Woebot Health Names Timothy Mariano Vice President and Medical Director

Woebot Health Names Timothy Mariano Vice President and Medical Director




Woebot Health Names Timothy Mariano Vice President and Medical Director

Dr. Mariano’s multidimensional experience to advance company’s medical, clinical and regulatory research

SAN FRANCISCO–(BUSINESS WIRE)–Woebot Health announced today that it has appointed Timothy Mariano, MD, PhD, MSc, as vice president and medical director. In the newly created position, Dr. Mariano will provide medical, clinical and regulatory leadership for the company’s growing pipeline of prescription digital therapeutics that are designed to scale to fill gaps in care and engage people to improve their mental health outcomes. Reporting to Chief Commercial and Strategy Officer Monique Levy, Dr. Mariano will also advance scientific partnerships and be a core member of the company’s Scientific Advisory Board.


“A practicing psychiatrist with extensive training and experience in engineering, psychology and drug development, Dr. Mariano brings an outstanding combination of skills to Woebot Health at just the right moment,” said Levy. “Developing efficacious digital therapeutics that are truly responsive and related requires working at the frontier of AI, conversational UX, science and regulatory strategy at the same time. We’re poised to make mental health accessible to all, and Dr. Mariano’s addition to the team will help to ensure that we take the fastest, most effective path there,” Levy added.

Before joining Woebot Health, Dr. Mariano was medical director at Sage Therapeutics, where he led the clinical development, medical monitoring and regulatory strategy for several early and late-stage studies, including the SHORELINE Study, a large clinical trial that is following patients with major depressive disorder (MDD) and evaluating the safety and tolerability of the company’s Zuranolone investigational medication. Prior to joining Sage Therapeutics, Dr. Mariano was an assistant psychiatrist at Brigham and Women’s Hospital and an instructor at Harvard Medical School. He was also a consultant to Ad Scientiam, a developer of digital patient monitoring solutions, and to Janssen Pharmaceuticals for its esketamine program for depression. Before starting his consulting work, Dr. Mariano completed his research-track residency training in psychiatry at Brown University’s Warren Alpert Medical School.

“The pandemic era has made it clear that more novel and engaging digital tools are needed to help people access mental health care in their moment of need,” Dr. Mariano said. “Woebot Health is at the forefront of a new age of engaging and effective digital therapeutics. It’s a very exciting time to be joining such a dynamic company.”

A licensed psychiatrist, Dr. Mariano will continue his practice at the Providence VA Medical Center in Rhode Island, his research affiliation at the Center for Neurorestoration and Neurotechnology (CfNN), and his academic position as Adjunct Assistant Professor of Biology and Human Behavior at Brown University.

Dr. Mariano holds a Bachelor of Science degree in biomedical engineering from Harvard College; completed his medical training and a PhD in biomedical engineering at Case Western Reserve University; and holds a Master of Science degree in experimental psychology from the University of Oxford. A prolific researcher with dozens of articles published in peer-reviewed publications, Dr. Mariano’s scholarly interests have focused on noninvasive brain stimulation for neuropsychiatric disorders and, more recently, novel teletherapy approaches utilizing mobile technology to reduce pain-related disability and mood symptoms.

About Woebot Health

Woebot Health’s mission is to make mental health radically accessible. Our breakthrough technology is engineered to engage, bringing the art and science of effective therapy together in a portfolio of targeted digital therapeutics and behavioral health products that scale to fill gaps in care and motivate people to take care of their mental health for a lifetime. Headquartered in San Francisco, Woebot Health is funded in part by venture capital firms New Enterprise Associates (NEA), Jazz Venture Partners L.P., and Social Discovery Ventures, with participation from Andrew Ng’s AI Fund. For more information, please visit woebothealth.com or follow Woebot on Facebook, Twitter and LinkedIn.

Contacts

Margot Carlson Delogne

Woebot Health

(781) 492-1039

margot@woebothealth.com

RxSense Partners With National Healthcare Solutions to Provide Modern Enterprise Solutions for Pharmacy Benefits

RxSense Partners With National Healthcare Solutions to Provide Modern Enterprise Solutions for Pharmacy Benefits




RxSense Partners With National Healthcare Solutions to Provide Modern Enterprise Solutions for Pharmacy Benefits

New Pharmacy Benefits Management Subsidiary VerusRx to Leverage RxSense’s Industry-Leading RxAgile Enterprise Platform and RxIQ Analytics

BOSTON–(BUSINESS WIRE)–RxSense®, the healthcare technology company improving transparency and access to affordable medications, today announced a new partnership to provide its transformative RxAgile enterprise solutions for pharmacy benefits to VerusRx, the newly launched pharmacy benefit management subsidiary of National Healthcare Solutions, Inc. (NHSI).

Dallas-based VerusRx was created for self-funded companies, TPAs and brokers to bring sensible drug pricing and significant savings to its end users. RxSense is delivering VerusRx a private label version of its customizable enterprise platform that provides flexibility to manage a wide variety of plan designs and control for unparalleled efficiency and cost-savings. RxSense will provide the pharmacy network and power claims processing through RxAgile, as well as its RxIQ analytics platform, with user-friendly dashboards offering deeper plan insights, to easily sort and evaluate data by categories, including claim type, pharmacy or geography.

