PMX

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

Retrieved on: 
Tuesday, April 18, 2023
Observational study, SOFA, Perfusion, Infection, EA, Research, Septic shock, Sepsis, Patient, PMX, TSX, Artificial organ, EAA, Pharmaceutical industry, Birth control

TORONTO, April 18, 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 positive results in EUPHAS-2, an observational study in Italy using EAA-guided PMX hemoadsorption as a treatment for patients with endotoxemic septic shock. The results were featured in Artificial Organs, a premier, peer-reviewed journal publishing the latest in research, development, translation, and clinical application of organ replacement therapies, and organ machine perfusion preservation.

Key Points: 
  • TORONTO, April 18, 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 positive results in EUPHAS-2, an observational study in Italy using EAA-guided PMX hemoadsorption as a treatment for patients with endotoxemic septic shock.
  • The study analysis included 50 patients with septic shock and endotoxin activity (EAT0) ≥ 0.6, who received Polymyxin-B hemoadsorption (PMX) therapy.
  • Among patients in the study, septic shock was mainly caused by 27 abdominal (54%) and 17 pulmonary (34%) infections.
  • Furthermore, as seen in EUPHAS-2 in patients with decreasing EAA, recovery from septic shock was faster.

Brie Larson, Kit Harington and Hailee Steinfeld to Headline The ACE Experience @ Superhero Comic Con & Car Show

Retrieved on: 
Friday, April 14, 2023
ACE experiment, Kate Bishop, Seating assignment, PMX, AC Comics, Partnership, SAN, Entertainment

SAN ANTONIO, April 14, 2023 /PRNewswire/ -- Brie Larson (Captain Marvel), Kit Harington (Jon Snow / Black Knight), and Hailee Steinfeld (Kate Bishop / Spider-Gwen) are headlining The ACE Experience @ Superhero Comic Con & Car Show happening July 7-8-9, 2023 (FRI-SAT-SUN) at Freeman Expo Halls in San Antonio, Texas!

Key Points: 
  • SAN ANTONIO, April 14, 2023 /PRNewswire/ -- Brie Larson (Captain Marvel), Kit Harington (Jon Snow / Black Knight), and Hailee Steinfeld (Kate Bishop / Spider-Gwen) are headlining The ACE Experience @ Superhero Comic Con & Car Show happening July 7-8-9, 2023 (FRI-SAT-SUN) at Freeman Expo Halls in San Antonio, Texas!
  • ACE Comic Con and PMX Events previously announced their official partnership for the upcoming Superhero Comic Con & Car Show in November 2022.
  • The two comic con powerhouses are uniting to bring the ultimate fan experience to San Antonio.
  • Stay tuned for additional celebrity guests announcements on the ACE Comic Con social channels at Facebook.com/TheACEUniverse or @acecomiccon on Instagram and Twitter.

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

Retrieved on: 
Friday, March 24, 2023
International joint venture, Cras, De novo, Marketing, Public, Dialysis, Hemoperfusion, ESS, Medical University of South Carolina, Patient, Medical device, Intensive care unit, Software, University, Baxter, Research, MDSAP, Sepsis, Certification, UCSF, TSX, EDEN, FDA, SAMI, Observational study, COVID-19, PMX, Contract research organization, MUSC, Mortality, Breakthrough, Lipopolysaccharide, University of California, San Francisco, Clinical trial, Medical school, Septic shock, Joint venture, Infomed, ICU, Pharmaceutical industry, Silviculture, Nursing, Spectral

TORONTO, March 24, 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 fourth quarter and for the year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • Importantly, we are in the process of engaging a new Contract Research Organization (“CRO”) to oversee the Tigris trial.
  • The new company, i-Dialco, is exclusively focused on advancing commercialization of the SAMI and DIMI dialysis devices in the North American markets.
  • We anticipate our initiatives aimed at enhancing trial recruitment and enrollment will assist in completion of Tigris as expeditiously as possible.
  • With the establishment of i-Dialco, the previous Dialco operations were considered discontinued as at December 31, 2022.

POLARIS UNLEASHES REVOLUTIONARY NEW GENERATION OF THE RZR XP - THE INDUSTRY'S BEST-SELLING SPORT SIDE-BY-SIDE

Retrieved on: 
Tuesday, March 7, 2023
Peter Hancock (professor), Season, CVT, Outdoor, Noise, Lighting, Family, Pro, Human factors and ergonomics, Walker Evans, Travel, US, Rockford, Flare, Dust, Walker Evans (racing driver), Head, RIDE, PULSE, Riders, Friends, Jeep four-wheel-drive systems, Ultimate, Lock, RZR, Maintenance, Polaris, Acceleration, PMX, GroundUP, Temperature, LED, Wind, COMMAND, Amusement park, Telescopic sight, Television

MINNEAPOLIS, March 7, 2023 /PRNewswire/ -- Polaris Off Road, the leader in off-road vehicle innovation, today unleashed the next generation of the industry's best-selling sport side-by-side, the RZR XP. The all-new 2024 RZR XP has been completely redesigned from the ground up to raise the industry standard for sport side-by-sides to an entirely new level – delivering class-leading durability, comfort and performance.

