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.
Viemed Healthcare, Inc. | July 06, 2022
Viemed Healthcare, Inc. a national leader in respiratory care and technology-enabled home medical equipment services, announced a third peer-reviewed and published study demonstrating the benefits of non-invasive ventilation at home The study, titled “Early Initiation of Non-Invasive Ventilation at Home Improves Survival and Reduces Healthcare Costs in COPD Patients with Chronic Hypercapnic Respiratory Failure: A Retrospective Cohort Study” was published in Respiratory Medicine, an internationally renowned scientific journal devoted to respiratory medical research.
“In addition to the significant clinical benefits demonstrated in previously published papers, this study demonstrates that NIVH improves health outcomes while simultaneously driving down overall healthcare costs. The study was also designed to investigate how the timing of NIVH initiation affected the outcomes. The results showed that the clinical and financial benefits of NIVH are greatest when therapy begins immediately following the diagnosis.”
Dr. William Frazier, Viemed’s Chief Medical Officer and co-author of the study
Using the 100% research identifiable fee-for-service Medicare claims from 2016 through 2020, the researchers found that using NIVH to treat chronic obstructive pulmonary disease with chronic hypercapnic respiratory failure is associated with significant reductions in mortality, hospitalizations, and total Medicare costs. In terms of cost-savings, Medicare expenditures for the year following NIVH initiation decreased by $5,484 compared to controls if treatment was begun within seven days of diagnosis. The cost reduction was $3,412 if NIVH was begun within 15 days of diagnosis. For patients whose therapy began more than 15 days after diagnosis, NIVH use was cost neutral and not associated with an increase in Medicare expenditures.
The primary clinical benefit was a reduced mortality in patients treated with NIVH. When a patient began therapy within seven days of diagnosis, the risk of death was reduced by 43%. Those patients who began therapy between eight and 15 days following diagnosis showed a mortality reduction of 31%, and patients who began therapy between 16 and 30 days following diagnosis showed a mortality reduction of 16%.
“NIVH is becoming widely accepted by clinicians as the standard of care for hypercapnic COPD-CRF treatment and this evidence supporting early initiation will help us to communicate the clinical and economic benefits to payors and partners,” said Casey Hoyt, Viemed’s CEO. “By accessing and treating more patients sooner, we can save lives, reduce hospital readmissions, and save money at the same time.”
ABOUT VIEMED HEALTHCARE, INC.
Viemed is a provider of in-home medical equipment and post-acute respiratory healthcare services in the United States. Viemed’s service offerings are focused on effective in-home treatment with clinical practitioners providing therapy and counseling to patients in their homes using cutting edge technology.
Nomi Health | July 14, 2022
Everyone Health has agreements with self-funded employers and third-party administrators for pre-negotiated, all-inclusive prices that save employers up to 70% relative to commercial fee-for-service rates. The company delivers these savings via Sano Surgery’s direct contracting with more than 10,000 physicians and facilities — surgical hospitals, ambulatory surgery centers, endoscopy centers, radiology centers, labs and more — in 300 of the largest U.S. cities across 48 states, all now part of Nomi Health’s national provider network.
“Nomi Health believes healthcare needs a rebuild, not a renovation. These companies share in our vision of extracting the complexity and cost from traditional healthcare, so buyers experience substantial savings and, most importantly, patients have greater access to more affordable care. In three short years, we expanded easy access to care to 15 million Americans, while significantly driving down cost of care to buyers. The immediate contributions of Everyone Health and Sano Surgery will accelerate this track record in the years ahead.”
Mark Newman, founder and CEO of Nomi Health
Founded by CEO Dutch Rojas 10 years ago, Sano Surgery has a network of nearly 6,000 medical facilities and 8,000 lab locations nationwide, ranging from radiology and orthopedics to women's health and oncology. This network enables Everyone Health to deliver higher quality medical treatments and services at lower prices. As a result, physicians benefit from predictable volumes and payments, while patients enjoy a more streamlined care and billing experience.
“My goal is affordable and accessible healthcare for all. We’ve built a nationwide network of physicians and medical facilities that allows us to bring substantially lower pricing and more transparent transactions to the market, benefiting countless Americans,” said Rojas, founder and CEO of Sano Surgery and Everyone Health. “As the dual crisis of access and affordability grows on the heels of the pandemic, the time is right to increase our impact as part of Nomi Health.”
The acquisitions enable buyers to turn to Nomi Health for a full suite of solutions — analytics, care delivery and a direct network — all underpinned by a modern claims infrastructure and payment rails. It also brings 12 full-time employees, including Rojas, to Nomi Health to accelerate the continued expansion of the company’s network of clinical partners, which is critical as Nomi Health takes its support and services into more communities nationwide.
The acquisitions of Everyone Health and Sano Surgery come on the heels of Nomi’s $200 million acquisition of healthcare analytics leader Artemis Health in January.
