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New federal legislation introduced to modernize communication technologies and services for people with disabilities.

Communication Service for the Deaf

Senator Edward J. Markey (D-Mass) and Representative Anna G. Eshoo (D-CA) introduced the Communications, Video, and Technology Accessibility Act (CVTA) on November 17, 2022. This bill will modernize the 21st Century Communications and Video Accessibility Act (CVAA), which was previously spearheaded by Senator Markey with bipartisan support in 2010. “Since I authored the 21 st Century Communications and Video Accessibility Act, technologies have changed. What hasn’t changed is our obligation to make sure that everyone – including people with disabilities – has equal access to the services and technologies they need to thrive,” said Senator Markey. “That is why I am introducing the Communications, Video, and Accessibility Technology Act, to update current laws on the books so that we can meet the technological moment and ensure opportunity, independence, and equal access for all.” CSD has provided leadership on the development of the new CVTA bill and will continue to provide support as the proposed legislation makes its way through Congress. Among its many improvements to the CVAA, the bill will update the definition of telecommunications relay services (TRS). A goal is to ensure that funding support is available for direct video calling (DVC), one of the services that CSD provides though its ASL Now program. This is a big step forward to modernizing current laws to ensure that effective telecommunication access is available for all. “Communication Service for the Deaf, the largest non-profit organization in the US devoted to serving Deaf communities, stands fully behind these amendments to the 21 st Century Communications and Video Accessibility Act (CVAA). The CVAA has gone a long way toward achieving communication equity and digital inclusivity, but must be made contemporaneous if its intended spirit is to be fully realized. The race to introduce new technologies often happens without the disability community’s participation, negatively impacting the quality-of-life for this population,” said Christopher Soukup, CEO, Communication Service for the Deaf. “The Video, Communications, and Technology Accessibility Act will ensure that no one is left behind, effectively close critical gaps in communication and video programming technologies that have occurred over the past 12 years, and enable all Americans with disabilities to benefit equally as new innovations are developed.” In addition to expanding telephone access under the TRS rules, the CTVA will direct the Federal Communications Commission’s to update its video programming accessibility obligations by requiring closed captioning on most online video programming; adopting rules that facilitate the ability of television viewers to activate, customize, and select preferred settings for closed captioning and audio description, and requiring audio description on most television and online programming. The CVTA also will push the FCC to ensure all new emerging telecommunications and video programming technologies are subject to appropriate accessibility regulations. Although the current session of Congress will adjourn at the end of this year, the CVTA is expected to be reintroduced in early 2023 after the next legislative session begins. Updates of the bill’s progress may be viewed here: https://www.congress.gov/bill/117th-congress/senate-bill/5121?s=1&r=3 About Communication Service for the Deaf Communication Service for the Deaf (CSD) is the world's largest Deaf-led social impact organization. For more than four decades, CSD has been a leader in creating and providing accessible and innovative solutions for the Deaf community. Today, CSD continues its work to create opportunities for personal and economic growth within the Deaf community, explicitly addressing leadership and employment. For more information, please visit CSD and follow us on Facebook, Twitter, Instagram, and LinkedIn. About ASL Now Since 2017, ASL Now powered by Connect Direct has been the leading provider of innovative call center solutions for communicating directly with Deaf customers in American Sign Language. Offering cutting-edge customer service through ASL Now decreases customer frustration and opens the door to a new market of loyal clients. This expertise provides an invaluable, time-saving solution for businesses, customers, and representatives. To learn more, visit ASL Now and follow us on Facebook and LinkedIn. Contact Details Communication Service for the Deaf Alyssa +1 518-569-1841 adrown@csd.org Company Website https://www.csd.org/

December 09, 2022 02:57 PM Eastern Standard Time

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United Network for Organ Sharing Seeks Better Air Transportation for Lifesaving Organs

