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Ypsomed Collaborated with CamDiab for Smartphone-based Automated Insulin Delivery
On March 22, 2022, Ypsomed, a leading manufacturer of injection and infusion systems for self-medication partnered with CamDiab Ltd, developer of CamAPS FX, an app for the management of glucose levels via insulin pumps using an adaptive, hybrid closed-loop approach. The easy-to-use loop solution is expected to be launched during the first half of 2022 for the mylife YpsoPump system in selected major countries in Europe and followed by other territories in the course of the year.
With this partnership, the world-leading, adaptive, hybrid closed-loop solution provided by CamDiab Ltd would enable users of the mylife YpsoPump to better manage their glucose levels through a responsive control algorithm running on a smartphone. The mylife CamAPS FX Android mobile application is the first CE-marked algorithm and is compatible with the Dexcom G6 CGM. It automatically adjusts the insulin delivery on the insulin pumps based on glucose readings from the Dexcom G6 CGM.
Simon Michel, CEO of Ypsomed, said, “We are very excited to work together with CamDiab Ltd, a trailblazer in developing interoperable loop systems. Together, we can make a step further in achieving our common goal, making the life of people living with diabetes as easy as possible. We are looking forward to rolling out this solution in Europe over the coming months, first on Android and then also on iOS.”
“Many years of research went into our hybrid closed-loop solution – and we are thrilled to bring our expertise to this project with Ypsomed, a leader in innovation in delivery systems for liquid drugs. We share a common goal, and that is to help people with diabetes and their families to live better lives – we are excited that technology and innovation can contribute to a better and healthier future,” said Roman Hovorka, Director CamDiab Ltd.
According to DelveInsight’s “Insulin Delivery Devices Market” report, the global Insulin Delivery Devices Market was valued at USD 14.23 billion in 2020, growing at a CAGR of 9.23% during the forecast period from 2021 to 2026, to reach USD 24.13 billion by 2026. The rise in demand for Insulin Delivery Devices is predominantly attributed to the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, and technological advancement in the product line, among others.
In addition, as per the DelveInsight analysis, among all the countries, North America is expected to dominate the overall Insulin Delivery Devices market during the forecast period. This domination is due to the increase in venture capital for the issuance of initial public offerings, favorable reimbursement policies, and the presence of improved healthcare infrastructure in the region.
HLT®, Inc. Received FDA Approval for Two TAVR Clinical Studies
On March 24, 2022, HLT Inc., part of the Bracco Group and committed to advancing transcatheter aortic valve replacement (TAVR) therapies to improve lives gained the US FDA nod for two clinical studies to assess the performance and safety of its HLT Meridian TAVR Valve System to treat aortic stenosis and aortic regurgitation among high-risk patients suffering from the aortic disease.
Unlike the TAVR solutions currently present, the HLT Meridian TAVR valve system has a non-obstructive design and also has the benefits of both the balloon-expandable and self-expanding platforms with a lower profile, that reduces the conduction and coronary obstruction. The Meridian TAVR has a unique design as it is the only TAVR valve with an isolated valve structure where the leaflets are not attached to an annular structure. The novelty of the design is intended to reduce tissue stress, improve long-term durability, minimize leakage and minimize ventricular exposure. Furthermore, the design of the device to enhance the hemodynamic performance is anticipated to reduce the concern of patient-prosthesis mismatch.
David R. Elizondo, President, and CEO of HLT said, “We are thrilled to be providing a minimally invasive option to patients suffering from the aortic disease. Currently, there are treatments available that focus specifically on aortic stenosis. The HLT technology has been designed to treat a much broader segment of aortic disease where current treatment options are limited. The HLT Meridian TAVR Valve System is designed to address both patients’ and physicians’ needs that are unmet by current offerings, and is intended to expand and optimize the clinical and procedural performance.”
“The HLT platform is exciting because its new single operator delivery system and unique valve design offer the promise of a more accurate, and thus possibly less complicated procedure, and better long-term outcomes due to the intended reduced stress on the individual valve leaflets. In addition, the delivery system is designed to allow precision in valve delivery. This, combined with the radial strength of the valve, is expected to be a great combination to treat non-calcified aortic annuli that are frequently seen in aortic regurgitation,” commented Dr. Satya Shreenivas, Chief Medical Officer at HLT and experienced interventional cardiologist with expertise in the care of patients with structural heart disease.
According to DelveInsight’s “Transcatheter Aortic Valve Replacement/Implantation Market” report, the global Transcatheter Aortic Valve Devices Market was valued at USD 2.80 billion in 2020, growing at a CAGR of 15.41% during the forecast period from 2021 to 2026 to reach USD 6.60 billion by 2026. 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 in 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 2021-2026.
