benefit From ART TM Treatment
Acute Respiratory Failure: Current Treatment Paradigm Acute Respiratory Failure Hypoxemia Hypercarbia Hypoxemia & Hypercarbia RESPIRATORY DETERIORATIO Nasal m ask F a c e m ask Nasal p lu g s BI P AP C P AP Non - Invasive Ventilation ECMO (selected pt.) Extracorporeal Membrane Oxygenation Oxygen Helmet HFNC (High Flow Nasal Cannula) T R E A T M E N T E S C E L A T I O N 1. A Grade 2C recommendation is a very weak recommendation; other alternatives may be equally reasonable. 2. Brown 3rd CA, Walls RM. The decision to intubate. In: The Walls Manual of Emergency Airway Management, 5th ed, Lippincott Williams & Wilkins, Philadelphia 2018. p.3. 3. h ttps://w ww.elso .org/Portals/0/ELSO%20Guidelines%20General%20All%20ECLS%20Version%201_4.pdf (Accessed on July 23, 2018). Copyright 2 C 0 op 1 y 8 ri - gh 2 t 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 In T s e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . TD LT ., D Al . l , r A igh ll ts ri r g es h er t v s e r d ese 2 r 8 ved Invasive ventilation
Our mission is to provide an alternative for invasive mechanical ventilation for acute respiratory patients who continue to deteriorate following non - invasive ventilation treatment. Non - invasive ventilation (NIV) - is the delivery of oxygen (ventilation support) via a face mask and therefore eliminating the need of an endotracheal airway. Invasive mechanical ventilation - is positive pressure delivered to the patient's lungs via an endotracheal tube or a tracheostomy tube. Copyright 2 C 0 o 1 p 8 yr - ig 2 h 0 t 2 2 2 I 0 n 1 s 8 p - 2 i 0 r 2 a 2 T In e sp c i h ra n T o e l c o hn g o ie lo s gi O es X O Y XY B B . . H H. . N N . . LT L D T . D , A . l , l r A ig l h l t r s ig re h se t r s ve r d ese 2 r 9 ved
1. Am J Respir Crit Care Med Vol. 196, P3 - 4, 2017. ATS Patient Education Series 2017 American Thoracic Society 2. Diling Wu et al. Frontiers in pharmacology MINI REVIEW published: 09 May 2019. doi: 10.3389/fphar.2019.00482 3. Kalil AC, Metersky ML, Klompas M, et al. Management of Adults With Hospital - acquired and Ventilator - associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016;63:e61 - e111. Mechanical ventilation requires intrusive intubation, c om a induc t i o n , an d c a n b e v e r y t r au m a t i c f o r p a t i e n t s : Potential Risks & Complications Ventilator - induced lung injury (VILI) Ventilator - associated pneumonia (VAP) Ventilator - induced diaphragmatic dysfunction (VIDD) Pneumothorax & tracheomalacia Oxygen toxicity of the lung Delirium Muscular atrophy High Cost of Treatment Long hospital stays Increased complication rate Patient re - admissions Requires weaning process Extended rehabilitation period Mechanical Ventilation Has Significant Downsides Copyright 2 C 0 op 1 y 8 ri - g 2 ht 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 I T ns e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . T L D T ., D Al . l , r A igh ll ts ri r g es h e t rv s e r d ese 3 r 0 ved
Why Is It Important to Prevent Invasive Ventilation? 1 - UpToDate July 2021 Lung injury can be an adverse consequence of mechanical ventilation. This injury is called ventilator - induced lung injury (VILI) and can result in pulmonary edema, barotrauma, and worsening hypoxemia that can prolong mechanical ventilation, lead to multi - system organ dysfunction, and increase mortality 1 . Ventilator - induced lung injury (VILI) Copyright 2 C 0 op 1 y 8 ri - g 2 ht 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 I T ns e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . T L D T ., D Al . l , r A igh ll ts ri r g es h e t rv s e r d ese 3 r 1 ved
Why Is It Important to Prevent Invasive Ventilation? 1 - UpToDate July 2021 Mechanical ventilation itself causes diaphragmatic muscle atrophy; a phenomenon called ventilator induced diaphragmatic dysfunction (VIDD) 1 . Controlled mechanical ventilation may lead to a very rapid type of disuse atrophy involving the diaphragmatic muscle fibers, which can develop within the first day of mechanical ventilation Ventilator - induced diaphragmatic dysfunction (VIDD) Copyright 2 C 0 op 1 y 8 ri - g 2 ht 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 I T ns e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . T L D T ., D Al . l , r A igh ll ts ri r g es h e t rv s e r d ese 3 r 2 ved
Ventilator - associated pneumonia (VAP) 1 is a type of hospital - acquired pn develops after more than 48 hours of mechanical ventilation. VAP is a com in the intensive care unit that is associated with an increased risk of death eumonia (HAP) that mon and serious problem Why Is It Important to Prevent Invasive Ventilation? 1 - UpToDate July 2021 Ventilator - associated pneumonia Copyright 2 C 0 op 1 y 8 ri - g 2 ht 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 I T ns e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . T L D T ., D Al . l , r A igh ll ts ri r g es h e t rv s e r d ese 3 r 3 ved
