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Prop 56 Cuts: Patients Will Suffer from Lack of Access to Proper Dental and Oral Healthcare – Leading to Severe and Costly Chronic Health Problems

Prop 56 Cuts: Patients Will Suffer from Lack of Access to Proper Dental and Oral Healthcare – Leading to Severe and Costly Chronic Health Problems

Business Wire7 days ago

ORANGE, Calif.--(BUSINESS WIRE)--Western Dental, California's largest Medi-Cal dental provider, with 223 offices in 35 counties across the state, will be forced to close offices if the current proposal to cut Proposition 56 funding moves forward. The company is evaluating the extent of the expected closures, along with other measures to offset the significant impact to dental offices.
Proposition 56, a measure overwhelmingly passed by California voters in 2016, directed revenue from a new tobacco tax to increase access to care for individuals and families that qualify for Medi-Cal (California's version of Medicaid) dental services. Prop 56 has not only made it possible for California dentists to provide access and care to more patients but also allowed new providers to open their doors and create a more stabilized and equitable health care system throughout the state, including areas where dentists were previously in short supply for everyone.
'Medi-Cal dental has been significantly under-resourced for decades. Proposition 56 provided critical funding that helped Western Dental open more than 100 new offices across the state and serve millions of patients, many in underserved areas who were otherwise without access to care,' said Preet Takkar, Chief Executive Officer of Western Dental. 'The current budget proposal represents dramatic cuts to dental reimbursement rates, which would make it impossible to keep many of these new offices open, while also impacting additional practices statewide. This proposal would reignite the dental access crisis that existed before the passage of Prop 56 and would ultimately cost the state more in the long run. Unfortunately, dental practices like ours across California will have to make tough choices—reassessing staffing, hours, and office locations—if this funding is eliminated.'
Today, Western Dental employs more than 4,000 people in California, including more than 750 dentists and hygienists who provide more than 1 million Medi-Cal patient visits every year.
'Dental care is more than just getting your teeth cleaned. It's essential primary care for children and systemic care for adults,' said Dr. Peter Truong, Western Dental's Chief Dental Officer. 'If dental care is eliminated or reduced, patients suffer adverse health consequences, including tooth decay, gum disease, systemic health issues and social and economic impacts that are far more costly to treat. Eliminating access to dental care will have significant health consequences for millions of Californians.
'Western Dental will be forced to make hard decisions in the coming weeks and months, should Prop 56 funding be eliminated. Unfortunately, that will likely include closing as many as 50 offices, reducing staff in many offices and reducing the number of Medi-Cal dental patients each practice is able to treat. The choices made by the Governor and California State Legislature will have a direct and immediate impact on access to necessary health care and jobs lost should Prop 56 funding be redirected and removed from dental care' added Mr. Takkar.
About Western Dental
Western Dental has been serving California communities for over 100 years, with a strong commitment to delivering high-quality, affordable dental care. With over 200 locations across the state, Western Dental provides a full spectrum of services including general dentistry, orthodontics, and pediatric care — creating a convenient, comprehensive 'Dental Home' for families across California. As part of the Sonrava Health family of brands, Western Dental shares in the mission to expand access and drive innovation in dental care.

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HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors
HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors

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HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors

Pivotal Study Advances to Establish Histotripsy as a Non-Thermal, Surgery-Free Alternative to Destroy and Liquefy Kidney Tumors MINNEAPOLIS, June 06, 2025--(BUSINESS WIRE)--HistoSonics, Inc., the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, today announced the completion of patient enrollment in its pivotal #HOPE4KIDNEY trial. This prospective, multi-center, single-arm trial is designed to evaluate the safety and effectiveness of the Edison System in destroying kidney tissue by treating primary solid kidney tumors. The trial enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years post-procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments. The Edison System remains in investigational use for kidney applications and is not yet FDA-approved for this indication. Data from the #HOPE4KIDNEY trial is expected to support a future submission for regulatory clearance to expand the use of histotripsy to treat kidney tissue/tumors. The Edison System is the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumors without surgery, radiation, or systemic therapies. Unlike invasive surgical approaches, histotripsy does not require incisions and enables real-time imaging and treatment monitoring, allowing physicians to target and control tissue destruction while sparing surrounding structures. "Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications," said Mike Blue, President and CEO, HistoSonics. "Completing enrollment in our pivotal kidney tumor trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumor types and indications. This achievement reflects the dedication of our team and clinical partners and brings us closer to transforming the treatment of solid tumors without the need for surgery." Dr. William C. Huang, MD FACS, Professor and Vice Chair of Urology at the NYU Grossman School of Medicine serves as a principal investigator at the NYU Langone Medical Center, the top enrolling site in the trial. Dr. Huang commented, "Histotripsy offers a novel, completely non-invasive treatment paradigm for kidney tumors that precisely images and treats tumors while preserving surrounding critical structures thereby minimizing the morbidity associated with traditional surgical and thermal ablative techniques." Dr. Michael McDonald, Assistant Professor of Urology at the University of Central Florida College of Medicine and Urologic Surgeon at AdventHealth at Celebration Florida, serves as a principal investigator for one of the participating sites in the trial. Dr. McDonald commented, "HistoSonics represents a paradigm shift proving that the most profound treatments for both benign and malignant diseases need not be the most invasive. The ability to precisely target and destroy tumors without scalpel or scar is the next step in the evolution of non-surgical intervention." The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival). United States Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit: View source version on Contacts Media contacts:Josh KingVice President of 608.332.8124 Kimberly HaKKH Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)
Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

