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EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

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Page 1: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

EDT:TSX

Page 2: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

7/14/2020 Spectral Medical Inc.2

Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future financial position, business strategy, budgets, litigation, projected costs, capital expenditures, financial results, taxes and plans and objectives. In some cases, forward-looking information can be identified by terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or other similar expressions concerning matters that are not historical facts. These statements are based on certain factors and assumptions regarding, among other things, expected growth, results of operations, performance, and business prospects and opportunities. While we consider these assumptions to be reasonable based on information currently available to us, they may prove to be incorrect. Forward looking-information is also subject to certain factors, including risks and uncertainties that could cause actual results to differ materially from what we currently expect. These factors include, among other things, the availability of funds and resources to pursue development projects, the successful and timely completion of clinical studies, and the ability to take advantage of business opportunities, the granting of necessary approvals by regulatory authorities, and general economic, market and business conditions. For more exhaustive information on these risks and uncertainties you should refer to our most recently filed Annual Information Form which is available at www.sedar.com. Forward-looking information contained in this presentation is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time.

Forward Looking Statements

Page 3: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Spectral Investment Highlights

1. Spectral is committed to commercializing a treatment for endotoxemic septic shock patients comprised of proprietary components (diagnostic and therapeutic) in the US Market

• Spectral’s addressable US market is ~US$1.5 billion p.a. • Septic shock is a leading cause of death in US ICUs and a leading contributor to healthcare costs• Currently no FDA approved solution in the market… Spectral has no competitor • Spectral Management has leading global sepsis expertise

2. Baxter Distribution Agreement – De-Risks PMX Commercialization & Solidifies Balance Sheet

• Distribution agreement economics (BAX Agreement is not a royalty/licensing agreement)• Baxter is the best commercialization partner – market leading US ICU presence and installed critical care devices provides ability to expedite market penetration of PMX• Strong external validation of both Tigris trial outcome and PMX commercialization through milestone payments and minimum purchase requirements• Solidifies Spectral’s balance sheet – Baxter US$5 million Upfront Exclusive Rights Payment non-refundable and non-dilutive

3. De-risked Phase III FDA Trial - Spectral is running an Open Label confirmatory trial for the PMX cartridge

• PMX demonstrated clinical benefit in prior studies and commercial success in Europe and Japan• Target patient group faces >40% mortality rate with limited treatment options • PMA submission modules 1-3 were reviewed by FDA• Favourable starting point to Tigris trial… FDA process allows inclusion of positive Euphrates trial subset (179 patients)• Estimated Tigris trial costs of ~$11 million (Company has spent ~$2.6 million to date)

4. Spectral transitioning into a diversified medical device company - Dialco subsidiary

• Commercialized proprietary CRRT machine (SAMI) in 2019… significant growth in 2020 from pipeline of RFP and clinical evaluations• Getting regulatory approval for DIMI (home dialysis version of SAMI) in 2020• No material incremental regulatory expenditures; Dialco has sales & marketing resources in place to execute all initial commercialization activities

7/14/2020 Spectral Medical Inc.3

Page 4: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

• Filed a $50 million base shelf prospectus as a measure to maintain financing flexibility in a volatile capital markets environment

− Timing on the back of the Jun/20 financing significantly reduced costs and potential regulatory process

• Provides the Company with flexibility to access capital markets as potential corporate development activities arise – including potential commercial scale-up activities, acquisitions and in-licensing opportunities

Recent Corporate Activities

7/14/2020 Spectral Medical Inc.4

Exploration of US Listing

• Company is studying potential benefits of a secondary listing on a senior US exchange – potential benefits include an increase in long-term shareholder value creation through broader exposure of sell-side and buy-side investment industry players and increased liquidity

• Company will determine if and when to apply for a listing on a US exchange, and when it is considered in the best interests of Spectral shareholders

• Approved share consolidation at AGM provides flexibility in preparation of a secondary US listing

COVID-19 Activities

• Creating heightened awareness of Spectral products amongst clinicians

• Spectral aligned resources to combat the COVID-19 pandemic, with entire product portfolio deployed to treat COVID-19 positive patients… first instance of EAA, PMX and SAMI simultaneously utilized to treat a single patient

• PMX previously utilized in analogous viral pandemics (avian flu – H5N1, swine flu – H1N1)

• COVID-19 patients treated with PMX at two US hospitals (avg. 2.5 PMX columns per patient), majority of patients had a rapid and positive response based on lowering oxygen and vasopressor requirements

