Last update 04 Nov 2024

Sodium Hyaluronate

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

DHA, Hyaluronan - TRB Chemedica, Hyaluronic acid - Lantibio

+ [75]

Target-

Mechanism-

Therapeutic Areas

Immune System DiseasesEye DiseasesMouth and Tooth Diseases+ [2]

Active Indication

Keratoplasty rejectionWounds and InjuriesCorneal Injuries+ [9]

Inactive Indication-

Originator Organization

Seikagaku Corp.

Active Organization

Shandong Bausch & Lomb Freda Pharmaceutical Co. Ltd.

Santen Pharmaceutical Co., Ltd.

Seikagaku Corp.

+ [6]

Inactive Organization

Chugai Pharmaceutical Co., Ltd.

Denka Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

JP (29 Nov 1986),

Artificial Lens Implant Migration

Regulation-

278

Clinical Trials associated with Sodium Hyaluronate

NCT06656403 / Not yet recruitingNot Applicable

Effect of Artificial Tears on Ocular Biometry Parameters

Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.

Start Date30 Oct 2024

Sponsor / Collaborator

Liaoning He Eye Hospital Group Co., Ltd.

NCT06376981 / RecruitingPhase 3IIT

Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.

Start Date19 Sep 2024

Sponsor / Collaborator

Centre Hospitalier Departemental Vendee

NCT06508125 / Not yet recruitingPhase 4IIT

Comparing the Efficacy of Cross-Linked and Non-Cross-Linked Hyaluronic Acid in Treating Subdeltoid Bursitis: A Double-Blind, Randomized Clinical Trial

This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

Start Date25 Jul 2024

Sponsor / Collaborator

Taipei Medical University

100 Clinical Results associated with Sodium Hyaluronate

100 Translational Medicine associated with Sodium Hyaluronate

100 Patents (Medical) associated with Sodium Hyaluronate

3,203

Literatures (Medical) associated with Sodium Hyaluronate

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

A 52-week follow-up, multi-center, randomized, double-blinded comparison of efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in Chinese population

Article

Author: Shao, Hui ; Wang, Lu ; Zhao, Hongyi ; Yang, Jianmin ; Tang, Jieying ; Chen, Qiang ; Chen, Lujia ; Zhang, Shihong ; Li, Weiwei ; Wang, Chuan

INTRODUCTION:

To investigate the efficacy and safety of Cutegel^® MAX (Cutegel) in the correction of moderate-to-severe nasolabial folds (NLFS) compared to Restylane^® (Restylane, control).

METHODS:

This study was a 52-week, multicenter, randomized, double-blinded, active-controlled clinical trial. Qualified participants with moderate-to-severe NLFs were randomly assigned in a 1:1 ratio to receive Cutegel or Restylane. For the primary efficacy endpoint, the response rate was defined as the percentage of subjects exhibiting an improvement of at least one-point based on blinded evaluation of Wrinkle Severity Rating Scale (WSRS) at 24 weeks after injection. Other secondary efficacy endpoints and treatment-emergent adverse events (TEAEs) were assessed.

RESULTS:

Of 340 subjects randomized, 317 completed the week 52 visit. In the per protocol set (PPS), the blinded evaluator-assessed response rates at week 24 were 81.17% for Cutegel versus 77.56% for Restylane (p = 0.327). The between-group treatment differences in response rates were 3.60% [95% confidence interval (CI) = (-5.39%, 12.60%)], which demonstrated the noninferiority of Cutegel. Other secondary efficacy endpoints supported this. No significant differences were observed in the occurrence of adverse events between the two groups.

CONCLUSION:

Similar to Restylane, Cutegel was effective and well tolerated in correcting moderate-to-severe NLFs among the Chinese population.

