AnchorDx Clinical Trial Enrols First Patient for its UriFind® Bladder Cancer Assay in the US
On November 23, 2022, AnchorDx, announced the first patient enrollment for its clinical trials of the UriFind® bladder cancer assay in the United States.
The UriFind® bladder cancer assay clinical trial in the United States, involving more than 1,000 patients across multiple centers, has officially begun patient enrollment, according to AnchorDx. In this perspective registrational study, the effectiveness of a non-invasive, quantitative real-time PCR (qPCR) assay developed to identify two DNA methylation biomarkers in urine samples from patients suspected of having bladder cancer will be assessed.
The US Food and Drug Administration awarded the assay a Breakthrough Device Designation (BTD) in July 2021. (FDA). The outcomes of this clinical trial are intended to satisfy the criteria for submitting a Premarketing Approval (PMA) application to the FDA in the United States. Three CAP/CLIA laboratories and about 10 urology clinics are expected to be part of the trial.
UriFind® is a urine-based, non-invasive molecular test for accurately detecting bladder cancer. UriFind® test has demonstrated improved sensitivity and specificity. It benefits early, micro, residual, and recurrent bladder cancer detection and offers a reliable foundation for bladder cancer clinical diagnosis.
Marina Bibikova, Chief Scientific Officer of AnchorDx said, “The UriFind® bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the U.S. Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high performing test for detection of bladder cancer. We are excited to evaluate its ability to inform patient care”.
“AnchorDx is committed to transform early detection and diagnosis of cancer as we continuously bring our tests into clinical practice through clinical validation. We are collaborating with leading urologists world-wide to gain important clinical evidence on the use of our UriFind® test. This clinical trial represents an important step towards commercialization of the test in the U.S.,” said Jian-Bing Fan, Founder, and Chief Executive Officer.
As per DelveInsight’s “Cancer Diagnostic Market” report, the global cancer diagnostic market was valued at USD 125.13 billion in 2021, growing at a CAGR of 9.43% during the forecast period from 2022 to 2027 to reach USD 214.88 billion by 2027. The demand for cancer diagnostics is expected to grow owing to the spike in cancer cases reported worldwide. In addition, the growing focus of manufacturers to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and the rising government initiatives for the early detection and management of cancer among patients is expected to augment the growth of the cancer diagnostic market during the forecast period from 2022-2027.
First System for Automated Insulin Dosing Launched by Ypsomed and CamDiab with Abbott’s FreeStyle Libre 3
On November 25, 2022, Ypsomed, announced that its mylife Loop could now be used with Abbott’s FreeStyle Libre 3 sensor in Germany. Together with the mylife CamAPS FX algorithm from CamDiab, the mylife YpsoPump and FreeStyle Libre 3 form an intelligent and automated insulin delivery system (AID) that is intended to assist people with type 1 diabetes in better managing their blood glucose levels and lessen the burden of ongoing diabetes management.
Based on real-time glucose data, the mylife Loop solution is intended to develop an intelligent, automated process for administering insulin. Continuous glucose monitoring ensures that the right insulin dose is given at the right time to a patient.
The users report having more freedom in their daily lives, including more time to spend with their families, being more active, and getting a better night’s sleep. The mylife Loop solution also gives parents of diabetic children a clear picture of their child’s glucose values at any time and control via a smartphone, allowing them to take appropriate action as needed.
“We are convinced that the major challenges facing society can only be solved through partnerships. We are therefore proud to expand our offering with Abbott to give the users of our mylife YpsoPump more freedom of choice in managing their diabetes. Our compact and easy-to-use insulin pump authorized to work with Abbott’s latest sensor and CamDiab’s adaptive hybrid closed-loop app will change the lives of thousands of people affected by diabetes,” said Sébastien Delarive, Chief Business Officer Diabetes Care at Ypsomed.
According to DelveInsight’s “Insulin Delivery Devices Market” report, the global insulin delivery devices market was valued at USD 15.51 billion in 2021, growing at a CAGR of 9.28% during the forecast period from 2022 to 2027, to reach USD 26.35 billion by 2027. The insulin delivery devices market is estimated to register positive revenue growth owing to the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, along with product development activities during the forecast period from 2022-2027.
NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64
On November 28, 2022, NeuroLogica, a Samsung Electronics Co. Ltd. subsidiary, announced the U.S. Food and Drug Administration had granted 510(k) clearance for the commercial use of the BodyTom® 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, a head-to-toe trauma imaging solution.
