Teleflex's Barrigel rectal spacer approved for use in Japan, reduces radiation toxicity.

Teleflex Incorporated has announced the availability of Barrigel rectal spacer in Japan, following regulatory approval, insurance coverage, and appropriate use criteria issuance by Japanese academic societies. Barrigel is a sculptable non-animal stabilized hyaluronic acid rectal spacer that has been proven to significantly reduce radiation exposure to the rectum during prostate radiation therapy. Initial cases have already commenced in Japan.

Teleflex Incorporated (NYSE: TFX) has announced the availability of Barrigel™ rectal spacer in Japan, following regulatory approval, insurance coverage, and appropriate use criteria issuance by Japanese academic societies. Barrigel is a sculptable non-animal stabilized hyaluronic acid (NASHA) rectal spacer that has been proven to significantly reduce radiation exposure to the rectum during prostate radiation therapy. Initial cases have already commenced in Japan.

The Barrigel™ rectal spacer uses innovative hyaluronic acid technology to deliver enhanced control and precision, significantly lowering the risk of rectal toxicity during prostate radiation treatment. Clinical data shows that 98% of men who were treated with Barrigel™ rectal spacer met the primary endpoint of achieving at least a 25% reduction in radiation to the rectum. Patients who met the primary endpoint averaged an 85% reduction in rectal V54 Gy radiation to the rectum, and Barrigel™ rectal spacer is proven superior in the reduction of acute and long-term Grade 1+ GI toxicity at 3 and 6 months compared to control [1].

The launch in Japan is particularly significant given that prostate cancer was the most common cancer among men in Japan in 2022, with 104,318 new cases—accounting for 18 percent of all cancer diagnoses nationwide [2]. The product is indicated for prostate cancer patients with T1-T3b disease [1].

Teleflex's Barrigel™ launch in Japan opens significant revenue opportunities in the world's second-largest medical device market. The product's 98% clinical success rate in reducing radiation by at least 25% positions it well against competitors in the Japanese market. The comprehensive regulatory pathway Teleflex navigated—including PMDA approval, insurance coverage, and academic society endorsement—suggests meticulous market preparation. This foundation, combined with physician training initiatives already underway in Chiba, indicates a well-executed commercialization strategy that should accelerate adoption and revenue generation.

References:
[1] https://www.globenewswire.com/news-release/2025/08/19/3135550/0/en/Teleflex-Announces-the-Launch-of-Barrigel-Rectal-Spacer-in-Japan-as-a-Proven-Safe-and-Effective-Option-to-Minimize-the-Harmful-Long-Term-Side-Effects-of-Prostate-Radiation-Therapy.html
[2] https://www.stocktitan.net/news/TFX/teleflex-announces-the-launch-of-barrigel-tm-rectal-spacer-in-japan-rsijoqv3m0sg.html