United Network for Organ Sharing

United Network for Organ Sharing (UNOS), the non-profit that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government, is seeking to systematically improve nationwide transportation for donated organs. In a letter sent today to U.S. Department of Transportation (DOT) Secretary Pete Buttigieg, UNOS leadership requested a meeting with the DOT as well as the Health Resources and Services Administration (HRSA), the Federal Aviation Administration (FAA) and the Transportation Security Administration (TSA) to discuss potential solutions for increasing efficiency for commercial air transportation of organs for transplant. The letter was authored by UNOS’ Interim CEO Dr. Maureen McBride, UNOS Board President Dr. Jerry McCauley, Vice President/President-Elect Dr. Dianne LaPointe Rudow, and Past President Dr. Matt Cooper. “Practical, logistical, and regulatory obstacles to the safe and efficient delivery of donor organs should be identified, remedied, and monitored,” wrote McBride, McCauley, Rudow and Cooper. “We believe you, the FAA and TSA could provide valuable assistance on how to increase the efficiency of commercial air transportation of organs for transplant.” During an OPTN Board of Directors meeting on Monday, December 5, Dr. McBride called for stakeholders across the donation and transplant community to help expand upon ongoing improvements to the national system, which included prioritizing potential solutions for safer and more efficient organ transportation. “Today we’re going to have a collaborative conversation about how the community can answer the public’s call for assurances that these precious gifts of life are delivered safely and efficiently to their destination,” said Dr. McBride to the OPTN board on Monday. “We’re going to ask all of you to prioritize potential solutions for how the OPTN can fix these problems. That includes advocating as a community for federal level solutions.” Also copied on the letter were HRSA Administrator Carole Johnson, FAA Acting Administrator Billy Nolen, Department of Homeland Security Secretary Alejandro Mayorkas and TSA Administrator David P. Pekoske. A copy of the full letter can be found here. About UNOS United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and are obligated to follow the policies the OPTN creates for allocating organs. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

December 08, 2022 03:10 PM Eastern Standard Time

Austin-Webcor JV Team Delivers World’s 1st WELL Core Certified Airport Terminal at San Francisco International Airport (SFO)

