<Solmedics’ special material soft tissue fixation medical device, ‘Quratus’>
Venture company Solmedics, specializing in open innovation for medical devices, announced that their grade 4 special material soft tissue fixation medical device, ‘Quratus’, received manufacturing approval from the Korean Food and Drug Administration (KFDA) on the 20th.
‘Quratus’ is a medical device used to fix soft tissues (ligaments, tendons, etc.) to the bone in cases of shoulder rotator cuff tears. It applies biodegradable polymer technology, which allows the implant to be absorbed and decomposed in the body, thereby addressing various side effects associated with permanent retention of conventional metal implants in the body.
Currently, the target market for ‘Quratus’, the domestic ‘non-metallic anchor’ market, is predominantly occupied by imported products. However, the proportion of domestic products is gradually increasing. From the product planning stage, Solmedics appointed prominent domestic medical professionals as a Medical Technology Advisory Board (Key Doctors) to actively reflect unmet needs in the medical field. Additionally, they internalized biodegradable polymer injection technology to secure a quality and performance advantage over domestic and international competitors. Solmedics also developed accessory products necessary for the use of ‘Quratus’, such as cannulas, punches, and self-tappers, enhancing product value.
In recognition of the product’s excellence, Solmedics signed a distribution agreement with Wonik, a medical device distribution company and the parent company of the Wonik Group, in May, even while the KFDA approval process was ongoing. This early achievement secured distribution channels ahead of time. Solmedics plans to build a long-term partnership with Wonik to jointly develop follow-up lineups for the ‘Quratus’ product and expand the target market to the entire sports medicine sector.
Jang Hong-shik, CEO of Wonik, stated, “We expect ‘Quratus’ to be a high-quality alternative in the domestic orthopedic market, which has been dominated by foreign products. Going forward, the two companies aim to become a key player in K-healthcare, attracting attention not only in the Korean medical market but also internationally through joint efforts and role sharing.”
Yoon-cheol Yang, CEO of Solmedics, expressed, “We are delighted to introduce a new product to patients and medical professionals with this KFDA approval. Using the biodegradable implant manufacturing technology acquired during the development of Quratus, we plan to continuously develop high value-added pipelines that can lead the global market.”
