MEDIA & PRESS RELEASES

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2024 MEDIA

Spectral combining diagnostics with targeted therapy in novel approach to septic shock

BioTuesdays
November 12, 2024

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2024 PRESS RELEASES

Spectral Medical Provides November Tigris Trial Update

136 patients enrolled. Company to host Tigris Trial Update Call December 16, 2024. TORONTO, Canada – December 2, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic...

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Spectral Medical Provides October Tigris Trial Update

135 patients enrolled TORONTO, Canada – November 4, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris...

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Spectral Medical Provides September Tigris Trial Update

132 patients enrolled TORONTO, Canada – October 3, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris...

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Spectral Medical Provides August Tigris Trial Update

Management provides view on recently announced Vantive-Carlyle Group transaction TORONTO, Canada – September 3, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic...

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Spectral Announces Second Quarter Results and Provides Corporate Update

Tigris Trial Enrollment Reaches 126 Patients

Strengthened Balance Sheet with Expected Funds to Complete Tigris Trial Enrollment

August 9, 2024

Spectral Medical Provides July Tigris Trial Update

125 patients enrolled Record July patient enrollment to start the second half of 2024 TORONTO, Canada – August 1, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and...

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Spectral Medical Inc. Announces Change to Auditor

TORONTO, Canada – July 11, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that MNP LLP (“MNP”) have today been appointed as the auditors...

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Spectral Medical Provides June Tigris Trial Update

116 patients enrolled June represents a new record breaking month for patient enrollment TORONTO, Canada – July 2, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and...

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Spectral Announces First Quarter Results and Provides Corporate Update

  • Tigris Trial Enrollment Reaches 106 Patients
  • Bought Deal Financing Expected to Fund Completion of Tigris Trial Enrollment 

May 13, 2024

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Spectral Medical Inc. Announces C$8.5 Million Bought Deal Convertible Note Financing

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES OF AMERICA OR TO ANY PERSON LOCATED OR RESIDENT IN THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA. 

May 9, 2024

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Spectral Medical Provides April Tigris Trial Update

  • 105 patients enrolled
  • April represents a record breaking month for patient enrollment 

May 6, 2024

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Spectral Medical Provides Tigris Trial Update

April 10, 2024

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Spectral Medical Chair to Retire From the Board of Directors

April 2, 2024

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Spectral Medical Announces Fourth Quarter and Fiscal 2023 Results and Provides Corporate Update

March 28, 2024

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Spectral Medical Provides February Tigris Trial Update

  • 93 patients enrolled
  • February represents a second record breaking consecutive month for patient enrollment

February 28, 2024

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Spectral Medical Announces Amendment and Extension of Exclusive Supply and Distribution Agreement With Baxter Healthcare Corporation

  • Baxter to act as exclusive partner to Spectral for 10 years following PMX approval by U.S. FDA

February 21, 2024

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Spectral Medical Announces Major Milestone by Reaching Its Interim Enrollment Target of 90 Patients

February 15, 2024

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Spectral Medical Provides Early February Tigris Trial Update

      • 88 patients enrolled
      • January being the highest enrollment month since the launch of Tigris

      February 5, 2024

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Spectral Medical Provides January Tigris Trial Update

  • 85 patients enrolled

January 30, 2024

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Spectral Medical Enrolls Patient 82 in Its Phase 3 FDA Tigris Septic Shock Trial

  • New patient enrollment sites accelerating screening activity
  • Screening activity exceeding 100 patients per week
  • Approaching interim enrollment target of 90 patients

January 10, 2024

2023

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Spectral Medical Provides Tigris Trial Update

81 patients enrolled

December 14, 2023

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Spectral Medical Provides November Tigris Trial Update

79 patients enrolled

December 4, 2023

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Spectral Medical Announces CFO Departure

December 1, 2023

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Spectral Medical Announces Publication of Tigris Trial Methods Paper and Simulation of Results

Tomlinson et al. Bayesian methods: a potential path forward for sepsis trials. Critical Care (2023) 27:432

November 14, 2023

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Spectral Medical Announces Third Quarter Results and Provides Corporate Update

  • Tigris Trial Enrollment Reaches 76 Patients
  • Crude mortality results continue to exceed expectations

November 9, 2023

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Spectral Medical Provides Tigris Trial Update