BodyTom 64 will make changes to the software and the data acquisition system to improve clinical workflows and the user experience (DAS). Incorporating Linux as the operating system and having the capacity to produce up to 64 cross-sectional CT images of a patient’s body, as opposed to the 32 produced by the predicate BodyTom® Elite, are two examples of these revisions.
The BodyTom 64 is a multi-departmental imaging solution with indications for both paediatric and adult imaging. It can be used for needs like neurosurgery, trauma, and interventional radiology.
Jason Koshnitsky, Sr. Director of Global Sales and Marketing of NeuroLogica said, “We’re thrilled to build off our expertise and elevate point-of-care imaging with our BodyTom 64, which can transform any room in a hospital into an advanced imaging suite. This full-body 64-slice CT scanner is an upgraded version of the BodyTom Elite CT scanner, providing enhanced functionality with the same high-resolution imaging capabilities.”
According to DelveInsight’s “Computed Tomography Market” report, the global computed tomography market was valued at USD 6.13 billion in 2021, growing at a CAGR of 6.36% during the forecast period from 2022 to 2027, to reach USD 8.87 billion by 2027. The increase in the demand for computed tomography is predominantly due to an upsurge in the cases of severe chronic diseases such as cardiovascular, oncological, and others, rapid technological advancements in product design, increased awareness of early diagnosis coupled with the rise in the geriatric population, is expected to bolster the growth of the computed tomography (CT) devices market during the forecast period from 2022-2027.
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
On November 29, 2022, UroMems, a global company developing breakthrough mechatronics technology to treat stress urinary incontinence (SUI) announced the first successful implantation of a smart automated artificial urinary sphincter (AUS) investigational device called the UroActiveTM System to treat stress urinary incontinence (SUI) for the first time.
By committing to altering the perception that these disorders are simply something to put up with without a real solution, UroMems seeks to improve the quality of life, dignity, and self-esteem of millions of men and women suffering from untreated chronic conditions worldwide.
The MyoElectroMechanical System-powered UroActive smart active implant is the first of its kind to treat SUI (MEMS). The goal of this ground-breaking system, which surrounds the urethral duct and is automatically adjusted based on the patient’s activity without the need for manual adjustments, is to give patients greater usability and a higher quality of life than is possible with the available options.
Hamid Lamraoui, UroMems chief executive officer and co-founder said, “This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women. This is the next important step in delivering our novel technology to a large, underserved patient population with unmet needs not addressed by current options on the market.”
“We see a high rate of today’s AUS implants that are revised or removed after three years. The potential of being able to personalize the therapy to the patient automatically, post-implantation is very appealing,” said Professor Daniel Elliott, a urologist at Mayo Clinic in Rochester, Minn., and clinical advisor to UroMems.
According to DelveInsight’s “Stress Urinary Incontinence Devices Market” report, the global stress urinary incontinence devices market was valued at USD 757 million in 2021, growing at a CAGR of 6.91% during the forecast period from 2022 to 2027, to reach USD 1130.32 million by 2027. The increase in demand for stress urinary incontinence devices is witnessing positive growth due to the rising prevalence of stress urinary incontinence cases among the population, a surge in the aging population prone to stress urinary incontinence, and weakening of the pelvic floor, diabetes, along with the development of innovative devices among others, are anticipated to drive the global stress urinary incontinence devices market during the forthcoming years.
Boston Scientific Announces Agreement to Acquire Apollo Endosurgery, Inc.
On November 29, 2022, Boston Scientific announced that it agreed to the acquisition of Apollo Endosurgery, Inc. for a cash price of $10 per share, reflecting an enterprise value of approximately $615 million.
The devices used during endoluminal surgery (ELS) procedures to close gastrointestinal defects, manage gastrointestinal complications, and help patients who are obese lose weight are part of the Apollo Endosurgery product portfolio. For patients with gastrointestinal disorders or morbid obesity, ELS offers a less invasive alternative to open and laparoscopic surgery, with the potential for a quicker recovery and reduced risk of surgical complications.
Due to the anticipated expansion of its endoscopic suturing system franchise, which includes its OverStitchTM Endoscopic Suturing System, OverStitch SxTM Endoscopic Suturing System, and X-TackTM Endoscopic HeliX Tracking System, Apollo Endosurgery is projected to generate net sales of roughly $76 million in 2022.
