Hallura, an Israeli aesthetic medical company developing hyaluronic acid (HA) dermal fillers with its proprietary BiOLinkMatrix platform, announced successful topline results from a multi-site European clinical trial. The trial investigated the safety and effectiveness of three BiOLinkMatrix gels (with different HA concentrations) for three different indications: lips enhancement, nasolabial folds correction and cheek enhancement.
Per a release from the company, the proprietary BiOLinkMatrix technology is a unique and smooth crosslinking method, which enables a lower HA concentration with fewer 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 biopolymer.
The trial included 132 subjects and met its primary performance endpoint, showing improvement in aesthetic appearance in all three indications, as measured on the Lip Volume and Thickness Scale, Wrinkle Severity Rating Scale and Mid-Face Volume Deficit Scale.
Treatment effectiveness was sustained in most of the subjects from one month to nine months after treatment, with more than 80% of clinicians and subjects reporting improvement on the Global Aesthetic Improvement Scale (GAIS). Common injection site responses, such as swelling, redness, firmness, lumps, itching, occurred at low rates with most resolving within one week.
“I was impressed that such an original formulation of HA is performing so well in a clinical study in terms of duration, tolerance and patient skin quality,” said principal investigator Dr. Gerhard Sattler from Rosenpark Research, Darmstadt, Germany. “Obviously, more clinical experience is needed to reach definitive conclusions, but it is certainly the most significant innovation I have seen in HA dermal fillers since the technology’s inception more than 25 years ago.”
“Hallura's vision is to make aesthetic dermal filler products that look, feel and perform like our own youthful skin. We strongly believe Hallura can transform the HA Market with its new technology platform by answering the consumer aspirations for natural volumization with predictable and safe results,” added Dr. Shimon Eckhouse, co-founder and Chairman of Hallura.