  • 76 patients enrolled
  • Emory Healthcare latest clinical site addition into the Tigris Trial

November 7, 2023

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Spectral Medical Announces Opening of Tigris Clinical Trial Site at the Mayo Clinic

October 16, 2023

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Spectral Medical Provides Tigris Trial Update

  • 74 patients enrolled
  • New sites to further accelerate patient enrollment
  • On track to onboard seven new trial sites around the end of November 2023

October 3, 2023

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Spectral Medical Provides Board Update

October 2, 2023

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Spectral Medical Supports World Sepsis Day

World Sepsis Day is Today, September 13, 2023 (ET/PT)

September 13, 2023

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Spectral Medical Featured in New Episode of ‘The Balancing Act’ Airing on Lifetime TV Focused on Endotoxic Septic Shock

Episode to be Broadcast on Monday, September 11th and Tuesday, September 19th 2023 at 7:30 a.m. (ET/PT)

September 8, 2023

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Spectral Medical Inc. Closes C$6.1 Million Bought Deal Convertible Note Financing

Tigris patient enrollment momentum continues reaching 72

The Company anticipates three additional trial sites to be activated in Q3

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

September 7, 2023

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Spectral Medical Inc. Announces Upsizing of Previously Announced Bought Deal Convertible Note Financing to C$5.5M

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES OF AMERICA OR TO ANY PERSON LOCATED OR RESIDENT IN THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA.

August 22, 2023

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Spectral Medical Highlights New Episode of ‘The Balancing Act’ Airing on Lifetime TV Focused on Endotoxic Shock

Episode to be Broadcast on September 11th, 2023, at 7:30 a.m. (ET/PT) preceding World Sepsis Day on September 13th

August 16, 2023

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Spectral Medical Announces Second Quarter Results and Provides Corporate Update

Tigris Trial Enrollment Reaches 71 Patients

August 10, 2023

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Spectral Medical Inc. Announces C$5 Million Bought Deal Convertible Note Financing

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES OF AMERICA OR TO ANY PERSON LOCATED OR RESIDENT IN THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA.

August 10, 2023

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Spectral Medical Announces Tigris Clinical Trial Update

Enrollment momentum continues as Tigris Trial reaches 69 patients

July 25, 2023

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Spectral Medical Announces the Opening of Three Additional Tigris Clinical Trial Sites

University of Alabama enrolls patient 65 after second day of opening for enrollment

July 5, 2023

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Spectral Medical Appoints Former FDA Director, Dr. David W. Feigal, Jr., to Its Board of Directors

June 27, 2023

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Spectral Medical Provides Update on Continued Favorable Tigris Clinical Trial Enrollment

Tigris trial enrollment at 64 patients

Crude mortality results continue to exceed expectations

June 20, 2023

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Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

June 8, 2023

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Spectral Medical Provides Update on Favorable Tigris Clinical Trial Enrollment

Reports significant uptick in enrollment activities

Tigris trial enrollment at 61 patients

May 30, 2023

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Spectral Medical Hosts Successful Investigator Meeting; Expected to Help Bolster Enrollment Activities

Tigris trial enrollment at 60 patients

May 24, 2023

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Spectral Medical Announces First Quarter Results and Provides Corporate Update

New Trial Sites Enroll 60% of New Patient Enrollments Since the Beginning of April

TIGRIS Patient Enrollment at 58 Patients 

May 12, 2023

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Spectral Medical Inc. Announces Director Resignation

May 4, 2023

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Spectral Medical Announces Positive Results of EUPHAS-2 Clinical Trial Evaluating PMX in Critically Ill Endotoxemic Septic Shock Patients

Reports 28-day mortality of just 36% for patients undergoing PMX hemoadsorption versus 75% predicted by widely accepted SAPS II mortality estimation tool

Results featured in premier peer-reviewed journal highlighting the benefits of PMX

April 6, 2023

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Spectral Medical Announces Investor Update Conference Call

April 6, 2023

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Spectral Medical Announces Fourth Quarter and Fiscal 2022 Results and Provides Corporate Update

Reports significant enhancements to accelerate Tigris patient enrollment including appointment of new Contract Research Organization

Management to host Investor Day on April 6, 2023

March 24, 2023

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Spectral Medical Announces the Opening of Two Additional Tigris Clinical Trial Sites

