Business Wire – Digital Health Global https://www.digitalhealthglobal.com digital health tools and services Mon, 10 Jun 2024 10:15:46 +0000 en-GB hourly 1 https://wordpress.org/?v=5.8 https://www.digitalhealthglobal.com/wp-content/uploads/2018/05/faviconDHI.png Business Wire – Digital Health Global https://www.digitalhealthglobal.com 32 32 Aptar Digital Health Partners with SHL Medical to Optimize Patient Experience with Self-Injectable Therapies https://www.digitalhealthglobal.com/aptar-digital-health-partners-with-shl-medical-to-optimize-patient-experience-with-self-injectable-therapies/ Mon, 10 Jun 2024 12:00:00 +0000 http://www.digitalhealthglobal.com/?guid=2442bf729e38505a301fc8f7c250e817 CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–Aptar Digital Health, a global leader in digital health solutions (Software as a Medical Device (SaMD) and digital Patient Support Programs), connected devices and disease management, today announced a collaboration with SHL Medical, a world-leading solutions provider of advanced drug delivery systems such as autoinjectors, pen injectors and innovative specialty delivery systems. The collaboration will extend SHL Medical’s connected device technologies by integrating Aptar Digital Health’s SaMD platform to provide comprehensive solutions to help patients on injectable therapies manage their disease.

As part of this collaboration, devices designed by SHL Medical, such as the Molly® Connected Cap – a smart retrofittable add-on for SHL Medical’s Molly® modular platform autoinjector – will benefit from Aptar Digital Health’s SaMD platform to enhance the patient experience by offering additional support during self-administration via a digital solution.

Aptar Digital Health’s SaMD platform offers digital health solutions adapted to the patient’s profile, disease state and treatment plan to empower them during their treatment journey. Through this partnership, SHL Medical will recommend Aptar Digital Health as a trusted digital partner that is recognized for its large portfolio of regulated digital health solutions and connected devices spanning multiple therapeutic areas and modes of administration. The partnership will leverage the capabilities of both companies to develop end-to-end solutions for the pharmaceutical industry that will support the enhancement of the patient experience during self-injection of innovative drugs such as GLP-1 for instance.

Embarking on a self-injection therapy and adhering to a consistent injection schedule can pose a challenge to patients in being actively involved in their treatment journey,” stated Sai Shankar, President of Aptar Digital Health. “By joining forces with SHL Medical, a world-class leader in innovative drug delivery systems, we aim to positively and durably change the experience of patients who must self-inject regularly.”

The increasing need for home-based treatments and the evolving healthcare landscape have created a need for collaborative innovation within the drug delivery industry,” added Ralph Howald, Chief Technical Officer at SHL Medical. “With our combined expertise, the partnership with Aptar Digital Health will serve as the first step in realizing a thoroughly-needed digital ecosystem for injectable drugs, starting with a digital transformation that will impact the end-to-end value chain in the future.”

With this partnership, Aptar Digital Health aims at reinforcing their portfolio of digital products and services to enhance the patient experience across the treatment journey. This offer spans from pre-prescription – direct-to-patient services, patient identification and activation – to support during and after prescription – companion apps, disease management platforms and targeted SaMDs to augment innovative drugs and contribute to improved patient adherence.

About SHL Medical AG

As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by their company purpose – Enabling Patients’ Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. SHL Medical also offers final assembly, labeling, and packaging solutions for their drug delivery systems.

In response to the rising trend in home therapy, SHL has increased developmental work in the digital healthcare sector to help improve the drug delivery ecosystem.

Located across Switzerland, Taiwan, Sweden and the US, their global team of experts collaborate seamlessly as one team in utilizing their comprehensive in-house manufacturing capabilities. Their solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into their designs and processes to contribute to a cleaner earth. For additional information, visit www.shl-medical.com.

About Aptar Digital Health

Aptar Pharma’s Digital Health division is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, connected drug delivery systems, onboarding, training and advanced data analytics services to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, please visit www.aptardigitalhealth.com and www.aptar.com.

Contacts

Ciara Jackson
Aptar Pharma
+49 151 1951 6502
ciara.jackson@aptar.com

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Sickle Cell Disease Foundation Announces Research Collaboration with FDA on the Use of Digital Health Technologies to Bridge Health Care Gaps https://www.digitalhealthglobal.com/sickle-cell-disease-foundation-announces-research-collaboration-with-fda-on-the-use-of-digital-health-technologies-to-bridge-health-care-gaps/ Tue, 04 Jun 2024 22:09:00 +0000 http://www.digitalhealthglobal.com/?guid=fd9f6b7270000c86822cc1c0daacc423 ONTARIO, Calif.–(BUSINESS WIRE)–The Sickle Cell Disease Foundation (SCDF) is proud to announce a research collaboration agreement (RCA) with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to develop best practices for the safe and effective use of artificial intelligence (AI) and machine learning (ML) systems and digitally-derived measures that matter to patients. Specifically, the collaboration will evaluate how digital health technologies can be used to better understand patients’ real-world experiences and evaluate meaningful benefit to those living with rare diseases, like sickle cell disease, for medical product development and public health purposes.

“Despite the recent advancements in treatment, individuals living with sickle cell disease continue to face significant challenges when receiving care. Inadequate knowledge of the disease among health care professionals, lack of research, and poor care coordination, among a few, lead to significant disparities in health outcomes,” said Mary Brown, President and CEO, Sickle Cell Disease Foundation. “We thank our partners, the Center for Inherited Blood Disorders and The Hills Tandem, for their steadfast commitment to this effort and look forward to our collaboration with the FDA to develop analytics and software approaches that will prioritize patients’ real-world experiences. Our collective goal is to improve quality of care and advance personalized medicine for all underserved communities affected by complex chronic and rare diseases through the emerging field of AI/ML health analytics.”

It is anticipated that the collaboration between the FDA and SCDF will lay the groundwork for best practices in the safe and effective use of AI and ML approaches for the development of novel digitally-derived endpoints. By analyzing longitudinal, de-identified patient-generated health data (i.e. granular biometric and self-reported symptoms data), socio-environmental data, and health information, collected from Institutional Review Board-approved studies led by SCDF in partnership with the Center for Inherited Blood Disorders (CIBD) and The Hills Tandem, the collaboration will develop a framework and software solutions to deploy on the data to help predict outcomes from lived experiences data. In addition, the research may provide insight into the use of real-world data to better design post-approval studies and labeling.

“At the FDA, patients are at the heart of everything we do. It is critical that patient input is incorporated into medical product development and throughout the Total Product Life Cycle,” said Vinay Pai, Ph.D., M.B.A., Digital Health Specialist in the Digital Health Center of Excellence at the U.S. Food and Drug Administration. “Collaborating with SCDF will help us to better understand and measure what matters most to patients and advance health equity, with the goal of improving the lives of those living with sickle cell and other rare diseases.”

