Spiro Devices, LLC Overview Presentation | JUNE 2020

Spiro Wave
Devices, LLC
Hospitals in rural America and
developing countries have
limited access to ventilators
and are particularly vulnerable
in the face of COVID-19.

This represents 85% of the

global population.

Most ventilators in India are likely already in use.

Photo: Getty Images, BBC

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 COVID-19 Index

Percent of global population living in developing areas : 85%

Ratio of ventilators to people in Nigeria : 1 per 1.2 million people
Population density ranking of Lagos, Nigeria : 4th
Number of ventilators to serve people across 41 African countries: 2,000
Ventilators to serve 11 million people in South Sudan : 4
Countries with no ventilators at all : 10
New cases globally last week : 252,487
States easing social distancing restrictions in the U.S. this week : 6
Deaths since Italy eased restrictions last week : 474 deaths
People who live in Rural America : 1 in 5
Percent of Coronavirus cases in Rural America last week : 1 in 3
Rural hospitals that have closed since 2005 : 170
Percent of rural hospitals downsizing services and operating in the red : 47%
Cost of a single ICU ventilator : $50,000
Cost of Spiro Wave : $5,000

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Spiro Wave is a low-cost
automatic resuscitator that
helps hospitals expand their
capacity to care for patients
with critical ventilation needs.

Spiro Wave automates a manual resuscitator while

increasing its functionality and quality control. The
device is authorized under FDA Emergency Use
Authorization (EUA).

Spiro Wave,inspired by MIT’s E-Vent

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Increased control over
mechanical ventilation

The device works with standard medical

components that are readily available in most
hospital settings. Pressure sensors and alarm
system allow clinicians to monitor and adjust
key respiratory and ventilation parameters
including:

○ Tidal volume
○ Respiratory rate
○ I/E ratio
○ Positive end-expiratory pressure (PEEP)
○ Airway limit pressure
Operator control panel

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An essential bridge Traditional Spiro Wave Traditional
Ventilators Ventilators

The device is considered a “bridge

ventilator” that allows hospitals to
Patients with severe
expand their capacity to care for respiratory illness and
patients needing invasive complex ventilatory needs

mechanical ventilation in

Number of Patients in Need

Patients needing
emergency situations and reallocate resuscitation and intubation
conventional ventilators for patients
with more sophisticated needs. Patients transitioning off
mechanical ventilation

Complexity of Ventilatory Need

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An accessible alternative
for global needs Spiro Wave

While some hospitals can purchase - Affordable: $3-5K/unit

expensive ICU ventilators, countries
and healthcare systems without that - Designed for rapid manufacturing
purchasing power have fewer
- Readily-available components
ventilators, smaller stockpiles, and
limited access to critical equipment.
- Intuitive controls and alarms

Spiro Wave provides the minimal - Expands critical care capabilities

essential ventilation functions
necessary using fewer parts and - Ready for distribution
available materials, creating a viable,
low-cost option hospitals worldwide.

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Utility beyond COVID-19 Current Market: National Preparedness

Emergency Use (FDA EUA)

Our team created an affordable ventilation device to
address the immediate needs of this crisis. It has become Local & National Stockpiles
clear that the device also has significant utility beyond this
crisis as an emergency ventilation device. Spiro Wave can
Growth Market: Emergency Operations
deliver critical respiratory and ventilation functionality in
everyday ambulatory and hospital settings.
Rural Hospitals