March 9, 2023

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Spectral Medical to Present at Microcap Rodeo's Annual Winter Wonderland - Best Ideas Virtual Investor Conference Today

February 22, 2023

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Spectral Medical Provides Update on Tigris Clinical Trial and Other Business Developments

January 12, 2023

2022

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Spectral Medical Announces Strategic Joint Venture with Infomed to Accelerate Commercialization of DIMI and SAMI Dialysis Devices

December 13, 2022

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Spectral Medical Announces Third Quarter Results and Provides Corporate Update

November 10, 2022

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Spectral Medical Inc. Closes $10.8 Million Public Offering and Concurrent Private Placement

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

November 2, 2022

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Spectral Medical Inc. Announces Pricing of Previously Announced Offering

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

October 6, 2022

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Spectral Medical Inc. Announces Proposed Public Offering of Units and Private Placement of Notes

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

October 5, 2022

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Spectral Medical Provides Update on Tigris Clinical Trial

October 4, 2022

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Spectral Announces FDA Approval to Add Up To 10 Additional Tigris Clinical Trial Sites

August 18, 2022

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Spectral Announces Second Quarter Results and Provides Corporate Update

August 12, 2022

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Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical and Distribution Partner Marathon Medical Awarded Contract to Provide SAMI Dialysis Devices to the US Department of Veterans Affairs

August 8, 2022

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Spectral Medical’s Chief Medical Officer, Dr. John Kellum, to be the Featured Speaker in Webinar Hosted by Sepsis Alliance.

July 26, 2022

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Spectral Medical Provides Update on Tigris Clinical Trial

July 20, 2022

Provides positive case study on patient enrolled at University of Michigan

14 clinical sites actively enrolling patients with 40 patients now randomized

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Spectral Medical Highlights From Vicenza Course 2022

Video replay of sponsored symposium explaining endotoxemic septic shock and the case for hemoperfusion therapy

July 14, 2022

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Spectral Medical to Participate at the Benzinga All Access event on July 15, 2022

July 13, 2022

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US FDA Grants Spectral Medical Breakthrough Device Designation for Toraymyxin™ (“PMX”) for the Treatment of Endotoxemic Septic Shock

Breakthrough designation expected to help accelerate regulatory review

July 11, 2022

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Spectral Medical Announces Results of Annual and Special Meeting of Shareholders

June 21, 2022

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Spectral and Dialco Announce Dr. John Kellum to be Featured as Keynote Lecturer at the 40th Vicenza Course on AKI and CRRT 2022

Dr. Kellum Invited to Participate on Additional Featured Panels

June 14, 2022

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Spectral Medical Announces Adoption of SAMI Device by the Largest Inpatient Dialysis Provider in South Florida

June 13, 2022

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May 16, 2022

Spectral Medical Announces Appointment of Leading Industry Executive Sam Amory as Dialco President 

Previously launched start-up division for a major medical device company that grew to the number two position in the U.S. market

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May 13, 2022

Spectral to Present at Microcap Rodeo’s Spring into Action Best Ideas Virtual Conference on May 16th.  

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May 13, 2022

Spectral Announces First Quarter Results and Provides Corporate Update

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April 27, 2022

Spectral to Present at Investor Summit Group’s Q2 In-Person Conference on May 3rd in NYC

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March 24, 2022

Spectral Medical Announces Fourth Quarter and Fiscal 2021 Results and Corporate Update

March 21, 2022

Spectral Medical Announces Appointment of Blair McInnis as CFO

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March 16, 2022

Dialco Medical Announces Formation of Medical Advisory Board to Support the Continued Development of DIMI Device

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March 4, 2022

Spectral Medical CMO Dr. John Kellum to Present at the 27th International AKI & CRRT Conference on March 7-10, 2022

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February 11, 2022

Spectral Medical Reports Progress on Tigris Clinical Trial

Patient mortality data continues to exceed expectations
Recent FDA approved SOFA amendment contributing to increased patient enrollment

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January 31, 2022

Spectral Medical Announces U.S. FDA Approval of DIMI Trial Protocol Amendment

Amendment expected to overcome key pandemic challenges and improve both site and patient enrollment

2021

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December 3, 2021

Spectral to Present at the SNN Network Canada Virtual Event on Wednesday, December 8, 2021