VerusRx has also launched a prescription discount card, powered by RxSense’s direct-to-consumer prescription savings service SingleCare. This will allow members who have limits on their employer funded benefits to use the discount program to save money on out of pocket expenses, and up to 80% on their medications.

VerusRx brings a strong value proposition to the middle-market, and our missions are aligned to deliver greater transparency and cost-savings through modern pharmacy benefits,” said Rick Bates, founder and CEO of RxSense. “Our customizable RxAgile platform uniquely provides flexibility and in-depth business insights for VerusRx to efficiently manage a wide variety of clients and their pharmacy needs.”

We needed to find a state-of-the-art claims processing system that delivers real-time analytics to help manage our clients’ day-to-day pharmacy benefit,” said Greg Greenlee, D.Ph., COO and EVP of NHSI’s new Pharmaceutical Division. “The powerful tools provided by RxSense will help our clients efficiently manage their pharmacy benefits and provide the insights for cost-efficiencies that will help them optimize plan performance.”

The RxAgile Difference

With an elegant architecture and simple to use interface, RxAgile provides clients with a variety of customizable solutions to meet their business needs, eliminate resource waste, and bring care to patients more efficiently.

Businesses that may have needed months to set up pharmacy benefits on legacy systems can now do so in days or weeks on RxAgile. The breakthrough platform delivers unprecedented transparency on plan performance, and an expected 30 percent increase in operational efficiency to clients.

The RxSense Story

RxSense was founded in 2015 with a singular focus on developing technology solutions that improve healthcare transparency and access to more affordable medications. Founder and CEO Rick Bates brought a seasoned group of healthcare veterans familiar with the challenges of the industry and paired them with a savvy tech team to develop a sophisticated architecture to address the pain points of pharmacy benefits administration. The result was RxAgile, a cutting-edge cloud-based platform that’s smart and simple to use, offering the speed and flexibility to meet the needs of any client.

RxSense was named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2020.

About RxSense

RxSense® is a healthcare technology company developing industry-leading solutions that improve transparency and access to more affordable medications for millions across America. RxSense’s transformative RxAgile enterprise solutions bring transparency, flexibility and efficiency to pharmacy benefit administration, serving pharmacy benefit managers, regional health plans, health systems, third party administrators, new healthcare and pharmacy entrants and healthcare technology companies. RxSense is headquartered in Boston with offices in New York City, greater Philadelphia and West Palm Beach, Fla. For more information, visit rxsense.com. RxSense was named among Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2020.

ABOUT NHSI

National Healthcare Solutions, Inc. is the single source solution for all medical cost containment, case management, third party administration and PPO needs, whether in the U.S. or abroad. NHSI is independently owned and part of an international healthcare group with more than 30 years of experience in the healthcare management industry.

Complete information about VerusRx, the new Pharmacy Benefit Management company, is available at www.verus-rx.com.

Contacts

Abigail Jaffe

Moxie Communications Group

Rxsense@moxiegrouppr.com

Novel SARS CoV-2 Saliva Collection Devices Address COVID-19 Testing Challenges, Improving Lab Efficiency and PCR Test Performance

Novel SARS CoV-2 Saliva Collection Devices Address COVID-19 Testing Challenges, Improving Lab Efficiency and PCR Test Performance




Novel SARS CoV-2 Saliva Collection Devices Address COVID-19 Testing Challenges, Improving Lab Efficiency and PCR Test Performance

GenTegra Announces Validation of Two New Saliva SARS-CoV-2 Sample Collection Products to Facilitate Expansion of COVID-19 Testing

PLEASANTON, Calif.–(BUSINESS WIRE)–#GenTegraGenTegra, LLC, a Pleasanton, California-based company, announced today a study on the development and characterization of two novel COVID-19 saliva sample collection tube devices. The publication is posted on medRxiv, the pre-print server for health sciences. https://www.medrxiv.org/content/10.1101/2021.01.20.20243782v1

The GenTegra GTR-STM™ and direct-into-PCR GenTegra GTR-STMdk™ saliva sample collection tubes are the only devices that eliminate dilution of virus levels in saliva samples, while providing a safe and convenient means to transport saliva samples at ambient conditions. The dried transport media formulation in both of these devices incorporates the company’s Active Chemical Protection™ (ACP) technology to provide substantial improvements in SARS-CoV-2 viral RNA stability, and RT-PCR process efficiency for COVID-19 saliva testing. Direct-into-PCR, GTR-STMdk eliminates the need for expensive and time consuming RNA extraction, improving the turnaround time for reporting test results. The two novel products are available to CLIA certified laboratories and IVD assay kit manufacturers pursuant to regulatory approvals in their respective US FDA Emergency User Authorization (EUA) protocols.

“By creating a dry transport media formulation of our proven ACP technology, we have eliminated many of the risks and error prone steps involved with current COVID-19 saliva collection products,” said GenTegra President Bob Barrett. “Most importantly, eliminating the addition of a liquid sample stabilizer may improve low copy number detection, and may address some of the concerns of potential false negatives due to sample dilution. This may be especially true when testing asymptomatic populations where viral load in saliva may be low and when multiple samples are pooled for greater testing efficiency,” added Barrett.

The company’s ACP technology incorporates a proprietary combination of small molecule inhibitors, antioxidants, metal chelators, and anti-microbials to provide total protection for SARS-CoV-2 virus and viral RNA at ambient temperatures. Proprietary ACP chemistry reduces saliva viscosity, inactivates contaminating RNases, and bacteria, and facilitates sterilization of samples at 95C making the sample safe for lab personnel and testing. ACP chemistry is guanidinium free making it compatible with lab automation and self-sterilizing PCR instrumentation.

