| From: Sultan | 5/6/2024 11:57:07 AM | | | | | | Spectral Medical Provides April Tigris Trial Update
Spectral Medical Inc.
Mon, May 6, 2024, 4:30 AM PDT3 min read
• 105 patients enrolled
• April represents a record breaking month for patient enrollment
TORONTO, May 06, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Enrollment:
- Robust enrollment activity continuing throughout 2024:
- 105 patients enrolled at end of April 2024
- Record monthly enrollment with seven patients enrolled in April
- 24 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
- With 45 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
- To support sustained enrollment, Spectral hosted an in-person Investigator Meeting March 12th & 13th in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego
- In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company’s strategic partner Baxter
Trial Sites:
- Continued progress opening additional high quality clinical sites
- Recently onboarded the University of Virginia
- Two pending sites in the pipeline finalizing contracting and training
- Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible
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| From: Sultan | 5/24/2024 7:01:05 PM | | | | | | AGM on June 7th.. Only two items on proxy.. Election of Directors and Public Accountants..
However, of note is the new director being appointed.. IMHO, this is meaningful in that the director is not only heavy duty but also note the Baxter connection..
Following is the profile..
Cristiano Franzi
Mr. Cristiano Franzi is a seasoned global healthcare executive and board director with a 30-year track record at leading global Med-Tech companies. As President EMEA for businesses of up to $4 billion in size at Baxter, Medtronic, and Covidien, Mr. Franzi has proven his ability to deliver value by developing 12 compelling visions, identifying new market opportunities, and articulating clear growth strategies while streamlining operations and implementing highly disciplined business models. From 2017 to 2023, Mr. Franzi served as President of Baxter EMEA and as a Member of Baxter’s global Executive Leadership team, where his most recent experience included serving as the interim global lead for the spin-off of the $4.5 billion Renal Care business (“Vantive”). Prior to Baxter, Mr. Franzi served as President, EMEA at Medtronic, and prior to that as President, EMEA at Covidien. Before that, he was the Vice President, International Marketing and Business Development at ev3, a private equity-backed medical device start up, where he played a key role in the international expansion of ev3 from inception to its $156 million IPO in 2005. Additionally, he has served as an industry leader on the Board of MedTech Europe, the industry association in Europe. Mr. Franzi also serves as an expert advisor to leading global private equity firms. Mr. Franzi completed the Advanced Management Program (AMP197) at Harvard Business School, holds an MBA from George Washington University, and a bachelor's degree in business administration from The American University. |
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| From: Sultan | 7/2/2024 12:53:17 PM | | | | | | Spectral Medical Provides June Tigris Trial Update
- 116 patients enrolled
- June represents a new record breaking month for patient enrollment
TORONTO, July 02, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Enrollment:
- Robust enrollment activity continuing throughout the first half of 2024:
- 116 patients enrolled at end of June 2024
- Record monthly enrollment with nine patients enrolled in June
- Thirty-five patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
- With 34 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
Trial Sites:
- Currently 23 clinical sites
- Recently onboarded the Thomas Jefferson University
- an experienced, high-quality site from the EUPHRATES trial
- Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible
Dr. John Kellum, Chief Medical Officer of Spectral, noted, “The excitement level has never been higher. In addition to record enrollment in June for the trial as a whole, individual sites have been extremely busy. The commitment to the success of the trial is evidenced from the broad participation from sites including enrollment on nights and weekends.”
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis globenewswire.com.
The trial methods are detailed in “ Bayesian methods: a potential path forward for sepsis trials”.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com. |
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| From: Sultan | 7/3/2024 12:57:17 AM | | | | | | Options exercised by insiders last couple of months
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| Jun 4/24 | Jun 3/24 | Walker, Paul M. | Direct Ownership | Common Shares | 51 - Exercise of options | 200,000 | $0.360
| | Jun 4/24 | Jun 3/24 | Walker, Paul M. | Direct Ownership | Options | 51 - Exercise of options | -200,000 | $0.360
| | Jun 4/24 | May 29/24 | Seto, Chris | Direct Ownership | Common Shares | 51 - Exercise of options | 565,000 | $0.360
| | Jun 4/24 | May 29/24 | Seto, Chris | Direct Ownership | Options | 51 - Exercise of options | -565,000 | $0.360
| | May 28/24 | May 21/24 | Stevens, William Charles | Direct Ownership | Common Shares | 51 - Exercise of options | 100,000 | $0.500
| | May 28/24 | May 21/24 | Stevens, William Charles | Direct Ownership | Options | 51 - Exercise of options | -100,000 | | | May 28/24 | May 14/24 | Bihl, Anthony Phillip | Direct Ownership | Common Shares | 51 - Exercise of options | 100,000 | $0.475
| | May 28/24 | May 14/24 | Bihl, Anthony Phillip | Direct Ownership | Options | 51 - Exercise of options | -100,000 |
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| From: Sultan | 7/22/2024 2:19:12 PM | | | | | | 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 UNITED STATES OR THE DISTRICT OF COLUMBIA.
TORONTO, July 22, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX:EDT) (the "Company" or "Spectral") is pleased to announce the closing of an additional non-brokered offering of US$1 million of 9% convertible notes of the Company (the “Notes”) at a price of US$1,000 per convertible note due on May 1, 2028 (the “Offering”).
The Notes were sold to one of the Company’s largest shareholders pursuant to the exercise of their anti-dilution pre-emptive rights relating to the closing of the offering of the approximately C$8.5 million offering of Notes that was completed on May 30, 2024.
“We are pleased to have one of our largest shareholders exercise their participation rights and invest more in the Company at such an exciting phase in our business,” said Chris Seto, CEO of Spectral. “The combination of a strong balance sheet and the current pace of patient enrollment has us well positioned as we close in on completing the Tigris trial and FDA submission.”
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 securities have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. state securities laws, and may not be offered or sold in the United States without registration under the U.S. Securities Act and all applicable state securities laws or compliance with the requirements of an applicable exemption therefrom. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor may there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About SPECTRAL MEDICAL INC.
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ ("PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in “ Bayesian methods: a potential path forward for sepsis trials”.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com. |
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