DIGITAL HEALTHCARE

Alira Health Expands its Digital Health Portfolio with the Acquisition of Self Care Catalysts

Alira Health | January 31, 2022

Alira Health, a global healthcare consulting and technology firm, announced that it has acquired Self Care Catalysts, Inc., a digital health company headquartered in Toronto, Canada. Self Care Catalysts focuses on patients and puts them at the center of human networks, technology, and science. Self Care Catalysts’ digital health platform, Health Storylines™, helps patients gain an intimate understanding of their health journey while managing their conditions and generating clinical and real-world evidence along the way. Health Storylines enables over 120,000 patients to be active and informed owners of their healthcare data across more than thirty major therapeutic areas. This is Alira Health’s third patient-centric digital health acquisition in the last four months and the first in North America.

“Today, it’s more important than ever to give patients and their care-giving circles the ability to map their own healthcare journeys. Self Care Catalysts derives their success from putting patients first and then extending their platform to help pharmaceutical, biotech and medtech clients streamline their efforts to bring new medicines and devices to market through direct patient access for Decentralized Clinical Trials (DCT) and Real World Evidence (RWE),” said Gabriele Brambilla, co-founder and CEO of Alira Health. “The acquisition of Self Care Catalysts is a strategic addition to our growing global portfolio of patient-centric technologies, making Alira Health a leading player in North America and Europe in DCT and patient-centric RWE solutions with over 150 studies run in partnership with over 250,000 patients.”

“Health Storylines helps patients make sense of their healthcare journey through meaningful data that they own and control. Patients choose to donate or share their data for a good cause, whether it is for clinical research, to inform policy makers, to seek help from their care providers with holistic data for better treatment planning, or simply to gain peace of mind. We share Alira Health’s mission to humanize healthcare and are pleased to become part of a company poised to transform healthcare.”

Grace Almendras-Castillo, Founder and CEO of Self Care Catalysts

Self Care Catalysts’ co-founders Grace Almendras-Castillo and Jared Adams will assume leadership roles at Alira Health in the development of digital patient and consumer health solutions in North America.

About Self Care Catalysts

Self Care Catalysts is a patient-driven clinical and real-world evidence, analytics and digital therapeutics company designed to inform care management, treatment decisions, product life cycle management and behavior change interventions. 

About Alira Health

Alira Health is an international patient-centric and technology-enabled advisory firm whose mission is to humanize healthcare. We work with healthcare and life sciences organizations looking for support across their entire solutions lifecycle. From development to medical care, we complement our clients’ expertise with a full spectrum of services including research and clinical development solutions, technology-powered consulting, and real-world evidence.

Our integrated and multidisciplinary team of over 500 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50% of MedTech companies and 50% of the top 50% of Pharma companies.

Spotlight

Risks are inherent in any healthcare IT infrastructure, whether or not that infrastructure involves cloud services. The recent adoption of cloud services for healthcare data storage and retrieval, however, carries with a fair amount of skepticism around security...


Other News
HEALTH TECHNOLOGY

Vitestro unveils autonomous blood drawing device, combining artificial intelligence, ultrasound imaging and robotics

Vitestro | May 31, 2022

Vitestro, a Dutch medical robotics company, unveiled the world's most advanced autonomous blood drawing device at the annual meeting of the Netherlands Society for Clinical Chemistry and Laboratory Medicine in Rotterdam. Vitestro's device combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion, ensuring accurate and secure blood collection. The venipuncture technology is adaptable to patients of 16 years of age onwards, comorbidities, and puncture difficulty. From 2023, Vitestro will initiate pivotal clinical studies for regulatory approval in Europe. EU-market introduction is anticipated in 2024. Healthcare shortages spark revolutionary developments Within healthcare, the clinical laboratory is the driving force. Accuracy and timeliness of laboratory tests are critically important, as they shape approximately 70% of all medical decisions made by physicians. It is unsurprising that blood collection is the most common invasive medical procedure, performed billions of times per year globally. Blood collection holds a pivotal role in clinical diagnostics yet is also burdened by the scarcity of skilled workers. By automating this labor-intensive procedure, we can transform the quality of care and create a sustainable healthcare system. Proprietary laboratory automation technology standardizes handling of the blood sample while the blood is collected. The device allows almost complete automation of the pre-analytical phase. This has the potential to reduce high blood test error rates, mainly caused by manual variability. In clinical studies, Vitestro already performed 1,500 automated blood draws in more than 1,000 patients with its prototype. Toon Overbeeke, Vitestro's Co-Founder and Chief Executive Officer said: "The mounting shortage of healthcare personnel is imminent. The pandemic has further led to loss of workforce, causing a bleak outlook for hospital output around the globe, and leading to reduced access and continuity of care. That's why revolutionary automation like our blood drawing device is inevitable to solve the industry's biggest problem." Outpatient phlebotomy care is redefined At first, Vitestro will implement the device in outpatient phlebotomy departments. Patients will have the option to choose between Vitestro's venipunture device or standard method. The device is intuitive to use, empowering patients to be self-reliant in the full blood collection procedure. In previous clinical trials, patients of all ages showed a high degree of openness, enthusiasm and willingness to adopt the innovation. A trained healthcare professional is able to supervise several devices, managing multiple patients simultaneously. The increased efficiency enables hospitals and clinical laboratories to address workforce shortage or even free up staff and deploy them where they are really needed. "We have spent nearly five years on the development of this breakthrough medical device. All relevant disciplines are represented in our dedicated, specialized team of 35 people. To prepare for production and commercialization, the team will double in size in the next two years. We have clear momentum in the market and will be the first to bring autonomous technology to European hospitals. With our technology we can help to build a more robust and resilient healthcare system." Toon Overbeeke, Vitestro's Co-Founder and Chief Executive Officer Anja Leyte, Director OVLG Laboratories, participating in clinical studies commented: "By introducing automated blood drawing, high quality as well as capacity is guaranteed in our laboratories. Vitestro's technology helps solving staffing shortages at our blood drawing department and improving sample standardization. Patients are also very enthusiastic." About Vitestro In 2017 Vitestro's founders rose to the challenge to create a better blood drawing experience. Today Vitestro is well underway to achieve its goal with a committed team of 35 highly skilled people with a track record in medical robotics, imaging software, AI, QA/RA and business development. Vitestro is based in Utrecht, the Netherlands. Vitestro is well funded by private investors and government subsidies.

