Spectral Medical Updates on Progress of Tigris Trial
Insights on the Tigris Trial from Spectral Medical
TORONTO, September 2024 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a leading company dedicated to advancing treatment options for sepsis and septic shock, has recently shared an update regarding its Tigris trial. This Phase 3 follow-up study focuses on evaluating the effectiveness of Polymyxin B Hemoperfusion (PMX) in treating adults affected by endotoxemia and septic shock.
Tigris Trial Enrollment Progress
The trial has seen vigorous enrollment as the second half of 2024 proceeds, maintaining a steady pace observed since the beginning of the year:
Current Enrollment Statistics
As of the end of August 2024, a total of 129 patients have participated in the Tigris trial. Notably, even through August, normally a slower month for clinical trials, four patients were successfully enrolled. To date in 2024, the enrollment has amounted to 48 patients, marking the highest recruit rate since the Tigris study commenced.
Final Enrollment Goals
With only 21 patients remaining for full enrollment, Spectral is entering the crucial final phase of the Tigris trial. Current enrollment trends suggest that the Tigris trial could conclude by December 2024, marking a significant milestone in their research.
Dr. John Kellum, Chief Medical Officer of Spectral, expressed satisfaction regarding the trial's momentum, stating, “It’s encouraging to witness strong enrollment over the summer months. Our sites are performing exceptionally well, and we are optimistic about concluding full enrollment by the end of 2024.”
Vantive-Carlyle Group Transaction
On August 13, 2024, Baxter International announced a definitive agreement with The Carlyle Group to divest its Vantive business. This arrangement, dubbed the Vantive-Carlyle transaction, is poised to have positive implications for Spectral Medical. Spectral's distribution agreement for PMX with Baxter will transfer to Vantive upon the completion of this deal, expected by late 2024 or early 2025.
Positive Outlook for Spectral
Chris Seto, Chief Executive Officer of Spectral, remarked on the transaction's significance, asserting, “The Carlyle Group's involvement marks a positive chapter for Spectral. They bring substantial private equity expertise in medical technologies, with over $40 billion in investments. While Vantive's ownership will shift, we expect their strategy regarding EAA and PMX to remain strong, ensuring fruitful commercialization efforts.”
Understanding Spectral Medical
Spectral Medical is on a mission to secure U.S. FDA approval for its pioneering Toraymyxin™ (PMX), a therapeutic device designed to cleanse the body of endotoxins responsible for sepsis. The company’s technology is guided by its proprietary Endotoxin Activity Assay (EAA™), which is currently the only FDA-cleared diagnostic tool for assessing sepsis risk.
Proven Efficacy and Expansion Plans
PMX is already approved for use in Japan and Europe, demonstrating safety and effectiveness in over 340,000 patients. In March 2009, Spectral acquired exclusive rights for PMX's development and commercialization in the U.S., followed by an exclusive distribution agreement in Canada in November 2010. Most notably, in July 2022, the FDA designated PMX as a Breakthrough Device, a commendation for its potential in treating endotoxic septic shock, a condition affecting approximately 330,000 people annually in North America.
About the Tigris Trial
The Tigris trial serves as a confirmatory assessment of PMX in comparison to standard care alone, comprising a randomized trial involving 150 patients deployed with Bayesian statistical methods. This study seeks to illustrate the efficacy of PMX in combating this aggressive form of sepsis.
Frequently Asked Questions
What is the Tigris trial about?
The Tigris trial is a Phase 3 study assessing the efficacy of PMX in patients with septic shock, comparing it to standard care.
Who is leading the Tigris trial?
The trial is being conducted by Spectral Medical Inc., directed by their Chief Medical Officer, Dr. John Kellum.
What are the recent enrollment figures for the trial?
As of August 2024, 129 patients have been enrolled, with strong recruitment continuing throughout 2024.
What is the significance of the Vantive-Carlyle transaction?
This transaction is expected to bolster Spectral’s market position, allowing a transition in PMX distribution to a firm with substantial financial backing.