About GenTegra

GenTegra’s mission is to improve the quality of biological research and medical care by protecting sample integrity. GenTegra is committed to providing solutions for maintaining the pristine quality of biological specimens. The decisions made from the analysis of such specimens, whether it be viral samples from an emerging infectious disease, RNAseq samples shipped around the globe, or whole blood from patient-directed sampling devices, is only as good as the stability and quality of the sample.

Contacts

Bob Barrett

President, GenTegra LLC

bobb@gentegra.com
https://gentegra.com/

Talkdesk announces Small Business Lending Solution and Talkdesk Vaccine Administration Solution to support COVID-19 relief and recovery

Talkdesk announces Small Business Lending Solution and Talkdesk Vaccine Administration Solution to support COVID-19 relief and recovery




Talkdesk announces Small Business Lending Solution and Talkdesk Vaccine Administration Solution to support COVID-19 relief and recovery

Talkdesk Small Business Lending Solution and Talkdesk Vaccine Administration Solution now available for fast Small Business Association loan processing and global vaccine support 

  • Talkdesk enables financial institutions to offer a better borrower experience for small businesses seeking PPP loans
  • Talkdesk offers health care providers a better way to communicate with patients seeking COVID-19 vaccines
  • Talkdesk cloud solutions increase the speed of deployment for financial institutions and health care providers to quickly reduce friction in the COVID-19 relief process

SAN FRANCISCO–(BUSINESS WIRE)–#COVID19Talkdesk®, Inc., the cloud contact center for innovative enterprises, today announced new solutions to address two significant challenges brought on by the coronavirus pandemic; Paycheck Protection Program (PPP) loan distribution and similar small business relief programs worldwide, and the global administration of COVID-19 vaccines. To facilitate the rapid and accurate allocation of PPP loans to the small businesses who need it most, and streamline the vaccination process worldwide, Talkdesk introduces its Small Business Lending Solution and its Vaccine Administration Solution, respectively.

A restart of the economy and return to a level of pre-COVID normalcy faces two considerable obstacles: ensuring the rapid dissemination of emergency capital to struggling businesses and efficient vaccine distribution to a vulnerable population. Despite the urgency, current customer service processes are often inadequate to successfully execute critical programs of this logistical magnitude. The first round of PPP loans in 2020 was beset by delays and errors while the current vaccine rollout has been slower than expected with some patients waiting on hold for hours to make an appointment. The administration of such widespread programs involve a high level of complex coordination across multiple stakeholders. Active engagement and follow-up between institutions — lenders and borrowers, health care providers and patients — is crucial to success. New technological solutions are needed to help the economic recovery with loans for struggling small businesses and to ensure the vaccine is delivered and administered efficiently.

“Small businesses are the lifeblood of the U.S. economy, driving innovation and competitiveness. Large financial institutions, community banks and even fintechs have the opportunity to rescue small businesses and save the economy through PPP loan distribution,” said Tiago Paiva, chief executive officer, Talkdesk. “At the same time, health care providers have the opportunity to protect and save lives with the critical administration of the COVID vaccine. Talkdesk aims to support both of these vital efforts through the Small Business Lending Solution and Vaccine Administration Solution, with rapid deployment options available immediately.”

Talkdesk is helping financial institutions re-imagine the borrower experience by reducing friction in the PPP loan distribution process. The Talkdesk Small Business Lending Solution is an end-to-end customer experience solution that streamlines the administration of PPP loans by banks, community development financial institutions (CDFIS), credit unions and small business lenders. With secure and robust customer experience solutions from Talkdesk, loan application and distribution processes are more synchronized and efficient through improved borrower engagement. The Talkdesk Small Business Lending Solution enables lenders to quickly stand up secure and dedicated contact centers in order to fast track the PPP loan application, approval and distribution process.

“Our experience applying for and receiving a PPP loan last year was frustrating due to process delays including long hold times and slow responses from the support centers,” said Scott Case, co-founder and chief executive officer, Upside Business Travel. “Talkdesk’s announcement of its Small Business Lending Solution is exactly what lender contact centers need to quickly and efficiently handle PPP loan applications and distribute funds where they are needed most.”

The process of administering the COVID-19 vaccine is a monumental global task that requires proactive outreach and patient engagement at multiple levels in order to ensure efficient, safe and successful outcomes. Vaccine administration adds new challenges for health care providers including outreach and education, increased call volumes, appointment management and ensuring completion rates. The Talkdesk Vaccine Administration Solution is an end-to-end solution for expediting the administration of the COVID-19 vaccine by providers. Flexible cloud solutions from Talkdesk are re-imagining the patient experience by reducing friction in the vaccine administration process for health care providers and increasing patient access through easy, seamless and convenient patient communication. Talkdesk is making its Vaccine Administration Solution free for six months to provider organizations and retail pharmacies administering the vaccine, with deployment available in as little as 24 hours.

