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Morton Plant Hospital Offers Robotic-Assisted Coronary Artery Bypass Surgery

Coronary/Structural Heart by Comments are Disabled

CLEARWATER, Fla., June 7, 2024 /PRNewswire/ — Morton Plant Hospital recently completed its first robotic-assisted, minimally invasive coronary artery bypass surgery (CABG), making it one of only two hospitals in the Tampa Bay area to offer robotic-assisted CABG. Morton Plant Hospital was ranked #1 in Florida for Cardiac Surgery in 2023 by Healthgrades.  Cardiothoracic Surgeon Michael Kayatta, MD, and his partner, Cardiovascular Surgeon John Ofenloch, MD, performed the procedure earlier this week, with the assistance of their highly skilled surgical team.  

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Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.

CABG surgery is needed when plaque has built up in arteries carrying blood to the heart causing the arteries to be severely narrowed. The surgeon creates a new path for blood to flow by using a healthy artery or vein from another part of the body and connects it past the blockage on the heart. 
In a traditional CABG, the surgeon cuts open the chest by dividing the breastbone and spreads the ribs to expose the heart. The heart is stilled, requiring the patient to be on a heart-lung machine during the surgery. Full recovery often takes about two months. The robotic-assisted CABG only requires four small incisions between the ribs. A small camera and surgical tools are attached to the robotic arms and guided through the incisions. The heart continues to beat through the procedure, with special tools stabilizing a part of the heart.Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.The computer console, which shows images of the heart magnified up to 10 times normal vision, gives the surgeon the ability to guide the surgical instruments, attached to the robotic arms, with his fingers while watching the screen. The robotic arms that are controlled by the surgeon have greater range of motion and are more precise than human arms. A major potential benefit of a robotic-assisted CABG is a quicker recovery for the patient. The smaller incisions should also result in less scarring. “We are excited to bring this new technology to patients at Morton Plant Hospital,” said Dr. Kayatta. “Many people hear robot and think a machine will be doing the surgery. We have a highly skilled, experienced team performing each surgery. The robot is simply a tool that helps us to treat more patients and get them back to their life in weeks rather than months.” Drs. Kayatta and Ofenloch are both with BayCare Medical Group’s Cardiovascular and Thoracic Surgery clinic in Clearwater.  For more information on heart and vascular services at BayCare: Heart and Vascular Services.About BayCareBayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.org.SOURCE Morton Plant Hospital

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BioMarin Presents New Phase 3, Four-Year Data Underscoring Long-Term Safety and Efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) at International Society on Thrombosis and Haemostasis 2024 Congress

Peripheral/Endo by Comments are Disabled

Data from Longest and Largest Hemophilia Gene Therapy Study Show Durable and Sustained Bleed Control and Factor VIII Expression Maintained Four Years Post-ROCTAVIAN Infusion
Additional Data Show Meaningful Impact of ROCTAVIAN on Health-Related Quality of Life (HRQoL) 
SAN RAFAEL, Calif., June 7, 2024 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that new data supporting the long-term safety and efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) will be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand, June 22-26, 2024.
“We are pleased to share data at ISTH demonstrating that ROCTAVIAN continues to offer durable and sustained bleed control and endogenous factor VIII expression four years after the infusion, representing the longest and largest Phase 3 follow-up results of a gene therapy in hemophilia,” said Hank Fuchs, M.D., president of Worldwide Research and Development at BioMarin. “Importantly, these Phase 3 data also indicate a plateauing of factor VIII levels after year three with the majority of patients remaining off prophylaxis, which shows ROCTAVIAN can offer long-term bleed protection for adults with severe hemophilia A and may provide relief from the burden of chronic infusions and injections.”  
Four-Year Data from Largest Phase 3 Hemophilia Gene Therapy Study Demonstrate Long-Term Safety and Efficacy of ROCTAVIANThe Phase 3 GENEr8-1 trial demonstrated that durable bleed control and sustained factor VIII (FVIII) expression were maintained four years after treatment with ROCTAVIAN, with FVIII activity near stable compared with results reported previously and no new safety signals observed. Of the 134 patients who received ROCTAVIAN in the study, the rollover population of 112 patients had baseline annualized bleeding rate (ABR) data prospectively collected during a period of at least six months while on routine FVIII prophylaxis prior to receiving ROCTAVIAN, and two of the 112 patients discontinued the study prior to year four. During year four, 73.6% of the remaining participants (81/110) had zero treated bleeds. Over the entire study period to the time of the data cut, 24 of the 134 total participants resumed prophylaxis with either FVIII or emicizumab without any complications. Mean FVIII activity at the end of year four (n=130) was 27.1 and 16.1 IU/dL as assessed by one-stage assay (OSA) and chromogenic assay (CSA), respectively. These levels are near stable from the previously reported three-year data. Over four years, the mean ABR for treated bleeds for the rollover population was 0.8 bleeds/year, and the mean ABR for all bleeds was 1.3 bleeds/year.
Table 1. Rates of bleeding and FVIII use over four years post-ROCTAVIAN treatment in the rollover population (N=112)