About the Sickle Cell Disease Foundation

The Sickle Cell Disease Foundation (SCDF) was incorporated in 1957 and is the first and oldest Sickle Cell Disease community-based organization of its kind in the nation. As the only organization in California approved to provide Hemoglobin-Trait Counseling Services and direct the Sickle Cell Educator/Counselor Certification Training Course, SCDF provides life-enhancing education, services and programs for individuals living with Sickle Cell Disease. SCDF broadens public awareness, delivers effective advocacy initiatives, and promotes innovative therapies to ultimately find a cure. Learn more by visiting www.scdfc.org.

About the U.S. Food and Drug Administration

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetic, dietary supplements, products that give off electronic radiation, and regulating tobacco products. Learn more about the FDA Center for Devices and Radiological Health by visiting https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health.

Contacts

Naty Alvarez

(916) 826-7855

naty@perrycom.com

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RadiusXR Achieves ISO 13485 and MDSAP Certifications, Announces Expansion into Canadian Market https://www.digitalhealthglobal.com/radiusxr-achieves-iso-13485-and-mdsap-certifications-announces-expansion-into-canadian-market/ Mon, 03 Jun 2024 14:04:00 +0000 http://www.digitalhealthglobal.com/?guid=a9a834a6b5671a17a8f06a203df3d7b1 PLEASANTON, Calif.–(BUSINESS WIRE)–#OphthalmologyRadiusXR, a leading innovator in digital health technology, is proud to announce that it has received ISO 13485 certification and the enhanced Medical Device Single Audit Program (MDSAP) certification. These prestigious certifications mark a significant milestone in RadiusXR’s commitment to delivering the highest quality standards and regulatory compliance in the medical device industry.

Expansion into North American Market

With the attainment of these certifications, RadiusXR is excited to announce its entry into Canada, one of the most requested markets. This strategic expansion allows RadiusXR to bring its cutting-edge glaucoma management and virtual reality perimetry (VRP) solutions to a broader audience of clinicians and patients.

Clinical Validation and NOVA Clinical Trial Results

RadiusXR’s platform is clinically validated and peer-reviewed, featuring groundbreaking advances in glaucoma management and VRP. Recently published in Translational Vision Science & Technology (TVST), the NOVA Clinical Trial demonstrated the exceptional accuracy and reliability of RadiusXR’s solutions. Key findings from the trial include:

  • A remarkable 0.94% correlation in mean deviation confirms the precision of RadiusXR’s measurements.
  • Statistical non-inferiority to traditional methods when staging glaucoma using Medicare definitions.
  • Unique photopic range measurement, consistent with industry standards, ensuring reliable clinical comparisons.

Innovative Features and Technology

RadiusXR’s innovative platform includes several unique features that set it apart from other solutions on the market:

  • Custom-Built Headset: The VRP is designed and manufactured specifically for ophthalmology, featuring microdisplay, broad dynamic range, and all-day battery life.
  • Radius In-Live®: Real-time patient exam monitoring with gaze tracking and reliability indications, providing instant alerts and detailed exam progress views.
  • EHR Integration: Seamlessly integrates with existing Electronic Health Records systems, adhering to DICOM conformance standards and supporting FHIR connect HL7 and DICOM Modality Worklist (DMDL).
  • EYEVIA: An immersive patient education and practice efficiency portal that allows clinicians to create and replay custom educational content, enhancing patient adherence and education.
  • Quick Orders: Streamlines the order creation process by bypassing repetitive configuration steps, improving workflow efficiency.

More About Radius XR:

The Radius XR (www.RadiusXR.com) platform is a revolutionary portable vision diagnostic and patient engagement system. It combines medical-grade diagnostics, business management tools, and patient education resources within a wearable spatial computing device. The RadiusExam® and proprietary algorithms provide diagnostic testing results equivalent to current gold standards demonstrated through a clinical trial that shows statistical noninferiority of estimated sensitivities compared to SITA-Standard. This comprehensive digital health platform combines proprietary hardware and software to empower medical professionals to diagnose patients accurately, enhance patient engagement, and reduce staff workload. It enables patients to perform self-guided vision exams with minimal supervision, thereby aiding in the growth of eye care practices.

For more information about RadiusXR and its revolutionary solutions, please visit RadiusXR.com.

Contacts

Media:
John Trefethen, MFA

Chief of Product

Media Kit
Media@RadiusXR.com
RadiusXR.com

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Massive Bio and Mika Health Combine AI and Next-Generation Sequencing Biomarker Testing to Empower Cancer Patients On Treatment and Those Searching for and Participating in Clinical Trials in the United States and Europe https://www.digitalhealthglobal.com/massive-bio-and-mika-health-combine-ai-and-next-generation-sequencing-biomarker-testing-to-empower-cancer-patients-on-treatment-and-those-searching-for-and-participating-in-clinical-trials-in-the-unit/ Sun, 02 Jun 2024 15:00:00 +0000 http://www.digitalhealthglobal.com/?guid=1c7cd72f263303a3f5bacbc985e0c74a Combination of AI-enabled clinical trial matching, genetic testing, symptom management, psychosocial, and lifestyle support addresses physical and mental health gaps patients experience in seeking and accessing treatments while accelerating access to these critical resources.

CHICAGO–(BUSINESS WIRE)–ASCO Annual Meeting – Massive Bio, a renowned leader in AI-driven oncology solutions and Mika Health, the premier oncology digital therapeutic platform, today announced a partnership to significantly expand patient access to psycho oncology services, next-generation sequencing (NGS) biomarker testing, and clinical trials. This collaboration will expand free patient access to Mika’s Digital Therapeutic to treat oncology specific fatigue, anxiety and depression as well as accelerate early access to the right on-market or investigative treatment and appropriate testing at the right time through Massive Bio’s platform.

“Patients who are waiting to find and access a clinical trial or on-market treatment that is effective in treating their cancer face tremendous challenges in their physical and mental health. Comprehensive NGS biomarker testing can greatly reduce that wait time by identifying targeted therapies for which they are eligible but is grossly under-utilized,” said Dr. Gandolf Finke CEO and Founder of Mika Health. “We’re thrilled to partner with Massive Bio to help more patients have more treatment options faster through improved access to genomic testing and matching to clinical trials that could save their lives – and to improve their experiences as they search for and access those treatments.”

The partnership is two-way. Patients receiving treatment on Mika’s personalized oncology Digital Therapeutic will have the ability to opt into Massive Bio’s AI-enabled clinical trial matching and NGS biomarker testing eligibility engine. Additionally, Massive Bio will make available Mika’s Digital Therapy to their cancer patient registry of hundreds of thousands of patients, expanding free access to digital psycho oncology services to treat fatigue, anxiety, and depression, a prevalent concern among those waiting to find the right treatments.