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Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

In the Phase 3 VISIONARY study, sibeprenlimab achieved a statistically significant and clinically meaningful 51.2% (P<0.0001) reduction in proteinuria at nine months of treatment when compared to placebo The safety profile of sibeprenlimab was favorable and consistent with previously reported data Immunoglobulin A nephropathy is a progressive, immune-mediated, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients under current optimized standard care Sibeprenlimab filed its Biologics License Application (BLA) and received Priority Review designation from the U.S. Food and Drug Administration (FDA) with a target action date of November 28th, 2025 PRINCETON, N.J. & TOKYO, June 06, 2025--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo1. The data were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data1. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group.1 Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo. Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March. Proteinuria reduction is a recognized surrogate marker correlating with delaying progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals2. Sibeprenlimab is an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. APRIL plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic Gd-IgA1 and immune complex formation3,4,5,6. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation7. Sibeprenlimab is administered in a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration or administration by caregiver, providing patients the option of convenience at home. "We are confident about the potential of sibeprenlimab and are grateful to the patients who are helping to further the science by participating in these important trials," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL has the potential to be an effective and safe approach for this progressive and irreversible kidney disease." The VISIONARY study continues in a blinded manner to evaluate the change in kidney function over 24 months as measured by estimated glomerular filtration rate (eGFR) and is expected to be completed in early 2026. Further prespecified and exploratory analyses of the data will be conducted to determine the full potential of sibeprenlimab for the treatment of IgAN1. "The VISIONARY Phase 3 interim analysis shows a robust proteinuria reduction of 51.2% in the group treated with sibeprenlimab relative to placebo. These results affirm our belief in the efficacy of sibeprenlimab in the largest Phase 3 IgAN trial to date. The study enrolled a diverse patient population reflective of the disease epidemiology," said Dr. Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. "The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab's safety profile from prior programs. This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN." About the VISIONARY Study The VISIONARY study is the largest IgAN trial to date, and is a multicenter, randomized, double-blind, placebo-controlled trial consisting of approximately 510 adult patients with IgAN who were receiving standard-of-care therapy (defined as maximally tolerated ACE inhibitor or ARB +/- SGLT2 inhibitor), designed to evaluate the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks, compared to placebo1. The primary efficacy endpoint is to evaluate the change in 24-hour uPCR at 9 months compared with baseline. The secondary endpoint is to evaluate the annualized slope of eGFR estimated over ~24 months1. About Sibeprenlimab Sibeprenlimab (formerly VIS649) was designed and engineered by Visterra, Inc., a wholly owned subsidiary of Otsuka. Pre-clinical and early-stage trials of sibeprenlimab were also conducted by Visterra. Sibeprenlimab is an investigational monoclonal antibody that selectively binds to and inhibits the activity of APRIL and plays a key role in the 4-hit process. By selectively binding and inhibiting APRIL, sibeprenlimab reduces the amount of immunoglobulin A (IgA) and Gd-IgA1 levels1. Lower levels of Gd-IgA1 in people with IgAN provide less substrate for immune complex formation7. Decreased immune complex formation should result in diminished deposition in the kidney, and reduced proteinuria and kidney inflammation8. By reducing the production of Gd-IgA1, sibeprenlimab may help slow kidney damage and progression toward ESKD3,4,5,6. By inhibiting APRIL, sibeprenlimab may help address one of the IgAN-specific drivers for nephron loss. About IgAN and APRIL IgAN is a progressive, immune-mediated, chronic kidney disease that typically manifests in adults aged 20-40 years and leads to ESKD over the lifetime of most patients9,10,11. IgAN is characterized by the accumulation of Gd-IgA1 complexes in the kidneys. IgAN can lead to progressive loss of kidney function and, eventually, ESKD, imposing a significant burden on patients10. Despite supportive care, there is an unmet need for treatments that address the root causes of the condition. Continued research in the disease remains crucial to uncovering opportunities for advancement in our understanding and treatment of patients 5. APRIL, a cytokine in the tumor necrosis factor (TNF) family, is integral to the pathogenesis and progression of IgAN. It promotes the survival and class switching of B cells to produce IgA, particularly the pathogenic galactose-deficient IgA1 (Gd-IgA1) that forms immune complexes in the kidneys5. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies' 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.'s global website is accessible at About Visterra Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit References Otsuka Pharmaceutical Development & Commercialization, Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Pointin Trials of IgA Nephropathy. Clin J Am Soc Nephrol. 2019;14(3): Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy ( Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 Gharavi, Ali G, et al. "Aberrant Iga1 Glycosylation Is Inherited in Familial and Sporadic IGA Nephropathy." Journal of the American Society of Nephrology : JASN, U.S. National Library of Medicine, May 2008, Kant, Sam, et al. "Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review - American Journal of Kidney Diseases." American Journal of Kidney Diseases, Apr. 2022, Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016 Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management of IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27. View source version on Contacts Contacts for Media Otsuka in the U.S. Robert MurphyCorporate CommunicationsOtsuka America Pharmaceutical, +1 609 249 7262 Otsuka in Japan Jeffrey GilbertLeader, Pharmaceutical PROtsuka Pharmaceutical Co., +81 3 6361 7379

