HeartBeam, Inc. | August 17, 2022
HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced it has submitted a 510(k) application to the US Food and Drug Administration for its HeartBeam AIMI™ platform technology for use in diagnosing heart attacks.
“The 510(k) submission of our first product, based on our platform technology, is an important milestone toward commercialization and underscores our continued progress toward making the HeartBeam AIMI platform widely available to help Emergency Department physicians correctly and expeditiously diagnose patients with chest pain or other symptoms of a heart attack. I am proud of the HeartBeam team for their commitment to achieving this critical step in bringing the Company’s technology to market. We look forward to working through the FDA review process toward our goal of clearance for the US market.”
Branislav Vajdic, PhD, HeartBeam CEO and founder
The HeartBeam AIMI platform technology is anticipated to assist health care professionals in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit with high costs associated with these visits. The goal of HeartBeam’s technology is to offer more accurate heart attack detection to triage patients and expedite treatment.
HeartBeam AIMI is software as a medical device with a 510(K) regulatory pathway. The HeartBeam algorithm used in an emergency department setting slots into existing physician workflow, leverages existing 12-lead ECG hardware and provides the attending physician with an instant comparison of the patient’s baseline and symptomatic ECG for their consideration in the patient’s diagnosis. This will allow physicians to quickly determine if a patient needs intervention or can be discharged which helps manage patient flow.
Jon Hunt, PhD, HeartBeam Executive Vice President and Chief Business Officer, added, “Our FDA approval process doesn’t require any human or animal trials, so there is good reason to believe that we will receive FDA clearance for a limited market release by end of 2022 and full commercial roll-out in Q1 2023. While the FDA conducts its regulatory review, our team will focus on executing key components of its commercialization plan and subscription revenue model. We continue to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize our products. We look forward to approval and offering our HeartBeam AIMI platform in an expected $500 million total addressable market.”
About HeartBeam, Inc.
HeartBeam, Inc. is a development stage digital healthcare company with proprietary ECG telemedicine technology that will redefine the way high risk cardiovascular patients are diagnosed in an ambulatory setting at any time and any place. Its breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack.
Cue Health Inc. | August 25, 2022
Cue Health Inc. a healthcare technology company announced a new collaboration with Fresenius Kidney Care to provide the most accurate* COVID-19 self-test to certain patients and clinical care teams.
People who are immunocompromised have been disproportionately affected by COVID-19 throughout the pandemic and remain highly dependent on measures that reduce the likelihood of infections, including vaccination. Cue can be used by vulnerable patient populations and their care partners to detect and treat COVID-19 early, often before complications arise and hospitalization is required. This is especially important in remote locations where timely and accurate results are critical for making clinical treatment decisions. Fresenius Kidney Care in Hawaii, Alaska, Puerto Rico, Guam, and Saipan will use the Cue Health Monitoring System and Cue COVID-19 Test to screen employees and test symptomatic immunocompromised patients in-center and at-home.
"This is a great example of how Fresenius Kidney Care is seeking out the best technologies to ensure we do everything we can to protect our vulnerable patient population from COVID-19," said Ines Dahne-Steuber, President of Spectra Laboratories, a Fresenius Medical Care company providing laboratory diagnostics to dialysis centers across the country. "This collaboration with Cue will help us provide patients with greater access to high-quality timely diagnosis and care in our effort to improve health outcomes while lowering costs."
Fresenius Kidney Care operates more than 2,600 dialysis centers in the U.S., providing more than 200,000 patients annually with services that include at-home peritoneal dialysis, at-home hemodialysis, in-center hemodialysis, and additional clinical care resources.
"By utilizing Cue's platform, Fresenius Kidney Care can continue to provide its life-saving services to immunocompromised patients with confidence they are using the most accurate COVID-19 self-test. We treat accuracy as non-negotiable so healthcare-affiliated organizations across the country can continue to trust Cue for their testing needs in high-stakes environments."
