Spectral Medical Inc. (TSX: EDT) recently hosted an investigator meeting in Charlotte, North Carolina on May 17 to 18, 2023. This in-person event was attended by PIs and CRCs from all existing and new trial sites, along with its newest CRO, Beaufort.
This gathering was organized to promote enrollment in the Tigris trial, which builds on the information gathered from their prior EUPHRATES trial; the purpose of this evaluation is to determine if Polymyxin B Hemoperfusion (PMX) can reduce mortality rates in septic shock patients. Join this monumental next-level enterprise in its mission to revolutionize therapeutics for sepsis and septic shock.
Approximately 70 people attended the event in person, taking advantage of the unique opportunity to experience everything up close and personal!
Tigris trial sites represented: 15 existing sites and six new or pending sites with site initiation visits conducted at the meeting for multiple sites.
Spectral is thrilled to welcome Beaufort to their team as their new Chief Revenue Officer – and with him, four representatives, including a project lead and head of quality assurance, to propel the company forward.
Spectral, partnering strategically with Baxter, had four representatives join forces – including clinical and marketing teams – to expand their commercial outreach.
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Spectral Medical is thrilled to report the extraordinary success of our recent investigator meeting! During the event, clinicians exchanged valuable information regarding past recruitment struggles, as well as how to best overcome such issues. Our attendees voiced collective concern over the universal lack of successful recruitment for ICU trials.
In response, Spectral Medical has implemented methods to accelerate the enrollment process, including the addition of multiple new sites influenced by an experienced CRO. The investigator meeting was key in solidifying our shared ambition to secure PMX FDA approval and bring the lifesaving treatment to market. With so much enthusiasm and solidarity, we are more confident than ever in our mission to succeed.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, is delighted to announce that two patients were recently randomized into the Tigris trial on May 22nd and 23rd, bringing its total enrollment to 60. This is a vital step in addressing the unmet need of endotoxemic septic shock — the most malignant form of sepsis.
With initiatives to aid acceleration of recruitment and enrollment appearing to pay off, we are all hopeful that interim enrollment of 90 patients will be achieved soon. It will be a major achievement for the team, allowing Baxter to view the data as well as triggering Spectral Medical’s milestone payment. After a successful investigator meeting, where thetrial outlook was positively received, further milestones can be expected in the near-term.
Spectral is on the brink of a medical breakthrough! After years of research and development, the company is proudly on its way to seek U.S. FDA approval for its revolutionary product for the treatment of patients with septic shock – Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device designed to remove harmful endotoxin from the bloodstream, and is the only FDA-cleared device of its kind to offer this revolutionary treatment backed by the Company’s Endotoxin Activity Assay (EAA™). With the future of medical treatment in its grasp, Spectral has the potential to change countless lives for the better!
Spectral has taken an important step in helping to reduce the incidence of endotoxemic septic shock in North America with its FDA Breakthrough Device Designation for PMX in July 2022. With more than 340,000 patients having already safely and effectively benefitted from PMX in Japan and Europe, Spectral now has exclusive development and commercial rights in the United States, and an exclusive distribution agreement in Canada for this highly promising therapy. Over 330,000 patients are diagnosed with septic shock in North America each year, and PMX has the potential to drastically reduce this number.
Spectral’s senior management believe that confidently investing in future research and development projects, as well as believing in the successful and timely completion of clinical studies, will help the company successfully capitalize on biomedical industry opportunities.
However, readers should be aware that various risks and uncertainties, such as the availability of funds, meeting regulatory requirements, and general economic conditions, could significantly impact results and leave them different than originally envisioned.