Austin Commercial & Webcor Joint Venture

San Francisco International Airport’s (SFO) Harvey Milk Terminal 1 Boarding Area B (BAB) is officially the world’s first WELL Core Certified airport terminal, exceeding the wellness-focused designation’s requirements with the highest available rating—WELL Certified Platinum. WELL Certification is administered by the International WELL Building Institute (IWBI ), the world’s leading organization focused on deploying people-first places to advance a global culture of health. “This exceptional accomplishment reflects the entire design-build team’s steadfast commitment, in collaboration with SFO, to delivering a space that uniquely prioritizes occupant health and well-being,” says Webcor Project Director, Design Wayne Campbell. The project’s design-build team includes the Austin Commercial & Webcor Joint Venture, along with HKS / Woods Bagot ED2 International / KYA. This momentous achievement closely follows Terminal 1 BAB’s Leadership in Energy and Environmental Design (LEED) BD+C v4 Platinum certification, which recently made headlines for becoming the world’s first airport terminal to achieve LEED BD+C v4 Platinum. These groundbreaking sustainability certifications are the culmination of years of tireless efforts made by the design-build team to meet both standards’ rigorous requirements. Setting a New Standard for Sustainable Airports While the LEED rating system examines whole building design, the WELL Building Standard focuses and expands on a space’s indoor environmental quality. According to the WELL Certification website, WELL represents “an investment in the world’s most valuable asset—people,” and was founded on the principles of being equitable, global, evidence-based, technically robust, customer-focused, and resilient. Being the first of its kind, Harvey Milk Terminal 1 BAB has become the foundation of WELL v2 ’ s current standards for airports and embraces the WELL Standard’s 10 concepts: air, water, nourishment, light, movement, thermal comfort, sound, materials, mind, and community. For this program, the air and materials concepts were rigorously integrated into the coordination of Terminal 1 BAB’s design and were weighted particularly heavily during the terminal’s on-site WELL performance evaluation. As outlined in SFO’s recent press release, highlights of the health and well-being measures incorporated into the terminal include: Highly efficient outdoor air filtration system to remove pollutants and odor to provide healthier indoor environments that meet WELL’s enhanced indoor air quality requirements as verified through third-party testing. Radiant heating and cooling to complement displacement ventilation to provide energy efficiency, improved indoor air quality, and enhanced passenger comfort. Online data provided by SFO that shows annual water quality test results, including enhanced taste properties. Dynamic glazed windows that change with the sun’s location to reduce glare and improve comfort. Large windows that harness daylight to reduce the need for electric lighting and to support occupants’ circadian rhythms. Building materials and furnishings with minimal human health impact based on Health Product Declarations (HPDs) and with low volatile organic compound emissions and content to support improved indoor environmental and air quality. Selection of products, systems, and materials with the least environmental or planetary impact based upon Environmental Product Declarations (EPDs). Green cleaning processes that support occupant and employee health during construction and after occupancy. Acoustic management through sound reducing surfaces, quieter mechanical systems, and the Airport’s ‘quiet airport’ program. “Unlike LEED, WELL primarily focuses on a building’s impact to the human experience (mind, nourishment, and community), which distinguishes it from the ‘traditional’ sustainability standard,” says Webcor Assistant Design Manager April Chang, who led the JV’s WELL Certification efforts. “Successful certification required third-party performance verification testing of water, light, and sound.” A Unique Partner in SFO From the beginning, SFO envisioned Harvey Milk Terminal 1 as a low-energy, low-carbon, LEED Gold-certified (at a minimum) building—a vision that eventually evolved into an even more innovative goal to reach Zero Net Energy readiness. “SFO’s Zero Energy and Resilient Outcomes (ZERO) Committee guided, supported, and collaborated with the project team to exceed LEED Gold certification standards through additional funding to support the additional Zero Net Energy and building health measures that were proposed after the original building program was completed,” says Austin Commercial Project Manager Kent DeRusha. “These measures enhanced energy efficiency and carbon emissions reductions and promoted improved human health in the built environment.” “The WELL Standard wasn’t originally designed for an airport setting,” Chang says. “Earning WELL Platinum Certification for this type of large-scale, 24/7 operation with multiple stakeholders was only possible because we had the support of SFO’s ZERO committee. SFO’s formation of a distinct committee, allocation of funds dedicated to achieving the terminal’s ambitious sustainability goals, and premium on improved human health in this airport terminal facility were key to our success. “It’s also worth noting that WELL is complementary to LEED certification; we didn’t have to modify the design to achieve WELL,” she continues. "The design-build team and ZERO committee had gone above and beyond to develop a design that outperformed LEED Platinum standards from the beginning.” "SFO's commitment to social responsibility and sustainability aligns with our mission to use research-proven strategies to positively impact occupant well-being for every project," says Allison Smith, Sustainable Design Leader at HKS, who also served on IWBI's Airport Advisory in 2020 and was the WELL Project Administrator for Terminal 1 BAB. "The process of pursuing and becoming the first to achieve this certification allowed our collective teams to better understand how to apply this people-focused standard to highly complex transportation projects and ultimately have a positive impact on the health and well-being of staff, tenants, and the traveling public." “We are honored to be the first airport in the world to achieve full WELL Certification,” says Airport Director Ivar C. Satero. “Harvey Milk Terminal 1 was designed with both our passengers and employees in mind… as a place to be relaxed, a place to be healthy, and a place to be inspired by the legacy of pioneering civil rights leader Harvey Milk. My sincere thanks go out to the entire project team for setting the new standard for how airport facilities can truly benefit the people who use them.” Ivar C. Satero, Airport Director, SFO and Dr. Matt Trowbridge, Chief Medical Officer, International WELL Building Institute accept the WELL Platinum Certification plaque for SFO Harvey Milk Terminal 1 BAB. Photo provided courtesy of Webcor SFO Harvey Milk Terminal 1 Boarding Area B (Credit: Kevin Meynell Photography) About Webcor Webcor is a premier provider of commercial construction services, known for its innovative and efficient approach, wide range of experience, cost effective design-build methodology, skill in concrete construction and expertise in building landmark projects. Webcor's mission is to build structures of superior quality with integrity, continuously improve its processes by employing the best talent in the industry and add social and economic value to its communities. Founded in 1971 and repeatedly honored as one of the Best Places to Work, Top California Contractors, Largest Bay Area General Contractors, Top Green Contractors, and Top Design-Build Contractors, Webcor has offices throughout the state in San Francisco, Alameda, San Jose, Los Angeles, and San Diego. More information is available on the Webcor website and on LinkedIn, Facebook, Twitter, and Instagram. About Austin Austin Industries is one of the nation’s largest, most diversified construction companies. With more than 7,000 employee-owners, Austin Industries provides civil, commercial, and industrial construction services through the expertise of its operating companies: Austin Bridge & Road, Austin Commercial, and Austin Industrial. Austin Commercial is nationally recognized for delivering exceptional safety performance, innovative construction solutions, world-class diversity-inclusion program, and innovative construction solutions across several markets, including aviation, corporate/office, healthcare, hospitality, mixed-use/retail/residential, semiconductor and fabrication plants, sports/public assembly/themed entertainment, and university/education. Learn more at www.austin-ind.com. Contact Details Shel Holtz, Webcor Sr. Communications Director +1 510-517-3845 sholtz@webcor.com