“At Krucial Staffing, we depend on our call center to handle inbound requests for staffing needs including urgent deployment of medical professionals for emergencies such as natural disasters and other crises. The COVID-19 pandemic created a massive demand for Krucial Staffing health care professionals, up to one million calls a day, which drove our need for a rapidly scalable solution to meet our skyrocketing call volumes,” said Brian Cleary, chief executive officer, Krucial Staffing. “Thanks to our quick-thinking, fast-moving and well-informed advisers at PlanetOne we connected with Talkdesk. After a brief phone call and live, online demonstration, we made the decision to move to Talkdesk — if the solution could be implemented fast. Talkdesk completed its implementation and go-live of more than 350 seats within three days, flawlessly.”

With Talkdesk Small Business Lending Solution and Talkdesk Vaccine Administration Solution, financial institutions and health care organizations have the ability to simplify the management of these complex interactions in a highly efficient manner. Leveraging best practices and delivering seamless customer experiences will positively impact business outcomes through the COVID crisis and extend well into the new normal.

Additional Resources:

Tweet this: Small Business Lending Solution and Vaccine Administration Solution now available from @Talkdesk for fast SBA loan processing and global vaccine support. #PPP #COVID19 https://bit.ly/36b4tc8

Social Networks:

About Talkdesk

Talkdesk® is the cloud contact center for innovative enterprises. Combining enterprise performance with consumer simplicity, Talkdesk easily adapts to the evolving needs of support and sales teams and their end-customers, resulting in higher customer satisfaction, productivity and cost savings. Over 1,800 innovative companies around the world, including IBM, Acxiom, 2U, Trivago and YMCA rely on Talkdesk to make customer experience their competitive advantage. Learn more and request a demo at www.talkdesk.com.

Talkdesk is a registered trademark of Talkdesk, Inc. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.

Contacts

Gavin Gustafson

gavin.gustafson@talkdesk.com
(801) 560-0073

Allego Delivers Smarter Virtual Selling and Enablement for Finance, Pharmaceutical and Manufacturing Industry Leaders

Allego Delivers Smarter Virtual Selling and Enablement for Finance, Pharmaceutical and Manufacturing Industry Leaders




Allego Delivers Smarter Virtual Selling and Enablement for Finance, Pharmaceutical and Manufacturing Industry Leaders

Forward-thinking brands like Fannie Mae, Recordati Rare Diseases and Johnson Health Tech select Allego for personalized, agile learning in a virtual environment

NEEDHAM, Mass.–(BUSINESS WIRE)–#salesAllego, the leader in sales learning and enablement solutions, today announced Fannie Mae, Johnson Health Tech and Recordati Rare Diseases as new customers. Each brand is a leader in its respective industry, and the breadth of verticals proves, regardless of the business, personalized and agile sales training and enablement is necessary for continued growth and success.

“Virtual selling is here to stay and we’re proud to be in a position to help our customers manage collaboration, content and learning in a whole new way while their teams can’t be together physically,” said Yuchun Lee, CEO and Co-Founder of Allego. “Innovative companies like Fannie Mae, Johnson Health Tech and Recordati Rare Diseases understand the importance of modern sales learning and enablement strategies and we’re excited to work with them to help their sales organizations personalize learning paths for their reps, share content and best practices more easily, and improve remote coaching to improve sellers’ success.”

Eric Zines, Forrester Principal Analyst, Sales Enablement, in a blog states, “Throughout the pandemic, B2B sales teams have leaned heavily on sales enablement to keep sellers in front of buyers, and this reliance will continue well into the new year.” Indicative, in Allego’s opinion, of why blue chip brands have partnered with Allego: the pandemic has served as an inflection point and the remote environment will continue to be the standard, rather than the exception.

When evaluating other vendors, these businesses chose Allego due to its ability to:

  • Expedite onboarding and continued learning processes with on-demand learning assets and material. Recordati Rare Diseases saw the benefit of podcast-style content and exercises that engage team members while enabling certifications that ensure company-wide accuracy and compliance.
  • Ensure company-wide best practices are understood and accurately distributed in real-time, with instant access via mobile devices or desktop. Fannie Mae selected Allego after recognizing the impact of a “just-in-time” training philosophy that provides reps with relevant content and insights at the moment of need, rather than quarterly training sessions that require additional time and travel.
  • Provide access to the best content at the moment of need to enable strong client conversations. With Johnson Health Tech’s previous solution, the sales team wasn’t able to efficiently access material like frequently asked questions and content hubs. With Allego, the most impactful and relevant assets, including best practices from top-performing peers, are readily available at the moment of need.

“Prior to using Allego, it became clear we needed to modernize our sales enablement strategy. With a newly formed enablement team on board and the team all working remote due to the pandemic, we knew we needed to make an investment in improving our sales learning and enablement technology,” said Josh Zimmer, director of Sales Enablement for Fannie Mae. “We chose Allego because of the complete enablement approach that begins at the moment of onboarding, all the way to our most seasoned reps. Our company may be working from different parts of the country, but we’re building stronger, more connected teams that are prepared for virtual selling in 2021 and beyond.”

To see how Allego can prepare your sales team for virtual selling in 2021 or to schedule a demo, visit Allego.com

About Allego, Inc.

Allego’s learning and enablement platform ensures that employees have the skills, timely knowledge, and supporting materials to accelerate team success. Instead of traditional onboarding and training marathons—which are rapidly outdated and quickly forgotten—enablement and training teams use Allego to deliver the fresh, bite-sized learning that employees need to close deals in today’s dynamic business environment. Content is personalized and mastered through reinforcement, on-the-job coaching, and peer collaboration. Nearly 500,000 professionals use Allego to onboard faster, deliver consistent messaging, quickly find critical sales content, rapidly adopt best practices, coach and practice more frequently, and collaborate more effectively. To learn more about Allego and learning and enablement in the flow of work, please visit https://www.allego.com.

