EX-99.1 2 ea148712ex99-1_inspiratechno.htm INVESTOR PRESENTATION OF INSPIRA TECHNOLOGIES OXY B.H.N. LTD., DATED OCTOBER 2021

 Exhibit 99.1

 

Revolutionizing Acute Respiratory Care O c t ob er 2021 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved

 

 

Forward looking - Statements 2 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved This presentation of Inspira TM Technologies Oxy B . H . N . Ltd . (the “Company”) contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities law . Words such as “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward - looking statements . For example, the Company is using forward - looking statements when it discusses its vision, the potential of its product, its strategy, market potential for its product, its paradigm, commercialization of its product, the potential to use its product together with mechanical ventilation, reimbursement strategy for its product, regulatory approval process of its product candidates, the benefits and use of its product candidates " intended patient population, lines of therapy and market milestones 2021 - 2023 to FLS and its future growth . The presentation also contains estimates with respect to the Company’s health economics model . Forward - looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain . Such expectations, beliefs and projections are expressed in good faith . However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed or indicated by the forward - looking statements . Forward - looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward - looking statements . For a more detailed description of the risks and uncertainties affecting the Company, the reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the risks detailed in the Company’s preliminary prospectus dated June [ 28 ], 2021 , filed with the SEC as a part of the Company’s Registration Statement on Form F - 1 (File No . 333 - 253920 ), and documents incorporated by reference therein . Forward - looking statements speak only as of the date the statements are made . The Company assumes no obligation to update forward - looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward - looking information except to the extent required by applicable securities laws . If the Company does update one or more forward - looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward - looking statements .

 

 

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. M V r equ i r e s i n tru si v e i n tub a t i o n , c om a i nduct io n , a n d c a n b e v e r y t r a u 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 • 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 Downsides¹ ˉ ³ 3 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved

 

 

Inspira TM Technologies is developing a potentially minimally invasive, cost - effective early extracorporeal blood oxygenation system that utilizes a proprietary hemo - protective Flow technology to rebalance oxygen saturation levels in one minute*, while the patient is awake and maintaining spontaneous breathing. 4 4 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved The intent is to minimize the need for mechanical ventilation. *Throughout 2019 - 2020, 25 animal studies were performed in 2 swine models by the veterinary team at LAHAV CRO in Israel (FDA - approved research facility) in conjunction with Inspira's team. Our scientific advisory board members, who are experts in their fields, were integrally involved in or viewed the studies at real - time.

 

 

Vision Redefining Artificial Respiration to impact millions of lives 5 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 5 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved

 

 

Investment Highlights Targeted medical Device companies 1. “Respiratory Care Devices Market by Product”. Report by “Research and Market”, June 2020. ID: 5129035 2. Forum of International Respiratory Societies. The Global Impact of Respiratory Disease – Second Edition. Sheffield, European Respiratory Society, 2017. The respiratory care market size is estimated to reach approximately $29.86 Bn by 2025¹ E st a b lis he d nee d ~20 million patients annually admitted to ICUs, requiring acute respiratory care², being intubated and placed on mechanical ventilation * Trademarks are the property of their respective owners. A novel therapy Revolutionary early extracorporeal respiratory support system ,intended to rebalance saturation and carbon dioxide levels in patients with acute respiratory failure, while they are awake and breathing App r o a c h i n g bot h IC U an d non - I C U markets Cost - effective, designed for deployment in and outside the ICU, in urban and rural hospitals Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 6

 

 

Our mission is to become the new standard of care, for acute respiratory patients, to be applied in awake and breathing patients. Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 7

 

 

The ART Ρ device Early Extracorporeal Respiratory Support 8 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved The product is currently in a developmental stage and has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA).

 

 

THE ART TM DEVICE Taking the load off the lungs INSERT Dual lumen cannula inserted into the jugular vein WITHDRAW Utilizing hemo - protective flow technology, the blood is treated with a minimum drop in blood pressure & a low shear force, protecting the red blood cells Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 9 ENRICH Blood is enriched with high concentrations of oxygen, and CO2 is removed CIRCULATE The enriched blood is returned to the body via the dual lumen cannula REBALANCE The returned enriched blood rebalances the patient’s saturation levels, easing the burden on the lungs

 

 

