St. Teresa Medical said yesterday it enrolled the 1st patient in a clinical trial of its Surgiclot clotting bandage.
The company won approval for a 40-patient study of Surgiclot from the U.K.’s Medicines and Healthcare products Regulatory Agency in June, St. Paul, Minn.-based St. Teresa said.
The 1st surgery using the bandage dressing was performed earlier this month by Sanjeev Madan at the Doncaster & Bassetlaw Hospital in South Yorkshire, U.K., the company said.
“It was Mr. Madan’s impression, as well as mine, that the reduction in blood loss was significant and dramatic, and that its use will lead to less morbidity for patients, shorter surgical times, lower costs, fewer transfusions, and less time in hospital,” St. Teresa chief scientific officer Dr. Tim Floyd said in a press release.
Surgiclot is a fibrin-based, dissolvable dressing designed to accelerate clotting by adding clot-forming proteins to the injury site, the company said.
The clotting bandage creates a physical barrier to oozing, flowing or pulsatile bleeding through solid electrospun dextran, the company said. The company hopes it will win indications for use in cancellous bone bleeding after the trial is completed.
“Mr. Madan was very pleased with the results, and commented it will allow him to send patients home sooner because of vastly reduced blood loss. The Surgiclot dressing is the only hemostatic dressing available with both dissolvable and resorbable qualities. The dressing dissolves in seconds to minutes, and leaves behind a robust clot to obtain hemostasis in less than 3 minutes,” CEO Philip Messina said in a prepared statement.
St. Teresa said it is hopeful for CE Mark approval in the European Union after the trial’s slated completion in the fall of this year.