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HEALTH TECHNOLOGY

Dura Software Acquires Leading Cloud-Based Telehealth Software Platform SecureVideo

Dura Software | January 20, 2022

Dura Software, specialists in acquiring and operating hyperniche software products, announced it has acquired SecureVideo, a cloud-based software company with extensive experience developing a secure SaaS telehealth platform for the healthcare industry. Expanding the Dura portfolio, SecureVideo is the ninth acquisition for Dura Software and furthers the Dura mission of acquiring niche software companies that serve critical business needs. "We are excited to welcome SecureVideo into the Dura portfolio of companies. Jonathan Taylor and his team have created a highly scalable SaaS solution that enables a loyal group of physicians and practitioners to serve their patients safely and effectively every day. SecureVideo has a seasoned team that understands the healthcare market and how to best leverage technology to make the lives of healthcare professionals and patients easier. " Paul Salisbury, CEO of Dura Software Serving the healthcare industry, SecureVideo produces a HIPAA-compliant, cloud-based telehealth platform designed to aid clients with quickly mastering their telehealth workflow. During 2020, SecureVideo's usage grew significantly, expanding to 30 times its typical usage, prompting the company to quickly scale its operations while it successfully met the growing needs of new and existing customers. As a trusted partner in the healthcare space, SecureVideo provides a flexible, reliable telehealth technology solution to behavioral health organizations, medical groups, hospitals, physician offices, specialty healthcare organizations and other medical organizations. The CEO of SecureVideo, Jonathan Taylor, will lead the company as it transitions into the Dura Software portfolio of companies. "The acquisition of SecureVideo by Dura Software will provide the resources and expertise we need to scale our product capabilities, customer support, and market reach well beyond what would have otherwise been possible," says Taylor. "With Dura's assistance, the company will be able to rapidly add important features and functionality to our world-class product, amplify our customer-first culture, and expand our customer footprint, all while maintaining the high standard of excellence we have always worked to achieve." Based in Alameda, California, SecureVideo will move its headquarters to San Antonio, while all employees will remain in their current locations. About Dura Software Dura Software is an expert in acquiring, owning and operating "Hyper-Niche" software businesses. Over the coming years, Dura will continue to expand by acquiring additional great businesses and by generating sustained profitable growth from business operations. Dura Software is based in downtown San Antonio and operates a portfolio of companies that includes 6Connex, DB Technology, Lane, DVSAnalytics, Eventory, Moki, NordicIT and Vertex Systems.

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MEDICAL DEVICES

Extremity Medical Files Patent Infringement Lawsuit Against Nextremity Solutions, Zimmer Biomet Holdings and Zimmer, Inc.

