MEDIA & PRESS RELEASES
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...
Spectral Medical Announces Third Quarter Results and Provides Corporate Update
Tigris Trial Enrollment at 135 Patients Strengthened Balance Sheet with Expected Funds to Complete Tigris Trial Enrollment TORONTO, Canada – November 8, 2024 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing...
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...
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...
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...
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...
Spectral Medical Inc. Announces Closing of Additional US$1 Million Convertible Notes
Large shareholder exercises anti-dilution pre-emptive rights 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...
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...
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...
Spectral Medical Inc. Announces Results of Annual Meeting of Shareholders
TORONTO, Canada – June 7, 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 the results of its Annual Meeting of shareholders (the...
Spectral Medical Inc. Announces Closing of Approximately C$8.5 Million Convertible Notes 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. TORONTO, Canada –...
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
Spectral Medical Inc. Announces C$8.5 Million Bought Deal Convertible Note Financing
May 9, 2024
Spectral Medical Provides April Tigris Trial Update
- 105 patients enrolled
- April represents a record breaking month for patient enrollment
May 6, 2024
Spectral Medical Provides Tigris Trial Update
April 10, 2024
Spectral Medical Chair to Retire From the Board of Directors
April 2, 2024
Spectral Medical Announces Fourth Quarter and Fiscal 2023 Results and Provides Corporate Update
March 28, 2024
Spectral Medical Provides February Tigris Trial Update
- 93 patients enrolled
- February represents a second record breaking consecutive month for patient enrollment
February 28, 2024
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
Spectral Medical Announces Major Milestone by Reaching Its Interim Enrollment Target of 90 Patients
February 15, 2024
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
Spectral Medical Provides January Tigris Trial Update
- 85 patients enrolled
January 30, 2024
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
Spectral Medical Provides Tigris Trial Update
81 patients enrolled
December 14, 2023
Spectral Medical Provides November Tigris Trial Update
79 patients enrolled
December 4, 2023
Spectral Medical Announces CFO Departure
December 1, 2023
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
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
Spectral Medical Provides Tigris Trial Update
- 76 patients enrolled
- Emory Healthcare latest clinical site addition into the Tigris Trial
November 7, 2023
Spectral Medical Announces Opening of Tigris Clinical Trial Site at the Mayo Clinic
October 16, 2023
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
Spectral Medical Provides Board Update
October 2, 2023
Spectral Medical Supports World Sepsis Day
World Sepsis Day is Today, September 13, 2023 (ET/PT)
September 13, 2023
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
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
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
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
Spectral Medical Announces Second Quarter Results and Provides Corporate Update
Tigris Trial Enrollment Reaches 71 Patients
August 10, 2023
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
Spectral Medical Announces Tigris Clinical Trial Update
Enrollment momentum continues as Tigris Trial reaches 69 patients
July 25, 2023
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
Spectral Medical Appoints Former FDA Director, Dr. David W. Feigal, Jr., to Its Board of Directors
June 27, 2023
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
Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders
June 8, 2023
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
Spectral Medical Hosts Successful Investigator Meeting; Expected to Help Bolster Enrollment Activities
Tigris trial enrollment at 60 patients
May 24, 2023
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
Spectral Medical Inc. Announces Director Resignation
May 4, 2023
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
Spectral Medical Announces Investor Update Conference Call
April 6, 2023
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
Spectral Medical Announces the Opening of Two Additional Tigris Clinical Trial Sites
March 9, 2023
Spectral Medical to Present at Microcap Rodeo's Annual Winter Wonderland - Best Ideas Virtual Investor Conference Today
February 22, 2023
Spectral Medical Provides Update on Tigris Clinical Trial and Other Business Developments
January 12, 2023
2022
Spectral Medical Announces Strategic Joint Venture with Infomed to Accelerate Commercialization of DIMI and SAMI Dialysis Devices
December 13, 2022
Spectral Medical Announces Third Quarter Results and Provides Corporate Update
November 10, 2022
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
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
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
Spectral Medical Provides Update on Tigris Clinical Trial
October 4, 2022
Spectral Announces FDA Approval to Add Up To 10 Additional Tigris Clinical Trial Sites
August 18, 2022
Spectral Announces Second Quarter Results and Provides Corporate Update
August 12, 2022
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
Spectral Medical’s Chief Medical Officer, Dr. John Kellum, to be the Featured Speaker in Webinar Hosted by Sepsis Alliance.
July 26, 2022
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
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
Spectral Medical to Participate at the Benzinga All Access event on July 15, 2022
July 13, 2022
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
Spectral Medical Announces Results of Annual and Special Meeting of Shareholders
June 21, 2022
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
Spectral Medical Announces Adoption of SAMI Device by the Largest Inpatient Dialysis Provider in South Florida
June 13, 2022
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
May 13, 2022
Spectral to Present at Microcap Rodeo’s Spring into Action Best Ideas Virtual Conference on May 16th.
May 13, 2022
Spectral Announces First Quarter Results and Provides Corporate Update
April 27, 2022
Spectral to Present at Investor Summit Group’s Q2 In-Person Conference on May 3rd in NYC
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
March 16, 2022
Dialco Medical Announces Formation of Medical Advisory Board to Support the Continued Development of DIMI Device
March 4, 2022
Spectral Medical CMO Dr. John Kellum to Present at the 27th International AKI & CRRT Conference on March 7-10, 2022
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
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
December 3, 2021
Spectral to Present at the SNN Network Canada Virtual Event on Wednesday, December 8, 2021
November 30, 2021
Spectral Medical Schedules Conference Call to Provide Clinical Update and Discuss Latest Developments
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
November 12, 2021
Spectral Announces Third Quarter Results and Provides Corporate Update
Reports early patient mortality data in Tigris Trial on target with expectations
October 25, 2021
Spectral to Present at the Benzinga Global Small Cap Conference on October 27, 2021
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
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
August 23, 2021
Spectral Medical Announces its Participation at Upcoming Investor Conferences
August 13, 2021
Spectral Announces Second Quarter Results and Provides Corporate Update
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
2020
November 11, 2020
- 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
August 5, 2020
- 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
August 4, 2020
- Adds significant experience and strength to the Company’s commercialization focus >
June 26, 2020
June 18, 2020
June 5, 2020
Promotion of Chris Seto to Chief Operating Officer >
May 27, 2020
May 15, 2020
April 28, 2020
- 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 >
April 20, 2020
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- 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 >
April 14, 2020
- 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 >
April 2, 2020
Two new hospitals in Canada and the U.S. place orders for SAMI >
March 27, 2020
March 12, 2020
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES >