First Patient Enrolled in Teleflex's Barrigel™ Rectal Spacer Trial for Post Radical Prostatectomy Radiation Therapy (PPRT)

WAYNE, Pa., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the first patient enrolled in the latest Barrigel™ rectal spacer randomized, controlled, single-blinded multicenter study: The PPRT Trial.

Barrigel™ rectal spacer is the first and only sculptable hyaluronic acid rectal spacer designed to significantly reduce radiation that reaches the rectum during prostate radiation therapy.^1-3 This new study will evaluate Barrigel™ rectal spacer in patients undergoing hypofractionated post-prostatectomy radiation therapy across sites in the U.S. and one site in Australia.



"Our first enrolled patient represents a significant milestone as we grow our body of clinical evidence for Barrigel™ rectal spacer with patients undergoing radiation therapy after a prior prostatectomy," said Martin T. King, MD, PhD, Radiation Oncologist with the Dana-Farber Brigham Cancer Center, Harvard Medical School Assistant Professor of Radiation Oncology, and principal investigator of the study.* "Our study endpoints are to demonstrate Barrigel™ rectal spacer as a safe and effective option that reduces prostate radiation side effects for this patient population."

Based on the segmentation of risk groups between low, medium and high, prostate cancer reoccurrence after radical prostatectomy ranges from 16 to 46 percent.⁴

Rectal spacers are used during prostate cancer radiation therapy to enable effective radiation dosage to the prostate while sparing healthy rectal tissue. This is especially important in hypofractionated treatment regimens, in which radiation is delivered at higher doses over a fewer number of treatment sessions. Unlike other rectal spacers made from different materials, which harden almost immediately after administration, the hyaluronic acid in Barrigel™ rectal spacer remains soft and pliable. This gives physicians time to sculpt, layer, and add more Barrigel™ rectal spacer as needed to optimize rectal protection.^1,5-7 Additionally, Barrigel™ rectal spacer is highly visible in real time using transrectal ultrasound, which helps to ensure optimal spacing.^1,5-7

"Scientific evidence serves as the cornerstone for the advancement and expansion of medical technologies, fostering trust between clinicians and patients," stated Michael Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia.* "I take great pride in being the first physician to treat a patient in this clinical trial."

Study sites will enroll patients who have:

• Undergone nerve-sparing prostatectomy (intrafascial)
• No radiographic evidence of local, regional, or distant metastatic disease via (PSMA) PET imaging
• An intact facial layer to support the Barrigel™ rectal spacer
• Had six months of androgen deprivation therapy, a first-line treatment for advanced prostate cancer

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).⁸

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.^5,9

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 can be used 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 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.

*Martin T. King and Michael Chao are paid consultants of Teleflex.

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.



© 2024 Teleflex Incorporated. All rights reserved.

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. Falagario UG et al. Biochemical Recurrence and Risk of Mortality Following Radiotherapy or Radical Prostatectomy. JAMA Netw Open (2023).
5. 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**
6. Gejerman G, Goldstein MM, Chao M et al. Barrigel spacer injection technique. Pract Radiat Oncol. 2023:e1-e5. (Drs Gejerman, Chao, Lederer, and Orio are paid consultants of Palette Life Sciences, now part of Teleflex).
7. Williams J, Mc Millan K, Chao M et al. Hyaluronic acid rectal spacer in EBRT: Usability, safety and symmetry related to user experience. J Med Imag Radiat Sci (2022).
8. Barrigel Injectable Gel Instructions for Use (2022).
9. 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.
   
   

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

Contacts:

Teleflex

Lawrence Keusch

Vice President, Investor Relations and Strategy Development

[email protected]

610-948-2836

Media Contact:

Glenn Silver

Partner National Media Relations Specialist

[email protected]

646-871-8485

APM968A