DLMR01

Medical Aesthetic Specialized Company based on Polymer R&D capacity

DLMR01


'Collagen regeneration filler to be injected into dermis or thinner dermal layer

Safe & Easy Collagen Stimulator

Collagen Regeneration

Preclinical Trial (Tested by: Chungang Univ. Hospital)

Biocompatibility

Biocompatibility Results:

NAMSA, USA
Test Category
Regulations
Study Details
Results
Cytotoxicity
ISO 10993-5
ISO Elution Method
Non-cytotoxic
Pyrogenicity
ISO 10993-11, USP <151>
USP Pyrogen Study - Material Mediated
Non-pyrogenic
Sensitization
ISO 10993-10
ISO Guinea Pig Maximization Sensitization Test
No sensitivity
Intracutaneous Irritation
ISO 10993-10
ISO Modified Intracutaneous Study in Rabbits
Non-irritant
Acute Systemic Toxicity
ISO 10993-11
Acute Systemic Toxicity Study in Mice
Non-toxic
Subchronic Toxicity
ISO 10993-11
13 Week Systemic Toxicity Study in Rats Following Subcutaneous Implant
Non-toxic
Genotoxicity
ISO 10993-3, OECD
guidelines 471

Bacterial Reverse Mutation Study
Non-mutagenic
OECD guidelines 474
Mouse Peripheral Blood Micronucleus Study
Non-mutagenic
ISO 10993-3, OECD
guidelines 490

Definitive Mouse Lymphoma Assay
Non-mutagenic
Local tolerance
ISO 10993-6
ISO Muscle Implantation Study in Rabbits – 4weeks
Non-toxic,
Non-irritant

ISO Muscle Implantation Study in Rabbits – 26weeks
Non-toxic,
Non-irritant

The long-term safety of DLMR01 was evaluated according to ISO standards by NAMSA, USA. Table below depicts the various in-vitro and in-vivo biocompatibility tests conducted. It can be concluded that DLMR01 is non-toxic, non-mutagenic, non-pyrogenic and totally biocompatible.

Clinical cases

Crow's feet
Case 1
Before
after 4 weeks
Case 2
Before
after 4 weeks