Teleflex (NYSE:TFX) has launched its Barrigel™ rectal spacer in Japan following regulatory approval from the Japanese PMDA. The product is a non-animal stabilized hyaluronic acid spacer designed to reduce rectal radiation exposure during prostate cancer radiation therapy.
Clinical data shows 98% of patients achieved at least a 25% reduction in radiation to the rectum, with average reductions of 85% in rectal V54 Gy radiation. The launch is particularly significant as prostate cancer was Japan’s most common cancer among men in 2022, with 104,318 new cases, representing 18% of all cancer diagnoses in the country.
Initial cases have already commenced in Japan under the direction of Dr. Jun Itami, with the product now available for immediate purchase following insurance coverage acceptance.
Teleflex (NYSE:TFX) ha avviato la commercializzazione in Giappone del dispositivo Barrigel™, uno spacer rettale, dopo aver ottenuto l’approvazione regolatoria dal PMDA giapponese. Il prodotto è uno spacer a base di acido ialuronico stabilizzato non animale, ideato per ridurre l’esposizione del retto durante la radioterapia per il cancro alla prostata.
I dati clinici mostrano che il 98% dei pazienti ha ottenuto almeno un 25% di riduzione della dose al retto, con una riduzione media del 85% nel V54 Gy rettale. Il lancio è particolarmente rilevante considerando che nel 2022 il carcinoma prostatico è stato il tumore più frequente tra gli uomini in Giappone, con 104.318 nuovi casi, pari al 18% di tutte le diagnosi di cancro nel paese.
I primi casi sono già iniziati in Giappone sotto la guida del dott. Jun Itami e il prodotto è ora disponibile per l’acquisto immediato, in seguito all’accettazione della copertura assicurativa.
Teleflex (NYSE:TFX) ha lanzado en Japón su espaciador rectal Barrigel™ tras recibir la aprobación regulatoria del PMDA japonés. El producto es un espaciador de ácido hialurónico estabilizado de origen no animal, diseñado para reducir la exposición rectal durante la radioterapia del cáncer de próstata.
Los datos clínicos indican que el 98% de los pacientes consiguió al menos una reducción del 25% en la radiación al recto, con reducciones medias del 85% en el V54 Gy rectal. El lanzamiento es especialmente relevante dado que en 2022 el cáncer de próstata fue el tumor más común entre los hombres en Japón, con 104.318 nuevos casos, representando el 18% de todas las diagnósticos de cáncer en el país.
Los primeros casos ya han comenzado en Japón bajo la dirección del Dr. Jun Itami, y el producto está disponible para compra inmediata tras la aceptación de la cobertura aseguradora.
Teleflex (NYSE:TFX)가 일본에서 Barrigel™ 직장 스페이서를 출시했습니다. 이는 일본 PMDA의 규제 승인 후 이루어진 것입니다. 이 제품은 동물 유래 성분을 사용하지 않은 안정화 히알루론산 스페이서로, 전립선암 방사선치료 중 직장의 방사선 노출을 줄이기 위해 설계되었습니다.
임상 데이터에 따르면 환자의 98%가 직장에 대한 방사선량을 최소 25% 이상 감소시켰고, 직장 V54 Gy 방사선은 평균 85% 감소했습니다. 이 출시는 2022년 일본에서 전립선암이 남성에서 가장 흔한 암으로 104,318건의 신규 환자가 발생해 전체 암 진단의 18%를 차지했다는 점에서 특히 의미가 큽니다.
초기 시술은 이미 Dr. Jun Itami의 지도 하에 일본에서 시작되었고, 보험 적용 승인에 따라 제품은 즉시 구매할 수 있습니다.
Teleflex (NYSE:TFX) a lancé au Japon son séparateur rectal Barrigel™ après l’approbation réglementaire de la PMDA japonaise. Le produit est un séparateur à base d’acide hyaluronique stabilisé d’origine non animale, conçu pour réduire l’exposition rectale lors de la radiothérapie du cancer de la prostate.
Les données cliniques montrent que 98% des patients ont obtenu au moins une réduction de 25% des rayonnements reçus par le rectum, avec une réduction moyenne de 85% du V54 Gy rectal. Ce lancement est particulièrement significatif puisque le cancer de la prostate était en 2022 le cancer le plus fréquent chez les hommes au Japon, avec 104 318 nouveaux cas, soit 18% de l’ensemble des diagnostics de cancer dans le pays.
