New Paper Underscores Inflammation’s Role in Atherosclerosis

July 19, 2024

The International Atherosclerosis Society today released a clinical proceedings white paper outlining the role of inflammation in atherosclerosis and the importance of early intervention.

The paper has four main sections:

The role of inflammation in atherosclerosis is explained, noting that local inflammation in the artery wall participates directly in the development of the condition. Systemic, chronic inflammation can also promote the advancement of atherosclerosis and increase the risk of developing cardiovascular diseases.
Using biomarkers to identify inflammatory risk in individual patients is now possible. Assessing levels of high-sensitivity CRP specifically can be used to help determine therapeutic strategies that may reduce the risk of major cardiovascular events.
Interventions that may mitigate inflammatory risk include lifestyle modifications as well as pharmaceutical interventions. Policy changes could also mitigate the inflammatory risk of atherosclerosis.
The burdens of disease are substantial. Atherosclerosis results in significant loss of life and greatly impacts household finances and economies worldwide.

Assessment & Treatment of Inflammation in Atherosclerosis is authored by four international experts:

Peter Libby, MD – USA
Wolfgang Koenig, MD, FRCP, FESC, FACC, FAHA – Germany
Jessica M. Peña, MD, MPH, FACC, FNLA – USA
Hiroaki Shimokawa, MD, PhD – Japan

READ WHITE PAPER: Assessment & Treatment of Inflammation in Atherosclerosis

Peter Libby, MD, President, of the International Atherosclerosis Society and Chair of the White Paper Expert Panel said, “Atherosclerosis is a primary cause of cardiovascular disease, the leading cause of death worldwide. This paper underscores the persistent need for a more complete understanding of the role of inflammation in atherosclerosis progression among physicians globally, how to identify such inflammation, and how to mitigate the inflammation-associated risk of adverse cardiovascular events. These steps are of the utmost importance for the development of effective treatment strategies that can reduce the morbidity and mortality caused by atherosclerotic cardiovascular disease.”

Bloom Nutrition Introduces Bloom Sparkling Energy Drinks

July 19, 2024

Bloom Nutrition, one of the fastest-growing supplement brands of the decade, known best as the #1 Greens brand in the United States, today launches Bloom Sparkling Energy, the brand’s first ready-to-drink canned beverage. Available exclusively at Target stores nationwide, Bloom Sparkling Energy offers a delicious new option made with better-for-you ingredients in the growing energy drink category. The expansion into energy drinks bolsters Bloom’s commitment to delivering flavor-forward, benefit-driven wellness solutions.

“Our mission is to help everyone bloom into their best selves, and energy consistently comes up as a key concern for Bloom consumers,” says Mari Llewellyn, co-founder of Bloom Nutrition. “We heard our community’s demands for an energy drink that not only fits their busy lifestyles, but prioritizes great taste and healthier ingredients. Bloom Sparkling Energy offers a delicious boost of clean energy whenever you need it.”

Entering a rapidly growing category that is poised for innovation, Bloom Sparkling Energy Drinks are meticulously crafted for the wellness-minded consumer, aiming to elevate the experience of traditional energy drinks. Formulated with healthier ingredients, including 180mg of natural caffeine from coffee bean extract, prebiotic fiber and functional ingredients, like lychee extract, apple cider vinegar, L-theanine and B vitamins, each can of Bloom Sparkling Energy delivers a superior taste experience and clean energy, with just 10 calories and 0g of sugar.

When it came time to select an exclusive retailer for their new beverage venture, Bloom turned to Target, a tried-and-true partner of the brand since first launching in retail in late 2022. “Target has been instrumental to our success. Together we made Bloom the #1 Greens brand and brought new consumers to the space,” says Bloom co-founder, Greg LaVecchia. “We’re excited to build on our partnership and achieve a similar impact within the Energy Drinks category.”

In 2021, Bloom Nutrition’s Greens & Superfoods powder became a TikTok-viral wellness sensation, holding the recognition of being the #1 Greens in the US. Since then, Bloom has become a leading supplement brand among female consumers, available at all major retailers nationwide including Target, Walmart, Sam’s Club, Kroger, GNC and more. This rapid expansion is primed for continued growth following the brand’s recent partnership with Nutrabolt earlier this year.

“The unwavering commitment that founders Mari and Greg have to their community continues to be the driving force behind the Bloom business,” says Doss Cunningham, founder of Nutrabolt. “We are excited to offer Nutrabolt’s expertise in beverage innovation and commercial expansion to help make their vision a reality and fulfill their consumers’ ever-growing needs and goals.”