December 08, 2022 09:00 AM Pacific Standard Time

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Empower Clinics and Specialty Network of North America to bring services to underserved communities

Empower Clinics Inc.

Contact Details Proactive Investors Canada Proactive Studio +1 604-688-8158 na-editorial@proactiveinvestors.com Company Website https://www.proactiveinvestors.ca/

December 08, 2022 08:44 AM Pacific Standard Time

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Chinese Lockdown Effects Ripple Marketwide; A Solution Urgently Needed

Sunshine Biopharma Inc.

Read the latest report on Sunshine Biopharma here. Protests have mounted in intensity across China in the past weeks, as more and more citizens become frustrated with the country’s radical “Zero-Covid” policies. This was part of the cause for the markets having a rocky opening last week, with Tesla, Inc. (NASDAQ: TSLA) and Apple, Inc. (NASDAQ: AAPL) stock falling and a widespread drop in the oil sector in response to the continuing instability. This uncertainty is a reminder that, even as some describe living with the virus as a ‘new normal,’ complacency toward Covid carries risks. Clearly, there is a need for more effective solutions. Sunshine Biopharma, Inc. (NASDAQ: SBFM) is a Canada-based pharmaceutical company combating COVID-19 through the development of SBFM-PL4, an antiviral treatment. It believes this drug, which it anticipates could be taken in tablet form from home, could be the kill shot for COVID and could help finally put an end to the pandemic. Partnering With The University of Arizona University For Covid Research A fully integrated pharmaceutical company, Sunshine Biopharma specializes in the research and development (R&D) of oncological and antiviral treatments and has multiple ongoing development projects, including SBFM-PL4. The strong team at Sunshine recently started a collaboration with the University of Arizona. Led by Dr. Gregory Thatcher, the collaboration will continue research into SBFM-PL4, and involve testing PLpro inhibitors to see how the drug reacts with the immune system. While companies like Pfizer (NYSE: PFE), Eli Lilly and Co. (NYSE: LLY), and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) have developed treatments for COVID, concerns around these drugs range from their limited efficacy to questions around their safety and drug resistance. Meanwhile, Sunshine’s drug targets nsp3 protease, the enzyme which suppresses the patient’s immune system and allows the Covid virions to effect maximal damage. As an nsp3 protease inhibitor, SBFM-PL4 doesn’t merely weaken the virus, like other treatments, but also supports overall health by allowing the patient’s immune system to fight back. The company is confident that, in a Covid-19 vaccine market worth $13.6 billion, its drug candidate could provide a welcome solution. “It is urgent that effective treatments and more specific vaccines be developed at an accelerated pace,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma. “We are delighted to be working with Dr. Gregory Thatcher, who is aiming to find a wide array of inhibitors for PLpro (also called nsp3), as this virus-encoded protease is responsible for the suppression of the human immune system.” Along with this important collaboration, Sunshine Biopharma can reflect proudly on a year that saw the company report growth in its financial position and a recent acquisition that may help the company enter the generic prescription drug market and become profitable. It is also developing a drug – Adva-27a – which it believes will be successful in treating various forms of multidrug-resistant cancer. In addition, the company is developing a vaccine-like mRNA treatment for cancer. Want to learn more about Sunshine Biopharma? Visit its website. In addition to working with the University of Arizona on the development of a treatment for COVID-19, Sunshine Biopharma is engaged in the development Adva-27a, a unique anticancer compound. Tests conducted to date have demonstrated the effectiveness of Adva-27a at destroying Multidrug Resistant Cancer Cells, including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells, and Uterine Sarcoma cells. Clinical trials for Pancreatic Cancer indication are planned to be conducted at McGill University’s Jewish General Hospital in Montreal, Canada. Sunshine Biopharma is also engaged in the development of a novel anticancer mRNA called K1.1. The data collected to date have shown that K1.1 mRNA is capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Studies using non-transformed (normal) human cells (HMEC) have shown that K1.1 mRNA had little or no cytotoxic effects. K1.1 mRNA is readily adaptable for delivery into patients using the proven mRNA vaccine technology. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Christine Petraglia - TraDigital IR +1 917-633-8980 investors@sunshinebiopharma.com Company Website https://sunshinebiopharma.com/

