<div>
  <ul>
    <li>
      <p>
        Guardant Health Japan has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Guardant360 CDx to be used as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy.
      </p>
    </li>
    <li>
      <p>
        Guardant360 CDx uses next-generation sequencing to provide comprehensive genomic profiling of cancer-related genes. The test is expected to offer a solution for the limitations of tissue biopsies and allow the collection of timely clinical data to provide patients with personalized treatment plans.
      </p>
    </li>
    <li>
      <p>
        <b>Analyst QuickTake: </b>
        The Guardant360 CDx liquid biopsy test is used to detect genomic alterations in cancer patients by analyzing circulating tumor DNA (ctDNA) in the blood. This test helps in identifying specific genetic mutations that can guide targeted therapy decisions for multiple types of cancer, including ESR1 mutations in ER+, HER2-advanced, or metastatic breast cancer. In August 2023, the test received 
        <a href="https://sp-edge.com/updates/20679">
          regulatory approval in Japan
        </a>
         to be included in treatments for patients with advanced solid tumor cancers.
      </p>
    </li>
  </ul>
  <p>
  </p>
</div>


<div>
  <p>
    <a href="https://www.prnewswire.com/apac/news-releases/guardant-health-japan-receives-regulatory-approval-of-guardant360-cdx-liquid-biopsy-as-companion-diagnostic-for-amivantamab-vmjw-to-identify-patients-with-inoperable-or-recurrent-nsclc-harbouring-egfr-exon-20-insertion-mutations-302234725.html">
      <b>Press release</b>
    </a>
  </p>
  <p>
  </p>
</div>


Precision Medicine

ANALYST_QUICK_TAKE

PROMINENT_CATEGORY

<div>
 <p>Guardant Health Japan secured approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for their Guardant360 CDx. This is intended as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC). The goal is to aid considerations for treatment with amivantamab-vmjw combined with chemotherapy. </p>
 <p>The Guardant360 CDx utilizes next-generation sequencing lending itself to comprehensive genomic profiling of cancer-related genes. The test is designed to overcome the complications associated with tissue biopsies and it facilitates the collection of vital clinical data, with the goal of creating personalized treatment plans for patients. </p>
</div> <p><b>Analyst QuickTake:<br>
 </b> The Guardant360 CDx liquid biopsy test is used to detect genomic alterations in cancer patients by analyzing circulating tumor DNA (ctDNA) in the blood. This test helps in identifying specific genetic mutations that can guide targeted therapy decisions for multiple types of cancer, including ESR1 mutations in ER+, HER2-advanced, or metastatic breast cancer. In August 2023, the test received <a href="https:<br>
//sp-edge.com/updates/20679"> regulatory approval in Japan </a> to be included in treatments for patients with advanced solid tumor cancers.</p>

Guardant Health Japan receives approval to use Guardant360 CDx as a companion diagnostic

Additive manufacturing makes objects by systematically adding material via a CAD program

Additive Manufacturing

<div>
 
 <p>6K Additive, a supplier of additive manufacturing materials, has been chosen by America Makes, an institution that collaborates on 3D printing projects in the US, to participate in the "Powder Alloy Development for Additive Manufacturing (PADAM)" project.</p>
 <p>The project, endowed with six million dollars from the Air Force Research Laboratory, aims to enhance the cost-efficiency and effectiveness of the production of niobium C-103 powder for laser powder bed fusion and directed energy deposition (DED) 3D printing processes. Additionally, it aims to extend the source pool and utilize a wider range of particle sizes for C-103, a niobium alloy utilized in high-temperature applications. The project will also include collaboration with Castheon, NASA Glenn Research Center, NSL Analytical, Lockheed Martin, and Firefly Aerospace.</p>
 <p>&nbsp;6K Additive plans to use its proprietary UniMelt microwave plasma process to generate C-103 powders from revert sources, reportedly enhancing efficiency in high-temperature and space applications.</p>
 