Administration of analgesia and sedation to ensure patient comfort and facilitate mechanical ventilation must be balanced against the known negative consequences of excessive sedation Deep sedation, especially early during mechanical ventilation, is associated with prolonged time to liberation from mechanical ventilation, longer ICU stays, longer hospital stays, and increased mortality 1 . Negative consequences of sedation resulting from mechanical ventilation Copyright 2 C 0 op 1 y 8 ri - g 2 ht 0 22 20 I 1 n 8 s - p 20 i 2 ra 2 I T ns e p c ir h a n Te o c l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . T L D T ., D Al . l , r A igh ll ts ri r g es h e t rv s e r d ese 3 r 4 ved 1 - Pearson, Steven D., and Bhakti K. Patel. "Evolving targets for sedation during mechanical ventilation." Current opinion in critical care 26.1 (2020): 47. Why Is It Important to Prevent Invasive Ventilation?
Why Is It Important to Shorten Invasive Ventilation? 1 Marini, John J., and Patricia RM Rocco. "Which component of mechanical power is most important in causing VILI?." (2020): 1 - 3. 2 Hermans, Greet, et al. "Increased duration of mechanical ventilation is associated with decreased diaphragmatic force." Critical Care 14.1 (2010): 1 - 1. 3 Papazian, Laurent, Michael Klompas, and Charles - Edouard Luyt. "Ventilator - associated pneumonia in adults: a narrative review." Intensive care medicine 46.5 (2020): 888 - 906. Copyright 2 Co 0 p 1 y 8 ri - gh 2 t 0 2 2 20 I 1 n 8 s - 2 p 0 i 2 ra 2 I T n T s e p c ir h a n Te o c l l h o n g o i lo e g s ie O s O X X Y Y B B. . H H .N .N . L . TD LT ., D Al . l , r A i A gh ll ts r r ig es h er t v s e r r d ese 35 rved Reduce ventilator - induced lung injury The severity of VILI depends both on the degree (as determined by ventilator settings) and duration of the mechanical insult applied to the lungs 1 Reduce ventilator - induced diaphragmatic dysfunction Increased duration of mechanical ventilation is associated with decreased diaphragmatic force 2 Reduce ventilator associated pneumonia VAP is reported to affect 5 - 40% of patients receiving invasive mechanical ventilation for more than 2 days, with large variations depending upon the country, ICU type, and criteria used to identify VAP 3
ART Device Offers Two Intervention Modalities Patients deteriorating with noninvasive ventilation treatment, would be treated with ART 1. 2. Prevent mechanical ventilation Avoid: VALI, VIDD and VAP 1. 2. Shorten mechanical ventilation period Reduce VALI, VIDD and VAP W h en Where I CU Medical ward I CU Objectives Prevention of mechanical ventilation Shortening invasive mechanical ventilation duration Mechanically ventilated patients, would be treated with ART, shortly following the initiation of mechanical ventilation Copyri C g o h p t y rig 2 h 0 t 1 8 - 2 2 0 0 2 1 2 8 - I 2 n 0 sp 2 i 2 ra In T s e p c i h ra no Te lo c g h i n e o s l O og X i Y es B. O H X .N Y . B L . T H D .N ., . A L l T l D ri . g , h A t l s l r r i e g s h e t r s v r e e d served
Possible Indications ART TM may be used for the treatment of acute respiratory failure patients leading to hypoxemia, hypercarbia or both who continue to deteriorate following non - invasive ventilation ARDS Pneumonia Ast h ma COPD Copyr C ig o h p t y rig 2 h 0 t 1 8 - 201 2 8 1 - I 2 n 0 s 2 p 2 ira In T s e p c ir h a n T o e lo ch gi n e o s lo O g X i Y es B O .H X . Y N. B L .H TD .N ., . A LT ll D r . ig , h A t ll s r r i e g s h e ts rv r e e d served All indications are subject to testing in human clinical trials
ART TM may be applied during non - invasive ventilation stage to prevent mechanical ventilation: patient is awake, mobile and breathes spontaneously Immediate oxygen saturation elevation and stabilization Decreased breathing efforts Patient can eat and drink Patient can communicate their symptoms and needs to the medical staff Patient can communicate with family and friends No need for sedation - delirium can be prevented Muscle mass loss can be prevented Avoiding all forms of complications associated with MV Reduction of mortality rate Copyr C ig o h p t y rig 2 h 0 t 1 8 - 201 2 8 1 - I 2 n 0 s 2 p 2 ira In T s e p c ir h a n T o e lo ch gi n e o s lo O g X i Y es B O .H X . Y N. B L .H TD .N ., . A LT ll D r . ig , h A t ll s r r i e g s h e ts rv r e e d served Potential Advantages - The Patient's Perspective The Company's product has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA) or the CE or other required regulatory agencies.
