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
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SOURCE Advanced Aesthetic Technologies, Inc.