Dr. Selin Kurnaz, PhD, Co-Founder and CEO of Massive Bio, remarked “Our partnership marks a significant leap towards global personalized cancer care at a time when too many patients are struggling to find effective treatments. By combining our AI expertise with Mika Health’s comprehensive Digital Therapy, we can significantly enhance cancer patient outcomes and experiences with the expanded access to innovative therapies and direly needed patient support. This collaboration not only addresses the immediate needs of patients but also bridges critical gaps in mental and physical health care during their treatment journey.”

Mark Slaughter, Chief Strategy & Growth Officer at Mika Health, added, “As cancer treatments become more sophisticated and personalized, patients are increasingly unable to identify and access the targeted therapy and psycho-oncological support they need. By combining forces with Massive Bio, Mika Health aims to close the access gap, raise the pervasiveness of standard of care quality, and accelerate time to the right treatment for patients.”

Mika Health’s digital therapeutic supports patients through AI-powered personalized psychotherapy, symptom management, side effect interception, and educational resources. By leveraging data-driven insights, the app helps patients manage their cancer journey more effectively at home, and prepares them for consultations and enhancing communication with healthcare providers. This comprehensive approach reduces cancer-related distress and improves overall patient well-being, making it an invaluable tool for both patients and healthcare professionals.

Massive Bio’s advanced AI technology streamlines the clinical trial enrollment process, providing hundreds of thousands of patients with more opportunities to participate in groundbreaking treatments. With over 14,000 actively recruiting interventional clinical trials, Massive Bio ensures that patients have access to the most current and relevant trials for their specific conditions. This partnership will enhance patient matching efficiency, reduce manual effort, and ultimately improve treatment options and outcomes for cancer patients.

Despite evidence that NGS biomarker testing dictates survivorship, in the United States and Europe, evidence of its underutilization is well-documented. For example, less than 50% of lung cancer patients for whom the testing is a standard of care receive it.1 The collaboration between Massive Bio and Mika Health will also benefit the research both companies are performing with pharmaceutical companies and patient advocacy groups, by providing real-world data and insights into patient experiences and treatment outcomes. This data can inform the development of new therapies, improve patient support services and access, and improve clinical trial design, ultimately leading to more effective cancer treatments and better patient care.

Dr. Arturo Loaiza-Bonilla, MD MSEd, Co-Founder and Chief Medical Officer of Massive Bio, emphasized, “Integrating Mika Health’s digital therapy with our AI system will empower both patients and oncologists with support that patients desperately need as they seek personalized and accessible treatments. This collaboration also expands awareness and utilization of biomarker and genomic testing when appropriate, optimizing chances of identifying effective therapies and clinical trials, benefiting all stakeholders involved in cancer care.”

About Massive Bio:

Massive Bio’s vision is to cover entire Pharma value chain with disruptive solutions to improve entire ecosystem from drug development to commercialization. Massive Bio is a unique tech-enabled big data platform with multiple use cases — addressing all friction points in end-to-end patient journey, enabling access to advanced treatment options for patients and optimizing drug commercialization for pharma. Utilizing AI to enhance equitable access and precision targeting for clinical trial matching, drug matching, and drug development, Massive Bio is committed to breaking down barriers in clinical trial enrollment, fostering value-based oncology decisions, and facilitating data-driven cancer treatment. Serving over four dozen pharmaceutical companies, contract research organizations, and hospital networks, Massive Bio has earned recognition from the National Cancer Institute with an SBIR contract, and it is founding member of CancerX Moonshot. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio boasts a global presence with nearly 100 people across 12 countries. For further details, please visit www.massivebio.com, https://askfiona.ai, https://drarturo.ai or interact with us on our social media channels.

About Mika Health

Mika is an app-based platform aimed at providing targeted and comprehensive support to people with cancer using digital technology. Through scientifically proven methods and techniques of therapy management, the Digital Therapeutics (DTx) helps patients to actively participate in their treatment and regain more quality of life – with daily symptom monitoring, psychologically oriented coaching courses, and AI-supported, personalized recommendations. To achieve this, Mika combines innovative machine learning technologies with a multimedia knowledge database of rigorously verified content, such as nutritional tips, exercise routines, or mindfulness training.

Fosanis, the Digital Health company behind Mika, was founded in Berlin in 2017 by Dr. Gandolf Finke and Dr. Jan Simon Raue and completed a Series-A financing round of more than 10 million euros in 2022. After tens of thousands of patients in Germany and the UK have already used the free DTx platform alongside their cancer therapy, the fifty-strong team of experts continues to expand its growth in the global HealthTech market. More information at www.mika.health.

1 Robert NJ, et al. Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices. ASCO 2021 Meeting Abstract. Available online at: https://meetinglibrary.asco.org/record/197070/abstract. Accessed on October 28, 2021.

Contacts

Media:

Massive Bio
Erkan Terzi
Chief Marketing Officer
+1 844 627 7246
pr@massivebio.com

Mika Health/ Fosanis GmbH
Shira Derasmo
+1 917 280 2497
shira@cuttlefishpr.com

Justus Meyer
+49 177 2908232
press@mika.health

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Mika Health and Cancer Support Community Aim to Close Gaps in Mental Health Care with United States’ First AI-Enabled “Precision Support” Digital Therapeutic That is Free for Cancer Patients https://www.digitalhealthglobal.com/mika-health-and-cancer-support-community-aim-to-close-gaps-in-mental-health-care-with-united-states-first-ai-enabled-precision-support-digital-therapeutic-that-is-free-for-c/ Fri, 31 May 2024 14:00:00 +0000 http://www.digitalhealthglobal.com/?guid=73806d2a58fb8593e0292cc0619ffaf9
  • Mika’s personalized, treatment-specific support will be available to one million patients and caregivers served by Cancer Support Community.
  • Multilingual and multicultural patient and caregiver resources and insights from CSC to optimize Mika’s therapeutic in order to address physical and mental health barriers.
  • CHICAGO–(BUSINESS WIRE)–Today, at the American Society for Clinical Oncology (ASCO) annual meeting, Mika Health, a global digital therapeutics developer specializing in meeting the needs of cancer patients, and Cancer Support Community (CSC), a recognized leader in cancer patient support and navigation, announced a partnership that will expand access to mental health and other vital support for patients and caregivers receiving cancer treatments. The organizations will debut the only AI-enabled evidence-based oncologic digital therapeutic that is completely free to patients and caregivers in the United States. The app-based platform was previously available only in Europe.

    “Many patients have unidentified mental health challenges or are unable to access the support they seek. Figuring out which cancer and cancer treatment symptoms require additional medical interventions can be difficult, particularly with regards to depression, anxiety or other mental health challenges that can present with commonly dismissed experiences such as fatigue, lack of sleep, and decreased appetite,” said Dr. Gandolf Finke, founder and Managing Director of Mika Health. “Through this landmark partnership with the esteemed Cancer Support Community, we’re thrilled to bring patients and caregivers in North America anytime, anywhere access to our personalized AI-enabled support at a crucial time when the need for mental health care is at an all-time high.”