Oxygenator Initiation System Pump THE ART TM T h e A R T d e vic e i s c om pri s e d o f a per m ane n t mo dul e an d a di s p os abl e r e s pi r a t o r y s upp o r t unit. T h e c om pa n y ’ s s t r a t e g i c bu s ine s s mo de l i s de s i g ne d t o enabl e t h e e x t en s i o n o f acu t e r e s pi r a t o r y c a r e b ey o n d th e I C U . Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 10

 

 

Dual Lumen Cannula & Adjustable Dual Lumen Component: L o w i m pac t r adiog r ap h y - f r e e dua l lu m e n c annula , w i t h sm al l dia m e t e r (18Fr ) an d a n t i - ai r - e m b o l i s m m echani s m t h a t e xpec t e d t o d r a w blood at a rate of 1 - 1.5L per minute* Initiation System Disposable Respiratory Support Unit Component: Plug - and - pl a y di s po s abl e c ar t r i d g e . s ui t abl e f o r depl o y m e n t bo t h i n I C U s an d g ene r a l m edi c a l uni t s Hemo - P r o t e cti v e Flow Pump Component: P r opri e t a r y he m o - p r o t e c t i v e pu m p ; de s igne d t o p rev e n t he m ol y s i s an d t h r o m bo s i s ART TM Device Primary Components *when used with initiation system Component: A u t ono m ou s ini t i a t io n s y st e m f o r s elf - pri m in g o f t h e e n t i r e bloo d ci r cui t , m ini m i z in g t h e nee d f o r a perfusionist Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 11

 

 

ART ’ s Innovative Features Hemo - protective flow technology aimed to reduce the risks of hemolysis & thrombosis Single insertion point of dual - lumen cannula aimed at lowering the risk of multiple infections & bleeding Proprietary plug - and - play disposable unit expected to reduce need for ICU - Level staff Self - priming capability designed to reduce operational errors and need for perfusionist TM Eliminates the need for a perfusionist Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 12

 

 

A R T ’ s P r oprie t a r y H e m o - P r o t e c t i v e Flow Technology Features Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 13 ~ 200cc of blood are being enriched at any given point, providing the patient a saturation boost in 1 minute* P r e s e n t in g inn o v a t i v e f e minimi z e h e m o l y s i s & t h A R T ’ s f e a t u r e s Disposable set designed for Low flow – high velocity a t u r e s e x p e rombosis Hemolysis reduction V c t e d t o T h r o m b o s is reduction 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 *Throughout 2019 - 2020, 25 animal studies were performed in 2 swine models by the veterinary team at LAHAV CRO in Israel (FDA - approved research facility) in conjunction with Inspira's team. Our scientific advisory board members, who are experts in their fields, were integrally involved in or viewed the studies at real - time.

 

 

ART's Respiratory Support System Potential Benefits • Reduced costs associated with MV c om p li ca tions • Increased patient throughput • Better respiratory care in ward setting • Reduction of patient load in ICU • Reduced staffing - No need for perfusionists • No need for surgical access team The patient's perspective • Immediate oxygen saturation elevation • Decreased work of breathing: x Improving compliance to HFNC x Improving compliance to pronation • Patient can communicate their symptoms and needs • No need for induced coma • Avoiding all forms of complications associated with MV Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 14 The clinician's perspective • Clinicians would be able to offer an alternative to mechanical ventilation • Minimal learning curve • Self priming system, minimizes the need for perfusionist • Self priming system results in less human errors • Designed to use in ICUs, general wards & ambulatory settings The hospital perspective

 

 

ART TM Offers Two Intervention Modalities Avoid VALI, Awake & breathing patients with deteriorating respiratory failure WHO WHERE • Avoid intubation, coma and MV • VIDD and VAP ICU General Medical Unit WH A T V A L U E MV = Mechanical Ventilation VALI = Ventilator - associated lung injury VIDD = Ventilator - induced diaphragmatic dysfunction VAP = Ventilator - associated pneumonia EARLY INTERVENTION Ventilated patients under induced coma • Reduce risk of ventilator induced injuries (VALI, VIDD and VAP) • Expedite ventilation & weaning period ADJUNCTIVE THERAPY, SUPPORTING THE USE OF MV I CU Copyright © 2018 - 20 P 21 Inspira Technologies OXY B.H.N. Ltd., All rights reserved 15

 

 

