Urinary Retention

Randomized, controlled study will be first in personalized spacing evidence to include patients who have a prostate cancer recurrence after prostatectomy.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 imagingAn intact facial layer to support the Barrigel™ rectal spacerHad six months of androgen deprivation therapy, a first-line treatment for advanced prostate cancer 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™ 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 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™ 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 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. 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, 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: 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.**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).**Data on File. As of 06/01/2024.Falagario UG et al. Biochemical Recurrence and Risk of Mortality Following Radiotherapy or Radical Prostatectomy. JAMA Netw Open (2023).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**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).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).Barrigel Injectable Gel Instructions for Use (2022).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:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485 APM968A

DUBLIN, Oct. 18, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist (LAMA), evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstructive pulmonary disease (COPD) patients. These data and analyses, published in the International Journal of Chronic Obstructive Pulmonary Disease, reinforce that YUPELRI provides consistent and durable improvements in lung function, as compared with placebo, over a full 24-hours. "Where previous data showed that revefenacin significantly improved peak and trough FEV1 at Day 85 compared with placebo in patients with moderate-to-very-severe COPD, this subset post-hoc analysis depicts a more comprehensive view of 24-hour bronchodilation as assessed by examining AUC over multiple time periods," said Dr. Donald A. Mahler, Emeritus Professor of Medicine at Geisel School of Medicine at Dartmouth in Hanover, NH and Pulmonologist and Respiratory Director at Valley Regional Hospital in Claremont, NH. "It provides additional valuable clinical insight into the duration and consistency of revefenacin over the entire dosing interval." Dr. Blake LeMaster, Assistant Professor of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, commented, "Importantly, this drug also exhibits a substantial peak response as well as bronchodilation over the initial 2-hour period as exhibited by FEV1 AUC 0-2H." He added, "Clinically meaningful bronchodilation was seen within the first 15 minutes of administration, persisting over the 24-hour duration during which patients underwent serial spirometry. These data demonstrate that revefenacin can provide rapid and prolonged bronchodilation with just a single dose." Key Study Findings: Analysis of a retrospective, pooled sub-study from Phase 3 Studies 0126 and 0127 demonstrated that revefenacin (n = 50) improved bronchodilation versus placebo (n = 47) in patients with moderate-to-very-severe COPD when assessed by FEV1 AUC. Rapid onset of bronchodilation was observed, with a mean FEV1 difference of 145 mL achieved at 15 minutes, exceeding the accepted Minimal Clinically Important Difference (MCID) of 100 mL with approximately 97.5% confidence. Day 84 bronchodilation improvements were sustained over 24 hours vs. placebo, with mean differences of 282 mL, 220 mL, 205 mL and 212 mL for FEV1 AUC0–2h, AUC0–12h, AUC12–24h and AUC0–24h, respectively, (p<0.001 for all). Trough FEV1 is an important endpoint often used in COPD trials and provides the magnitude of lung function benefit at the end of a given dosing interval. FEV1 AUC measurements provide additional information on the magnitude and consistency of bronchodilation throughout the dosing interval, including both daytime and nighttime effects. As patients depend on the magnitude of sustained bronchodilation to address COPD symptoms, combined use of both trough FEV1 and FEV1 AUC may allow for a more comprehensive assessment of bronchodilator efficacy to support clinical decision-making. About Studies 0126 and 0127 Studies 0126 (placebo, n = 209; 88 mcg revefenacin, n = 212; and 175 mcg revefenacin, n = 198), and 0127 (placebo, n = 208; 88 mcg revefenacin, n = 205; and 175 mcg revefenacin, n = 197) were replicate Phase 3 studies which included adults ≥40 years old with documented moderate-to-very-severe COPD, and a current or past smoking history of ≥10 pack-years. Subjects were randomized 1:1:1 to receive revefenacin 88 mcg, revefenacin 175 mcg, or placebo administered once-daily in the morning by a standard jet nebulizer (PARI LC Sprint) for 12 weeks. The prespecified primary efficacy endpoint was change from baseline in trough FEV1 on Day 85. Peak FEV1 on Day 1 was a secondary endpoint and FEV1 AUC from 0 to 2 hours (FEV1 AUC0–2h) on Days 1, 15, 29, 57, and 84 was a prespecified exploratory endpoint1. While both revefenacin 88 mcg and 175 mcg doses were investigated in these trials, the post hoc analysis reported herein focused only on the 175 mcg dose as this is the dose approved by the FDA2. About YUPELRI YUPELRI® (revefenacin) inhalation solution is the first and only once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the maintenance treatment of COPD in the U.S. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD. Important Safety Information What is YUPELRI®? YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both. It is an anticholinergic medicine which helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. It is used long-term as 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer to improve symptoms of COPD for better breathing. Who should not use YUPELRI? Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you. Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate). Do not use in children. It is not known if YUPELRI is safe and effective in children. Before using YUPELRI, tell your healthcare provider about all your medical conditions, including if you: have eye problems such as glaucoma. YUPELRI may make your glaucoma worse. have prostate or bladder problems, or problems passing urine. YUPELRI may make these problems worse. have liver problems. are allergic to any of the ingredients in YUPELRI, or any other medicines. are pregnant or planning to become pregnant. It is not known if YUPELRI may harm your unborn baby. are breastfeeding. It is not known if the medicine in YUPELRI passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take: Other anticholinergics (including tiotropium, ipratropium, aclidinium, umeclidinium, glycopyrrolate) Atropine Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. What are the possible side effects with YUPELRI? YUPELRI can cause serious side effects, including: Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away. New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include: Red eyes Blurred vision Seeing halos or bright colors around lights Eye pain or discomfort Nausea or vomiting Urinary retention. People who take YUPELRI may develop new or worse urinary retention. Symptoms of urinary retention may include: difficulty urinating urinating frequently urination in a weak stream or drips painful urination If you have any of these symptoms, call your healthcare provider right away before taking another dose. Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash hives severe itching swelling of your face, mouth, and tongue difficulty breathing or swallowing If you have any of these symptoms, stop taking YUPELRI, and call your healthcare provider right away before taking another dose. Common side effects of YUPELRI include: Cough Runny nose Upper respiratory tract infection Headache Back pain Tell your healthcare provider if you get any side effects that bother you or that do not go away. These are not all the possible side effects with YUPELRI. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or . How should I use YUPELRI? Read the step by step instructions for using YUPELRI in the FDA-approved Prescribing Information and in the Patient Information Leaflet YUPELRI is only for use with a nebulizer. Do not use YUPELRI more often than prescribed. Do not mix YUPELRI with other medicines in your nebulizer. Do not use other medicines that contain an anticholinergic for any reason. Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse. Call your healthcare provider or get emergency medical care right away if your breathing problems get worse. you need to use your rescue inhaler medicine more often than usual. your rescue inhaler medicine does not relieve your symptoms. This summary does not include all the information about YUPELRI and is not meant to take the place of a discussion with your healthcare provider about your treatment. Please see the full prescribing information and instructions for use at About Theravance Biopharma / Viatris Collaboration Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Forward-Looking Statements This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's expectations regarding its future profitability, expenses and uses of cash, the Company's goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future royalty payments, the ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts; contingent payments due to the Company from the sale of the Company's TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company's cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on August 8, 2024, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. Contact: [email protected] 650-808-4045 1Ferguson GT, Feldman G, Pudi KK, et al. Improvements in lung function with nebulized revefenacin in the treatment of patients with moderate to very severe COPD: results from two replicate Phase III clinical trials. Chronic Obstr Pulm Dis Apr. 2019;6(2):154–165. doi:10.15326/jcopdf.6.2.2018.0152 2 YUPELRI (revefenacin). Package Insert. Theravance Biopharma and Mylan Inc.; 2018. SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

• Barrigel™ rectal spacer provides high quality rectal spacing, enabling low dose to the rectum during prostate cancer radiation therapy, with an excellent toxicity and safety profile; and low incidence (0.32-1%) of rectal wall infiltration (RWI), which can be safely reversed using hyaluronidase4,5 • Data demonstrate safety and efficacy of Barrigel™ rectal spacer in stereotactic body radiation therapy (SBRT) for patients undergoing repeat therapy6 WAYNE, Pa., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the presentation of data supporting the safety and efficacy of Barrigel™ rectal spacer, ​​the first and only sculptable hyaluronic acid​ rectal spacer. It is designed to significantly reduce radiation that reaches the rectum during prostate cancer radiation therapy.1-3 The data were presented in three abstracts5-7 at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting, which took place in Washington, DC, September 29 to October 2, 2024. Rectal spacers are used during prostate cancer radiation therapy to enable effective radiation dosing 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.1,8-10 Additionally, Barrigel™ rectal spacer is highly visible in real time using transrectal ultrasound, which helps to ensure optimal spacing.1,8-10 Approximately 300,000 men will be diagnosed with prostate cancer this year in the U.S. alone. The incidence rate has increased by 3% per year overall over the past decade.11 “Building on the safety and efficacy of Barrigel™ rectal spacer previously proven in a randomized clinical trial,1 the data presented at ASTRO 2024 demonstrate that excellent outcomes can also be achieved in real-world settings and in patients undergoing repeat radiation therapy,” said Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex. “They also show that rare instances of unintended injection regions can be reversed with hyaluronidase, a naturally occurring enzyme. This is an important advantage over other rectal spacers, which cannot be reversed following the initial procedure and require time for biodegradation. Our ASTRO 2024 data underscore our ongoing commitment to advancing outcomes for patients with malignant and benign prostate conditions.” Presented Abstracts 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)7 This abstract reports retrospective data from 100 men undergoing moderately fractionated EBRT (60Gy/62Gy in 20 fractions) for localized prostate cancer using Barrigel™ rectal spacer in Australia. Implants were assessed for quality (mSQS score), symmetry (FV score), and RWI (rectal wall infiltration), and acute and late gastrointestinal (GI) toxicity were also evaluated. Excellent implant quality (mSQS score=1) was reported for 74 patients; 