CTX Crescita Therapeutics Inc

Laboratoires FILLMED files for Health Canada Approval of ART-FILLER^® Injectables in Canada

LAVAL, QC, Jan. 21, 2021 /CNW Telbec/ - Crescita Therapeutics Inc. (TSX: CTX) and (OTC US: CRRTF) ("Crescita" or the "Company"), a commercial dermatology, today announced that Laboratoires FILLMED ("FILLMED") has submitted a New Medical Device License ("MDL") application for the ART FILLER^® range of products.

Crescita and FILLMED entered into an agreement in January 2020, granting Crescita the exclusive rights to distribute the ART-FILLER injectables product range and the New Cellular Treatment Factor^® ("NCTF^®") in Canada. The ART FILLER is an exclusive collection of five hyaluronic acid ("HA")-based fillers. Since it was developed in 2016, healthcare professionals including dermatologists and plastic surgeons outside Canada have used it to create or restore the volumes and contours of the face, to temporarily eliminate superficial-to-deep wrinkles and facial folds, and to augment and volumize the lips.

The ART-FILLER range of products were submitted for approval by Health Canada as Class III medical devices. Due to backlogs created by the COVID-19 pandemic, it is estimated that the average target review time for a Class III MDL application may take as long as 6-9 months.

In 2018, the dermal filler market in North America was worth approximately US$1.6B. Driven by the growing demand for innovative and advanced dermal fillers, the region is expected to lead the estimated 7.8% CAGR for the global market through to 2026[1].

The Company is planning to launch FILLMED's NCTF products onto the Canadian market in the first half of 2021, while it anticipates launching the ART-FILLER range imminently following its approval by Health Canada by late 2021 or early 2022.

"With the increasing popularity of minimally invasive and non-invasive aesthetic procedures and the increasing public acceptance of these procedures, we are excited to enter the growing medical aesthetic market with such remarkable, high quality products, which are already well-known and widely used in over 60 countries across the globe," said Serge Verreault, Crescita's President and CEO. "In preparation for the launches, we have engaged with Canadian dermatologists and medical aesthetic practitioners by creating advisory boards and are working to create awareness for the brand with certain pre-launch activities. We will also provide specialized training to our commercial team in order to ensure the flawless execution of our planned marketing and sales campaigns," added Mr. Verreault.

"With Crescita, we have a partnership with a company that has strong commercial presence in Canada, giving us the ability to expand our footprint in the North American market," says Christophe Foucher, Laboratoires FILLMED's CEO.

About Crescita Therapeutics Inc.
Crescita (TSX: CTX and OTC US: CRRTF) is a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house R&D and manufacturing capabilities. The Company offers a portfolio of non-prescription skincare products and early to commercial stage prescription drug products and owns multiple proprietary drug delivery platforms that support the development of patented formulations that can facilitate the delivery of active ingredients into or through the skin.

Supported by a sales force covering Canada and executing a business to business to consumer marketing approach, Crescita sells its non-prescription skincare products domestically through spas, medispas, and medical aesthetic clinics, as well as internationally, through distributors. Crescita's portfolio also includes a prescription product called Pliaglis^®, that utilizes the Company's proprietary phase-changing topical cream Peel technology, a part of the DuraPeel™ family, which are self-occluding, film-forming cream/gel formulations, that provide extended release delivery of the active ingredients to the site of application. Pliaglis is a topical local anesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures. The product is currently approved in over 25 different countries and sold by commercial partners in the U.S., Italy, Brazil, sold in Canada by the Company, and was most recently licensed to partners in Austria and Mexico and China.

Crescita's expertise in product formulation and development can be leveraged in combination with its patented transdermal delivery technologies to develop and manufacture creams, liquids, gels, ointments and serums under its CDMO infrastructure. The Company operates out of a 50,000 square-foot facility located in Laval, Québec, which produces the majority of its non-prescription skincare products, such as LDR, Pro-Derm, Dermazulene and Alyria. Formulations manufactured by or for Crescita include cosmetics, natural health products and products with Drug Identification Numbers. For additional information, please visit www.crescitatherapeutics.com.