Contacts

Allison Rynak

617-645-0314

arynak@allego.com

BLASTmedia for Allego

Jake Doll

317-806-1900 ext. 122

allego@blastmedia.com

CareView Communications, Inc. Executes Hospital Agreement with Jefferson Hospital

CareView Communications, Inc. Executes Hospital Agreement with Jefferson Hospital




CareView Communications, Inc. Executes Hospital Agreement with Jefferson Hospital

LEWISVILLE, Texas–(BUSINESS WIRE)–CareView Communications, Inc. (“CareView” or the “Company”) (OTCQB: CRVW), an information technology provider to the healthcare industry, today announced the execution of a hospital agreement with Jefferson Hospital in Louisville, Georgia, a public, non-for-profit hospital providing primary medical and surgical care to Louisville and surrounding communities since 1974. Jefferson Hospital and its three primary care facilities located in Louisville, Wadley and Wrens, Georgia, are devoted to family oriented primary care.

The three-year agreement with Jefferson Hospital was executed pursuant to the Company’s new revenue model following the expansion and modernization of its platform, which includes a variety of camera solutions specifically designed to address clinical needs in general safety, applications for use in ICUs, behavioral health settings, and negative pressure COVID-19 units. Jefferson Hospital is utilizing our platform in negative pressure COVID-19 units for continuous monitoring and patient interaction. Our telemedicine platforms are fully enabled for virtual nurse applications, which will help provide a more personal experience for patients by allowing face-to-face communication.

Sandra McRee, CareView’s Chief Operating Officer, stated, “We recently updated our contracting model to align with the preferred acquisition model in the hospital industry. We now sell hospitals our proprietary hardware and then charge them annually for a software licensing fee. We believe this model is providing a shorter approval time for each hospital contract. We are looking forward to installing our equipment in Jefferson Hospital to help them continue their excellent patient care while providing enhanced services to their negative pressure COVID-19 units and their community.”

About CareView Communications, Inc.

As a leader in turnkey patient video monitoring solutions, CareView is redefining the standard of patient safety in hospitals and healthcare facilities across the country. For over a decade, CareView has relentlessly pursued innovative ways to increase patient protection, providing next generation solutions that lower operational costs and foster a culture of safety among patient, staff and hospital leadership. With installations in more than 150 hospitals, CareView has proven that its innovative technology is creating a culture of patient safety where patient falls have decreased by 80% with sitter costs reduced by more than 65%. Anchored by the CareView Patient Safety System, this modular, scalable solution delivers flexible configurations to fit any facility while significantly increasing patient safety and operational savings. All configurations feature HD cameras, high-fidelity 2-way audio/video, LCD displays for the ultimate in capability, flexibility, and affordability. Corporate offices are located at 405 State Highway 121 Bypass, Suite B-240, Lewisville, TX 75067. More information about the Company and its products and services is available on the Company’s website at www.care-view.com.

Forward Looking Statements

Statements made in this release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.

Contacts

Steven G. Johnson

President and Chief Executive Officer

CareView Communications, Inc.

(972) 943-6050

Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis

Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis




Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis

  • Invasive candidiasis (IC) is characterised as a severe, life-threatening Candida infection of the bloodstream and/or deep/visceral tissues1,2
  • Despite advances in antifungal therapy, IC is still an area of significant unmet patient need associated with high mortality, particularly in immunocompromised and critically ill patients3
  • Rezafungin is a novel, once-weekly echinocandin, currently in Phase 3 clinical trials for both the treatment of invasive candidiasis and prophylaxis against severe invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation
  • Mundipharma has the exclusive rights to develop and commercialise rezafungin in all markets outside of the United States and Japan, where rights are retained by Cidara

CAMBRIDGE, U.K. & SAN DIEGO–(BUSINESS WIRE)–Mundipharma and Cidara Therapeutics today announced that the European Commission (EC) has now adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to rezafungin, a novel, once-weekly echinocandin, for the treatment of invasive candidiasis (IC).4

The EMA considers ODD status for medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than five per 10,000 people in the EU.5 It is estimated that IC occurs in around 0.84 per 10,000 people in the EU,6 and mostly affects hospitalised, immunocompromised or critically ill patients.2

IC continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, mortality rates are as high as 40%.3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidaemia and deep-seated tissue candidiasis.1

Brian Sheehan, Ph.D., Chief Scientific Officer, Mundipharma, commented:Orphan drug designation is an important milestone in the development of rezafungin, which is currently in phase 3 clinical trials. Fungal infections still pose a major threat to the lives of hospitalised or immunocompromised patients. We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition.”

The EC decision adopting the COMP opinion follows that of the U.S. Food and Drug Administration (FDA), which has already designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status and ODD for its use in the treatment of IC, including candidaemia.

Jeffrey Stein, Ph.D., President and Chief Executive Officer, Cidara, added: “We are pleased by the decision of the EMA to grant orphan drug designation to rezafungin, further supporting its potential as the first new antifungal for the treatment of serious invasive Candida infections in nearly 15 years. We look forward to continuing to work closely with our colleagues at Mundipharma to advance rezafungin through late-stage clinical development.

