Osmind | September 16, 2022
Osmind, the public benefit corporation helping clinicians and researchers advance life-saving mental health treatment, announced the launch of integrated Zoom Virtual Visits within its technology platform for mental health clinicians. Now clinicians can access both asynchronous and synchronous digital communication tools, all within the Osmind patient app. Virtual visits extend Osmind’s already integrated experience—between clinicians and patients—and generalist and specialist mental health clinicians, making it easier and safer to meet high patient demand.
”The future of mental health care requires omnichannel care where telehealth plays a role in a larger continuum of treatments. As clinicians, we have a professional obligation to only use telehealth platforms that are HIPAA-compliant. Zoom offers a strong product with powerful user experience over alternatives. We are thrilled to partner to offer their industry-leading solution.”
Carlene MacMillan, MD and Vice President of Clinical Innovation at Osmind
Osmind’s platform today fosters a therapeutic alliance between researchers, psychiatrists, mental healthcare specialists, and the patients they serve. With this launch, Osmind is expanding treatment options for mental health clinicians treating those vulnerable: people with moderate-to-severe mental health conditions, including patients with treatment-resistant depression and anxiety who may not have the ability to leave their homes to commute, or are geographically restricted from in-person visits.
Clinicians and patients stay empowered through progress monitoring and journaling tools. This alliance is strengthened with virtual visits, allowing clinicians to create a virtual visit appointment, share that link with the patient, and launch the virtual visit directly from the Osmind app. With Osmind now a part of Zoom’s ISV Partner Program, clinicians can take advantage of Zoom’s secure, HIPAA-compliant video technology without needing to manage additional vendor overhead or requiring patients to install new technology on their phones or computers.
The demand for psychiatric care in the U.S. is only growing. In 2019, 47.7% of adults with a serious mental illness reported an unmet need for mental health services in the previous year, according to the U.S. Department for Health and Human Services.
“With the integration of Zoom technology and the Osmind EHR, we are together addressing a significant need in healthcare: clinics can now treat the most at-risk patients securely from where they’re most comfortable with a click of a button, revolutionizing access to care,” said Matt Cipolla, ISV Partner Account Manager, Zoom Video Communications. "We are proud to welcome Osmind into our ISV Partner Program to help transform the mental health landscape.”
Clinicians need flexibility in service delivery to meet demand and expand access. Patients save time and money from not needing to commute. Clinicians, patients, and caregivers are additionally frequently already familiar with Zoom, making it seamless for parties to log in to their session.
Osmind is a San Francisco–based public benefit corporation led by scientists, technologists, and psychiatrists to advance new evidence-generating medicine that helps people living with moderate to severe mental health conditions.
Antengene Corporation Limited | September 19, 2022
Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.
At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.
Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.
Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.
ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.
"We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene's first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world."
Dr. Bo Shan, Antengene's Chief Scientific Officer
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® already approved in mainland China, South Korea, Singapore and Australia.
Tivic Health | October 18, 2022
Tivic Health® Systems, Inc. a commercial-phase health technology company focused on bioelectronic medicine, announced it has entered into a definitive agreement to acquire the Reliefband product line for nausea treatment and all related assets from Reliefband Technologies, LLC.
Reliefband has been an innovator in wearable, FDA-cleared electronic therapeutics for treatment of nausea and vomiting. Reliefband has multiple products available both over-the-counter and by prescription.
“We are incredibly excited to add the full suite of Reliefband products to our commercial portfolio. The Reliefband team successfully pioneered a direct-to-consumer business model for medical products. This acquisition, when combined with our growing direct-to-consumer sales of ClearUP, will significantly accelerate Tivic’s revenue opportunities.”
Jennifer Ernst, CEO of Tivic Health
Recurring nausea impacts approximately 1 in 6 US adults. According to QY Research, nausea treatment is a $2.4B market in the US and $5.5B globally, growing at 6.5% CAGR.
Reliefband’s wrist-worn electronic nerve stimulators have been FDA-cleared for treatment of nausea associated with seven independent clinical indications, including nausea from motion sickness, pregnancy, migraines, anxiety, chemotherapy, various medications and hangovers.
The patented products are backed by 40 peer-reviewed clinical studies and have generated over 3500 Amazon reviews averaging 4+ stars.
