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AL MAMZAR, DUBAI UNITED ARAB EMIRATES

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Medicurtain

Medicurtain

Up to 93% of patients develop adhesions after all kinds of surgeries, which result in the following clinical consequences:

  • Bowel obstruction up to 74%
  • Infertility up to 20%
  • Chronic pelvic pain up to 50%
  • Repeated surgery in 35% of patients within 10 years
  • Intestinal perforation during following surgery up to 19%

Global anti-adhesion barrier market is expected to be US$ 2.7 billion by 2022.

However…

What are the problems of currently marketed surgical adhesion barriers?

Film Type

Gel/Solution Type

Difficult to use (self-rolling)

Limited to use on laparoscopy & hysteroscopy

Less efficacy because of low viscosity

Required to remove residual materials in solution type

The solution to the current problems

Innovation of Surgical adhesion barrier

MEDICURTAIN

Core Advantages

Novel dual mechanism of action based on patented technology Supreme viscosity + Anti-inflammatory effect

CE MDR certification & German FSC Verified leading edge technology of Shin Poong

Proven efficacy & safety By the largest clinical studies ( > 680 patients)

Easier & faster Easy to use in operations, even for beginners

INNOVATION OF DUAL ANTI-ADHESION TECH

Hyaluronic acid (HA): Advanced physical barrier

Hydroxyethyl starch (HES): Anti-inflammatory effect

Supreme viscosity based on the patented technology

Inhibition of inflammation to prevent from main cause of adhesion

INDICATIONS & DOSAGE

  • Anti-adhesions during surgery

Medicurtain® is intended to prevent or reduce the post-surgical adhesion formation after hysteroscopic, abdominal, spinal, thyroid and nasal/sinus surgeries.

  • 1.2 mL, 2.0 mL and 5.0 mL
  • Pre-filled syringe

5 PIVOTAL CLINICAL TRIALS

 

Indication
 

Hysteroscopic surgery

Laparoscopic surgery

Spinal surgery

Thyroid surgery

Nasal/Sinus Surgery

Total

 

Number of patients

 

223 

107 

87 

 186 

77

680

Do you know…

One of the main causes of Postoperative adhesion is Inflammation.

HES has anti-inflammatory effect by reducing leukocyte migration.

Fact 1

Fact 2

DUAL MECHANISM OF ACTION

Hyaluronic acid (HA)

Hydroxyethyl starch (HES)

Advanced physical barrier effect of innovatively improved viscosity

Anti-inflammatory effect

VISCOSITY COMPETITOR COMPARISON TABLE

Shear Rate : Temporal change of shear. Indicated by a temporal change in the imaginary angle between two straight lines.

Global Competitor Comparison Table

† Hysteroscopic, abdominal, spinal, thyroid and nasal/sinus surgeries.

‡ Viscosity on target tissue was calculated based on in vitro lab grade test and ex vivo evaluation test [graded from grade 1 (highest) to grade 4 (lowest)].

Pre-Clinical Study

Results

  • Medicurtain® shows significantly superior efficacy compared to liquid type and normal saline.
  • Medicurtain® shows equivalent efficacy to film-type.

Strength of adhesions

Severity of adhesions

Area of adhesions

Method : Testing for the grade, strength and area of adhesion after grouping as Medicurtain®, film-type adhesion barrier, liquid-type adhesion barrier, and nomal saline.

Phase III Clinical Study : Hysteroscopic Surgery

Results

Incidence and severity of adhesions were significantly reduced in the Medicurtain® group compared to the control group.

1) Incidence of adhesions (ITT)

2) Severity of adhesions (ITT)

Study Design : Multicenter, randomized, blind, placebo controlled study for evaluation efficacy and safety of the Medicurtain®. (N=223)

Method : Comparison in the adhesion formation rates & grades following the 4 weeks after hysteroscopic surgery.

Phase III Clinical Study : Laparoscopic Surgery

Results

Non-incidence of adhesion rate was significantly increased in the Medicurtain® group compared to the control group. Medicurtain® group’s non-incidence of adhesion rate was 21.8% higher than the control group.

1) Non - Incidence of adhesions

2) Severity of adhesions

Method : Comparison of formation rates and grades of adhesion observed on the eighth week after laparoscopic surgery by laparoscopy, which was the first 2nd look procedure evaluated in Korea. (N=128)

Clinical Trial Digest : Safety Summary

Results

  • Based on the safety results, it is concluded that Medicurtain® is well tolerable and safe as a surgical adhesion barrier.
  • According to the following clinical results below*, adverse events from the Medicurtain® group are not significant.

* Hysteroscopic Surgery

** P-value > 0.05 : not significant

Clinical Trial Efficacy and Safety Conclusion

  • 5 clinical studies of Medicurtain® proved its superior efficacy in hysteroscopic, laparoscopic, spinal, thyroid and nasal/sinus surgeries in 680 patients.
  • After safety analyses of 5 clinical studies, Medicurtain® is proven to be safe and well-tolerated through largest scale clinical studies.