Key Points: 
  • Stronger than ever before, the Polaris RZR XP chassis provides improved trail agility and rugged durability in rough conditions.
  • Featuring an all-new rugged design, the 2024 RZR XP is designed to keep riders out with their crew even longer.
  • Designed with customization in mind, the RZR XP offers six plug-and-play Polaris PULSE ports and is factory prewired throughout the vehicle.
  • Shipping to dealers in April, RZR XP is available in two and four-seat configurations in three trims: Sport, Premium and Ultimate.

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

Retrieved on: 
Thursday, January 12, 2023
Medical school, Hospital, PMX, Acute, Medical University of South Carolina, Hemoperfusion, Standard of care, Dialysis, EDEN, TSX, FDA, Total, Randomized controlled trial, Knowledge, Partnership, EAA, SAMI, Death, Marketing, Lipopolysaccharide, Patient, Sepsis, Observational study, Mortality, Clinical trial, Intensive care unit, Baxter, CDC, Septic shock, Pharmaceutical industry, Health insurance, Q4

TORONTO, Jan. 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 provided a business update focusing 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.
  • Chris Seto, Chief Executive Officer of Spectral Medical, commented, “We continue to aggressively advance our Tigris trial with 50 of the 150 total patients now enrolled and randomized in the study.
  • Moreover, we have seen a 30-40% increase in sepsis cases at our trial sites compared to last summer.
  • To meet final trial enrollment in 2023, we estimate the need for approximately 20 productive trial sites.

Spectral Medical Announces Strategic Joint Venture With Infomed to Accelerate Commercialization of Dimi and Sami Dialysis Devices

Retrieved on: 
Tuesday, December 13, 2022
Septic shock, Dialysis, PMX, Peritoneal dialysis, Renal replacement therapy, Hemoperfusion, Software, FDA, SAMI, Hospital, Plasmapheresis, Sepsis, Toronto Stock Exchange, News, EDT, Intelligence, Hemofiltration, Knowledge, Overload, Ultrafiltration, International joint venture, Joint venture, Certification, TSX, MDSAP, Growth, Medical device, U.S. FDA, Risk, Chronic kidney disease, Patient, Health Canada, Pharmaceutical industry, Infomed, Spectral

The new joint venture company, i-Dialco Inc. (“i-Dialco” or the “Joint Venture”)), will be exclusively focused on advancing commercialization of the SAMI and DIMI dialysis devices in the North American markets.

Key Points: 
  • The new joint venture company, i-Dialco Inc. (“i-Dialco” or the “Joint Venture”)), will be exclusively focused on advancing commercialization of the SAMI and DIMI dialysis devices in the North American markets.
  • Under the Joint Venture, Spectral will contribute SAMI and DIMI regulatory approvals, as well as transfer its Medical Device Single Audit Program (MDSAP) certification to i-Dialco.
  • Infomed, an established medical device manufacturer and original developer of the SAMI and DIMI devices, will contribute all hardware, software and certain other intellectual property to further develop the SAMI and DIMI platforms.
  • Spectral will own 30% of the Joint Venture and Infomed will own 70% of Joint Venture.

THE ACE EXPERIENCE AT SUPERHERO COMIC CON & CAR SHOW COMING IN 2023

Retrieved on: 
Tuesday, November 29, 2022
Universe, SAN, Autograph, Illustrator, Multimedia, Partnership, Photo op, ASSIST, Comic Con Scotland, Family, PMX, ACE, Entertainment

SAN ANTONIO, Nov. 29, 2022 /PRNewswire/ -- PMX Events is proud to announce their official partnership with ACE Comic Con for their upcoming Superhero Comic Con & Car Show, taking place over three days on July 7-9, 2023 at Freeman Expo Halls in San Antonio, Texas. The two comic con forces will unite to produce "The ACE Experience" at the summer show.

Key Points: 
  • The two comic con forces will unite to produce "The ACE Experience" at the summer show.
  • The ACE Experience will bring energetic programming, globally recognized celebrity guests, illustrators, exhibitors and one-of-a-kind Photo Ops and Autographs experiences for fans.
  • Produced by PMX Events, the Superhero Comic Con & Car Show is an annual pop culture fan festival in San Antonio attended by over 35,000 fans.
  • Superhero Comic Con & Car Show also features hundreds of exhibitors and special attractions like the Superhero Car Show, which features over 50 iconic Hollywood movie vehicles and tribute cars, as well as an entertainment stage.

