720105Scaling up of Tissue Expander ManufactureClosedGRD Development of PrototypeInnovate UKThis project is to set up a medium scale pilot plant so that we can supply the needs of three sets of surgeons who are about to start clinical trials using our novel self-inflating tissue expander. The plant will also be capable of supporting initial sales of the product through the distribution channel. The device is novel because it expands anisotropically (in one direction), has a controlled expansion rate (to prevent tissue damage) and a time delay before expansion starts (to let nearby tissue heal). Once implanted the device can expand to generate new tissue thatis identical to the surrounding tissue. The list of treatments is extremely broad and ranges from treating genetic disorders (such as cleft palate and underbite), to plastic surgery (skin revision around burns and after radical mastectomy) and cosmetic and restorative dentistry (repairing gums and areas around lost teeth). The first trial will be in treating underbite - this condition afflicts up to approximately 1/4 of the Chinese population; the second will be in restoring tissue around lost teeth; and the third will be in revision surgery around burns and scars. It is anticpated that additional trials will be started once these three are underway. The pilot plant will be able to produce batches of up to 50 devices, a tenfold increase over the current facility. This will be sufficient to meet the surgeons' needs for these three initial trials. The information gained from this project will enable us to develop a full scale production facility. The project will be broken down into three stages: Stage 1 to produce enough quantity of the initial anisotropic hydrogel of the desired size. Stage 2 to coat the hydrogels with our special expansion controlling coatings and Step 3 to cut out the finished devices.