Moreover, as per the DelveInsight analysis, the approval and launch of devices for aortic stenosis indication will lead to an increase in the demand for transcatheter aortic valve replacement devices in the aortic stenosis application, thereby leading to an increase in the overall transcatheter aortic valve replacement devices market growth.
FDA Approved Fresenius Kabi’s SMOFlipid® Lipid Injectable Emulsion for Pediatric Patients Requiring Parenteral Nutrition
On March 24, 2022, FDA granted an expanded indication for SMOFlipid® Lipid Injectable Emulsion (ILE) developed by Fresenius Kabi for pediatric patients in the US which include term and preterm neonates, thus making it the first and only four-oil lipid emulsion for parenteral nutrition patients of every age.
SMOFlipid is a source of calories and essential fatty acids for parenteral nutrition when the enteral or oral nutrition is insufficient or contraindicated in adult and pediatric patients, including term and preterm neonates.
Gordon Sacks, PharmD., senior director of Medical Affairs, Fresenius Kabi USA, said, “The FDA approval of SMOFlipid for pediatric patients represents an important expansion of our parenteral nutrition portfolio and our continued commitment to providing innovative nutrition products to our clinical partners and the patients they serve. A pediatric indication for SMOFlipid allows clinicians to meet the unique nutritional needs of even our most vulnerable patients at every age.”
Pete Allen, senior vice president, Nutrition and Infusion Therapy, Fresenius Kabi USA added, “There is a genuine need for alternative oil-based injectable lipid emulsions for patients of all ages. Being able to meet these needs now with SMOFlipid for pediatric patients demonstrates our dedication to innovation when it comes to helping patients thrive on parenteral nutrition.”
According to the analysis done by DelveInsight, the Intravenous Solution market will surge due to the rising prevalence of various diseases such as gastrointestinal diseases, neurological diseases, and cancer, where intravenous solutions are the main sources of energy for the patients. Furthermore, innovations in the product arena such as the introduction of premixed solutions for better convenience and to reduce the amount of packaging waste, and the availability of solutions in portable packages, which becomes easier for the patients to use the drips at the comfort of their home rather than a hospital is also expected to augment the market.
Sientra Gained Regulatory Nod to Market Breast Implants in Canada
On March 24, 2022, Sientra, Inc., a medical device company focused on enhancing lives by advancing the art of plastic surgery, received approval to market the Company’s line of smooth surface, High-Strength Cohesive (HSC and HSC+) silicone gel breast implants from the Health Canada.
The company will market its breast implants in Canada through its local partner Kai Aesthetic, a leading distributor of medical aesthetics products and technology.
Ron Menezes, President and Chief Executive Officer of Sientra said, “Health Canada’s approval of Sientra implants in Canada represents another significant milestone for the Company as we continue to strategically expand into international markets. As only the third silicone gel breast implant manufacturer approved in Canada—and the first in nearly two decades—we look forward to providing Canadian consumers with the latest generation technology backed by our clinically proven, unrivaled ten-year safety data,1 and our industry-leading Platinum20™ warranty.”
Dr. Julie Khanna, a plastic surgeon at ICLS in Oakville, Ontario, and past president of the Canadian Society of Plastic Surgeons commented, “After watching its development for close to 20 years, the introduction of this new breast technology into the Canadian market is exciting for plastic surgeons and their patients. With Sientra’s compelling 10-year safety data and low product complication rates, this is going to be a huge benefit for our patients.”
According to DelveInsight’s “Breast Implants Market” report, the global breast implants market was valued at USD 1.80 billion in 2020, growing at a CAGR of 7.00% during the forecast period from 2021 to 2026, to reach USD 2.70 billion by 2026. The increase in demand for breast implants is predominantly attributed to the growing incidence of breast cancer among the population across the globe. In addition, the rise in demand for cosmetic surgeries among women to enhance their aesthetic appeal could also be a potential factor in increasing the breast implants market.
Moreover, an increase in the number of breast augmentation surgeries and technological advancement in the product portfolio is expected to bolster the breast implant market during the forecasted period. In addition, as per the DelveInsight analysis, the silicone breast implant is anticipated to hold a significant market during the forecasted period. Silicone implants are particularly good for women who do not have much soft tissue coverage, offering a more natural, softer feel that is closer to natural breast tissue. Moreover, silicone gel implants come from the manufacturer pre-filled whereas saline implants are filled post-implantation. Thus, the advantages associated with a silicone breast implant are likely to boost the segmental growth of the market.