    Mika helps patients understand their condition and reduce distress by staying on track with therapy by:

    • Intercepting side effects and symptoms to enable clinical interventions
    • Reducing impact of disease-related anxiety, stress, and depression
    • Feeling more in control with insightful education, exercises, and advice on nutrition, emotional well-being and stress-reduction
    • Orchestrating therapy for patients along their treatment continuum; medication adherence, appointment coordination, diagnostics, and more

    The tool, which is certified for its quality and safety as a medical device in the EU, can be personalized to specific cancers and treatments to provide a personalized support experience. Mika is continuously co-developed and trusted by patients and their families, as well as clinicians all over the world.

    “Through our patient experience research and work supporting hundreds of thousands of people impacted with cancer every year, we know that many people struggle to access the mental health support that they need and want,” said CSC CEO Sally Werner. “Our prior experience piloting app-based mental health interventions showed reductions in anxiety and depression so we are excited to partner with Mika in bringing their AI-enabled evidence-based digital therapeutic to people coping with the challenges that come with a cancer diagnosis,” Werner added. “We are thrilled to work alongside an innovative leader in digital therapeutics whose commitment to improving cancer patients’ access to care aligns so strongly with ours.”

    About Mental Health and Cancer

    One in three people treated for cancer in hospitals have a mental health condition such as depression or anxiety and those who received chemotherapy, radiation or surgery have the highest cumulative burden of psychiatric disorders1. The good news is, people who receive support have fewer symptoms of depression and often see improvement in their physical health, are more likely to follow through with medical care and have a better quality of life with longer survival times2. Ninety percent of studies show cost reduction following psychosocial intervention3.

    However, in a survey of 600 cancer patients in the U.S. conducted by CSC, 60% of respondents never received a physician referral for a mental health screening and two in five cancer patients who asked for mental health support did not receive it, reporting access issues including financial barriers to treatment and telehealth, long appointment wait times, and difficulty getting an appointment. Most cancer patients report wanting support to help reduce distress and improve emotional well-being, such as exercise (66%) and nutrition programs (61%).4

    About the Partnership

    Mika and CSC will collaborate across several core areas:

    • Access to Mika for patients, caregivers, and clinicians served at CSC’s nearly 200 network partner locations, and through other healthcare partnerships
    • Co-development of multilingual and multicultural patient experience components to enhance health equity, inclusion, and diversity, and leverage CSC’s Patient Reported Outcomes (PRO) validated screener and digital assessments
    • Co-development of a multilingual and multicultural caregiver experience with Patient Reported Outcomes (PRO) validated screener and digital assessments
    • Joint Data Science and Clinical Research into psychosocial patient behaviors and treatments to improve patient and caregiver quality of life and mitigate distress, depression, anxiety, and fatigue. Additionally, the organizations will collaborate on research into complex therapy support platforms like CAR-T Cell Therapy and Radioligand Therapy

    About Cancer Support Community

    The Cancer Support Community is a global nonprofit that uplifts and strengthens people impacted by cancer. We are dedicated to fostering a community where people find connection, compassion, and knowledge. We provide professionally led support and navigation services, along with social connections and award-winning education — when, where and how impacted individuals prefer throughout their cancer experience. These resources are available at over 190 Cancer Support Community, Gilda’s Club, and healthcare partner locations as well as online and over the phone — all at no cost. We amplify the voices of those impacted by cancer through research and advocacy and create solutions that break down barriers to care and close the healthcare gap for communities whose members are disproportionately affected by cancer.

    About Mika Health

    Mika Health is an app-based platform aimed at providing targeted and comprehensive support to people with cancer using digital technology. Through scientifically proven methods and techniques of therapy management, the Digital Therapeutics (DTx) helps patients to actively participate in their treatment and regain more quality of life – with daily symptom monitoring, psychologically oriented coaching courses, and AI-supported, personalized recommendations. To achieve this, Mika combines innovative machine learning technologies with a multimedia knowledge database of rigorously verified content, such as nutritional tips, exercise routines, or mindfulness training.

    Fosanis, the Digital Health company behind Mika, was founded in Berlin in 2017 by Dr. Gandolf Finke and Dr. Jan Simon Raue and completed a Series-A financing round of more than 10 million euros in 2022. After tens of thousands of patients in Germany and the UK have already used the free DTx platform alongside their cancer therapy, the fifty-strong team of experts continues to expand its growth in the global HealthTech market. More information at us.mika.health.

    Editor’s Note:

    We are pleased to arrange interviews or background talks with Mika and/or Cancer Support Community.

    ______________________________

    1 Chang, W.H., Lai, A.G. Cumulative burden of psychiatric disorders and self-harm across 26 adult cancers. Nat Med (2022). https://doi.org/10.1038/s41591-022-01740-3
    2 https://www.mhanational.org/cancer-and-mental-health
    3 Mausbach BT, Decastro G, Schwab RB, Tiamson-Kassab M, Irwin SA. Healthcare use and costs in adult cancer patients with anxiety and depression. Depress Anxiety. 2020 Sep;37(9):908-915. doi: 10.1002/da.23059. Epub 2020 Jun 2. PMID: 32485033; PMCID: PMC7484454.

    4 https://www.cancerandmentalhealth.com/wp-content/uploads/2024/02/Cancer-and-Mental-Health-Report.pdf

    Contacts

    Press:

    Mika Health
    Shira Derasmo
    +1-917-280-2497
    shira@cuttlefishpr.com

    Cancer Support Community
    Nathalie Casthely
    +1-917-572-4517
    ncasthely@cancersupportcommunity.org

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    Allurion Announces Expansion of AI Weight Loss Coach to Support Patients on GLP-1s https://www.digitalhealthglobal.com/allurion-announces-expansion-of-ai-weight-loss-coach-to-support-patients-on-glp-1s/ Thu, 30 May 2024 15:00:00 +0000 http://www.digitalhealthglobal.com/?guid=917e2666e3b2085f316d649bbe002f3d Company also announces first commercial agreements for the Virtual Care Suite in the United States

    NATICK, Mass.–(BUSINESS WIRE)–$ALUR #AllurionAllurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the expansion of its Artificial Intelligence (AI)-powered weight loss coach, Coach Iris, to support patients prescribed GLP-1s and other anti-obesity medications and the first commercial agreements for its Virtual Care Suite (VCS) in the United States. With this update to Coach Iris, patients now have access to 24/7 personalized coaching and guidance specific to GLP-1s and other anti-obesity medications, such as treatment duration, side effects, and consequences of stopping their treatment. They can also engage with Coach Iris for tailored meal plans, recipes, exercise routines, stress management techniques, and motivational insights.