About Nomi Health
Nomi Health is a nationwide direct healthcare system making it easier than ever for any buyer of healthcare to access the highest quality affordable care for their communities. The company’s direct care ecosystem encompasses a real-time operating and payment system — inclusive of analytics and payment rails — as well as an integrated care delivery infrastructure featuring essential care services, pharmacy and an open network. To date, Nomi Health has saved buyers of care an average of 30 percent compared to traditional healthcare costs, while enabling them to give their communities more access to lower cost, high quality care.
From rural counties to some of the largest cities in America, Nomi Health has administered everyday healthcare services to more than 14 million Americans and counting in hundreds of communities nationwide. During COVID-19, this direct care model played a pivotal role in care access, public health and keeping economies open and operating.
Based in Orem, Utah, Nomi Health employs more than 2,000 nationwide, working to lower healthcare expenses, widen care access and improve the patient experience. The company is led by an experienced, cross-functional leadership team with clinical, healthcare, technology and finance backgrounds. Nomi Health has so far invested more than $10 million dollars in improving the well-being of the communities it serves.
Harris Williams | August 01, 2022
Harris Williams, a global investment bank specializing in M&A advisory services, announces it is advising The CM Group, a portfolio company of NaviMed Capital (NaviMed), on its pending sale to OPEN Health, a portfolio company of Astorg. The CM Group is a leading medical communications platform offering a set of integrated solutions to the U.S. domestic biotech and pharma industries. The transaction is being led by Paul Hepper, Nick Owens, Lucas Scholl, Rob Crampton and Gabby Struckell of the Harris Williams Healthcare & Life Sciences Group.
“Investor interest in outsourced pharma commercialization services is driven by complex therapies becoming an increasing portion of new drug launches, declining access to physicians, and the increasing importance of directly reaching patient populations. Differentiated platforms such as The CM Group are benefiting disproportionally from these trends,” said Paul Hepper, a managing director at Harris Williams.
“The combination of OPEN Health and The CM Group brings together two best-in-class commercialization businesses, with stellar reputations in the industry and an exciting opportunity to service leading pharmaceutical companies globally,” said Nick Owens, a director at Harris Williams.
“Harris Williams was a phenomenal partner and exceeded our expectations throughout the transaction. The team’s knowledge of the sector and extensive buyer relationships led to an optimal outcome. We look forward to the next phase of growth with the OPEN Health and Astorg teams and are excited about building a global leader in pharma commercialization,”
Daniel Leonard, CEO of The CM Group
Grounded in science—and powered by the patient voice—The CM Group is an integrated healthcare agency of innovative and imaginative subject-matter experts dedicated to providing scientific and commercialization strategies and services to the life sciences industry.
NaviMed is a Washington, D.C.-based private capital firm with over $400 million of assets under management, focused exclusively on the healthcare industry. NaviMed invests in fast-growing lower-middle market healthcare businesses that it believes are poised to benefit from the reform and technology innovation reshaping the healthcare industry. The firm focuses on healthcare services, healthcare IT, hospital products and pharmaceutical services businesses. NaviMed targets profitable private companies with up to $10 million of EBITDA and double-digit revenue growth. NaviMed’s senior investment team has a track record of value creation spanning, in the aggregate, dozens of investments and more than $11 billion of enterprise value created over the course of their combined careers.
OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support its clients in improving health outcomes and patient wellbeing. OPEN Health is united as one flexible organization, harnessing the power of the collective to solve complex challenges.
Astorg is a European private equity firm with over €17 billion of assets under management. Astorg works with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the U.S., providing them with the strategic guidance, governance and capital they need to achieve their growth plans. Enjoying a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body, Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London; Paris; New York; Frankfurt, Germany; Milan; and Luxembourg.
Harris Williams, an investment bank specializing in M&A advisory services, advocates for sellers and buyers of companies worldwide through critical milestones and provides thoughtful advice during the lives of their businesses. By collaborating as one firm across Industry Groups and geographies, the firm helps its clients achieve outcomes that support their objectives and strategically create value. Harris Williams is committed to execution excellence and to building enduring, valued relationships that are based on mutual trust. Harris Williams is a subsidiary of the PNC Financial Services Group, Inc.
The Harris Williams HCLS Group has experience across a broad range of sectors, including healthcare providers; payors and payor services; outsourced pharmaceutical services; medical device supply chain; healthcare IT; and pharmacy.
Harris Williams LLC is a registered broker-dealer and member of FINRA and SIPC. Harris Williams & Co. Ltd is a private limited company incorporated under English law with its registered office at 8th Floor, 20 Farringdon Street, London EC4A 4AB, UK, registered with the Registrar of Companies for England and Wales (registration number 07078852). Harris Williams & Co. Ltd is authorized and regulated by the Financial Conduct Authority. Harris Williams & Co. Corporate Finance Advisors GmbH is registered in the commercial register of the local court of Frankfurt am Main, Germany, under HRB 107540. The registered address is Bockenheimer Landstrasse 33-35, 60325 Frankfurt am Main, Germany. Geschäftsführer/Directors: Jeffery H. Perkins, Paul Poggi.Harris Williams is a trade name under which Harris Williams LLC, Harris Williams & Co. Ltd and Harris Williams & Co. Corporate Finance Advisors GmbH conduct business.