FDA Warns Medical Device Bluetooth Security Flaw Could Disrupt Function

HealthITSecurity | March 05, 2020

A set of cybersecurity flaws found in a range of medical devices with Bluetooth Low Energy (BLE) could allow a hacker to remotely crash a device or access its data, according to a recent alert from the Food and Drug Administration. The BLE is used to pair and exchange data between two devices to perform specific functions and preserve battery life. However, researchers discovered a flaw, dubbed SweynTooth, that could allow a hacker to remotely crash the device, stop its function, or access functions typically only available to the authorized user. The vulnerability affects the BLE wireless communication technology found in certain products designed by several microchip manufacturers, including Texas Instruments, NXP, Cypress, Dialog Semiconductors, Microchip, STMicroelectronics, and Telink Semiconductor.

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A handful of the most promising hits are chosen for chemical modification to improve target specificity, potency, chemical and metabolic stability, water solubility, and other pharmacological parameters. Improved hits are now known as “lead compounds”.


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HEALTH TECHNOLOGY

UPS to Acquire Multinational Healthcare Logistics Provider Bomi Group

UPS | August 08, 2022

UPS announced plans to acquire Bomi Group, an industry-leading multinational healthcare logistics provider. The transaction will add temperature-controlled facilities in 14 countries and nearly 3,000 highly-skilled Bomi Group team members to the UPS Healthcare network in Europe and Latin America. “As a leading global healthcare logistics company, Bomi enhances our portfolio of services and accelerates our journey to become the number one provider of complex healthcare logistics. UPS Healthcare and Bomi Group employees share similar values and our cultures are firmly rooted in a relentless focus on quality. The combination of our two teams will significantly improve our healthcare customers’ ability to continue to develop and deliver life-saving innovations.” EVP and President of UPS International, Healthcare and Supply Chain Solutions Kate Gutmann Since 1985, Bomi Group has provided high value-added services for the Medtech and Pharma sectors with a customized and tailored approach. It is a quality-focused company devoted to healthcare that has built solid and long-lasting business relationships with more than 150 multinational customers worldwide. Key Bomi Group leaders, including CEO Marco Ruini, will continue in their roles to provide seamless service to Bomi Group customers after the transaction closes. Bomi Group’s employees will also continue to play vital roles in the combined organization. “With over 35 years in the healthcare logistics industry, our team has developed best-in-class services designed to meet and exceed the needs of our medical technology and pharmaceutical customers,” said Ruini. “Joining the UPS team will expand those capabilities and create an even more integrated and powerful global network for our customers.” The acquisition will add more than 350 temperature-controlled vehicles and four million square feet to the UPS Healthcare global footprint, offering customers access to faster shipping times, greater production flexibility, and offerings to help them attract new business. The acquisition will play a key role in the delivery of next-generation pharmaceutical and biologic treatments that increasingly require time-critical and temperature-sensitive logistics. “We are focused on building healthcare logistics capabilities and services that allow our customers to deliver the newest healthcare innovations,” said UPS Healthcare President Wes Wheeler. “We are excited to combine Bomi’s talent, expertise and capabilities with UPS Healthcare – together, we will provide unmatched solutions to our customers, powered by UPS’s integrated, global smart logistics network.” The acquisition of Bomi is part of UPS Healthcare’s continued expansion of its network and services to meet growing demand – including Bomi, UPS Healthcare has doubled its global footprint since 2020. Recent expansions include newly constructed and soon-to-be-opened dedicated state-of-the-art healthcare logistics facilities in Germany and Australia, and expanded campuses in Hungary and the Netherlands. UPS Healthcare also recently enhanced UPS Premier, a technology-led service that can prioritize and track critical shipments within 10 feet of their location anywhere in UPS’s global network. UPS Premier brings worldwide visibility, control, reliability and product recovery capabilities to UPS Healthcare customers. These expansions and new services meet the complex and varied needs of UPS Healthcare’s customers, helping them turn logistics into a competitive advantage. The transaction is expected to close by the end of the year, subject to customary regulatory review and approval. The value and terms of the transaction are not being disclosed at this time. J.P. Morgan Securities LLC served as the financial advisor to UPS. About UPS UPS is one of the world’s largest companies, with 2021 revenue of $97.3 billion, and provides a broad range of integrated logistics solutions for customers in more than 220 countries and territories. Focused on its purpose statement, “Moving our world forward by delivering what matters,” the company’s more than 500,000 employees embrace a strategy that is simply stated and powerfully executed: Customer First. People Led. Innovation Driven. UPS is committed to reducing its impact on the environment and supporting the communities we serve around the world. UPS also takes an unwavering stance in support of diversity, equity and inclusion. About UPS Healthcare UPS Healthcare delivers unparalleled healthcare logistics expertise to its customers around the world. UPS Healthcare has 11+ million square feet of cGMP and GDP-compliant healthcare distribution space globally. Services include inventory management, cold chain packaging and shipping, storage and fulfillment of medical devices, and lab and clinical trial logistics. UPS Healthcare's global infrastructure, its UPS® Premier visibility service, its track and trace technology, and its global quality system are well-suited to meet today's complex logistics demands for the pharmaceutical, medical device, and laboratory diagnostic industries. About Bomi Group BOMI GROUP is a leading Italian multinational company in the field of integrated logistics serving the Healthcare sector. Bomi is the logistics partner of more than 150 customers worldwide, including major players in the medical device, in vitro diagnostics, biomedical and pharmaceutical sectors. The Group is present through its subsidiaries and affiliates in 14 countries worldwide, with a particular focus on Europe and South America, employs over 3,000 people and has its own fleet of vehicles for daily deliveries to hospitals, clinics, laboratories, pharmacies and home patients.

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HEALTH TECHNOLOGY

Harris Williams Advises The CM Group on its Pending Sale to OPEN Health

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.

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HEALTH TECHNOLOGY

Softheon Expands to Artificial Intelligence in Care Management for Health Plans through Acquisition of NextHealth Technologies

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." shared Grossman 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. About Softheon 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.

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HEALTH TECHNOLOGY

HeartBeam Expands Patient Population for Emergency Department Software Technology Solution

HeartBeam, Inc. | July 04, 2022

HeartBeam, Inc. a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced that HeartBeam is expanding the available patient population for the Company’s Emergency Department software technology solution. In evaluating the ECG database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina, a serious cardiac condition. In light of the most recent 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain and in consultation with its clinical advisors, HeartBeam elected to include the full data set for clinical validation studying in support of the 510K submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the FDA. Due to the expanded available patient population, HeartBeam expects to file a 510K with the full data set for clinical validation no later than August 15, 2022 and does not affect the timeline for 510K submission of the Telehealth product. “It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue. Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention.” Russell Jones, MD, Interventional Cardiologist, Chair of the Ischemia Performance Improvement Committee at Phoebe Putney Health System HeartBeam’s platform technology is anticipated to assist physicians 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. HeartBeam’s software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies. “We believe our commercialization path is on track,” said Branislav Vajdic, PhD, CEO and founder. “The decision to include the broader patient population does not impact the scheduled submission for HeartBeam’s core technology platform for our Telehealth solution, which remains on schedule to submit in Q4 2022.” 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.

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A handful of the most promising hits are chosen for chemical modification to improve target specificity, potency, chemical and metabolic stability, water solubility, and other pharmacological parameters. Improved hits are now known as “lead compounds”.

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