Maria Von’s History

 

2008

Maria Von Med-Biotechnology Co., Ltd. founded in Taipei, Taiwan

Developed cell culture system with Industrial Technology Research Institute ITRI

Planned central laboratory in compliance with Good Tissue Practice GTP


2009

Established GTP laboratory and completed laboratory construction

Completed GTP laboratory quality system


2010

Inspected by Taiwan food and Drug Administration TFDA

Developed Platelet Rich Plasma PRP medical device

Obtained research subsidy from SMEA, Taiwan


2011

Submitted clinical trial application of phase I autologous fibroblast therapy

Obtained ISO13485 and ISO9001 certificates


2012

Obtained medical device GMP certificate from TFDA

Launched sales of sterile-degree PRP kit


2013

Completed phase 1 clinical trial of autologous fibroblast therapy

Submitted clinical trial application of phase I allogeneic fibroblast therapy


2014 

Awarded patent of plasma collection device (Taiwan/China/Japan)

Awarded patient of blood separation device (Taiwan/China)

Obtained ISO13485 and ISO9001 certificates


2015

Obtained class II medical device GMP certificate from TFDA

Awarded patent of blood separation device (Germany)

Launched sales of class II PRP kit

Submitted clinical trial application of phase II autologous fibroblast therapy

Signed MOC with Japan Tissue Engineering Co., Ltd. (J-TEC)

Completed the first international cell therapy collaboration between Taiwan and Japan for severe burn patients in Formosa Fun Coast explosion


2016

Obtained Tissue Bank certificate for Amnion Banking

Started phase II clinical trial of autologous fibroblast therapy

Started phase I clinical trial of allogeneic fibroblast therapy

%e8%8b%b1%e6%96%87logo

ADDRESS

7F., No.29-1, Ln.169, Kangning St.,
Xizhi, New Taipei City, Taiwan

CONTACT

+886-2-2693-3232