</div> <p><b>Analyst Quicktake:<br>
 </b> This news marks the second time that American Makes has selected the company to participate in one of its projects. Last month, the company <a href="https:<br>
//sp-edge.com/updates/32452"> partnered with RTX Technology Research Center and the University of Arizona </a> as part of the EARTH project under America Makes and the National Center for Defense Manufacturing and Machining to make aerospace and defense product manufacturing more sustainable.</p>

6K Additive awarded project to develop C-103 powder for additive manufacturing

<div>

<p>Innovative Space Carrier (ISC), a company in Tokyo specializing in space transportation systems, has entered into a partnership with WAAM3D, Cranfield University, and Aichi Sangyo. All these organizations bring different specialties to the table - WAAM3D is a metal AM solutions provider, while Aichi Sangyo is known for their metal 3D printers. The collaboration aims to develop reusable space transportation vehicles.</p>
<p>The partnership will allow ISC to procure 3D printers from WAAM3D in Japan for the purpose of creating propellant tanks and other necessary components for space transport. This should contribute to the flexibility and efficiency of the development process.&nbsp;</p>

</div>

WAAM3D partners with Innovative Space Carrier, Cranfield University, and Aichi Sangyo for space transport development

Using real-time data to create dynamic virtual representations of the real world

Digital Twin

<div>
 <p>Akselos, a provider of digital twin technology, has launched a new software called Structural Performance Management for FPSO 4.0. The software is designed for Floating Production Storage and Offloading (FPSO) vessels and aims to enhance their operations and longevity.</p>
 <p>The software offers several benefits including a reduction in operating costs, optimal planning for inspections and maintenance, minimal downtime, and faster resolution of structural issues. Utilizing RB-FEA technology, the software produces millimeter-level precision for monitoring structural integrity. It develops a digital twin of the FPSO and has the capability to integrate various data such as inspection, metocean, tank fills, and unloading.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> Akselos has entered partnerships to offer digital twin solutions for FPSOs in the past. Last September, the company partnered with <a href="https:<br>
//sp-edge.com/updates/21998"> Yinson Production and Enauta </a> to deploy Akselos' digital twin technology on the floating vessel Atlanta FPSO in Brazil's Santos Basin.</p>

Akselos introduces software for FPSO monitoring

Membership-based, non-insurance healthcare companies helping maintain a steady state of well being.

Preventive Healthcare

<div>
 <p>Alex Therapeutics, a digital health provider, is partnering with Navamedic, a pharmaceutical company from Sweden, to create a companion app specifically designed to manage Parkinson's disease treatment. </p>
 <p>This application will offer patients who are taking Flexilev, a prescription medication for Parkinson's, assistance in managing their medication. This will augment the function of the OraFID dose dispenser, creating a unique combination to promote adherence to personalized treatment schedules. With its initial launch in Sweden, Norway, and Denmark planned within the next year, there are also plans for this app to be expanded globally in future.</p>

</div> <p><b>Analyst QuickTake:<br>
 </b> In <a href="https:<br>
//www.prnewswire.com/news-releases/pfizer-and-alex-therapeutics-announce-a-strategic-commercial-partnership-to-provide-evidence-based-digital-therapeutics-to-patients-starting-in-germany-301471350.html"> January 2022 </a> , the company partnered with Pfizer to develop a digital therapeutics (DTx) app to treat nicotine addiction. The company had also partnered with Vicore Pharma to develop a DTx for treating anxiety and depression in patients with idiopathic pulmonary fibrosis.</p>

Alex Therapeutics partners with Navamedic to develop Parkinson's disease companion app

Disrupting the traditional financial system using blockchain

Decentralized Finance (DeFi)

<div>
 
 <p>The DeFi infrastructure provider, INFINIT, has successfully procured USD 6 million in a funding event. This round of funding was spearheaded by Electric Capital and Mirana Ventures, with contributions from other entities such as Hashed, Lightspeed Faction, Robot Ventures among others.</p>

