Teleflex Incorporated Launches Barrigel™ Rectal Spacer in Japan to Enhance Prostate Cancer Radiation Therapy Safety

Teleflex's Barrigel™ rectal spacer launches in Japan, reducing rectal toxicity during prostate radiation therapy using innovative hyaluronic acid technology.

Quiver AI Summary

Teleflex Incorporated announced the launch of the Barrigel™ rectal spacer in Japan, following regulatory approval and acceptance of insurance coverage. This innovative device uses a sculptable non-animal stabilized hyaluronic acid (NASHA) technology to enhance control and precision during prostate radiation therapy, significantly reducing rectal toxicity. Initial cases have already been conducted successfully. According to Teleflex's CEO Liam Kelly, this launch marks a significant step in their global expansion strategy, aiming to make Barrigel™ the standard care for prostate cancer patients. The device has shown remarkable results in reducing radiation exposure to the rectum, with a U.S. clinical study indicating that 98% of men using it achieved substantial reductions in radiation dose. With prostate cancer being the most prevalent cancer among men in Japan, the introduction of Barrigel™ is expected to greatly benefit patients undergoing related treatments.

Potential Positives

Launch of Barrigel™ rectal spacer in Japan marks a significant expansion milestone for Teleflex, enhancing its global market presence.
Approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) demonstrates the product's compliance with rigorous regulatory standards, boosting credibility and trust in the company's innovation.
Promising clinical data showing that 98% of patients achieved significant reductions in rectal radiation exposure underscores the product's efficacy, potentially positioning Barrigel™ as a standard of care in prostate cancer treatment.
Training efforts led by top radiation oncologists to ensure proper usage highlight Teleflex's commitment to effective product implementation and physician education in Japan.

Potential Negatives

Potential risks and complications associated with the use of Barrigel™ rectal spacer are detailed in the release, including serious issues such as infection, rectal mucosal damage, and needle penetration complications, which may raise concerns among health professionals and potential patients.
The press release highlights a launch following regulatory approval but does not provide information on market readiness or potential barriers in the Japanese healthcare system, which could hinder the product's commercialization and adoption.
The need for qualified and trained physicians to administer the spacer may limit its availability and use, impacting market penetration and overall sales potential.

FAQ

What is Barrigel™ rectal spacer?

Barrigel™ rectal spacer is a hyaluronic acid-based device that helps protect the rectum during prostate cancer radiation therapy.

How does Barrigel™ reduce rectal toxicity?

Barrigel™ creates space between the prostate and rectum, significantly lowering the radiation dose to the rectum.

Is Barrigel™ available for purchase in Japan?

Yes, Barrigel™ rectal spacer is now available for purchase in Japan following regulatory approval and insurance coverage acceptance.

Who can benefit from Barrigel™ rectal spacer?

Men undergoing radiation therapy for prostate cancer with T1-T3b disease are the primary candidates for Barrigel™.

What are the training requirements for physicians using Barrigel™?

Only qualified physicians with experience in ultrasound guidance and injection techniques can administer Barrigel™ rectal spacer.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$TFX Congressional Stock Trading

Members of Congress have traded $TFX stock 3 times in the past 6 months. Of those trades, 1 have been purchases and 2 have been sales.

Here’s a breakdown of recent trading of $TFX stock by members of Congress over the last 6 months:

REPRESENTATIVE LISA C. MCCLAIN has traded it 2 times. They made 1 purchase worth up to $15,000 on 07/16 and 1 sale worth up to $15,000 on 07/22.
REPRESENTATIVE ROBERT BRESNAHAN sold up to $15,000 on 02/25.

To track congressional stock trading, check out Quiver Quantitative's congressional trading dashboard.

$TFX Insider Trading Activity

$TFX insiders have traded $TFX stock on the open market 6 times in the past 6 months. Of those trades, 6 have been purchases and 0 have been sales.

Here’s a breakdown of recent trading of $TFX stock by insiders over the last 6 months:

LIAM KELLY (Chairman, President & CEO) purchased 1,500 shares for an estimated $172,605
JAEWON RYU purchased 1,500 shares for an estimated $172,500
STUART A RANDLE purchased 1,000 shares for an estimated $115,860
ANDREW A KRAKAUER purchased 1,000 shares for an estimated $115,250
GRETCHEN R HAGGERTY has made 2 purchases buying 500 shares for an estimated $57,375 and 0 sales.

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$TFX Hedge Fund Activity

We have seen 195 institutional investors add shares of $TFX stock to their portfolio, and 386 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

UBS GROUP AG removed 1,850,171 shares (-55.8%) from their portfolio in Q2 2025, for an estimated $218,986,239
MORGAN STANLEY removed 667,134 shares (-18.8%) from their portfolio in Q2 2025, for an estimated $78,961,980
BLACKROCK, INC. removed 394,096 shares (-6.8%) from their portfolio in Q2 2025, for an estimated $46,645,202
DIMENSIONAL FUND ADVISORS LP added 373,938 shares (+43.1%) to their portfolio in Q2 2025, for an estimated $44,259,301
PZENA INVESTMENT MANAGEMENT LLC added 356,107 shares (+inf%) to their portfolio in Q2 2025, for an estimated $42,148,824
WORLDQUANT MILLENNIUM ADVISORS LLC removed 346,131 shares (-93.4%) from their portfolio in Q2 2025, for an estimated $40,968,065
GLENVIEW CAPITAL MANAGEMENT, LLC removed 329,976 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $45,599,383

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

$TFX Analyst Ratings

Wall Street analysts have issued reports on $TFX in the last several months. We have seen 1 firms issue buy ratings on the stock, and 1 firms issue sell ratings.

Here are some recent analyst ratings:

Morgan Stanley issued a "Overweight" rating on 05/05/2025
B of A Securities issued a "Underperform" rating on 03/04/2025

To track analyst ratings and price targets for $TFX, check out Quiver Quantitative's $TFX forecast page.

$TFX Price Targets

Multiple analysts have issued price targets for $TFX recently. We have seen 7 analysts offer price targets for $TFX in the last 6 months, with a median target of $137.0.

Here are some recent targets:

Larry Biegelsen from Wells Fargo set a target price of $131.0 on 08/01/2025
Shagun Singh from RBC Capital set a target price of $135.0 on 08/01/2025
Anthony Petrone from Mizuho set a target price of $135.0 on 08/01/2025
Richard Newitter from Truist Securities set a target price of $137.0 on 05/05/2025
Patrick Wood from Morgan Stanley set a target price of $173.0 on 05/05/2025
Craig Bijou from B of A Securities set a target price of $140.0 on 03/04/2025
Matt O'Brien from Piper Sandler set a target price of $140.0 on 02/28/2025

Full Release

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 therapy ¹ .”

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 ^, ¹ ⁰

Barrigel ^™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy ¹ and is cleared for rectal spacing in the United States, Australia, Europe and Japan. ¹ ¹ 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.

*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

Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).*
Svatos M, Chell E, King MT et al. Med Phys (2024).*
Gejerman G, Goldstein MM, Chao M et al. Pract Radiat Oncol (2023).***
Williams J, Mc Millan K, Chao M et al. J Med Imag Radiat Sci (2022).
Japan Injectable Gel Instructions for Use (2025)
Data on file. As of 4/01/2025.
King MT, Svatos M, Orio PF III et al. Pract Radiat Oncol (2023).*
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.**
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.
Restylane ^® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021.
Data on file Teleflex. 2025

Contacts:

Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836

Media Contact
Glenn Silver
FINN Partners
National Media Relations Specialist
[email protected]
646-871-8485

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