The Latest Cardiac and Vascular News
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. Receipt of this new CPT […]
IRVINE, Calif.–(BUSINESS WIRE)– Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announces that the U. S. Centers for Medicare & Medicaid Services (CMS) granted a Transitional Pass-Through (TPT) Payment for the DETOUR System, effective January 1, 2024. The TPT Payment […]
SOUTH JORDAN, Utah, Dec. 18, 2023 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today outlined the ongoing succession planning process for its Chief Executive Officer (CEO). Pursuant to an Amended and Restated Employment Agreement, effective June 8, 2023, Merit […]
TEL AVIV, Israel, Dec. 18, 2023 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced the appointment of Eyal Morag, M.D., as Chief Medical Officer (CMO). Dr. Morag brings extensive experience as […]
This milestone will fuel Implicity’s rapid US expansion by providing valuable co-sell support and benefits including seamless integration, increased reliability, and expanded access to AWS services
CAMBRIDGE, Mass., Dec. 13, 2023 /PRNewswire/ — IMPLICITY®, a leader in remote patient monitoring and cardiac data management solutions, announced it has joined the Amazon Web Services (AWS) Independent Software Vendor (ISV) Accelerate Program, a co-sell program for AWS partners that provide software solutions that run on or integrate with AWS. The program helps AWS partners drive new business by directly connecting participating ISVs with the AWS Sales organization.
“This is an important milestone that amplifies our reach and validates our mission to bring digital innovation to cardiology. By deepening our relationship with AWS, we can help even more clinicians improve cardiac care by delivering cutting-edge solutions that enable more efficient and effective remote monitoring,” said Jon Hunt, PhD., Implicity’s Chief Commercial Officer in North America.
Implicity’s AI-powered* platform allows healthcare professionals to better manage the growing streams of patient information being produced by cardiac implantable electronic devices (CIEDs), such as pacemakers and implanted defibrillators. The solutions can also interpret data and automatically alert care teams when intervention is required.
The AWS ISV Accelerate Program provides Implicity with co-sell support that enables partners to meet customer needs through collaboration with AWS field sellers globally. Co-selling provides better customer outcomes and assures mutual commitment from AWS and its partners.
“Before Implicity, our team would have spent hours weeding through alerts and reports. This would have delayed the treatment of patients with clinically significant events or critical episodes. Additionally, their customer support and service has been second to none. They are truly dedicated to helping clinicians streamline their care and optimize their workflow. This system is life-changing,” said Dan Morris, Device Clinic Lead at the Heart Center of Nevada.
AWS ISV Accelerate program members are held to the industry’s highest standards. To gain acceptance into the AWS ISV Accelerate Program, proof of customer excellence was required to validate the success users have experienced using the technology. Implicity also had to pass a rigorous technical and security review of its platform to ensure the quality and design of its solutions. The program gives Implicity-focused co-selling support and access to expanded sales enablement resources from AWS. It also provides technical enablement and business resources to enhance Implicity’s offerings and drive innovation.
About ImplicityImplicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure.
Implicity’s platform provides critical health information augmented by FDA-cleared AI* algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub**, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 94,000 patients in over 195 medical facilities across the US and Europe. To learn more, visit www.implicity.com
*FDA cleared Class II medical device and CE marked Class I (under MDD) medical device; see the instructions for use for more information.
**Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes
Media Contact:Andrea LePaineMedia Junction[email protected]m
SOURCE Implicity
LONDON, Dec. 13, 2023 /PRNewswire/ — Belgium-based medical device design company SYNDEO Medical has made Business Worldwide Magazines 2023 “20 Most Innovative Companies to Watch” list. The list is a celebration of trailblazing organizations that are changing the game in their respective industries and altering the corporate landscape. Encompassing healthcare, banking, industry, construction, energy, and more, these companies are at the cutting edge of breakthrough technologies, innovation and modernized business structures. Those included in the list demonstrate a shared goal of developing revolutionary products and technology that drive scalable business models and disrupt established industries and markets.
Led by Justin Lampropoulos, the company is on a mission to revolutionise the way healthcare practitioners access tools they need, by bridging the gap between past and future.
At the heart of every operating theatre lies a combination of essential tools and materials needed to save and improve lives. Everything from surgical gloves to gowns, scalpels and intricate medical devices are brought together for every specific surgery, and for decades these were all conveniently provided in customised, sterile packs. This tailor-made approach worked for medical teams, and it’s what they came to expect, but over the past five to seven years custom packs have become virtually extinct due to reduced funding and other external pressures.