Study Results Substantial ongoing positive changes in the blood oxygenation levels Reference for normal levels - Julia Hooley, MSN, RN. American Nurse Today. Volume 10, Number 1. January 2015 Throughout 2019 - 2020, 25 animal studies were performed in 2 swine models by the veterinary team at LAHAV CRO in Israel (FDA - approved research facility) in conjunction with Inspira's team. Our scientific advisory board members, who are experts in their fields, were integrally involved in or viewed the studies at real - time. 32.13 mmHg 26.91 mmHg Partial Pressure of carbon dioxide A R T O f f * ART On* 84.96% 94.76% Oxygen Saturation levels ART O f f * ART O n* 49.3 mmHg 65.08 mmHg Partial Pressure of Oxygen A R T O f f * ART On* SaOշ PaOշ pCOշ (P<0.0001) (P<0.0001) (P<0.0001) No significant change * Average results Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 16

 

 

Intended Patient Population and Lines of Therapy Adult COPD patients (Chronic Obstructive Pulmonary Disease) Patient Population Acute hypoxemic failure adult patients T R E A T M E N T E S C E L A T I O N RESPIRATORY DETERIORATIO • Nasal mask • F ace mask • Nasal pl u gs • BiPAP • CPAP Non - Invasive Ventilation¹ Invasive Mechanical V e n til a tio n ² T h e A R T Device ECMO ³ ( Ext r a c orpo r ea l Membrane Oxygenation) • HF NC ( H igh Flow Nasal Cannula) 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. https:// www.elso.org/Portals/0/ELSO%20Guidelines%20General%20All%20ECLS%20Version%201_4.pdf (Accessed on July 23, 2018). Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 17

 

 

$20Bn Total Addressable Market for the ART TM 20 million globally per year¹ 1,250$ per treatment/disposable unit (estimated target price) $20 Bn T o t al Ma r k e t* *80% of 20 million¹ patients annually¹ (treated today by MV) at a direct treatment cost of $1,250 for ART disposables unit (cost per patient per treatment) 1. Forum of International Respiratory Societies. The Global Impact of Respiratory Disease – Second Edition. Sheffield, European Respiratory Society, 2017 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 18

 

 

Market Penetration and Gaining Market Share We have developed a flexible business model to drive global deployment PRICING MODEL ART device distributed as an OPEX when bundled with 15 disposable respiratory support units X 15 Novel technology ART device Disposable respiratory support units + Healthcare Centers, Medical Services & Medical Device Companies Priced at $1,250 per patient to support OPEX model (estimated target price) Contracting regional providers for distribution & aftermarket services of system & supplies Multiple c o n s u m e r types Selling Disposable Aftermarket Services * Subject to change Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 19

 

 

Reimbursement Strategy Inspira plans to utilize existing CPT Codes using a “New Approach” to an existing procedure E xp ec t e d t o e li m in a t e complications a ssoc i at e d w it h M V A i m e d t o r e du c e l e n g t h o f s ta y & r e - ad m i ss i o n s D es i gn e d t o r e du ce d c o s t s & o p e r a ti o na l expenses D es i gn e d t o r e du c e h os p i t a l & s t af f bu r d e n cms.gov: MS DRG based reimbursement for respiratory care Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 20

 

 

Go - to - Market Strategy Establishing multiple recurring revenue streams across medical sectors & markets PURSUING WORLD - WIDE R E G U L A T O R Y AP P R O V A L S Uni t ed S t a t es Europe Asia S outh Ameri c a Africa Middle East COLLABORATING WITH STRATEGIC MEDICAL CENTERS & PROFESSIONAL ASSOCIATIONS Strategic partners for regional deployments Target health associations, such as: “The American Thoracic Society”, “The Extracorporeal Life Support Organization” OPTIONAL TREATMENT INDICATIONS • • Early saturation elevation, preventing MV To be used with MV • • PURSUING COLLABORATIONS WITH STRATEGIC PARTNERS Global Medical Device Companies, Multinational Electronics Contract Manufacturers Potentially, global medical device companies may acquire ART primary components for blood enrichment applications Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 21

 

 

Regulatory Submission (Multi - Step approach) Q 4 - 2021 Components ART ART TM 510(k) Support De Novo* ECLS 510(k) To - date the ART500 has not been tested on humans and is subject to the regulator’s requirement. *Will require a new 510(k) marketing clearance or, depending on the modification, a de novo or other Q4 - 2022 Q 3 - 2023 22 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 22 Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved

 

 