Baseline
Year four
All post-prophylaxis cessation (week 5 to data cutoff)

(n=112)
(n=110)
(n=112)

ABR (treated), bleeds/year

Mean ± standard deviation (SD)
4.8 ± 6.5
0.9 ± 2.3
0.8 ± 2.0

Median (Q1, Q3)
2.8 (0.0, 7.6)
0.0 (0.0, 1.0)
0.0 (0.0, 0.5)

  Annualized FVIII infusion rate, number/year

Mean ± SD
135.9 ± 52.0
10.6 ± 29.5
6.1 ± 15.6

Median (Q1, Q3)
128.6 (104.1, 159.9)
0.0 (0.0, 3.0)
0.6 (0.0, 3.0)

  ABR (all), bleeds/year

Mean ± SD
5.4 ± 6.9
1.2 ± 2.5
1.3 ± 2.2

Median (Q1, Q3)
3.3 (0.0, 7.9)
0.0 (0.0, 1.0)
0.5 (0.0, 1.3)

  Participants with 0 bleeds (treated), n (%)
36 (32.1)
81 (73.6)
61 (54.5)

  Participants with 0 bleeds (all), n (%)
34 (30.4)
68 (61.8)
29 (25.9)

Results Suggest Positive Impact of ROCTAVIAN on Health-Related Quality of LifeIn an additional analysis from the Phase 3 GENEr8-1 study, ROCTAVIAN provided important improvements in health-related quality of life (HRQoL) over four years in people with severe hemophilia A, even for those with FVIII levels below 5%. These improvements were measured using the Haemo-QOL-A assessment, a questionnaire designed to measure HRQoL in people with hemophilia A and B. Four years after treatment, the average Haemo-QOL-A Total Score increased by 6.2 points from baseline, with improvements observed in Physical Functioning (4.8 points), Role Functioning (5.9 points), and Consequences of Bleeding (9.2 points). Based on FVIII activity at year four, average Haemo-QOL-A Total Score increased by 6.3, 5.8, and 6.9 points for participants with FVIII activity in ranges ≥40%, ≥5% to ULN. Patients also experienced adverse reactions from corticosteroid use.
Isotretinoin, Efavirenz, and HIV Positive Patients: Isotretinoin is not recommended in patients who are benefiting from ROCTAVIAN. Efavirenz is not recommended in patients treated with ROCTAVIAN. Clinical studies of ROCTAVIAN did not include sufficient numbers of patients with HIV to determine whether the efficacy and safety differs compared to patients without HIV infection.
Females and Males of Reproductive Potential: ROCTAVIAN is not intended for administration in women. There are no data on the use of ROCTAVIAN in pregnant women or regarding lactation. For 6 months after administration of ROCTAVIAN, men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception, and men must not donate semen.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to BioMarin at 1-866-906-6100.
Please see the ROCTAVIAN full Prescribing Information for additional Important Safety Information.
About BioMarin
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of genetic conditions. BioMarin’s unparalleled research and development capabilities have resulted in eight transformational commercial therapies for patients with rare genetic disorders. The company’s distinctive approach to drug discovery has produced a diverse pipeline of commercial, clinical, and pre-clinical candidates that address a significant unmet medical need, have well-understood biology, and provide an opportunity to be first-to-market or offer a substantial benefit over existing treatment options. For additional information, please visit www.biomarin.com.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: data to be presented at the 32nd Congress of the International Society on Thrombosis and Haemostasis, including the oral and poster presentations; the development of BioMarin’s ROCTAVIAN program generally; the safety profile, efficacy and potential positive impact of ROCTAVIAN for adults with severe hemophilia A; and the potential benefits of ROCTAVIAN for adults with severe hemophilia A, including offering long-term bleed protection, providing relief from the burden of chronic infusions and injections, helping treated patients move more freely and reducing the burden of caring for bleeding episodes. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of ROCTAVIAN; any potential adverse events observed in the continuing monitoring of the patients in the clinical trials; the content and timing of decisions by the Food and Drug Administration, the European Commission and other regulatory authorities; BioMarin’s success in the commercialization of ROCTAVIAN, including achieving adequate market share and reimbursement levels; whether ROCTAVIAN will have the impacts and benefits as anticipated; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin® and ROCTAVIAN® are registered trademarks of BioMarin Pharmaceutical Inc.

