Maria Perez
Maria is an experienced writer, providing content for Healthcare Industry News since 2021. Working as a senior writer, Maria focuses on news reporting, making the complex healthcare topic comprehensible for readers. Maria’s expertise and dedication to delivering accurate stories make him a trusted source on our site.
by Maria Perez | Apr 12, 2024 | Digital Health
The European Commission’s recent approval of Illumina’s divestment plan for GRAIL is a big development in the biotechnology sector, particularly in the area of genetic and cancer screening technologies. Under the terms agreed upon with the Commission, Illumina is set to ensure GRAIL’s operational independence, primarily by capitalizing the entity with approximately $1 billion. This move is intended to sustain GRAIL for roughly two-and-a-half years, providing a more moderate financial burden than the potential $2 billion forecasted in worst-case scenarios by financial analysts at Evercore ISI. This capitalization represents the European Commission’s strict requirements for corporate divestitures and highlights the regulatory hurdles companies must overcome in high-stakes biotech separations. The decision to either conduct a trade sale or a spin-off remains on the table, with the latter freeing Illumina from further financial obligations towards GRAIL post-divestment.
The financial intricacies of this divestment are particularly notable. Illumina, which concluded the previous fiscal year with $1.05 billion in cash reserves, might need to secure an additional $500 million to $1 billion through new debt instruments to meet the capitalization requirements for GRAIL. This perspective, shared by Evercore analysts, suggests that the financing challenges are manageable within the broader financial strategy of Illumina. The flexibility offered by the European Commission in this regard allows Illumina to navigate its fiscal and strategic priorities effectively, potentially through a mix of asset sales or spin-offs without strict price or payment structure mandates. This approach could enable Illumina to adjust its strategies in response to market conditions and regulatory landscapes, which is important in maintaining investor confidence and operational continuity.
The broader implications of the European Commission’s decision extend beyond financial structuring to impact Illumina’s strategic market positioning. According to analysts from Leerink Partners, this approval is a step forward for Illumina as it seeks to refocus on its core operations amidst challenging macroeconomic conditions and escalating market competition. The biotech industry, especially sectors involved in clinical and genetic research, is marked by rapid innovation and regulatory complexities. By divesting GRAIL, Illumina could streamline its operations and concentrate resources on enhancing its technological offerings and market reach. This realignment is intended to optimize Illumina’s product lifecycle and competitive stance, particularly as it navigates the demands of clinical end-markets and the evolving regulatory frameworks governing genetic research and diagnostics.
The structural and strategic nuances of the divestment process reveal the balance companies like Illumina must achieve between regulatory compliance and business objectives. The European Commission’s oversight, while ensuring fair competition and market health, also imposes certain constraints that Illumina must navigate. This includes the limitation of retaining up to a 14.5% ownership stake in GRAIL, a condition set to ensure the independence of GRAIL post-divestment. Such regulatory conditions are necessary for shaping the competitive dynamics within the biotech industry and defining the pathways through which companies like Illumina can pursue growth and innovation. By adhering to these guidelines, Illumina aims to enhance its corporate governance and strategic focus, reinforcing its leadership position in the genomic research and diagnostics markets. This scenario shows the complexities between innovation-driven market strategies and regulatory frameworks in shaping the future trajectories of leading biotech entities.
by Maria Perez | Apr 11, 2024 | Artificial Intelligence
Roche has recently solidified a partnership with Prenosis to distribute its AI sepsis detection tool, Sepsis ImmunoScore, across the United States. This diagnostic tool, which has received FDA De Novo authorization, marks an advancement in the battle against sepsis, a condition noted for its high mortality rate, accounting for one in every three hospital deaths annually and affecting an estimated 1.7 million American adults each year. Integrated into Roche’s Navify Algorithm Suite, the Sepsis ImmunoScore utilizes a sophisticated algorithm that evaluates up to 22 patient-specific parameters, including vital signs like respiratory rate and blood pressure, along with lab-based biomarkers such as Procalcitonin. This integration allows the algorithm to assess the likelihood of a patient developing sepsis within 24 hours, providing a timeframe for potential life-saving intervention. The inclusion of this tool in the Navify suite shows an effort to streamline access to validated medical algorithms, enhancing diagnostic precision and allowing timely medical responses.
