St. Teresa Medical announced the enrollment of the first patient into its human clinical trial for its product, SURGICLOT, which is classified by the UK’s regulatory agency MHRA, and Nemko PreSafe, a global testing and certification company specializing in medical devices, as a medical device class 111 with medicinal ancillary action.
On June 18, St. Teresa Medical received approval for a 40-patient study from MHRA in the UK.
According to CEO and Co-Founder Philip Messina, on July 6 Mr. Sanjeev Madan, a consultant orthopedic surgeon at Doncaster & Bassetlaw Hospital in South Yorkshire, UK performed a pelvic osteotomy (bone is shortened, lengthened, or alignment is changed) using the SURGICLOT dressing on the first patient in St. Teresa’s human trial.
Dr. Tim Floyd, chief scientific officer for St. Teresa Medical, was present at the first surgery.
"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," said Floyd.
"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 three minutes," Messina added.
The dressing achieves its primary mode of action through the solid electrospun dextran, which initially creates a physical barrier to oozing, flowing or pulsatile bleeding.
The SURGICLOT dressing will be the first hemostatic dressing indicated for use in cancellous bone bleeding when the dressing is CE Marked (a European Union safety requirement) after the human trial is completed during the Fall of 2015.
St. Teresa Medical’s Good Laboratory Practice animal studies required by both the MHRA and the US FDA have scientifically proven the U.S. Pharmacopeia-grade electrospun dextran, human thrombin and fibrinogen are completely resorbed by the tissue.