Hy-Silk™ the first Silk Fibroin Lixivium based dermal filler has recently received CE approval and is due to launch into UK and EU markets imminently.
Widely used in tissue engineering, Silk Fibroin has many properties that make it an exceptional component for a new generation of dermal filler. It has the fundamentals of being highly biocompatible and negligible immunogenicity, however the most exciting development is in how the hydrogel behaves as it is pushed through a needle/cannula and when inside tissue.
Hy-Silk™ is a hydrogel which is comprised of Silk Fibroin Lixivium and Hyaluronic Acid inside a carrier of Phosphate Buffered Saline.
The Hyaluronic Acid and Silk Fibroin Lixivium cross-link without the need for any chemicals, rather they naturally cross link under ultrasonication, this negates concerns held by practitioners over the use of BDDE and SVP.
The final Hy-Silk™ hydrogel solution is both thixotropic and self-healing. This has major implications for the administration of Hy-Silk vs other dermal fillers.
A “thixotropic gel” is one which reduces in viscosity when shear stress is applied to it. Pushing gel through a needle or cannula applies shear stress to a gel. The result is that when Hy-Silk™ is being administered it actually converts to a liquid solution inside the
needle/cannula.
What this means is that a practitioner can use the thinnest of needles (Hy-Silk™ comes with 34G needles) to maximise patient comfort, reduce swelling/bruising and perhaps most importantly; vastly improve the placement precision within the tissue. Injection force is also vastly reduced (by a factor of 9).
When a solution is “self-healing” this means that it reforms into its original state once the shear force has stopped being applied.
What this means is that Hy-Silk™ reforms as a gel solution once it leaves the needle or cannula. The full gelation process takes approximately 4 hours however it commences immediately.
Longevity
The Silk Fibroin Lixivium fully encapsulates the cross-linked hyaluronic acid, improving its in-vitro tissue degradation rate by a factor of 2 and leaving a product that remains in situ for between 12 and 18 months.
Safety
Silk Fibroin Lixivium is fully dissolvable in alkaline salt solution. Dissolving the Silk Fibroin Lixivium will destroy the bonds between the cross linked hyaluronic acid, thus reducing it to a liquid state.
It has been proven that Hyaluronic Acid causes irritation and swelling of vessels should a VO incident occur, this leads to the quickening of a full occlusion and subsequently necrosis etc. As the hyaluronic acid is encapsulated by the Silk Fibroin Lixivium, the irritation and swelling does not occur, this reduces the rate at which a full occlusion could occur, and also the likelihood.
The thixotropic and self-healing nature of Hy-Silk™ means that even if injected into a vessel, a practitioner would have longer to administer a dissolution protocol, this reduces the damage caused by immediate full occlusions that go unnoticed.
Hy-Silk™ are seeking UK and European distributors for their product range (Light, Deep and Ultra Deep) with a view to a full launch in Feb/March 2021.
