Vascular Calcification

- Data from the largest retrospective analysis of ENPP1 Deficiency provides insights into the evolution of the disease’s serious cardiovascular and musculoskeletal complications - - Findings highlight the urgent need for early and improved diagnosis, care and treatments that address the long-term systemic effects of ENPP1 Deficiency - BOSTON, April 10, 2025 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced the publication of a paper titled, “Phenotypic characterization of ENPP1 deficiency: generalized arterial calcification of infancy and autosomal recessive hypophosphatemic rickets type 2” in JBMR Plus that characterizes the severity and progression of ENPP1 Deficiency. Inozyme collaborated with leading disease experts Carlos Ferreira, M.D., of the National Institutes of Health (NIH), Frank Rutsch, M.D., of Münster University Children’s Hospital and other global contributors to collect natural history data in the largest retrospective analysis of ENPP1 Deficiency published to date. “This comprehensive study illustrates the devastating, systemic nature of ENPP1 Deficiency, highlighting its severe cardiovascular implications starting as early as infancy and evolving to significant musculoskeletal complications over a lifetime as individuals go through childhood, adolescence, and then adulthood,” said Matt Winton, Ph.D., Senior Vice President and Chief Operating Officer of Inozyme Pharma. “The findings underscore a critical need for earlier diagnosis and effective treatments. Our lead investigational therapy, INZ-701, is uniquely positioned as a potential transformative therapy to address the underlying causes and systemic impacts of this severe condition.” Detailed Analysis Reveals Severity and Disease Progression ENPP1 Deficiency frequently manifests as Generalized Arterial Calcification of Infancy (GACI) or Autosomal Recessive Hypophosphatemic Rickets Type 2 (ARHR2), representing age-dependent phenotypes that evolve on a continuum over a lifetime. Of the 84 individuals with ENPP1 Deficiency in the analysis, 51 had a recorded diagnosis of GACI, only 19 of whom survived beyond infancy; 22 were diagnosed with GACI and progressed to ARHR2; and 11 presented initially with ARHR2. Importantly, a majority of patients (60%) with a history of GACI had prenatal findings, and a GACI diagnosis (median age of 0.8 months at diagnosis) was usually associated with early-onset arterial calcification, respiratory distress, heart failure, and hypertension, necessitating acute inpatient care. Additional findings from the publication included: By age 55, over 95% of patients with ENPP1 Deficiency will have had cardiovascular, musculoskeletal, and other organ complications.Vascular calcification and cardiovascular complications onset predominately in infancy – 60% of patients had arterial or aortic calcification within the first 3 months of life. Notably, cardiovascular complications were evident in patients without a diagnosis of GACI – 64% of the group diagnosed with ARHR2-only had cardiovascular manifestations.By age 10, approximately 70% of patients developed serious musculoskeletal complications, primarily rickets significantly impairing quality of life. Additional complications associated with ARHR2 include hearing impairment and ongoing risk of cardiovascular problems. These findings highlight that ENPP1 Deficiency is a progressive, lifelong condition requiring coordinated, multidisciplinary care. Even for those who survive infancy, the majority will face ongoing cardiovascular, skeletal, and systemic complications, underscoring the need for early diagnosis and long-term management to improve outcomes. About ENPP1 Deficiency ENPP1 Deficiency is a serious and progressive rare disease that affects blood vessels, soft tissues, and bones. Individuals who present in utero or in infancy are typically diagnosed with generalized arterial calcification of infancy (GACI Type 1), with about 50% of these infants not surviving beyond six months. Children with this condition typically develop autosomal-recessive hypophosphatemic rickets type 2 (ARHR2), while adolescents and adults may develop osteomalacia, or softened bones. ARHR2 and osteomalacia cause pain and difficulty with movement. Additionally, patients may experience hearing loss, calcification in arteries and joints, and heart problems. ENPP1 Deficiency is an autosomal recessive disease and biallelic mutations are estimated to occur in approximately 1 in 64,000 pregnancies worldwide. Many individuals with just one copy of the mutated gene (monoallelic ENPP1 