Military Operations

Healthcare in the Field

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Automation
technologies
addressing global
problems and opening
up new markets
Spiro Wave brings increased control
to manual emergency processes and
relieves clinicians to focus on other
critical tasks.
Like the Lucas Chest Compression
System, Spiro Wave delivers
hospital-level care to emergency
operations in the field.
Spiro Devices, LLC
Analogous Story
Lucas Chest Compression System
Before:
Until the Lucas V2 deployment in 2009, in-field
healthcare providers like EMTs delivered chest
compressions manually, with limited
effectiveness and large physical strain.
Now, The Lucas device delivers those
compressions mechanically, with safety and
consistency that cannot be achieved via human
compressions, improving patient outcomes and
provider safety.
Our Story
Spiro Wave Resuscitation & Ventilation
Before:
In-field healthcare providers delivered bag-valve-mask
compressions manually to resuscitate patients and
provide ventilation until equipment became available.
Now, the Spiro Wave automates resuscitation and
delivers precise ventilation with intuitive monitoring that
frees up clinicians for other critical tasks.
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Today
Spiro Wave is
a streamlined, high-fidelity
emergency ventilation device.
The simple design allows for intuitive
operation and efficient device
maintenance, making it an ideal
addition to extend ventilation
resources in healthcare systems.
Spiro Devices, LLC
Product Roadmap
An FDA 510(k) approved A compact, rapidly deployable
ventilation device. system for mobile ICUs.
Mid-term Long-term
Upgrades include: Additions include:
Monitoring hardware: flow sensor and additional Patient monitoring (EKG, oxygen saturation,
motor position sensor. end-tidal CO2, blood pressure) and IV infusion
capabilities.
Software upgrades: additional ventilation modes,
such as Volume Control, Assist Control, and
This creates a streamlined anesthesia workstation
Synchronized Intermittent Mandatory Ventilation
or “essential critical care tech in a box”.
(SIMV) with both flow and pressure triggers.
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Rapid Progress

Milestones

3,000 devices sold to New York City

April 17, 2020 FDA Emergency Use Authorization

$1M grant from NY Empire State Development

$100,000 grant from Army’s xTech

$100,000 grant from NYC EDC

$100,000 grant from FUZEHUB

Discussing 10,000 unit order with U.S.

Department of Defense

New York Times, April 20, 2020

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In discussions with
officials across the globe
New York
Pennsylvania
Spiro Wave is addressing immediate US DoD
Egypt Lebanon
shortages worldwide and bolstering
Mexico
emergency stockpiles for the future.
Colombia
Ethiopia
Impacted hospitals across the globe Peru
Brazil Philippines
are expressing interest in this simple,
affordable, and durable device. We’re South Africa
also in discussions with traditional
medical device distributors.

3,000+ Spiro Waves produced in New York City

Regional leaders & Health Ministers with expressed interest

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Timeline
Q1/Q2 2020

Product Successful Trials FDA Authorization Distribution to Production Scales

Development New York City
NYC team collaborates Successful porcine trials; Emergency Use NYCEDC purchases Boyce Technologies begins
with MIT researchers peer reviewed by Authorization (EUA) 3,000 units; begins manufacturing ~500
accredited clinicians received April 17 distribution to hospitals units/week at LIC facility

MARCH APRIL MAY

Global Engagement Manufacturing Partners Global Expansion

Active discussions civic leaders Contract production partners Distribution to regional
and health ministers in South compliant with the FDA or partners with both U.S. and
America, Africa, Middle East, international equivalent overseas production
and Asia.

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Spiro Devices Team

Charles Boyce, Scott Cohen, Marcel Botha, Ingrid Pangandoyon, Marlon Nepomuceno, Rich Mokuolu,
Chairman CEO Chief Product Officer COO Director of Operations Supply Chain Management

Owen Trueblood, Liad Yamin, Ilya Ostrovskiy, Hannah Mishin, Colin Kelly, Robert Boggess,
Software & Product Design & Software Engineer Product & Process Control Director of Design Clinical Training & Support
Electronic Engineer Mechanical Engineer

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 Clinical advisors Regulatory advisors
with MIT engineering backgrounds with science & engineering experience

Dr. Alexander Slocum Jr., Sheila Walsh Pickering,

Dr. Albert Kwon, MD MD, PhD Sabrina Varanelli PhD

Anesthesiologist, Resident Physician, CEO, Nemedio; Medical Device Regulatory Affairs

Westchester Medical Center Medical College of Wisconsin Medical Robotics Specialist and Quality Systems Consulting

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Strategic Partners

Brooklyn Navy Yard, home to Newlab & 10xBeta Boyce Technologies Facility, Long Island City

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A powerful movement

The New York Times

New York Needed Ventilators. So They Developed One in a Month

The Wall Street Journal

New York City Plans to Stockpile Supplies for Future Pandemics

Fast Company
These new MIT-inspired low-cost ventilators are rolling out in NYC hospitals

NPR OnPoint
The Need For Innovation, Especially In A Crisis

Voice of America
How US Startups Built a Low-Cost Ventilator in a Month

Breaking Defense
Army Awards $200K For Stopgap Ventilators

New York Times, April 20, 2020

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Spiro Wave

Thank
You For more information,
contact scott@newlab.com

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