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November 30, 2021

Spectral Medical Schedules Conference Call to Provide Clinical Update and Discuss Latest Developments

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November 29, 2021

Spectral Medical Announces U.S. FDA Approval of Tigris Trial Protocol Amendment to Expand Inclusion Criteria 

Amendment aligns eligibility for Tigris with current clinical practice in septic shock

Potential to improve Tigris enrollment rates by 25% to 50% and reduce time to trial completion

Five additional clinical sites now participating with 15 total sites fully on board

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November 12, 2021

Spectral Announces Third Quarter Results and Provides Corporate Update

Reports early patient mortality data in Tigris Trial on target with expectations

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October 25, 2021

Spectral to Present at the Benzinga Global Small Cap Conference on October 27, 2021

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October 20, 2021

Spectral and Dialco announce Dr. John Kellum to be featured AS Keynote Lecturer at the 39th Vicenza Course on AKI and CRRT

Dr. Kellum Invited to Participate on Additional Featured Panels

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September 13, 2021

Spectral Medical’s CMO Recognized as a World Expert in Sepsis; Supports World Sepsis Day and Sepsis Awareness Month

Spectral Sponsors Live Webinar hosted by its CMO at the Sepsis Alliance Symposium

September 13th is World Sepsis Day; September is designated as Sepsis Awareness Month

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August 23, 2021

Spectral Medical Announces its Participation at Upcoming Investor Conferences  

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August 13, 2021

Spectral Announces Second Quarter Results and Provides Corporate Update

 

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August 9, 2021

Spectral Medical Announces Internal Reorganization of its Wholly Owned Subsidiary
Dialco Medical to Enhance Operations and Accelerate Commercialization

Outlines anticipated milestones related to its DIMI and SAMI devices

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July 28, 2021

Spectral Medical Inc. Provides Tigris Clinical Trial Update

  • Recruitment activity returning to normalized levels with 12 trial sites actively screening patients
  • 15 sites on track to open for enrollment by the end of Q3 2021

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July 27, 2021

Spectral Medical Inc. Closes $10 Million Offering of Units

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July 21, 2021

Spectral Medical Inc. Announces $10 Million Offering

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July 20, 2021

Spectral Medical Inc. Announces Overnight Marketed Offering

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June 7, 2021

Dialco Medical Inc. Engages CROMSOURCE as Contract Research Organization Partner for DIMI IDE Trial

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June 4, 2021

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

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May 14, 2021

Spectral Announces First Quarter Results and Provides Corporate Update

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May 11, 2021

Spectral Medical to Present at the Q2 Virtual Investor Summit on May 17th

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May 5, 2021

Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces DIMI Usability Trial Posted on the ClinicalTrials.gov Website

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April 15, 2021

Spectral Medical Announces Exercise of Warrants for Gross Proceeds of Approximately $3.0 Million

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April 8, 2021

Spectral Medical’s Dialco Medical Announces 20 Year Exclusive License Agreement for DIMI Hemodialysis System in the United States and Canada

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March 31, 2021

Spectral Medical’s Wholly-Owned Subsidiary Dialco Medical Announces Receipt of Health Canada License for DIMI

  • Immediately enables DIMI to be used within Canadian hospitals, clinics and in home

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March 26, 2021

Spectral Announces Fourth Quarter and Fiscal 2020 Results and Corporate Update

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March 8, 2021

Spectral Medical Announces the Appointment of Chris Seto to CEO

Dr. Paul Walker will remain on the Board of Directors focusing on the seamless transition of management and on ensuring continuity of the Tigris Trial

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March 4, 2021

Spectral Medical Engages Crescendo Communications to Provide Investor Relations Services in the United States

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March 2, 2021

Spectral Medical to Participate at the Upcoming H.C. Wainwright Global Life Sciences Conference

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February 23, 2021

Spectral Medical Announces that its Wholly-Owned Subsidiary Dialco Medical has been Granted FDA IDE Authorization to Conduct a Trial of DIMI for Home Hemodialysis Use

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February 1, 2021

Spectral Medical Appoints Dr. John Kellum as Chief Medical Officer

A World Authority in Blood Purification and Renal Replacement Therapy

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January 11, 2021

Spectral Medical to Present at the H.C. Wainwright Virtual BioConnect Conference

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January 6, 2021

Spectral Medical to Present at the SNN Network Canada Virtual Event on January 7, 2021

