바이오스펙테이터

by Jongwon Jang

Secure minimal invasiveness and safety with 'shape-memory' technology; expand its pipelines from fistula stents.

TMD LAB is dedicated to developing new convergent products, including a human body insertable stent made of a new material that is now ready to enter the global market.

Prof. Sung Hak-Joon of Yonsei University College of Medicine, who founded TMD LAB in 2018, believes that polymers that can restore to the original shape in response to a certain stimulus (temperature) can be used for various purposes in the medical field site. Such polymers are now ready for commercialization after years of research.

Prof. Sung said, "Shape-memory material can be utilized as invasive materials to minimize damage to tissues when a medical device is inserted into the human body."

Prof. Sung, who majored in biomedical engineering in Georgia Institute of Technology and Vanderbilt University, has conducted research on shape memory polymers that can be used for a long period of time for medical purpose. He has now secured the source technology of shape-memory polymers. The product developed by him has excellent biocompatibility and safety thanks to the use of U.S. FDA-approved polymers.

TMD LAB's shape memory polymers have two characteristics. First, shape memory polymers are designed to respond to body temperature to make it applicable to the human body. Second, they can quickly restore to their original shape withing 0.5 to several minutes. The restoration speed is controllable.

The first product made of shape memory polymers is fistula stent. Prof. Sung said, "Fistula stent has a small market, but its advantage is that it has a low level of risk. To promote and spread a new and unfamiliar material like 'shape memory polymers' in the domestic medical device market, I chose fistula stent as the first pipeline.”

TMD LAB's fistula stent made of shape memory polymers can enlarge in response to the body temperature to expand the fistula. The possibility as a medical material was confirmed in an animal model conducted by TMD LAB with rabbits, in which a new fistula stent was inserted into a clogged tear duct. The company has already completed comparative evaluation of shape memory polymers' physical properties with silicon, in-vitro cytotoxicity test, biofilm inhibition test, and in vivo efficacy test. CEO Kang Mi-Lan of TMD LAB said, "We have been implementing related procedures through consultation with the KFDA. We aim to get approval by the end of 2020 and release it to the market in 2021.”

TMD LAB's next follow-up pipeline is a vascular exterior wall wrapping stent for covering the external wall of blood vessel. Prof. Sung said, "Wrapping from the outside of blood vessel can prevent blockage in physical and biological aspects. An animal model confirmed the medical application possibility of the vascular exterior wall wrapping stent because it was found that it could reduce the occurrence of turbulent flow."

Shape memory polymers can be utilized to develop various kind of products such as lifting thread, cosmetic implants, pancreatic cancer stents, ureteral stents, and ophthalmic implants. These are TMD LAB's potential pipelines.