Ayub Khattak, Chairman and CEO of Cue Health
Fresenius Kidney Care is one of the growing number of healthcare-affiliated organizations and internationally-recognized hospital systems throughout the U.S working with Cue to transform how diagnostic healthcare is delivered to close gaps in the patient journey and drive improved health outcomes. Cue is used in many other point-of-care settings such as Johns Hopkins Medicine and Mayo Clinic, by world-class organizations across the country, including Google, the National Basketball Association, and Major League Baseball, and in homes.
Cue's test uses molecular nucleic acid amplification technology (NAAT) providing lab-quality results directly to connected mobile devices in 20 minutes. The test can detect all known COVID-19 variants and subvariants of concern - including Omicron, BA.4, and BA.5 - and can be used on adults and children (age 2 years and over for over-the-counter (OTC) / home use and under 2 for professional use), with or without symptoms.
About Cue Health
Cue Health is a healthcare technology company that makes it easy for individuals to access health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, regulatory approval from India's Central Drugs Standard Control Organization, and PSAR authorization from Singapore's Health Sciences Authority. Cue was founded in 2010 and is headquartered in San Diego.
Softheon | July 01, 2022
Softheon, a leading cloud-based eligibility, enrollment, and billing provider for health plans and government agencies, has acquired NextHealth Technologies, an AI-powered SaaS-based healthcare analytics platform. With the acquisition, Softheon will be better able to help health plans sell and deliver efficient, high-quality care through synergies in the companies' respective products and solutions. Health plans cans save tens or even hundreds of millions of dollars on medical and operational costs through Softheon's growing suite of solutions.
The acquisition significantly enhances Softheon's talent density, enhancing go-to-market strategies, engineering processes, and leadership. The overall speed and capability of NextHealth's AI solutions will increase through Softheon's propriety technology.
Softheon CEO, Eugene Sayan, will continue to lead the company. Eric Grossman, NextHealth's founder, has become the combined organization's Chief Commercial Officer, supporting Sayan's vision and the company's growth objectives.
Sayan shared, "Artificial Intelligence in healthcare is here, and we are seeing the incredible impact it can have on both members and carriers. Our goal has been to make healthcare more affordable, accessible, and plentiful, and we see AI as a clear path forward to bring efficiencies to our carrier partners. This acquisition is a testament to Softheon's commitment to helping health plans tackle some of their biggest challenges, such as population health and the movement toward consumerism in healthcare."
NextHealth Technologies, founded in 2013, offers a cloud-based platform that utilizes rigorous methodologies and standardized processes to enable health plan customers to identify impactable populations, measure which clinical initiatives work best for whom, and integrate data-driven decisions into the workflow in real-time to derive the highest ROI from their analytics investments.
"We are thrilled to be part of Softheon's continued growth and expansion. This is an incredible opportunity for our respective teams. NextHealth's technical and service staff will continue to build and support cutting-edge applications of AI for carrier member populations with the support and resources of a larger company. We see a bright future for our health plan partners as we bring those tools to bear to deliver significant value and reduced costs."
Softheon's purchase of NextHealth is expected to bring economies of scale and operating leverage to the combined company. NextHealth investors, Norwest Venture Partners and TT Capital Partners, will become investors in Softheon and expressed excitement on the prospects of the transaction.
"Together, NextHealth and Softheon can provide better care at lower medical and administrative costs while advancing the application of AI in healthcare." said Casper de Clercq, General Partner at Norwest Venture Partners.
"The acquisition of NextHealth will enhance Softheon's AI capabilities for health plans," said Ryan Engle, partner at TT Capital Partners, "Member data spanning shopping and enrollment through claims creates opportunities for proprietary methodologies to shape member behavior and create value for plans."
Softheon has continued its growth and expansion, having completed more than 20 million enrollments since the inception of the Affordable Care Act, through public and private exchange technology. The acquisition comes after the company introduced its first foray into AI by creating a machine learning algorithm that predicts which members are at risk of letting their insurance coverage lapse, as featured in Bloomberg Law.