To find out more about the rezafungin clinical trials programme, please visit: https://clinicaltrials.gov/ct2/results?cond=&term=rezafungin&cntry=&state=&city=&dist=&Search=Search

-Ends-

About Rezafungin

Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections. Echinocandins are a class of antifungal drugs that act by inhibiting β (1, 3)-D- glucan synthase, a key enzyme necessary for integrity of the fungal cell wall.7

In studies to date, rezafungin has demonstrated a unique pharmacokinetic profile with a prolonged half-life and is also dosed for front-loaded plasma exposure which, in contrast to all other echinocandins, is intended to allow for once-weekly IV therapy for inpatient and outpatient use.8In Vitro data demonstrate that rezafungin has potent antifungal activity against representative strains of Candida spp, Aspergillus spp, and Pneumocystis spp.9,10 Data from the Phase 2 STRIVE study showed that rezafungin met all of its objectives for safety, tolerability and efficacy in the treatment of patients with candidaemia and/or IC.11

Rezafungin is currently in Phase 3 development. The ReSTORE trial (NCT03667690) is an ongoing, global, randomised, double-blind, controlled, pivotal Phase 3 study to evaluate the safety, tolerability and efficacy of rezafungin compared to caspofungin for the treatment of candidemia and IC in approximately 184 qualifying patients. The primary efficacy outcome measure for the EMA is Global Cure at Day 14 while the primary efficacy outcome measure for the FDA is All-Cause Mortality at Day 30. The ReSPECT trial (NCT04368559) is an ongoing global, randomised, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic blood and marrow transplantation. The trial is expected to enroll approximately 462 adults with underlying conditions, and receive either rezafungin or the standard antimicrobial regimen for 90 days, at which time fungal-free survival will be measured as the primary efficacy outcome.

About Mundipharma

Mundipharma is a global (ex-US) network of independent associated companies with a presence across Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East.

As a dynamic, forward-looking organisation we are dedicated to bringing innovative treatments to patients in the areas of Pain & Supportive Care and Consumer Healthcare as well as other severe and debilitating disease areas.

Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com

About Cidara Therapeutics

Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company’s portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara’s proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to rezafungin’s efficacy and potential as a once-weekly treatment and its ability to prevent severe fungal infections and disease. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

References:

  1. Cortes JA, Corrales IF. Invasive Candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/books/fungal-infection/invasive-candidiasis-epidemiology-and-risk-factors. Last accessed December 2020.
  2. Arendrup MC, Patterson TF. Multidrug-Resistant Candida: Epidemiology, Molecular Mechanisms, and Treatment. J Infect Dis 2017;216(3):S445-S451. Available at https://pubmed.ncbi.nlm.nih.gov/28911043/. Last accessed December 2020.
  3. Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015; 373:1445-1456.
  4. European Commission. Community Register of orphan medicinal products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm Last accessed 21 January 2021.
  5. European Medicines Agency. Applying for orphan designation. Available at https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview. Last accessed December 2020.
  6. Data on file – Mundipharma application for orphan medicinal product designation, October 2020.
  7. Drugs.com. Echinocandins: What are Echinocandins? Available at https://www.drugs.com/drug-class/echinocandins.html. Last accessed December 2020.
  8. Zhao Y, Perlin DS. Review of the Novel Echinocandin Antifungal Rezafungin: Animal Studies and Clinical Data J. Fungi 2020;6:192.
  9. Pfaller MA, Carvalhaes C, Messer SA, et al. Activity of a long-acting echinocandin, rezafungin, and comparator antifungal agents tested against contemporary invasive fungal isolates (SENTRY Program, 2016 to 2018). Antimicrob Agents Chemother 2020 64:e00099-20.
  10. Ong V, Ashbaugh A, Cushion MT. Rezafungin Prevention of Pneumocystis Pneumonia and Pneumocystis Reactivation Using Different Doses and Durations of Prophylaxis in a Mouse Model. Biology of Blood and Marrow Transplantation 2020;26(3):S328-S329.
  11. Thompson GR, Soriano A, Skoutelis A, et al. Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial. Clinical Infectious Diseases, ciaa1380, https://doi.org/10.1093/cid/ciaa1380

 

Contacts

Mundipharma Contacts:
Rob Gallo

Corporate Communications, Mundipharma

rob.gallo@mundipharma.com
+44 (0)777 300 9578

Helen Rae

Makara Health

helenrae@makarahealth.com
Tel: +44 (0) 23 81 247 327

Cidara Contacts:
INVESTOR CONTACT:

Brian Ritchie

LifeSci Advisors

britchie@lifesciadvisors.com
+1 212-915-2578

MEDIA CONTACT:

Karen O’Shea, Ph.D.

LifeSci Communications

koshea@lifescicomms.com
+1 929-469-3860

Navitus Health Solutions Wins Six 2021 AVA Digital Awards

Navitus Health Solutions Wins Six 2021 AVA Digital Awards




Navitus Health Solutions Wins Six 2021 AVA Digital Awards

MADISON, Wis.–(BUSINESS WIRE)–Navitus Health Solutions, a full pass-through pharmacy benefit manager (PBM), today announced that its marketing department received four awards and two honorable mentions from the 2021 AVA Digital Awards, an annual global competition that honors excellence in digital creativity, branding and strategy. The two Platinum, two Gold and two Honorable Mention awards highlight Navitus’ work in digital advertising and content marketing over the past year.