PMX / EAA

• US FDA approved supplemental Investigational Device Exemption (IDE) in Q2/20 for use of PMX in treatment of COVID-19 patients

− Collaborated with FDA to accelerate approval, with potential to use data in support of the PMA for Tigris

• Health Canada issued an Interim Order in Q2/20 for expanded indication of use to treat COVID-19 patients

• Tigris trial – Spectral submitted updated FDA protocol to increase number of Tigris to mitigate potential enrollment delays due to the COVID-19 pandemic

• Anticipating a multi-country launch of EAA with an existing distribution partner in mid-Q4/20

Dialco

• Dialco experiencing increased commercial activity – late Q1/20 added two major hospitals as new customers for its SAMI device

• SAMI: continuing to be utilized to treat numerous patients with acute renal failure at both a prominent US university and a large GTA hospital

• Installation and training has predominantly been virtual… continue to commercialize and deploy despite many restricted access ICUs

• DIMI: first FDA 510k approval expected in Q3/20; Dialco pursuing regulatory paths for other large potential niche dialysis markets evolving from the COVID-19 pandemic

Jun/20 $5.1mm Financing

• Company raised gross proceeds of CAD$5.1 million – fully-brokered $0.60 unit offering via short form prospectus:

− Initiated broadening of Company’s shareholder base – 100% institutional raise, comprised of 11 Canadian and US-based institutions new to Spectral

− Proceeds raised addresses Company’s anticipated costs to complete the Tigris trial

Filed Base Shelf

Prospectus

Page 5: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Spectral’s Targeted Therapy for Septic Shock

Page 6: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

PMX Opportunity: Baxter Distribution Agreement Summary

7/14/2020 Spectral Medical Inc.6

Provision Details

Appointment of Baxter • Baxter is exclusive distributor of PMX in US and Canada upon payment of Upfront Exclusive Rights Payment;• Baxter shall be entitled to retain the exclusive distribution rights as long as it pays the Milestone Exclusivity Payments and meets the Minimum Purchase

Requirements• Baxter is appointed non-exclusive distributor of EAA globally

Governance • Joint steering committee of equal representation by each party to facilitate dialogue with respect to activities including clinical, regulatory, supply, marketing and Commercialization activities of PMX and EAA

Regulatory • Spectral maintains control over the PMX regulatory process (ie, Tigris trial), and solely responsible for all costs and expenses

Commercialization of PMX • Baxter responsible to commercialize the Products entirely on its own behalf and its own expense

Minimum Purchase Requirements for PMX Products

• Baxter required to meet Minimum Purchase Requirements to maintain exclusivity post-FDA approval• [specific quantities and prices not disclosable]

Product Prices • [specific pricing not disclosable]

Milestone Payments #1 Baxter shall pay to Spectral US$5M within three weeks after execution of the Agreement (Upfront Exclusive Rights Payment);#2 Within 60 days receipt of TIGRIS Interim Data (60% patient enrollment), Baxter shall have the right to make an Initial Milestone Exclusive Rights Payment;#3 Within 90 days of FDA approval of PMX, Baxter shall have the right to make the Second Milestone Exclusive Rights Payment… which will vary on a binary basis based on a Relative Mortality Benefit threshold

Term • 10 year Initial Term• Renewal Term – automatically renew two additional five-year periods

Baxter Partnership is a Distribution Agreement and NOT a License/Royalty Agreement

Page 7: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

PMX Opportunity – Illustrative Financial Benefits to Spectral

7/14/2020 Spectral Medical Inc.7

• There are 1.7 Million patients each year in the US diagnosed with sepsis

• There are 330K patients who are expected to develop sepsis shock

• There are 120K patient in the US each year that fit the Tigris/EUPHRATES patient population

• There are not expected to be any competing therapeutic devices for 7 years

• PMX will be premium priced (gross margins anticipated at over 70%) – current European pricing ~USD$6,000 per PMX column; LASER consultant report indicated US market pricing of ~USD$7,500 per PMX column (2016)

• Based on Spectral Management experience, typical medical device distribution agreement economics range from 40%-60% revenue sharing on consumables… the more unique the product, the higher the revenue split to the product owner

• ~$1.5 Billion USD opportunity

• Secondary endpoint support the pharmaco-economics of the treatment

• Target market penetration of 35-40% through distribution partnership

Illustrative US Market Penetration of EDT Addressable Market (%)