    Coach Iris is part of the VCS, a dynamic weight-loss management suite powered by AI and featuring remote patient monitoring, predictive analytics, telehealth, and care team collaboration. The VCS is available to healthcare professionals offering GLP-1 and other anti-obesity medication therapy, bariatric surgery, and weight loss devices.

    “I have seen firsthand how difficult it is for providers to offer best-in-class care for patients living with obesity. It demands close follow-up and lifestyle modification coaching at scale for sustained results,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “We believe VCS and, specifically, Coach Iris, can help ease this burden for them. We are excited to now work with our U.S. clinical partners to help them achieve better, more sustainable weight loss outcomes for their patients.”

    Dr. Christopher McGowan, a triple board-certified physician in internal medicine, gastroenterology, and obesity medicine based in North Carolina and founder of True You Weight Loss, chose to integrate VCS and Coach Iris into his treatment algorithm. “As part of a clinical team of weight loss experts that provides minimally invasive and non-surgical weight loss options, we have a diverse patient population that requires personalized care and attention,” said Dr. McGowan. “Allurion’s Virtual Care Suite equips us with digital capabilities to provide even deeper, personalized care for our patients.”

    According to a recent study by Blue Cross Blue Shield, 58% of patients discontinue use of GLP-1s before reaching a clinically meaningful health benefit, and 30% of patients discontinued use of the medications within the first month. Those who saw their doctor more often were more likely to continue the treatment, emphasizing the need for greater care management.

    Dr. Alexander Shapsis, a triple board-certified physician and President of Atlantic Gastroenterology and EndoSlim Clinic based in New York, chose VCS, in part, to support his GLP-1 patients. “GLP-1s and other anti-obesity treatments demonstrate the most effective results when they are integrated into a holistic weight loss program,” said Dr. Shapsis. “This requires seamless communication between the provider and patients. We chose Allurion’s VCS and its remote patient monitoring technology because the platform was built specifically for weight loss clinics and properly supports the needs of my staff and patients.”

    In an Allurion study, 87% of providers who used the VCS reported increased patient accountability, 88% reported increased efficiencies in their practice, and 82% reported increased patient engagement. “We are committed to adopting innovative technologies that enhance patient care. We immediately saw the immense value of Coach Iris and how it will help our patients stay engaged throughout their weight loss journey,” said Paul Barros, Co-Founder and CEO of Pivot Weight Loss. “This multi-purposed, digital tool works in tandem with our bariatric-trained dieticians, ensuring a blend of expert guidance and AI technology.”

    “Weight loss clinics in the United States are experiencing explosive growth due to high patient demand for a number of therapies, including GLP-1s,” said Brian Conyer, VP of Digital Health at Allurion. “As a result, we believe there is a significant opportunity for our digital products and AI-powered technology to help clinics and providers meet the demand, maintain positive patient outcomes, and continue to grow.”

    About Allurion

    Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

    For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.

    Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

    About True You Weight Loss

    True You Weight Loss is the nation’s first and only physician-founded medical practice exclusively focused on providing non-surgical, state-of-the-art weight loss procedures and support. Dr. Lauren Donnangelo, Dr. Daniel Maselli, and Dr. Christopher McGowan are among the few physicians in the nation who are triple board-certified in internal medicine, gastroenterology, and obesity medicine, and leaders in the area of endobariatrics.

    About Atlantic Gastroenterology

    Atlantic Gastroenterology is a state-of-the-art clinic located in the New York area. The practice specializes in all aspects of gastroenterology, hepato-billiary diseases, and hepatology.

    About Pivot Weight Loss

    Pivot Weight Loss provides a modernized bariatric surgery journey to help patients achieve weight loss goals by combining expert surgeons, technology, and a friendly support team trained to encourage and educate, not judge.

    Forward-Looking Statements

    This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the ability of the Allurion Program, including the VCS, to improve patient and clinical outcomes, including outcome improvements over time, the impact of a behavior change coaching skills course, and the impact of gLP-1s on the Allurion Program. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the VCS, (ii) the timing of, and results from, our clinical studies and trials, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the Israel-Hamas conflict on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the VCS platform, and (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 (as subsequently amended) and other documents filed by Allurion from time to time with the U.S. Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.

    Contacts

    Global Media:
    Cedric Damour
    PR Manager
    +33 7 84 21 02 20
    cdamour@allurion.com

    Investors:
    Mike Cavanaugh, Investor Relations
    ICR Westwicke
    (617) 877-9641
    mike.cavanaugh@westwicke.com

    ]]>
    Lifeguard Digital Health Announces 100 Lives Saved Through Its Overdose Prevention Apps https://www.digitalhealthglobal.com/lifeguard-digital-health-announces-100-lives-saved-through-its-overdose-prevention-apps/ Thu, 30 May 2024 14:00:00 +0000 http://www.digitalhealthglobal.com/?guid=3a1c7b87a166671fa35e7ab1c5dec5fb The LifeguardLite™ and LifeguardConnect™ Apps from Lifeguard Digital Health are saving lives during the opioid crisis.

    VANCOUVER, British Columbia–(BUSINESS WIRE)–Lifeguard Digital Health announces that 100 lives have been saved through its LifeguardConnect™ and LifeguardLite™ platforms. The company’s goal is to continue to expand its global footprint through more strategic partnerships, continuing to develop innovative digital solutions and creating preventative strategies utilizing the comprehensive anonymous data that Lifeguard receives through its platforms. All aimed at a more expanded solution for harm reduction and other various public health challenges, that help improve and save lives in the process.

    The British Columbia-headquartered organization had successfully saved 50 lives by 2023 through its LifeguardConnect platform. LifeguardLite™ was launched in 2023, aimed at filling the harm reduction gap in Supportive Housing settings. The innovative device is designed for vulnerable individuals living in supportive housing and has already had a significant impact in the harm reduction space. Over the past year, the LifeguardConnect and LifeguardLite platforms have saved an additional 50 lives, with the lives saved increasing at an accelerated rate.

    So far, 2,137 LifeguardLite™ sessions have been recorded, serving 800+ users in British Columbia. Lifeguard Digital Health’s platforms have had a total of 38,194 unique app users, and 150,693 all-time sessions so far, prompting 217 emergency responder calls and 101 overdose reversals.

    “We will continue to develop and improve our products to keep adding to the lives saved,” said Jeff Hardy, Chief Executive Officer of Lifeguard Digital Health. “We are proud of this accomplishment but with the increase in installations over Canada and the US, 100 lives saved is just the start. The stigma around addiction is isolating and dangerous, and with our first of its kind technology, we can help prevent overdoses while being at the forefront in reducing harm, preventing deaths, and saving lives in collaboration with emergency services.”

