Staples and suture are the most widely used devices in closure of the surgical incision. Both the techniques are effective in their purpose, however associated with certain risks such as infection and scars. While sutures are cost effective and time-consuming, staples offer more rapid and consistent solution. With the advancement of technology, there are new techniques being introduced such as the absorbable, tapes, and adhesive compounds. Moreover, these devices are available in different materials.
Cold plasma offers great advantages over the conventional methods including watertight tissue seal, elimination of a foreign-body reaction to sutures or clips, reduction in surgical procedure time, and reduction of trauma. A recent study conducted on porcine skin incisions demonstrated comparable and favorable wound healing results macroscopically as well as histopathologically. There wasn’t any epidermal damage, infection, bleeding, and wound dehiscence detected on at the incision site.
Selection of an apt technique or device is essential for optimal healing.
An Israeli company, IonMed has received FDA approval for its new cold plasma based surgical incision closure device called BioWeld1. Plasma has shown manifold benefits in tissue welding, enhancement of tissue repair, disinfection, control of bleeding, and destruction of cancer cells. However, due to high temperature of plasma, it results in harmful effects on the body tissues. Therefore, scientists at IonMed found a way to use cold plasma for effective and safe sealing of wounds. The process takes a few minutes but leaves minimal scars. The device can be used for skin grafts along with its bioadhesive tape – Chitoplast strips. The combined action of bioadhesive and plasma provides the basis for natural healing process.
IonMed received CE mark for BioWeld1 in 2014 and the clinical trials got completed in 2015. Once the product has the CE clearance, it can also be used in skin grafts and traumatic wounds. The product is being used in the United States and will be commercialized extensively in the Europe too.
According to the Trendlines Group, an innovation commercialization company, there are about 5 million skin grafts annually conducted in the EU. Moreover, there are nearly 70 million surgeries conducted annually in the Unites States requiring incision closures. Moreover in the U.K., there are around 5.89 million surgeries where wound closure devices could be used. Even if a small percentage of these surgeries start using this device, could be a great start for cold plasma surgical incision device. The potential thus is very huge for cold plasma bio-welding devices like BioWeld1 which offers great advantages over the conventional staples and sutures.
Established players in the global Cold Plasma Bio-welding Device market such as Ethicon, Inc., Baxter International, Inc., 3M Company, Covidien PLC, Coloplast A/S, and Smith & Nephew need to come up with new technologies and compete with such advanced and better devices to sustain their market share.
Cold plasma could prove to be beneficial in expediting wound closure, tissue healing, attaining positive outcomes and providing sufficient tensile strength. Continuous investment is required to make the cold plasma bio-welding device BioWeld1, widely available.
Major market players are focused on gaining product approvals to expand their product portfolio. For instance, in August 2019, the U.S. FDA approved a US Medical Innovations LLC-developed cold atmospheric plasma system ‘Canady Helios Cold Plasma System and Scalpel’ for human clinical trials.
Major institutes are also focused on research and development activities related to cold plasma bio-welding technology. For instance, in September 2019, researchers from University of Antwerp, Belgium, evaluated the influence of the cell type, cancer type, and cell culture medium on direct and indirect cold atmospheric plasma treatment.
Similarly in August 2019, researchers from Leibniz Institute for Plasma Science and Technology found that plasma treatment is a safe and promising therapeutic option and that it does not promote metastatic behavior in pancreatic cancer cells in vitro and in ovo.