7.5% 15.0% 25.0% 35.0% 45.0%

No. Patients 9,000 18,000 30,000 42,000 54,000

No. PMX Columns 18,000 36,000 60,000 84,000 108,000

PMX EBITDA Potential

$35M $70M $117M $164M $211M

No. EAA Kits 45,000 90,000 150,000 210,000 270,000

EAA EBITDA Potential

$2M $4M $6M $9M $11M

Total EDT EAA + PMX EBITDA Potential

$37M $74M $123M $173M $222M

Sources:1. Sepsis numbers from CDC2. Septic data from NIS database 20133. Guidelines from surviving sepsis campaign 2016

Illustrative Potential US Net Economics to Spectral – PMX + EAA (per annum)

Notes: Number of patients based on estimated addressable patient population of 120,000 patients p.a.

Page 8: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Addressable US Market Size ~ US$1.5B

7/14/2020 Spectral Medical Inc.8

Sources:1. Natural Center for Emerging and Zoonotic Infectious Disease (NCEZID), Centers for Disease Control and Prevention, Division of Health Care Quality Promotion (DHCOP) data reports, 2016.2. NIS database 20133. Spectral Management estimates, based on Euphrates trial data overlay of NIS database 2013

>40% Mortality & Limited Therapeutic Options

• 20% mortality

• 1.7M patients with sepsisSEPSIS1

• > 40% mortality

• 330K patients in septic shockSEPTIC SHOCK2

SPECTRALTARGET MARKET3

• > 40 % mortality

• Spectral estimates US$1.5B+ market▪ 100-120K patients with multiple organ dysfunction and high

level of EAA▪ Estimated $15K per EAA+PMX treatment price models

Page 9: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Measuring & Treating Endotoxemic Septic Shock

7/14/2020 Spectral Medical Inc.9

EAA™ A Diagnostic to Measure Endotoxin ActivityA predictor of ICU mortality in septic patients.Sold globally. Evidence of utility in thousands of patients.

1

PMX has Proven Efficacy: to Remove Endotoxin2

Polymyxin B coated fibers, bench test results - each cartridge can remove up to 20 µg of endotoxin.

2

Clinical Body of EvidenceMore than 3001 peer reviewed papers reporting on more than 10,000 patients.More than 200,000 treatments around the world, less than 0.1% rate of SAE

3

The EUPHRATES TrialPost-Hoc analysis demonstrated reduced mortality at 28 days in key subgroup.

4

A Clear Registration Pathway for PMXThe Tigris trial, designed to build on the Euphrates generated body of evidence has been reviewed and approved by the FDA.

5

Sources:1. Report of Prior Investigations (“ROPI”) is a report that is part of the Code of Federal Regulations, Title 21, Volume 8, Revised as of April 1, 2018, CITE: 21CFR812.272. “Novel Insights into the Direct Removal of Endotoxin by Polymyxin B Hemoperfusion.” Romaschin AD, Obiezu-Forster CV, Shoji H, Klein DJ.

Page 10: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

PMX Endotoxin Removal Cartridge:Real World Clinical Evidence

7/14/2020 Spectral Medical Inc.10

• Regulatory acceptance in Japan, Europe, Canada and many other countries

• >300 published papers1

• Approx. 10,0001 patients entered into trials

• 200,000+ patients treated worldwide

• 20+ years of proven safety profile worldwide

• Results from Spectral’s recently completed EUPHRATES trial, have been published in JAMA and Intensive Care Medicine

Sources:1. Report of Prior Investigations (“ROPI”) is a report that is part of the Code of Federal

Regulations, Title 21, Volume 8, Revised as of April 1, 2018, CITE: 21CFR812.27

Page 11: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Lessons Learned From the EUPHRATES Trial

7/14/2020 Spectral Medical Inc.11

• While the top line data did not demonstrate a mortality benefit, it did show a trend for cardiovascular improvements in the PMX group

• The post-hoc analysis identified a subset of patients who benefitted from the PMX treatments1,2

• When strict patient selection criteria are applied, including high severity of illness (MOD score > 9) and an endotoxin activity level as measured by EAA between 0.6 and 0.89, PMX use compared to sham3 is associated with a ~29% relative risk reduction in mortality at 28 days

