PMX

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

Retrieved on: 
Wednesday, August 16, 2023
Hope, Septic shock, Balancing, Sepsis, ESS, Patient, PMX, TSX, EAA, The Balancing Act, Pharmaceutical industry, Nursing

TORONTO, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today highlighted a new episode of The Balancing Act with a segment focused on advancing therapeutic options for sepsis and endotoxic septic shock.

Key Points: 
  • TORONTO, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today highlighted a new episode of The Balancing Act with a segment focused on advancing therapeutic options for sepsis and endotoxic septic shock.
  • The episode features the severe complications of endotoxic septic shock (ESS), and follows Spectral’s pivotal TIGRIS trial which is poised to vastly improve outcomes with a targeted diagnostic test (EAA) and its lead product PMX (ToraymyxinTM PMX-20R) for treatment of patients with endotoxic septic shock.
  • Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, “We continue to work aggressively to complete the enrollment of our Tigris Trial and currently have 71 patients enrolled to date.
  • We are proud to be a part of this effort to help patients suffering from endotoxic septic shock and hope to bring a new standard of care to the market.”

Certain PIMCO Closed-End Funds Announce Tender Offers for Auction Rate Preferred Shares

Retrieved on: 
Tuesday, August 15, 2023
PTY, New York Stock Exchange, PCN, Mini-tender offer, Tender offer, PML, PMF, PZC, PNI, Personal Information Agent, Exchange, PNF, PFL, Tender, PYN, PCQ, PMX, PHK, Security (finance), PFN, Letter, Fund, ARPS, NYSE, PCK, Cryptocurrency

Each Fund's Tender Offer will expire at 5:00 P.M., New York City Time, on September 18, 2023, unless the Tender Offer is extended.

Key Points: 
  • Each Fund's Tender Offer will expire at 5:00 P.M., New York City Time, on September 18, 2023, unless the Tender Offer is extended.
  • This announcement is not a recommendation, an offer to purchase or a solicitation of an offer to sell ARPS of the Funds.
  • Each Fund’s Tender Offer is conditioned on certain conditions as set forth in the Tender Offer Documents.
  • Any questions regarding the Tender Offers can be directed to the Funds’ Information Agent, Equiniti Fund Solutions, Inc., at (877) 478-5044.

Spectral Medical Announces Second Quarter Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Observational study, Marketing, Grace note, Baxter, Septic shock, Balancing, Sepsis, ESS, Patient, PMX, TSX, ICU, EDEN, FDA, EAA, Balancing Act, The Balancing Act, Bought deal, Pharmaceutical industry, Nursing, Television, Fine chemical

TORONTO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • TORONTO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the second quarter ended June 30, 2023 and provided a corporate update.
  • During the second quarter, the Company continued to execute on a number of key business initiatives that are targeted at enhancing and accelerating Tigris enrollment.
  • The Company remains on schedule to onboard an additional 7 new sites over the next quarter bringing the total sites to 25.
  • The Company concluded the second quarter of 2023 with cash of $2,521,000 compared to $8,414,000 of cash on hand as of December 31, 2022.

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

Retrieved on: 
Thursday, August 10, 2023
Note, NOT, FOR, Toronto Stock Exchange, AMERICA, Sale, Convertible, PMX, Offering, ITS, ANY, TSX, Security (finance)

TORONTO, Aug. 10, 2023 (GLOBE NEWSWIRE) --  Spectral Medical Inc. (TSX:EDT) (the "Company" or "Spectral"), is pleased to announce that it has entered into an agreement with Paradigm Capital Inc. (the “Underwriter”), in connection with a bought deal private placement of convertible notes (the “Offering”) for gross proceeds of approximately C$5 million, consisting of the sale of 9% convertible notes of the Company (the “Convertible Notes”) at a price of US$1,000 per Convertible Note.

Key Points: 
  • 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, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX:EDT) (the "Company" or "Spectral"), is pleased to announce that it has entered into an agreement with Paradigm Capital Inc. (the “Underwriter”), in connection with a bought deal private placement of convertible notes (the “Offering”) for gross proceeds of approximately C$5 million, consisting of the sale of 9% convertible notes of the Company (the “Convertible Notes”) at a price of US$1,000 per Convertible Note.
  • The net proceeds from the Offering are expected to be primarily used by the Company on its Phase III registration trial (Tigris) for its PMX treatment for endotoxemic septic shock and for general corporate and working capital purposes.
  • The Offering is expected to close on or about August 30, 2023 (the “Closing Date”) and will be subject to regulatory approvals and customary closing conditions, including listing of the common shares issuable upon conversion of the Notes on the Toronto Stock Exchange.

New Direct Fit Radio for 2014+ Harley-Davidson® Motorcycles by Rockford Fosgate®

Retrieved on: 
Friday, July 28, 2023
MSRP, Electra, CB, USB, LCD, PMX, Radio, OEM, Motorcycle, Cassette tape

TEMPE, Ariz. , July 28, 2023 /PRNewswire/ -- Rockford Fosgate (www.rockfordfosgate.com), the industry leader in high-performance audio systems, is excited to announce a new factory source unit replacement for 2014+ Harley-Davidson® touring motorcycles.