The ongoing collaboration between Roche and Prenosis, which began in 2020 and expanded in 2021, has focused on making the Sepsis ImmunoScore widely available in the U.S. healthcare market. By incorporating this AI tool into the Navify Algorithm Suite—a platform launched in April 2023—Roche has broadened the utility of its diagnostic offerings and created a channel for healthcare providers to seamlessly integrate these advanced tools into existing workflows. This platform is designed to be embedded within existing medical record software and information systems, ensuring compliance with global data regulations and enhancing user accessibility. The suite features Roche’s clinically validated algorithms and is open to third-party software developers, offering a solution that covers various disease areas. This approach simplifies the integration process for healthcare facilities and enhances the functionality and appeal of the Navify platform, enabling more efficient decision-making and potentially transforming patient outcomes across multiple clinical settings.
The development of the Sepsis ImmunoScore by Prenosis is the result of extensive research and collaboration with multiple hospital systems over a decade, aimed at building the largest proprietary biobank and dataset for fast-moving immune responses in acute care settings. This dataset now includes over 100,000 blood samples from more than 25,000 patients across ten health systems in the United States. By using this unique and extensive dataset, Prenosis has been able to enhance the typical hospital clinical datasets by adding biological data, enabling the rapid development of a suite of AI diagnostics and precision therapeutics specifically tailored for acute care environments. The Sepsis ImmunoScore itself uses this dataset to categorize patients into four discrete risk stratification levels, providing clinicians with an actionable understanding of sepsis risk. This stratification aids in the early detection of sepsis and helps allocate medical resources more effectively, which is necessary for improving sepsis outcomes and reducing related healthcare costs.
Roche’s partnership with Prenosis goes beyond the mere technological innovation embodied in the Sepsis ImmunoScore. It represents a shared commitment to advancing healthcare through precision medicine and the ethical application of AI. The extensive market reach of Roche Diagnostics combined with the clinical utility of the Sepsis ImmunoScore promises to broaden access to this tool, enabling a greater number of hospitals and healthcare providers to implement it responsibly. This collaboration is poised to impact the healthcare landscape by enhancing the accuracy of sepsis diagnosis and streamlining clinical workflows. As both companies continue to leverage their respective strengths, Roche in diagnostic reach and regulatory compliance, and Prenosis in precision medicine and AI analytics, their partnership will allow future advancements in the urgent and ongoing fight against sepsis.
by Maria Perez | Apr 8, 2024 | Digital Health, Telehealth News
Grow Therapy has recently secured $88 million in funding, a move aimed at expanding its reach and building new partnerships within the healthcare sector. Launched in October 2020, Grow Therapy has emerged as a key player in the mental health care industry, offering in-depth solutions to both therapists and patients seeking accessible and effective care. Led by Sequoia Capital, with contributions from Goldman Sachs Alternatives and PLUS Capital, alongside support from artists and athletes including Anna Kendrick, Lily Collins, Dak Prescott, Joe Burrow, Jrue Holiday, and Lauren Holiday, this Series C funding round marks a milestone for the company. It follows previous successful funding rounds, bringing Grow Therapy’s total funding to an impressive $178 million within just three years since its inception.
The mission of Grow Therapy is to allow individuals access to quality mental health support regardless of their background, location, or financial circumstances. CEO Jake Cooper emphasizes the pressing need for such accessibility, highlighting the company’s commitment to building an environment where people can easily find trusted and affordable care while also creating sustainable and rewarding careers for therapists. At the heart of Grow Therapy’s offerings is its three-sided platform, which provides integrated software and services catering to patients, providers, and payers alike. This includes features such as seamless patient-provider matching, insurance billing, electronic health records (EHR), telehealth software, and care navigation. By assisting mental health therapists in establishing private practices covered by insurance, Grow Therapy aims to bridge the gap between demand and accessibility in mental health care.