Sources:1. JAMA. 2018;320(14):1455-1463. doi:10.1001/jama.2018.146182. Intensive Care Med. 2018; 44:2205–2212 doi.org/10.1007/s00134-018-5463-73. Sham being what is given to patients in the control group not receiving PMX

Page 12: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

The Basis For Going Forward

• EUPHRATES data base considered robust and therefore results are solid (FDA, JAMA, ICM)

• Results show that there is a population that responds to treatment showing a clinically significant reduction in 28 day mortality

• FDA has approved trial for this population of patients Tigris will be run in 10 sites familiar with the EAA and PMX targeted approach, from the EUPHRATES trial

• The trial enrollment time is anticipated to be 18 months

• There are no other large sponsored sepsis trial in the US at this time so that there is no competition for patients

• PMA approval gives 7-10 years of market exclusivity in the US

7/14/2020 Spectral Medical Inc.12

Page 13: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Regulatory Status: Confirmatory TIGRIS Trial

7/14/2020 Spectral Medical Inc.13

1) Trial Design agreed upon with the FDA: US sites only, randomized (2:1), Open Label trial

2) Prior population consists of 179 patients from US sites in EUPHRATES (target weight* 75%)

3) 150 new patients to be added from the TIGRIS trial

EUPHRATES Evidence [TIGRIS Prior]:US patients with MOD>9 and EAA 0.6-0.9:• N= 90 PMX with 38% mortality• N= 89 controls with 48% mortality

TIGRIS New Patients• 100 PMX• 50 controls• Same inclusion and exclusion criteria, same sites

TIGRIS: Bayesian trial designed to show:• Minimum 10% difference in mortality

*Statistical analysis plan not finalized, prior weight may change

Target Weight 75% Weight 100%

Page 14: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

PMX Saves Lives… Significant Mortality Benefits

7/14/2020 Spectral Medical Inc.14

Figure 2: Kaplan-Meier estimates of the probability of survival to day 28 among 76 ITT subjects with above median EAA reduction, by treatment groups.

ACTIVE

(N=35)

SHAM

(N=41)

P-value

Mortality Status N (%) N (%)

Alive 30 (85.7) 25 (61.0)

Dead 5 (14.3) 16 (39.0) 0.01622

Table 2: Mortality status at day 28 with above median reduction, by treatment groups among 76 randomized subjects

Page 15: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

PMX/EAA Milestones: Path to FDA Approval

7/14/2020 Spectral Medical Inc.15

Q2 2019Site selection and contract negotiation

Q4 20193 sites activelyenrolling patients

Q1 20209 sites actively screening / enrolling patients;

10th site identified

H1 2022Anticipated FDA Approval and PMX Launch

Q1 2019

Beginning of TIGRIS

Finalized protocolMarch 24/19

FDA Approval

Q4 2021Anticipated Trial completion and FDA Submission

Q1/Q2 2021Anticipated interim Tigris enrollment (60%)

- Baxter has 60 days to exercise right to maintain exclusive distribution rights

Page 16: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Wholly owned subsidiary of Spectral Medical

Dialco Medical Inc.

Page 17: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Investment Highlights for Dialco Medical

Growing niches within the $10B1 dialysis market • Large market opportunity – potential US market in excess of $1 billion (Acute and Home)

− Current CRRT market is $200M and growing 10% per year− Limited existing providers: US market – Baxter and NxStage; Cdn market – Baxter only− Important niche market for Dialco’s DIMI strategy – moreover, provides clinical evaluation validation for the DIMI concept

− HHD $500M and growing 14% per year− Increasing pressure to transition HD into an at-home setting in the US, with an Executive Order signed in Jul/19− COVID-19 pandemic potentially the major catalyst for accelerating changes in treatment and patient flow

Disruptive Technology• Spectral’s SAMI CRRT machine removes operational complexity from dialysis treatments• 12 years of IP protection and 20+ years of exclusive license

Dialco in Commercialization Mode• Sales team growth in US and Canada in 2020 and 2021• SAMI: Market ready CRRT model – FDA and HC approved

− Sales in first year (2019) of commercialization in excess of $500k− Strong pipeline of RFP and clinical evaluation activity in US and Canada

• DIMI: Near term approval for Home dialysis model – HC and 510k approval anticipated in Q3 2020− FDA approval will be a stepwise process… each step approval opens up commercially actionable market segments

which Dialco can penetrate

17

1

2

3

1. Machines and consumables – excludes dialysis services market (nursing visits, education, etc.) .

Page 18: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

FDA Cleared Acute Dialysis (CRRT) in Hospital • Removing complexity and increasing its

adoption• Second in the market in Canada, cost effective

alternative in US.

