TFX Teleflex Inc

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced three clinical studies4-6 focused on its Barrigel™ rectal spacer are to be presented at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting, which will take place in Washington, DC, from September 29 to October 2, 2024. The featured data will contribute to the expanding body of clinical evidence regarding the safety and efficacy of Barrigel™ rectal spacer, the first and only commercial hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during prostate cancer radiation therapy.1 The company will also be exhibiting and hosting a Barrigel™ Educational Symposium at the John F. Kennedy Center for the Performing Arts.

Barrigel™ rectal spacer is a Non-Animal Stabilized Hyaluronic Acid (NASHA) spacer designed to reduce radiation that reaches the rectum during prostate cancer radiation therapy, with the goal of improving patient quality of life. It has been clinically proven to significantly reduce unwanted radiation exposure in 98.5% of patients.1 Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease.

“Radiation therapy can have a significant and positive effect on the treatment of prostate cancer, and these data further demonstrate Barrigel™ rectal spacer as a safe and effective option for patients that reduces prostate radiation side effects,” said Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex. “This research underscores Teleflex’s commitment to advancing therapies that improve patient outcomes and set new benchmarks in prostate cancer care.”

Presentation Information:

1. Impact of Hyaluronic Acid (HA) Rectal Spacer Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity Outcomes – an Australian Experience (Abstract #3222); Tuesday, Oct. 1, 2:30-3:45 ET, Hall CThis retrospective multi-institutional review assessed the implant quality and gastrointestinal (GI) toxicity of Barrigel™ rectal spacer in prostate cancer patients treated with moderately hypofractionated external beam radiotherapy (EBRT).4

2. Rectal Wall Infiltration with Hyaluronic Acid Based Rectal Spacer Reversal Protocol (Abstract #3185); Tuesday, Oct. 1, 2:30-3:45 ET, Hall CThis retrospective analysis assessed the outcomes of inadvertent rectal wall infiltration (RWI), which can occur with rectal spacers, following use of Barrigel™ rectal spacer.5

3. Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity (Abstract #3236); Tuesday, Oct. 1, 2:30-3:45 ET, Hall CThis study evaluated outcomes in prostate cancer patients who had previously been treated with EBRT but experienced localized recurrence and were treated with SBRT. These patients often are not candidates for repeat radiation due to concerns about safely implanting a rectal spacer in previously irradiated tissue.6

Barrigel™ Educational Symposium Information:

On September 30 at 6:00 p.m. at the REACH at the John F. Kennedy Center for Performing Arts, Teleflex will host an educational symposium, “The Science of Personalized Spacing.” The event will feature a panel discussion with Peter F. Orio III, DO, MS, FASTRO, FABS*; Daniel Kim, MD*; Nedhim Ruhotina, MD*; Michael Greenberg, MD*; and Martin King, MD,* who will discuss best practices for addressing challenging cases with Barrigel™ rectal spacer.

Teleflex Booth Activities:

At the Teleflex booth 1223 in the ASTRO Annual Meeting Exhibit Hall, clinicians can view the Barrigel™ rectal spacing procedure or perform it via a simulation. In addition, Michael Greenberg, MD* and John Han-Chih Chang, MD* will conduct clinical discussions and case presentations on September 29 and 30. Dr. Greenberg will present at 11:00 a.m. and 3:00 p.m. and Dr. Chang will speak at 1:00 p.m. and 4:00 p.m.

About Barrigel™ Rectal SpacerBarrigel™ 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 is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).7

Hyaluronic acid is a substance naturally present in the human body and is highly compatible 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.8,9

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

Barrigel™ Rectal Spacer Important Safety InformationBarrigel™ 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 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.

*Peter F. Orio III, Daniel Kim, Nedhim Ruhotina, Michael Greenberg, Martin King and John Han-Chih Chang are paid consultants of Teleflex.

About Teleflex IncorporatedAs 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.

References:

1. Mariados NF, Orio PF, Schiffman Z, et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: a randomized clinical trial. JAMA Oncol. 2023; e1-e8.**
2. King MT, Svatos M, Orio PF III et al. Evaluating the Quality-of-Life Effect of Apical    Spacing with Hyaluronic Acid Prior to Hypofractionated Prostate Radiation Therapy: A Secondary Analysis, Pract Radiat Oncol. 2023;e1-e6. (Study sponsored by Palette Life Sciences, now part of Teleflex).**
3. Data on File. As of 06/01/2024.
4. Lin YH, et al. Impact of Hyaluronic Acid (HA) Rectal Spacer Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity Outcomes – an Australian Experience. Abstract #3222. Presented at ASTRO 2024.
5. Hong A, Bolton D, Ramani S, et al. Rectal wall infiltration with hyaluronic acid based rectal spacer reversal protocol. Abstract #3185. Presented at ASTRO 2024.
6. McLean L, et al. Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity. Abstract #3236. Presented at ASTRO 2024.
7. Barrigel Injectable Gel Instructions for Use (2022).
8. Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.
9. Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi.org/10.1002/mp.17292**

**Study sponsored by Palette Life Sciences, now part of Teleflex.

Forward-Looking StatementsAny 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, Titan SGS, 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. © 2024 Teleflex Incorporated. All rights reserved. APM942A

Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836

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