The Refine Support System is a soft and flexible suture-mesh-anchor system designed to lift and support tissue, according to London-based Sinclair Pharma. The company said that the system can be used for a variety of different cosmetic or reconstructive tissue procedures, including standalone procedures or to enhance other cosmetic or reconstructive procedures.
“Over the last several years I have had the opportunity to treat over 150 patients with the Refine Support system as we have developed the product and techniques. I have found Refine to be highly beneficial in both my breast lift and breast reduction procedures, providing a means to achieve and maintain upper pole fullness that I find to be unobtainable without Refine. The technique learning curve is short and we have had minimal adverse events. My patients are very active and routinely engage in sports and aerobic workouts without any limitations. It would be very hard to imagine no longer having the Refine Support system in my armamentarium given the results and patient satisfaction we are achieving; results that we cannot obtain in any other way,” Dr Bruce Van Natta of Indianapolis’ Indiana University Medical Center said in a prepared statement.
Sinclair said that Refine system will be incorporated into its Silhouette portfolio.
The Refine system has already received clearance from the FDA for the reinforcement of soft tissue in plastic or reconstructive procedures, according to a press release.
Sinclair said it will submit the product for regulatory review in Europe and Brazil, as well as markets in Asia, the Middle East and Latin America, with hoped-for approvals and launches in those regions in 2019.
“This acquisition is another important milestone in our strategy of building a leading global pure-play aesthetics company. The Refine product strengthens our Silhouette brand and gives us immediate access to the $600 million US breast cosmetic surgery market. We believe this product has significant global potential both as a standalone and to complement other regularly performed procedures. Following future regulatory approvals, we will launch the product into the other large aesthetic markets around the world, with the initial focus on Europe and Brazil,” Sinclair CEO Chris Spooner said in a press release.
The company said it amended its distribution agreement with ThermiGen to include distribution of the newly acquired Refine system.