FUTURE OF HEALTHCARE
Radius XR | November 17, 2022
Today at the CES Unveiled New York event, Radius XR™, a new fashion-forward wearable healthcare technology brand, was named a CES® 2023 Innovation Awards Honoree in both the Digital Health and Virtual & Augmented Reality categories.
Radius was selected from among a record number of submissions to this year’s CES Innovation Awards program. The announcement was made ahead of CES 2023, the influential technology event, happening Jan. 5-8 in Las Vegas, NV.
Radius XR builds on the therapeutic legacy of IrisVision, a leader in digital vision technologies and itself a 2019 CES Innovation Winner. The Radius proprietary XR assistive device brings together—for the first time—multimodal diagnostics, practice management, and patient engagement.
“This is a tremendous honor for our new company. It follows on the success of our IrisVision visual assistive device, which has provided a life-changing solution for thousands of individuals living with legal blindness and low-vision conditions. Radius expands on our commitment to vision health by providing the eyecare industry with an easy-to-use wearable device capable of performing standard perimetry tests. Other exams include color vision, visual acuity, contrast sensitivity—a comprehensive suite of standard vision tests. Development of additional exams is ongoing.”
Radius founder and CEO Ammad Khan
Radius enables patients to quickly and easily conduct vision tests with minimal guidance or intervention by the staff. The device’s RadiusExam® software and proprietary algorithms provide diagnostic testing results equivalent to current exam gold standards. “By designing our own hardware and software, we’re able to overcome many of the challenges inherent in the off-the-shelf headsets already on the market. Matching visual field strategies, background luminance, stimulus size and dynamic range allows us to mirror the current standards, making it easy and intuitive for clinicians to transition to Radius,” said John Trefethen, Radius Chief Marketing Officer.
In addition, the included Business Suite helps clinicians manage everyday aspects critical to their practice's ongoing success. Features like patient education, staff training and clinician onboarding are now possible inline with the Radius platform.
Radius is the industry’s lightest wearable device and has the look and feel of a pair of stylish sunglasses. The compact, lightweight design overcomes the challenges of expensive and bulky legacy devices that force patients to sit in uncomfortable positions for testing. With Radius, exams can be conducted anywhere, even in the waiting room, eliminating the need to shuttle patients between machines, which can be challenging for individuals with mobility or vision issues.
The CES Innovation Awards program, owned and produced by the Consumer Technology Association (CTA)®, is an annual competition honoring outstanding design and engineering in 27 consumer technology product categories. Those with the highest rating receive the “Best of Innovation” distinction. An elite panel of industry expert judges, including members of the media, designers, engineers and more, reviewed submissions based on innovation, engineering and functionality, aesthetics, and design.
The CES 2023 Innovation Awards honorees, including product descriptions and photos, can be found at CES.tech/innovation. Radius will be on display at the Innovation Awards Showcase at CES 2023 in Las Vegas in January.
About Radius XR
The Radius XR platform is a portable vision diagnostic and patient engagement system that combines medical-grade diagnostics, business management, and patient education tools in a single wearable XR device. The RadiusExam® and proprietary algorithms provide diagnostic testing results equivalent to current exam gold standards, with the clinical science validated by Deming regression. As the algorithm presents stimuli to patients, it adapts to responses to maximize the algorithm's speed.
The total hardware and software system helps medical professionals diagnose patients with accuracy, grow their eyecare practices, enhance patient engagement, and reduce staff workload by enabling patients to perform self-guided vision exams with minimal supervision.
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
Abbott | November 21, 2022
Abbott has been recognized by the Consumer Technology Association with three CES 2023 Innovation Awards for its life-changing technologies that are advancing the health tech industry and improving the lives of people worldwide. The CTA is the organization behind the Consumer Electronics Show the most influential technology event in the world.
Ahead of the CES 2023 event, three of Abbott's industry-leading tech advancements won CES 2023 Innovation Awards, all within the Digital Health award category
Aveir VR Leadless Pacemaker – The world's only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placement and designed to be completely retrievable. The system was developed by Abbott to treat patients with slow heart rhythms and eliminates wires used to deliver therapy in traditional pacemakers.
Proclaim Plus SCS System – Abbott's latest advancement in neurostimulation therapy to treat chronic pain using low doses of targeted BurstDR™ stimulation that can be adjusted as a person's therapeutic needs evolve across up to six areas of the body, which is more pain sites in the body than ever before.
Alinity m Monkeypox PCR test1 – A first of its kind, Abbott received FDA Emergency Use Authorization of its PCR test for detecting the monkeypox virus.
The CES Innovation Awards program is an annual competition honoring outstanding design and engineering in consumer technology products. The program recognizes the year's most innovative products in a multitude of consumer technology product categories and distinguishes the highest-rated in each.
Last year, Abbott became the first-ever healthcare company to keynote CES, and the company has received nine CES Innovation Awards in the past two years.
Other Abbott products previously honored with CES Innovation Awards include FreeStyle Libre 32, the world's smallest, thinnest3 and most accurate4 14-day glucose sensor and a CES 2022 Best of Innovation Award winner; BinaxNOW™5, the #1 COVID-19 self test in the U.S.; and the UltreonTM 1.0 intravascular imaging and coronary physiology software platform, which helps guide and optimize stenting decisions, combining optical coherence tomography with artificial intelligence.
In addition to the CES 2023 awards, Abbott also was recently recognized with other top honors for its healthcare technology including its revolutionary FreeStyle Libre technology being named the best medical technology in the last 50 years by the Galien Foundation. The FreeStyle Libre portfolio has transformed the lives of approximately 4.5 million people6 living with diabetes globally.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
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.