Tamsulosin Hydrochloride

Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLift™ System for BPH 1 -2 First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLift™ System at Three Months. 3 First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI). 4 WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System’s advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes. 1-2 The UroLift™ System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S. 5 “These studies underscore our commitment to evidence-based innovation. The UroLift™ System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies. “With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we’re giving clinicians and patients the critical data to support evidence-based shared decisions.” The following research presentations outlined the key findings from the studies: Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT 1 † Men treated with the UroLift™ System were significantly more satisfied with their results at two weeks and at one month after treatment. 1 Those who received the UroLift™ System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to Rezūm™ patients. 1 UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT 2 † At three months, men who were treated with the UroLift™ System showed significantly better symptom improvement compared to those who took medication. 2 UroLift™ System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLift™ System. 2 Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment 3 Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months. 3 Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility 4 This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas. 4 “These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of Barrigel™ rectal spacer product development and research. “With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment." For more information about the UroLift System, visit www.UroLift.com , and for more information about Barrigel Rectal Spacer, visit www.Barrigel.com . About the UroLift™ System The UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure, 6 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe. 7 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.** 8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability. 10 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. 1 1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide. 1 2 Learn more at www.UroLift.com . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 3 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA). 1 4 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. 15-16 Barrigel ™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy 1 3 and is cleared for rectal spacing in the United States, Australia, and Europe. 1 7 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 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 . Individual results may vary. 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. References *Paid consultants of Teleflex. **No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study †Studies sponsored by Teleflex. ‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep. Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. † Roehrborn et al, AUA 2025. UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.† Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment . Poster presented at AUA; April 26, 2025. Las Vegas, NV. Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility. U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness. Shore, Can J Urol 2014 Rukstalis, Prostate Cancer and Prostatic Dis 2018 AUA BPH Guidelines 2003, 2020 McVary, Urology 2019 Roehrborn, Can J Urol 2017 Roehrborn, J Urol 2013 Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology. Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023). Barrigel Injectable Gel Instructions for Use (2022). 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 † 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. Data on file Teleflex. 2025. MAC03086-01 Rev A Contacts: Teleflex Lawrence Keusch Vice President, Investor Relations and Strategy Development investor.relations@teleflex.com 610-948-2836 Media Contact: Glenn Silver Partner National Media Relations Specialist glenn.silver@finnpartners.com 646-871-8485 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Hanmi Pharm Begins Local Sales of Urological Product 'Aditams' in Mexico with Partner 'Laboratorios Silanes' Launch completed in February, Hanmi Pharm's Third Product to Enter Latin America Aditams, The First Urological Combination Drug for OPG and ED Exported to Mexico SEOUL, South Korea, April 2, 2025 /PRNewswire/ -- Hanmi Pharmaceutical's combination therapy for Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED), Gugutams, is entering the Mexican market under the local brand name "Aditams." Continue Reading Aditams Hanmi Pharmaceutical announced that it has completed the launch of Aditams in Mexico under the export agreement signed in October 2020 with the Mexican pharmaceutical company 'Laboratorios Silanes'. Under the agreement, Hanmi Pharmaceutical plans to export Gugutams to the Mexican market for a period of seven years, starting in February 2025. Gugutams, developed by Hanmi Pharmaceutical, is the world's first urological combination therapy combining two active ingredients: tamsulosin, a treatment for Obstructive Prostatic Growth (OPG), and tadalafil, a treatment for erectile dysfunction (ED). It is also noteworthy as the first prescription drug in Korea to apply Poly-Cap technology, which integrates multiple active ingredients into a single capsule. Laboratorios Silanes, a leading pharmaceutical company in Mexico founded in 1943, is committed to providing innovative healthcare solutions and driving rapid growth in the industry. It has established itself as a key player in the Latin American pharmaceutical market through its robust distribution network and strategic collaborations with global partners. Silanes previously collaborated with Hanmi Pharmaceutical in 2023 to successfully introduce the hypertension and dyslipidemia combination treatment 'Amosartan Q', under the local brand 'Lodarta' and in 2024 to introduce the combination hypertension treatment 'Amosartan Plus' under the local brand 'Bicartial-CTD'. Following these products, Gugutams, under the local brand 'Aditams', becomes Hanmi Pharmaceutical's third product in the Latin American region. Aditams, as the first urological combination therapy to enter the Mexican market, is expected to offer a new treatment option for patients suffering from both Obstructive Prostatic Growth (OPG) and erectile dysfunction (ED). By managing both conditions with a single medication, it significantly enhances patient convenience and maximizes therapeutic efficacy. Hanmi continues to focus on expanding its partnerships in emerging markets such as the Middle East and Latin America, in addition to its established presence in developed markets like North America and Japan. The company aims to leverage strategic partners like Laboratorios Silanes as key footholds to broaden its product portfolio and regional reach. Park Jae-hyun, CEO of Hanmi Pharmaceutical, stated, "As the first urological combination therapy to enter the Mexican market, Gugutams is expected to present a new treatment paradigm for local patients." He added, "Through this collaboration with Laboratorios Silanes, we aim to solidify Hanmi Pharmaceutical's presence in the Latin American market and leverage this as a foundation to further strengthen our competitiveness in the global pharmaceutical industry." Official Websites: About Hanmi Pharmaceutical: Hanmi Pharmaceutical is an R&D-focused pharmaceutical company committed to developing globally innovative therapies in areas of high unmet medical needs such as obesity/metabolism, oncology, and rare diseases. Hanmi leverages proprietary platform technologies, including long-acting biologics and bispecific antibodies, to address unmet medical needs. The company emphasizes open innovation and has established numerous global partnerships to advance its research and development efforts. SOURCE Hanmi Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED