Suturion starts clinical study
The innovative medical technology company, Suturion, based in Lund Sweden, main objective for 2022 was to initiate the required clinical study to achieve CE-mark according to MDR. In January 2023, the company reached its goal by starting the study and is intended to support registration of the product for future commercialization. Suturion’s CEO Paan Hermansson tells us more about this important event and milestone.
Suturion is developing an innovative product that will help surgeons close the abdominal wall, fast and easy with a consistent high-quality suture line. Read more about the company here suturion.com
The previous two studies concluded that Suture TOOL appears to be a promising device for performing a rapid standardized high-quality suture line for fascial closure and for clinical use.
It’s safe, easy, and fast resulting in a high-quality suture line with a short learning curve and a high functionality ranking.
Since the two feasibility studies have promising results, much of Suturion’s focus in 2022 has been on preparing for the clinical study.
The first patient was included in January 2023 and a total of thirty-eight (38) patients will be included to complete the clinical trial. The primary objective of the study is to evaluate the clinical performance of Suture TOOL for abdominal wall closure in men and women undergoing open abdominal surgery (laparotomy), in terms of the proportion of patients with an SL/WL ratio ≥ 4.
The secondary objectives are to assess whether the new data will be able to confirm that Suture TOOL improves abdominal wall closure, safe, fast and results in a high-quality suturing line.
Read more about the feasibility studies here https://suturion.com/research/
COMMENTS FROM THE CEO
What does it mean for Suturion that you have now started the clinical study?
The start of the study is of course an important milestone for Suturion as we strive to confirm the results we saw in our pre-study and the cadaver study last year.
Now you have started to include patients in the study. Can you tell us a little more about which patients you specifically want to include?
-The patients we are targeting will be men and women (18+ years) undergoing elective laparotomy (open abdominal surgery) for benign or malignant disease by midline incision.
What interest have you seen so far from patients to be included in the study?
-In general, patients are often willing to participate in clinical studies, especially when it is a product that can help improved healing. Since it does not require anything from the patient and is not burdensome, it makes it easier for the patient to be positive about participation.
Your goal is to present the results in Q2 2023. What can be said today about the outcome of the study?
-The analysis will be performed after all 38 patients have been completed and our current forecasts estimate that the study could be completed around summer of 2023, with possible market approval as early as end of 2023. This is, of course, based on recruitment forecasts and if everything goes as planned.