SPECTRAL MEDICAL
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 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 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
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