Meitheal Pharmaceuticals Expands Specialty Biopharmaceuticals Portfolio with Acquisition of CONTEPO™ (Fosfomycin for Injection) from Nabriva Therapeutics

July 18, 2024

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has acquired North America rights to CONTEPO™ (fosfomycin for injection) from Nabriva Therapeutics. CONTEPO™ is a novel, intravenous (IV), broad spectrum antibiotic with demonstrated activity against most multi-drug resistant (MDR) strains that cause complicated urinary tract infections (cUTI).

“The strategic addition of CONTEPO™ to our robust product portfolio provides us with a novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As a fully integrated biopharmaceutical company, Meitheal is uniquely positioned to advance CONTEPO™ through the final stages of the regulatory process and, if approved, deliver a consistent supply of this high-quality antibiotic to patients and providers in need of an innovative option for drug resistant urinary tract infections.”

Under the Asset Purchase Agreement, Meitheal acquires North America rights to CONTEPO™, including any results of development and regulatory activities, and all intellectual property (IP) rights, technology, and know-how related to CONTEPO™. In exchange, Nabriva will receive payment upon closing and a royalty on net U.S. sales of CONTEPO™.

Fosfomycin for intravenous (IV) administration is marketed outside the U.S. where it has been approved across nine indications, including cUTI and other serious bacterial infections. CONTEPO™ utilizes a new dosing approach to optimize the compound’s pharmacokinetics and pharmacodynamics and has demonstrated efficacy by meeting the primary endpoint in the pivotal ZEUS™ trial for patients with cUTI, including acute pyelonephritis.

“The treatment paradigm for complicated infections in the U.S. is fragmented and inefficient with increasing antibiotic resistance rendering many traditional treatment options obsolete,” said Brett Novak, Meitheal Senior Vice President of Commercial Operations. “CONTEPO™, with demonstrated efficacy against most contemporary multi-drug resistant strains and a differentiated mechanism of action, has the potential to serve as the alternative antibiotic treatment of choice in appropriate patients, and provide them with the right spectrum of coverage for complicated UTIs.”

Nabriva submitted the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for the approval of CONTEPO™ (fosfomycin for injection) for the treatment of cUTI, including acute pyelonephritis. A decision is expected from the FDA later this year. In preparation for commercial launch, Meitheal will establish a full commercial marketing and sales organization in addition to a medical science liaison (MSL) team to support clinician needs.

Meitheal’s parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in capital and research and development in recent years to support sustainable product supply across the Company’s focus areas including branded biopharmaceuticals.

Hanger Ventures Announces Inaugural Investment

July 18, 2024

Hanger Ventures, a Hanger, Inc. business whose primary objective is to advance orthotics and prosthetics innovation and improve patient outcomes, today announced its debut investment in Bionic Power, a Canadian-based firm. A developer of active lower body smart orthotic devices that enhance personal mobility, Bionic Power is raising Series A Round funding, with Hanger Ventures committing as the lead investor.

“We are thrilled to make our inaugural investment in Bionic Power,” shared James Campbell, Ph.D., Hanger Ventures President and Hanger, Inc. Chief Clinical Officer. “We look forward to contributing clinical research, along with technical and commercial expertise, to bring innovative solutions to the market that have the potential to meet an unmet clinical need and improve the quality of life for individuals with mobility challenges.”

Bionic Power devices enhance walking abilities for children and adults with neuromuscular diseases and conditions, including cerebral palsy, spina bifida, and stroke. The collaboration provides Bionic Power with financial funding and services for product development, clinical trials, and go-to-market support.

“When we learned about the creation of Hanger Ventures, we felt the opportunity was a great match for Bionic Power’s needs, and the subsequent discussions confirmed our initial impression,” shared Gualtiero Guadagni, Ph.D., Bionic Power Chief Executive Officer. “Hanger Ventures is offering far more than capital, and we are eager to leverage their support to expand our business and have a greater impact on those who can benefit from our life-changing products.”

Blood Filtration Offers Hope in the Fight Against Pancreatic Cancer

July 18, 2024

In a groundbreaking advancement of a novel cancer treatment, researchers have successfully deployed Seraph® 100 blood filtration media to demonstrate removal of Circulating Tumor Cells (CTCs) from the blood of patients suffering from advanced pancreatic cancer.

The published results are foundational for ExThera Medical’s innovative circulating tumor cell reducing device, the ONCObind™ Procedure Hemoperfusion Filter (ONCObind™), to pave the way for improved longevity and better outcomes by reducing or eliminating cancer metastasis. ONCObind™ uses the Seraph® 100 filtration media to filter circulating tumor cells from the blood.

