Spectral Medical's Tigris Trial Progress: Implications for Investors

Spectral Medical Inc. (TSX: EDT) recently provided an update on its Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (PMX) in treating endotoxemia and septic shock. As of October 2024, 135 patients have been enrolled, with an estimated completion around year-end 2024. This progress has significant implications for investors, particularly those seeking stable, income-focused investments.

The Tigris trial's robust enrollment in 2024, with 54 patients enrolled so far compared to 31 in all of 2023, demonstrates the growing interest and importance of endotoxic septic shock treatment. The trial's Bayesian statistical design and the use of PMX, a therapeutic hemoperfusion device, are likely contributing to the enthusiasm and commitment of trial sites.


Upon completion, the Tigris trial will provide data from 150 patients, which Spectral Medical will use to submit a New Drug Application (NDA) to the U.S. FDA. Assuming successful results, Spectral could receive FDA approval in late 2025, bringing PMX to the U.S. market and generating significant revenue.


For investors focused on income and stability, Spectral Medical's progress in the Tigris trial presents an attractive opportunity. The company's unique product for treating septic shock, Toraymyxin™ (PMX), has already been approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients. With the potential U.S. market for septic shock treatments estimated at approximately 330,000 patients annually, Spectral Medical's success in the Tigris trial could lead to substantial revenue growth and dividend payouts.

In conclusion, Spectral Medical's Tigris trial progress highlights the potential for investors to capitalize on undervalued opportunities in the healthcare sector. As the company works towards U.S. FDA approval for PMX, investors can benefit from the stable, income-focused investment strategy advocated by the Income Method. By diversifying their portfolios with companies like Spectral Medical, investors can secure steady returns and capitalize on market opportunities.