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Comparison of Advanced Aesthetic Technologies, Inc.'s 2.5% Agarose Gel with Hyaluronic Acid Filler for the Correction of Moderate to Severe Nasolabial Folds Reveals Equivalent Results

BROOKLINE, Mass., May 25, 2021 /PRNewswire=KYODO JBN/ --

-- Results of Split-Face Study to Determine the Efficacy and Safety of 2.5%

Agarose Gel Filler for the Correction of Nasolabial Folds Published in Peer

Reviewed Journal

Advanced Aesthetic Technologies, Inc. (AAT), a leader in aesthetic gel implant

technology, is proud to announce that Algeness(R) VL (2.5% Agarose Gel)

demonstrated equivalent efficacy, safety, and usability compared to those of

NASHA-L based on a split-face study published in the Journal of Cosmetic

Dermatology.

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"Agarose gel filler is a naturally occurring polymer gel with a

three-dimensional structure similar to the extracellular matrix, which achieves

its duration without the need for crosslinking. Our objective with this study

of 66 patients was to determine the efficacy and safety of 2.5% agarose gel

filler for the correction of nasolabial folds as compared with NASHA-L. Our

assessments included assessment of the nasolabial fold (NLF), Wrinkle Severity

Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS [blinded

investigator]), as well as subject satisfaction, adverse events, and

usability," according to lead investigator Nicolò Scuderi MD of the Department

of General and Plastic Surgery at the University of La Sapienza, Rome, Italy.

Among the 66 participants in the study, 46 individuals or 66.7% were available

for evaluation at 3 months, when mean change in WSRS was identical for both

products ( -1.1(+_) 0.4 for 2.5% agarose; -1.1(+_) 0.4 for NASHA-L). Scores for

each product remained similar across all time points and began to return to

baseline between 7 and 8 months. GAIS score followed a similar pattern, rising

between months 7 and 8 (2.7 (+_) 0.6 for 2.5% agarose at month 7 and 3.3 (+_)

0.5 at month 8, vs.  2.7 (+_) 0.6 for NASHA-L at month 7-3.3 (+_) 0.5 at month

8). The longevity of both fillers was confirmed by Ultrasound. All adverse

events were transient in nature and resolved within 15 days, most events were

mild in nature, and the number and severity of events was similar between the

two fillers. According to Dr. Scuderi, "We continue to be impressed with the

clinical outcomes of the novel Algeness(R) range of dermal fillers. This is the

first 100% natural, biocompatible and biodegradable filler on the market to

date, which differentiates it from other injectable products."

U.S. based investigator Brian Kinney, MD, FACS, Division of Plastic Surgery,

University of Southern California, Keck School of Medicine, in Beverly Hills,

CA, adds, "These results add to the growing body of evidence that confirms that

Algeness(R) (2.5% agarose gel filler) has a high safety profile and is well

tolerated by patients. We concluded that this unique dermal filler compound had

a longevity which was equivalent to one of the most widely used fillers,

NASHA-L a hyaluronic acid."

Doug Abel, CEO of AAT commented, "We are very pleased with the outcome of this

important study which demonstrate that in this initial clinical study, the

results with 2.5% agarose gel are equivalent to those of NASHA-L. This is

another significant milestone demonstrating the efficacy and performance of our

proprietary Algeness(R) technology. This notable recognition from three

internationally respected plastic surgeons reconfirms the durability of the

Algeness(R) technology and secures its place as a differentiator in the global

dermal filler market.  We have begun the process to pursue both US FDA approval

for Algeness® and, through our strategic Partner, registration in China."

Algeness(R) is a patented family of fully resorbable injectable gel implant

dermal fillers that are 100% natural, providing advantages in terms of safety,

skin rejuvenation, and natural looking results both at rest and during facial

movement. Typical clinical advantages include minimal swelling upon injection

and immediately visible results. Algeness(R) holds a CE Mark and is currently

distributed in over 30 countries worldwide.

About Advanced Aesthetic Technologies, Inc.

AAT is a fast growing, global corporation developing new technologies for

aesthetic medicine. Our lead products, the Algeness(R) family of injectable

implants, are the culmination of more than 10 years of scientific and clinical

research and were developed with the goal of providing aesthetic injectors

advances in the ability to achieve deep structural support, clean definition,

and exceptional clinical outcomes where the result at the time of treatment is

the final outcome. Algeness(R) 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(R) and agarose as well as in pursuit of

new and innovative technologies to enhance aesthetic medicine and expand our

portfolio. Algeness

(R) is CE Marked, has multiple additional country level registrations, and is

currently available in over 30 countries. AAT is in the process of pursuing

registration in the US through the FDA and also in China through the

partnership with Lanzhou Biotechnique Development Co., LTD (Lanzhou) and their

parent company China National Biotec Group Co., LTD (CNBG).

http://www.algeness.com

References

Scuderi N, Fanelli B, Fino P, Kinney BM. Comparison of 2.5% agarose gel vs

hyaluronic acid filler, for the correction of moderate to severe nasolabial

folds. J Cosmet Dermatol. 2021;00:1– 8. https://doi.org/10.1111/jocd.13962

Contact: filler@algeness.com

SOURCE: Advanced Aesthetic Technologies, Inc.