Many cancers become deadly when they spread from their original site to other parts of the body. CTCs, which travel through the bloodstream, play a critical role in metastatic cancer. By removing these cells, ExThera Medical’s ONCObind offers a promising approach to interrupting this spread, for longer patient survival.

The hemoperfusion media demonstrated significant reduction of circulating tumor cells in patient blood samples. Authors of the paper further suggested that blood purification using Seraph® 100 media may be considered a pioneering novel therapy for PDAC, either alone or in combination with existing therapies. Additionally, they asserted that the results of this study may also be relevant for establishing treatment procedures for other cancers, as they postulated that reducing metastatic potential of the disease may improve survival.

“By removing CTCs, we can potentially interrupt the metastatic process and improve patient outcomes,” according to the lead researcher on the study, Dr. Peter Kuhn, PhD, Founding Director of the USC Michelson Convergent Science Institute of Cancer, and coauthor of the publication. “This device represents an opportunity to significantly improve the care for patients with pancreatic cancer and is potentially applicable to other forms of cancer.”

In the study, blood samples of patients with pancreatic ductal adenocarcinoma (PDAC) underwent in vitro blood filtration using the Seraph® 100 media. The results showed a significant reduction in CTCs, suggesting an oncology focused product could be used as a therapeutic tool either alone or in conjunction with other cancer treatments such as chemotherapy and radiation.

“The potential of this device to extend and improve the lives of cancer patients is immense,” said Erin Borger, CEO of ExThera Medical. “Researchers observed on average a 94% reduction in circulating tumor cells with a single use of our technology. We are eager to continue our research and see the impact it can have on patient care.”

Gwen Stefani Headlined the 19th Annual Feinstein Summer Concert | Raises $3.6M to Support Medical Innovation

July 18, 2024

Grammy Award-winning, multiplatinum-selling global singer-songwriter Gwen Stefani headlined the 19th annual Feinstein Summer Concert, which raised $3.6 million to advance scientific discovery at Northwell Health’s Feinstein Institutes for Medical Research.

For more than two decades, researchers at the Feinstein Institutes have made important discoveries that have transformed the treatment of conditions such as lupus, arthritis, sepsis, cancer, psychiatric illnesses and Alzheimer’s disease. More than 5,000 researchers and staff at the Feinstein Institutes are dedicated to producing knowledge to cure disease, directly impacting the care of over 2 million Northwell patients each year.

“The remarkable work at the Feinstein Institutes sets it apart as a global leader that is truly changing the future of how we treat disease,” said Northwell President and CEO Michael J. Dowling. “Thanks to our generous donors and the collaborative nature within Northwell, we are able to push boundaries in meaningful ways to improve health care for all.”

Since its inception, the Feinstein Summer Concert has raised more than $40 million to accelerate research and fuel the development of innovative therapies to treat illness and cure disease. The event, held on July 11th at Old Westbury Gardens, propels Northwell’s ability to pioneer solutions that are impacting the trajectory of medicine around the world.

“For 19 years, the Feinstein Summer Concert has fostered an extraordinary community of supporters who champion our mission to discover and invent groundbreaking therapeutic innovations,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and the Karches Family Distinguished Chair in Medical Research. “Philanthropy has a remarkable ripple effect; each supporter and advocate starts a ripple that makes a lasting impact on future health care, locally and worldwide. Our generous donors enable Northwell to alleviate suffering and illness by making medical breakthroughs and leading clinical trials aimed at curing and eradicating disease.”

Chris Wragge, co-anchor of “CBS 2 News This Morning” and “CBS 2 News at Noon,” served as the event’s emcee for the eighth year. Catering and event design were coordinated by Larry Scott of Lawrence Scott Events. The Feinstein Institutes thanks its generous donors and this year’s leadership sponsors, the Susan and Leonard Feinstein Foundation and Donald Zucker and Barbara Hrbek Zucker.

The Feinstein Summer Concert supports Northwell’s Outpacing the Impossible campaign, a comprehensive $1.4 billion fundraising effort that supports Northwell’s promise to the people it serves. The campaign’s objectives include improving hospitals and clinical programs, accelerating research and funding endowment.

For more information about supporting the Feinstein Institutes and Northwell Health, visit: give.northwell.edu/feinstein-institutes-medical-research.