Vela Diagnostics Launched Two NGS-Based Pan-Cancer Panels
On March 28, 2022, Vela Diagnostics, a leading provider of integrated IVD system solutions launched new OncoKey® SL 60 and 525 Plus Panels based on Next-generation Sequencing (NGS) and are intended for the detection of DNA and RNA cancer biomarkers from formalin-fixed paraffin-embedded (FFPE) tissue specimens, for up to 64 samples in a single sequencing run.
With only 40 ng of nucleic acid the panel can detect the following biomarkers in one assay: single nucleotide variations (SNVs), insertions/deletions (INDELs), copy number variations (CNVs), microsatellite instability (MSI), fusions, splice variants, oncogenic viruses, and bacteria, as well as measuring the tumor mutation burden (TMB).
Moreover, these NGS-based panels are highly-automated and produce results within 5 days, requiring only 2.5 hours of hands-on time, and provide high sample traceability, from automated sample extraction to data quality control (QC). In combination with dual UMI-UDI adapters, hybrid capture target enrichment, sequencing by synthesis, and a thoroughly validated bioinformatics pipeline, the panels boast high sensitivity and comprehensive variant profiling, plus sequencing coverage uniformity. Both the panel’s workflow is wrapped around the Illumina sequencing platforms.
Dr. Andreas Goertz, Managing Director of Vela Diagnostics’ European organization, said, “ VELA’s OncoKey® 60 and 525 Plus Panels represent an exciting development in precision medicine for cancer. These panels consist of clinically relevant genes of interest and were designed based on input from key opinion leaders in oncology, as well as references to professional guidelines, curated clinical trials, and cancer databases.”
“Vela Diagnostics is planning to launch our OncoKey® 60 and 525 Plus Panels in Q4 2022 in the USA and the Asia Pacific. Using these panels on Vela Diagnostics’ automated workflow will reduce human error and minimize sample cross-contamination which can be generated by using a manual workflow. In addition, our VELA® Analytics solutions and services can identify and interpret genetic variants in tumors making it possible to provide actionable options for healthcare and research professionals quickly and accurately,” added Sam Dajani, CEO and Executive Chairman of Vela Diagnostics.
According to DelveInsight’s “Next-Generation Sequencing Market” report, the global Next-Generation Sequencing market was valued at USD 7.80 billion in 2020, growing at a CAGR of 18.96% during the forecast period from 2021 to 2026, to reach USD 22.03 billion by 2026. The increase in demand for Next-Generation Sequencing is primarily attributed to the rising cases of infectious diseases such as the sudden outbreak of COVID-19 and the escalating burden of cancer, worldwide. Moreover, the rising application of NGS technology in clinical diagnosis and scientific research, and advantages such as efficient turnaround results, high speed, and accuracy exhibited by the NGS technology, among others are some of the factors that would contribute to the global Next-Generation Sequencing market growth in the forthcoming years. Additionally, as per the analysis done by DelveInsight, the Asia Pacific region has the future potential for the Next-Generation Sequencing market. This is predominantly due to the burgeoning cases of various infectious diseases, and the growing cancer burden in the region. Moreover, the presence of regional companies focused on developing and manufacturing advanced NGS-based systems would propel the market during the forecasted period.
Synchron Declared Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode™ for Severe Paralysis
On March 29, 2022, Synchron, a clinical-stage brain interface platform company, declared positive results from a study that enrolled four people with ALS and received an implant of Synchron’s Stentrode™ device. The results of the study were presented at the American Academy of Neurology’s 74th Annual Meeting. Synchron is the only company to receive FDA approval to conduct clinical trials of a permanently implanted Brain-Computer Interface (BCI).
The Stentrode™ is a small mesh-like device attached with 16 sensors that expand to line the vessel wall. The device is inserted through a patient’s vein until it reaches the brain and does not require any invasive surgery. The device is connected to an electronic device in the chest that then relays the brain signals from the motor cortex, the part of the brain that generates signals for movement, into commands for a laptop computer.
During the study, the researchers monitored the enrolled participants for one year and found the device to be safe, with no serious adverse events that led to disability or death.
Thomas Oxley, MD, Ph.D., CEO & Co-Founder at Synchron said, “These results are a huge advancement for the field of BCI. We’ve shown that our endovascular BCI approach is safe, and allows patients to accomplish daily online tasks without invasive brain surgery. Years of research and technological development culminated at this moment, and as we continue to develop our technology, it has the potential to change the lives of millions of patients globally who suffer from paralysis and other debilitating neurological and brain-related diseases.”
According to the analysis done by DelveInsight, the Brain-Computer Interface market will propel owing to the increasing R&D for advancements in treatment options for chronic conditions such as cerebrovascular diseases, sleep disorders, brain disorders, and fatal injuries. Also, the rising number of government projects supporting the development of BCI and various technological advancements such as the miniaturization of devices, and others are expected to drive the market in the upcoming years.