Minneapolis-based Relievant also claimed that its new tools provide more predictable and exact BVN targeting during Intracept.
The business built its newest instruments to perform predictably across a range of bone densities. Coming with bevel and diamond edges, that were added to facilitate consistent access with a depth marker for ideal positioning, Relievant also included a curved cannula assembly in its J-stylet when designing the instruments. True steerability is made possible by this, resulting in a predictable route to the BVN. The radiofrequency-delivering Intracept RF probe also got updated, and now had a flexible shaft, which increased the operating clearance for the C-arm, empowering physicians to access and target the BVN more easily.
President and CEO Tyler Binney said that the launch highlighted the company’s commitment to continued innovation. “We are pleased to announce the launch of several new instruments offering greater control, precision, and ease of use during the procedure,” said Binney. “These next-generation Intracept Access Instruments are purpose-built to enhance BVN access and procedural efficiency while consistently delivering positive outcomes.
As per DelveInsight’s “Bone Void Fillers Market” report, the global bone void fillers market was valued at USD 3,503.60 million in 2022, growing at a CAGR of 8.02% during the forecast period from 2023 to 2028 to reach USD 5,547.23 million by 2028. The demand for bone void fillers is primarily being boosted by the increasing prevalence of various orthopedic diseases such as osteoarthritis, osteoporosis, scoliosis, and bone tumor, among others. Further, the rising clinical limitations such as bone infection during surgical procedures, the rising focus of market players on increasing the R&D activities and the subsequent launch of antibiotic-eluting void fillers, rising statistics of dental diseases, increasing adoption of synthetic bone void filler, the rising burden of the geriatric population suffering from afore-said diseases, and the increasing product launches and approval across the globe among others are thereby contributing to the overall growth of the bone void fillers market during the forecast period from 2023-2028.
Thermo Fisher Rolled out Two New Research Use Reproductive Health Assays
On June 18, 2023, Thermo Fisher Scientific introduced two new research use reproductive health assays, the Ion ReproSeq PGT-A Kit and the Ion AmpliSeq Polyploidy Kit, for accelerating fertility research studies.
The next-generation sequencing-based assays were created to support preimplantation genetic testing-aneuploidy (PGT-A) used to guide intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) research. They were designed to run on the Ion Torrent Genexus Integrated Sequencer.
In order to improve future fertility treatment options, PGT-A testing is used in IVF and ICSI research to identify chromosomal abnormalities in embryonic samples. The ReproSeq PGT-A Kit can be used by researchers to investigate important scientific and genetic discoveries that are anticipated to improve future generations’ health and the chances of successful pregnancies.
Additionally, when the ReproSeq PGT-A Kit is used in conjunction with the add-on Ion AmpliSeq Polyploidy Panel kit, they have access to more quality control features. These characteristics make it possible to identify triploidy in embryos, identify contamination, and prevent sample mix-ups.
Thermo Fisher Scientific’s clinical next-generation sequencing and oncology president, Garret Hampton said, “Building on Thermo Fisher’s existing reproductive health offerings, today’s launch brings the benefits of next-generation sequencing to more research labs with the potential of rapid, in-house testing and analysis. Considering the far-reaching implications for those struggling with infertility, researchers must have reliable and accurate testing available to advance the fertility field and ultimately improve reproductive health for all.
According to DelveInsight’s “Next-Generation Sequencing Market” report, the global next-generation sequencing (NGS) market was valued at USD 9.28 billion in 2022, growing at a CAGR of 18.96% during the forecast period from 2023 to 2028, to reach USD 26.30 billion by 2028. 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.
EarliTec Diagnostics Received FDA 510(k) Authorization for Next-Generation EarliPoint Evaluation for Autism Spectrum Disorder
On June 13, 2023, EarliTec Diagnostics, Inc., a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood vulnerabilities, announced that the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder for children ages 16 to 30 months received FDA 510(k) authorization.
Additionally, EarliTec announced the commercial launch of EarliPoint, enabling the company to collaborate with providers on the introduction of EarliPoint Evaluation and advancing its mission to make earlier and more effective diagnosis and treatment of Autism Spectrum Disorder available to all children.
The updated EarliPoint Evaluation is carried out by licensed healthcare professionals and uses a portable tablet to show scenes of social interactions. More than 120 focal preferences are measured every second by eye-tracking technology. These data are compared using patented analysis technology to age-expected reference metrics to see if the child is missing important social learning opportunities. Clinicians have a timely, objective, and accurate reading of the presence of autism, the severity of the child’s social disability, and the child’s level of verbal ability and non-verbal learning after reviewing the data, which includes a personalized and detailed report with visualizations from the test.
