Huons Group’s Humedix is in the final stages of bringing its innovative composite filler Valpien to market, with the goal of securing regulatory approval in the latter half of this year.
Humedics announced on Friday that it has submitted an application for domestic product approval for Valpien, a novel composite filler that combines polydeoxyribonucleotide sodium (PN) and hyaluronic acid (HA).
Valpien improves upon existing HA fillers by incorporating PN, known for its tissue regeneration properties. The addition of lidocaine, a local anesthetic, makes it less painful than traditional PN fillers. This application follows the successful completion of confirmatory clinical trials in December last year.
The clinical study, conducted at Chung-Ang University Hospital, involved 171 adults seeking improvement in crow’s feet wrinkles. Researchers used the IGA-LCL Wrinkle Severity Scale to assess crow’s feet wrinkles at rest as the primary endpoint.
Participants were divided into two groups: one receiving Valpien and a control group using a commercially available product. The study compared improvement rates at baseline and 18 weeks post-initial treatment. Results showed Valpien’s non-inferiority in reducing crow’s feet wrinkles. Safety assessments revealed similar or lower incidence of adverse events at the application site for Valpien compared to the control, with notably less injection site pain.
With these promising clinical results, Humedics has filed for product approval with the Ministry of Food and Drug Safety, eyeing a potential launch later this year. The company is also preparing to apply for Medical Device Regulation (CE MDR) certification in Europe during the same period.
Humedix Chief Executive Officer (CEO) Kang Min-jong expressed optimism, stating that Valpien’s addition to the aesthetic portfolio, which includes fillers, toxins, medical devices, and skin boosters, is expected to boost the market share in the domestic aesthetic medical sector. They’re also set to expand the global footprint by securing European certification, complementing the existing exports of HA Ellabie fillers to China and South America.
In a related development, Humedix has entered into a tripartite business agreement with Huons Meditech and VNCO to collaborate on aesthetic business initiatives.
VNCO’s SKENA is a cutting-edge artificial intelligence (AI)-powered skin diagnostic device. It employs a combination of ultrasound and contact-based precision measurements to quantify and analyze collagen density in the dermis and fascia layer condition, leveraging AI to provide comprehensive data for skin consultations.
Humedix and Huons Meditech anticipate creating effective synergies by expanding treatment opportunities through consultations based on SKENA’s skin diagnostic data at their partner medical institutions.
The partnering companies plan to bolster their joint marketing efforts, including expanding their reach to medical professionals through webinars and academic activities. They aim to capitalize on Humedix’s market recognition and network, along with Huons Meditech’s international business expertise, to drive SKENA’s market expansion.