The SENSORA™ platform objectively identifies structural murmurs, a sign of valvular heart disease, with a Care Pathway Analytics software that provides downstream visibility into patient flows, clinical outcomes, and patient economics by following patients with identified structural murmurs throughout the care continuum. The Care Pathway Analytics is intended to support important decisions by identifying care gaps that can be transformed into increased operational efficiencies, such as decreased delays in care delivery, length of stay, and readmission rates, all while enhancing patient and physician satisfaction.
Connor Landgraf, Co-founder & CEO of Eko, said, “Our vision for SENSORA™ is to make cardiovascular disease detection simple and accurate in frontline care settings like primary care and urgent care. During a routine physical exam, patients can now have access to advanced structural murmur detection and arrhythmia assessment by their primary care physician in seconds, making early intervention possible for millions of patients with silent cardiovascular disease. We are making the world’s most universal medical exam objective and accurate.”
“The primary care setting is a patient’s first line of defense for identifying and diagnosing heart disease,” said Dr. John Chorba, Assistant Professor in Residence, Division of Cardiology, Zuckerberg San Francisco General Hospital and Department of Medicine, the University of California San Francisco. He further added, “However, we know from clinical evidence that detection rates are low. The SENSORA™ platform promises to better serve patients by increasing the accuracy and consistency of structural murmur identification and improving patients’ lives by getting them into treatment earlier.”
As per DelveInsight’s “Cardiac Monitoring Devices Market” report, the global cardiac monitoring devices market will grow at a CAGR of 5.4% during the forecast period from 2022-2027. The demand for cardiac monitoring devices is subjected to increase owing to factors such as the rising prevalence of cardiovascular diseases, technological advancements in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness programs regarding cardiovascular diseases, among others, during the forecast period.
Co-Diagnostics, Inc. Initiated Clinical Evaluations for its At-Home and Point-of-Care Co-Dx PCR Home™ Platform
On February 22, 2023, Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced the commencement of clinical evaluations for its at-home and point-of-care Co-Dx PCR Home™ platform and initial COVID-19 test, consisting of clinical trials and analytical studies that are expected to support submissions to the United States FDA and other regulatory bodies.
The company’s real-time PCR platform was created for infectious disease detection in point-of-care and at-home settings, with multiplex panels anticipated to follow after the platform, receives its initial regulatory authorization. The company will not be supplying anticipated completion dates at this time because the evaluations depend on locating and enrolling a specific number of both symptomatic and asymptomatic COVID-19-positive and negative patients at testing sites.
Dwight Egan, CEO of Co-Diagnostics, said, “The commencement of our clinical evaluations represents the achievement of a profound milestone for our company. It is the culmination of a development process that spans over two years of research and development and has harnessed the expert skills of well over a hundred dedicated scientists, engineers, and support staff. The new at-home and point-of-care testing (POCT) platform represents a high degree of innovation that brings together the power of our patented Co-Primer™ technology coupled with other proprietary IP, setting a new standard for compact POCT that unlocks the multiplexing potential of real-time PCR. We believe this invention holds significant promise for the United States and around the world, including regions of the globe that have not previously had access to the quality-of-life advantages of inexpensive, powerful, accurate diagnostic technology. We are excited to begin these clinical evaluations and to leverage the power of our ground-breaking science in this new and revolutionary platform.”
According to DelveInsight’s “Polymerase Chain Reaction Market” report, the global polymerase chain reaction market was valued at USD 4.90 billion in 2021, growing at a CAGR of 8.66% during the forecast period from 2022 to 2027, to reach USD 8.04 billion by 2027. The polymerase chain reaction market is slated to witness increasing revenue owing to factors such as a rise in the prevalence of diseases caused by pathogens, increasing applications in the field of clinical diagnostics, along with latest technological advancements to further enhance accuracy, among others, during the forecast period.