The technology from EarliTec measures a child’s moment-to-moment looking behaviour, which is otherwise invisible to the human eye, to quantify social-visual engagement.
By providing EarliPoint Severity Indices that correlate with levels of social disability, verbal ability, and non-verbal learning as determined by clinicians using the most recent gold-standard tools, EarliTec’s EarliPoint Evaluation can help in the early detection of Autism Spectrum Disorder.
EarliPoint offers the first objective Autism Spectrum Disorder diagnostic and assessment tool for providers by directly measuring a child’s moment-by-moment preferential attention to crucial social information in the environment.
Early diagnosis can make all the difference in helping children with autism get the support they need to develop essential language and communication, social, and cognitive skills. The brains of infants and young children show remarkable neuroplasticity, forming millions of neural connections as they learn and experience new things like social interaction,” said Sarabeth Broder-Fingert M.D., M.P.H. and a member of EarliTec’s Clinical Advisory Board. Sarabeth also said, “By enabling clinicians to make earlier diagnoses, EarliPoint has the potential to help families take advantage of this plasticity and tailor interventions to help their children as needed to ultimately live their best and happiest lives. EarliPoint also holds the potential to enhance equity in autism diagnosis. The current standard of care leads to substantial inequity, I am optimistic that EarliPoint’s accessible design will allow for more equitable diagnosis and treatment.
Although the prevalence of autism is growing, our healthcare system is missing a critical developmental window for children. Our goal is to help parents and care providers access earlier autism diagnosis during the life stage when interventions can be most impactful,” said Tom Ressemann, EarliTec’s Chief Executive Officer. Tom Ressemann added, “In most cases, EarliPoint Evaluation can be completed in an existing appointment. With EarliPoint’s efficiency, we anticipate that providers can shrink waitlists and help caregivers understand more quickly if their child has Autism Spectrum Disorder. We are focused on building more equitable access to early diagnosis. The next generation of EarliPoint marks an exciting milestone in our work toward a more rewarding life for all children with Autism Spectrum Disorder and their families.
According to DelveInsight’s “Digital Health Market” report, the global digital health market was valued at USD 178.37 billion in 2022 and is estimated to grow at a CAGR of 18.25% during the forecast period from 2023 to 2028 to reach USD 486.55 billion by 2028. The digital health market is observing remarkable market growth due to the growing awareness and adoption of digital healthcare, rising demand for IoT, Artificial Intelligence, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries along with the increasing product or service launches & approvals, and the presence of key players in the market, among others will create a requisite for the digital health in the market. Therefore, the market for digital health is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.
FDA Cleared ReddyPort® Non-Invasive Ventilation Device
On June 18, 2023, ReddyPort announced that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV).
A self-sealing valve on ReddyPort’s elbow enables seamless oral access to the patient’s mouth without the need to remove the mask, lowering the possibility of therapeutic pressure loss and maintaining lung compliance.
ReddyPort’s elbow gives bedside clinicians the ability to use the company’s oral care products (toothbrush, Yankauer, suction swab, and applicator swabs) for routine Q2/Q4 oral care and dry mouth relief while minimizing unforeseen mask removal, which frequently results in improperly fitted masks, pressure sores, and time-consuming re-fitting procedures.
Patients and medical professionals can use the ReddyPort elbow to use the ReddyPort microphone.
The ReddyPort System, which is centered on the ReddyPort elbow, supports the success of NIV by giving clinicians quick access to deliver oral care, without the need for mask removal or loss of therapeutic pressures.
“ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition,” said Tony Lair, ReddyPort CEO.
According to DelveInsight’s “Surgical Mask & Respirator Market” report, the global surgical mask and respirator market is estimated to grow at a CAGR of 5.31% during the forecast period from 2023 to 2028. The increase in demand for surgical masks and respirators is primarily attributed to the increasing number of surgeries due to the increasing prevalence of chronic disorders. Further, the surge in epidemic and pandemic outbreaks will increase the overall market of surgical masks and respirators, as these devices are used to prevent the transmission of the virus. Additionally, the increasing prevalence of airborne and respiratory disorders due to excessive exposure to pollution and chemicals across the world is anticipated to bolster the market, thereby contributing to the growth of the surgical mask and respirator market during the forecast period from 2023-2028.
EndoTheia Announced Successful Clinical Study Results for a Novel Medical Device for Endoscopic Surgery
On June 18, 2023, EndoTheia, Inc., announced the successful completion of the first-in-human clinical study performed at Vanderbilt University for their groundbreaking technology, radically improving minimally invasive endoscopic surgery.
All primary and secondary endpoints were successfully met, and there were no negative side effects, as reported by EndoTheia. The FDA recently named EndoTheia’s ENT endoscopic surgery technology a Breakthrough Device, which was followed by the company’s announcement.