Contacts:

Investors                               
Media

Traci McCarty                   
Andrew Villani

BioMarin Pharmaceutical Inc.        
BioMarin Pharmaceutical Inc.

(415) 455-7558                  
(628) 269-7393

SOURCE BioMarin Pharmaceutical Inc.

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BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036.   The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart.   BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke. BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. “Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” And in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

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Medtronic chairman and CEO Geoff Martha to speak at Goldman Sachs global healthcare conference

Financial by Comments are Disabled

DUBLIN, June 6, 2024  /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 45th annual Goldman Sachs global healthcare conference on Tuesday, June 11, 2024.
Geoff Martha, Medtronic chairman and chief executive officer, will answer questions on the company beginning at 10:40 a.m. EDT (9:40 a.m. CDT).
A live webcast of the Q&A session will be available on June 11, 2024, by clicking on the Events link at http://investorrelations.medtronic.com. An archive of the Q&A session will be available on the same webpage later in the day.
About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn. 
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 
Contacts:
Erika Winkels                        Ryan WeispfenningPublic Relations                   Investor Relations+1-763-526-8478                 +1-763-505-4626
SOURCE Medtronic plc

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AVS Receives IDE Approval from FDA for Pivotal Intravascular Lithotripsy Study

Peripheral/Endo Regulatory by 0 comments

June 06, 2024 07:58 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its pivotal […]

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Hypertrophic Cardiomyopathy 101

Coronary/Structural Heart by Comments are Disabled

What every student-athlete should knowMISSION, Kan., June 6, 2024 /PRNewswire/ — (Family Features) You may find it difficult to wrap your mind around the idea of an energetic student-athlete with a cardiac diagnosis. Heart conditions may be more often associated with older individuals, but you might be surprised to learn hypertrophic cardiomyopathy is the most common condition responsible for sudden cardiac death in young athletes. In fact, it’s the cause of 40% of sudden cardiac death cases.

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Photo courtesy of Shutterstock

Photo courtesy of Shutterstock

It’s estimated 1 in every 500 adults living in the United States has hypertrophic cardiomyopathy, according to the American Heart Association, but a significant percentage are undiagnosed. More than 80% of individuals who experience this condition show no signs or symptoms before sudden cardiac death. While sudden cardiac death is rare, it can occur during exercise or in its aftermath. That’s why it’s important for student-athletes and their loved ones to learn more about this condition and talk to a doctor about their risk.