In the first half of 2023, Boston Scientific anticipates concluding the deal, pending the fulfilment of customary closing requirements. In 2023, the effect on Boston Scientific’s adjusted earnings per share is anticipated to be negligible, and positive after that. Due to amortisation expense and acquisition-related net charges, the effect on GAAP earnings per share is anticipated to be either less accretive or more dilutive, depending on the situation.
“Endoluminal surgery is an emerging field and a core focus for our Endoscopy business. We intend to expand our global capabilities in ELS with the differentiated innovation that Apollo Endosurgery offers, and we will continue to focus on procedural adoption as well as professional education in this exciting space. This acquisition also enables us to enter a new adjacency – the endobariatric market – and deliver strong, continued growth across our business.” said Mike Jones, senior vice president and president, of Endoscopy, Boston Scientific.
According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market” report, the global minimally invasive surgical (MIS) devices market was valued at USD 28,873.25 million in 2021, growing at a CAGR of 7.38% during the forecast period from 2022 to 2027 to reach USD 42,499 million by 2027. The rise in demand for minimally invasive surgical (MIS) devices is predominantly attributed to the increasing prevalence of various cancers, such as lung, cardiovascular, and neurodegenerative diseases, among others. Furthermore, the presence of factors such as the expansion of the aging population, technological advancements in the product, such as the development of surgical robots, and others are expected to drive the demand for overall minimally invasive surgical (MIS) devices during the forecast period from 2022-2027.
SeekInCure® Cancer Recurrence Monitoring Kit Gets CE-IVD Mark Approval
On November 28, 2022, SeekIn Inc, a pioneer in blood-based cancer early detection and monitoring technology, announced that the SeekInCure® Cancer Recurrence Monitoring Kit received CE Mark approval and is now ready to be made available in the European Union and other nations that recognize the CE-IVD Mark.
Following curative resection of the primary tumor, cancer recurrence is caused by minimal residual disease (MRD), which is currently undetectable by imaging, laboratory testing, or clinical evaluation. Therefore, there is a significant unmet need for a sensitive and precise clinical tool that can help identify MRD patients who are more likely to relapse or that enables lower-risk patients without MRD to avoid unnecessary and potentially harmful therapy.
For all cancer patients undergoing radical surgery, SeekInCure® is a blood-based, cost-efficient, and tumor-naive approach for molecular residual disease (MRD) assessment and recurrence monitoring. The approach dynamically monitors the change in molecular tumor burden (MTB) in blood after surgery to identify patients with MRD who may benefit most from adjuvant therapies and to monitor for the recurrence of the disease. It does this by combining genomic/epigenetic signals (copy-number aberrations [CAN] and fragment size [FS]) and protein tumor markers quantification.
By continuously monitoring the changes to the cancer genome in cell-free DNA (cfDNA), combining with protein tumor markers, outfitting big data and artificial intelligence, and monitoring cancer recurrence and risk assessment for post-operation cancer patients, SeekInCure® is used to monitor cancer. Additionally, this method does not call for tumor analysis.
“This test only requires an 8ml blood draw within a month after radical surgery to assess whether MRD exists, meanwhile, peripheral blood can also be collected regularly after surgery to monitor cancer recurrence. We have conducted a prospective study to evaluate the effectiveness of SeekInCure to detect MRD in patients with hepatocellular carcinoma (HCC), and this study has confirmed the excellent performance of SeekInCure in the detection of MRD and the prognostic value of MRD in HCC patients. In addition, the blood-only features make it to be a cost-effective approach and faster turnaround time to allow clinicians to make a quick treatment decision,” said Mao, M.D., Ph.D., SeekIn’s founder and CEO. He further stated that “CE-IVD Mark is a recognition of the performance of SeekInCure, and is also a milestone for SeekIn, representing our test may be more widely accessible to cancer patients around the world. We believe that SeekInCure® can be a powerful tool for MRD detection and recurrence monitoring for the patients after radical surgery.”According to DelveInsight’s “Blood Cancer Diagnostics Market” report, the global blood cancer diagnostics market is expected to increase owing to the factors such as the increasing prevalence of blood cancer worldwide, the increasing geriatric population, the rising number of risk factors associated with blood cancer and the growing focus on improving the safety, and usability of blood cancer diagnostics for end users, among others.