24 patients had a score of 2 and only 2 patients had a 0 score. Symmetrical rectal spacing (FV score=1) was achieved in 97% of implants. Physicians deemed Barrigel™ rectal spacer very easy (98%) or easy (2%) to implant. No acute or late GI toxicity > Grade 2 was reported; 7 acute and 5 late Grade 1 toxicity events were reported. RWI occurred in 1 patient and was reversed with hyaluronidase with no subsequent adverse effects. Only 1 case of regional prostate cancer recurrence has been reported with median follow-up of 1.68 years. Rectal Wall Infiltration (RWI) with Hyaluronic Acid Based Rectal Spacer Reversal Protocol (Abstract #3185)5 This abstract reports data from a retrospective analysis of inadvertent RWI in 5,000 Australian men receiving Barrigel™ rectal spacer for prostate cancer radiation therapy. Results of magnetic resonance imaging (MRI) were used to identify RWI. Patients with RWI were followed for the remainder of their radiation therapy and for an additional 3 months following completion of radiation therapy. The study identified 16 patients (0.32%) with RWI after Barrigel™ rectal spacer insertion (Grade 1 by FV criteria n=5, Grade 2 n=6, Grade 3 n=5), with a median volume of misplaced Barrigel™ rectal spacer of 2.8 cc (total average Barrigel™ rectal spacer volume was 9.2 cc). No post-procedural GI symptoms or acute Grade 2+ GI toxicity were reported among these 16 men, and the rectal mucosa was intact in the 12 men who underwent sigmoidoscopy. Seven of the 16 men underwent Barrigel™ rectal spacer reversal procedures with hyaluronidase, all of which were successful, and no post-reversal complications were reported. The other 9 men were monitored. No severe adverse complications (mucosal ulceration, pelvic abscess, recto-prostatic fistula) have been reported among the 16 men with RWI. The presence of RWI resulted in delayed initiation of radiation therapy in 11 men (median delay = 3.2 months). “These real-world, retrospective analyses offer further evidence that Barrigel™ rectal spacer provides safe, effective, and high-quality spacing in routine clinical practice,” said Michael Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia, and author on the two aforementioned abstracts.† “They also show that the incidence of RWI with Barrigel™ rectal spacer is quite rare—only 0.32%—and that these rare cases can be reversed effectively with hyaluronidase. Reversal is not feasible when RWI occurs with other spacers because the inorganic materials of which they are made cannot safely be dissolved in the body and must be absorbed over time. This is another important benefit of Barrigel™ rectal spacer that should be considered when selecting a rectal spacer for men undergoing prostate cancer radiation therapy.” Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity (Abstract #3236)6 This abstract reports Barrigel™ rectal spacer safety, rectal separation, ease of spacer placement, and treatment toxicity in 17 men undergoing repeat local radiation therapy for prostate cancer using SRBT. There was a 100% success rate for Barrigel™ rectal spacer placement, with no use of saline dissection and no adverse events reported. Mean minimum separation between gross tumor volume (GTV) and rectal tissue was 8.7 (± 5.6) mm, and adequate separation was achieved in 86.4% of cases. No >Grade 1 GI toxicity or acute Grade 3+ urinary toxicity were reported, and there was 1 case of Grade 3 hemorrhagic cystitis (which the patient also experienced during initial EBRT). Maximum point dose (Dmax) for radiation was 22.7 Gy (± 6.8), and the dose received by 30% (D30) and 60% (D60) of the prostate was 6.8 Gy (±3.0), and 3.0 Gy (± 2.2), respectively. “Patients with local recurrence of prostate cancer treated initially with EBRT (external beam radiation therapy) are often not considered for repeat radiation therapy,” said LaToya McLean, MD, a resident member at Thomas Jefferson University in Philadelphia, Pennsylvania and lead author on the abstract. “A key reason for this is concern about safely and effectively placing a rectal spacer in tissue that has been previously irradiated, as this tissue may be scarred or have adhesions that make it difficult to separate. In this study, we show that Barrigel™ rectal spacer can be used safely and effectively to achieve meaningful rectal separation that allows patients with local prostate cancer recurrence to receive radiation therapy while meeting dosimetric constraints. I hope these findings will help reduce the barriers to radiation therapy that these patients face.” 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 is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).12 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.8,13 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 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 to reduce the radiation dose delivered to the anterior rectum. Barrigel 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 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. Potential complications associated with the use of Barrigel include, but are not limited to: pain associated with Barrigel injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel 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. † Michael Chao is a paid consultant 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. 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. References: Mariados NF, Orio PF III, King MT et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: A randomized clinical trial. JAMA Oncol. 2023:e1-e8.*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.*Data on File. As of 06/01/2024.Hong A, Ischia J, Chao M. Case report: Reversal of hyaluronic acid rectal wall infiltration with hyaluronidase. Front Oncol. 2022;12:870388.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 October 1, 2024.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 October 1, 2024.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 October 1, 2024.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*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).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).American Cancer Society. Key Statistics for Prostate Cancer. www.cancer.org. 2023. Accessed: Jan 26, 2023. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.Barrigel Injectable Gel Instructions for Use (2022).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:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485 APM943A