Localized Prostate Carcinoma

NEEDHAM, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced three presentations at the 16th Annual International Oncolytic Virotherapy Conference (IOVC), taking place October 27-30, 2024, in Rotterdam, the Netherlands. The presentations will showcase Candel’s advancements in innovative viral immunotherapies, including new data from the ongoing phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma (rHGG), a presentation on a new multimodal immunotherapy candidate from the enLIGHTEN™ Discovery Platform, and a Company overview, focused on Candel’s broad clinical and preclinical pipeline. In detail: E. Antonio Chiocca, MD, PhD, Professor of Neurosurgery at Harvard Medical School, and recently appointed Executive Director of the Center for Tumors of the Nervous System (CTNS) and co-chair of the Executive Committee for Mass General Brigham (MGB) Cancer Center, will deliver an oral presentation titled “Oncolytic immunoactivation clinical trial in rHGG: Preliminary safety and feasibility from longitudinal Injections.” The presentation will review safety and tolerability data from the multiple injection cohort of the ongoing phase 1b clinical trial of CAN-3110 in rHGG and will describe early clinical data and biomarker analysis from the first six patients enrolled in this cohort. The investigators observed ongoing improved survival compared to historical controls, with 3 out of 6 patients still alive after more than one year (12.2, 13.0, and 18.7 months, respectively) after initiation of experimental treatment with repeated CAN-3110 injections. The data also show discrepancies between imaging and histologic findings, suggesting radiologic pseudo-progression: there was a near absence of tumor cells alongside dense lymphocyte infiltrates in biopsies obtained after CAN-3110 administration, especially in patients with enhancement on post-treatment MRI scans. Qiuchen Guo, PhD, Discovery Scientist at Candel Therapeutics, will present a poster titled “A first-in-class multimodal immunotherapy for enhanced immune activation in the tumor microenvironment as a novel therapeutic strategy for solid tumors.” The presentation will focus on the latest asset from the enLIGHTEN™ Discovery Platform, a multimodal viral therapeutic candidate encoding IL-12 and IL-15. Data will include the ability of the asset to induce expansion and activation of natural killer and CD8+ T cell populations, resulting in significant tumor growth inhibition and regression in two different models. “Targeting IL-12 and IL-15 has been the focus of many therapeutic approaches. However, progress has been hindered by limited local target engagement and systemic toxicity,” said Anne R. Diers, PhD, Senior Director of Research at Candel Therapeutics. “Leveraging the biological activity of the Alpha-201 programmable vector, we have successfully delivered these cytokines to the tumor microenviroment, inducing tumor oncolysis and enhancing antigen presentation, resulting in profound antitumoral activity without added toxicity in these in vivo models”. Francesca Barone, MD, PhD, Chief Science Officer at Candel Therapeutics, will present a corporate overview of the company, titled “Off-the-shelf therapy, individualized anti-tumor response: Reprogramming the immune system by viral immunotherapy for the treatment of solid tumors.” This comprehensive review of Candel's pipeline will include updates on clinical and preclinical programs with a focus on Candel’s lead experimental medicine, CAN-2409. “The in-depth analysis of paired biopsy samples and MRIs obtained from patients undergoing multiple injections of CAN-3110 confirmed and extended the findings observed after a single injection of this agent,” said Francesca Barone, MD, PhD. “These recent data from our ongoing phase 1b clinical trial show the ability of CAN-3110 to trigger profound activation of the immune system and tumor clearance associated with improved survival in this therapy-resistant population.” “The breadth of the data presented during the 16th Annual IOVC underscores the transformative potential of Candel’s therapeutic approach,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “These presentations reflect the progress that the company has made in designing new therapies and translating groundbreaking discoveries into potential clinical candidates. We are excited by the encouraging overall survival data after CAN-3110 experimental treatment in recurrent glioblastoma, which suggests a long tail of survival, as previously observed with immunotherapies in other solid tumors.” About CAN-3110 CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in rHGG, supported by the Break Through Cancer Foundation. CAN-3110 has previously received U.S. Food and Drug Administration (FDA) Fast Track Designation and Orphan Drug Designation for the treatment of rHGG. About CAN-2409 CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), borderline resectable pancreatic ductal adenocarcinoma (PDAC), and localized, non-metastatic prostate cancer in ongoing clinical trials. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer is being conducted under a Special Protocol Assessment with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. About the enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting and the 2023 International Oncolytic Virus Conference, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer. During the American Association for Cancer Research (AACR) Annual Meeting 2024, Candel presented preclinical data, unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in NSCLC (phase 2), borderline resectable PDAC (phase 2), and localized, non-metastatic prostate cancer (phase 2b and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: http://www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including key data readout milestones and presentations; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s programs, including the ability of the Company’s programs to treat difficult-to-treat cancers; and expectations regarding the potential benefits conferred by orphan drug designation and fast track designation. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; the Company’s ability to continue as a going concern; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC) including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, Inc.tjenkins@candeltx.com Media Contact:Ben ShannonVice PresidentICR HealthcareCandelPR@icrhealthcare.com _________________________________ 1 Ling AL, et al. Nature. 2023;623(7985):157-166.