The FDA issued a “call to action” asking medical device manufacturers to develop new, reasonably priced, disposable devices to treat biliary disease in response to alarming infection rates in reusable duodenoscopes that are challenging to sterilize. EndoTheia’s new device is intended to address this call.
“EndoTheia is proud to have been able to respond to this call-to-action from the FDA in a unique and outside-the-box way,” said Robert J. Webster, III, Ph.D., Co-Founder and President of EndoTheia. Robert J. added, “We took a look at what others were doing within the space and saw mostly incremental advancements and/or costly fully disposable endoscope solutions.”
“EndoTheia is pleased to report the success of this first-in-human clinical study. It is a major milestone for EndoTheia and for the 700,000 patients suffering from the biliary disease per year domestically,” stated Joshua Gafford, PhD, Co-Founder, and Chief Technology Officer of EndoTheia. He added, “We are deeply appreciative of the patients and clinical investigators who participated in this study, and look forward to the broad clinical impact of this technology following FDA clearance.”
Dr. Keith Obstein, Professor of Medicine, Division of Gastroenterology at Vanderbilt University Medical Center, noted, This device enabled us to clearly visualize the duodenal papilla en face with a standard forward-viewing endoscope, which normally would not be possible, and has the potential to eliminate the risk of infection from reusable duodenoscopes. This would be a huge win for patients, hospitals, and healthcare systems.
According to DelveInsight’s “Disposable Endoscopes Market” report, the global disposable endoscopes market was valued at USD 1.69 billion in 2022, growing at a CAGR of 12.44% during the forecast period from 2023 to 2028 to reach USD 3.41 billion by 2028. The demand for disposable endoscopes is primarily being boosted by the increasing prevalence of various disorders related to the gastrointestinal tract, respiratory tract, and others amongst the population and the onset of the COVID-19 pandemic that has raised the market for disposable endoscopes contributing to the overall growth of the disposable endoscopes market during the forecast period from 2023-2028.
Neurolief Announced Positive Results from the MOOD Trial Interim Analysis: Brain Neuromodulation Therapy for Major Depressive Disorder
On June 18, 2023, Neurolief, a medical neurotechnology innovator focused on neurological and neuropsychiatric disorders, announced positive results from a planned interim analysis of the ongoing randomized controlled MOOD pivotal trial. MOOD is studying Relivion®DP, a new novel neuromodulation therapy for the treatment of Major Depressive Disorder (MDD).
A neuromodulation system called Relivion®DP was given the FDA’s Breakthrough Device Designation for its cutting-edge technology to treat depression. The patient wears the device on their head to receive treatments, much like a headset. The device uses three adaptive output channels to send small electrical pulses to the brainstem through six occipital and trigeminal nerve branches. This mechanism modifies brain networks linked to mood and stimulates neurotransmitter release in the brainstem.
Relivion®DP, a component of a digital therapeutics platform, enables psychiatrists to remotely monitor patients, analyze their data, and personalize treatments to improve outcomes. It does this using a dedicated smartphone app and a cloud database.
The MOOD clinical trial is a prospective, multi-centered, placebo-controlled, randomized double-blind clinical trial that is being conducted in 12 clinical sites across the US and one in Israel. The primary endpoint of the study evaluates changes in depressive symptoms in patients with major depressive disorder who have not responded satisfactorily to prior antidepressant treatments from baseline to eight weeks after treatment initiation when using Relivion®DP in comparison to the control group.
The independent Data Monitoring Committee (DMC) of the study reviewed statistical findings from an interim efficacy and safety analysis that was planned in advance. The DMC recommended that patient enrollment be continued up to the final planned sample size based on data from 80% of the initially planned study sample size because the interim results are positively favorable. After the final patient has finished the treatment protocol, which is anticipated in the second quarter of 2024, the full study results will be made public and submitted to the FDA and CE.
The successful results of this planned interim analysis are an extremely important milestone for our company,” stated Scott Drees, Chief Executive Officer of Neurolief. Scott Drees further added, MDD is a debilitating condition of epidemic proportion with severe negative impact on patients and humanity. Making this new promising therapy available is a top priority for Neurolief. It has the potential to be life-changing for treatment resistant depression (TRD) patients whose symptoms do not sufficiently improve with antidepressant medications. We can now progress toward making Relivion®DP available to the millions of patients in desperate need.
According to DelveInsight’s “Neuromodulation Devices Market” report, the global neuromodulation devices market was valued at USD 5.71 billion in 2022, growing at a CAGR of 8.95% during the forecast period from 2023 to 2028, to reach USD 9.56 billion by 2028. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.
