Hallura plans to submit for regulatory approval in key territories after successful study completion at 12-month patient follow-up.

Hallura Ltd’s hyaluronic acid (HA) dermal fillers with its proprietary BiOLinkMatrix platform performed well for lip enhancement, nasolabial folds correction. and cheek enhancement, according to topline results.

The proprietary BiOLinkMatrix technology is a 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, the company states.

The study's primary performance endpoint was fully met, and 132 patients 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 percebt of clinicians and subjects reporting improvement on the Global Aesthetic Improvement Scale (GAIS). 

Following successful study completion at 12-month patient follow-up, Hallura aims to submit for regulatory approval in key territories.

The injections were also safe. Side effects included common injection site responses, such as swelling, redness, firmness, lumps, itching, occurring 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. 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," says study author Dr Gerhard Sattler from Rosenpark Research in Darmstadt, Germany.

"This marks an important milestone for Hallura, with topline clinical results demonstrating excellent performance and safety in all three major facial treatment indications. We believe the data shows the potential of BiOLinkMatrix gels to reduce and shorten typical post treatment reactions and may therefore meet the growing demand for effective and better tolerated aesthetic treatments," adds Dr. Stephane Meunier, co-founder and CEO of Hallura. 

"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," says Dr. Shimon Eckhouse, co-founder and Chairman of Hallura.