Article

Prodizen 'WORLD PRP' Gets U.S. FDA Approval for 510k

  • 작성일 : 2021.09.23
  • 조회수 : 207

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Participation in IMCAS in 2020. WRALDPRP TEAM (left), FDA510K approved WORLDDPRP

 (domestic name: sPRP) (right) Photo = Prodigy 


[World Biz = Reporter Park Bo-ra]


On the 23rd, Prodizen, a regenerative medical company, reported the acquisition of the US FDA 510K (Class 2) approval for "WORLDPRP (domestic name: sPRP)." 


According to the company, the PRP kit is a disposable medical device that collects regenerative factors using blood from the body, and has long been used in sports medicine, orthopedics, beauty, and hair loss abroad, but Korea had limited therapeutic use in orthopedics until relatively recently.


obtained clinical data to secure significance at three university hospitals using a system called limited medical technology, and through this, new medical technology was passed, according to Prodizen.From 2014 to 2018, Prodizen obtained clinical data to secure significance at three university hospitals using a system called limited medical technology, and through this, new medical technology was passed, according to Prodizen. 

The company explained that it is seeking to expand indications such as ophthalmology and obstetrics and gynecology. 


Prodizen is a company that developed and produced PRP, and has recently obtained approval for U.S. FDA medical devices after acquiring European CE certification, ISO13489: 2016, and Canada certification in 

2019, a Prodizen official said. "Based on this, we will be able to launch activities to expand our global business." 


According to the company, the global PRP market is currently estimated to be about 300 billion won in 2021, of which the US market is the market with the greatest demand. In addition, the company explains that demand in the overseas PRP market is continuously increasing.  




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