Bioelectronic Medicine Company Received FDA Approval for its Bioelectric Technology
On March 1, 2023, Boomerang Medical, a women-led bioelectronic medicine company, was granted Breakthrough Device Designation from the Food and Drug Administration (FDA) for its bioelectronic technology targeting the treatment of Inflammatory Bowel Disease (IBD). Currently available treatments for IBD patients include medications, biologics, nutrition, physical therapy, and behavioral health therapy. In the search for additional treatment options, researchers participating in the Boomerang IBD clinical trial are exploring the potential of bioelectronic medicine. The goal of this therapy is to stimulate the parasympathetic nervous system to decrease stress on the body and reduce inflammation.
Leading IBD clinics in New York City, Charleston, Houston, Wichita, and Philadelphia will be enrolling patients for a single-arm pilot study by Boomerang. The Boomerang study, in contrast to typical IBD studies, will accept patients with Crohn’s disease and ulcerative colitis who may or may not have previously received biologic therapy.
Heather Simonsen, President, and Chief Executive Officer of Boomerang Medical said, “Living with IBD affects every facet of life. Unfortunately, there are millions of Americans of all ages currently suffering from Crohn’s disease and ulcerative colitis. As the rate of IBD continues to increase, we are committed to generating clinical evidence for this innovative bioelectronic therapy to diversify the treatment options for IBD.”
According to DelveInsight’s “Inflammatory Bowel Disease (IBD) Market” report, the global inflammatory bowel disease market is estimated to grow at a CAGR of 5.72% during the forecast period from 2022 to 2027. The IBD market is slated to witness positive growth owing to the rising prevalence of IBD, including Crohn’s Disease and Ulcerative Colitis, increasing risk factors for IBD, research and development activities in the IBD drugs arena, growing focus on improving the safety and usability of IBD drugs and diagnostic devices, among others during the given forecast period.
Late-clinical Data of Abbott’s Minimally Invasive Heart Devices Presented Positive Results
On February 28, 2023, Abbott, announced late-breaking data for their next-generation Navitor™ transcatheter aortic valve implantation (TAVI) system and Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder.
The results from the TAVI system study supported Navitor’s recent US Food and Drug Administration (FDA) approval to treat people with severe, symptomatic aortic stenosis who are at high or greater risk for open-heart surgery.
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder displayed its benefits by the immediate and complete closure of the LAA – a differentiator from competing therapies – for patients with atrial fibrillation (AFib) at risk of stroke.
Based on the results from the PORTICO NG study conducted for the Navitor™ TAVI system, it was found to be a safer and more effective treatment option for patients with severe, symptomatic aortic stenosis.
The significant findings of the Navitor™ study were as follows:
- High procedural success rate (97%)
- Low rate of all-cause mortality (1.9%) and disabling stroke (1.9%) at 30 days
- Excellent PVL results, including 0% moderate or greater PVL at 30 days
“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” said Michael Reardon, M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval of Navitor. He further added, “The trial provides promising results on the safety and effectiveness of Navitor in addressing this common heart valve disease, highlighting a reduction in the backflow of blood around the valve due to the system’s design.”
According to DelveInsight’s “Transcatheter Aortic Valve Replacement Devices Market” report, the global transcatheter aortic valve replacement (TAVR) devices market was valued at USD 3.23 billion in 2021, growing at a CAGR of 15.41% during the forecast period from 2022 to 2027 to reach USD 7.64 billion by 2027. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation, and the technological advancements pertaining to the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2022-2027.
SOPHiA GENETICS and QIAGEN Announced Partnership to Combine Strengths in Next-generation Sequencing
On March 1, 2023, Sophia Genetics, a cloud-native software company in healthcare, announced a new partnership with QIAGEN N.V., pairing QIAseq reagent technology with the SOPHiA DDM™ platform to analyze and enhance tumor analysis through next-generation sequencing.
The partnership will allow customers to order QIAseq panels processed by SOPHiA DDM™, a cloud-based platform that analyses data from various sources to enable completely new research perspectives.
The partnership will initially support homologous recombination repair (HRR), a unique type of biomarker test to find tumors that have specific mutations that may make them sensitive to PARP inhibitors in oncology, using QIAseq Targeted DNA Pro panels for somatic variant detection (a DNA alteration that occurs after birth).