December 08, 2022 09:25 AM Eastern Standard Time

AmeriLife’s Agent Support Group Announces New Leadership & Company Name

AmeriLife

Agent Support Group (ASG), one of the oldest and most established life insurance brokerages in the U.S. and an affiliate of AmeriLife Group, LLC (“AmeriLife”), today announced the elevation of Jay Scheiner to CEO of the firm and principal with AmeriLife. Scheiner succeeds Sam Kaufman, who recently announced his retirement after leading Agent Support Group through 50 years of growth and innovation. Scheiner will take over day-to day operations while focusing on its core business of providing advanced case design and underwriting support for life insurance, long-term care and annuities. “Our core mission at ASG is to provide concierge-level service to life insurance agents, financial advisors, and professionals in other insurance disciplines, helping them develop and expand the life insurance area of their practice,” said Scheiner. “I look forward to continuing ASG’s strong legacy and accelerating our growth as an integral part of the AmeriLife team.” In a related decision, ASG Partner Gary Bleetstein also announced his retirement after 16 years with the firm and more than 45 years of success in key roles in the insurance industry. With Bleetstein’s retirement, ASG’s Mark Milbrod will assume the role of vice president and continue to assist ASG in providing unrivaled service to its client partners. Scheiner takes the reigns of ASG at a pivotal moment for both the business and its brand, as it re-introduces itself to the insurance market under the name ASG, An AmeriLife Company. The firm’s new name and logo reflect its legacy as one of the longest-serving life brokerages in the New York metropolitan area and its deep, long-held connection with AmeriLife, while also repositioning it as a forward-looking firm that supports the modern financial advisor. “Jay and Mark are the right leaders for the moment, and we look forward to working closely with them as they usher ASG into a new and exciting era,” added Mike Vietri, AmeriLife’s Chief Distribution Officer. “We’re also incredibly grateful for the leadership and contributions of both Sam and Gary over the many years, and wish them well in retirement.” ### About ASG, An AmeriLife Company Founded in 1973, ASG (formerly known as Agent Support Group) provides insurance services for professional advisors, including advanced case design for estate and business planning life insurance, impaired risk underwriting, and point of sale assistance for life, annuity, disability and long-term care insurance. ASG, which has its principal offices in New York City and Manhasset, N.Y., is a member of LIBRA Insurance Partners, assuring direct access to top-rated carriers and underwriting. For more information, visit ASGLife.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 300,000 insurance agents and advisors and more than 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado +1 321-297-1112 jmaldonado@amerilife.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/

December 08, 2022 09:00 AM Eastern Standard Time

MGC Pharmaceuticals delivers its largest-ever order

MGC Pharmaceuticals Ltd

Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

December 08, 2022 08:46 AM Eastern Standard Time

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AiViva Says Its AIV001 Shows Potential Promise To Treat Post-Surgical Incisional Scarring And Keloids

