LivaNova Education Series:
Life Support Simplified
Intended for Investor Use Only - Not Intended for Use by Patients or HCPs
Safe Harbor
Certain statements in this presentation, other than purely historical information, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements include, but are not limited to, LivaNova's plans, objectives, strategies, financial performance and outlook, trends, the amount and timing of future cash distributions, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, our actual financial results, performance, achievements or prospects may differ materially from those expressed or implied by these forward-looking statements. In some cases, you can identify forward- looking statements by the use of words such as "may," "could," "seek," "guidance," "predict," "potential," "likely," "believe," "will," "should," "expect," "anticipate," "estimate," "plan," "intend," "forecast," "foresee" or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based on estimates and assumptions that, while considered reasonable by LivaNova and its management based on their knowledge and understanding of the business and industry, are inherently uncertain. These statements are not guarantees of future performance, and stockholders should not place undue reliance on forward-looking statements. There are a number of risks, uncertainties and other important factors, many of which are beyond our control, that could cause our actual results to differ materially from the forward-looking statements contained in this presentation, including the risks relating to the COVID-19 pandemic or settlement of litigation, as well as those described in the "Risk Factors" section of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission by LivaNova. All information in this presentation is as of the date of its release. The Company does not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation.
In this presentation, "LivaNova,""theCompany,""we,""us"and "our" refer to LivaNovaPLC and its consolidated subsidiaries.
1
"Advanced Circulatory Support" Defined
Advanced Circulatory Support (ACS)
ECMO | PVAD |
Extracorporeal | Percutaneous |
Membrane | Ventricular Assist |
Oxygenation | Devices (LV & RV) |
Veno-Arterial | Veno-Venous | Extracorporeal | Intracorporeal |
LivaNova ACS Products
Does Not Include:
- Long-termMCS (LVAD devices)
- Cardiac support standard of care (intra-aortic balloon pump / IABP)
- Respiratory support standard of care (invasive mechanical ventilation / IMV)
*LivaNova ACS products are temporarily indicated for ECMO therapy greater than 6 hours. See Indications for use for more information. LivaNova is currently | |
pursuing 510(k) clearance for ECMO therapy greater than 6 hours. | 3 |
ACS candidate patients present to the hospital with multiple interrelated problems
- CARDIAC: ELECTRICALPROBLEM
- Unstable or lack of electrical impulse in the heart to trigger muscle firing
- Therapies: Pharmaceuticals, Percutaneous Coronary Intervention (PCI), Ablation (re-wiring the heart to fix signals), Pacemaker (long-term device)
- CARDIAC: PLUMBING PROBLEM (coronary or structural)
- Heart muscle has limited capacity to squeeze, create pressure in the circulatory system and move blood throughout the body
-
Therapies: Pharmaceuticals, PCI (Angioplasty / Stent), Intra-aortic Balloon Pump (IABP),
Advanced Circulatory Support, Implantable Ventricular Assist Device (long-term device), Heart Transplant
- RESPIRATORY PROBLEM
- Lung capacity to exchange oxygen & carbon dioxide into the bloodstream is reduced (COPD, long-term damage
from smoking, H1N1, pneumonia, acute respiratory distress syndrome, COVID-19)
- Therapies: Pharmaceuticals, Non-Invasive Ventilation (NIV, mask/nasal oxygen), Invasive Mechanical Ventilation (IMV), Advanced Circulatory Support, NO LONG-TERMRESPIRATORY DEVICES, Lung Transplant
4
Significant market opportunities in multiple underpenetrated patient populations
Total ACS Candidate
Patients
926k
Available Patients
216k
or
$3.2B
9%
Penetration
21k
Patients | Total | Available | $ TAM | Penetration |
Cardiogenic Shock1 | 49k | 30k | $450M | ~50% |
Available : Includes STEMI and without | ||||
predominant RV infarction or | ||||
mechanical complications | ||||
RV Failure2 | 36k | 10k | $150M | ~20% |
Available: at hospitals with MCS | ||||
capability | ||||
