The University of Arkansas

Several healthcare IT vendors have unveiled new offerings that help health systems improve patient access, address provider burdens and drive cost optimization over the past week. Oracle Health said Monday that it wants to help tame provider administrative challenges by replacing manual processes with cloud-based automated claims processing, while Luma Health on Tuesday released machine learning and natural language processing enhancements to transform workflows. Also this past week, athenahealth said it aims to improve holistic care delivery with new behavioral health integration in its cloud-based electronic health records. And Clarify Health hopes to foster greater transparency and build trust by offering direct access to performance measures and predictive analytics that span cost, quality and utilization. Oracle leverages FHIR Oracle said the general availability of automated data exchange between healthcare providers and payers will change the way authorizations are handled. "Healthcare has long been plagued by costly, time-intensive and antiquated claims processing that results in billions of unnecessary fees each year, and ultimately a strained relationship between providers and payers," Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said in a statement. About 70% of authorizations are handled by phone or fax, with payers and providers sharing about 25% of documents related to reimbursement, Oracle said. The new clinical data exchange platform could help tame the burden of administrative tasks and move providers and payers away from these manual processes by sending medical records through a secure, centralized network. It also helps providers streamline payer data request responses and ease the staff burdens, according to Kent Hoyos, vice president and chief information officer at Pomona Valley Hospital Medical Center. Providers select what data to make accessible to their payer partners in the platform and can audit selected clinical data with chosen payers to confirm exactly which data was received, according to Oracle. Payers retrieve clinical data via FHIR queries or bulk processing in an industry-standard format with no additional point-to-point connections required. Faster payer responses and claims reimbursements could also hasten the speed of patient care. "Automating the process will help speed approval of necessary patient clinical services as well as payment processing and shorten the wait time for our patients to receive the care they need," Hoyos said in a statement. Luma automates with genAI San Francisco-based Luma Health announced two new artificial intelligence products for its patient success platform on Tuesday. The multi-model generative AI named Spark can be used to address common operational challenges for health systems, including high call volume and manual fax processing. "Our vision is to use this latest groundbreaking technology to solve persistent challenges on a massive scale, and now the technology is equipped to help us deliver a next-generation patient experience," Aditya Bansod, Luma's co-founder and chief technical officer, said in a statement. "Health systems are doing more than ever to serve their patients with fewer staff and resources, and they don't have time to waste on AI solutions that offer shallow EHR integration or create more overhead," Luma's co-founder and CEO Adnan Iqbal added. "That's why we focused Spark on the most common challenges we hear from health systems: high call volume, backlogged referrals, lost revenue and not enough staff to handle it all manually." Woven into the company's patient success platform, Spark has bi-directional integration with leading EHRs, including Oracle Health, Epic, eClinicalWorks, Meditech, athenahealth, NextGen and Greenway Health, Luma said. The first two Spark-enabled tools automate fax processing – Luma's Fax Transform – and provide a patient-facing voice AI concierge – Luma's Navigator. Provider staff can use Luma's Fax Transform to automatically parse structured data from faxes including referrals, prescription refills and more, to verify information then the referral is automatically created in a health system's EHR. DENT Neurologic Institute said it is experiencing three times faster fax processing and 70% time savings on fax workflows with the new tool. "We receive a lot of faxes – over 500 per day across the organization – and it's just impossible to keep up with manually," Emily Smythe, the institute's manager of quality and analytics, said in a statement. "Processing a single fax can take up to five minutes. Fax Transform automates it completely, so it takes 10 seconds or less to file a fax." The University of Arkansas for Medical Sciences adopted Luma's AI concierge and within one month saved 98 manual call center staff hours, automated 95% of phone call responses, processed 1,200 cancellations without any human interaction and more, according to the announcement. "The team was spending three hours daily just listening to patient voicemails and then going in and canceling appointments," Michelle Winfield-Hanrahan, RN, UAMS' chief clinical access officer and associate vice chancellor for access, said in a statement. "Our outcomes have been very positive, and really exceeded what I expected." Athenahealth integrates behavioral health To enable personalized care, EHR company athenahealth has launched athenaOne for Behavioral Health. The suite includes treatment plans, group therapy capabilities, tailorable session documentation, a privacy toolkit, patient engagement tools and more, athena announced last week. "Behavioral health providers strive to provide comprehensive, meaningful care but are often faced with a perfect storm of challenges that can get in the way of delivering care that achieves desired health outcomes," Chad Dodd, the company's vice president of product management, said in a statement. The new certified platform also includes mental health practice and revenue cycle management tools with workflows and embedded services for coordinated care. By integrating behavioral health and primary care into one solution that supports various care models, including outpatient behavioral health practices, intensive outpatient programs and partial hospitalization programs, providers can access relevant patient data from across the healthcare ecosystem in a single view. Patients can also self-schedule appointments and communicate with providers and staff on the new platform. Clarify launches AI for performance control Because traditional analytics fall short of delivering actionable intelligence that optimizes provider networks and manages costs effectively, Clarify Health said it is leveraging its Clara IQ artificial intelligence to empower health plans to drive value. "Our industry continues to struggle with delivering more effective care for each dollar spent," Todd Gottula, the company's founder and president, said in a statement. "We've invested significantly in developing fully integrated measures and benchmarks. This enables health plans to understand provider performance, utilization patterns, referrals and clinical populations at a granular level." The new Performance IQ Suite, powered by the Clarify Atlas Platform, offers direct access to performance measures and detailed analytics and also enables providers to understand how they are evaluated. Health plans can use the insights to optimize provider performance, assess competitive networks, redirect referrals to high-performing specialists based on comprehensive cost and quality metrics, reduce unnecessary spending and more, Clarify said. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS Media publication.