01 Dec 2024·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Temperature-sensitive injectable chitosan-based hydrogel for endoscopic submucosal dissection

Article

Author: Jiang, Zhen ; Han, Baoqin ; Liu, Wanshun ; Cui, Jingzhao ; Ju, Ruibao ; Zhang, Zhenguo ; Liu, Shourui ; Wang, Shuo

Endoscopic submucosal dissection (ESD) is an effective treatment for polyps and early gastrointestinal cancers, but requires a high level of operator skill. Injecting submucosal materials (SIM) helps create a fluid cushion between the mucosal and muscular layers, making the procedure easier and reducing associated risks. However, SIMs commonly used in current clinical practice tend to spread quickly and fail to provide long-lasting submucosal fluid cushions (SFC). Thus, there is a critical need for a material that is easy to inject while also maintaining a durable barrier. We prepared succinylated hydroxybutyl chitosan (HBC-SA) by adding succinic anhydride (SA) to hydroxybutyl chitosan (HBC). The hydrogel had excellent temperature-sensitive properties and was able to be injected via an endoscopic injection needle even after gel formation. In vitro and in vivo studies showed that it has satisfactory biocompatibility. Functional experiments showed that the submucosal lifting properties of this hydrogel were significantly better than that of normal saline (NS) and sodium hyaluronate (SH), two commonly used clinical materials. In addition, the hydrogel possessed excellent hemostatic properties. Based on these results, HBC-SA is a promising candidate for submucosal injection during ESD.

01 Dec 2024·CARBOHYDRATE POLYMERS

Enhancing cell activities through integration of polyanionic alginate or hyaluronic acid derivatives with triboelectric nanogenerators

Article

Author: Shakibi, Reyhaneh ; Abdolmaleki, Parviz ; Kolahdouz, Mohammadreza ; Daemi, Hamed ; Abadijoo, Hamed ; Khayamian, Mohammad Ali ; Dashtianeh, Mahshid

The impact of electrical stimulation has been widely investigated on the wound healing process; however, its practicality is still challenging. This study explores the effect of electrical stimulation on fibroblasts in a culture medium containing different electrically-charged polysaccharide derivatives including alginate, hyaluronate, and chitosan derivatives. For this aim, an electrical stimulation, provided by a zigzag triboelectric nanogenerator (TENG), was exerted on fibroblasts in the presence of polysaccharides' solutions. The analyses showed a significant increase in cell proliferation and an improvement in wound closure (160 % and 90 %, respectively) for the hyaluronate-containing medium by a potential of 3 V after 48 h. In the next step, a photo-crosslinkable hydrogel was prepared based on hyaluronic acid methacrylate (HAMA). Then, the cells were cultured on HAMA hydrogel and treated by an electrical stimulation. Surprisingly, the results showed a remarkable increase in cell growth (280 %) and migration (82 %) after 24 h. Attributed to the electroosmosis phenomenon and an amplified transfer of soluble growth factors, a dramatic promotion was underscored in cell activities. These findings highlight the role of electroosmosis in wound healing, where TENG-based electrical stimulation is combined with bioactive polysaccharide-based hydrogels to promote wound healing.