Medicaid work rules' bureaucratic nightmare
Medicaid work rules' bureaucratic nightmare

Axios

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  • Axios

Medicaid work rules' bureaucratic nightmare

Republicans insist that Medicaid work requirements will weed out people who shouldn't be on the safety net program's rolls in the first place. The reality is that the red tape and bureaucratic hoops to jump through will have far broader effects, according to health policy experts. Why it matters: Coverage losses stemming from work rules will be a key focus in the Senate this month as lawmakers debate the sweeping GOP budget bill that contains the most significant changes to Medicaid in the program's history. What's inside: The bill, which passed the House in May, includes a new federal requirement for those ages 19 to 64 to work or participate in 80 hours of community engagement per month to keep their Medicaid coverage. The requirement was supposed to take effect in 2029, but the House Freedom Caucus insisted the timeline be moved up to Dec. 31, 2026 — which would generate around $50 billion more in savings per year. Senate Republicans, even the more moderate members, have expressed support for the work requirements, including moving up the timeline. The White House contends that 4.8 million able-bodied adults are choosing not to work and said this week that work requirements "will strengthen the system to better help those most in need of assistance." House GOP leadership this week also cited recent statistics from the American Enterprise Institute that state Medicaid recipients who don't report working say they spend 4.2 hours watching TV and playing video games (compared with 2.7 hours for recipients who work). State of play: Most able-bodied Medicaid recipients work full or part time. Some states have already imposed work requirements, resulting in thousands of people either losing their coverage or finding it very difficult to sign up. Arkansas implemented a work requirement in 2018 that lasted less than a year and left 18,000 fewer people covered, or about 25% of the eligible population, per KFF. A court eventually ruled the program violated Medicaid law. Work requirements began in Georgia as part of a Medicaid expansion in June 2023, and as of January, only 6,500 adults had enrolled — a fraction of the 25,000 the state expected would sign up in the first year, KFF says. New Hampshire also tried to launch work requirements but stopped after a month, after only 8,000 of the 25,000 people subject to the requirement had complied. The Congressional Budget Office this week estimated that 4.8 million people could become uninsured by 2034 due to the Medicaid work requirements measure in the reconciliation bill. How it works: States would have to build systems to track all of the enrollees and their work statuses, likely adding significant costs to their program budgets. Then, enrollees would have to contact states, which could be required as often as once a month, to show that they're working or participating in another eligible activity like caretaking. Enrollees would have to submit paperwork proving a disability, substance abuse disorder or other criteria to qualify for an exemption. One concern is that the envisioned system doesn't account for informal arrangements, such as whether a person is paid in cash for domestic work, seasonal jobs in agriculture or even being self-employed. It also assumes that covered people would be aware of the work requirements and would try to comply. What they're saying: "The experience in Arkansas was that the people who lost coverage because of the work requirements for the most part became uninsured," said Jennifer Tolbert, deputy director of the Medicaid program at KFF. "There was no increase in the share of those working." "In all of these states, we see time and again that the people hurt include workers who are supposed to be exempt, including people with disabilities who are supposed to be exempt," said Leonardo Cuello, a research professor at the Georgetown University Center for Children and Families. The bottom line: Work requirements don't appear to encourage people to work, and the large savings in the budget bill are likely to appear because of people losing their health coverage. "The argument is that this is about waste, fraud and abuse. That's not how this bill produces savings," said Ben Sommers, a health economist at Harvard who studies work requirements. "These are savings from kicking eligible people out of Medicaid who should have that coverage, who need it for their health care, because they can't navigate this big bureaucratic mess that the bill creates," he said.

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