– Statistically significant vocal biomarker speech latency data reinforce the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia – – Additional vocal biomarker data from ongoing open label extension study evaluating brilaroxazine in schizophrenia expected Q4 2024 – CUPERTINO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announces new vocal biomarker data from Phase 3 RECOVER trial of brilaroxazine in schizophrenia was presented during a virtual key opinion leader event hosted by the Company on September 4, 2024 featuring Brian Kirkpatrick, MD, MSPH (Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences, Arkansas) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute, New York). A replay of the event can be found at https://revivapharma.com/events/. “Brilaroxazine has demonstrated a safety profile comparable to placebo, with broad spectrum efficacy across the major symptom domains of schizophrenia, including negative symptoms,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “These new vocal biomarker data provide an objective tool that further supports the primary and secondary endpoints evaluated in the RECOVER trial. We look forward to further evaluating vocal biomarker data from patients in our ongoing open label extension study with topline data expected in the fourth quarter of the year.” Dr. Brian Kirkpatrick, Professor, Psychiatric Research Institute, University of Arkansas for Medical Sciences added, “The results using this objective, automated vocal biomarker confirms robust treatment effects on total, positive, and negative symptoms, social function, disorganization and overall efficacy following treatment with brilaroxazine. These findings are consistent with previous assessments and add to the clinical data supporting a strong treatment effect across domains with brilaroxazine.” Key highlights of the vocal biomarker data include: Speech latency is an emerging objective vocal biomarker that can help validate scale-based assessments completed by human ratersBrilaroxazine demonstrated a strong efficacy for negative symptoms and other key symptoms of schizophrenia such as total and positive symptoms, disorganization, and social functioning in the pivotal phase 3 RECOVER trial in schizophreniaStatistically significant results of the vocal biomarker speech latency data analysis from the RECOVER trial further support the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia Dr. Mark Opler, Chief Research Officer at WCG Inc. and Executive Director of the PANSS Institute, New York added, “Current marketed therapies do not address critical aspects of schizophrenia such as negative symptoms and cognition. In addition to suboptimal efficacy, the poor tolerability of current antipsychotics also contributes to low treatment adherence and high discontinuation rates across patients. The consistent, widespread efficacy of brilaroxazine across multiple domains, coupled with the very strong efficacy-to-side-effect ratio, supports the potential of brilaroxazine to significantly address unmet needs in the treatment of schizophrenia.” About BrilaroxazineBrilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in the pathophysiology of several conditions including schizophrenia, psoriasis and interstitial lung diseases like pulmonary hypertension, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). Positive topline data from the global Phase 3 RECOVER trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains including reduction in key proinflammatory cytokines implicated in the pathophysiology of schizophrenia and comorbid inflammatory conditions at week 4 with 50 mg of brilaroxazine vs. placebo, with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitors. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications. About Reviva Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Corporate Contact:Reviva Pharmaceuticals Holdings, Inc.Laxminarayan Bhat, PhDwww.revivapharma.com Investor Relations Contact:LifeSci Advisors, LLCBruce Macklebmackle@lifesciadvisors.com

- Second annual DREAMS Grant Program awards $25,000 each to three U.S.