Founded in 2000, Softheon's Software-as-a-Service (SaaS) and Business Process-as-a-Service (BPaaS) solutions solve complex challenges for health plans and government health agencies. Currently, Softheon's solutions serve 8 State agencies and over 90 health plans. Issuers and consumers utilizing Medicaid, Medicare, and the ACA Marketplace benefit from Softheon's innovative technology that reduces administrative overhead and enhances user-experiences. Softheon is an Agent, Broker, and Merchant of Record that facilitates health insurance enrollment, administration, and renewal.
About NextHealth Technologies
NextHealth Technologies, based in Denver, is an AI-powered analytics platform that rapidly optimizes the effectiveness of health plans' cost, quality, and service enhancement initiatives resulting in significantly reduced costs and improved outcomes. Its cloud-based solution utilizes scientifically rigorous methodologies and standardized processes, enabling and promoting a culture of measurement. The platform is HITRUST-certified, scalable, and is deployed with expert services to ensure client adoption and success. Know what works™ and make it better.
Sequana Medical NV | August 29, 2022
Sequana Medical NV a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces the appointment of Alexandra Clyde as an independent Non-Executive Director of the Company. Ms. Clyde is a highly experienced global business executive with an exceptional understanding and track record of successfully navigating health economics and reimbursement in the medical device industry. The Company also announces that Erik Amble will step down as a member of the Board of Directors after the board meeting of 7 September 2022, and will continue to attend the meetings as a board observer in a non-voting capacity.
“Alex will be a critical member of our Board as Sequana Medical prepares to expand commercialization of the alfapump. Her experience from more than 25 years at Medtronic, a global leader in healthcare technology, and her understanding of healthcare systems around the world will prove invaluable as we continue to grow our business and seek to transform the care of liver disease and heart failure. On behalf of the Board, I would also like to thank Erik for his tremendous contributions to the Company and we are pleased to still have him as an observer on the Board.”
Pierre Chauvineau, Chairman of the Board at Sequana Medical
Ms. Clyde added: “I believe that both of Sequana Medical’s programs – the alfapump® and DSR® therapy – have the potential to deliver tremendous benefit to patients and the healthcare community. In these two large and growing patient populations, liver disease and heart failure, drug-resistant fluid overload is a significant and burdensome challenge with limited effective treatment options. Sequana Medical is in an exciting position to help these patients and reduce the burden of disease. I look forward to working with the Board and management team to help the Company reach its potential.”
Mr. Amble added: “At this time in the Company’s evolution, it is critically important that the Board brings expertise to help guide the Company’s commercial readiness activities in North America. With Doug and Alex now on the Board, I am confident that the Board is well positioned to guide Sequana Medical as it enters a period of potential exponential growth. It’s been a pleasure to work with Sequana Medical’s Board and management team for more than 15 years and I look forward to continuing my involvement as a Board observer.”
Ms. Clyde is Senior Vice President of Global Health Economics, Policy, and Reimbursement for Medtronic plc. In this role, she leads a global function of more than 300 reimbursement and health economics professionals and provides company-wide leadership on health and payment policy. She is a member of the Duke Margolis Value-Based Payment and Innovative Technology Consortium, the Health Technology Assessment International (HTAi) Policy Forum, and the Advisory Board for the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. She is a former member of the Health Care Payment Learning and Action Network’s Guiding Committee which is charged by the US Secretary of Health and Human Services with accelerating the health care system’s transition to alternative payment models (APMs) by combining the innovation, power, and reach of the public and private sectors. She has also participated in various Centers for Medicare and Medicaid Services technical advisory councils as well as other private and public sector initiatives to improve value in health care. Alex graduated from Colgate University with a B.A. in Economics and from Harvard University with a M.S. in Health Policy and Management.
Sequana Medical NV is a pioneer in treating drug-resistant fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. Fluid overload is a well-recognized problem in these growing diseases, causing severe problems for the large number of patients for whom current medicines are no longer effective. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life.