Enhancement of In-hospital Applications• Open platform for hemoperfusion.• Organ protection in organ donors.• Out of center – Hospital Dialysis.

Regulatory Path for Home Dialysis• 510k and Health Canada submissions will be based

on the already cleared CRRT version (SAMI)• CE mark already obtained• More than 100 dialysis sessions already

performed.

Adapts the Treatment … • To the patient’s needs• Machine that keeps the home patient

connected with doctor and nurses

Enhancing Home Dialysis Adoptions• Empowering patients to take control of their life

through a simple, safe and affordable home hemodialysis

Dialco’s Devices… Disruptive TechnologySAMI (CRRT) and DIMI (Home Hemodialysis)

18

• SAMI and DIMI remove operational complexity from dialysis treatments for all dialysis stakeholders• DIMI addresses many of the barriers to adoption for HHD, including:

– Lack of confidence in patient’s ability to carry out HHD treatments (both patient and doctor)– Disconnect between patient and caregiver– Complexity of technology and required skillset– Maintenance, usability & training– Treatment flexibility

SAMI – CRRT DIMI – HHD

Commercial in 2019• $0.5M sales in 2019• Building on commercial activities in 2020• Addition of salesforce resources in 2020 and 2021

Page 19: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

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Competitive Environment – High Level Overview Feature DIMI (Dialco) Tablo (Outset) System One (NxStage) Hemocare (CVS) SC+ (Quanta)

Overview • Second to the US HHD market with negligible market share

• First to the HHD market, with ~90% US market share

• Previously known as Baxter VIVIA

Dialysis Modalities • HD, PD, HDF, HF • HD • HD • HD • HD

Portability • High • Low • High • Low • Medium

Dialyzer Type • Open platform – use any licensed dialyzer

• Closed system - dialyzers prefixed to blood tubing

• Closed system – dialyzers prefixed to blood tubing

• Closed system – dialyzers prefixed to blood tubing

• Open platform – use any licensed dialyzer

Dialysate / Water requirements

• Pre-filled sterilized bag • Prepared online / requires reverse osmosis unit (“RO”)

• Pre-filled sterilized bag or prepared w/Pureflow

• Prepared online / requires reverse osmosis unit

• Prepared online / requires water purification system

Home Modifications

• None • Electrical and small plumbing • Small plumbing • Electrical and small plumbing • Plumbing and electrical

Concentrates • Not required • Required • Required when used w/Pureflow

• Required • Required

Disinfection / Maintenance

• Not required / yearly check • Chemical & hot water / monthly check on RO unit

• Hot water / monthly check on RO unit

• Hot water / monthly check on RO unit

• Not required

Regulatory Status • In hospital use pending 510k approval

• 510k approved • 510k approved • FDA IDE trial ongoing • No FDA submission to-date

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Dialco Achievements To-Date

Timing Achievement

January 2018 • FDA and Health Canada regulatory approvals cleared for SAMI

December 2018 • SAMI manufacturing and license agreement finalized between Spectral and Infomed

March 2019 • Dialco structured as wholly-owned subsidiary of Spectral

• First commercial sales transaction for SAMI

• DIMI license and regulatory agreement finalized between Dialco and Infomed

December 2019 • Dialco submits traditional FDA 510k package

Q1/20 • Commercial sales with two new customers (prominent US university medical centre and GTAhospital)

• Successful remote installation, set-up and high-level training on-line of SAMI

Q2/20 • SAMI successfully used to treat COVID-19 positive patient in conjunction with PMX and EAA underand emergency access request

• SAMI deployed and utilized at its US university medical centre customer to treat both COVID-19 andnon-COVID-19 patients with renal failure

• Dialco submits DIMI application with COVID-19 provision to Health Canada

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Dialco – DIMI Regulatory Pathway

Regulatory Submission Intended Use Timing Market Segment / Size

FDA Traditional 510K • Acute and chronic dialysis (HD, HDF,UF) in hospitals and health carefacilities

• Submitted Dec/19

• FDA required further biocompatibility and electromagnetic capability analysis conducted by certified labs

• Expected approval Q3/20

• US$200-300M

• In-center & hospital: any hospital facility and dialysis center, including self dialysis centers, field hospitals and SNFs