On average, every pack contains about 30/40 different components, which means those involved in hospital procurement have to buy all of those products independently, fly them, manage the purchase orders, and deliver. The complexity of producing an additional 10-15 purchase orders with the associated contracts and sales representatives puts a huge strain on patient care, finances, and overall efficiency. Doctors and nurses were spending hours shopping for specific items of equipment when they want to be focusing on patient care, so it became clear that a new solution was needed.
SYNDEO Medical stepped in to reinvent the approach that combined the affordability and scalability needed to meet modern pressures with the flexibility, choice and familiarity associated with traditional packs.
Focusing on radiology and cardiology, SYNDEO packs combine all the time-saving advantages of standardised packs with a tailored selection based on specific interventional healthcare needs. The company has partnered with healthcare professionals to create customised procedural solutions that are both efficient and improve patient outcomes.
The SYNDEO approach also saves money, thanks to a revolutionary pricing model. As a result, medical teams often find themselves paying as little as 70% less than they were on standard packs.
Approximately 80% of the components are manufactured and assembled in-house, in direct collaboration with SYNDEO’s strategic partners. This gives the company complete control of the entire process, enabling the team to maintain consistently high standards and manage supply chain speeds, establishing SYNDEO as a company that challenges the status quo.
SYNDEO’s packs also help healthcare departments reduce waste. Because the tools needed for one surgery may be completely different to the next, many packs contain unused items which end up in landfill. The customised approach means that medical departments only get the tools they need. The company also offers a new line of green and sustainable eco products, all with a great biodegradability profile.
To learn more about how SYNDEO Medical is driving a revolution in healthcare packs, visit www.syndeomedical.be
Further information about the “20 Most innovative Companies to Watch, 2023” Awards can be found at https://www.bwmonline.com/awards/20-most-innovative-companies-to-watch-2023-winners/
About Business Worldwide Magazine
Business Worldwide Magazine is the leading source of business and dealmaker intelligence throughout the world. Our quarterly magazine and online news portal enables an established audience of corporate dealmakers to track the latest news, stories and developments affecting the international markets, corporate finance, business strategy and changes in legislation. This readership includes of CEO/CFO – Banks, Corporate Lawyers and Venture Capital/Private Equity Companies to name a few.
ContactDavid Jones Awards DepartmentE: [email protected]W: www.bwmonline.com
SOURCE Business Worldwide Magazine
ATLANTA, Dec. 12, 2023 /PRNewswire/ — West Physics Consulting, LLC (“West Physics”), the leading national provider of integrated medical and health physics consulting services, announced today that it has completed the purchase of Radiation Protection Services, Ltd. (“RPS”), a respected regional provider of medical and health physics services based in Springfield, IL.
“We are thrilled to announce the acquisition of Radiation Protection Services. This strategic addition to West Physics helps us to expand our capabilities and capacity, and will further enhance our service delivery in Illinois, Missouri, Iowa, and Indiana. We welcome the RPS team to our organization and we look forward to achieving great success by combining forces and adding RPS’ radioactive material and imaging equipment testing skills and experience to the West Physics platform,” stated Dr. Geoffrey West, President & Chief Executive Officer of West Physics.
RPS customers are expected to benefit from the stability and support of the nation’s top medical and health physics provider. RPS customers will now have access to subject matter expertise in the areas of MRI safety, CT and fluoroscopy dose optimization, and clinical image analysis and review for ACR accreditation. Additionally, West Physics is excited to bring their world-class online training and reports portals to the RPS client base. Finally, the combination will result in increased scheduling flexibility, faster report turnaround, and enhanced support for customers.
“We’ve looked at a number of options over the last few years to help us take RPS to the next level in terms of growth and sophistication, and more importantly, to allow us to serve our customers even better,” said Doug Neuweg, President of RPS. “Becoming a part of West Physics was the clear winning option. They have built an incredible reputation over the years for being innovative, smart, and reliable and for also being totally committed to customer service. Our team is excited to add the resources of West Physics to our operation and to have many more colleagues to help us and our customers going forward,” continued Mr. Neuweg.
This acquisition aligns with West Physics’ strategy to provide premier medical and health physics services nationwide and globally. With RPS now part of West Physics, our team has grown to over 130 professionals serving over 6,000 customer sites across all 50 states, U.S. territories, the Caribbean, and the Middle East. We continue to be the largest diagnostic medical physics consulting practice in the United States, enabling us to deliver unparalleled quality and value for our customers.
About West Physics:
West Physics, headquartered in Atlanta, Georgia, is a global provider of medical and health physics testing and radiation safety consulting services. West Physics serves over 6,000 client sites, including hospitals, freestanding imaging centers, mobile imaging providers, and physician offices throughout the 50 U.S. states, federal territories, the Caribbean and the Middle East. West Physics specializes in assisting healthcare providers in maintaining their accreditation with organizations such as The Joint Commission, the American College of Radiology, the Intersocietal Accreditation Commission, and in radiation regulatory compliance with state and federal agencies. For more information, please visit http://www.westphysics.com.