What is PMX and its current status?
PMX is a therapeutic device targeting endotoxins in the blood and has received approval for use in several markets, with ongoing efforts for FDA approval in the U.S.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/
Related Articles
- Lerner Publishing Group Expands Portfolio with New Acquisition
- Plastic Caps and Closures Market Set to Reach USD 96.28 Billion
- Global PET-CT Scanner Market Set for $4.9 Billion Growth
- SS Innovations' First Mantra Surgical System Sale in Latin America
- Yukon Metals Unveils Promising Gold and Copper Discovery
- Constellation Brands Revises Fiscal 2025 Financial Outlook
- Polarean Imaging Welcomes Alan Huang as VP of Sales
- BW Offshore Adjusts Convertible Bonds for Shareholders' Dividend
- Procaps Group Outlines Strategic Vision for Future Success
- GLOBO Language Solutions Explores AI in Medical Interpretation
- Simtra BioPharma Solutions Welcomes Dr. Mike Schaefers
- DemandScience Achieves a Historic 11th Inc. 5000 Honor
- Object Management Group Launches New Journal of Innovation
- Altamira Therapeutics Attends H.C. Wainwright Conference 2024
- Healthcare Mobility Solutions Market Foresees Major Growth
- Sustainable Apparel Market Projected to Hit USD 24.53 Billion
- Fleet Management Software Market Growth to USD 93.17 Billion
- The Surging Mixed Reality Market: Predicted to Hit USD 76.91 Billion
- ChartPath and WoundZoom Partner to Revolutionize Wound Care
- IR Spectroscopy Market Growth Predictions Highlighted by R&D
- Nutricosmetics Market Expected to Exceed $16.93 Billion Growth
- Johnny Clark Welcomes EFFO: The Ultimate Frying Oil Solution
- INmune Bio Inc. Joins Baird 2024 Global Healthcare Conference
- Spectral Capital Launches NOOT: A Revolutionary Quantum Social Media
- John Ballantyne Joins Glucotrack Board to Advance Innovation
Recent Articles
- Bio-Based Coatings Market Growth Driven by Eco-Friendly Demand
- 180 Degree Capital Corp. Reports Discount Management Highlights
- Henry Steinberg Takes Over as Global Head of EQT Exeter
- dxFeed Partners with PriceSquawk to Enhance Trading Experience
- H&R Block Elevates Andy Phillips as VP of The Tax Institute
- AITX’s RAD Achieves Record Growth and Revenue in Q2 FY 2025
- Huddle House Launches MVP Waffle Tacos to Delight Guests
- Rob Faw Unveils Leadership Strategies for Today's Challenges
- Pasithea Therapeutics Welcomes Dr. Rebecca Brown to Advisory Board
- Ruder Finn Appoints Zack Kass to Lead New AI Advisory Council
- CMR Surgical Appoints New Leaders to Drive Innovation
- Invivyd's PEMGARDA™ Effectiveness Against SARS-CoV-2 Variants
- Amicus Therapeutics Upcoming Investor Conferences Announcement
- Interactive Display Market Projected to Hit $18.51 Billion by 2031
- AliveDx Achieves IVDR-CE Mark for Groundbreaking Celiac Test
- Industrial 3D Printing Market Projected to Reach $88 Billion
- Copenhagen Airports A/S Projects Strong Growth for 2024
- SKF Welcomes Susanne Larsson as Chief Financial Officer
- Results from Recent Riksbank Certificate Auction on September 3
- Exploring AI Growth: Opportunities Beyond Nvidia in 2024
- ADVANZ PHARMA's Stance on OCALIVA® Marketing Authorization Revocation
- SeeByte and Kraken Robotics Collaborate for Integrated Solutions
- Exploring Promising Space Stocks for Future Growth
- Hyundai Motor Group Hosts Trilateral Executive Dialogue for Cooperation
- Antony Mattessich Takes the Helm at Amphista Therapeutics