Innovative hyaluronic acid technology delivers enhanced control and precision, significantly lowering the risk of rectal toxicity during prostate radiation treatment.^1-4

Initial cases have now been performed in Japan.

WAYNE, Pa., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced Barrigel™ rectal spacer is now available for purchase in Japan, effective immediately following regulatory approval, insurance coverage acceptance and appropriate use criteria issuance by Japanese academic societies.

First cases commenced earlier this month following the approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Barrigel™ rectal spacer, the first and only sculptable non-animal stabilized hyaluronic acid (NASHA) rectal spacer proven to significantly reduce radiation that reaches the rectum during prostate radiation therapy.^1,5,6,7

“Japan commercialization represents a key milestone in our global expansion strategy for the Barrigel™ rectal spacer,” said Liam Kelly, Chairman, President and CEO of Teleflex. “This launch supports our mission to offer the next-generation, NASHA rectal spacer that enables precise, symmetrical placement^1,2,7—providing physicians with effective and proven control over the shape and placement of the implant.⁸ We remain committed to making Barrigel™ rectal spacer the standard of care for men undergoing prostate cancer radiation therapy.”

In 2022, prostate cancer was the most common cancer among men in Japan, with 104,318 new cases—accounting for 18 percent of all cancer diagnoses nationwide.⁹ Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease.⁵

A U.S. clinical study found that 98 percent of men who were treated with Barrigel™ rectal spacer met the primary endpoint of achieving at least a 25 percent reduction in radiation to the rectum.¹ Patients who met the primary endpoint averaged an 85 percent 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.^1,6

Yoshiko Inoue, Teleflex Managing Director, Japan, said 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.¹ “We’re proud to support this important advancement and remain committed to educating healthcare professionals on the value of rectal spacing and its adoption throughout Japan,” she said.

Beginning in late May, training took place in Chiba, Japan under the direction of Dr. Jun Itami, who is among the top radiation oncologists in the country. “Barrigel™ rectal spacer is unique in that it does not impose time constraints during injection and offers excellent visibility under ultrasound^1-4. This allows physicians to monitor the injection in real time and place the required amount precisely^1,7 where needed for each individual patient,” said Dr. Itami. “As a result, a reliable distance between the prostate and rectum can be maintained, enabling safer and more robust radiation therapy planning, representing a new standard in rectal protection during radiation therapy¹.”

About Barrigel™ Rectal Spacer
Barrigel^™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.¹ Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).⁵

Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.^2,10

Barrigel^™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy¹ and is cleared for rectal spacing in the United States, Australia, Europe and Japan.¹¹ Barrigel^™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease.⁵ For more information about Barrigel^™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters.

Barrigel™ Rectal Spacer Important Safety Information
Barrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time.
Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area.
As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners.

© 2025 Teleflex Incorporated. All rights reserved.

*Study sponsored by Palette Life Sciences, now part of Teleflex
** Data from the Barrigel Pivotal Study analyzed using the same methodology as the Fischer-Valuck study
***Drs Gejerman, Chao, Lederer, and Orio are paid consultants of Palette Life Sciences, now part of Teleflex.

References

1. Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).*
2. Svatos M, Chell E, King MT et al. Med Phys (2024).*
3. Gejerman G, Goldstein MM, Chao M et al. Pract Radiat Oncol (2023).***
4. Williams J, Mc Millan K, Chao M et al. J Med Imag Radiat Sci (2022).
5. Japan Injectable Gel Instructions for Use (2025)
6. Data on file. As of 4/01/2025.
7. King MT, Svatos M, Orio PF III et al. Pract Radiat Oncol (2023).*
8. Fischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J. Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wall. Pract Radiat Oncol. 2017;7(3):195-202.**
9. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer.
10. Restylane^® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021.
11. Data on file Teleflex. 2025
    

Contacts:

Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

Media Contact
Glenn Silver
FINN Partners
National Media Relations Specialist
glenn.silver@finnpartners.com
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