Les premiers cas ont déjà commencé au Japon sous la direction du Dr Jun Itami, et le produit est désormais disponible à l’achat immédiat suite à l’acceptation de la prise en charge par l’assurance.
Teleflex (NYSE:TFX) hat in Japan sein Barrigel™-rektales Spacer nach der Zulassung durch die japanische PMDA eingeführt. Das Produkt ist ein nicht-tierisch stabilisiertes Hyaluronsäure-Spacer, das entwickelt wurde, um die Strahlenbelastung des Rektums während der Strahlentherapie bei Prostatakrebs zu verringern.
Klinische Daten zeigen, dass 98% der Patienten mindestens eine 25%ige Reduktion der Strahlenbelastung am Rektum erreichten, mit durchschnittlichen Reduktionen von 85% im rektalen V54 Gy. Der Markteintritt ist besonders bedeutsam, da Prostatakrebs 2022 in Japan die häufigste Krebserkrankung bei Männern war, mit 104.318 Neuerkrankungen, was 18% aller Krebsdiagnosen im Land entspricht.
Erste Fälle wurden in Japan bereits unter der Leitung von Dr. Jun Itami durchgeführt, und das Produkt ist nach Annahme der Versicherungsdeckung nun sofort verfügbar.
Positive
Clinical study showed 98% of patients achieved at least 25% reduction in rectal radiation
Average 85% reduction in rectal V54 Gy radiation achieved
Product launch in Japan expands market presence in region with high prostate cancer incidence (104,318 new cases in 2022)
Received regulatory approval and insurance coverage acceptance in Japan
Insights
Teleflex’s Barrigel launch in Japan opens significant revenue opportunity in world’s second-largest medical device market with 104K+ annual prostate cancer cases.
Teleflex’s Japanese launch of Barrigel™ rectal spacer represents a strategic market expansion for the company’s radiation oncology portfolio. This hyaluronic acid-based device creates separation between the prostate and rectum during radiation therapy, with clinical data showing an average 85% reduction in rectal radiation exposure and significant decreases in gastrointestinal toxicity.
The timing is opportune as Japan reported 104,318 new prostate cancer cases in 2022, making it the most common cancer among Japanese men at 18% of all cancer diagnoses. This large addressable market provides substantial revenue potential for Teleflex, particularly valuable as the company seeks growth drivers.
Technically, Barrigel offers meaningful differentiation as a sculptable non-animal stabilized hyaluronic acid (NASHA) spacer that gives physicians precise control over shape and placement. 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.
08/19/2025 – 06:30 AM
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 placement1,2,7—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 ultrasound1-4. This allows physicians to monitor the injection in real time and place the required amount precisely1,7 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
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
investor.relations@teleflex.com
610-948-2836
Media Contact
Glenn Silver
FINN Partners
National Media Relations Specialist
glenn.silver@finnpartners.com
646-871-8485
APM1275
FAQ
What are the clinical benefits of Teleflex’s Barrigel rectal spacer (TFX)?
The Barrigel rectal spacer achieved 98% success rate in reducing rectal radiation by at least 25%, with patients averaging an 85% reduction in rectal V54 Gy radiation exposure during prostate cancer treatment.
When did Teleflex (TFX) launch Barrigel in Japan?
Teleflex launched Barrigel in Japan in August 2025 following PMDA approval, insurance coverage acceptance, and appropriate use criteria issuance by Japanese academic societies.
What is the market opportunity for Teleflex’s Barrigel (TFX) in Japan?
In Japan, prostate cancer was the most common cancer among men in 2022, with 104,318 new cases, representing 18% of all cancer diagnoses nationwide.
What makes Teleflex’s Barrigel (TFX) unique compared to other rectal spacers?
Barrigel is the first and only sculptable NASHA rectal spacer that offers real-time monitoring during injection, precise symmetrical placement, and doesn’t impose time constraints during the procedure.
Which patients are eligible for Teleflex’s Barrigel rectal spacer (TFX)?
Barrigel rectal spacer is indicated for prostate cancer patients with T1-T3b disease.
AloJapan.com