Gunze: Entering the US market with artificial skin: Wound dressing, PELNAC®
Gunze:
Enter the US market with the wound dressing “PELNAC®”.
So far, it has been deployed in Japan, Europe, the Middle East, and Asia.
A large number of clinical achievements and product characteristics have been evaluated.
We have recently signed an exclusive sales contract with a US medical device sales company.
Pre-sale at some facilities from October.
Full-scale sales will begin nationwide from January 2021.
Wound dressing “THE RAGENESIS ™” launched in the US
-Concluded an exclusive sales contract in the United States with Misonix, a major US medical device company-
Gunze Co., Ltd .:
We have signed an exclusive sales contract in the United States with the US medical device Misonix for the wound dressing “THE RAGENESIS ™” (PELNAC®).
Misonics:
Pre-sale will begin in October 2020, and full-scale sales will begin in January 2021.
background:
In June 1993, we obtained manufacturing and marketing approval for “PELNAC®” from the Ministry of Health, Labor and Welfare.
Since then
Burn III degree,
Traumatic skin defect,
Skin defects after tumor / nevus resection, etc.
It has been sold in Japan as a medical device used for the treatment of diseases (Note 1).
PELNAC®:
Japanese market:
Adopted by more than 60% of university hospitals in Japan.
We have contributed to improving the QOL of patients from the beginning of sales.
Overseas market:
Overseas, we have obtained CE marking and regulatory approval from each country, and sell mainly to Europe, the Middle East, South Africa, China, South Korea, and Brazil.
US FDA approval:
In April of this year, we obtained 510 (k) approval from the US FDA and have been preparing for the start of sales.
Gunze Co., Ltd.
https://www.gunze.co.jp/corporate/news/2020/09/20200923001.html
Gunze to sell artificial skin “Pernac” jointly developed with Kyoto University School of Medicine in the US from October
https://www.kyoto-np.co.jp/articles/-/364740
New artificial skin from Kyoto University approved for manufacturing
-Adsorption and sustained release of cell growth factors-
Enables skin regeneration comparable to cell therapy-
— Kyoto University