The SOPHiA DDM™ applications will support a variety of QIAGEN kit-based applications. It is intended to make it possible for customers to use SOPHiA GENETICS’s Set-Up Program, an effective and dependable procedure created to establish and show the analytical performance of any test before it is executed. Customers will be able to use QIAseq technologies to better and more effectively design new workflows as a result.
It is intended to extend the collaboration with SOPHiA GENETICS to other analytical spheres, such as the use of specialized QIAseq panels. It is the first partnership in the QIAseq Platform Partnership from QIAGEN.
Thomas Schweins, Senior Vice President of the Life Sciences Business Area at QIAGEN said, “Our Platform Partnership Program will enable more customers to benefit from the high quality of the QIAGEN NGS preparation kits through the use of a wider range of analytics solutions to address their unique analysis and interpretation needs. SOPHiA GENETICS is our first partner thanks to their deep and unique expertise and reputation. We look forward to offering our customers a combination of best-in-class solutions and expanding our collaboration.”
According to DelveInsight’s “Next-Generation Sequencing Market” report, the global next-generation sequencing market was valued at USD 9.28 million in 2021, growing at a CAGR of 18.96% during the forecast period from 2022 to 2027 to reach USD 26.30 million by 2027. The next-generation sequencing market is observing significant market growth, primarily owing to the mounting figures of various infectious diseases, such as the sudden outbreak of COVID-19 and the escalating burden of cancers worldwide. Moreover, the rising applications of next-generation sequencing in clinical diagnosis and scientific research, high speed, and accuracy, among others, are expected to propel the market for next-generation sequencing during the forecast period from 2022-2027.
SpectraWAVE Secured 510(k) Clearance for its HyperVue™ Intravascular Imaging System
On March 1, 2023, SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), received the Food and Drug Administration (FDA) 510(k) clearance for its flagship intravascular imaging system, HyperVue™.
The system combines state-of-the-art ease of use with next-generation DeepOCT™ images and near-infrared spectroscopy (NIRS) to support doctors as they optimize coronary stenting in the cardiac catheterization lab. In addition, as part of a first-in-human study, the system has now been employed by numerous doctors.
The HyperVue system is the first to combine DeepOCT and NIRS, two vital imaging technologies while enhancing image quality and cath lab procedure efficiency. Rapid pullbacks of both imaging modalities are provided by the Starlight™ Imaging Catheter in a single, discrete, no-flush form factor.
“This is a landmark day for SpectraWAVE, but more importantly, a critical step towards improving outcomes for patients with coronary artery disease,” said Eman Namati, Ph.D., Chief Executive Officer of SpectraWAVE. “Our proprietary DeepOCT-NIRS imaging system pushes the technological limits of optical coherence tomography—both in image quality and depth—while combining it with spectroscopy for the first time, packaging both into a no-flush catheter with an artificial intelligence-powered user experience. With this regulatory clearance, we are excited to begin the transition to a commercial entity and launch our product.”
“Clinical evidence strongly suggests that patients benefit from intravascular imaging-guided stent optimization. After completing the first-in-human procedures, it’s clear SpectraWAVE has built something truly special with a combination of DeepOCT and NIRS, paired with a workflow and AI-enabled image analysis that will prove beneficial for precise and optimal CAD treatment. The DeepOCT technology provides exceptional visualization of critical structures such as the external elastic membrane and calcium, while NIRS removes the guesswork in classifying lipidic plaques. I believe the HyperVue system will enable comprehensive and seamless PCI optimization, but also act as a trailblazing tool for future applications in high-risk vulnerable plaque detection and treatment.”According to DelveInsight’s “Intravascular Ultrasound Market” report, the global intravascular ultrasound market (IVUS) market was valued at USD 714.85 million in 2021 and is likely to register a CAGR of 7.10% during the forecast period from 2022 to 2027 to reach USD 1,065.26 million by 2027. The intravascular ultrasound (IVUS) market is observing remarkable market growth due to the factors such as the rising prevalence of cardiovascular diseases (CVDs) and its risk factors such as obesity, diabetes, and high blood pressure, increasing technological advancements coupled with increasing product launches are creating a positive market growth during the forecast period (2022-2027).