An important aspect of Grow Therapy’s recent advancements is its enhanced measurement-informed care infrastructure, designed to elevate the care experience for both clients and providers. This new technology stack includes proprietary telehealth infrastructure for in-session support, a system for measurement-informed care delivery, and enhancements to features available for providers delivering care in-person or via telehealth. Grow Therapy’s platform boasts impressive statistics, having facilitated over 3 million patient visits, with 94% of them in-network. With a network of more than 12,000 providers across various specialties, the company operates in 24 states, offering care both in-person and via telehealth. The startup prides itself on achieving quick time-to-care, high satisfaction rates, and symptom reduction, particularly for moderate to severe cases.
The timing of Grow Therapy’s expansion aligns with a growing recognition of the importance of mental health care, as evidenced by recent guidelines from the U.S. Preventive Services Task Force recommending routine screenings for anxiety across different age groups. With half of young adults reporting symptoms of anxiety and depression, there is a clear necessity to improve access to mental health services, a focus of Grow Therapy’s operations.
In response to the evolving nature of mental health care, Grow Therapy is dedicated to ensuring that insurance covers these necessary visits, addressing the challenges posed by fragmented legacy systems. Partnering with over 75 insurers, including major players like Aetna, Humana, and UnitedHealth, the company is committed to facilitating access to trusted mental health care while allowing therapists to build and scale their practices effectively. As Grow Therapy continues to innovate and expand its offerings, supported by funding and a growing network of stakeholders, it stands at the front of a shift in mental health care delivery. With a focus on accessibility, effectiveness, and sustainability, the company is poised to make a meaningful impact on the well-being of individuals and communities nationwide.
by Maria Perez | Apr 8, 2024 | Healthcare Industry News
KnowBe4, a leading provider of security awareness training and simulated phishing platforms, has recently published its 2024 Security Culture Report, offering valuable insights into the evolving security situation, particularly within North American organizations. This comprehensive study examines how cybersecurity initiatives related to the human element impact organizational behaviors and attitudes towards security. Defined by KnowBe4 as the collective mindset, practices, and norms influencing an organization’s approach to security, security culture is key to mitigating human-based risks. The report reveals that while the overall security culture score globally remains at a low-moderate level, there is a clear trend toward integrating cybersecurity initiatives beyond just technology controls, highlighting the growing recognition of the responsibility that people bear in promoting a strong security culture.
The 2024 Security Culture Report points out great disparities in security culture performance across various industries in North America. While organizations in the insurance, financial services, and banking sectors demonstrate robust security cultures, smaller organizations outperform larger counterparts, attributed to more efficient leadership communication and a greater sense of individual responsibility. However, despite being prime targets for cybercriminals, sectors such as government, manufacturing, and education struggle to adhere to adequate standards, contributing to a slight dip in the overall security culture score. This disparity emphasizes the need for organizations, especially those heavily targeted by cybercriminals, to prioritize security culture and invest appropriately in reducing human-based risk.
The healthcare and pharmaceuticals sector, characterized by its handling of highly sensitive personal information and stringent compliance obligations such as those mandated by HIPAA, has become acutely aware of the importance of security culture. The industry’s adaptation to evolving healthcare practices, including the widespread adoption of telehealth and remote patient monitoring, has required an increased emphasis on robust cybersecurity measures to safeguard patient data. However, this change has also exposed vulnerabilities within the sector, with cybercriminals seizing the opportunity to target remote workers accessing corporate networks through personal devices.
Despite the sector’s comprehensive understanding of risk management, evidenced by its response to emerging threats, the KnowBe4 report highlights persistent vulnerabilities within the healthcare and pharmaceuticals industry. The sector maintains a consistent performance level, with a security culture score of 73, aligning with last year’s results. However, this apparent confidence belies the fact that the sector remains vulnerable to data breaches, as demonstrated by the IBM Cost of a Data Breach Report 2023, revealing that the healthcare and pharmaceutical industries face the highest average cost of data breaches compared to other sectors. The report further highlights on notable incidents within the healthcare sector, including high-profile cyberattacks such as the breach affecting 11 million patients at the for-profit HCA Healthcare and the ransomware attack on Ardent Health Services, which led to service disruptions across multiple hospitals. Healthcare organizations have also fallen victim to attacks initiated through their vendors and contractors, emphasizing the pervasive vulnerability within the sector. In the pharmaceutical industry, data breaches are primarily attributed to malicious attacks (45%), human error (28%), and IT failures (27%), with threat actors exploiting avenues such as phishing, compromised credentials, and cloud misconfigurations.