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

Retrieved on: 
Wednesday, November 2, 2022
ICU, Indian stock exchange, SEDAR, Spectral, News, SAMI, U.S. FDA, Unit, Risk assessment, GLOBE, NYSE, PMX, Agent, Prospectus, Risk, Finance Secretary (India), Baxter, Renal replacement therapy, TSX, Distribution, RRT, Sale, EAA, Baxter International, Health Canada, Company, FDA, Patient, EDT, Sepsis, Standby Equity Distribution Agreement, Note, Federal Food, Drug, and Cosmetic Act, Septic shock, Security (finance), Pharmaceutical industry, Medical device

TORONTO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX: EDT) (“Spectral” or the “Company”) is pleased to announce that it has closed its previously announced prospectus offering of units (the “Units”) of the Company (the “Unit Offering”) and concurrent private placement (the “Note Offering” and together with the Unit Offering, the “Offering”) of US$5 million of convertible senior notes (the “Notes”). Aggregate gross proceeds raised pursuant to the Offering were approximately C$10.8 million. The Offering was conducted by Paradigm Capital Inc. (the “Agent”) and consisted of the sale of 10,061,250 Units at a price of C$0.40 per Unit and 5,000 Notes at a price of US$1,000 per Note. Each Unit consisted of one common share of the Company (a “Common Share”) and one-half (½) of one Common Share purchase warrant of the Company (each whole warrant, a “Warrant”), with each Warrant entitling the holder thereof to acquire one Common Share at a price of C$0.48 for a period of 36 months following today’s date.

Key Points: 
  • TORONTO, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX: EDT) (Spectral or the Company) is pleased to announce that it has closed its previously announced prospectus offering of units (the Units) of the Company (the Unit Offering) and concurrent private placement (the Note Offering and together with the Unit Offering, the Offering) of US$5 million of convertible senior notes (the Notes).
  • Aggregate gross proceeds raised pursuant to the Offering were approximately C$10.8 million.
  • Each Note is convertible into approximately 2,828 Common Shares, subject to customary anti-dilution and make-whole fundamental change adjustments.
  • While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect.

PIMCO Closed-End Funds Declare Monthly Common Share Distributions

Retrieved on: 
Tuesday, November 1, 2022
Government agency, Unitary state, PML, Mission statement, New York Stock Exchange, PDO, Contingent convertible bond, Federal Reserve Board of Governors, Investment, PCQ, New, Environment, Leg, Calendar, Loss, Record, Delinquent, PNF, Government, Annual report, Income, Time, PMX, Risk, Clos, FDIC, Tax, NAV, Bank, PIMCO, PNI, News, Sale, PCK, PMF, PZC, Life insurance, Security (finance), Fund

Returns are calculated by determining the percentage change in net asset value (NAV) or market price (as applicable) of the Funds common shares in the specific period.

Key Points: 
  • Returns are calculated by determining the percentage change in net asset value (NAV) or market price (as applicable) of the Funds common shares in the specific period.
  • There can be no assurance that all distributions paid by these Funds will be exempt from federal income taxes or applicable state or local income taxes.
  • The tax treatment and characterization of a Funds distributions may varysignificantly from time to time because of the varied nature of the Fundsinvestments.
  • As with any stock, the price of a Funds common shares will fluctuate with market conditions and other factors.

Spectral Medical Inc. Announces Pricing of Previously Announced Offering

Retrieved on: 
Thursday, October 6, 2022
News, RRT, Sepsis, National instrument, Federal Food, Drug, and Cosmetic Act, Agent, Septic shock, Risk, Sale, TSX, PMX, Toronto Stock Exchange, Spectral, Indian stock exchange, U.S. FDA, Patient, Warrant, Finance Secretary (India), Health Canada, Renal replacement therapy, SAMI, Company, United, EDT, Prospectus, GLOBE, Offering, FDA, SEDAR, Security (finance), Pharmaceutical industry, Medical device, Unit, Note, Unit

TORONTO, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (TSX: EDT) (“Spectral” or the “Company”) is pleased to announce that further to its previously proposed prospectus offering of units (the “Unit Offering”) of the Company (the “Units”) and private placement (the “Note Offering” and collectively with the Unit Offering, the “Offering”) of convertible senior notes (the “Notes”), Paradigm Capital Inc. (the “Agent”) has agreed to offer, on a "best efforts" agency basis, Units at a price of C$0.40 per Unit (the “Unit Issue Price”). Gross proceeds of the Offering will be a minimum of C$8.5 million between the Unit Offering and the Note Offering.

Key Points: 
  • Gross proceeds of the Offering will be a minimum of C$8.5 million between the Unit Offering and the Note Offering.
  • Closing of the Note Offering is conditional on closing of the Unit Offering, finalizing a securities purchase agreement and other customary conditions of closing for a transaction of this nature.
  • It is expected that the Company and the Agent will enter into a definitive agency agreement with respect to the Offering.
  • Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum.