IonMed Announces Successful Completion of the First European Cold Plasma Clinical Study for Closure of Surgical Wounds
Results from a 16 patient study led by Prof. Abrahamyan at the Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology in Yerevan, Armenia demonstrate the safety and effectiveness of IonMed's BioWeld1TM cold plasma system. BioWeld1 is the first cold-plasma surgical system to reach advanced human clinical stages and is expected to reach the market later this year.
Thermal and Cold Plasma Plasma is simply a gas in which a proportion of the particles are ionized. Under certain electrical conditions plasma forms beams which can be directed in a very selective fashion. Previous studies have shown the profound potential of plasma in multiple surgical scenarios including disinfection, treatment of burns and chronic wounds, control of bleeding and tissue welding.
To date, commercial plasma technologies have relied on legacy approaches which utilize thermal plasma, which involves significant heat deposition of above 80 C. However, these high temperatures imply that the technology needs to be carefully deployed in order to mitigate harm to adjacent tissues as a result of nerve damage, burns and tissue cooking effects. IonMed's scientists have developed the BioWeld1, a proprietary surgical system based on deposition of cold plasma. Since cold plasma operates at less than 40 C the BioWeld1 system creates desired plasma related tissue effects without the heating and cooking effects which have limited utility of prior systems.
Cold plasma's different thermal profile means that it may enable medical applications which cannot be addressed by thermal plasma and other surgical energy systems. One such application is closure of surgical wounds by welding together tissues, thus obviating the need to use staples or sutures, potentially providing better, more consistent cosmetic results and fewer wound infections.
In the study, surgeons used the BioWeld1 system to close skin incisions of 16 women undergoing Caesarean section by welding them together using cold plasma and a specialized film developed by the company. The surgeons did not use any sutures or surgical staples to close the skin. Surgeons evaluated the integrity of the wound, the likelihood of complications including infections and the cosmetic results several weeks following the procedure.
"The results from this study are very encouraging and in my opinion, set the stage for more advanced research on external as well as internal surgical applications," said Professor Gian Carlo Di Renzo, MD, Professor and Chairman Dept. OB/GYN and Centre for Perinatal and Reproductive Medicine, Santa Maria della Misericordia University Hospital San Sisto - Perugia, Italy. "As surgeons, we seek better ways to connect tissue, to minimize damage to healthy tissue and obtain better clinical and cosmetic results for patients. I am excited by the potential of the BioWeld1 system to expand our possibilities in the operating room," concluded Dr. Di Renzo.
"I am very pleased with the study findings and our system's performance," said Amnon Lam, IonMed's CEO. "We believe that our technology may assist in key applications such as tissue welding, intestinal anastomosis and treatment of burns and chronic wounds. We are currently expanding our capital base in order to launch the first cold plasma-based surgical device, while planning the next phase of our clinical and technological development." About IonMed IonMed's BioWeld1 proprietary technology is the first cold plasma based surgical tool to reach advanced clinical stages. The company's cold plasma generator along with dedicated end effectors and tissue film are investigated for various applications including tissue welding as well as other internal applications. The company expects to receive CE Mark later this year and plans to initiate its US FDA process in order to commercialize the technology in the US. IonMed is head quartered in Yokneam, Israel. For more information, visit our website at http://www.ion-med.com.