- As a government project, comparative clinical trial of “Monofix” and overseas products is in progress with patient enrollment rate of 43%

- Robotic laparoscopic surgery contributes to shortening of operation time; clinical trials for further surgical use under way

- Expected to lead the localization of surgical suture through expansion of scope into multiple departments and verification of its effectiveness and safety

 

▲ Packaging and product of “Monofix,” Korea’s first knotless surgical suture developed by Samyang Holdings

 

 

Samyang Holdings is pushing to expand the scope of use for the knotless biodegradable barbed suture “Monofix.”

 

Samyang Holdings (CEO: Eom Tae-ung) announced on the 30th that the clinical trial to verify the effectiveness and safety of Monofix by expanding the departments such as urology and surgery is underway. Monofix is a barbed suture brand released by Samyang Holdings in 2019. Prior to its launch, Monofix received recognition for both convenience and suturing ability according to user evaluations conducted on domestic medical teams that performed surgery using robotic laparoscopy.

 

Samyang Holdings has been conducting a study on the efficacy and safety of Monofix compared to overseas products during robot-assisted laparoscopic partial nephrectomy with the urology medical team at four large general hospitals in Seoul since last April. Conducted as the government project, it is scheduled to be carried out until April 2024 targeting a total of 173 patients. At present, 75 clinical trial patients have been enrolled with the patient enrollment rate of 43%.

 

 

▶ Enlarged photo of “Monofix” self-developed by Samyang Holdings. A more robust and convenient suture finish is possible due to the attachment of a stopper (triangle shape on the right) at the end of the thread.

 

 

Robot-assisted laparoscopic partial nephrectomy is a sophisticated surgery that preserves kidney function as much as possible by inserting a robotic arm by making a small hole in the patient’s skin. Operating surgeon remotely controls the robotics to remove only the tumor (cancer) region from the patient’s kidney. A knotless barbed suture is essential for suturing since tying a knot is difficult in this process.

 

In addition, Samyang Holdings started an investigator-initiated trial (IIT) in collaboration with surgical staff members to verify the safety and effectiveness of Monofix for patients who underwent minimally invasive surgery after being diagnosed of colorectal cancer. An IIT is a clinical trial conducted directly by an investigator (clinician) from clinical design to data management to find a better treatment.

 

The clinical trial is to be conducted for one year and a half to evaluate the safety and effectiveness of fascia suture using Monofix on patients who underwent minimally invasive surgery after being diagnosed of colorectal cancer. Samyang Holdings plans to actively induce the use of Monofix in surgeries based on the results of this clinical trial.

 

An official from Samyang Holdings stated, “We will once again verify the efficacy and safety of Monofix by securing usage data from various departments to widen the scope of use and take the lead in the localization of surgical suture.” Although the domestic barbed suture market is continuously growing through the increase of robotic laparoscopic surgery, the market was entirely dependent on imports before the release of Monofix.

 

Monofix by Samyang Holdings contains fine barbs (thorns) on the surface of the thread, eliminating the need for a knot. Sutures can be started immediately without a separate procedure through a self-developed “stopper” that is attached to the end of the thread, which helps to shorten the operation time. Existing competitive products had to be fixed by passing the thread through the loop located at the end of the thread during the first suture. In addition, Monofix is more firmly attached to the tissue compared to other products that make barbs by cutting the surface of the thread only once; Monofix uses a self-cutting method that cuts the surface of the thread twice and processes it three-dimensionally to form barbs.