Crescita files for new medical device license
Laboratoires FILLMED files for Health Canada Approval of ART-FILLER® Injectables in Canada
LAVAL — Crescita Therapeutics Inc., a commercial dermatology company, announced on Jan. 21 that Laboratoires FILLMED (“FILLMED”) has submitted a New Medical Device License 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® in Canada. The ART FILLER is an exclusive collection of five hyaluronic acid-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.
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.