Key Points: 
  • A full color, glove friendly, 7-inch touchscreen LCD gives complete control when navigating the infotainment system.
  • Featuring Apple CarPlay®, Bluetoooth® streaming audio, and USB connectivity, this Sirius-XM® ready radio puts cutting edge technology at the riders' fingertips.
  • Further enhancing the Rockford Fosgate experience, the PMX-HD14 is optimized specifically for Rockford Fosgate motorcycle systems and eliminates the need to flash the radio, giving Rockford Fosgate audio systems class leading sound.
  • Installation is also made simple with a direct fit installation, with specifically provided trim panels, using factory mounting points and factory connectors.

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

Retrieved on: 
Tuesday, June 27, 2023
CDER, University of California, San Diego, Drug, Medicine, CDRH, University, Senior, Office of Inspector General, U.S. Department of Health and Human Services, Berkeley, Stanford University, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, Biotechnology, Public, FDA Center for Devices and Radiological Health, Septic shock, CDO, Bangladesh Technical Education Board, Sepsis, Food and Drug Administration, Public health, Partner, MD, Division, PMX, Center for Drug Evaluation and Research, TSX, Knowledge, FDA, Device, Biostatistics, Food, World Health Organization, European Medicines Agency, Pharmaceutical industry, Research

Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas.

Key Points: 
  • Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas.
  • He has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas.
  • “We are extremely proud to have Dr. Feigal join our Board of Directors,” commented, Anthony Bihl, Chairman of the Board at Spectral Medical.
  • We look forward to his contributions to Spectral and aiding in the advancement of PMX to market.”

Spectral Medical Provides Update on Continued Favorable Tigris Clinical Trial Enrollment

Retrieved on: 
Tuesday, June 20, 2023
Septic shock, Sepsis, Standard of care, Patient, PMX, Randomized controlled trial, Management, TSX, Knowledge, Mortality, Lipopolysaccharide, Pharmaceutical industry, Nursing

TORONTO, June 20, 2023 (GLOBE NEWSWIRE) -- 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 enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Key Points: 
  • The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.
  • During the first quarter, the Company implemented a number of business initiatives, as outlined in Spectral’s investor update call on April 6, 2023, that are targeted to enhance and accelerate Tigris enrollment.
  • Management is pleased to report positive progress on the following initiatives:
    11 patients enrolled in the Tigris trial during the second quarter, subsequent to the Company’s investor update call.
  • The enrollment rate experienced over the past ten weeks maintains the target timeline of 90 patients enrolled around the end of 2023.

Spectral Medical Provides Update on Favorable Tigris Clinical Trial Enrollment

Retrieved on: 
Tuesday, May 30, 2023
Septic shock, Sepsis, Standard of care, Patient, PMX, Randomized controlled trial, Management, TSX, Knowledge, Mortality, Lipopolysaccharide, Nursing

TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- 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 enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Key Points: 
  • The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.
  • During the first quarter, the Company implemented a number of business initiatives, as outlined in Spectral’s investor update call on April 6, 2023, that are targeted to enhance and accelerate Tigris enrollment.
  • Witnessing early indications of Tigris Investigator Meeting acting as a catalyst for enrollment, with three patients enrolled in the subsequent week.
  • Enrollment rate increased to 0.19 patients per site, per month from the previous 0.18, due to strong enrollment in April and May.

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

Retrieved on: 
Wednesday, May 24, 2023
Acceleration, Interim, Marketing, Baxter, Head, Septic shock, Sepsis, Standard of care, Patient, PMX, Randomized controlled trial, TSX, Knowledge, Mortality, ICU, FDA, Balancing Act, The Balancing Act, Lipopolysaccharide, Pharmaceutical industry, Fine chemical

Tigris trial sites represented: 15 existing sites and six new or pending sites with site initiation visits conducted at the meeting for multiple sites.

Key Points: 
  • Tigris trial sites represented: 15 existing sites and six new or pending sites with site initiation visits conducted at the meeting for multiple sites.
  • “We are pleased with the overwhelming success of our investigator meeting held last week,” commented Chris Seto, Chief Executive Officer of Spectral Medical.
  • Interim enrollment would be a significant milestone as Baxter will have the opportunity to view the data as well as submit a milestone payment to Spectral.
  • We were encouraged by the outlook of the trial and felt a high level of support and enthusiasm from participants at the investigator meeting.

Spectral Medical Announces First Quarter Results and Provides Corporate Update

Retrieved on: 
Friday, May 12, 2023
University, SAPS, Observational study, Marketing, Baxter, University of California, San Francisco, Clinical trial, Research, Septic shock, Sepsis, Hemoperfusion, ISAC, ESS, Patient, UCSF, PMX, Management, TSX, Mortality, ICU, EDEN, FDA, Pharmaceutical industry, Nursing, Fine chemical, Cryptocurrency

TORONTO, May 12, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • TORONTO, May 12, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the first quarter ended March 31, 2023 and provided a corporate update.
  • Importantly, Tigris mortality data continues to exceed our expectations and has been consistent with our recent announcement of the EUPHAS-2 study results .
  • Transition activities are progressing well, with full change from the incumbent CRO expected by the end of the second quarter.
  • The Company concluded the first quarter of 2023 with cash of $4,886,000 compared to $8,414,000 of cash on hand as of December 31, 2022.