Safra Catz, Chief Executive Officer, Oracle, said that they anticipate this acquisition to be gradually increased to Oracle’s earnings on a non-GAAP basis in the first full fiscal year after closing and contribute tremendously more to earnings in the second fiscal year and thereafter. Healthcare is the largest and most vital vertical market in the world with USD 3.8 trillion last year in the United States alone. Oracle’s revenue growth rate has already been growing this year, Cerner will be a further additional revenue growth engine for years to come as they expand their business into many more countries worldwide. That is exactly the growth strategy they adopted when they bought NetSuite except the Cerner revenue opportunity is even larger.
David Feinberg, President, and Chief Executive Officer, Cerner further added that joining Oracle as a dedicated Industry Business Unit offers an unprecedented opportunity to accelerate their work modernizing electronic health records (EHR), enhancing the caregiver experience, and enabling more connected, high-quality, and efficient patient care.
The transaction is anticipated to be completed in the calendar year 2022.
As per DelveInsight analyst, this transaction will help Oracle to become a market leader in the digital healthcare segment in the future as the digital healthcare segment has seen growth in the last few years and was further positively impacted by COVID-19.
Zynex announces enrollment of the first patient in a Hemodialysis clinical trial
On December 20, 2021, Zynex Inc, a medical device company focusing on the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced the initiation of enrollments for a hemodialysis clinical trial for their fluid monitoring system, CM-1500, approved by FDA in February 2020.
The study, set to be conducted at DaVita Clinical Research clinics, United States, is zeroed at further characterizing changes in the device’s patented Relative Index during hemodialysis procedures where a large volume of fluid is withdrawn from patients. The CM-1500 is a non-invasive monitor developed with the intention to monitor patients’ fluid balance in hospitals and surgical centers.
Donald Gregg, VP of Zynex Monitoring Solutions said that investing in clinical evidence is critically vital to clearly articulate how their device performs in various care settings, and the hemodialysis population is of particular interest owing to the controlled setting and known volume eliminated from patients on a regular basis.
The study is anticipated to finish enrollments in the first quarter of 2022.
BD completes acquisition of Scanwell Health
On December 21, 2021, BD (Becton, Dickinson and Company) finished the acquisition of the privately-held company, Scanwell Health Inc., renowned for their smartphone-enabled at-home medical tests, letting BD develop at-home diagnostic tests for a range of infectious diseases comprising COVID-19/influenza A+B, group A strep and additional menu for identifying infections and managing the chronic disease on Scanwell’s digital platform.
The is anticipated to give an edge to BD in terms of product and technology exclusivity as the Scanwell app is a key differentiator in the market for at-home COVID-19 testing. So far, no other company has deployed the phone’s camera to click the test’s image, which is then evaluated by the app. While other COVID-19 home tests utilise smartphones as part of their process, BD Veritor™ At-Home COVID-19 Test is the first and only test utilising smartphones as an analyzer to digitally comprehend the test results and offer a definitive POSITIVE or NEGATIVE digital display of testing results.
Dave Hickey, president of Life Sciences for BD., said that the COVID-19 pandemic has accelerated the shift to new care settings, and BD is ready to deliver a smart, connected at-home diagnostic ecosystem to bolster traditional and telehealth providers and consumers. This acquisition will let them expand and scale their digital capabilities in-house to accelerate the market for transformative at-home solutions now and in the future.
The terms of the transaction have not been revealed. Scanwell financial results will be covered under the Integrated Diagnostic Solutions business within the Life Sciences segment.
According to DelveInsight’s In Vitro Diagnostics Market & Competitive Landscape, the global In Vitro Diagnostics Market was worth at USD 67.82 billion in 2020, increasing at a CAGR of 4.17% during the forecast period from 2021 to 2026, to touch USD 86.35 billion by 2026. The in-vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics among others.
Sight Sciences obtains US FDA approval for the TearCare® System for treatment of Meibomian Gland Dysfunction (MGD) in Dry Eye disease
On December 22, 2021, Sight Sciences Inc received the 510(k) clearance from the US Food and Drug Administration (FDA) for the TearCare® System aimed at treating the meibomian gland dysfunction (MGD) which is considered as the leading cause of dry eye disease (DED). The indication clears TearCare for the application of localized heat therapy in adult patients with evaporative DED due to meibomian gland dysfunction when used in conjunction with the manual expression of the meibomian glands.
The TearCare System works by providing safe and effective localized heat therapy, in conjunction with manual gland expression and it is intended to help liquefy or soften thickened meibum for effective gland clearance. The TearCare System’s intuitive design delivers a consistent, optimum level of therapeutic heat (45 degrees Celsius) to the outer surface of the eyelids in order to achieve and maintain an inner eyelid temperature of 41-42 degrees Celsius which is crucial to melt meibum. The TearCare System comprises a reusable hardware controller, the SmartHub™, and a software-controlled eyelid technology called the SmartLids®.
