On July 13, 2022, CGBIO (CEO Yu Hyun-seung), a specialized bio-regenerative medicine company, announced that it had acquired a manufacturing license to produce a “Tromba” for the first time in Korea and had established a portfolio of cerebrovascular stents as a Korean medical device company, together with alpha-stent (-stent), a stent for treating cerebral aneurysms.

The importance of the cerebrovascular stent is becoming more and more apparent. Stroke, the fourth-leading cause of death in Korea and the primary factor in sudden death, is a representative cerebrovascular disease and relates to a condition in which brain tissue does not function correctly because of irregularities in a brain blood vessel. A stroke can be classified into two types: cerebral hemorrhage caused by bleeding in brain blood vessels and cerebral infarction caused by a decrease in cerebral blood flow. The incidence rate for cerebral infarction is about 70%, and for cerebral hemorrhage is about 30%.

For the treatment of cerebral infarction, reopen blood vessels by removing blood clot that causes blockage. If found within the golden time, it can be treated by injecting thrombolytic drugs; if not, a stent must be inserted to dissolve the blood clots.

For cerebral hemorrhage, a bundle of coils is put into the swollen blood vessel to prevent a burst of “cerebral aneurysm,” which is the weak area of the blood vessel wall that stretches and swells like an alveolus. In the event that the cerebral aneurysm’s entry is broad, a stent supporting the coil is inserted at the bottom as an auxiliary means.

The domestic cerebral vascular stent market is valued at approximately 31.9 billion won, of which the cerebral aneurysm stent market is worth about 23.5 billion won and the cerebral thrombus removal stent market is about 8.4 billion won. However, there have been no domestic products on the market and only imported products have been used.

With Tromba’s license, it is expected that domestic products will be able to replace the stent for cerebral thrombus removal, which has been 100% entirely dependent on imported products. It is expected that local patients will also be able to get a cerebral thrombus removal stent with outstanding performance at an affordable price.

Tromba is a recoverable stent used to treat acute cerebral infarction, which restores blood flow by dissolving blood clots in patients with ischemic stroke whose intracranial blood vessels are blocked by clots as well as patients who are unsuitable for or who have failed to respond to Tissue Plasminogen Activator (t-PA) treatment.

The current cerebral thrombus removal stent is a cylindrical tube type or straight plate type, which due to its relatively poor performance, makes them difficult to be applied to curved blood vessels. Or it is made of a radiation-permeable material, which makes it difficult to check the procedure’s results through radiographic imaging after the procedure.

Tromba has a “spiral plate” structure that combines a straight wire with a rolled stent. This combination is highly flexible to enter curved blood vessels, and the rolled stent is made of radiation-impermeable wires that are woven together so the procedure’s results can be checked through radiography after it is completed.

Additionally, CGBIO also produces an “Alpha Stent,” a stent for the treatment of cerebral aneurysms. After about 7 years of research and development, the alpha stent, a cerebrovascular stent that CGBIO began developing through the industrial convergence source technology development project of the Ministry of Trade, Industry, and Energy in 2012, was successfully developed for the first time in Korea in 2019.

The Alpha Stent, the first stent for the treatment of cerebral aneurysms developed in Korea in 2019, increased the procedure’s convenience compared to earlier existing stents. Alpha stents were developed to be flexible and can be positioned during surgery, unlike other cerebrovascular stents that are commonly used in Korea, which have limitations such as being less flexible or unable to be positioned during surgery.

Alpha stents are also expected to take the position of cerebral aneurysm treatment stents, which have been dependent on imported products.

CEO Yu Hyun-seung said, “We are delighted to establish the first cerebrovascular stent portfolio of a domestic medical device company with the successive development of a stent Tromba for cerebral thrombus removal following the alpha stent and will continue to expand as a cerebrovascular intermediation medical device company.” and “In the future, CGBIO will keep creating next-generation stents to support the domestic production of imported products while offering affordable treatment options with excellent products to cerebrovascular patients.”