News (Medical) associated with Sodium Hyaluronate

30 Oct 2024

·www.prnewswire.com

Avanos Medical, Inc. Announces Third Quarter 2024 Results, retirement of CEO

ALPHARETTA, Ga., Oct. 30, 2024 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today reported third quarter 2024 financial results and announced the retirement of its CEO, Joe Woody. Gary Blackford, Avanos Board Chairman, noted, "Joe has decided to retire after leading Avanos for the past seven years. Joe has agreed to assist the Company in the transition of leadership, and will continue to consult with the Company through April of next year. Avanos is better positioned financially and organizationally today to achieve its longer-term value creation goals because of Joe's leadership these past seven years and we thank him." Blackford continued, "We are also pleased to announce that Michael Greiner has agreed to serve as interim CEO for Avanos. As Avanos' CFO and Chief Transformation Officer, Michael has demonstrated his ability to deliver consistent results against our three-year transformation plan and he is well positioned to step in as interim CEO." Third Quarter 2024 Financial Highlights Total net sales from continuing operations were $170.4 million, a 0.5% decrease from the comparable prior year period. Net income from continuing operations was $5.9 million, compared to net loss from continuing operations of $8.8 million a year ago. Adjusted net income from continuing operations totaled $16.7 million, compared to $14.0 million a year ago. Diluted earnings per share from continuing operations was $0.12, compared to diluted loss per share of $0.19 a year ago. Adjusted diluted earnings per share from continuing operations was $0.36, compared to $0.30 a year ago. Adjusted EBITDA was $30.6 million, compared to $27.8 million a year ago. "Although we are pleased with our transformation progress, we fell short in the third quarter of our stated objective of mid-single-digit organic growth, which also negatively impacted gross profit margin for the quarter," said Michael Greiner, Avanos' interim chief executive officer. "We had a few strong pockets of sales performance for the quarter, including continued execution in our digestive health business and double digit growth for Game Ready and IVP. However, underperformance in our surgical pain category, particularly ON-Q, negatively impacted our overall sales performance." Third Quarter 2024 Operating Results From Continuing Operations For the three months ended September 30, 2024, net sales totaled $170.4 million, a decrease of 0.5% compared to the prior year period, due to lower demand for our surgical pain and hyaluronic acid ("HA") products and lower pricing on our HA products. This was partially offset by continued strong demand and volume in our Digestive Health portfolio, primarily from our NeoMed neonatal and pediatric feeding solutions, as well as continued demand for our Game Ready product and increased demand for our Trident product. Gross margin during the third quarter of 2024 was 54.5%, compared to 55.8% in the prior year period. Adjusted gross margin was 58.0% compared to 58.2% last year. Gross profit margin decreased primarily due to costs related to our restructuring initiatives and plant separation costs associated with the divestiture of our respiratory health ("RH") business (the "Divestiture"). In addition, lower pricing for our HA products was partially offset by favorable volume and product mix. Selling and general expenses as a percentage of net sales was 43.6% for the third quarter of 2024, compared to 45.9% for the third quarter of 2023. On an adjusted basis, selling and general expenses as a percentage of net sales was 39.8% for the third quarter of 2024, compared to 41.6% for the third quarter of 2023. Selling and general expenses decreased primarily due to savings realized from the execution on our ongoing three-year transformation process (the "Transformation Process") and disciplined spending. Operating profit in the third quarter of 2024 was $12.0 million, compared to $1.2 million in the prior year period, primarily due to lower selling and general expenses related to the execution on Transformation Process and restructuring priorities. On an adjusted basis, operating profit totaled $25.3 million, compared to $23.0 million a year ago. Adjusted EBITDA from continuing operations was $30.6 million in the three months ended September 30, 2024, compared to $27.8 million in the three months ended September 30, 2023. First Nine Months of 2024 Operating Results From Continuing Operations For the nine months ended September 30, 2024, net sales were $508.2 million, an increase of 1.6% compared to the prior year period, primarily due to strong demand for our Digestive Health and Game Ready products. This was partially offset by lower demand and pricing for our HA products. Gross margin was 55.7%, compared to 56.9% last year. Adjusted gross margin was 59.1% compared to 59.2% last year and was impacted by the same items noted above for the third quarter. Selling and general expenses as a percentage of net sales were 47.0% for the nine months ended September 30, 2024, compared to 52.1% for the prior year period. The decrease was primarily due to disciplined spending, partially offset by non-recurring expenses associated with the Transformation Process and the Divestiture. On an adjusted basis, selling and general expenses as a percentage of net sales was 42.9% for the first nine months of 2024, compared to 44.8% in the prior year period. Operating profit was $22.3 million, compared to an operating loss of $7.0 million in the prior year period, primarily due to increased demand for our Digestive Health products and lower selling and general costs, partially offset by lower volume and pricing of our HA products. On an adjusted basis, operating profit was $63.4 million compared to $52.6 million a year ago. Net income from continuing operations for the nine months ended September 30, 2024 was $10.7 million, compared to net loss from continuing operations of $20.9 million a year ago. Adjusted EBITDA for the nine months ended September 30, 2024 was $79.0 million, compared to $66.8 million in the prior year period. Cash Flow and Balance Sheet Cash flow from operations for the third quarter was $23.0 million, compared to $29.1 million a year ago. Cash from operations less capital expenditures, or free cash flow, for the third quarter was $20.0 million, driven primarily by cash flow provided by operating activities, compared to $25.2 million a year ago. The Company's cash balance at September 30, 2024 was $89.0 million, compared to $87.7 million at year-end 2023. Total debt outstanding, net of unamortized discounts, was $162.0 million at September 30, 2024, compared to $168.0 million at December 31, 2023. Discontinued Operations Net sales from discontinued operations were $10.5 million in the three months ended September 30, 2024, compared to $31.1 million in the three months ended September 30, 2023. Net sales from discontinued operations were $41.0 million in the nine months ended September 30, 2024, compared to $93.9 million in the nine months ended September 30, 2023. 