IOMED, Inc. Receives CE Mark Clearance For Bioweld1™ Cold Plasma System
YOKNEAM, Israel, October 20, 2014 /PRNewswire/ --
IonMed announced today that it has received CE Mark clearance for its Bioweld1™ cold plasma system for surgical incision closure. Bioweld1 is the first system in the rapidly emerging field of plasma medicine designed for use in operating room settings as an alternative to surgical staples, sutures and sealants.
"The use of cold plasma holds enormous promise as a new therapeutic paradigm in wound care, and more broadly in medicine," said Shai Levanon, CEO of IonMed. "With the CE Mark clearance of Bioweld1, our first system, we have achieved important validation for our technology, a key milestone for the company, and a significant step towards commercialization." He added that IonMed expects to select a distribution partner and begin commercializing the system in the EU in 2015.
The patented Bioweld1 system combines a plasma generating device, including a disposable plasma emitting head and a medical plaster, Chitoplast™, which covers the wound and assists in approximating the incision edges. To seal the incision and promote coagulation and healing, the Chitoplast 'solder' is affixed to the incision edges, and the plasma jet is applied along the incision edge. Chitoplast consists of adhesive plaster strips and a film, based on chitin, a natural biomaterial with established hemostatic and antimicrobial properties. The CE Mark clearance is based on positive preclinical as well as clinical studies, including a trial of 20 women undergoing elective cesarean section and a pilot human evaluation of skin grafting. Other studies in preclinical models have documented safety, rapid disinfection, and efficacy in skin graft closure.
About Plasma Medicine and the Bioweld1 System
Plasma, ionized gas, is known as the fourth state of matter after solids, liquids and gases. High temperature plasmas have long been used in healthcare for cauterization and sterilization. The potential of non-thermal (cold) plasma, produced at atmospheric pressure is based on both the technology's safety at room temperature and advances in understanding the interaction of the chemically active species plasma produces with cells and tissues. Reactive species, such as free radicals, nitric oxide and hydrogen peroxide, play key roles in cell signaling and biological processes important to wound care including promotion of coagulation, microbial deactivation, stimulation of healing mechanisms.
IonMed's Bioweld1 is the first cold plasma-based system optimized for use in the operating room setting. The system is very compact, and includes a disposable, plasma head that emits the plasma and is designed to maintain sterility of the operating field, similar to diathermia (radiofrequency ablation) devices. The system uses helium as the carrier gas. The company has developed an effective manufacturing process for the device and its plasma head that meets ISO13485 quality standards.
About IonMed
IonMed (http://www.ion-med.com), a portfolio company of The Trendlines Group (http://www.trendlines.com) and of Generali Financial Holdings Fund, is developing and commercializing non-thermal (cold) plasma technology to enhance surgical wound closure and wound healing. IonMed has developed the first system, Bioweld1™, to harness the potential of cold plasma in surgical settings and an innovative initial application that combines cold plasma with a proprietary biological film to enable non-invasive 'tissue welding' for sealing skin wounds.
Media relations:
Shiri Goldstein Fiks
shiri-gf@ofirpr.co.il
+972-4-9535030
Help employers find you! Check out all the jobs and post your resume.
IonMed announced today that it has received CE Mark clearance for its Bioweld1™ cold plasma system for surgical incision closure. Bioweld1 is the first system in the rapidly emerging field of plasma medicine designed for use in operating room settings as an alternative to surgical staples, sutures and sealants.
"The use of cold plasma holds enormous promise as a new therapeutic paradigm in wound care, and more broadly in medicine," said Shai Levanon, CEO of IonMed. "With the CE Mark clearance of Bioweld1, our first system, we have achieved important validation for our technology, a key milestone for the company, and a significant step towards commercialization." He added that IonMed expects to select a distribution partner and begin commercializing the system in the EU in 2015.
The patented Bioweld1 system combines a plasma generating device, including a disposable plasma emitting head and a medical plaster, Chitoplast™, which covers the wound and assists in approximating the incision edges. To seal the incision and promote coagulation and healing, the Chitoplast 'solder' is affixed to the incision edges, and the plasma jet is applied along the incision edge. Chitoplast consists of adhesive plaster strips and a film, based on chitin, a natural biomaterial with established hemostatic and antimicrobial properties. The CE Mark clearance is based on positive preclinical as well as clinical studies, including a trial of 20 women undergoing elective cesarean section and a pilot human evaluation of skin grafting. Other studies in preclinical models have documented safety, rapid disinfection, and efficacy in skin graft closure.
About Plasma Medicine and the Bioweld1 System
Plasma, ionized gas, is known as the fourth state of matter after solids, liquids and gases. High temperature plasmas have long been used in healthcare for cauterization and sterilization. The potential of non-thermal (cold) plasma, produced at atmospheric pressure is based on both the technology's safety at room temperature and advances in understanding the interaction of the chemically active species plasma produces with cells and tissues. Reactive species, such as free radicals, nitric oxide and hydrogen peroxide, play key roles in cell signaling and biological processes important to wound care including promotion of coagulation, microbial deactivation, stimulation of healing mechanisms.
IonMed's Bioweld1 is the first cold plasma-based system optimized for use in the operating room setting. The system is very compact, and includes a disposable, plasma head that emits the plasma and is designed to maintain sterility of the operating field, similar to diathermia (radiofrequency ablation) devices. The system uses helium as the carrier gas. The company has developed an effective manufacturing process for the device and its plasma head that meets ISO13485 quality standards.
About IonMed
IonMed (http://www.ion-med.com), a portfolio company of The Trendlines Group (http://www.trendlines.com) and of Generali Financial Holdings Fund, is developing and commercializing non-thermal (cold) plasma technology to enhance surgical wound closure and wound healing. IonMed has developed the first system, Bioweld1™, to harness the potential of cold plasma in surgical settings and an innovative initial application that combines cold plasma with a proprietary biological film to enable non-invasive 'tissue welding' for sealing skin wounds.
Media relations:
Shiri Goldstein Fiks
shiri-gf@ofirpr.co.il
+972-4-9535030
Help employers find you! Check out all the jobs and post your resume.