BioCure's LiquiGel™* is one of the first effective, easy-to-use, nontoxic liquid embolic agent providing a clog-free targeted embolization for a range of embolization indications. In its initial format, it will be most suited to peripheral embolization. 

 

*LiquiGel™ is not yet approved for use in any country

 

LiquiGel™ Embolic Agent's advantages can be best demonstrated against current approved preformed and liquid agents which suffer from a variety of usage and performance drawbacks including some or all of the following drawbacks: 

 

Clogging in the catheter

The physician uses a syringe to push product down through a long catheter tube to the intended site. The current preformed solid materials can clog the catheter itself, or at the catheter tip as it arrives at the site, making the procedure complex and time-consuming. The physician often tries to locate the catheter tip next to the site of where the embolic agent is to be placed. Thus, the diameter of the catheter may be limited leading to frequent

clogging of the catheter by the solid embolic agent. Even liquid agents such as cyanoacrylate, which is similar to instant glue, has the same tendency to gel on contact and clog the catheter. With the introduction of LiquiGel™ Embolic Agent, BioCure will provide the physician with a clog-free environment within the catheter and because of its material properties will even allow the physician to initially inject some liquid agent, stop and restart again to precisely measure the amount of embolic agent he/she wishes in order to achieve the desired blockage. 

 

Visualizing the embolic agent

To determine the target site of injection, the physician will routinely inject contrast agent which will show up the blood vessel network on a live X-ray fluoroscopy monitor. At the time of injection of preformed solid embolic agents, the physician can only guess the location of the solid embolic agent by watching the flow of the contrast agent. The effectiveness of the embolization procedure (blockage of the artery) is judged by the use of additional contrast agent after the injection of the embolic agent. However, using LiquiGel™ Embolic Agent, the contrast agent is briefly retained. This allows direct visualization of the flow and location of the LiquiGel™ Embolic Agent during the procedure. 

 

Rapid change from liquid to solid (gelation)

 After passing through the mixing tip of the catheter, LiquiGel™ Embolic Agent turns from a liquid to a solid mass (gelation) extremely rapidly - in 1-2 seconds - and the conversion to the gel is very efficient - greater than 95% -- even in flowing blood. A cast of the gel is formed in the vessel or defective vessel providing excellent blockage independent of blood clotting assisting the embolic effect. The penetration of the gel into the small blood vessels is easily controlled. Safe, non-toxic, biocompatible liquid agent Another BioCure first is the base material Nelfilcon™ – first used as a revolutionary new contact lens – which is a derivative of the well-known PVA (poly vinyl alcohol) polymer. This polymer material has been shown in both historical scientific studies, medical device usage, and in BioCure's internal studies to be inert and non-toxic, unlike all the other current liquid embolic agents, with very mild inflammation response to healthy tissue. 

 

Proprietary delivery system 

BioCure has developed a novel catheter delivery system with a proprietary tip design which allows the liquid to commence its change to the solid form (gelation) in the catheter itself without any concern of clogging of the material before delivery. This also allows precise site targeting of the blockage site. LiquiGel™ Embolic Agent as a platform for a broad pipeline of new product development and indications. The liquid format and the material properties of Nelfilcon™ lend themselves to further embolic developments including: 

 

• Development of a microcatheter version of the system allowing broad neurovascular usage 

• The addition of chemotherapeutic agents to the material which may prove to be useful in fighting underlying cancers 

• The addition of anti-infectives, antibacterials and growth factor
   

Liquigel Investigational Status

BioCure is seeking commercial partners for Liquigel, it compares very well to the GelSpheres technology, sold by BioCure in 2010 and commercially available under the trade name BeadBlock®.  In a potential restart of this program, Liquigel would be placed under BioCure's QSR Design Control and follow a similar path for approval.