Deficiency) exhibit severe symptoms, suggesting that the worldwide prevalence of ENPP1 Deficiency may be much higher than current estimates. Currently, there are no approved therapies for ENPP1 Deficiency. About Inozyme Pharma Inozyme Pharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics that target the PPi-Adenosine Pathway, a key regulator of bone health and blood vessel function. Disruptions in this pathway underlie a range of severe diseases, including ENPP1 Deficiency. Our lead investigational therapy, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to restore PPi and adenosine levels. INZ-701 is currently in late-stage clinical development in ENPP1 Deficiency, with the potential to expand into additional indications where deficiencies in the PPi-Adenosine Pathway contribute to disease pathology. Through our pioneering work, we aim to transform treatment options for patients affected by these devastating conditions. For more information, please visit https://www.inozyme.com/ or follow Inozyme on LinkedIn, X, and Facebook. Contacts Investors:Inozyme PharmaStefan Riley, Senior Director of IR and Corporate Communications(617) 461-2442stefan.riley@inozyme.com Media:Biongage CommunicationsTodd Cooper(617) 840-1637todd@biongage.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/eb5daae6-15b5-4d55-9f50-d2e8d88a974d

New AI-powered platform leverages routine imaging to identify hidden health risks for women as they age, improving quality of life and reducing healthcare costs NEW YORK, April 1, 2025 /PRNewswire/ -- Covera Health, a leader in advancing quality-driven radiology, today announced the launch of Protect Her, an innovative AI-powered solution designed to enhance early detection of critical health conditions predominantly impacting women ages 40 and up. Protect Her leverages the latest advances in radiology AI to identify early signs of breast cancer, cardiovascular disease and osteoporosis during routine scans that women are already receiving, such as mammograms, chest CTs, and chest x-rays. This platform can often detect disease before symptoms appear, empowering women to proactively seek timely, and potentially lifesaving care. Addressing a Critical Gap in Women's Healthcare Each year, millions of women undergo routine imaging scans, yet many serious conditions go undiagnosed. Cardiovascular disease, breast cancer, and osteoporosis are among the leading causes of death and disability in women, yet early signs of these conditions are often overlooked in routine imaging. For example: 1 in 5 breast cancers are missed on screening mammograms Up to 1 in 6 women show early signs of heart disease—such as breast arterial calcifications—on routine mammograms, yet these indicators are rarely reported or acted upon Approximately 1 in 2 women with osteoporosis will experience an osteoporotic fracture in their lifetime, and of those that suffer osteoporotic hip fractures, 20% will not survive beyond the first year Protect Her works at the point of care to ensure women get the most out of their radiology exams with no additional effort. "Early detection is the single most powerful tool we have to improve health outcomes, particularly for women, who are frequently underdiagnosed in these areas," said Ron Vianu, CEO of Covera Health. "Protect Her empowers providers with AI-powered insights that can detect serious and life-threatening conditions early, allowing women to get the right care before it's too late. This is a game-changer for women's health." AI-Powered Detection During Routine Imaging Protect Her works by analyzing imaging studies that women are already undergoing—such as mammograms and chest x-rays—to flag undetected conditions that traditional radiology may overlook: Breast Cancer: AI can detect subtle patterns that may indicate early malignancies, increasing detection rates and reducing missed cancers. Cardiovascular Disease: Protect Her flags breast arterial calcifications (BAC), a marker of heart disease visible on mammograms but rarely reported and Coronary Artery Calcium (CAC) on chest CT scans, a key predictor of heart disease. Osteoporosis: AI scans routine images for signs of vertebral spine fractures, which are often missed in early stages. Benefits for Employers & Health Plans For employers, benefits managers and payors, Protect Her represents a proactive approach to managing healthcare costs and improving employee well-being. This platform allows organizations to prioritize the health and well-being of their employee population, while also delivering lower long-term healthcare costs and higher workplace