AiViva BioPharma

Interested in investing in AiViva’s campaign? Click here to get started! Scarring can have negative physical, aesthetic, and psychological effects if left untreated. A growing awareness of treatment options and technological advancements has given its treatment industry adoption a boost. Scars result from injuries, surgeries, illness, burns and acne. Scars form on your skin or inside your body when one heals an injury or trauma. Our body’s wound healing process can cause the overproduction of collagen, a protein found in the dermis or second layer of the skin, resulting in raised lumpy scarring or keloids. Keloids tend to grow larger over time and in some cases, reappear after treatment. A scar never completely goes away. When it comes to scarring, where it occurs matters. A wound in an area that moves, like your elbow and knee, is more likely to scar. A scar on the face would be harder to heal because one’s face is constantly exposed to the environment. The Growing Market For Scar and Keloid Treatments The keloid and scar treatment market is burgeoning. One reason for this could be an increasing number of accidents, surgeries, and other injuries around the world each year. The combined hypertrophic and keloid scar treatment global market was valued at $6.34 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 8.47% from 2022 to 2030. Companies like Sanoma Pharmaceuticals (NASDAQ: SNOA) are partnering with e-commerce sites like Amazon.com Inc. (NASDAQ: AMZN) to provide hypertrophic and keloid scar treatment products in the U.S. Partnerships like this are also expected to drive the retail pharmacy segment. There are reportedly no approved drugs on the market for the prevention of scars following surgery. The appearance of scar may be improved by laser therapy, steroid injections, or silicon sheets. Dermatologists and plastic surgeons may surgically remove a scar to restore function of a body part that may have been restricted by the scar. Keloid scars are difficult to get rid of and tend to return after treatment in a majority of cases. Current treatments for keloids include steroidal injections at the scar site, cryosurgery (freezing), keloidectomy (surgical removal), pressure dressings, silicone sheeting and gels and radiation. While each of these treatment options by themselves, or when combined with others, could help by treating and improving physical appearance and skin sensitivity issues such as itch and pain, a scar never goes away. How AiViva’s AIV001 Treatment Could Address Scar Formation AIV001 is a compound that could address the negative impacts of scarring. AIV001 has been found to be effective in modulating inflammation and scarring of the skin as well as reducing neovascularization (cell proliferation) associated with some cancers, according to AiViva. The company says it has seen positive signals from its phase I clinical trial of AIV001 for incision-based dermal scarring and wound healing. Trial results showed that AIV001 was safe and well tolerated in the local intradermal treatment of incisional wounds and reduced fibrosis through only a single dose with no systemic side effects observed in humans. These results suggest that the intradermal AIV001 treatment could potentially have significant clinical utility by modulating the aberrant scarring associated with fibrosis during the wound-healing process. “Scarring has been a significant issue that can cause debilitating aesthetic, functional and psychological effects. There are no (Food and Drug Administration) FDA-approved therapeutics for the treatment of post-operative scars, therefore, AIV001 has the potential to be a transformative treatment in this space,” AiViva CEO Diane Tang-Liu said. About AiViva Biopharma: AiViva Biopharma, is a clinical stage biotech company founded in 2015 by four pharmaceutical industry veterans with more than 300 years of combined industry experience. AiViva's founders have demonstrated a successful track record across the full spectrum of drug development and commercialization, in addition to raising capital, and IPOs on the NYSE and NASDAQ.AiViva was formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs. The company has raised over $30 million in capital so far, including over $10 million raised in 2022. AiViva was rated as a top 20 clinical-stage biopharma company by Life Sciences Review in 2022. Interested in investing in AiViva? Click here. If you would like to learn more about AiViva, check out its website. AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ. The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. Benzinga may receive monetary compensation from the issuer, or its agency, for publicizing the offering of the issuer’s securities. This content is for informational purposes only and is not intended to be investing advice. This is a paid ad. Please see 17(b) disclosure linked in the campaign page for more information. Contact Details Michael office@aiviva.com Company Website https://aiviva.com/

December 08, 2022 08:00 AM Eastern Standard Time

Planned Government Move To Expand Access To Drugs For End-Stage Renal Disease Patients Could Shine The Spotlight On Unicycive

Unicycive Therapeautics, Inc.