2024 Outlook For the year, the Company anticipates revenue from continuing operations of between $683 million and $688 million, adjusted gross margin from continuing operations of approximately 59.0% and adjusted diluted earnings per share from continuing operations of between $1.30 and $1.35. Non-GAAP Financial Measures This press release and the accompanying tables include the following financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S., or GAAP, and are therefore referred to as non-GAAP financial measures: Adjusted net income; Adjusted diluted earnings per share; Adjusted gross and operating profit; Adjusted effective tax rate; Adjusted EBITDA; and Free cash flow. These non-GAAP financial measures exclude the following items, as applicable, for the relevant time periods as indicated in the accompanying non-GAAP reconciliations to the comparable GAAP financial measures: Certain acquisition and integration charges related to acquisitions. Expenses associated with restructuring and transformation activities, including the Divestiture in the fourth quarter of 2023. Expenses associated with European Union Medical Device Regulation ("EU MDR") compliance. The amortization of intangible assets associated with prior business acquisitions. The tax effects of certain adjusting items. The benefit associated with the tax effects of the CARES Act. The positive or negative effect of changes in currency exchange rates during the year. The Company provides these non-GAAP financial measures as supplemental information to its GAAP financial measures. Management and the Company's board of directors use net sales on a constant currency basis, adjusted net income, adjusted diluted earnings per share, adjusted operating profit, adjusted EBITDA, and free cash flow to: (a) evaluate the Company's historical and prospective financial performance and its performance relative to its competitors, (b) allocate resources and (c) measure the operational performance of the Company's business units and their managers. Management also believes that the use of an adjusted effective tax rate provides improved insight into the tax effects of the Company's ongoing business operations. Additionally, the compensation committee of the Company's board of directors will use certain of the non-GAAP financial measures when setting and assessing achievement of incentive compensation goals. These goals are based, in part, on the Company's net sales on a constant currency basis and adjusted EBITDA, which will be determined by excluding certain items that are used in calculating these non-GAAP financial measures. Our competitors may define these non-GAAP financial measures differently, and as a result, our measure of these non-GAAP financial measures may not be directly comparable to those of other companies. Items excluded from these non-GAAP financial measures are significant components in understanding and assessing financial performance. These non-GAAP financial measures are supplemental measures of operating performance that do not represent, and should not be considered in isolation or as an alternative to, or substitute for, the financial statement data presented in the Company's consolidated financial statements as indicators of financial performance. These non-GAAP financial measures have limitations as analytical tools, and should not be considered in isolation, or as a substitute for analysis of the Company's results as reported under GAAP. We compensate for these limitations by relying primarily on our GAAP results and using these non-GAAP financial measures as supplemental information. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the attached financial tables. Conference Call Webcast Avanos Medical, Inc. will host a conference call today at 9 a.m. ET. The conference call can be accessed live over the internet at or via telephone by dialing 800-836-8184 in the United States. A replay of the call will be available at noon ET today by calling 888-660-6345 in the United States and entering passcode 38787#. A webcast of the call will also be archived in the Investors section on the Avanos website. About Avanos Medical, Inc. Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior solutions that will help patients get back to the things that matter. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today's most important healthcare needs, including providing a vital lifeline for nutrition to patients from hospital to home, and reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands globally and holds leading market positions in multiple categories across its portfolio. For more information, visit and follow Avanos Medical on X (@AvanosMedical), LinkedIn and Facebook. Forward-Looking Statements This press release contains information that includes or is based on "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as "may," "believe," "will," "expect," "project," "estimate," "anticipate," "plan" or "continue" and similar expressions. Forward-looking statements are based on the current plans and expectations of management and are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; shortage in drugs used in our Surgical Pain and Recovery products or other disruptions in our supply chain; the ongoing regional conflicts between Russia and Ukraine and in the Middle East; our ability to successfully execute on or achieve the expected benefits of our transformation initiative or our divestiture, acquisition or merger transactions; inflationary pressures; financial conditions affecting the banking system and the potential threats to the solvency of commercial banks; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the impact of investigative and legal proceedings and compliance risks; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; and changes in the competitive environment. The information contained herein speaks only as of the date of this release and we undertake no obligation to update forward-looking statements, except as may be required by the securities laws. Additional information concerning these and other factors that may impact future results is contained in our filings with the U.S. Securities and Exchange Commission, including our most recent Form 10-Q. SOURCE Avanos Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementExecutive Change