    “Lifeguard will also be focusing efforts on how the anonymous data we receive can help us to create and support preventative strategies. Our goal is to make our products obsolete through the creation of these preventative measures. There is an urgent need for sharing and collaboration on a national level to better respond to the increasingly complex global opioid crisis, which Lifeguard aims to facilitate,” he added.

    Lifeguard Digital Health also announced this week the launch of Connect V6. After extensive research with Lifeguard’s clients and people with lived experience (PWLE), we have new upgrades including a simplified user interface which will make it easier to navigate. The app has also added more services and resources to its catalog, which have been categorized for quick searches and filtering. Additionally, the updated app has made it easier to access the most popular features, such as the timer and expanded input for drug alerts.

    “Both LifeguardConnect and LifeguardLite are key tools in providing early intervention, which is vital as we respond to someone experiencing toxic drug poisoning,” BCEHS Chief Operations Officer Jennie Helmer said. “Working together, through innovative partnerships like these with Lifeguard Digital Health, saves lives.”

    The world is facing an unprecedented opioid crisis and Lifeguard Digital Health is stepping up to the challenge. With no one-size-fits-all solution to the overdose crisis, Lifeguard is poised for exponential growth to ensure vulnerable individuals have better access to life-saving options. The organization has set up partnerships beyond its home in British Columbia, and is now taking their digital health solution across Canada, US, Australia and India in an effort to save more lives.

    About Lifeguard Digital Health

    Lifeguard Digital Health creates digital health solutions that reduce harm, prevent involuntary deaths, and improve quality of life. The company integrates digital health technology innovations on its ‘evan’ platform, including artificial intelligence (AI), internet of things (IoT), blockchain, and informatics. Complying with the highest/current levels of security and privacy regulations, it works closely with health authorities and emergency health services. For more information, please visit www.lifeguarddh.com

    Contacts

    For media inquiries:

    Jessica Phillips
    Magnolia Marketing Communications
    Email: jessica@magnoliamc.com
    Phone: 236-865-6916

    ]]>
    Aptar Digital Health and Iona Mind Announce Partnership to Deliver Scalable Mental Health Support to Chronic Disease Patients https://www.digitalhealthglobal.com/aptar-digital-health-and-iona-mind-announce-partnership-to-deliver-scalable-mental-health-support-to-chronic-disease-patients/ Wed, 29 May 2024 15:30:00 +0000 http://www.digitalhealthglobal.com/?guid=c698b69aadd364f289400b4986fb7beb CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–Aptar Digital Health, a global expert in Software as a Medical Device (SaMD), digital Patient Support Programs (PSPs) and disease management solutions, and Iona Mind, a global leader in low-intensity Cognitive Behavioral Therapy (CBT) solutions for mental health, today announced a partnership to help support patients with chronic diseases to manage their psychological stress and emotional wellbeing. Benefiting from the combined capabilities and digital platforms of both organizations, the partnership will provide integrated solutions to pharmaceutical partners aiming to enhance patient experiences.

    Low-intensity CBT has demonstrated efficacy in 30 systematic reviews and 50 controlled trials. The Iona Mind platform contains low-intensity CBT programs for managing common mental health conditions and general wellbeing. Leveraging the latest innovations in software, data science and user experience design, the Iona Mind platform can create bespoke digital products to support patients at any point of their journey.

    These products can be used to help chronic disease patients who typically have high rates of common mental health issues such as anxiety, low mood, and persistent recurring negative thoughts. Compared to the general population, it is estimated that mental health conditions are two to three times more likely to occur in people with chronic diseases. Consequently, mental health comorbidities increase overall treatment complexity and costs. For instance, people diagnosed with major depression use healthcare services more, and this can lead to a twofold increase in healthcare spending1.

    Iona Mind uses its proprietary development program IMDP (Iona Mind Development Program) to work with patient advocate groups and ensure each product is adapted for the population at hand. This ensures inclusivity and accessibility when serving diverse patient populations, such as underrepresented groups or patients with chronic illnesses.

    Under this partnership, Aptar Digital Health, with its extensive experience in SaMDs, companion apps and disease management solutions, will bring a comprehensive understanding of patient and healthcare professional needs. Aptar Digital Health’s platform and expertise in developing and implementing end-to-end digital health solutions at a global scale will complement Iona Mind’s ability to deliver mental health support at various stages of the patient journey. The partnership aims to bring evidence-based and scalable mental health support to any patient, using solutions based on the Aptar Digital Health platform. This powerful combination has the potential to make mental health support more accessible to millions of chronic disease patients.

    Sai Shankar, President of Aptar Digital Health, commented, “We are excited to join forces with Iona Mind and bring our combined expertise to address the mental health challenges faced by patients with chronic diseases. Our collaboration represents a major step forward in our shared mission to improve the lives of millions of people worldwide.”

    Added Geneviève D’Orsay, Chief Medical Officer at Aptar Digital Health, “Supporting the mental health of patients with cancer is crucial for enhancing their overall journey. A growing number of evidence shows the importance of considering the emotional distress associated with the patient experience, especially in the field of cancer. We are pleased to collaborate with Iona Mind, and to offer accessible mental health support to more patients.”

    Jonathan Baker, CEO and Founder of Iona Mind, stated, “At Iona Mind, we are delighted to be collaborating with Aptar Digital Health. By combining Aptar’s proven experience with digital patient support with Iona Mind’s industry-leading expertise in low-intensity cognitive behavioral therapy and mental health, we know that together, we will be able to significantly impact many lives.”

    About Iona Mind

    Iona Mind is a global leader in scalable mental health solutions, specializing in low-intensity cognitive behavioral therapy. With a focus on innovative technologies and patients, Iona Mind is dedicated to improving outcomes and reducing the burden of these complex conditions. The company’s Iona Mind platform coupled with the Iona Mind Development Program enable providers to quickly create bespoke solutions that meet the psychological needs of their populations. For more information, visit https://www.ionamind.com.

    About Aptar Digital Health

    Aptar Pharma’s Digital Health division is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar Digital Health creates end-to-end solutions to enhance patient experiences every day, leveraging a holistic ecosystem of digital interventions. Amplified by an industry-leading portfolio of products and solutions, Aptar Digital Health’s offering combines mobile and web apps, connected drug delivery systems, onboarding, training and advanced data analytics services to actively empower patients and create a positive treatment journey. Aptar is headquartered in Crystal Lake, Illinois and has more than 13,000 dedicated employees in 20 countries. For more information, please visit www.aptardigitalhealth.com and www.aptar.com.

