Back to All NewsHallura Announces Successful Topline Results of European Multi-Site Clinical Trial
Posted By American Med Spa Association, Friday, March 25, 2022
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Hallura Ltd., an Israeli aesthetic medical company developing next generation Hyaluronic Acid (HA) Dermal Fillers with its proprietary BiOLinkMatrix platform, announced 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 BiOLinkMatrix by HALLURATM platform, a new smooth crosslinking method, is the next generation in Hyaluronic Acid (HA) Dermal Fillers offering more natural, safe and elastic-lifting solutions to patients.
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.
Read more at PR Newswire >>
The BiOLinkMatrix by HALLURATM platform, a new smooth crosslinking method, is the next generation in Hyaluronic Acid (HA) Dermal Fillers offering more natural, safe and elastic-lifting solutions to patients.
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.
Read more at PR Newswire >>