 <p>INFINIT provides a unique DeFi abstraction layer to facilitate the creation and expansion of decentralized applications across unified blockchain networks. This layer allows users to create a variety of DeFi applications, such as decentralized exchanges, yield protocols, and perpetual platforms. It also simplifies the development process by removing the need to code in intricate languages like Solidity or Rust. Instead, users can utilize TypeScript to add new features to existing applications or even create brand new applications.</p>

</div>

INFINIT raises USD 6 million in funding to enhance infrastructure

Automation to improve business efficiency

Workflow Automation Platforms

INCUMBENTS_PRESENT

<div>
 
 <p>Salesforce announced the introduction of Agentforce, a range of automated solutions powered by artificial intelligence. These solutions are intended to facilitate automation across various domains such as service, sales, commerce, and marketing.</p>
 <p>The platform is built on Salesforce's existing platform and utilizes the recently developed Data Cloud. This technology unifies customer data and metadata in real-time. Included in this suite are ready-to-use agents for assorted roles like sales development, service, marketing campaign optimization, and an Agent Builder which allows users to create their own agents.</p>
 <p>The platform is user-friendly, enabling users to define topics, create natural language instructions, build an action library using low-code tools, and customize the AI to meet their unique requirements without needing advanced technical skills. Additionally, Agentforce plans to feature a broad partner network of prominent companies including AWS, Google, Honeywell, IBM, Workday, Zoom, Coupa, and Box. These partners have developed over 20 agents and agent actions that will be available on the Salesforce’s AppExchange marketplace.&nbsp;</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> This launch has entered Salesforce into the Gen AI-powered agent-building space, which has seen rapid growth in popularity over the last few months. It joins some leading automation players as well as similar incumbents, which have made recent strides via new product launches. This includes 1) <a href="https:<br>
//sp-edge.com/companies/256440"> Pipefy </a> , which <a href="https:<br>
//sp-edge.com/updates/32584"> launched an AI agent solution </a> to enhance service delivery; 2) <a href="https:<br>
//sp-edge.com/companies/60912"> Automation Anywhere </a> , which <a href="https:<br>
//sp-edge.com/updates/30479"> launched an AI studio </a> for users to create and manage custom AI Agents; and 3) <a href="https:<br>
//sp-edge.com/companies/6554"> Zendesk </a> , which <a href="https:<br>
//sp-edge.com/updates/28594"> launched an AI agent solution </a> for customer service automation.</p>

Salesforce announces suite of AI-powered autonomous agent solutions

A concentration of wealth and a willingness to adopt age-in-place technologies present new opportunities.

Age Tech

<div>
 
 <p>The US Food and Drug Administration (FDA) has sanctioned a software update enabling Apple's AirPods Pro 2 to serve as over-the-counter hearing aids.</p>
 <p>Post Apple's announcement of a novel hearing aid feature for the second-generation AirPods Pro, the FDA approval followed. Apple deemed it as "the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature." In a clinical study encompassing 118 subjects with mild to moderate hearing impediments, the feature exhibited comparative perceived benefits similar to professional fitting of the identical device.</p>
 <p>Such advancement aligns with Apple's commitment to hearing health. It has also introduced a new Hearing Protection mode and a Hearing Test feature for AirPods Pro users.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> In <a href="https:<br>
//sp-edge.com/updates/23600"> November 2023 </a> , Soundwave Hearing obtained FDA 510k clearance for Sontro, its OTC hearing aids. While Soundwave’s hearing aids are designed specifically to be hearing aids, Apple’s AirPods are considered the first wireless earbuds that have also been cleared as FDA-approved hearing aids.</p>

FDA approves Apple AirPods Pro as over-the-counter hearing aids

Incorporating technology to improve efficiency and success rate of clinical trials