    ______________________________
    1
    Major Depression: The Impact on Overall Health (2018)
    https://www.bcbs.com/the-health-of-america/reports/major-depression-the-impact-overall-health

    Contacts

    Ciara Jackson
    Aptar Pharma
    +49 151 1951 6502
    ciara.jackson@aptar.com

    ]]>
    PureTech Founded Entity Akili Interactive and Virtual Therapeutics Announce Entering Into Definitive Merger Agreement to Establish Leading Digital Health Company https://www.digitalhealthglobal.com/puretech-founded-entity-akili-interactive-and-virtual-therapeutics-announce-entering-into-definitive-merger-agreement-to-establish-leading-digital-health-company/ Wed, 29 May 2024 15:09:00 +0000 http://www.digitalhealthglobal.com/?guid=d3956794c1d62f8ce6f92781b5312205 Akili to operate as wholly owned subsidiary of Virtual Therapeutics

    BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, and Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

    As of May 7, 2024, PureTech owned 12,527,477 of the outstanding shares of Akili common stock.

    The full text of the announcement from Akili and Virtual Therapeutics is as follows:

    Virtual Therapeutics, Akili Interactive Enter Into Definitive Merger Agreement to Establish Leading Digital Health Company

    Akili to operate as wholly owned subsidiary of Virtual Therapeutics

    Kirkland, Wash., and Boston, Mass.– Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, and Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, today announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

    Under the terms of the agreement, Akili shareholders will receive $0.4340 per share of common stock in cash. The per share purchase price represents an approximately 4% premium to Akili’s closing stock price on May 28, 2024 and an approximately 85% premium to Akili’s closing price on April 29, 2024, the last trading day prior to Akili’s public announcement that it was evaluating potential strategic alternatives. Following completion of the transaction, the combined organization will operate as Virtual Therapeutics, a privately held company, with Akili operating as a wholly owned subsidiary.

    In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan Elenbaas, co-founder and CEO of Virtual Therapeutics. “The team at Akili has been successful in applying clinical and scientific rigor to bring new products forward, and we believe their expertise will complement our efforts. Together, we can build a company that brings these behavioral services to as many patients as possible – regardless of where they are or barriers that exist for them today.”

    Akili ran a thorough strategic process and we believe that this transaction represents Akili’s commitment to delivering value to the Akili stockholder,” added Matt Franklin, Chief Executive Officer of Akili. “Virtual Therapeutics has been built by a team with decades of success in the gaming industry and elected to focus their expertise to help solve the growing mental health crisis. Combining our proven track record developing and deploying rigorously validated mobile digital therapeutics with Virtual Therapeutics’ robust portfolio of VR-based mental health solutions and gaming expertise, we aim to create a compelling platform to address mental health needs across several high-impact indications.”

    Transaction Details

    The transaction, approved by both of Virtual Therapeutics’ and Akili’s board of directors, is expected to close in the third quarter of 2024, subject to certain closing conditions, including the tender of a majority of Akili shares into a tender offer to be launched by Virtual Therapeutics and Akili having not less than a specified amount of cash-on-hand, depending on the closing time. The transaction is not subject to a financing condition.

    Upon completion of the transaction, Akili’s common stock will no longer be listed on any public stock exchange.

    Advisors

    TD Cowen is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel to Akili. Baker & McKenzie LLP is acting as legal counsel to Virtual Therapeutics.

    About Akili

    Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.

    About Virtual Therapeutics

    Virtual Therapeutics is a digital health company delivering scalable, accessible, affordable, and personalized solutions for mental health and mental fitness. Leveraging extensive expertise as game developers, the company crafts and curates rich, appealing experiences that combine proven therapeutic techniques with modern gameplay mechanisms to delight and engage users. Virtual Therapeutics uses powerful cloud-based platform to gather and analyze various data streams to continuously measure, validate, and report effectiveness, seamlessly deploy and maintain its solutions, and provide users and partners with a truly turnkey experience. For more information, visit https://www.vthera.com/.

    Contact

    For Akili
    Matt Franklin, President and Chief Executive Officer
    InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com

    For Virtual Therapeutics
    Ian Stone, Inizio Evoke Communications
    ian.stone@inizioevoke.com
    619-518-3518

    Forward-looking Statements

    This communication relates to the proposed transaction pursuant to the terms of the Agreement and Plan of Merger, dated May 29, 2024, by and among Virtual Therapeutics Corporation (“Parent”), Alpha Merger Sub, Inc. (“Purchaser”), and Akili, Inc. (“Akili”). This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), about the proposed acquisition of Akili by Parent and the operations of the combined company that involve risks and uncertainties relating to future events and the future performance of Akili. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

    These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Akili’s stockholders will tender their stock in the offer; the possibility that competing offers will be made by third parties; the occurrence of events that may give rise to a right of one or both of Parent and Akili to terminate the merger agreement; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any; the possibility that the proposed transaction may not be completed in the time frame expected by Parent and Akili, or at all; the risk that Akili may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; the effects of the proposed transaction on relationships with Akili’s employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction; significant or unexpected costs, charges or expenses resulting from the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed acquisition on the market price of Akili’s common stock; unknown liabilities related to Parent or Akili; the nature, cost and outcome of any litigation and other legal proceedings involving Akili or its officers and directors, including any legal proceedings related to the proposed acquisition; and risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. A more complete description of these and other material risks can be found in Akili’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and other documents that may be filed by Akili from time to time with the SEC, as well as the Schedule TO and related tender offer documents to be filed by Parent and its indirect wholly owned subsidiary, Purchaser, and the Schedule 14D-9 to be filed by Akili. Parent and Akili also plan to file other relevant documents with the SEC regarding the proposed transaction.

    Any forward-looking statements speak only as of the date of this communication and are made based on management’s current beliefs and assumptions and on information currently available to Parent and Akili, and the reader is cautioned not to rely on any forward-looking statements. Parent and Akili do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

    Additional Information and Where to Find It

    The tender offer for all of the outstanding shares of common stock of Akili referenced in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Akili, nor is it a substitute for the tender offer materials that Parent, Purchaser or Akili will file with the SEC. The solicitation and offer to buy the common stock of Akili will only be made pursuant to an Offer to Purchase and related tender offer materials that Parent and Purchaser intend to file with the SEC. At the time the tender offer is commenced, Parent and Purchaser will file with the SEC a Tender Offer Statement on Schedule TO, and thereafter Akili will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. AKILI’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF AKILI SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal, certain other tender offer documents, as well as the Solicitation/Recommendation Statement will be made available to all stockholders of Akili at no expense to them and will also be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting either Parent or Akili. Copies of the documents filed with the SEC by Akili will be available free of charge on Akili’s website at www.Akiliinteractive.com or by contacting Akili’s Investor Relations Department at InvestorRelations@Akiliinteractive.com or PR@Akiliinteractive.com.