Extremity Medical, LLC | April 07, 2022

Extremity Medical, LLC, a global medical device company focused on the development of innovative implants and instruments for upper and lower extremities, announcedthat it filed a lawsuit against Nextremity Solutions, Inc.; Zimmer Biomet Holdings, Inc.; and Zimmer, Inc., alleging infringement of an Extremity Medical patent* for its intraosseous fixation platform arising from the marketing of the InCore® Lapidus System by these companies. The complaint was filed in the U.S. District Court for the District of Delaware. Extremity Medical has amassed an intellectual propertyportfolio that includes 49 patents in the U.S. and several foreign countries. The novel and patented technology of Extremity’s intraosseous fixation platform provides surgeons with a zero-profile solution for fusion and fixation of bones within the upper and lower extremities, with the ability to be implanted through minimal incisions. This technology is currently marketed globally by Extremity under the trade names IO FiX, IO FiX Plus, IO FiX 2.0, IO Freedom, CarpalFiX, ApeX and XMCP. “Extremity Medical has invested a tremendous amount of effort and resources in research and development to create innovative technology to improve the lives of patients and meet surgeons’ needs. Our intellectual property is a critical component in making such advancements possible and we are committed to protecting it,” Matthew Lyons, Extremity Medical Chief Executive Officer, Founder and Chairman of the Board About Extremity Medical, LLC Extremity Medical, was founded in 2008, and is a privately-held medical device company based in Parsippany, NJ. The company is known for creating innovative implants and instruments for upper and lower extremity orthopedic procedures, including fusion and motion preservation. The company is focused on developing solutions for challenging cases that promote better outcomes, especially in patients with poor bone quality.

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FUTURE OF HEALTHCARE

Endonovo Therapeutics Signs Agreement with NAMSA to Develop Reimbursement Strategy for Endonovo Medical Products

Endonovo Therapeutics, Inc. | April 26, 2022

Endonovo Therapeutics, Inc. announced an agreement with NAMSA – a leading Global Contract Research Organization and medical device reimbursement specialist – as strategic advisors to develop in-patient and out-patient medical reimbursement strategies for Endonovo’s flagship PEMF product SofPulse®. “Engaging NAMSA as strategy advisors to develop and apply proven medical device reimbursement strategies is a huge advantage for Endonovo and our shareholders, according to Endonovo CEO Alan Collier. “NAMSA is a proven medical device development partner with relevant therapeutic know-how that is critical when seeking acceleration of reimbursement efforts and commercialization objectives,” he pointed out. NAMSA was founded in 1967 as a scientific research company and later transitioned into a Global CRO and Medtech (Medical Technologies) reimbursement specialist. Today, it has 1,000 strategic associates who provide Medtech reimbursement advisory expertise to more than 300 clients in 15 global regions. NAMSA offers a full continuum of reimbursement services for medical technologies. Their reimbursement consultants provide: payer relations, medical policy research, coverage advocacy, Healthcare Common Procedure Coding System Current Procedural Terminology code analysis/applications and health economic analysis. “Our team strives to bring impactful products like the Endonovo SofPulse into higher adoption. With this technology, and its favorable economics, there are multiple opportunities ahead for serving populations in need. We will work together with the Endonovo team to improve market access for this novel device in the very near term.”, Joseph Sierra, Director, Reimbursement Consulting, North America, NAMSA NAMSA provides strategic guidance and tactical support to fast-track medical device commercialization and to make an immediate impact on patient healthcare worldwide. NAMSA’s services have grown to include regulatory, reimbursement and quality consulting as well as clinical research. These additions have helped NAMSA to become the pre-eminent 100% medical device-focused Global CRO that offers proven strategic solutions throughout the full development continuum. NAMSA is the only US FDA ASCA accredited medical device biocompatibility laboratory in the world. This allows medical device sponsors to fast-track commercialization efforts, while achieving time and cost efficiencies in every major market of the world. Collier stated: “We are fortunate to be working directly with Joseph Sierra, at NAMSA. With over 10 years of reimbursement experience, and his proven track-record in developing successful medical device reimbursement strategies is exemplary and will be helpful in developing the path toward reimbursement for our main product SofPulse®. Joseph is an adjunct instructor at USC Masters of Health Administration Program, and his prior professional work includes successful stints with NeoFect USA and Medtronic Ltd. where he demonstrated a record of success leading roles in reimbursement programs, analysis, and strategies for their medical devices.” NAMSA’s reimbursement expertise and track-record in the introduction and adoption of medical devices into multiple medical specialties includes: orthopedics, cardiovascular surgery, general surgery, plastic surgery, neurology, robotic surgery and wound care. Collaborating with NAMSA on global reimbursement allows Endonovo to explore reimbursement for the U.S. medical markets as well as the European Union market adoption through SofPulse® medical CE Mark. Additional target markets would be Taiwan and other Asian countries. About Endonovo Therapeutics Inc. Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system disorders, including traumatic brain injury, acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses pulsed short-wave radiofrequency at 27.12 MHz, has been FDA-cleared and CE marked for the palliative treatment of soft tissue injuries and post-operative pain and edema. It also has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease, non-alcoholic steatohepatitis cardiovascular and peripheral artery disease and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.

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Spotlight

Risks are inherent in any healthcare IT infrastructure, whether or not that infrastructure involves cloud services. The recent adoption of cloud services for healthcare data storage and retrieval, however, carries with a fair amount of skepticism around security...

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