With proper knowledge and the support of a skilled care team, it’s possible to manage hypertrophic cardiomyopathy with heart-healthy actions to prevent complications or worsening cardiovascular conditions like atrial fibrillation (a quivering or irregular heartbeat), stroke or heart failure. Hypertrophic cardiomyopathy awareness and education for athletes by the American Heart Association is made possible in part by a grant from the Bristol Myers Squibb Foundation.
What is hypertrophic cardiomyopathy?Hypertrophic cardiomyopathy is the most common form of inherited heart disease and can affect people of any age. It’s defined by thickening and stiffening of the walls of the heart. The heart’s chambers cannot fill up or pump blood out adequately, so the heart is unable to function normally.There are different types of this condition. Most people have a form of the disease in which the wall that separates the two bottom chambers of the heart (the septum) becomes enlarged and restricts blood flow out of the heart (obstructive hypertrophic cardiomyopathy).However, sometimes hypertrophic cardiomyopathy occurs without significant blocking of blood flow (nonobstructive hypertrophic cardiomyopathy). The heart’s main pumping chamber is still thickened and may become increasingly stiff, reducing the amount of blood taken in then pumped out to the body with each heartbeat.What are possible symptoms?Symptoms can include:
shortness of breath
chest pain
heart palpitations
fatigue
The severity of symptoms can vary, but if you experience them or if you have a family history of hypertrophic cardiomyopathy or sudden cardiac death, it may be a good idea to speak to your doctor about whether you have this condition.For some people, symptoms can get worse and new symptoms can appear over time, resulting in people dealing with harsher effects and a diminished ability to do the activities they love. This decrease in functions can be one of the most challenging aspects of the disease. Keeping your health care team aware of any new or changing symptoms allows them to work with you to develop a plan to manage these symptoms and reduce their impact.How is hypertrophic cardiomyopathy diagnosed?Medical history, family history, a physical exam and diagnostic test results all factor into a diagnosis. A common diagnostic test is an echocardiogram that assesses the thickness of the heart muscle and observes blood flow from the heart.If anyone in your family has been diagnosed with hypertrophic cardiomyopathy, other heart diseases or has been told they had thick heart walls, you should share that information with your doctor and discuss the need for genetic testing. Because this condition is hereditary, first-degree relatives, which include siblings and parents, should be checked.Learn more at heart.org/HCMStudentAthlete.Photos courtesy of ShutterstockMichael French[email protected]1-888-824-3337editors.familyfeatures.comAbout Family Features Editorial SyndicateA leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com.SOURCE Family Features Editorial Syndicate

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MiRus Siegel™ TAVR: First in Human Results Presented at New York Valves

Coronary/Structural Heart by Comments are Disabled

Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet.  Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications.  At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL. "The ease of use and hemodynamics were impressive" commented Pradeep K. Yadav, MD.  "On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning.  The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love.  Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability." The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment  and with the valve pre-mounted on the balloon.The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil."This initial data is striking and potentially heralds a new age for TAVR," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute.  "The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible.  From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients.  We are truly on the precipice of surgical-like outcomes with the Siegel THV!!"About MiRus, LLC.MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease.  Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.* MiRus® , Siegel™  are all trademarks of MiRus, LLC. Contact:Pam CowartVP of Clinical Affairs[email protected]770-861-4804SOURCE MiRus

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CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath

Peripheral/Endo by Comments are Disabled

BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years. While vascular access for hemodialysis can be initiated in an inpatient setting, ambulatory surgical centers or vascular access centers offer a less-invasive, outpatient-based alternative for patients. The company estimates that up to 100,000 HD-CVC placements occur each year, and pass-through status ensures that providers are reimbursed separately for administration of DefenCath in this setting of care. Given that approximately 50% of catheter-related bloodstream infections, or CRBSIs, can occur within the first 90 days that a catheter is inserted, it is critical to protect the line beginning at the time of placement. DefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath. LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. DefenCath is contraindicated and has warnings and precautions in patients with: Known heparin-induced thrombocytopenia (HIT).Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.  If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures. To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see the full Prescribing Information. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576

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Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke

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75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P

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