Clément Vidal Is Appointed New CEO at eCential

July 18, 2024

eCential Robotics is pleased to announce the appointment of Clément Vidal as its new Chief Executive Officer. Clément Vidal, an Ecole Polytechnique and Stanford University graduate, has 20 years of experience in the Pharmaceutical and Medical Device industry, especially as CEO of surgical robotics company Endocontrol. Clément will be succeeding Stéphane Lavallée, founder, who will now serve as non-executive Chairman of the Board.

“Through his excellent management of key strategic development programs within eCential Robotics, Clément has proven himself to be not only an amazing leader, but a visionary with a solid understanding of the surgical robotics market,” said Lavallée. “I am most confident that Clément will succeed in taking the company to the next level, with the same passion and commitment to innovation that has always been our hallmark.”

A unique company and product
Founded in 2009, eCential Robotics started its journey with only a handful of visionary engineers to invent the surgical technologies of the future. Working hand-in-hand with leading surgeons around the world, the company developed the first open, unified yet modular and scalable 2D/3D imaging, navigation and robotic guidance system for spine surgery. Recognized with several innovation awards, the company attracted strong funding partners, leading to an initial limited release in Europe with over 10 systems sold and installed. Having received FDA clearance for its platform, the team is now gearing up to develop its activities in the US.

Accelerating activities with implant partners and US customers

“I am honored to take on the role of CEO at such an exciting time for the company,” said Vidal. “The team recently demonstrated its ability to successfully partner with MedTech companies, as well as commercialize our proprietary robotics system by signing a supply contract with a major healthcare group in the United States.”

Under Clément Vidal’s leadership, eCential Robotics will continue to build a culture of excellence, enhance the company’s product portfolio roadmap, develop its commercial activities in the US as well as partner internationally with implant manufacturers, tech companies and research labs to expand the range of Applications available on its unique Open eCential Platform.

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

July 18, 2024

HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today introduced the next-generation HeartFlow Plaque Analysis with an interactive experience. This upgraded platform is the only plaque analysis tool fully integrated with FFRCT (when FFRCT is performed), delivering impactful insights to enhance clinical decision-making and enabling personalized patient treatment plans.

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

“Having access to a patient’s whole coronary picture, with both quantified plaque and physiology, is a game changer as a clinician. I can reference the cross-sectional views with plaque by type when reviewing my patient’s workup and have confidence in the accuracy and actionable insights that I know I’ll get from HeartFlow Plaque Analysis,” said Sarah Rinehart, M.D., F.A.C.C., F.S.C.C.T., medical director of CV imaging, nuclear and CT, Charleston, WV. “With a quantitative measurement of a patient’s plaque volume, I can more accurately assess risk and develop a personalized, targeted treatment plan.”

When FFRCT is performed, the new interactive experience integrates highly accurate plaque quantification with lesion specific FFRCT values, showcasing a 3D plaque model and comprehensive plaque analysis by territory across calcified, non-calcified and low attenuation. The platform also offers the ability to view cross-sectional color-coded images of each plaque type where it was quantified along the vessel. This comprehensive view of a patient’s plaque burden enables a personalized treatment, a process that is supported by published prospective data which show:

HeartFlow Plaque Analysis is the only non-invasive plaque assessment with 95% agreement for total plaque volume measures vs. the gold standard IVUS.¹
Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.²

“Accurately diagnosing a patient’s risk for coronary artery disease is critical for determining the best treatment. Our new interactive plaque experience marks an exciting era in AI-enabled cardiac technology, where we are now the only company that offers a fully integrated view of a patient’s true burden of coronary artery disease,” said HeartFlow chief medical officer Campbell Rogers, M.D., F.A.C.C. “The elevated visualization of Plaque Analysis integrated with our flagship FFR_CT Analysis, sets HeartFlow apart as a wholistic solution for CT analysis, enabling physicians to enhance personalized treatment decisions.”

HeartFlow’s continued investment and commitment to supporting technologies that enhance diagnostic accuracy and patient care comes on the heels of HeartFlow AI Plaque Analysis achieving a major milestone towards Medicare coverage which should allow for future expanded patient access.

Brainomix and Boehringer Ingelheim Launch Strategic Partnership in Fibrosing Lung Disease

July 18, 2024

Brainomix, a pioneer in artificial intelligence (AI) imaging solutions, has announced it has entered into a partnership with German pharmaceutical company Boehringer Ingelheim for a collaborative programme of activity to improve the care of patients with fibrosing lung disease in the US.

This landmark project will focus on the opportunity for AI imaging analysis using Brainomix 360 e-Lung on routine CT scans to accelerate the diagnosis and improve access to treatment for people living with fibrosing lung disease.