Respiratory Failure3 | 202k | 98k | $1.5B | ~2% |
Available: severe ARDS or AE-COPD | ||||
patients on invasive mechanical | ||||
ventilation | ||||
Cardiac Arrest4 | 639k | 78k | $1.2B | ~1% |
Available: IHCA at hospitals with eCPR | ||||
capability | ||||
High Risk PCI | 121k | 46k | Not a primary focus of | |
LivaNova | ||||
Source: 1. Thom et al. Heart disease and stroke statistics-2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006; 113: e85-e151. Assumption: slight decline (0.5%) in annual patient population for cardiogenic shock. 2. Gerges 2014. "Right ventricle in acute and chronic pulmonary embolism (2013 Grover Conference series)". https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278597. Peacock AJ, Murphy NF, McMurray JJV, et al. An epidemiological study of pulmonary arterial hypertension. Eur Respir J 2007;30:104-9. 3. Lindenaur, P. Hospital patterns of Mechanical Ventilation for Patients with Exacerbations of COPD. Ann Am Thorac
Soc Vol 12, No 3, pp 402-409, Mar 2015. The ARDS Definition Task Force, "Acute Respiratory Distress Syndrome, the Berlin Definition of ARDS" JAMA 2012,301(23):2526-25338. 4. US Average annual incidence in adults. AHA, Circulation, | |
"Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the US." July 2019. | 5 |
Note: U.S. market only; data sources OUS limited but WW penetration also low |
$TAM uses ASP of $15-20K
LivaNova ACS products are not currently indicated for Cardiogenic Shock, RV Failure, or Cardiac Arrest. LivaNova ACS products are temporarily indicated for ECMO therapy greater than 6 hours. See Indications for Use for more information. LivaNova is currently pursuing PMA approval for a Right Ventricular Failure indication and 510(k) clearance for ECMO therapy greater than 6 hours.
Highlights
Mission
Vision
Positioning
Markets
- To save and improve the lives of critically-ill patients through the development and delivery of simple and effective life support solutions.
- To become the extracorporeal membrane oxygenation (ECMO) platform of choice among U.S. hospital centers and establish a global footprint for the ACS portfolio.
- A simple and versatile ACS platform with differentiated cannulation enabling hospital centers to successfully deploy ACS to underserved patient populations.
- Gain share in Cardiogenic Shock and Right Ventricular Failure in the short term while developing long term market opportunities in Respiratory Failure and Cardiac Arrest.
LivaNova ACS products are not currently indicated for Cardiogenic Shock, RV Failure, or CardiacArrest. LivaNovaACS products are temporarily indicated for ECMO therapy greater than 6 hours. | |
See Indications for Use for more information. LivaNova is currently pursuingPMA approval for a Right Ventricular Failure indication and510(k) clearance for ECMO therapy greater than6 hours. | 6 |
Commercial success supported by multiple internal & external initiatives
Commercial Execution
Medical Education
Regulatory Authorizations
Clinical Evidence
Innovative Products
Annual field | Inside sales | Healthcare | ||
sales expansion | capability | econ support | ||
CME & hands-on | eLearning | Partnership with | ||
product training | university | KOLs & societies | ||
U.S. FDA label | Full CE-mark | Leverage | ||
extensions | (EU) approvals | INT channel | ||
Expand/publicize | IIR case series & | Comparative | ||
THEME registry | literature studies | clinical data | ||
Next generation | Cannulae | Remote monitor | ||
oxygenation | innovation | & sensors | ||
7
The need for LifeSPARC
- Despite ACS growth, legacy technology has hindered success
- Less powerful than competing ECMO (lower flows or larger cannulae)
- LifeSPARC offers 40% more pumping power; on par with ECMO competition
- Legacy product priming process is unfamiliar and lengthy
- 3-minute LifeSPARC setup process delivers "the perfect prime" every time
- Large, heavy controller inhibits patient mobility & ease of transport
- LifeSPARC 1/3 the size & weight with removable handheld controller
Legacy "Escort" Platform
8
LifeSPARC is a new circulatory support platform designed to simplify hospital programs
- LifeSPARC is a single operating system for simple but powerful circulatory support capabilities across departments / indications
- Streamlined user interface minimizes the learning curve and ongoing training requirements for nursing staff and other patient caregivers