The FDA clearance of this device is based on the data reported from multiple studies of the TearCare System, including recent safety and effectiveness clinical data from the pivotal OLYMPIA study. At one-month post-treatment in the OLYMPIA study, patients who received a single TearCare procedure showed significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score, which increased by 3.0 ± 4.4 seconds and 11.2 ± 11.1, respectively. TearCare subjects also showed significant reductions in mean eye dryness, Symptom Assessment in Dry Eye (SANDE), and Ocular Surface Disease Index (OSDI) scores (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5, respectively. In the study, 72% of TearCare patients showed OSDI improvement by at least one severity category, and 81% of TearCare patients met Miller’s definition of clinically meaningful improvement in OSDI.
Paul Badawi, Co-Founder, and CEO, Sight Sciences, said that MGD is the main cause of DED and can be serious complications for patients if left untreated, yet both the comprehension and meibomian gland dysfunction treatment as the underlying cause of dry eye is still evolving. They remain dedicated to bringing an insurance-recognized treatment option to the millions of underserved meibomian gland dysfunction patients.
According to DelveInsight’s Meibomian Gland Dysfunction Market, MGD is a highly prevalent disorder that may contribute to the demand for therapeutic devices along with conventional pharmaceutical treatments. The device may prove to be of great importance in patients with meiboman gland dysfunction and help inhibit the progression to dry eye disease.
According to DelveInsight’s Severe Dry Eye Market, approximately 16.4 million people in the United States have been diagnosed with dry eye disease (DED).
Labcorp to acquire Personal Genome Diagnostics
On December 23, 2021, Labcorp entered into a definitive agreement with Personal Genome Diagnostics Inc with the aim to acquire Personal Genome Diagnostics (PGDx), an established name in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products.
As per the terms of the agreement, Labcorp will pay USD 450 million in cash at closing and up to an additional USD 125 million on achieving future performance milestones.
This acquisition of PGDx and its technology would help Labcorp’s existing liquid biopsy capabilities and expand Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, thereby positioning Labcorp at the forefront of driving better patient outcomes in oncology. Labcorp’s global reach in turn is expected to benefit PGDx in terms of providing the opportunity to bring PDGx technology and products to pharmaceutical companies for clinical trial research to massively improve cancer treatments, potentially impacting clinical outcomes in millions of people with cancer.
Adam Schechter, chairman, and CEO of Labcorp said that Labcorp’s leadership and scale in diagnostic testing and drug development, coupled with PGDx’s innovative technology and suite of capabilities, will speed up access to personalized treatments for cancer patients globally. PGDx’s comprehensive portfolio of next-generation sequencing products will meaningfully add to their breadth of capabilities, in line with their strategic priority to lead in oncology. PGDx’s technology is well-positioned in a vital segment with strong growth prospects.
The transaction is anticipated to close in the first half of 2022.
According to DelveInsight’s In Vitro Diagnostics Market & Competitive Landscape, the global In Vitro Diagnostics Market was worth USD 67.82 billion in 2020, increasing at a CAGR of 4.17% during the forecast period from 2021 to 2026, to touch USD 86.35 billion by 2026. The in-vitro diagnostics market is estimated to show positive revenue growth due to the factors such as the increasing prevalence of various infectious diseases, the rising prevalence of various cancers, increasing hematological diseases cases, and growing product development activities with respect to in vitro diagnostics among others.
According to DelveInsight’s ‘Liquid Biopsy in Cancer Diagnostics Market & Competitive Landscape, the liquid biopsy market is estimated to showcase good revenue growth because of the factors such as the rising prevalence of cancer coupled with the increase in demand for fast, minimally invasive diagnostic tests, and rising product development activities with respect to in vitro diagnostics among others.
FDA grants Regulatory Clearance to Nobel Biocare N1™ Implant System
On December 27, 2021, Envista Holdings Corporation received regulatory clearance from the US Food and Drug Administration for their Nobel Biocare N1™ implant system.
N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New highlights of the system comprise an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance.
The Nobel Biocare N1™ system comprises the novel highlight of the OsseoShaper™, an instrument redefining site preparation and is set to reshape implantology with optimized workflows, better patient comfort, and faster treatment times. By gently ‘shaping’ the osteotomy at low speed and without irrigation, the OsseoShaper™ decreases noise and vibration compared to conventional drilling protocols. This leads to enhanced patient comfort and has been shown in pre-clinical studies to preserve vital bone.
Amir Aghdaei, Chief Executive Officer, Envista, stated that for over 50 years, Nobel Biocare has been a pioneering force behind implantology. The need for high-quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system lets clinicians set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can proffer to patients.
Patrik Eriksson, President of Nobel Biocare, mentioned that drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ offers a completely new approach designed for patient comfort, streamlined workflow, and enhanced predictability; while at the same time, respects biology to achieve fast osseointegration. They are happy to partner with clinicians to bring the N1 system to US-based patients.According to DelveInsight’s ‘Dental Implants Market & Competitive Landscape, the Dental Implants market is estimated to register negative growth owing to the effects of the COVID-19 pandemic which saw a drastic decrease in dental procedures and consultations.
