Neuramis®

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Global Hyaluronic acid filler, Neuramis®

Neuramis® is a high-quality hyaluronic acid filler manufactured with Medytox’s own technology.
Neuramis® is highly effective for skin rejuvenation, wrinkle correction and volume augmentation.

Global Botulinum toxin type A, Neuronox®

How does Neuramis® fill?1,2

Hyaluronic acid (HA) fillers are the most common and non-permanent injectables.
Neuramis® could reduce facial wrinkles and restore facial volume.
It would be practical to use the different products considering the injection depth in skin.

lasquo Example of Injection depth in Neuramis® series rasquo
how does neuramis fill

Why Neuramis®?2,3

1. Neuramis® is Safe²

1) High-quality of raw material

Neuramis® is manufactured using a high-quality hyaluronic acid that is registered in the Drug Master Files(DMFs) of FDA and certified by the European Directorate for the Quality of Medicines (EDQM). Neuramis® raw materials comply with even higher standards than required by the European Pharmacopoeia (Ph. Eur) to enhance safety.

Neuramis® Deep
lasquo Management standard of HA raw materials rasquo
Category Ph. Eur Neuramis®
Residual protein Maximum 0.3% or 0.1% Less than 0.1%
Endotoxin <0.5 or 0.05IU/mg <0.04IU/mg

2) Improved Refining Process with SHAPE technology

SHAPE(Stabilized Hyaluronic Acid and Purification Enhancement) technology is the exclusive technology of Neuramis®. It stabilizes cross-linking and enhances the purification process. The Neuramis® series minimizes the amount of residual BDDE through a lengthy natural dialysis process.

lasquo 2 Step of cross-linking rasquo
2 Step of cross-linking 이미지

3) In-house quality-control

The general industry standard for the amount of residual BDDE is less than 2 ppm; however, Medytox only sells products after complying with rigorous in-house quality-control standards which require products with non-detectable level of BDDE. (In-house equipment specification)

BDDE Standard solution

BDDE Standard solution 그래프

Neuramis® Series

Neuramis® Series 그래프

4) Proven Safety

A comparative study on injections between Neuramis® Deep Lidocaine and Product A into nasolabial folds reported fewer adverse events from with Neuramis® Deep Lidocaine.

Number of Treatment-related adverse event

proven safety 그래프

2. Neuramis® is Effective

1) Outstanding cohesiveness

Despite pressure from surrounding tissues, Neuramis® maintains its original shape after injection thanks to outstanding cohesiveness between the particles.

lasquo Cohesiveness Test rasquo

Neuramis® Deep

Neuramis® Deep

Biphasic

Product A(Biphasic)

Other Monophasic

Product D(Monophasic)

Video : Cohesiveness test

1) Neuramis® is not spread in the water and stayed in shape compared with Biphasic fillers.
2) Neuramis® can maintain its form and shape in the body.

2) Outstanding skin integration

Neuramis® shows outstanding skin integration which blends well with tissue around the skin after injection, giving a natural look.​​

lasquo Histologic images after filler injection rasquo

Non-injected

Non-injected 이미지

Neuramis® Deep

Neuramis® Deep 이미지

Biphasic

Product A(Biphasic) 이미지
*Red: HA filler

3) Proven efficacy

In a comparative study on injections between Neuramis® Deep Lidocaine and Product A, the nasolabial folds receiving the Neuramis® product showed great improvement and satisfaction.

<Efficacy Assessment>

WSRS Score by three Independent expert

WSRS 그래프

Fig1. Wrinkle Severity Rating Scale(WSRS) score of Neuramis® and control group evaluated with photographic assessment by three independent expert panels.

<Satisfaction Assessment>

GAIS Score by blinded Investigators

GAIS 그래프

Fig2. Global Aesthetic Improvement Scale(GAIS) score for Neuramis® and control group evaluated with live assessment by blined investigators

* p<0.05, Difference between Neuramis® Deep Lidocaine and Product A.

Study Method

In a randomized, multicenter, double-blind, intra-individual comparison and controlled Phase III study on 60 subjects, injections of Neuramis® Deep Lidocaine and Product A were made to nasolabial folds of each subject to assess wrinkle improvement.

Efficacy Assessment

When photo evaluators assessed photos to measure changes in the Wrinkle Severity Rating Scale (WSRS), Neuramis® Deep Lidocaine (1.64±0.74) showed great improvement in week 24 of the study.
(Neuramis® Deep Lidocaine : 1.64±0.74, Product A : 1.45±0.54)

Satisfaction Assessment

According to Global Aesthetic Improvement (GAIS) score evaluated by the investigators, Neuramis® Deep Lidocaine produced a high level of satisfaction in week 24 of the study. (Neuramis® Deep Lidocaine : 2.36±0.55, Product A : 2.00±0.55)

3. Neuramis® is a Global product

Neuramis® is a global product, registered in 36 countries with rapidly growing sales in more than 30 countries.

Product ranges2

product range 테이블

*UTW(Ultra Thin Wall needle)

The Ultra Thin Wall needle has a larger inner diameter compared to regular needles.
It improves flow rates and lowers extrusion force during injection.

product range 이미지

Clinical studies

  • 1. Neuramis® Deep

    Changsik Pak et al. A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds, Arch Plast Surg. 2015 Nov;42(6):721-8.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4659985/

  • 2. Neuramis® Deep Lidocaine

    Hong Jin Joo et al. A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds, Plast Reconstr Surg. 2016 Mar;137(3):799-808.

    https://www.ncbi.nlm.nih.gov/pubmed/26910660

Neuramis® information


References
  • Fredric S Brandt et al. Hyaluronic acid gel fillers in the management of facial aging, Clin Interv Aging. 2008 Mar; 3(1): 153–159
  • Data on file
  • Hong jin joo et al. Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds, Plast Reconstr Surg. 2016 Mar;137(3):799-808