Taiwan Biomaterial Co., Ltd. (TWBM) has turned a loss into a profit this year, with EPS of NT$0.44 for the first three quarters. The artificial brain membrane product, which was previously affected by the relocation of the plant, is expected to return to normal revenue next year and more resources are planned to promote it. The development of a nickel-titanium wire product for cerebral blood vessels is scheduled to be delivered to the FDA in the second half of next year, which will be an important potential growth driver in the future.

The two major products include a self-developed foam brain membrane and a negative pressure thrombus removal catheter system for cerebral strokes, which is being marketed in the US in collaboration with Incept, an innovative international medical materials company. The gross margin of the product is approximately 75-80% and the consumables are approximately 60-75%.

This year's operations have improved significantly, with the main driver of growth being the thrombus removal catheter system for stroke, mainly due to the contribution of the negative pressure pumping system and the shipment of peripheral consumables such as blood exchange and suction tubes.

General Manager Wen-Hsi Wang said in an investor meeting recently that the world's artificial brain membrane is US$480 million, and TWBM's product has the advantage of completing both brain membrane repair and cerebrospinal fluid leakage prevention, and has already obtained marketing approval in Taiwan and has been sold in more than 20 hospitals. However, the relocation of the plant in Taiwan from last year to this year, some of which had to be re-validated and certified, had an impact on sales, but it is expected to return to normal next year.

The negative pressure thrombus removal catheter system for stroke mainly targets 800,000 people in the United States each year, with about 50% of the stroke population disabled and the economic loss amounting to US$65 billion, of which 87% are ischaemic stroke, with a market size of about US$700 million in the US. The system has a unique design that allows for greater suction to remove deep-seated blood clots.

In the future, in addition to the existing embolism extraction system, the company is also potentially cooperating in ongoing development to discuss new possibilities for the treatment of stroke. As for the development of a guidewire for cerebral vascular use, TWBM has planned to send it to the FDA in the third quarter of next year, which will be an important potential growth engine in the future.

As for the original degenerative arthritis tissue repair and regeneration product, we have discussed it with TFDA and CDE before, and originally we wanted to use the clinical trial as the basis for further development, but TFDA raised more questions and wanted us to present more data before the clinical trial. The product is still at an early stage, so we will stop here for the time being and solve the problems before we have the opportunity to discuss it clinically.