Targeting Major Milestones 2021 - 2023 H1 - 2022 Strategi c A g ree m ent Distribution Agreement Component Deployment FDA Filing Component 510(k) COMPONENT H2 - 2022 FDA 510(k) Filings - ART support ECLS - Components Distri b u ti o n A g ree m ent Medical Collaboration Regulatory Filings Dist r i b u ti o n A g reeme n t Strategic Agreement Pro du ct Dep l o ymen t /P re - Sa l e s Medical Collaboration Clinical evidence/clinical trial H1 - 2023 ART support ECLS Deployment in Leading Hospital Strategic Agreement Medical Collaboration Preliminary clinical evidence H2 - 2023 FDA De Novo Filing ART “New Intent of Use” CE Filing ART Orders, Subject to Regulatory Clearance Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 23

 

 

Leadership Urologic surgeon, inventor, entrepreneur & venture capital investor. Vast experience in leading high growth, publicly traded medical companies. Co - founded Vidamed Inc., acquired by Medtronic Inc. (NYSE: MDT). Co - founded Medinol, partnered with Boston Scientific (NYSE: BSX). Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 24 Former CFO, CIO and Corporate Manager Elscint (Formerly NASDAQ & TSE : ELT), Sanmina - Medical Division (NASDAQ: SANM). Plasan Group - Executed M&As and strategic joint ventures. Experience in manufacturing & setting up operations to support high - growth delivery. Co - Founded Nano Dimension (NASDAQ : NNDM) Served as COO & Director . Serial entrepreneur & investor. Multi - industry experience in growing companies from concept to market penetration and sales. Cardiologist, ICU Physician & Cardiology Researcher, Senior hyperbaric & diving physician. Sheba Medical Center, Israel Naval Medical Institute, Technion Institute of Technology, Meir Medical Center, Tel Aviv University P r o f . Bena d G old w a s s e r , M D , M B A Chairman Joe Hayon, MBA Co - Founder, President & CFO Dagi Ben - Noon, BSc Co - Founder, CEO Dr. Udi Nossinovitch, MD, PhD Co - Founder, CSO

 

 

Scientific Advisory Board Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 25 Respiratory physician & specialist in respiratory disease. Professor of Respiratory Medicine at University of Notre Dame & University of WA. Chairman of Research at UND, Director of the WA Lung Transplant Program, Sub - training at Freeman Hospital in Newcastle upon Tyne, Stanford University, Palo Alto & the Alfred Hospital, Melbourne. Cardiac Surgeon & Director of ECMO Israel, Adult Cardiac Surgery, Heart Transplants, Assist Devices & ECMO, Intensive Care Treatment, Sheba Medical Center at Sheba Hospital. Cambridge University, UCLA, Hebrew University of Jerusalem, Cardiac surgery clinical fellowship in UCLA and research fellowship at Cedars Sinai Medical Center. Senior physician at the Medical Intensive Care unit and at the Pulmonology Institute at the Hadassah Medical Center. Lecturer at the Hebrew University Faculty of Medicine & Hadassah Medical School. Current research: Chronic Obstructive Pulmonary Diseases, &prevention of sepsis related organ dysfunction with Allocetra. Veterinary surgeon & expert in laboratory animal science, Israeli Prime Minister’s Office, Chairwoman of the National Animal Experimentation Ethics Committee, Founder of GLP/GMP companies: SeruMed GMP Ltd .: Production of anti - venom serum . BioSphera Ltd .: Specialized in pre - clinical research Prof Eli Gabbay, MD, FRACP Res p i r atory Ad visor Dr. Yigal Kasif, MD ECMO Advisor Dr. Avraham Abutbul, MD ICU Respiratory Advisor Dr. Orit Cohen Jacob, MDV Clinical & Research Advisor

 

 

Scientific Advisory Board - cont. Dr. Dekel Stavi, MD I n tens i vist Ad visor Has considerable experience in leadership and Extracorporeal Life Support programs, cardiology aspects of Intensive Care Unit (“ICU”) patients and treating hemato - oncology patients in ICUs. Prior to joining the interdepartmental program of critical care at the University of Toronto, he served as a senior intensive care physician at a leading Israeli hospital - the Tel Aviv Sourasky Medical Center (Ichilov), where he initiated its institutional extracorporeal membrane oxygenation (ECMO) program. A director of the Medical ICU at Sourasky Medical Center since 2020 and is also Treasurer of the Israeli ECMO Society since 2019. Dr. Lichter completed her residency programs in Internal Medicine (2015) and Intensive Care (2017) at the Sourasky Medical Center. Prior to this, Dr. Lichter was a Captain in the IDF, holding several positions as a field doctor in combat units. Dr. Yael Lichter, MD I n tens i vist Ad visor Copyright © 2018 - 2021 Inspira Technologies OXY B.H.N. LTD., All rights reserved 26

 

 

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