Both Reliefband and ClearUP products offer consumers ways to manage health-related conditions without the issues and side effects often associated with medication use. Both are FDA-cleared, highly effective, fast-acting, convenient, and drug-free. Both currently are sold primarily online, and both have received CE Marks allowing international expansion.
In addition to the Reliefband direct-to-consumer branded products, Tivic will also acquire Reliefband’s Reletex-branded prescription nausea treatments. Reletex products are currently distributed by hospitals and medical professionals and are reimbursed under HCPCS code E0765 for certain conditions.
“We look forward to growing Tivic with the addition of clinically proven, revenue-producing bioelectronic products that have seen strong customer adoption and growth,” continued Ernst.
Consideration to be provided by Tivic consists of up to $33.5 million, of which up to $1.5 million can be paid, at the election of Tivic, in restricted common stock of Tivic. Consideration is subject to working capital adjustments, less Reliefband transaction expenses and any indebtedness of Reliefband at closing.
The transaction is expected to be consummated in the fourth quarter of 2022 or first quarter of 2023 after the satisfaction of certain customary closing conditions, including but not limited to securing the financing necessary to pay the purchase price. Additional information on the transaction can be found in a Current Report on Form 8-K filed by Tivic with the Securities and Exchange Commission (SEC).
FUTURE OF HEALTHCARE
Visionable and Verizon | September 22, 2022
Verizon Business and Visionable, a leading health technology company based in the U.K., announced that they are expanding their partnership which will enable both companies to work on a range of connected healthcare solutions, via Visionable’s patented technology powered by Verizon’s 5G Ultra Wideband and 5G Edge network, in the U.S.
Verizon and Visionable are working together on a secure next-generation digital healthcare collaboration platform that enables healthcare professionals to access data, collaborate and share resources within the APAC and EMEA regions. The partnership seeks to address some of healthcare’s biggest challenges including connecting frontline responders to specialist doctors during emergencies and enabling access to community-led care for patients needing long-term support.
“The healthcare industry generates a massive amount of data, but its ability to make good use of that data has long been hampered by network architectures that cannot handle it efficiently, securely, or cost-effectively. Through the combination of 5G and Edge computing, healthcare facilities and professionals will have access to secure near-real-time connectivity creating a new link between doctor and patient. As a result, illnesses could someday be diagnosed and treated more quickly, and medical costs could potentially decrease,”
Scott Lawrence, Senior Vice President for Verizon Global Solutions
Today’s announcement follows the launch of Visionable’s private-5G enabled Connected Healthcare Center in the U.K. in May. The center showcases the benefits of next-generation connectivity and collaboration across a patient’s care journey from urgent and emergency care to virtual wards to in-person care and rehabilitation, supported by Verizon private 5G.
“Our partnership provides real-time connectivity and productivity, when and where it counts and costs. Together with Verizon, we endeavor to support our healthcare teams by enabling them to bring healthcare to the patient wherever they are,“ said Alan Lowe, CEO and Co-Founder of Visionable.
This engagement is part of Verizon’s continued strategy to partner with customers, startups, universities, and large enterprises to explore how 5G can disrupt and transform nearly every industry. This includes Verizon’s strategic partnership with Emory Healthcare in Atlanta where Verizon is collaborating with Emory Healthcare to help spur the development of healthcare solutions powered by 5G Ultra Wideband.
Today’s announcement builds on the company’s network-as-a-service foundation and supports its growing private networks, mobile edge compute and business solutions.
Visionable is a UK company that is helping make connected healthcare a reality in the UK and around the world. Driven by the belief that affordable, high-quality, timely healthcare is a basic human right that should be accessible to all, Visionable’s patented, real-time & multi-streaming technology enables critical remote decision-making by clinicians wherever they are located have created their own proprietary clinical collaboration platform. This enables the hospital to come to the patient and for healthcare teams to collaborate freely across multiple locations. Visionable is trusted by 25% of the top 100 UK hospitals, 100 more than 90 NHS organisations, 46 and 34 NHS Trusts., over 16,000 NHS staff. Visionable’ s specialist advisory board includes Lord Victor Adebowale, previous NHS board member, Mike Farrar, ex-NHS Chief Executive and leader of the North West England Strategic Authority and Dr Junaid Bajwa, practising physician and MSD’s Digital Accelerator’s Global Lead for Strategic Alliances.
Verizon Communications Inc. (NYSE, Nasdaq: VZ) was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control.