The Precision of Stereotactic Body Radiation Therapy (SBRT), an Advanced Treatment Technique, Enables Treatment in Five Days, Significantly Reducing the Time Men Must Spend Undergoing Care MADISON, Wis., Oct. 17, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that results of the PACE-B – Prostate Advances in Comparative Evidence – trial were published in the New England Journal of Medicine (NEJM). The research builds on previously reported data and shows that at five years, stereotactic body radiation therapy (SBRT) provides comparable rates of cancer control, tolerability and sexual functioning to conventional radiotherapy (CRT), while reducing the overall treatment timeframe from up to 39 days of treatment to just five days. The Accuray CyberKnife® System was used in the SBRT treated arm of the PACE-B study and showed excellent disease control with low rates of toxicity for men with prostate cancer. Prostate cancer is the second most common cancer diagnosed in men, with almost 1.5 million new cases identified worldwide in 20221. While it is typically a slow-growing and manageable disease, it's important that men have access to treatment options, such as SBRT delivered using the CyberKnife System, that can not only manage the cancer but also enable them to get back to a healthy, full life, faster. SBRT uses advanced techniques to deliver ultra-hypofractionated radiation therapy – very high doses of radiation are given over a few days – necessitating an extremely high degree of targeting accuracy and precision. The PACE-B trial enrolled men with low- or intermediate-risk prostate cancer who received SBRT in either five sessions or CRT in 20 or 39 sessions. Chief Investigator Professor Nicholas van As, Medical Director and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Professor in Precision Prostate Radiotherapy at The Institute of Cancer Research, London, said: "At The Royal Marsden and the ICR, we are focused on developing smarter, better and kinder treatments for patients across the UK and internationally. Standard radiation treatment is already highly effective and is very well tolerated in people with localized prostate cancer but for a healthcare system and for patients, to have this treatment delivered just as effectively in five days as opposed to four weeks is hugely significant. "To be able to sit with a patient and say, 'We can treat you with a low toxicity treatment in five days, and your chance of keeping the cancer at bay for five years is 96 percent,' is a very positive conversation to have. We expect our trial to be practice changing and people with intermediate risk prostate cancer should be given the option of SBRT as an alternative to conventional radiation or prostate surgery." SBRT: Comparable Results to Conventional Radiotherapy in 75 Percent Less Time Both groups attained high rates of cancer control at five years, with similar rates of 94.6 percent for CRT and 95.8 percent for SBRT achieved without the use of androgen deprivation therapy (ADT), also known as "hormone therapy." SBRT was well-tolerated and treatment-related impairment (such as urinary, bowel and sexual function) and bother were comparable to CRT. "Bother" refers to the annoyance that patients experience because of a decline in their ability to perform certain functions. At five years, 29.1 percent of men treated with CRT and 26.4 percent of men receiving SBRT reported erectile dysfunction, while participants in both groups stated they had stable urinary and bowel symptoms at this time point. "As a radiation oncologist who has had the privilege of treating numerous men with prostate cancer, I am grateful that the medical community continues to invest resources into refining our approach to this common diagnosis. The results of the PACE-B trial are published in one of the premier medical journals and are a game-changer. They provide the most compelling level of data to date in support of prostate SBRT for early-stage disease, and directly inform the standard of care. This trial empowers men who require or prefer radiation treatment to utilize SBRT, a technique that not only offers highly effective cancer therapy, but also significantly reduces the disruption to their lives compared to traditional schedules. This trial represents a crucial step forward in improving medical care and enhancing the quality of life for men diagnosed with prostate cancer," said Seth Blacksburg, M.D., MBA, Chief Medical Officer at Accuray. Continued Dr. Blacksburg, "The CyberKnife® System is supported by more than 30 years of global clinical data, including the results from the PACE-B trial. The system equips medical care teams to treat prostate cancer with tremendous confidence, assuring them of a tool that consistently delivers extremely accurate treatments. This reliability not only enhances the likelihood of successful outcomes but also minimizes potential side effects, providing an optimal approach to curing this common medical condition." The prostate gland can move unpredictably and rapidly throughout the treatment, sometimes moving as much as 10 mm in as little as 30 seconds due to normal patient bodily functions2,3,4,5. The ability to track, detect and correct for this motion is key to ensuring the radiation is delivered to the tumor. Throughout the course of treatment, the CyberKnife System continually collects images to determine exactly where the tumor is, helping to ensure that clinicians deliver radiation exactly where they want it. The system detects the tumor motion and automatically adjusts the radiation beam in real time to match the motion of the tumor, giving clinicians confidence to apply smaller treatment margins and enabling higher doses and fewer treatments. The CyberKnife System is the only radiotherapy device that can track and automatically correct for prostate motion and maintain sub-millimeter accuracy throughout treatment delivery. About the PACE-B Trial The PACE trial data provides level 1 clinical evidence – the strongest level of evidence on which to guide practice changes. PACE-B is a prospective, randomized trial conducted in 35 centers in the UK, Canada and Ireland, comparing five-fraction SBRT to conventionally fractionated or moderately hypofractionated external beam radiotherapy (CFMHRT) for localized prostate cancer. The PACE-B trial is funded by Accuray, sponsored by The Royal Marsden and coordinated by the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU). Of the 874 patients enrolled, data up to five years on 874 patients treated with radiotherapy were analyzed; 433 receiving SBRT and 441 standard radiotherapy. Forty-one percent of men treated with SBRT in the study received treatment using the CyberKnife platform. About Accuray Accuray is committed to expanding the powerful potential of radiation therapy to improve as many lives as possible. We invent unique, market-changing solutions designed to deliver radiation treatments for even the most complex cases—while making commonly treatable cases even easier—to meet the full spectrum of patient needs. We are dedicated to continuous innovation in radiation therapy for oncology, neuro-radiosurgery, and beyond, as we partner with clinicians and administrators, empowering them to help patients get back to their lives, faster. Accuray is headquartered in Madison, Wisconsin, with facilities worldwide. To learn more, visit or follow us on Facebook, LinkedIn, X, and YouTube. Media Contact Beth Kaplan Public Relations Director, Accuray +1 (408) 789-4426 [email protected] 1 World Cancer Research Fund International. 2 Drexler and Furweger. "Quality assurance of a robotic, image guided radiosurgery system." WC 2009, IFMBE Proceedings 25/I, 492-495, 2009. 3 Kilby W, Dooley JR, Kuduvalli G, Sayeh S, Maurer CR. The CyberKnife® Robotic Radiosurgery System in 2010. Technology in Cancer Research & Treatment. 2010;9(5):433-452. doi:10.1177/153303461000900502. 4 Yu C, Main W, Taylor D, Kuduvalli G, Apuzzo ML, Adler JR Jr. An anthropomorphic phantom study of the accuracy of Cyberknife spinal radiosurgery. Neurosurgery. 2004 Nov;55(5):1138-49. doi: 10.1227/01.neu.0000141080.54647.11. PMID: 15509320. 5 Antypas C, Pantelis E. Performance evaluation of a CyberKnife G4 image-guided robotic stereotactic radiosurgery system. Phys Med Biol. 2008 Sep 7;53(17):4697-718. doi: 10.1088/0031-9155/53/17/016. Epub 2008 Aug 11. PMID: 18695294. SOURCE Accuray Incorporated 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.libproxy1.nus.edu.sg/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