29 Oct 2024

·www.globenewswire.com

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

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

Radiation TherapyClinical Study

17 Oct 2024

·www.globenewswire.com

New Data Presented at ASTRO 2024 Further Demonstrate the Safety and Efficacy of Barrigel™ Rectal Spacer, the First and Only Sculptable Hyaluronic Acid Rectal Spacer, in Patients Undergoing Radiation Therapy for Prostate Cancer(1-3)

• 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

Radiation TherapyClinical ResultClinical StudyASCO

100 Deals associated with Sodium Hyaluronate

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KEGG	Wiki	ATC	Drug Bank
D03354	Sodium Hyaluronate	M09AX01 S01KA01 R01AX09	DBSALT001489

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Keratoplasty rejection	JP	AMO Japan KK	15 Feb 2018
Wounds and Injuries	KR	DONGIN PHARMACEUTICAL Co.,Ltd	28 Oct 2005
Corneal Injuries	CN	Santen Pharmaceutical (China) Co. Ltd.	01 Jan 2003
Cataract	JP	Seikagaku Corp.	18 Jan 1999
Osteoarthritis, Knee	CN	Shandong Bausch & Lomb Freda Pharmaceutical Co. Ltd.	01 Jan 1996
Periarthritis scapulohumeralis	CN	Shandong Bausch & Lomb Freda Pharmaceutical Co. Ltd.	01 Jan 1996
Stevens-Johnson Syndrome	JP	Santen Pharmaceutical Co., Ltd.	20 Jan 1995
Xerophthalmia	JP	Santen Pharmaceutical Co., Ltd.	20 Jan 1995
Bursitis	JP	Seikagaku Corp.	18 Dec 1989
Artificial Lens Implant Migration	JP	Seikagaku Corp.	29 Nov 1986