-based non-profit organizations working to achieve greater equality for those living with Duchenne - - Announced in celebration of World Duchenne Awareness Day, grants are designed to fund efforts advancing diversity, equity, inclusion and accessibility within the Duchenne community - BOSTON, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets long considered inaccessible. The Company today announced the recipients of its second annual Entrada Diversity, Representation, Equity and Advocacy MatterS (DREAMS) Grant Program. Entrada DREAMS grant recipients – CureDuchenne, The Little Hercules Foundation (LHF) and Walking Strong – will each be awarded $25,000 to support programs working to embrace diversity, equity, inclusion and accessibility (DEIA) while uplifting members of the Duchenne community who are currently underrepresented or underserved. “We’re thrilled to announce the 2024 recipients of the second annual DREAMS Grant Program in conjunction with World Duchenne Awareness Day. This year’s World Duchenne Awareness Day theme, ‘raise your voice for Duchenne,’ emphasizes the importance of amplifying voices to advocate for the rights, inclusion and well-being of people living with Duchenne. At Entrada, we believe in the power of lived experience and are guided by the voices of our community, with our DREAMS Grant Program serving as an important example,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “The efforts of these organizations to expand access to care, education and resources are inspiring, and the Entrada team is honored to expand their reach across the whole Duchenne community.” Entrada DREAMS Grant Recipients CureDuchenne is a global leader in research, patient care and innovation for improving and extending the lives of those with Duchenne muscular dystrophy. The DREAMS grant will support The CureDuchenne International Outreach Program, which enhances global awareness and training on Duchenne through virtual and in-person conferences across various countries that may have limited access to education, healthcare and resources. The grant will play a key role in enabling the program to expand efforts to diagnose, treat and support individuals affected by Duchenne in Nepal, Uganda and China and other countries throughout 2024-2025. The Little Hercules Foundation (LHF) is committed to ensuring that people living with rare diseases get access to treatments and care they need. The LHF team works with families across the Duchenne community to navigate the complexities of the US healthcare system. The DREAMS grant will enable the LHF to grow their individualized case management services for members of the Duchenne community and subsidize the cost of translation services when supporting families whose first language is not English.Walking Strong seeks to empower individuals affected by Duchenne and their families by providing comprehensive support, funding cutting-edge scientific research and building a strong and compassionate community. Walking Strong’s programs are available to all Duchenne families and provide services such as free one-on-one mental wellness and life coaching, access to mobility and assistive devices, and canine support animals. The DREAMS grant will enable Walking Strong to expand the reach of these services to more families. Entrada expresses our gratitude to the esteemed review committee of neuromuscular specialists and patient advocates who selected the Entrada DREAMS grant recipients in the second year of the annual program, including: Sean Baumstark, Founder, de:terminence and Co-Host, Two Disabled Dudes PodcastKeisha Greaves, Founder and Chief Executive Officer, Girls Chronically RockAmaris Sánchez-Larragoity, PsyD, PsychologistAravindhan Veerapandiyan, MD (Dr. Panda), Associate Professor of Pediatrics, University of Arkansas for Medical Sciences, Director of Comprehensive Neuromuscular Program, Arkansas Children’s Hospital “This year’s DREAMS Grant Program recipients are empowering the Duchenne community to demand a care system that prioritizes and delivers on diversity, equity, inclusion and accessibility. While there is always more work to be done, these organizations are making critical progress in combating disparity and improving outcomes for all patients living with Duchenne,” said Dr. Panda. “It’s been an honor to serve on this year’s review committee alongside a true powerhouse group of experts.” About Entrada DREAMS Grant ProgramEntrada DREAMS is a competitive grants program designed to fund efforts within the Duchenne muscular dystrophy community to better identify, understand and reach those who are currently underrepresented and underserved. Applicants are encouraged to demonstrate collaboration with minority-led or local community organizations to overcome barriers that limit the delivery of health education and support for individuals and families. The annual program was launched in 2023 and it awards three grants of $25,000 each to U.S.-based non-profit organizations. Project proposals are reviewed, scored and ranked by an independent committee comprised of neuromuscular specialists and patient advocates with expertise in Duchenne, DEIA (diversity, equity, inclusivity and accessibility), social impact and health. About Entrada Therapeutics Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn. Investor and Media ContactCaileigh Dougherty Head of Investor Relations & Corporate Communicationscdougherty@entradatx.comPatient Advocacy ContactSarah FriedhoffHead of Patient AdvocacyPatientAdvocacy@entradatx.com