    In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Akili files annual, quarterly and current reports and other information with the SEC. Akili’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

    About PureTech Health

    PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

    For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to the proposed acquisition of Akili by Virtual Therapeutics and the resulting proceeds to be received by the Company as a shareholder of Akili, as well as our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts

    PureTech
    Public Relations
    publicrelations@puretechhealth.com

    Investor Relations
    IR@puretechhealth.com

    UK/EU Media
    Ben Atwell, Rob Winder
    +44 (0) 20 3727 1000
    puretech@fticonsulting.com

    US Media
    Nichole Bobbyn
    +1 774 278 8273
    nichole@tenbridgecommunications.com

    ]]>
    Virtual Therapeutics, Akili Interactive Enter Into Definitive Merger Agreement to Establish Leading Digital Health Company https://www.digitalhealthglobal.com/virtual-therapeutics-akili-interactive-enter-into-definitive-merger-agreement-to-establish-leading-digital-health-company/ Wed, 29 May 2024 15:00:00 +0000 http://www.digitalhealthglobal.com/?guid=ab83c7cc7869964a5a5030db94de176c Akili to operate as wholly owned subsidiary of Virtual Therapeutics

    KIRKLAND, Wash. & BOSTON–(BUSINESS WIRE)–Virtual Therapeutics, a company focused on improving mental health at scale using engaging, immersive games, and Akili, Inc. (Nasdaq: AKLI), a leading digital therapeutics company, today announced the signing of a definitive merger agreement to form a diversified, leading digital health company.

    Under the terms of the agreement, Akili shareholders will receive $0.4340 per share of common stock in cash. The per share purchase price represents an approximately 4% premium to Akili’s closing stock price on May 28, 2024 and an approximately 85% premium to Akili’s closing price on April 29, 2024, the last trading day prior to Akili’s public announcement that it was evaluating potential strategic alternatives. Following completion of the transaction, the combined organization will operate as Virtual Therapeutics, a privately held company, with Akili operating as a wholly owned subsidiary.

    “In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan Elenbaas, co-founder and CEO of Virtual Therapeutics. “The team at Akili has been successful in applying clinical and scientific rigor to bring new products forward, and we believe their expertise will complement our efforts. Together, we can build a company that brings these behavioral services to as many patients as possible – regardless of where they are or barriers that exist for them today.”

    “Akili ran a thorough strategic process and we believe that this transaction represents Akili’s commitment to delivering value to the Akili stockholder,” added Matt Franklin, Chief Executive Officer of Akili. “Virtual Therapeutics has been built by a team with decades of success in the gaming industry and elected to focus their expertise to help solve the growing mental health crisis. Combining our proven track record developing and deploying rigorously validated mobile digital therapeutics with Virtual Therapeutics’ robust portfolio of VR-based mental health solutions and gaming expertise, we aim to create a compelling platform to address mental health needs across several high-impact indications.”

    Transaction Details

    The transaction, approved by both of Virtual Therapeutics’ and Akili’s board of directors, is expected to close in the third quarter of 2024, subject to certain closing conditions, including the tender of a majority of Akili shares into a tender offer to be launched by Virtual Therapeutics and Akili having not less than a specified amount of cash-on-hand, depending on the closing time. The transaction is not subject to a financing condition.

    Upon completion of the transaction, Akili’s common stock will no longer be listed on any public stock exchange.

    Advisors

    TD Cowen is acting as exclusive financial advisor and Goodwin Procter LLP is acting as legal counsel to Akili. Baker & McKenzie LLP is acting as legal counsel to Virtual Therapeutics.

    About Akili

    Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.

    About Virtual Therapeutics

    Virtual Therapeutics is a digital health company delivering scalable, accessible, affordable, and personalized solutions for mental health and mental fitness. Leveraging extensive expertise as game developers, the company crafts and curates rich, appealing experiences that combine proven therapeutic techniques with modern gameplay mechanisms to delight and engage users. Virtual Therapeutics uses powerful cloud-based platform to gather and analyze various data streams to continuously measure, validate, and report effectiveness, seamlessly deploy and maintain its solutions, and provide users and partners with a truly turnkey experience. For more information, visit https://www.vthera.com/.

    Forward-looking Statements

    This communication relates to the proposed transaction pursuant to the terms of the Agreement and Plan of Merger, dated May 29, 2024, by and among Virtual Therapeutics Corporation (“Parent”), Alpha Merger Sub, Inc. (“Purchaser”), and Akili, Inc. (“Akili”). This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), about the proposed acquisition of Akili by Parent and the operations of the combined company that involve risks and uncertainties relating to future events and the future performance of Akili. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

    These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Akili’s stockholders will tender their stock in the offer; the possibility that competing offers will be made by third parties; the occurrence of events that may give rise to a right of one or both of Parent and Akili to terminate the merger agreement; the possibility that various closing conditions for the proposed transaction may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any; the possibility that the proposed transaction may not be completed in the time frame expected by Parent and Akili, or at all; the risk that Akili may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; the effects of the proposed transaction on relationships with Akili’s employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transaction; significant or unexpected costs, charges or expenses resulting from the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed acquisition on the market price of Akili’s common stock; unknown liabilities related to Parent or Akili; the nature, cost and outcome of any litigation and other legal proceedings involving Akili or its officers and directors, including any legal proceedings related to the proposed acquisition; and risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. A more complete description of these and other material risks can be found in Akili’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and other documents that may be filed by Akili from time to time with the SEC, as well as the Schedule TO and related tender offer documents to be filed by Parent and its indirect wholly owned subsidiary, Purchaser, and the Schedule 14D-9 to be filed by Akili. Parent and Akili also plan to file other relevant documents with the SEC regarding the proposed transaction.

    Any forward-looking statements speak only as of the date of this communication and are made based on management’s current beliefs and assumptions and on information currently available to Parent and Akili, and the reader is cautioned not to rely on any forward-looking statements. Parent and Akili do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

    Additional Information and Where to Find It

    The tender offer for all of the outstanding shares of common stock of Akili referenced in this document has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Akili, nor is it a substitute for the tender offer materials that Parent, Purchaser or Akili will file with the SEC. The solicitation and offer to buy the common stock of Akili will only be made pursuant to an Offer to Purchase and related tender offer materials that Parent and Purchaser intend to file with the SEC. At the time the tender offer is commenced, Parent and Purchaser will file with the SEC a Tender Offer Statement on Schedule TO, and thereafter Akili will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. AKILI’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF AKILI SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal, certain other tender offer documents, as well as the Solicitation/Recommendation Statement will be made available to all stockholders of Akili at no expense to them and will also be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting either Parent or Akili. Copies of the documents filed with the SEC by Akili will be available free of charge on Akili’s website at www.Akiliinteractive.com or by contacting Akili’s Investor Relations Department at InvestorRelations@Akiliinteractive.com or PR@Akiliinteractive.com.

    In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Akili files annual, quarterly and current reports and other information with the SEC. Akili’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

    Contacts

    For Akili
    Matt Franklin, President and Chief Executive Officer
    InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com

    For Virtual Therapeutics
    Ian Stone, Inizio Evoke Communications
    ian.stone@inizioevoke.com
    619-518-3518

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