초록

1. 메디커튼 갑상선 적응증 임상시험
- 임상시험 완료 : 갑상선 전절제 수술환자의 유착에 대한 안전성 및 유효성 확인
- 적응증 추가 : 식약처 승인으로 적응증 추가(2015. 01. 27)
2. 메디커튼 비부비동 적응증 임상시험
- 임상시험 완료 : 내시경 비부비동 수술환자의 유착에 대한 안전성 및 유효성 확인
- 적응증 추가 : 식약처 승인으로 적응증 추가(2015. 10. 16)

Abstract ▼

Ⅰ. Purpose & necessity
- Medicurtain is the product based on biopolymer and supplemented weakness of existing anti-adhesion agent.
Additional clinical trials of thyroid and sinus indication of Medicurtain have been processed and completed to strengthen international competitiveness and acceler

Ⅰ. Purpose & necessity
- Medicurtain is the product based on biopolymer and supplemented weakness of existing anti-adhesion agent.
Additional clinical trials of thyroid and sinus indication of Medicurtain have been processed and completed to strengthen international competitiveness and accelerate globalization.

Ⅱ. Contents and range of Research
1. Clinical trial of thyroid
- Multicenter investigation, randomized, patient & evaluator-blind and active-controlled design clinical study for assessment of safety and efficiency in adhesion of thyroid total thyroidectomy surgical patients
- Clinical trial at Clinical Research Center - Ewha Womans University Mokdong Hospital, Korea University Ansan Hospital, Gangnam Severance Hospital, Bundang Cha Hospital
- After completion of clinical trial, additional indication - additional indication with approval of MFDS
2. Clinical trial of sinus
- Multicenter, matched pairs, randomization, single-blind, assessor-blinding, active-controlled design clinical study for assessment of safety and efficiency in adhesion of endoscopic sinus surgical patients
- Clinical trial at Clinical Research Center - Korea University Guro Hospital, Gangnam Severance Hospital
- After completion of clinical trial, additional indication - additional indication with approval of MFDS

Ⅲ. Results
1. Clinical trial of thyroid
- Completion in clinical trial: confirmation of safety and efficiency in adhesion of thyroid total thyroidectomy surgical patients
- Approval of MFDS for additional indication(2015.01.27)
2. Clinical trial of sinus
- Completion in clinical trial: confirmation of safety and efficiency in adhesion of endoscopic sinus surgical patients
- Approval of MFDS for additional indication (2015.10.16)

Ⅳ. Application Plan of Results
- It is expected that substitution of import will take effect with supply of product satisfying both of medical doctor and patient with qualified safety, efficiency and convenience in use. Many companies in countries of the world are displaying interest in the product, such as it is now under negotiation with companies of Poland, Indonesia, Russia etc. And contracts are processed with companies of Iran, China, Malaysia, Myanmar, Sudan and Vietnam. For overseas expansion to advanced country in pharmaceutical areas, we look for the business partner and proceed commercialization with consulting company specialized in global license-out. With these efforts, it is expected to achieve intensification of international competitiveness and globalization of the product.