ART TM treatment* may be added to mechanically ventilated patients Reduction of ventilation period Less aggressive ventilation - less PEEP, less driving pressures >>> reduced barotrauma and volutrauma Reduction of forms of complications associated with MV Reduction of mortality rate Potential Advantages - The Patient's Perspective Copyr C ig o h p t y rig 2 h 0 t 1 8 - 201 2 8 1 - I 2 n 0 s 2 p 2 ira In T s e p c ir h a n T o e lo ch gi n e o s lo O g X i Y es B O .H X . Y N. B L .H TD .N ., . A LT ll D r . ig , h A t ll s r r i e g s h e ts rv r e e d served * ART Treatment - Early extracorporeal blood oxygenation with 1 - 1.5 liters of blood. The Company's product has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA) or the CE or other required regulatory agencies.
Minimize the need for a medical team with prior experience with extracorporeal respiratory systems Reduced length of stay >>Increased patient throughput Reduced staffing Smaller Cannula (compared to ECMO's cannulas) may prevent the need for surgical access team Reduced costs associated with mechanical ventilation complications Reduction of patient load in ICU Potential Advantages - The Hospital Perspective Copyr C ig o h p t y rig 2 h 0 t 1 8 - 201 2 8 1 - I 2 n 0 s 2 p 2 ira In T s e p c ir h a n T o e lo ch gi n e o s lo O g X i Y es B O .H X . Y N. B L .H TD .N ., . A LT ll D r . ig , h A t ll s r r i e g s h e ts rv r e e d served
Clinicians would be able to offer an alternative to mechanical ventilation Self priming system results in less human errors No prior extracorporeal respiratory systems experience is needed Cannula size will allow ICU physicians to insert it without a surgeon involvement Potential Advantages - The Medical Team Perspective Copyr C ig o h p t y rig 2 h 0 t 1 8 - 201 2 8 1 - I 2 n 0 s 2 p 2 ira In T s e p c ir h a n T o e lo ch gi n e o s lo O g X i Y es B O .H X . Y N. B L .H TD .N ., . A LT ll D r . ig , h A t ll s r r i e g s h e ts rv r e e d served
Study Results I n sp i r a T e c hn ol ogi e s OX Y B .H.N. LT D. , Al l ri g h ts re se rv e d 2018 - 2022 Copyr i g h t
54 Copyright 20 C 1 o 8 p - y 2 r 0 ig 2 h 2 t In 2 s 0 p 18 ir - 2 a 02 T 1 e I c n h sp n ir o a l T o e g ch ie no s lo O gi X es Y O B XY .H B . .H N .N . . L L T T D D. . , , A A ll l r l ig r h ig ts h r t e s se r r e ve s d erv 5 e 4 d Conclusion ART treatment in hypoxemic animal model, resulted in significant increase of oxygen saturation of 8% - 10%. A flow rate of 1 liter per minute, was sufficient to provide a saturation increase of 8 - 10%. Pulmonary artery saturation, exhibiting ART oxygenation independent of oxygenation resulting from lung activity, increased by 26%. ART exhibited a significant decrease of PaCO2. Blood pressure was unaffected.