YOKNEAM, Israel, March 2, 2022 /PRNewswire/ -- Hallura Ltd., an Israeli aesthetic medical company developing next generation Hyaluronic Acid (HA) Dermal Fillers with its proprietary BiOLinkMatrix platform, announced today successful topline results from its multi-site European clinical trial in three indications for lips enhancement, nasolabial folds correction and cheeks enhancement. The company's open-label, multi-center trial is evaluating the safety and effectiveness of three BiOLinkMatrix gels using different HA concentrations.
The proprietary BiOLinkMatrix technology is a unique and smooth crosslinking method enabling a lower HA concentration and a reduction in impurities. It is designed to create more natural, highly elastic, biodegradable and very safe HA dermal fillers by retaining the natural physical properties of the HA bio-polymer.
In 132 patients enrolled, the study's primary performance endpoint was fully met and showed improvement in aesthetic appearance in all three indications, measured on the Lip Volume and Thickness Scale, Wrinkle Severity Rating Scale, Mid-Face Volume Deficit Scale. Treatment effectiveness was sustained in most of the subjects from 1-month to 9-months after treatment with more than 80% of clinicians and subjects reporting improvement on the Global Aesthetic Improvement Scale (GAIS). A very positive safety profile was demonstrated with common injection site responses, such as swelling, redness, firmness, lumps, itching, occurring at low rates with most resolving within one week.