HC License as Extension of SAMI family

• Acute and chronic dialysis (HD, HDF,UF) in hospitals, health care facilitiesand home

• Submitted Q2 2020 • $35-70M

• Same market segment as above and HHD in Canada

FDA traditional 510K and HC –Peritoneal Dialysis

• Automated PD in hospitals and homeenvironment (Baxter AMIA aspredicated device)

• Submission ~Q4 2020 • US$140-280M• Peritoneal dialysis in US and Canada• Spectral focused on the “vintage” PD patients –

patients losing residual renal function and transitioning to HHD

• Strategic market for DIMI to gain stronger position in HHD

FDA IDE for Home Hemodialysis

• Protocol for data collection on 25patients going through training forhome use of DIMI and practicingdialysis with their partners in a clinic

• Submission ~Q3 2020 • N/A

FDA Special 510K IDEM-BOX • Remote monitoring software • Submission ~Q1 2021 • N/A

FDA Special 510K Home Hemodialysis

• Extension for home use • Submission ~Q2 2021 • US$400M growing at ~7%+ p.a. since 2003;• US market rapidly growing, with political pressure to

move treatment to a home environment (and likely more so post COVID pandemic)

• Stepwise FDA regulatory path to in-home use• Each step approval has a commercially actionable market segment for Dialco to penetrate

Page 22: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

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Dialco – Path to Shareholder Maximization

Continuous DialcoTechnology Validation

DIMI Regulatory Approvals

DIMI Commercialization Activities

Enhanced Business Model

Maximize Available Alternatives

• Continue commercialization activities with SAMI – building RFP and clinical evaluation activities

• Provides continued clinical validation of Dialco devices, increased market awareness and feedback

• Dialco moving expeditiously as possible to gain all stepwise regulatory approvals for DIMI

• Validates and de-risks the technology for any potential commercialization or financial partners

• Upon each DIMI step approval, penetrate associated market segments in both Canada and the US

• Topline revenue generation and growth should validate commerciality of Dialco business model… should provide further fundamental basis for Dialco value

• Enhance and strengthen Dialco business platform:

– Potential acquisitions to vertically integrate – manufacturing, services, other

– Potential to significantly increase margins, geographic markets, etc.

• Building on previous activities, all available shareholder value maximization alternatives available to be explored, including:

– distribution partnership(s), sale; IPO, spin-off, etc.

Page 23: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Spectral Medical Inc.Corporate Highlights

Page 24: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Spectral Summary

Baxter Agreement… confidence in outcome of Tigris trial… de-risks PMX commercialization

Spectral has significant depth of experience in product development, regulatory successes and clinical trials

Large addressable end markets provide significant potential upside/reward for Spectral shareholders

Near term inflection points for both PMX and Dialco pathways

COVID-19 pandemic increasing awareness of Spectral and Dialco products; potentially opening large niche markets for DIMI

Potential for Dialco to partner with strategic medical companies, which recognize/acknowledge Dialco’s targeted markets are high growth

Financial requirements to complete reasonable

7/14/2020 Spectral Medical Inc.24

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Company Highlights

7/14/2020 Spectral Medical Inc.25

TSX: EDT

Established 1991

Number of employees 25

Offices & Facilities Toronto, Canada

Recent Share Price1 $0.59

Shares Outstanding1 236,605,745

Market Capitalization1 ~ $140 M

Insider Ownership1 ~ 40% (Toray – 19.3%; Birch Hill Equity Partners – 15.2%)

Cash2 $7,771,000

Total Debt Nil

1 as at July 7, 20202 as at March 31, 2020; does not include gross proceeds of Jun/20 financing

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Capitalization

7/14/2020 Spectral Medical Inc.26

3

1 weighted average exercise price of $0.462 7,472,331 warrants (exercise price of $0.45; expiry date of April 20/21);4,250,000 warrants (exercise price of $0.75; expiry date

of June 18/22; 510,000 broker warrants (exercise price of $0.60; expiry date of June 18/22)

No. OutstandingCommon Shares 228,105,745Options 9,505,190

As at July 7, 2020 No. Outstanding

Common Shares 236,605,745

Options1 8,926,062

Warrants2 11,722,331

Fully Diluted Shares Outstanding 257,764,138

As at March 31, 2020

Cash 7,771,000

Pro Forma Cash (addition of net proceeds of June/20 financing) 12,369,000

Total Debt -

Page 27: EDT:TSX - Spectral · • Creating heightened awareness of Spectral products amongst clinicians • Spectral aligned resources to combat the COVID-19 pandemic, with entire product