While the Healthcare and Pharmaceuticals sector has demonstrated promising improvements in specific dimensions of security culture, including attitudes, behaviors, and norms, there remain critical areas that necessitate improvement. Notable enhancements include single-point improvements in attitudes (76), behaviors (77), norms (74), and responsibilities (69), along with a two-point increase in comprehension (75), indicating an increased understanding of security matters among employees. However, there is still room for improvement, particularly in developing increased awareness and accountability among employees in the areas of cognition (70) and responsibilities. Cultivating a robust security culture becomes a priority to effectively mitigate risks, protect sensitive patient information, and uphold regulatory compliance standards as the healthcare sector continues to withstand with cybersecurity challenges.
by Maria Perez | Apr 8, 2024 | Digital Health
Synchron is making progress with the launch of a patient registry aimed at paving the way for a groundbreaking brain implant trial. With its headquarters in New York City, Synchron has been developing innovative technology to compete with Elon Musk’s Neuralink, gaining support from prominent figures like Bill Gates and Jeff Bezos. Their latest achievement involves the deployment of a patient registry to facilitate the preparation for a large-scale clinical trial necessary for seeking regulatory approval from the Food and Drug Administration (FDA).
Synchron’s journey into the BCI industry has been marked by its development of the Stentrode device, a groundbreaking innovation intended to allow individuals with limited mobility to operate digital devices through neural signals. The attention the technology has gained from investors such as Bill Gates’ and Jeff Bezos’ investment firms, indicates recognition of its potential impact. Synchron’s decision to establish a patient registry shows its commitment to collaboration and transparency within the healthcare community as it progresses towards regulatory approval.
Synchron’s innovation is shown through its Stentrode device, designed to enable individuals with limited mobility to operate digital devices using their thoughts. What sets the Stentrode apart from its competitors is its minimally invasive implantation procedure, eliminating the need for open brain surgery. Through an endovascular technique, the device is implanted via the jugular vein and positioned atop the motor cortex, the brain region responsible for movement. Once in place, the Stentrode expands to press electrodes against the vessel wall, allowing it to record neural information and deliver currents to targeted areas. The signals captured by the Stentrode are then transmitted wirelessly to an external receiver, forming a seamless interface between the brain and external devices. The efficacy and safety of such technology necessitate clinical trials, prompting Synchron to begin recruiting participants for an in-depth study. CEO Thomas Oxley revealed plans to include “dozens of participants” in the trial, with interest already expressed from numerous clinical trial centers.
Synchron’s initiative aligns with the broader landscape of BCI technologies, where companies like Neuralink and Blackrock Neurotech are also making strides in similar domains. Despite the promising potential of BCI, challenges persist, as highlighted by a 2022 report from the U.S. Government Accountability Office citing the complexity of individualized brain signals. Despite this, the prospect of restoring functionality to individuals with severe paralysis through BCI remains an exciting area in medical innovation.
Synchron’s commitment to community engagement is evident through the establishment of a community-centered BCI registry, allowing collaboration among patients, caregivers, and clinicians. This initiative serves as a platform for knowledge sharing and shows the grassroots movement surrounding BCI technology. As the company prepares for the next phase of clinical trials, the registry will play an important role in maintaining connectivity and facilitating informed decision-making among stakeholders. Synchron’s operations show a shift in healthcare, where neurotechnology holds the promise of transforming the lives of individuals with motor impairments. Through their innovative approach and commitment to advancing BCI technology, Synchron is poised to make contributions to the field, offering hope and autonomy to those in need.