satisfaction and productivity. By catching diseases early, organizations can: Improve diagnostic accuracy by enabling Covera's AI driven platform to support the detection and verification of incidental clinical findings on imaging reports. Reduce high-cost claims associated with late-stage cancer, heart attacks, and osteoporotic fractures. Improve workforce productivity, as early intervention leads to better treatment outcomes and less missed work. Support a healthier employee population, leading to lower long-term healthcare costs and higher workplace satisfaction. "AI has the ability to transform how we practice medicine, especially when it comes to our ability to detect early signs of disease," said Dr. Phoebe E. Freer, a leading expert in the field. Dr. Freer is a Professor of Radiology and serves as a Breast Cancer Screening Leader with the American College of Radiology. She is also a Fellow of the Society of Breast Imaging. "By using advanced technology to analyze a patient's image beyond the primary concern, we can detect high-impact conditions more readily, giving patients and their physicians critical insights that may help them act before a crisis occurs." About Covera Health Covera Health is redefining quality in radiology to improve patient outcomes and reduce healthcare costs. By combining advanced AI with deep clinical expertise, Covera has developed a suite of innovative radiology programs—including a nationwide Centers of Excellence network—that reduce diagnostic errors and drive better outcomes, lowering the total cost of care. Protect Her is the latest step in Covera's mission, enabling earlier detection of significant illness or disease and transforming radiology into a proactive, high-value tool for care. For more information on Protect Her, please reach out to [email protected]. Media Contacts Covera Health [email protected] SOURCE Covera Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEAUFORT, S.C.--( BUSINESS WIRE )--A new report published by THE SAGE GROUP reviews recent calcium research and quantifies the number of CLI patients with calcified leg arteries. “Almost all CLI patients have arterial calcification. Calcification is associated with symptoms, increased amputation and higher mortality. In patients undergoing endovascular revascularization, the presence of calcium creates numerous challenges, including increased procedural complications,” stated Mary L. Yost, President. “Both intimal artery calcification (IAC) and medial artery calcium (MAC) are found in the lower limb arteries. While equally prevalent in the femoropopliteal and infrapopliteal arteries, the type of calcification varies by vascular territory. MAC is more prevalent in the arteries below-the-knee,” Yost elucidated. Characterized by severe linear vascular calcification, MAC is primarily found in the media but can also involve the intima. On plain X-rays, it shows up as a railroad track pattern. Located in the intima, IAC appears as dots or patchy areas of calcification. According to Ms. Yost, “Coronary artery calcium has been studied extensively. However, much less is known about calcium in the lower limbs. With the recent publication of studies investigating calcium in peripheral artery disease (PAD) patients, this knowledge gap has been reduced. In particular, research has focused on MAC, which predominates in the leg arteries, but not in the coronary arteries.” “MAC is now considered an independent cause of PAD,” Yost stated. “MAC, a nonatherosclerotic disease, is strongly associated with aging, diabetes and chronic kidney disease.” “In CLI patients, MAC predicts mortality, as well as major and minor amputation,” she continued. About the Report: Calcium in Peripheral Artery Disease: Characteristics, Consequences and Prevalence by Vascular Territory and by Type Of Calcium This report reviews the characteristics, consequences and prevalence of calcium in PAD and CLI. The prevalence and severity of calcium in CLI patients and limbs is estimated for the 2020-2040 period. The percent prevalence of calcium is estimated for three vascular territories: aortoiliac, femoropopliteal and infrapopliteal. Estimates by type of calcium, medial and intimal, in each vascular territory are included. Additional information: https://www.thesagegroup.us/reports/calcium-in-peripheral-artery-disease-characteristics-consequences-and-prevalence-by-vascular-territory-and-by-type-of-calcium/ THE SAGE GROUP, a research and consulting company, specializes in arterial and venous disease in the lower limbs. Additional information: www.thesagegroup.us .