About FILLMED 
FILLMED has designed, developed and marketed anti-aging products for aesthetic medicine professionals since 1978: for surgeons, dermatologists and aesthetic medicine practitioners. These products correct the signs of aging and improve skin quality. Over the years, NCTF^® and ART FILLER^® injectables ranges have become benchmark products for both practitioners and patients. They are distributed extensively in more than 60 different countries across the globe.

About NCTF^® 135 HA 
FILLMED NCTF 135 HA is an injectable solution indicated for the rejuvenation of the skin, improvement of skin quality and fine lines. Since 1978, NCTF has been the undisputed leader in skin rejuvenation with over 3 million bottles sold in more than 60 countries in 2020. Comprising hyaluronic acid and revitalizing ingredients, NCTF 135 HA is a hydration booster providing the essential ingredients for skin health. It slows and corrects age-related skin changes: dryness, dullness, uneven complexion, dilated pores and wrinkles.

About ART-FILLER^® 
ART FILLER is an exclusive collection of five hyaluronic acid-based fillers designed to smooth out superficial-to-deep wrinkles, plump up the lips and create/restore the volumes and contours of the face. Each product of the range has been developed bearing in mind a precise treatment objective, thanks to four optimized textures tailored to match each injection site. 

Developed, manufactured and launched in 2016 by Laboratoires FILLMED, the ART FILLER range benefits from an innovation in R&D: the Tri-Hyal^® technology. Made of non-animal origin hyaluronic acid, the gels feature a perfect equilibrium between free hyaluronic acid, long chains and very long chains hyaluronic acid.  For an optimal injection experience, each product contains 0.3% lidocaine.

The high performance and the tolerance of ART FILLER have been proven over an 18-month period through a unique study combining clinical evaluations and instrumental-based measurements. The ART FILLER collection is to the practitioner what the palette is to an artist: a way to express his art.

Forward-Looking Statements
This press release contains "forward-looking information" as defined under Canadian securities laws (collectively, "forward-looking statements"). The words "plans", "expects", "does not expect", "goals", "seek", "strategy", "future", "estimates", "intends", "anticipates", "does not anticipate", "projected", "believes" or variations of such words and phrases or statements to the effect that certain actions, events or results "may", "will", "could", "would", "should", "might", "likely", "occur", "be achieved" "continue" or "temporary"  and similar expressions identify forward-looking statements and include statements regarding the Company's plans, objectives and responses to the COVID-19 pandemic. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking statements.

Forward-looking statements are not historical facts but instead represent management's expectations, estimates, projections and assumptions regarding future events or circumstances. Such forward-looking statements are qualified in their entirety by the inherent risks, uncertainties and changes in circumstances surrounding future expectations which are difficult to predict and many of which are beyond the control of the Company. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Material factors and assumptions used to develop the forward-looking statements, and material risk factors that could cause actual results to differ materially from the forward-looking statements, include but are not limited to the risks of, and future impacts related to, COVID-19, including the response of domestic and international governments to the virus; the impact of COVID-19 on the Company's operations, personnel, supply chain, product sales, royalties, customer demand and financial flexibility;  changes in the business or affairs of Crescita; the ability of Crescita's licensees to successfully market its products; competitive factors in the industries in which Crescita operates; relationships with customers, suppliers and licensees; changes in legal and regulatory requirements; foreign exchange and interest rates; prevailing economic conditions; and other factors, many of which are beyond the control of Crescita. 

Additional factors that could cause Crescita's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Crescita's most recent Annual Information Form under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Crescita with Canadian securities regulatory authorities and commissions. These and other factors should be considered carefully, and readers should not place undue reliance on Crescita's forward-looking statements when making decisions, as forward-looking statements involve significant risks and uncertainties. Forward-looking statements should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not the times at or by which such performance or results will be achieved.

All forward-looking statements are based only on information currently available to the Company and are made as of the date of this press release. Except as expressly required by applicable Canadian securities law, the Company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements in this press release are qualified by these cautionary statements.

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SOURCE Crescita Therapeutics Inc.