About Radiation Protection Services, Ltd.:
Founded in 1986, Radiation Protection Services, Ltd. (“RPS”) is a privately owned company that provides radiation physics testing and consulting services for medical and industrial facilities that utilize x-ray-producing equipment or radioactive materials. RPS provides services to customers in Illinois, eastern Missouri, southeastern Iowa, and western Indiana, providing flexible and rapid response times along with personalized service. RPS staff specialize in ensuring regulatory compliance and radiation safety for their customers and their customers’ patients.
Media Contact: Denny Runnion, denny@westphysics.com
SOURCE West Physics Consulting, LLC
Industry-leading conversion to and engagement with Karoo’s unique wraparound cardiac care model led to emergency department diversion in 20% of patients during proof-of-concept period
ALBUQUERQUE, N.M., Dec. 12, 2023 /PRNewswire/ — Karoo Health, the only operational provider of cardiac value-based care (VBC) enablement, today released results of its first proof of concept (POC) with participating cardiac providers. Study data was collected from June through November 2023. Among the findings:
70% of eligible patients were converted to the Karoo VBC model in the most recent month of the POC period
95% digital engagement rate was demonstrated among enrolled patients throughout the POC period
20% of the patient panel was diverted from unnecessary ED visits during the POC period, leading to significant cost-of-care savings
Karoo seamlessly integrates dedicated on-site and virtual care teams with proprietary technology to facilitate the transition to, and success in, value-based care for cardiology providers, networks, health plans, and at-risk primary care groups. Karoo’s innovative enablement model is essential for enhancing patient health, reducing overall cost of care, and amplifying performance in HEDIS and Stars measures.
“Our proof of concept affirms the effectiveness of our cardiac VBC model,” said Karoo COO Chentelle Lane. “Our recent conversion rates exceeding 70 percent of eligible patients, compared to the 25 to 30 percent typically observed in other VBC companies, along with an impressive digital patient-engagement rate of 95 percent, underscore our unwavering commitment to execution and making a significant impact on the current and future state of cardiac care. Karoo is the only operational company using VBC to improve patient outcomes and lower cost of care in cardiovascular disease.”
“Karoo is making a difference in our overall approach to patient care,” said Harvey White, M.D., Founder and Executive Director of Vessel Health, an innovative provider of cardiovascular care in Albuquerque, N.M. “Karoo effortlessly integrates with our staff’s considerable medical expertise with supporting care teams and complementary technologies to break down barriers to better health by giving our providers more time to focus on important clinically-driven interactions.”
Karoo operations are led by a team of seasoned healthcare industry veterans, with Chentelle Lane serving as the Chief Operating Officer. Lane, who previously held the position of COO of Care Services at Cityblock Health, brings a wealth of experience from executive roles at Somatus and naviHealth. Complementing this expertise, Karoo has assembled an impressive team that has helped craft and lead some of the most prominent VBC companies in the industry, including Main Street Health, naviHealth, and Contessa Health.
About Karoo HealthHeart disease is currently the leading cause of death in the United States, with one person dying every 33 seconds due to cardiovascular illness. Employing an exclusive mix of specialized care teams and proprietary technology grounded in value-based principles, Karoo enables cardiology providers, networks, health plans, and at-risk primary care groups to seamlessly transition to, and succeed in, value-based care, and excel in outcomes-driven initiatives crucially required within the cardiac domain. For more information, visit the company at www.karoohealth.com or connect with them on LinkedIn.
SOURCE Karoo Health
BOSTON, Dec. 12, 2023 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, has completed its previously announced acquisition of OpSens Inc., a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology.
Haemonetics acquired all outstanding shares of OpSens for CAD $2.90 per share in the all-cash transaction, representing a fully diluted equity value of approximately USD $255 million at the current exchange rate. In connection with the closing of the transaction, OpSens’ common shares will cease trading in the public market and will be delisted from the Toronto Stock Exchange and withdrawn from the OTCQX.
“Expanding our Hospital portfolio with OpSens’ products creates exciting growth and diversification opportunities, while providing immediately accretive financial benefits,” said Chris Simon, Haemonetics’ President and Chief Executive Officer. “We are pleased to officially welcome OpSens to Haemonetics and look forward to driving greater access to OpSens’ essential solutions and benefits for physicians and patients throughout the world.”
OpSens offers commercially and clinically validated optical technology for use primarily in interventional cardiology. OpSens’ core products include the SavvyWire®, the world’s first and only sensor-guided 3-in-1 guidewire for TAVR procedures, that acts as a pacing and pressure monitoring wire advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients, and the OptoWire®, a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (FFR) and diastolic pressure ratio (dPR) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease. OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications.