2020

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November 27, 2020

Spectral Medical to Host Virtual Investor Day on December 4, 2020

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November 24, 2020

Spectral Medical Announces that its wholly owned subsidiary Dialco Medical has received MDSAP certification

  • MDSAP is the highest quality and regulatory standard in the medical device industry

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November 11, 2020

Spectral Announces Third Quarter Results

  • Dialco’s DIMI receives FDA 510(k) clearance for use in hospital and clinical settings – a significant step in the full regulatory development of DIMI
  • Tigris trial sites increased to eleven, with additional sites identified
  • Company to host Virtual Investor Day on December 4th, 2020

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November 11, 2020

Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

  • Operating the SAMI viewed as both simple and safe by the nurses
  • Successful remote deployment of SAMI with only 3 hours of virtual training

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November 3, 2020

Spectral and Dialco Sponsored Symposiums at the 38th Vicenza Course on AKI and CRRT

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September 8, 2020

Spectral to Present at H.C. Wainwright & Co. 22nd Annual Global Investment Conference 

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August 28, 2020

U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI

  • Immediately enables DIMI to be used within U.S. hospitals, clinics and skilled nursing facilities
  • U.S. skilled nursing facilities market represents an estimated US$2 billion market annually 

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August 14, 2020

Spectral Announces Second Quarter Results

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August 10, 2020

US FDA Approves Spectral Medical’s Protocol Amendment for TIGRIS

Protocol Amendment allows for increase in TIGRIS sites to 15 while potentially accelerating patient enrolling and offsetting any COVID-19 pandemic-related delays

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August 5, 2020

Spectral Medical Provides Corporate Update

  • Early Tigris trial observations in-line with Euphrates post-hoc results
  • Investigator-driven studies show endotoxin levels significantly elevated in most patients with COVID-induced septic shock
  • Q4 2020 EAA multi-country European launch
  • DIMI traditional FDA 510(k) approval for in hospital use expected in Q3 2020

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August 4, 2020

Spectral Medical Inc. Appoints John E. Nosenzo to its Board of Directors

  • Adds significant experience and strength to the Company’s commercialization focus >

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June 26, 2020

Spectral Medical Inc. Files Preliminary Base Shelf Prospectus >

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June 18, 2020

Spectral Medical Inc. Closes Previously Announced $5.1 Million Public Offering of Units >

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June 5, 2020

Spectral Announces Voting Results of Annual General and Special Meeting and
Promotion of Chris Seto to Chief Operating Officer
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May 27, 2020

Spectral Medical Inc. Announces Proposed Public Offering of Units >

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May 15, 2020

Spectral Announces First Quarter Results >

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April 28, 2020

Spectral Medical Provides Corporate Update

  • The Company remains well positioned with financial strength
  • COVID-19 patients using PMX in the U.S. showing positive signs in recovery
  • SAMI used successfully for CRRT in COVID-19 patients >

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April 20, 2020

Health Canada Issues an Interim Order for Spectral Medical’s PMX to Treat COVID-19 Patients

    • PMX has successfully been used for treatment in COVID-19 patients in the U.S., Japan and Italy 
    • Interim Order expands already approved PMX Health Canada indications for use to include treatment of COVID-19 patients >

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April 14, 2020

US FDA Approves an Investigational Device Exemption for Spectral Medical PMX to Treat COVID-19 Patients Suffering from Septic Shock

  • PMX has successfully been used for treatment in COVID-19 patients in the U.S., Japan and Italy
  • IDE approval provides access to PMX to help clinicians treat COVID-19 patients in septic shock
  • Publications have demonstrated endotoxin removal by PMX can decrease cytokine storm and dependency on ventilators >

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April 2, 2020

Spectral Provides Update on the Commercial Development of its SAMI Device for Continuous Renal Replacement Therapy

Two new hospitals in Canada and the U.S. place orders for SAMI >

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March 27, 2020

Spectral Announces Fourth Quarter and Fiscal 2019 Results >
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March 12, 2020

Spectral Medical Inc. Withdraws Public Offering 
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES >
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March 5, 2020

Spectral Medical Inc. Announces Proposed Public Offering of Common Shares
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES >
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February 4, 2020

Baxter and Spectral Medical Announce Exclusive Distribution Agreement For Blood Filter in U.S. and Canada >