Tissue approximation is a key step in surgery, for example during closure of skin incisions, intestinal anastomosis and anatomical repairs such as hernia and urinary incontinence. Traditional methods of suturing and stapling are effective, yet not ideal. For example, suturing is cost-effective but time-consuming and user-dependent; and while stapling offers a more rapid and consistent solution, it is significantly more expensive and associated with suboptimal cosmetic results, anastomotic strictures and potential for leaks in internal applications.
IonMed has developed BioWeld1™, a proprietary cold plasma-based surgical system comprised of a generator, hand-held piece and single-use plasma head. Our system can be used with various end-effectors. To optimize tissue welding IonMed’s solution also includes a solder derived from chitosan, which together with the cold plasma jet induces rapid clotting and tissue welding. The system was tested for safety and efficacy of skin closure in several preclinical trials followed up more recently with clinical studies demonstrating closure of laparoscopic incisions and C-section incisions). The studies demonstrated safety, effective closure and good cosmetic outcome. The BioWeld1 system is expected to obtain CE Mark in Q4 2013. US FDA clearance will very probably be obtained via the 510k pathway and we are in the process of finalizing our plan for FDA clearance.
Plasma, which is ionized gas, has been receiving significant exposure as the next-generation energy solution for numerous surgical applications. Plasma has been shown to enable tissue welding, tissue disinfection, to promote hemostasis and enhance healing of chronic wounds, all of which represent vast clinical needs and market opportunities. Yet, to date adoption of plasma into surgery has been curtailed due to the high temperature profile of thermal plasma (>80ºC) which causes damage to adjacent tissues. To overcome this challenge and tap the large potential of plasma in surgery IonMed is bringing to market a proprietary cold plasma surgical system. Our differentiated technology which is covered by 6 pending patents which capture our innovations in plasma energy deposition enables practical implementation of surgical cold plasma (<40ºC).
Advanced tissue welding enabled by cold plasma
Stage: Business development
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