Pulmonary fibrosis is a chronic lung condition that is progressive and life-limiting. Untreated, patients can have a lifespan as short as 5 years from diagnosis, and yet despite this, often wait up to 2 years for diagnosis. The key to the best survival for patients with fibrosing lung disease is the earliest initiation of treatment, but identifying patients eligible for treatment based on imaging can be challenging, even for experts.

Through this partnership, Brainomix will deploy its FDA-cleared e-Lung software to leading US pulmonology centers and their networks of referring sites. The data generated will validate the value of e-Lung, highlighting the potential of digital technology to optimize pathways of care and improve outcomes for people with fibrosing lung disease, a vision shared between Brainomix and Boehringer Ingelheim.

Dr Michalis Papadakis, CEO and Co-Founder of Brainomix said: “There is an urgent need to improve the identification of people with fibrosing lung disease. This will enable earlier access to specialist care and the opportunity for faster initiation of treatment, which can slow the worsening of the disease. The patient pathway for people with fibrosing lung disease is currently fragmented and, it can take many years for a patient to be diagnosed.

“This partnership enables us to leverage our established experience and expertise connecting stroke networks to develop a similar network model of care for patients with fibrosing lung disease, generating real-world evidence that will drive the opportunities we have with e-Lung to help improve outcomes for patients and their families.”

Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim said: “At Boehringer Ingelheim, we know how critical early and confident detection of progression is for people living with fibrosing lung disease. We believe that Brainomix 360 e-Lung has the potential to revolutionize the diagnostic landscape and thereby enable earlier treatment decisions at a pivotal stage of the patient’s journey. This can ultimately improve patient outcomes and quality of life of those affected.”

Brainomix 360 e-Lung received FDA clearance in May 2024, the same month the company announced a series of new studies highlighting the prognostic value of its lung imaging biomarkers in patients with fibrotic lung disease. The studies, presented at the American Thoracic Society (ATS) Conference in San Diego, reflect the company’s expanding Life Sciences partnerships and academic collaborations with luminary research centers in the lung space.

Bon Secours Mercy Health and Philips Sign Multi-Year Strategic Collaboration

July 17, 2024

Royal Philips (NYSE: PHG, AEX: PHIA) a global leader in health technology and Bon Secours Mercy Health (BSMH), one of the nation’s largest Catholic health systems, today announced a multi-year strategic collaboration for patient monitoring. Putting BSMH clinicians in control, the collaboration will reduce the digital burden on staff and give them more time to spend with patients.

The partnership provides access to the latest Philips monitoring innovations, including a scalable patient monitoring platform that integrates patient data and provides vital insights. It will standardize patient monitoring for BSMH’s 49 hospitals, reducing costs through a predictable payment model and enabling further reinvestment in innovation.

“This collaboration is part of our commitment to drive improved healthcare quality while reducing costs and addressing healthcare issues facing entire communities,” said Jodi Pahl, Chief Nursing Officer for workforce experience and nursing outcomes, Bon Secours Mercy Health. “This 10-year journey will bring innovations that will transform care delivery.”

BSMH provides patients care more than 11 million times annually through its network of more than 1,200 care sites, 60,000 associates and 49 hospitals serving communities in Florida, Kentucky, Maryland, New York, Ohio, South Carolina and Virginia, as well as Ireland.

“With implementation occurring over the next three years, followed by seven years of maintenance and updates, we’re positioned to be at the leading edge of technology,” said Pahl. “This uplifts our Mission to improve the health and well-being of our communities and supports our commitments to innovation and stewardship.”

Julia Strandberg, Chief Business Leader, Connected Care at Philips said: “This partnership is a testament to BSMH’s focus on strong clinical engagement and our combined commitment to improving the patient and staff experience. As BSMH’s clinical technology partner, we’re leaning in to understand their needs and apply innovative technologies that can improve patient outcomes. BSMH is committed to bringing quality care to more people by eliminating time-consuming data roadblocks for their staff.”

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The International Atherosclerosis Society today released a clinical proceedings white paper outlining the role of inflammation in atherosclerosis and the importance of early intervention.

In a groundbreaking advancement of a novel cancer treatment, researchers have successfully deployed Seraph® 100 blood filtration media to demonstrate removal of Circulating Tumor Cells (CTCs) from the blood of patients suffering from advanced pancreatic cancer.

Grammy Award-winning, multiplatinum-selling global singer-songwriter Gwen Stefani headlined the 19th annual Feinstein Summer Concert, which raised $3.6 million to advance scientific discovery at Northwell Health’s Feinstein Institutes for Medical Research.

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