TechDerm Biologics Completes Clinical Enrollment for Scalp Filler Targeting Non-Scarring Alopecia
Techderm
Medical Biomaterials R&D Developer
Recently, HangZhou Techderm Biological Products CO., Ltd successfully completed the enrollment of all subjects in a prospective, multi-center, randomized, untreated control, evaluator-blinded, superiority clinical trial for the efficacy and safety of "scalp filler" used to treat non-scarring alopecia by filling the dermal layer of the scalp.
It is reported that HangZhou Techderm Biological Products CO., Ltd. has completed the enrollment this time."Scalp Filler" byPhosphate Buffer, Non-Crosslinked Hyaluronic Acidand other components, the product is used forFilling the scalp dermis layer to treat non-scarring alopecia, protecting and promoting hair follicle growth, without entering the systemic circulation.。On June 26, 2023, the Medical Device Standards Management Center of the National Medical Products Administration released "Summary of Attribute Determination Results for Drug-Device Combination Products in 2022-2023》, which clearly states: 1.Pharmaceutical and Device CombinationA product refers to a medical product composed of both pharmaceuticals and medical devices, produced as a single entity.Mainly based on drug effectsThe drug-device combination products should be registered according to the relevant requirements for drugs.Mainly based on the effect of medical devicesThe drug-device combination products should be registered according to the relevant requirements for medical devices; 3.Common types of drug-device combination products includeDevices with drug coatings or drug-impregnated or drug-combined, pre-filled drug delivery devices/systems, pre-filled biologic delivery devices/systems, devices with biologic coatings or combined with biologics, topical liquids or gelsProducts, etc.. At the same time, inFrom June 1, 2022 to May 31, 2023InMedical Device-Based Drug-Device Combination ProductsA total of 28, among which"Scalp-related Medical Aesthetic InjectablesThree drug-device combination products have been defined as being primarily medical devices, respectively:Techderm's "Hair Filler", Huaxi Biological's "Injectable Sodium Hyaluronate Composite Solution HAIRCARE", and Meixing Space's "Injectable Sodium Hyaluronate Composite Solution CellBooster®HAIR"。
HangZhou Techderm Biological Products CO., Ltd was established inIn 2012, HangZhou Techderm Biological Products CO., Ltd was established in Hangzhou, the capital of paradise. It is a technology innovation enterprise dedicated to hyaluronic acid products, integrating research and development, production, and sales. The company covers an area of nearly 3,000 square meters, with more than a thousand square meters of production area. Its clean workshops and microbiological purification laboratories are designed according to the standards of sterile medical device production management and cleanroom construction and acceptance specifications, achieving a cleanliness level of Class 10,000.
Hyaluronic Acid Brand under the CompanySofiderm®Si Yi Mei, includingYesCross-linked Filler, Efficacy Hyaluronic Acid, and Hyaluronic Acid SkincareThree major series,Currently registered in over 30 countries including the EU, UK, Russia, Brazil, and China, exported to more than 100 countries and regions with sales exceeding one million units. Strictly manufactured according to international standards, certified by Canada MDSAP and Norway DNV ISO13485.
March 18, 2021，Techderm's Registration Application“Cross-linked Sodium Hyaluronate Gel for InjectionOfficially approved by the National Medical Products Administration (NMPA) for marketing, Registration No.: GuoXieZhuZhun 20213130191, with the main component being20mg/mLCross-linked HA and non-cross-linked HA, with cross-linked HA content of 18mg/mL and non-cross-linked HA content of 2mg/mL, the product is suitable forInjection into the mid to deep dermal tissue of the facial skin to correct moderate to severe nasolabial folds.。
It is reported that the trade name isSi Yi Mei®ClearIf“Medical Cross-linked Sodium Hyaluronate GelA particle-free HA linear cross-linking modification process method is adopted, which increases the compactness of the HA spatial network structure by forming stable covalent bonds between HA molecules. After cross-linking, the HA is uniformly viscous and in a fluid state.
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