Receiving six accolades from the AVA Digital Awards reflects the innovative work and creativity of our talented team,” said Byron Mickle, SVP of Sales and Marketing and Chief Growth Officer. “These awards underscore our team’s commitment to strategically communicate our passion for helping clients reinvent their pharmacy benefits with our unique, full pass-through approach and superior clinical care model.”

Navitus’ Platinum awards include:

  • E-Annual Report: The 40-page 2019 Drug Trend Report highlights Navitus’ industry-leading drug trend that saved its clients 16% more than the forecasted industry average. It also explores network management, formulary management, utilization management, specialty pharmacy, opioids, and forecasts future industry trend drivers.
  • Digital Advertising Campaign: Navitus developed a digital advertising campaign demonstrating how its pass-through pharmacy benefit model results in greater transparency and cost savings for clients. The campaign centered around its eBook titled: PBM Transparency and How it Impacts Real Cost Savings.”

Navitus’ Gold awards include:

  • Blog – Single Post: Navitus’ blog post “Is Your PBM More Like Cable or Streaming?” compares the switch from cable to streaming services to demonstrate the similar process of switching from a traditional PBM to a full pass-through PBM partner like Navitus.
  • Integrated Marketing Campaign: Using a variety of content, including educational graphics and a rideshare infographic/board game, Navitus took buyers “on a new ride” to demonstrate parallels between comparing the value propositions of industry disruptors such as pass-through PBMs to traditional PBMs and disruptors in the rideshare industry to traditional taxi services.

Navitus’ Honorable Mentions include:

  • Blog Series: Navitus published a two-part blog series to discuss the impact of Covid-19 on the opioid crisis and strategies for plan sponsors to help combat opioid abuse and misuse during these unprecedented times.
  • Short Form Web Video – Company Overview: “The Navitus Story” communicates Navitus’ passion for taking pharmacy benefits purchasers on a new adventure in pharmacy benefit management.

The AVA Digital Awards recognize outstanding achievement by creative professionals involved in the concept, direction, design and production of media that is part of the evolution of digital communication. The awards program is administered and judged by the Association of Marketing and Communication Professionals, consisting of several thousand production, marketing, communication, advertising, public relations and freelance professionals.

About Navitus

Navitus Health Solutions, owned by SSM Health and Costco Wholesale Corporation, serves as a full pass-through pharmacy benefit manager (PBM) and industry alternative to traditional models. As such, Navitus is committed to taking the unnecessary costs out of pharmacy benefits to make prescriptions more affordable for hundreds of plan sponsors (i.e. employers, health plans, unions, governments, etc.) and their 7 million members. By combining a unique pass-through approach that returns 100% of rebates and discounts with a focus on lowest-net-cost medications and comprehensive clinical care programs, Navitus helps reduce costs and improve member health. To learn more about Navitus, call 877.571.7500 or visit www.navitus.com.

Contacts

Katie Brashear

Navitus@AllisonPR.com

New FDA 510(k) Clearance Highlights Ultrasound Capabilities of Longeviti ClearFit Implant

New FDA 510(k) Clearance Highlights Ultrasound Capabilities of Longeviti ClearFit Implant




New FDA 510(k) Clearance Highlights Ultrasound Capabilities of Longeviti ClearFit Implant

Cranial Implant Allows for Ultrasound Imaging Post Operation

BALTIMORE–(BUSINESS WIRE)–Longeviti Neuro Solutions today announced a new 510(k) clearance by the U.S Food and Drug Administration (FDA) for the ClearFit® implant that acknowledges the use of ultrasound in post-operative imaging.

Longeviti’s focus is to develop innovative solutions for complex brain surgery. The company is advancing neurosurgery through the development of low-profile intracranial devices (LIDs) that address the functional and reconstructive needs of patients with neurological conditions. The Longeviti ClearFit implant is a neuro reconstructive implant that surgeons use to reconstruct a patient’s cranium. The implants are patient-specific, implantable prosthetics that are intended to correct and restore bony voids and defects of the cranium.

Research has shown that current post-neurosurgical imaging modalities carry risks due to radiation exposure, and that approximately 29,000 future cancers could be related to CT scan use in the U.S. per year.1

Using ultrasound in post-operative imaging is something we’ve thought about, but never really had the technology to do previously. With ClearFit we can do it, and we can do it in the doctor’s office. It is really a great concept. The object here would be to be able to follow a tumor or follow a surgical bed in the office and not have to give the patient an MRI or CT scan every time,” said Christopher Duma, MD, Medical Director, Brain Tumor Program, Hoag Memorial Hospital.

My colleagues and I are extremely excited about this breakthrough from Longeviti. Published data shows us that approximately 1 in 1000 adults get cancer in their head because of CT scan radiation, and 1 in 500 children,” said Chad Gordon, MD, Director of Neuroplastic Surgery and Professor in the Department of Plastic Surgery and Neurosurgery at Johns Hopkins. “I see this breakthrough as having two benefits: First, the introduction of safe immediate postoperative live brain video. Second, that we can now image much more frequently, when needed, whether there are areas of concern or to put our patients’ minds at ease.”

It is our hope that with this new clearance from the FDA, more surgeons will leverage the ClearFit implant for the benefits to them and their patients. There is no other implant on the market that both reconstructs a patient’s skull, and has FDA clearance for post-operative imaging using ultrasound,” said Jesse Christopher, co-founder and CEO, Longeviti.

The capabilities of the ClearFit implant will be showcased and discussed at the 2021 Annual Meeting of the American Society of Neuroimaging. On Jan. 28 at 2:30 pm EST, Jan-Karl Burkhardt, MD, will present the results of a clinical study, which sought to analyze the safety and feasibility of the ClearFit implant using ultrasound imaging after a neurovascular procedure. Christopher Duma, MD, will be speaking on ClearFit implants Register to attend the upcoming event.

Watch a video illustrating how the Longeviti ClearFit Implant works. https://youtu.be/AsTn5EkS-ss

About Longeviti

Longeviti is advancing neurosurgery through the development of low-profile intracranial implants that address the functional and reconstructive needs of patients with neurological conditions. Since 2018, the company has brought several FDA-cleared implants to market. Longeviti’s focus is to develop innovative solutions for complex brain surgery that return patients to anatomical normalcy. For more information, visit www.longeviti.com and follow Longeviti on Twitter or LinkedIn.


1Biological Effects of Ionizing radiation VII Phase II. National Academics Press 2006; Smith-Bindman R. Arch Int Med 2009

Contacts

Shay Smith

Health+Commerce

shay@healthandcommerce.com

Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper

Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper




Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper

Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials

SALT LAKE CITY–(BUSINESS WIRE)–#changinglivesFoldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal biomaterial properties for the flexible leaflets of a totally synthetic valve replacement.”

LifePolymer is a proprietary biopolymer that was engineered at the molecular level to solve problems commonly experienced by prosthetic heart valves, including earlier heart valves attempting to use polymeric leaflets, such as material degradation, thrombosis and calcification.1,2,3

The LifePolymer material is used in the company’s portfolio of Tria biopolymer heart valves that reimagine the heart valve and are intended to resist calcification, withstand stresses and strains of the heart, and restore patient quality of life without lifelong use of anticoagulants.

“Replacement of traditional xenogeneic pericardial tissue leaflets with high-performance SiPUU (siloxane-based polyurethane-urea, or LifePolymer) provides the advantages of a highly controlled leaflet design, ideal and tailored mechanical properties, a robust supply chain, and lower manufacturing costs,” state the authors. “Together with the earlier reported work on this new SiPUU copolymer, an exhaustive data set now confirms LifePolymer’s suitability for use as a leaflet in a replacement heart valve.”

Data that was cited in the article included:

  • Previous publications4,5 demonstrate generally outstanding in vitro and in vivo resistance of LifePolymer to aggressive oxidative attack, using an accelerated model with a level of strain >10 times the strain expected to be seen in an aortic valve leaflet. The strained LifePolymer devices showed no signs of degradation (e.g. pitting or cracking) even after six months under these accelerated conditions.
  • The Tria valve with LifePolymer leaflets has shown exceptional hemocompatibility.6,7
  • An ex-vivo thrombosis assay using the LifePolymer-based device supported low coagulation activation, producing nearly undetectable levels of platelet attachment and fibrin deposition in situ, both key markers of thrombosis.6
  • The Tria valve with LifePolymer leaflets passed all standard biocompatibility and biostability testing.6

The first of the company’s products – an aortic surgical heart valve – is currently enrolling a U.S. clinical study as a result of FDA approval of an expanded study last October. Its second device, a mitral surgical valve, was approved by the FDA for a U.S. clinical study last month, with the first human case expected to take place within the next several weeks. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.

The Tria valves are the first and only heart valves to be robotically manufactured, reducing variability and enabling high precision, repeatability and quality, while substantially improving the economics of heart valve manufacturing.

To learn more about Foldax, visit www.foldax.com.

About Foldax

Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs.

Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.

References:

  1. Kidane AG, Burriesci G, Cornejo P, et al. Current developments and future prospects for heart valve replacement therapy. J Biomed Mater Res Part B Appl Biomater. 2009; 88(1):290–303. [PubMed: 18615473]
  2. Ghanbari H, Viatge H, Kidane AG, Burriesci G, Tavakoli M, Seifalian AM. Polymeric heart valves: new materials, emerging hopes. Trends Biotechnol. 2009; 27(6):359–367. [PubMed: 19406497]
  3. Kütting M, Roggenkamp J, Urban U, Schmitz-Rode T, Steinseifer U. Polyurethane heart valves: past, present and future. Expert Rev Med Devices. 2011; 8(2):227–233. [PubMed: 21381912]
  4. L. S. Dandeniyage, W. Knower, R. Adhikari, M. Bown, R. Shanks, B. Adhikari, P. A. Gunatillake, J. Biomed. Mater. Res. Part B, Appl. Biomater. 2019, 107, 2557.
  5. L. S. Dandeniyage, R. Adhikari, M. Bown, R. Shanks, B. Adhikari, P. A. Gunatillake, Mater. Today Comm. 2019, 18C, 110.
  6. Data on file at Foldax.
  7. L. S. Dandeniyage, R. Adhikari, M. Bown, R. Shanks, B. Adhikari, C. D. Easton, T. R. Gengenbach, D. Cookson, P. A. Gunatillake, J. Biomed. Mater. Res. Part B, Appl. Biomater. 2018, 106, 1712.

 

Contacts

Michelle McAdam, Chronic Communications, Inc.

michelle@chronic-comm.com
(310) 902-1274