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CENTER VALLEY, Pa., March 19, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today it applauds the new Obesity Bill of Rights . Continue Reading Olympus applauds the newly launched Obesity Bill of Rights and will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. Olympus will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. The program, spearheaded in January 2024 in the U.S. by the National Consumers League (NCL), a nonprofit consumer advocacy group, in conjunction with the National Council on Aging (NCOA), establishes a set of rights to "assure screening, diagnosis, counseling and effective treatment based on medical treatment guidelines." This ongoing effort to gather support is expected to culminate in a fully implemented Bill of Rights by Dec. 31, 2029. The NCL and NCOA are working at the grassroots, employer, state and federal levels on this effort to ensure equal access to care for all obesity patients. NCL and NCOA worked with health leaders and obesity specialists to draft these Bill of Rights tenets that are intended to change the narrative, such that the healthcare industry more effectively sees obesity as a treatable chronic disease that can be treated with the same "respect, attention and medical care" as other chronic conditions. Statistics regarding obesity are staggering: 108M people in the U.S. are considered obese, only 10% of whom get help from medical professionals and only 2% of whom are treated with new medications. More than 230 conditions are worsened by obesity. Obesity is connected to $1.73 trillion in annual medical costs in the U.S. 400K premature deaths annually are linked to obesity.1 "Olympus provides equipment to the surgical community that helps in the treatment of obesity, and statistics show that not enough people have access to this type of treatment," said Paul Skodny, Executive Director for Health Economics and Market Access at Olympus Corporation. "It is our hope that awareness of treatment options and equitable access and insurance coverage will help address the detrimental health impacts of obesity." Bariatric Surgery as a Solution for Weight Loss Because of recent pharmaceuticals' entry into the market, such as semaglutide-based medications, obesity treatment has been receiving more attention. Surgical treatment which can complement medical management, has a lengthy track record, having been available to patients for decades with favorable long-term outcomes.2 Studies show patients typically lose the most weight one to two years after bariatric surgery and see substantial improvements in obesity-related conditions. Despite the growing number of obesity-related health problems, fewer than 2% of those eligible for bariatric surgery elect to have it.3 Given these statistics, Olympus, maker of technologies for performing minimally invasive bariatric procedures, sought to understand the awareness level and concerns of eligible patients in a survey conducted in 20194: Marginal Awareness around Benefits: A little more than 50% of respondents demonstrated only marginal awareness that bariatric surgery causes hormonal changes that improve weight loss by maintaining or enhancing energy expenditure.5 Worry about Gaining Weight Back: 20% of respondents were avoiding bariatric surgery because of concerns about surgery complications and gaining the weight back. Awareness around Insurance Opportunities: 56% of respondents were aware that insurance covers bariatric surgery in most qualified cases.6 Surgical benefits are real and should be known to more patients. Studies show that: Patients may lose as much as 60% of excess weight six months after surgery, and 77% of excess weight as early as 12 months after surgery. On average, five years after surgery, patients maintain 50% of their excess weight loss.1 The majority of bariatric surgery patients with diabetes, dyslipidemia, hypertension, and obstructive sleep apnea experience remission of these obesity-related diseases.1 Statistically, the risk of death during weight-loss surgery procedures is less than 1 percent. All abdominal operations carry the risks of bleeding, infection in the incision, thrombophlebitis of legs (blood clots), lung problems (pneumonia, pulmonary embolisms), strokes or heart attacks, anesthetic complications and blockage or obstruction of the intestine. These risks are greater in patients with severe obesity.7 To learn more about Olympus' state-of-the-art technologies for performing minimally invasive bariatric surgeries, visit the Bariatrics product page. About Olympus At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals striving to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit medical.olympusamerica.com. _______________________________ 1 Americans now have an Obesity Bill of Rights. NCLnet.org. . Published January 31, 2024. Accessed February 29, 2024. 2 Story of Obesity Surgery. asmbs.org. . Published 2023. Accessed February 29, 2024. 3 . February 27, 2020. Accessed February 29, 2024. 4 The Olympus-commissioned online survey was conducted mid-December 2019. 5 Public Education Committee. Benefits of Bariatric Surgery: ASMBS. American Society for Metabolic and Bariatric Surgery. . Accessed February 29, 2024. 6 Manning S. How to get your health insurer to pay for your weight-loss surgery. Insure.com. . Published September 24, 2020. Accessed February 29, 2024. 7 Available Procedures. Yale New Haven Health. . Accessed March 15, 2024. SOURCE Olympus Corporation of the Americas

