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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

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. 

IonMed’s BioWeld1

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.

Market Potential

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 wound care 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.

Key Developments

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.


Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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