Toyobo launches major marketing initiative for Nerbridge(TM) in the U.S., setting sights on the global nerve conduit market

OSAKA,Japan,April 14,2022 -- Toyobo Co.,Ltd. has launched a major U.S. marketing initiative for Nerbridge TM("the product",hereafter),a conduit for peripheral nerve regeneration.

On January 11,2022,Toyobo kicked off the sales promotion campaign at a conference jointly held in Carlsbad,California,by three societies – the American Association for Hand Surgery (AAHS),the American Society for Peripheral Nerve (ASPN) and the American Society for Reconstructive Microsurgery (ASRM). The campaign is being conducted in partnership with the exclusive U.S. distributor of NerbridgeTM,Synovis Micro Companies Alliance,Inc. (hereafter Synovis),a subsidiary of Baxter International Inc.,a global medtech leader.

The global nerve conduit market is estimated at around 150,000 units as of 2021 and has been growing at a rate of 15 percent per annum*1. The U.S. accounts for about 70 percent of the share,making it the biggest market of its kind in the world.

Toyobo plans to feature the product in collaboration with Synovis at conferences held by various societies. At the events,the company plans to present data*2,3 on clinical tests,post-sale surveys and clinical practice it has accumulated since the company started marketing the product in Japan in 2013. The societies to which Toyobo will showcase the product are those holding conferences across the United States,including ASRM,ASSH and the American Society of Plastic Surgeons.

The product is a medical device used with the aim of facilitating regeneration and reconstructing functions of peripheral nerves severed or lost due to external injury. The device is a tube made of polyglycolic acid filled with sponge-shaped collagen,which enables the creation of an environment to induce nerve growth and reconstruct the severed section. The sponge-like structure of collagen has been confirmed as effective in multiplying nerve cells. The nerve conduit products made of synthesized materials that are available on the overseas market have reportedly caused some instances of triggering inflammatory reactions when the materials have decomposed inside the body*4. However,such events were not found with Nerbridge TMin a systematic literature search Toyobo has been making for the past several years in Japan. Using Nerbridge TM makes it unnecessary to harvest healthy peripheral nerves for autografting,reducing the patient's burden and shortening the time needed for surgical treatment.

Toyobo plans to enhance the production capacity of the product by the end of 2025 as well as expanding the scope of its clinical applications. To respond to the increasing demand expected for nerves conduits in the U.S. and elsewhere in the world,Toyobo will strengthen its production and sales capacities,thus becoming the leading company in the nerve conduit business field.

About Nerbridge TM

Brand name: Nerbridge TM

US FDA 510(k): Clearance No. K152967／Nerve Cuff

JP MHLW: Approval No.22500BZX00106000／Absorbent nerve regeneration inducer with the use of collagen

*1 Global Nerve Conduit,Nerve Wrap and Nerve Graft Repair Product Market Growth 2021-2026

*2 Product document of NerbridgeTM

*3 Kusuhara H,et al. A clinical multi-center registry study on digital nerve repair using a biodegradable nerve conduit of PGA with external and internal collagen scaffolding.、Microsurgery. 2018;1–5.

*4 Kehoe S,et al.,FDA approved guidance conduits and wraps for peripheral nerve injury: A review of materials and efficacy、Injury,Int. J. Care Injured 43 (2012) 553–572.

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