- Small but powerful magnetically levitated pump enables rapid and repeatable deployment within the sterile field
- Lightweight controller and docking station enables easy patient mobility and facilitates interdepartmental transport
9
The LifeSPARC Platform: Designed to simplify life support from start to finish
• No excess ports:
• blood in/out + O2 in/vent
• No heat exchanger
• No gas blender
10
The LifeSPARC Platform: Designed to simplify life support from start to finish
- No excess ports:
- blood in/out + O2 in/vent
- No heat exchanger
- No gas blender
- Pre-connectedpump & oxygenator
11
The LifeSPARC Platform: Designed to simplify life support from start to finish
- No excess ports:
- blood in/out + O2 in/vent
- No heat exchanger
- No gas blender
- Pre-connectedpump & oxygenator
- Priming tray to prime circuit in 3 minutes or less
- Clamps built into the tubing
12
The LifeSPARC Platform: Designed to simplify life support from start to finish
- No excess ports:
- blood in/out + O2 in/vent
- No heat exchanger
- No gas blender
- Pre-connectedpump & oxygenator
- Priming tray to prime circuit in 3 minutes or less
- Clamps built into the tubing
- No infusion line
13
The LifeSPARC Platform: Designed to simplify life support from start to finish
- No excess ports:
- blood in/out + O2 in/vent
- No heat exchanger
- No gas blender
- Pre-connectedpump & oxygenator
- Priming tray to prime circuit in 3 minutes or less
- Clamps built into the tubing
- No infusion line
- 4-screenGUI
14
The LifeSPARC Platform: Designed to simplify life support from start to finish
- No excess ports:
- blood in/out + O2 in/vent
- No heat exchanger
- No gas blender
- Pre-connectedpump & oxygenator
- Priming tray to prime circuit in 3 minutes or less
- Clamps built into the tubing
- No infusion line
- 4-screenGUI
- Everything you need for the procedure in one Kit box
15
LifeSPARC versatility offers all four primary modes of circulatory support in a single platform
Veno-Arterial (VA) ECMO
Key Components:
- Sterile, on-patient centrifugal pump
- Oxygenator (pre-connected)
- 24 Fr venous drainage cannula
• 15 or 17 Fr arterial cannula
Percutaneous LA-FA Bypass
Key Components:
- Sterile, on-patient centrifugal pump
- 21 Fr transseptal cannula (62/72 cm)
- 15 or 17 Fr arterial cannula
Veno-Venous (VV) ECMO
Key Components:
- Sterile, on-patient centrifugal pump
- Oxygenator (pre-connected)
- 29 or 31 Fr dual-lumen cannula
• Venous dilator set
Percutaneous RA-PA Bypass
Key Components:
- Sterile, on-patient centrifugal pump
- 29 or 31 Fr dual-lumen cannula
- Venous dilator set
LivaNova ACS products are not currently indicated for Cardiogenic Shock, RV Failure, or CardiacArrest. LivaNovaACS products are temporarily indicated for ECMO therapy greater than 6 hours. See | |
Indications for Use for more information. LivaNova is currently pursuing PMA approval for a Right Ventricular Failure indication and510(k) clearance for ECMO therapy greater than6 hours. | 16 |
Competing circulatory support platforms provide a limited subset of options
VA-ECMO | VV-ECMO | PVAD (L) | PVAD (R) |
LifeSPARC
Impella
CardioHelp
CentriMag*
* CentriMag is a centrifugal pump only; additional technology (oxygenator and cannulae) are required to complete the circuit
LifeSPARC includes an integrated and sterilized extracorporeal pump motor for placement within the sterile field, designed to minimize hemodilution and reduced circuit volume.
LifeSPARC offers exclusive cannulation options in each support category:
• ProtekDuo Dual Lumen: Unique RA-to-PA cannulation via a single RIJ access point
- ProtekSolo Transseptal: Direct LV pre-load reduction via left atrial cannulation
• ProtekSolo Arterial: | Advanced cannula securement features |
17
Why ECMO? Because some patients need MORE circulatory support
The COVID-19 pandemic has revealed a lack of widespread extracorporeal circulatory support options across the U.S.
Only ~ 4.9% of U.S. community hospitals currently offer advanced respiratory support capability.1
LifeSPARC enables mid-tier programs to emulate the most successful centers in the U.S.
1 % of U.S. community hospitals participating in the ELSO registry with an adult ECMO program (www.elso.org). | 18 |
Why ECMO? Because some patients need MORE respiratory support.
