WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has announced the commercial launch of its Barrigel™ rectal spacer in Japan, marking a significant step in the company’s international expansion strategy. The rollout follows regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), insurance coverage acceptance, and the issuance of appropriate use guidelines by Japanese academic societies.
A Milestone for Global Expansion
Barrigel™ is the first and only sculptable non-animal stabilized hyaluronic acid (NASHA) rectal spacer designed to reduce radiation exposure to the rectum during prostate cancer treatment. According to Teleflex Chairman, President, and CEO Liam Kelly, this development underscores the company’s commitment to offering next-generation technologies aimed at improving patient outcomes.
“Japan commercialization represents a key milestone in our global expansion strategy for the Barrigel™ rectal spacer,” Kelly said. “We remain committed to making Barrigel™ rectal spacer the standard of care for men undergoing prostate cancer radiation therapy.”
Addressing a Critical Health Need
Prostate cancer remains a major health concern in Japan, where it was the most common cancer among men in 2022, with over 104,000 new cases — approximately 18% of all cancer diagnoses nationwide. Barrigel™ is indicated for prostate cancer patients with T1–T3b disease, offering a proven option to minimize complications associated with radiation therapy.
U.S. clinical data highlighted the device’s effectiveness, showing that 98% of patients achieved at least a 25% reduction in rectal radiation exposure, with an average decrease of 85% in rectal V54 Gy radiation levels. Additionally, Barrigel™ demonstrated superior results in reducing both short-term and long-term gastrointestinal toxicity compared to control groups.
Expanding Access and Physician Training
Yoshiko Inoue, Teleflex Managing Director for Japan, emphasized the importance of expanding treatment options: “With the launch of Barrigel™ rectal spacer in Japan, more men will have access to a solution that helps minimize the rectal side effects of prostate cancer radiation therapy.”
Training for Japanese physicians began in late May at Chiba, led by Dr. Jun Itami, a leading radiation oncologist. Dr. Itami highlighted the device’s unique advantages, noting that it allows for real-time monitoring under ultrasound and precise, individualized placement. “As a result, a reliable distance between the prostate and rectum can be maintained, enabling safer and more robust radiation therapy planning,” he said.
Looking Ahead
The introduction of Barrigel™ in Japan represents a pivotal moment for Teleflex as it strengthens its presence in international markets. By offering a scientifically validated, patient-focused solution, the company aims to improve quality of care while setting a new standard for rectal protection during prostate cancer treatment.
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