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.
| 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.
Today, typical aesthetic injectable HA dermal fillers for wrinkle management and facial reshaping are highly concentrated products cross-linked via the chemical BDDE, or other epoxides, in order to sustain the effect. 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. Principal Investigator, Dr Gerhard Sattler from Rosenpark Research, Darmstadt, Germany, regarded worldwide as an authority in aesthetic dermatology, commented, “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.” “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,” added 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,” commented Dr. Shimon Eckhouse, co-founder and Chairman of Hallura. Following successful study completion at 12-month patient follow-up, Hallura aims to submit for regulatory approval in key territories. About Hallura Ltd. Founded in November 2017 by Dr. Stéphane Meunier, Mrs. Alona Gellerman, Dr. Per Hedén and Dr. Shimon Eckhouse and with its headquarters, R&D, and manufacturing in Yokneam Israel. Learn more at: https://hallura.com/ Photo - https://mma.prnewswire.com/media/1758023/Hallura_BiOLinkMatrix.jpg Press contact:
SOURCE Hallura Ltd. |
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