AAT announces additional significant updates
RADNOR, Pa., Jan. 29, 2025 /PRNewswire/ — Advanced Aesthetic Technologies, Inc. (“AAT”) announced today that their partner in China has obtained approval to market their unique dermal filler Algeness® VL agarose facial injection filler, a 2.5% agarose gel dermal filler. AAT’s development and distribution partner is Lanzhou Biotechnique Development Co., Ltd. (“LanDev”), the aesthetic section company of China National Biotec Group Company Limited (belonging to Sinopharm Group, “CNBG”), which acted as the agent for Algeness® VL agarose facial injection filler and obtained the registration license as an imported Class III medical device from the National Medical Products Administration. Algeness® is the first officially approved agarose-based injection filler in China.
Algeness® is the culmination of many years of scientific and clinical research to define a novel biocompatible material to fill wrinkles and volume loss in facial soft tissues. Their team of scientists and physicians worked with Algeness® to create an exceptional 100% natural and biodegradable injectable implant with a unique injection technique.
According to Doug Abel, President and CEO of AAT, “We are excited and look forward to the entry of Algeness® into the large aesthetic market in China through our partner LanDev. We believe that LanDev is the ideal partner to maximize the success of Algeness® in China as they are the sole domestic Chinese manufacturer of botulinum toxin and their product, Hengli, was the first to launch in China and holds significant market share. This approval marks a significant accomplishment by the LanDev, CNBG, AAT, and Ghimas teams and our regulatory advisors and partners.”
“We see the upcoming entry into the market in China with such a strong partner as transformational for the Company, and a demonstration of the clinical performance of this truly unique product,” he adds.
This important achievement follows a series of significant milestones for Advanced Aesthetic Technologies that were reached over the last two years including:
- Successfully advancing the clinical trial to be submitted to the US FDA as part of the Pre-Market Authorization (PMA process) through the primary safety and efficacy endpoints with additional, ongoing patient follow up.
- Advancing the balance of the required information for US FDA submission in 2025.
- Obtaining the CE Mark under the elevated requirements of the Medical Device Regulations (MDR) initially with therapeutic claims and recently expanding the label to include aesthetic claims under Annex XVI.
- Acquiring a controlling interest in Ghimas, S.p.A., the original developer and manufacturer of Algeness®.
Plastic Surgeon Dr. Omer Buhsem from Istanbul serves as the Medical Director for Algeness® and has conducted preclinical work with the product portfolio. “I believe that Algeness®, through its unique rheology and structure, brings an important additional tool to our aesthetic armamentarium from both efficacy and safety perspectives. With my patients, I am uniquely able to define the desired shape while working with a product that I have found to be very safe.” Dr. Buhsem has previously published a 700-patient retrospective of his experience with Algeness®.
The unique Algeness® dermal filler continues to receive very positive reviews from aesthetic practitioners globally. According to dermatologist Dr. Tatjana Pavicic of Munich, Germany, “Algeness® is a true revolution in the field of aesthetic medicine. It stands out for its purely natural composition, biocompatibility, and the remarkable, natural-looking results we can achieve for our patients. In our nearly 10 years of experience with Algeness®, my patients report high satisfaction with the immediate lift and long-lasting results, and I appreciate the product’s excellent safety profile and predictability.”
The approval in China combined with the Company’s achievement of critical milestones launches AAT into the next stage. Future commercialization in China combined with the potential for US approval, the significant product performance data developed to support registration, and the unique product profile provide the foundation for Algeness® to have an important place in medical aesthetics.
About Advanced Aesthetic Technologies, Inc.
AAT is a fast-growing, global corporation developing new technologies for aesthetic medicine. Their Algeness® family of injectable implants is the culmination of many years of scientific and clinical research with the goal of providing aesthetic treatment providers with advances in the ability to achieve deep structural support, clean definition, and exceptional clinical outcomes where patients receive their outcome at the time of treatment. Algeness® is a 100% natural and biodegradable filler based on purified agarose with a differentiated clinical and safety performance profile. AAT continuously invests in research and product development to expand the scientific knowledge on Algeness® and agarose while continually pursuing new and innovative technologies to expand our portfolio.
Algeness® is the all-natural, biodegradable, biocompatible agarose-based gel implant, free of all synthetic or cross-linking chemicals. Algeness® dermal fillers add immediate facial volume with excellent persistence without the cross-linking chemicals found in Hyaluronic Acid fillers. It is currently available in many markets in for concentrations of agarose to match specific cosmetic improvements of the lips, fine lines, naso-labial folds and for shaping the cheeks, jawline and other facial areas. In China, only Algeness® VL agarose facial injection filler is now approved for the treatment of nasolabial folds.
As of this release, AAT is in the process of pursuing registration in the U.S. market through the U.S. Food and Drug Administration (FDA).
For more information, Algeness.com
For media inquiries, Media@algeness.com
For more information about Algeness® Dermal Filler: Filler@algeness.com
For inquiries about global distribution: Algeness.com/algeness
Facebook: Facebook.com/Algeness
Instagram: Instagram.com/Algeness/
LinkedIn: https://www.linkedin.com/company/advanced-aesthetic-technologies-inc-algeness/
Advanced Aesthetics Technologies, Inc.
150 North Radnor-Chester Road, Suite F-200, Radnor, PA 19087
Logo – https://mma.prnewswire.com/media/1517333/algeness_logo_Logo.jpg
View original content: