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).
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.
Florence Healthcare | November 18, 2022
Florence Healthcare™, a clinical research technology company headquartered in Atlanta, Georgia, announced the completion of a year-long third-party study on the impact of Site Enablement Platforms™ on clinical research timelines and costs.
The study by Marketcap Consulting is the first to compare how traditional site management approaches differ from site-first Site Enablement Platforms. The study looked at the impact of traditional sponsor portals and new Site Enablement Platforms on research sponsor and Contract Research Organization study timelines and budgets.
“Pharma sponsors and CROs realize the importance of enabling sites to do their best work - but only recently have they discovered that traditional site portals are more hindrance than help. Yet, these organizations weren't able to measure the true impact of switching to a Site Enablement Platform. This year-long study aimed to fix that and highlight how linking fragmented workflows accelerates the full lifecycle of clinical trials.”
Ryan Jones, CEO of Florence Healthcare
Site enablement is a new technology category that prioritizes the needs of the site, a major shift from past technology that only looked at the experience of the sponsor. These platforms, including Florence Healthcare’s SiteLink™, insist on ease-of-use and ease-of-setup for the site, quality support, and simplified integrations. SiteLink works in conjunction with eBinders™, an electronic Investigator Site File solution used by over 12,000 research sites in 45 countries.
About the Study
Marketcap Consulting conducted interviews with clinical research operations leaders harnessing SiteLink, examined timelines and study costs, and analyzed the impact across the sites in the study. On average, the team found that SiteLink accelerated study start-up by four weeks and study close-out by two weeks at every site. For a 50-site study, this six-week acceleration reduced cash burn by one million dollars.
“We can see a clear positive impact on study timelines and cash burn when research sponsors and CROs implement Site Enablement Platforms,” said Joel White, founder of Marketcap Consulting. “This early study reveals that by enabling sites to do their best work, the clinical research industry unlocks value across the full research cycle.”
“While the financial impact of switching to SiteLink makes investing in site enablement an easy choice for sponsors and CROs, it’s really the acceleration of studies that gets our team at Florence Healthcare excited,” said Jones. “We aim to double the output of research teams by the end of the decade, and enabling sites is the way to do it.”
About Florence Healthcare
Florence Healthcare’s clinical trial software helps more than 12,000 research sites in 45 countries manage their documents, data, and workflows. The Florence Healthcare™ platform also provides remote access so sponsors and Contract Research Organizations can collaborate with their sites around the world. Florence Healthcare users now perform 5.8 million remote monitoring activities each month.
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.