Clinical Trial Technology

<div>
 
 <p>Paradigm Health and Sheba Medical Center, the largest hospital in Israel, have formed a partnership along with ARC Innovation to create a global clinical research network. The team intends to leverage Paradigm's AI-driven platform to revolutionize clinical trials, making them more efficient and patient-centric.</p>
 <p>The aim of this partnership is to bring the site of these trials closer to the homes of patients, to improve recruitment and retention, and to automate processes. Through this strategy, trial costs could potentially reduce while accelerating the development of novel treatments.</p>
 <p>Sheba and ARC are also planning to broaden the reach of this clinical trial platform to their global network of hospitals to improve accessibility to innovative treatments and to standardize methodologies. Their ambition is to become one of the first fully integrated AI-based hospitals in the world.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> This marks the second international partnership Paradigm Health has secured in 2024. In <a href="https:<br>
//sp-edge.com/updates/32922"> August 2024, </a> the company partnered with Fujitsu to enhance clinical trials and tackle drug loss in Japan. Additionally, earlier this <a href="https:<br>
//sp-edge.com/updates/33191"> month </a> , Paradigm partnered with Florida Cancer Specialists to expand clinical trial access.</p>

Paradigm Health and Sheba Medical partner to optimize clinical trials

Managing employee health-related benefits

Health Benefits Platforms

<div>
 
 <p>XP Health, a vision care platform, has raised a total of USD 55.3 million funds with its latest Series B funding round fetching USD 33.2 million. The round was led by QED Investors with participation from Canvas Ventures, American Family Ventures, HC9 Ventures, Valor Capital Group, and Manchester Story.</p>
 <p>The raised funds will likely be used for further advancing and expanding XP Health's AI-driven platform. This platform provides employee eye exams and eyewear benefits at a cost lower than traditional vision insurance plans.</p>
 <p>XP Health has managed to increase its business customer base to over 3,000 in the last two years from an original 30. Customers include companies such as DocuSign, Navistar, Chegg, and Sequoia Consulting. According to XP Health, its members can make savings of as much as 69% off retail prices when purchasing eyeglasses virtually via its platform.</p>
 
</div>

XP Health raises USD 33.2 million in Series B funding to expand vision care platform

A decentralized version of the web powered by the blockchain

Web3 Ecosystem

<div>
 
 <p>Stablecoin and payments infrastructure provider, Circle, has expanded its Web3 Services product suite to fully support the Arbitrum One blockchain. This means its full-stack blockchain infrastructure platform, which already accommodates chains such as Avalanche, Ethereum, Polygon PoS, and Solana, has increased its range of support.</p>
 <p>For Arbitrum, Circle's Web3 Services suite includes programmable wallets, a smart contract platform, and a gas station.</p>
 <p>The firm believes that this integration will provide significant support to the rapidly growing community of developers on Arbitrum. It will enable them to create multi-chain applications for DeFi and other enterprise use cases, and benefit from near-instantaneous transaction settlement at substantial scale with minimum costs.</p>
 
</div>

All Updates

Guardant Health Japan receives approval to use Guardant360 CDx as a companion diagnostic

6K Additive awarded project to develop C-103 powder for additive manufacturing

WAAM3D partners with Innovative Space Carrier, Cranfield University, and Aichi Sangyo for space transport development

Akselos introduces software for FPSO monitoring

Alex Therapeutics partners with Navamedic to develop Parkinson's disease companion app

INFINIT raises USD 6 million in funding to enhance infrastructure

Salesforce announces suite of AI-powered autonomous agent solutions

FDA approves Apple AirPods Pro as over-the-counter hearing aids

Paradigm Health and Sheba Medical partner to optimize clinical trials

XP Health raises USD 33.2 million in Series B funding to expand vision care platform

Circle expands Web3 Services product suite to Arbitrum

Precision Medicine

Guardant Health Japan receives approval to use Guardant360 CDx as a companion diagnostic

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