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Preclinical	JP	Tenri University	25 May 2011
Rheumatoid Arthritis	Preclinical	JP	Kyoto University	18 Jun 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04839692 (CTgov)	Phase 4	Lymphoid Interstitial Pneumonia	37	Hyaluronic acid filler (Young Females (21-30 Years Old))	wwpoamdmiw(smxblwvoeh) = ckwjwjwmtd pidjuucnap (ganluhoisv, hpqcppqhta - lytntphrpi) View more	-	28 Jul 2023
				Hyaluronic acid filler (Post Menopausal Females)	wwpoamdmiw(smxblwvoeh) = yviocesewk pidjuucnap (ganluhoisv, styswjnjiy - aofrqflehf) View more
WCD2023	Not Applicable	-	30	hyaluronic acid filler (Sharp needle injection technique)	lbkxtylszo(fsfielkgtx) = equally in both techniques ywnimykjwc (vsaicltgkj ) View more	-	05 Jul 2023
				hyaluronic acid filler (Blunt-tip microcannula injection technique)
ARVO2023	Not Applicable	Dry Eye Syndromes meibomian gland disfunction (MGD)	-	Sodium Hyaluronate plus Hydrocortisone Sodium Phosphate Eye drops	ufvwyugjbd(ztsemdfckd) = vffnlanxkp egloxgwyzb (xvlcsdlxix ) View more	Positive	23 Apr 2023
				Sodium Hyaluronate and Trehalose Eye drops	ufvwyugjbd(ztsemdfckd) = gtqazyigxg egloxgwyzb (xvlcsdlxix ) View more
AAD2023	Not Applicable	-	287	Hyaluronic Acid Filler HARES	yhoiiuegoq(wapgqiaiae) = bpldmfykwd ppfjcfuwak (myqnajjqvv )	Positive	17 Mar 2023
EADV2022	Not Applicable	-	-	sodium hyaluronate	fwbksjfpnv(fyahhlxusk) = puoriqxyob rnseeahwpl (bimoufwbrt ) View more	-	07 Sep 2022
				sodium hyaluronate	pxplbykhcc(dqorogxmug) = jxdduabyhs fxcweyurpz (afcncwzkqo ) View more
NCT02984228 (CTgov)	Phase 4	Osteoarthritis \| Shoulder Pain	70	PRP (Platelet-rich Plasma (PRP))	eetehhdcuk(dasyfvtvts) = joumcpbvmr zubgllwmbs (kbshlhiiuz, etpzkalsou - wvlahhyxui) View more	-	08 Aug 2022
				Ultrasound+hyaluronic acid (Hyaluronic Acid)	eetehhdcuk(dasyfvtvts) = wibqgerkmw zubgllwmbs (kbshlhiiuz, cjkfrxxcow - ndvagwlqrh) View more
ARVO2022	Not Applicable	Dry Eye Syndromes matrix metalloprotease 9 (MMP9)	12	Sodium Hyaluronate, Xanthan gum and osmoprotectants solution	qwhzolwgrv(ogzrzvaiph) = oxpdtstjlm vtkrcngpxz (moicdgobhg )	-	01 Jun 2022
SOYA STUDY (EULAR2021)	Not Applicable	Osteoarthritis, Knee	-	MPS-HA2%	dknpvfnilr(alivwmtvjk) = gpsvhoqmnq gfidyfpuof (omrwhrwukx )	Positive	02 Jun 2021
NCT04081610 (PRO-037, CTgov)	Phase 1	Dry Eye Syndromes	34	lagricel ofteno multidose (Lagricel® Ofteno Multidose)	vcfzhicygq(rluyidahcg) = rhvwwistik romxdjbrng (stbhmdvfxu, thicqvpiut - ajamydpduj) View more	-	03 May 2021
				lagricel ofteno single dose (Lagricel® Ofteno Single Dose)	vcfzhicygq(rluyidahcg) = qeziyjagok romxdjbrng (stbhmdvfxu, qfzpgehvfc - rlljatzlao) View more
NCT01895959 (CTgov)	Phase 4	Osteoarthritis, Knee	12	Euflexxa	pvpjoaiowq(pfirhjhoni) = jaobqypbfy wdxusvpzti (asadxxmgkt, mfoslqibpt - zptasojohd) View more	-	18 Nov 2020

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Sodium Hyaluronate

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