Used to physically fill or reconstruct the nasal cartilage tissue when it is depressed or damaged due to an accident or disease

1) Stored at room temperature immersed in sterile physiological saline (1~30’C)

2) Avoid direct sunlight and high temperature and high humidity

3 years from the date of manufacture

1) This product has been gamma-sterilized and must not be re-sterilized, and even once opened, the product must not be re -sterilized and reused. 

2) This individually packaged product is intended for use by only one patient. 

3) Before using this product, you must read all instructions for use and precautions for use. If the instructions for use and precautions for use are not properly followed, the product may not perform properly or may cause infection or side effects.

4) This product is a biomaterial for tissue restoration for the treatment of patients and should be used by professional medical personnel, and use other than the intended use is prohibited.

 

1) If there is a possibility that a patient experiences side effects, do not use.

 

1) Do not use for transplantation if package integrity had been compromised and the user shall contact L&C Bio for exchange or return.

2) If opened product is contaminated or left in non-sterile environment prior to transplantation, it shall not be used for transplantation and the user shall contact L&C Bio for return or discard it properly. 

3) The allergic reaction of the pregnant to reagents and solutions used in process shall be checked prior to transplantation. 4) If there is a possibility that the patient may cause side effects, it should not be used. This is especially true for immunocompromised patients. 

5) This product must be used within the expiry date indicated on the product label, and if the product has expired, you must contact L&C Bio for a return or exchange. 

6) Store this product in a cool, dry place, avoiding direct sunlight, according to the recommended storage conditions. 

7) Expected Medical Device Adverse Reactions: Medical device adverse reactions found in clinical trials include redness of the non-distributive area, edema of the non-distributive area, milia, change in the angle of the implant, and pain. All of these adverse reactions were mild, but precaution should be observed when using this product.

1) Although no adverse events related to pregnancy occurred in childbearing women included in the clinical trial of this product, continuous observation and caution are required when used in women of child bearing potential.

2) There are no clinical data for this product for pregnant or lactating women. Its use is not recommended for safety reasons. 

3) Since clinical trials have not been conducted on the safety and efficacy of this product for newborns, infants, and children, its use is not recommended.

If side effects are discovered in a transplanted patient, report it immediately to LNC Bio, and the hospital and doctor who performed the transplant take necessary medical measures for the patient.

A 'multicenter, randomized, subject/evaluator blinded, non-inferior, comparative clinical trial' was conducted from April 29, 2019 to March 08, 2021 to compare and evaluate the efficacy and safety of this product in patients requiring rhinoplasty. A total of 56 subjects were randomly assigned 1:1 and underwent rhinoplasty with this product or control device as a test device.

1) Clinical trial method

As a clinical trial for subjects who need rhinoplasty to compare it with a licensed control medical device, safety and efficacy were evaluated for 48 weeks after the final application of the test device and control device during rhinoplasty. A total of 56 subjects were enrolled, 28 each in the test group and the control group.

2) Subject information

Out of the 56 subjects, 3 control subjects were excluded due to withdrawal of consent, and a total of 53 subjects completed the clinical trial by 48 weeks. There were 54 subjects who completed the primary efficacy evaluation at the 24th week. Looking at their demographic information, women has high proportion with 34 (62.96%) compare to men, 20 (37.04%), and the average age was 40.96. ± 13.67 (years).

3) Efficacy evaluation result

The primary efficacy evaluation was the amount of change in subject satisfaction (ROB: Rhinoplasty Outcome Evaluation) 24 weeks after surgery compared to before surgery. As a result, 24.26±17.24 points increased in the test group, and 18.27±17.60 points increased in the control group. The difference in mean satisfaction (ROE) score change between the test group and the control group was confirmed to be non-inferior to the control group because the lower limit of the one-sided 97.5% confidence interval was -.53 points, which is larger than the non-inferiority limit of -5 points. Until 48 weeks after surgery, the change in satisfaction (ROE) score was significantly increased compared to before surgery, and the non-head angle and non-messial distance significantly increased and continued compared to before surgery.

4) Safety evaluation result

Among the 28 subjects in the test group, 10 subjects (35.71%) had adverse events, a total of 18 cases, 13 cases were medical device adverse events. Adverse events were minor redness of the nasal passages, edema, milia, changes in the implant angle, and pain. There were no serious adverse events or serious adverse medical device reactions. There was no significant difference between the control group and the control group for the occurrence of adverse events.

5) Conclusion

This product has been proven to be effective and safe for 48 weeks as a nasal implant.

1) The product is produced in the GMP process certified by the Ministry of Food and Drug Safety. It is recommended to use the product in a similar environment (aseptic environment) and facility to those of its manufacturing environment. 

2) Make sure that the affected or procedural area is not contaminated before product use.