Senior Management

7/14/2020 Spectral Medical Inc.27

Paul Walker, M.D., Ph.D., F.R.C.S.CDirector, President & Chief Executive Officer

• Dr. Walker joined Spectral as President and CEO in April 2001. Prior to that, he held the position of COO of the Toronto General Hospital, and was Surgeon in Chief and Vice President of the Surgical Directorate of the University Hospital Network. Dr. Walker was an active Vascular Surgeon and the Director of the Intensive Care Program, and Professor of Medicine at the University of Toronto. As CEO of Spectral, Dr. Walker lead the transformation of Spectral from a diagnostic company to a leading theragnostics company focused on bringing unique commercial products to market that fill unmet medical needs

• A pioneer in the area of endotoxin and its role in sepsis, and the co-inventor of the Endotoxin Activity Assay (EAA™), Dr. Walker is a frequent participant at leading sepsis and critical care conferences, has been a keynote speaker at symposiums focusing on the role of endotoxin in sepsis, and is the author of over 100 scientific publications. He received his M.D. from the University of Western Ontario, his Ph.D. from the Salgrenska University of Göteborg, Sweden, and is a graduate of the Advanced Management Program from Harvard School of Business.

Chris SetoChief Operating Officer &Chief Financial Officer

• Mr. Seto is the Chief Financial Officer of Spectral Medical. In his role, he oversees the financial management of the company including, finance, accounting, treasury and capital market financings as well as corporate planning/development and investor relations. Prior to joining Spectral Medical, Chris was the CFO of MJardin Group Inc. (CSE:MJAR) and GrowForce Holdings Inc. Additionally, Chris has over 20 years of capital markets and financial management experience, including senior investment banking positions with Paradigm Capital, UBS Securities and CIBC World Markets; and financial management experience in the telecom and healthcare industries with Bell Canada and Warren Shepell.

• Chris holds a B. Comm. from McMaster University, an MBA from Richard Ivey School of Business, and a Certified Management Accountant designation (C.M.A. 1999).

Dr. Gualtiero Guadagni, Ph.DPresident, Dialco Medical Inc.

• Dr. Guadagni is President of Dialco Medical Inc., Spectral’s wholly owned subsidiary in the space of renal replacement therapies. Within Spectral, Dr Guadagni is responsible for the development and expansion of commercial opportunities for Toraymyxin and Spectral’s EAA™ in Canada, the United States and Europe as well as for the company’s R&D and Manufacturing operations.

• Dr. Guadagni has more than 20 years of extensive experience in products and markets development of medical devices for extracorporeal circulation. Prior to joining Spectral in 2013, Dr. Guadagni spent 10 years at ESTOR S.P.A (Milan-based company specialized in the production, promotion and sale of advanced biomedical devices in the areas of dialysis, intensive care and hemodynamics) where he was the company’s sales and marketing director, and member of the Board of Directors.

• Dr. Guadagni has a PhD in bioengineering and a master’s degree in mechanical engineering, both from Politecnico di Milano University in Italy.

Debra M. Foster, BSc.Vice President, Clinical Development

• Ms. Foster brings more than 20 years of experience to the Spectral team, and is responsible for the clinical evaluation as needed for design validation of Spectral devices. Additionally, she oversees the company’s Regulatory and Quality Assurance operations. She brings to Spectral an innovative approach to managing clinical trials and has lectured to medical professionals on the topics of sepsis and clinical trials for sepsis internationally. She has extensive experience in leading both regulatory and quality system portfolios.

• Initially her career focused on critical care nursing and then critical care clinical research. Ms. Foster values many years as a member of the Canadian Critical Care Trials Group where she developed expertise in clinical trial design, operation and execution.

• Ms. Foster holds a Bachelor of Sciences degree in Human Biology from the University of Toronto.

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Board of Directors

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Anthony Bihl Chairman of the Board, CEO, Bioventus LLC

Kevin Giese Former CEO and Director of Medwell Capital

Jun Hayakawa General Manager, Pharmaceutical & Medical Device Business Planning Dept. of TORAY

Paul Walker President & CEO of Spectral Medical Inc.

William Stevens Former Principal of Birch Hill Equity Partners & Managing Director, Westerkirk Capital Inc.