In conjunction with the transaction, Haemonetics increased its fiscal year 2024 GAAP revenue growth guidance range from 7 – 9% to 8 – 10% and reaffirmed all other fiscal 2024 guidance issued in its second quarter earnings release on November 2, 2023. In fiscal year 2025, Haemonetics expects OpSens to contribute $55 to $65 million in revenue, to be slightly accretive to earnings per diluted share on a GAAP basis and to contribute approximately $0.10 to $0.15 in adjusted earnings per diluted share, excluding one-time acquisition and integration-related costs.
In addition to expected immediate and longer-term financial benefits for Haemonetics, the acquisition expands the company’s Hospital business unit portfolio with innovative fiber optic sensor technology in the attractive interventional cardiology market. Haemonetics’ commercial success with its VASCADE® Vascular Closure portfolio, combined with extensive existing commercial and clinical infrastructure, will accelerate customer access to OpSens’ products.
Haemonetics financed the acquisition through a combination of cash-on-hand and a $110 million draw under its revolving credit facility. Following this acquisition, Haemonetics estimates that its net debt to EBITDA ratio, as defined in Haemonetics’ existing credit agreement, will be approximately 2.3x. Haemonetics expects to pay down the majority of the outstanding balance of the revolving credit facility within the next few months.
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements do not relate strictly to historical or current facts and may be identified by the use of words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “forecasts,” “foresees,” “potential” and other words of similar meaning in conjunction with statements regarding, among other things, (i) plans and objectives of management for the operation of Haemonetics, (ii) the anticipated financial impact of the transaction on Haemonetics’ operating results, (iii) the anticipated benefits to Haemonetics arising from the completion of the acquisition, (iv) the impact of the acquisition on Haemonetics’ business strategy and future business and operational performance, (v) the company’s estimated net debt to EBITDA ratio, as defined in Haemonetics’ existing credit agreement; (vi) the timeline to repay the revolving credit facility draw used to finance the acquisition, and (vii) the assumptions underlying or relating to any such statement. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics’ current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.
Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the failure to realize the anticipated benefits of the acquisition, Haemonetics’ ability to predict accurately the demand for products and products under development by it or OpSens and to develop strategies to successfully address relevant markets, the impact of competitive products and pricing, technical innovations that could render products marketed or under development by Haemonetics or OpSens obsolete, risks related to the use and protection of intellectual property, and the risk that using debt to finance, in part, the acquisition will increase Haemonetics’ indebtedness. These and other factors are identified and described in more detail in Haemonetics’ filings with the U.S. Securities and Exchange Commission (“SEC”). Haemonetics does not undertake to update these forward-looking statements.
Non-GAAP Financial Measures
This press release contains financial measures that are considered “non-GAAP” financial measures under applicable SEC rules and regulations. Management uses non-GAAP measures to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results. Performance targets for management are also based on certain non-GAAP financial measures. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, Haemonetics’ reported financial results prepared in accordance with U.S. GAAP. In this release, supplemental non-GAAP measures have been provided to assist investors in evaluating the expected impact of Haemonetics’ acquisition of OpSens and provide a baseline for analyzing trends in the company’s underlying businesses. We strongly encourage investors to review the company’s financial statements and publicly-filed reports in their entirety and not rely on any single financial measure.
When used in this release, adjusted earnings per diluted share excludes restructuring costs, restructuring related costs, digital transformation costs, amortization of acquired intangible assets, asset impairments, accelerated device depreciation and related costs, costs related to compliance with the European Union Medical Device Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”), integration and transaction costs, certain tax settlements and unusual or infrequent and material litigation-related charges, and the tax impact of these items. Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures to similarly titled measures used by other companies.
The company does not attempt to provide reconciliations of forward-looking adjusted earnings per diluted share guidance to the comparable GAAP measures because the combined impact and timing of recognition of certain potential charges or gains, such as restructuring costs and impairment charges, is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of the company’s financial performance.
Investor Contacts:
Olga Guyette, Sr. Director-Investor Relations & Treasury
David Trenk, Manager-Investor Relations
(781) 356-9763
(203) 733-4987
[email protected]
[email protected]
Media Contact:
Josh Gitelson, Director-Global Communications
(781) 356-9776
[email protected]
SOURCE Haemonetics Corporation
PETOSKEY, Mich.–(BUSINESS WIRE)–BioStar Capital, a strategic venture capital firm focusing on transformative medical technologies primarily in the fields of cardiovascular disease, orthopedics, and robotics, has announced it has closed its fifth fund at $130.3 million, more than its three previous funds combined. “We have been encouraged by the level of […]
