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Spotlight

TWBM Addresses Unmet Clinical Needs with Innovation

According to Technavio, the global medical devices market size will grow by US$119.98 billion during 2018-2022. How do entrepreneurs seize these thriving business opportunities? How do startups such as Taiwan Biomaterial Company (TWBM) position themselves in the biomedical industry? In this issue of ITRI TODAY, Dr. Chun-Jen Liao, CEO of TWBM, discusses his experience in founding and leading his company.

TWBM CEO Dr. Chun-Jen Liao (center) and his team.

TWBM CEO Dr. Chun-Jen Liao (center) and his team.

Foamagen reduces the time and risks of dura mater repair. TWBM developed innovative technology for early degenerative arthritis tissue repair and regeneration. The stroke interventional treatment devices. The nickel-titanium alloy guide wire used for stroke interventional treatment.

TWBM, an ITRI spinoff dedicated to implantable medical devices, was listed on OTC in Taiwan this June. The company works closely with surgeons to explore unmet clinical needs and deliver innovative solutions. Featured products include the world’s only foamy dura substitute, stroke interventional treatment devices, and tissue repair and regeneration technology for early degenerative arthritis.

Seven years ago Dr. Liao left ITRI to found TWBM. At that time, he explained, his goal was not to find applications derived from existing technological core competence. Rather, he focused on discovering market demands and trying to integrate technologies needed to develop products that fulfill the niche. “At TWBM, we do not limit ourselves to certain R&D topics; we go for anything that is worth addressing,” said Dr. Liao. This explains why the company has diverse product categories, from surgical solutions for brain dura reconstruction, to a pump system to remove blood clots and enzymatic treatment for knee cartilage degeneration.

In Dr. Liao’s view, the key to a successful business is envisioning the future of the company first. “You start at the end of the story, and work backwards to the beginning,” he said. “This way you can ensure all the bits you are envisioning will be accounted for, reducing the risks of getting lost.” By integrating global and local R&D value chains, the company strives to jointly develop the world’s leading high-end medical devices, hoping to establish a profitable business model for Taiwan’s biotechnology industry.

Dr. Liao pointed out that the major challenge of running a startup like TWBM is that in the medical device industry, time-to-market is very long—usually more than a decade. “You don’t even know whether you will succeed or not. The results are unpredictable,” said Dr. Liao. “Our foamy dura substitute, which was transferred from ITRI, took nearly 10 years to acquire approval from the Taiwan Food and Drug Administration (TFDA); now it is a ‘Me Only’ product.” Dr. Liao stressed that despite uncertainty and high risks, persistence in R&D, innovation and funding is required. “It’s all about making the impossible possible. You are doomed to fail if you think things are impossible,” said Dr. Liao resolutely.

With its eye on the U.S. medical device market—the largest around the world—TWBM has been collaborating with its U.S. partner to keep up with market demands and find new market spaces that transcend competition. Through its partnership with Incept from Silicon Valley, TWBM is the third company to develop the pump system for stroke interventional treatment. Moreover, TWBM adopts the “R&D in Taiwan, manufacturing in U.S.” approach, in which it takes advantage of the well-established biomedical industry chain in the U.S. to enable fast production. TWBM continues to maximize its value through processes such as proof of concept, translational research, patent portfolios, GMP pilot manufacture, clinical trials, and regulatory certification.

As Chairman of TWBM Arthur Lu stated: how big you dream, how far you go. With its commitment to saving lives and helping the world, TWBM tackles every milestone and hurdle on the way of becoming a role model for Taiwan’s medical device industry. “I always feel that Taiwan needs a company like TWBM,” said Dr. Liao in earnest.

Highlight Products

Foamagen, the Foamy Dura Substitute

This revolutionary technology was developed for dura reconstruction after brain and spinal surgeries. High-pressure gas and collagen are mixed in the spray gun to produce a highly porous foamy gel that is lightweight and watertight. The ergonomic foamy gun allows medical staff a natural hand posture and stable grip, thereby replacing the time-consuming and technique-sensitive surgical procedure for dura mater repair.

Stroke Interventional Treatment Devices

The devices that TWBM developed for stroke interventional treatment include an aspiration pump system and nickel-titanium alloy guide wires used for clot removal in ischemic stroke. The former has received the FDA 510(k) clearance, and the latter is expected to do the same next year.

Early Degenerative Arthritis Tissue Repair and Regeneration

TWBM uses enzymes to partially dissolve the cartilage matrix of the knee joint in order to achieve cartilage tissue regeneration and repair. This technology enables one-time surgery, which reduces pain and recovery time for patients.

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