In the U.S., reimbursement of dialysis expenses by the Centers for Medicare & Medicaid Services (CMS) is done using a prospective payment system (PPS) which enables the payout of a predetermined amount to providers of dialysis services. In October, the CMS published its “Final Rule” updating payment rates and policies for the PPS for end-stage renal disease (ESRD), for the calendar year 2023. The ESRD PPS, often referred to as “the bundle”, is the government-funded program that pays for renal dialysis services and certain prescription drugs for patients with late-stage chronic kidney disease (CKD). A category of drugs called phosphate binders that dialysis patients need to be able to control a severe complication of their disease known as hyperphosphatemia is currently not covered under the ESRD PPS. Therefore, dialysis patients currently resort to sourcing their phosphate binders through prescription drug plans run by for-profit insurance companies, a process which is fraught with challenges due to these branded prescriptions being more expensive and difficult to access. In the 2023 Final Rule, the CMS commented on its intention to include phosphate binders in the bundle, stating that the addition of phosphate binders would “mitigate the risk of potential access issues for minority populations, which include African-American/Black, Asian, Hispanic, and Other non-white populations, promote health equity for patients that lack Medicare Part D coverage or have coverage less generous than the Part D standard benefit, and contribute to better clinical outcomes by leveling the playing field for all patients with ESRD”. This change is slated to be implemented in 2025 through the TDAPA (transitional drug add-on payment adjustment) –- a direct government payment program that takes the reimbursement process out of the hands of private insurance companies. During a minimum 2-year TDAPA period starting in 2025, CMS will evaluate the additional cost of adding phosphate binders into the PPS “bundle” and then make the change permanent. CMS’s goal in this planned change to phosphate binder reimbursement is to “result in better drug therapy management for the ESRD beneficiary, and to improve their access to these medications”. This development could be great news for Unicycive Therapeutics Inc. (NASDAQ: UNCY). The company is developing what they believe to be a best-in-class phosphate binder they hope to get approved by the FDA in 2024. The company is developing an investigational new drug called Renazorb TM (lanthanum dioxycarbonate that binds and eliminates phosphate in the gastrointestinal tract. Renazorb utilizes a proprietary nanoparticle technology being developed by Unicycive for the treatment of hyperphosphatemia in CKD patients on dialysis. Unicycive says that it has completed a clinical trial studying Renazorb in 32 healthy volunteers with encouraging results – as per the study Renazorb was minimally absorbed into the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. Renazorb was found to significantly reduce urine phosphate excretion and significantly increase fecal phosphate excretion at doses at and above 3000 mg/day. The company says that Renazorb offers potential advantages over the most commonly used phosphate binder – Renvela – because it dramatically reduces the number and size of pills that patients are required to take. Many people suffering from CKD are weighed down by a high pill burden due to their various other comorbidities that require taking multiple pills. This leads to patients neglecting to take their medication because they are overwhelmed by the number and size of the pills they must take. Unicycle says that the efficiency and smaller size of Renazorb pills could reduce the pill burden for these patients by 3 to 4 fold. Renazorb also has an added convenience for patients since it is swallowed with water instead of having to be chewed. Renazorb is protected by patents in the U.S. and other countries outside the U.S. including Canada, Europe, Japan, China, and Australia, with validity until 2031. “Gaining early patient access and reimbursement for newly launched branded drugs can be a challenge” stated Doug Jermasek, Executive Vice President at Unicycive. “For-profit insurance plans often restrict access to new drugs or impose very high patient copays. Beginning in 2025, and coinciding with the expected launch of our promising new medicine, these barriers will be removed for patients and their healthcare providers. We are excited by the potential to launch RENAZORB into this new environment of expanded patient access.” Unicycive is also developing a drug for the treatment of acute kidney injury – namely UNI 494 – for which the company is filing to begin Phase 1 human trials. Other companies developing drugs for the treatment of CKD include Ardelyx Inc. (NASDAQ: ARDX), Akebia Therapeutics Inc. (NASDAQ: AKBA), and Cara Therapeutics. ( NASDAQ: CARA). To learn more about Unicycive visit its website. Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Anne Marie Fields - Stern Investor Relations +1 212-362-1200 annemarie.fields@sternir.com Company Website https://unicycive.com/