Invasive Mechanical Ventilation (IMV) was utilized in 320 of 2,634 discharged COVID-19 patients across 12 New York area hospitals.
18-65y | >65y | TOTAL | ||||
# | % | # | % | # | % | |
Discharged Alive | 33 | 23.6% | 5 | 2.8% | 38 | 11.9% |
Died | 107 | 76.4% | 175 | 97.2% | 282 | 88.1% |
TOTAL | 140 | 180 | 320 |
Excerpt from Table 5. Clinical Measures and Outcomes for Patients
Discharged Alive, Dead, and In Hospital at Study End Point by Age
Richardson S, Hirsch JS, NarasimhanM, et al. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. | |
2020;323(20):2052-2059. doi:10.1001/jama.2020.6775 | 19 |
Why ECMO? Because some patients need MORE respiratory support.
88%
successful extubation
73%
survival to discharge
Mustafa AK, Alexander PJ, Joshi DJ, et al. Extracorporeal Membrane Oxygenationfor Patients With COVID-19 in Severe Respiratory Failure. JAMA Surg. Published online August 11, 2020. doi:10.1001/jamasurg.2020.3950
20
We reduce complexity
so hospital caregivers can
focus on the patient
not the circuit.
Indications for Use
- COVID-19UPDATES: The U.S. Food and Drug Administration (FDA) issued guidance on April 6, 2020 to temporarily expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address the novel coronavirus (COVID-19) public health emergency. While the FDA is permitting this temporary change to our indication for use, this change is not equivalent to an ECMO 510(k) clearance. As a result of the guidance, cardiopulmonary devices, including select devices from TandemLife | LivaNova, are now temporarily indicated for ECMO therapy greater than 6 hours. To read the full announcement, click here.
Indications for Use
-
LifeSPARC System: In the U.S., the LifeSPARC system is intended to pump blood through an
extracorporeal circuit for periods lasting less than six hours for the purpose of providing either: (i) full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. - Contraindications for Use: The LifeSPARC System should not be used with extracorporeal circuits that create a pressure differential greater than 600 mmHg between the inflow and the outflow of the Pump. Because of the non- occlusive nature of the LifeSPARC Blood Pump, the Pump should not be used for cardiotomy suction.
- TandemHeart Controller: The TandemHeart System is intended to pump the blood through an
extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava - TandemHeart Pump: The TandemHeart pump is intended to pump the blood through an extracorporeal
circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Indications for Use
- TandemLung Oxygenator: The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
- Contraindications for Use: No contraindications are known provided the device is used within the Indications for Use and in accordance with the stated operating conditions.
- ProtekSolo 62 and 72 cm Transseptal Cannulae: The Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump, which returns blood to the patient via the femoral artery or other appropriate site.
- Contraindications for Use: The Transseptal Cannula Set should not be used when any anatomical, medical, or physiological impairment may contraindicate the use of a femoral access procedure or transseptal access to the left atrium.
- ProtekSolo Venous Cannula: The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
- Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The introducer is only to be used with the appropriately sized Venous Cannula.
These devices are not intended for use except as indicated above.
Indications for Use
- ProtekSolo 15 and 17 Fr Arterial Cannulae: These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The Cannula Introducer is intended to facilitate proper insertion and placement of the Cannula within the vessel for extracorporeal circulatory support.
- Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula introducer is only to be used with the appropriately sized TandemHeart Cannula. These devices are not intended for use, except as indicated above.
- ProtekDuo 29 and 31 Fr and ProtekDuo RD 31 Fr Veno-Venous Cannulae: The ProtekDuo Veno-VenousCannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
- Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula Introducer is only to be used with the appropriately sized ProtekDuo Veno-Venous Cannula. These devices are not intended for use except as indicated above.
- VoyagerVest: The Voyager Vest is intended to provide secure attachment of Extracorporeal Life Support (ECLS) components (pump, oxygenator, and tubing) to the patient during cardiopulmonary bypass.
- Contraindications for Use: The VoyagerVest kit is only intended for use with compatible products manufactured and tested by CardiacAssist, Inc. The VoyagerVest kit should not be used on patients with a known allergy to neoprene.
Q & A
Attachments
- Original document
- Permalink
Disclaimer
Livanova plc published this content on 09 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 November 2020 17:31:00 UTC