The world's first non-surgical cervical HSIL treatment validated by an international Phase III clinical study with proven efficacy; The response rate increased by 89.4% compared to the placebo control group, with a low incidence of adverse events; The China new drug application submission is expected in Q2 2024, while ex-China product development is in active progress. SHANGHAI, March 18, 2024 /PRNewswire/ -- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases announced that the multicenter Phase III global clinical study data of its non-surgical treatment for cervical HSIL product APL-1702 demonstrated significant efficacy and good safety profile, with new advancements in clearance rate of high-risk HPV16 and/or HPV18. Key data from the study were presented in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting. APL-1702 is a pioneering cold light photodynamic drug-device combination product, used as a non-surgical therapy for treating cervical HSIL. This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Response is defined as the conversion of cervical epithelial tissue pathology to normal or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance. According to the study results, between November 2020 and July 2022, a total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. were randomized and enrolled in this study. The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to that in the placebo control group, indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%)[1]. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups[2]. According to the "Global Cancer Statistics 2020" report, there were 604,127 new cases of cervical cancer in women worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common cancer among women. Cervical cancer incidence ranks second among malignant tumors in Chinese women. According to the "National Cancer Report 2024" released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, with 55,700 deaths from cervical cancer. The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years[3]. According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase. Women with cervical precancerous lesions have unmet clinical needs for non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage. Furthermore, cervical precancerous lesions require long-term monitoring and management because even after surgical treatment, there is a risk of persistent disease or recurrence, with a higher risk of developing cervical cancer compared to the general population (5 times higher risk of invasive cancer within 10 years). Therefore, post-operative follow-up for at least 25 years is necessary. Importantly, if cervical precancerous lesions recur, subsequent surgical interventions become more challenging and carry higher risks, potentially resulting in total hysterectomy. Thus, early surgical intervention increases the difficulty of long-term management. Non-surgical therapies that preserve the intact cervix and avoid or delay cervical trauma are of significant importance for the long-term management of patients with cervical precancerous lesions. Professor Chen Fei, Chief Physician of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital, expressed her delight with the research findings, stating, "I am extremely pleased with the results of this study. Treating HSIL serves as the final barrier against cervical cancer. Previous international studies on HSIL have not been successful, but this study, utilizing a multicenter trial design and strict definition of efficacy endpoints, has achieved positive results, which is no easy feat. As a clinician, I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible." Professor Qiao Youlin, a member of the WHO Global Expert Group for Cervical Cancer Elimination and a professor at the School of Population Medicine and Public Health at the Chinese Academy of Medical Sciences/Peking Union Medical College, believes that in addition to vaccination and screening, treatment of cervical precancerous lesions is a crucial component of secondary prevention for cervical cancer. However, progress in the field of medication for cervical precancerous lesions has been relatively slow, with high barriers to overcome, and there are currently no approved treatment drugs worldwide. "It is gratifying to see the emergence of innovative products like APL-1702, which simultaneously possess clinical value in addressing the treatment gap, public health value in cervical cancer prevention and control, and social value in promoting fertility-friendly options. This breakthrough will safeguard women's health and make a positive contribution to the acceleration of the 2030 global and Chinese action plans for cervical cancer elimination". Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702. The study not only demonstrates remarkable efficacy but also exhibits a favorable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. We express our gratitude to all the patients, physicians, and researchers who participated in this study, as their support and dedication have been invaluable. We are actively preparing the new drug application for APL-1702 and plan to submit it in the second quarter of this year. Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible." References ： EUROGIN: Photodynamic therapy with APL-1702 for high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study (YHGT-CEV-1/APRICITY) SGO: APL-1702 long-term efficacy and safety for cervical histologic high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study Gao Shujun, Sui Long. Standardized management and follow-up of high-grade squamous intraepithelial lesions of the cervix[J]. Chinese Journal of Practical Gynecology and Obstetrics. 2020,36(07):604-608. About APL-1702(Cevira ® ) APL-1702(Cevira ®) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira ® holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira ® in July 2019. Cevira ® is a registered trademark of Photocure ASA, based in Oslo, Norway. About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally. SOURCE Asieris

Trial met the primary efficacy endpoint demonstrating non-inferiority of the incidence of acute kidney injury for INTERCEPT Red Blood Cells compared to conventional red blood cells CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury (AKI) following transfusion of study RBCs. AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery. In transfused subjects, by modified intent to treat (mITT pre-specified primary endpoint population) the incidence of AKI was 29.3% (46/157) for INTERCEPT RBC recipients compared to 28.0% (45/161) for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14.0% (p = 0.001). The safety endpoint of the proportion of patients with any related treatment-emergent adverse events (TEAEs) within 28 days of last transfusion was not significantly different for INTERCEPT RBCs (2.5%) compared to conventional RBCs (0.6%) (p = 0.130). There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs. The trial’s independent Data Safety and Monitoring Board (DSMB) evaluated these patients and was supportive of continued transfusion, having found no adverse health effects from trial transfusions. This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs. Cerus plans to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular premarket approval (PMA) submission. “We are extremely pleased by the positive topline results of the ReCePI clinical trial,” stated Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer and principal investigator for the ReCePI clinical trial. “The ReCePI clinical trial is a pioneering trial in the field of transfusion medicine, providing critical information about pathogen reduced INTERCEPT RBCs compared to conventional RBCs. We continue to look forward to completing the RedeS clinical trial, Cerus’ ongoing pivotal Phase 3 clinical trial for INTERCEPT RBCs enrolling a broader patient population requiring RBC transfusion for acute and chronic anemia.” “Today’s news from the ReCePI clinical trial is an important milestone for the INTERCEPT RBC program,” stated William “Obi” Greenman, Cerus’ president and chief executive officer. “We are now one meaningful step closer to potentially making pathogen reduction available for RBCs, the most commonly transfused blood component in the U.S., with approximately 11 million transfused units annually. If approved, pathogen reduced RBCs would complement our existing commercial portfolio of INTERCEPT Systems for Platelets, Plasma, and Fibrinogen Complex, providing clinicians and patients access to the benefits of pathogen inactivation across all transfused components. We are grateful to all the patients, blood centers, and physicians who participated in the ReCePI clinical trial.” Cerus anticipates initiating a modular PMA application to the U.S. Food and Drug Administration (FDA) in the second half of 2025, with the final PMA module submission planned for the second half of 2026, upon the anticipated completion of the RedeS clinical trial. Data from preclinical studies, manufacturing information, previously reported Phase 1 and Phase 2 clinical trials in the U.S., and the successfully completed Phase 3 clinical trials in the EU (STARS and SPARC) will be included in the modular PMA submission. Cerus expects the data from the ReCePI clinical trial to be presented at upcoming medical conferences as well as to be submitted for peer reviewed publication. Webcast The Company will host a webcast at 9:00 A.M. EDT this morning, during which management will discuss the results of the ReCePI clinical trial. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at A replay will be available on Cerus’ website approximately three hours after the call through April 2, 2024. ABOUT ReCePI The ReCePI Phase 3 clinical trial was a prospective, multicenter, randomized, double-blinded, controlled, non-inferiority design trial (ClinicalTrials.gov: NCT03459287) to evaluate the efficacy and safety of RBCs prepared with the INTERCEPT RBC System in patients requiring transfusion for acute blood loss during complex cardiac surgery. Adult subjects at high risk of need for RBC transfusion received either conventional (control) or INTERCEPT RBCs during and for 7 days after complex cardiovascular surgery (CVS), including thoracic aorta surgery. The primary efficacy endpoint was the proportion of transfused patients with acute kidney injury (AKI) defined by increased serum creatinine (≥0.3 mg/dL or 26.5 µmol/L) from pre-transfusion baseline, within 48 hours of surgery. Safety endpoints were defined as related TEAEs through 28 days after enrollment; or antibodies with confirmed specificity to INTERCEPT RBCs through 75 days after enrollment. The ReCePI trial enrolled and randomized a total of 581 patients across 18 clinical study sites. The mITT population included 321 patients requiring RBC transfusions in the trial. Not all enrolled patients required RBC transfusion. INTERCEPT RBCs used in the ReCePI trial were produced by several blood centers in the U.S. The development program of the INTERCEPT Red Blood Cell System has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number HHSO100201600009C. ABOUT THE INTERCEPT BLOOD SYSTEM FOR RED BLOOD CELLS The INTERCEPT Blood System for Red Blood Cells is designed to inactivate blood-borne pathogens and donor leukocytes in RBCs intended for transfusion. The RBC system is designed to prevent pathogen replication by using a small molecule compound added to RBC concentrates to form bonds within nucleic acids in pathogens and leukocytes that may be present in donated RBC collections. The nucleic acid targeted mechanism of action is designed to preserve the therapeutic qualities of the RBCs. RBCs, platelets, and plasma do not require nucleic acid replication for therapeutic efficacy. The RBC system is under development and is not yet approved anywhere in the world. Cerus has filed for a CE Mark for the RBC system under the Medical Device Regulation and anticipates initiating a modular PMA application submission to the FDA in the second half of 2025. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Forward Looking Statements Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to: the therapeutic and commercial potential of INTERCEPT RBCs, including Cerus potentially making pathogen reduction available for RBCs; Cerus’ planned modular premarket approval (PMA) submission and the anticipated timing thereof, including Cerus’ plan to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular PMA submission; the anticipated completion of the RedeS clinical trial and the anticipated timing thereof; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain and time-consuming development and regulatory process, including the risks that (a) the topline results reported herein and related findings and conclusions are subject to change following a more comprehensive review of the data from the ReCePI clinical trial, (b) Cerus’ planned modular PMA submission for INTERCEPT RBCs may be delayed or may not occur for a variety reasons, including those outside of the control of Cerus, (c) Cerus may be unable to report data from its RedeS clinical trial in a timely manner or at all and that even if reported, such data may not be supportive of Cerus’ planned modular PMA submission for INTERCEPT RBCs, (d) even if submitted, Cerus’ planned modular PMA submission for INTERCEPT RBCs may not be accepted by the FDA for review in a timely manner or at all or if accepted for review, may not be approved by the FDA in a timely manner or at all, (e) Cerus’ expectation that, if Cerus’ planned modular PMA submission for INTERCEPT RBCs is approved, the FDA would require a post marketing study, (f) Cerus may be unable to obtain CE Mark approval of INTERCEPT RBCs in a timely manner or at all, and (g) Cerus may otherwise be unable to obtain the requisite regulatory approvals to advance its pipeline programs and bring them to market in a timely manner or at all; risks related to product safety, including the occurrence of antibody reactivity to INTERCEPT RBCs; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus’ supply chain could be negatively impacted as a result of the evolving impact of macroeconomic developments, including the ongoing military conflicts in Ukraine and Israel, rising interest rates, inflation and the evolving effects of the COVID-19 pandemic, (b) Cerus’ manufacturers could be unable to comply with extensive FDA and foreign regulatory agency requirements, and (c) Cerus may be unable to maintain its supply agreements with its third party suppliers; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction is safe, effective and economical; risks associated with Cerus’ need for additional funding; risks associated with macroeconomic developments, including ongoing military conflicts in Ukraine and Israel and the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus’ business operations; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC March 5, 2024. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.