Other News

Avicenna.AI secures MDR certification for medical imaging AI portfolio

Neuro by Comments are Disabled

French AI company achieves key EU regulatory compliance for multiple algorithms that identify, detect, and quantify severe conditions from medical images. 
LA CIOTAT, France, July 3, 2024 /PRNewswire/ — Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. This development means the company’s product portfolio is fully compliant with the European Union’s MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe.
The MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU.
Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions.
Avicenna.AI’s products have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.
“Obtaining MDR certification is a significant milestone for Avicenna.AI,” said Stéphane Berger, Regulatory Manager at Avicenna.AI. “It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”
The company’s MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the products are also CE-marked and FDA-cleared.
“Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products,” added Berger.
All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.
About Avicenna.AIFounded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI’s website at www.avicenna.ai. 
For more information, contact:Stéphanie Bellavia, Marketing Manager, Avicenna.AIEmail: [email protected] 
SOURCE Avicenna.AI

Continue Reading →

Microbot Medical Partners with Baptist Hospital of Miami to Participate in its Pivotal Human Clinical Trial

Peripheral/Endo by Comments are Disabled

BRAINTREE, Mass., July 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board approval and signed a Clinical Trial Agreement with Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute.   This is the second announced site that will participate in the clinical trial for Microbot’s LIBERTY as part of its Investigational Device Exemption (“IDE”).   The Company had recently announced Brigham and Women’s Hospital as another participating site. The principal investigator at Baptist Hospital of Miami will be Ripal Gandhi, MD, FSVM. “I am very excited to participate in the trial. I believe this technology has the potential to change how we perform endovascular procedures,” said Dr. Gandhi. “We believe the interest in the LIBERTY technology is overwhelming, as evident by the fast pace of enrolling and activating leading sites into the pivotal trial since we announced the IDE. We are excited for our partnership with Baptist Hospital of Miami, which is one of the leading hospitals in the United States,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty IR@microbotmedical.com

Continue Reading →

CorMedix Inc. Announces Outpatient Availability of DefenCath

Peripheral/Endo by Comments are Disabled

BERKELEY HEIGHTS, N.J., July 03, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath as directed by the Center for Medicare & Medicaid Services (CMS). CorMedix received NDA approval of DefenCath under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15, 2024. This week CorMedix began shipping orders for DefenCath to dialysis operators under previously announced commercial agreements, and anticipates additional customer agreements and orders in the upcoming weeks. “I am very excited to have now commenced outpatient distribution of DefenCath, an important milestone for CorMedix and for patients, who will now have access to the first and only FDA approved antimicrobial catheter lock solution,” says CorMedix CEO, Joseph Todisco. “I am impressed with how efficiently our customers are rolling out the launch of DefenCath thus far, and I am looking forward to expanding access in the upcoming months as we solidify additional customer contracts.” 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. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and began outpatient commercialization on July 1st following the effectiveness of outpatient reimbursement from CMS. 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 StatementsThis 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 Advisorsdaniel@lifesciadvisors.com (617) 430-7576

Continue Reading →

Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure

Coronary/Structural Heart Financial by Comments are Disabled

OXFORD, England, July 2, 2024 /PRNewswire/ — Ultromics announced today that the American Medical Association (AMA) has issued a Category III Current Procedural Terminology (CPT) code for EchoGo® Heart Failure, a crucial advancement in enhancing the accessibility of Ultromics’ ground-breaking technology in hospital outpatient settings.

Continue Reading

The American Medical Association (AMA) has issued a Category III CPT® code (0923T) for reimbursing EchoGo® Heart Failure.

EchoGo® Heart Failure uses AI to detect heart failure with preserved ejection fraction (HFpEF) from a single, routinely acquired echocardiographic video. The technology leverages large datasets and advanced algorithms to identify patterns and correlations that may go undetected by traditional diagnostic methods. The AI insights aid clinicians in diagnosis, monitoring, and expediting treatment responses, significantly enhancing the detection and management of patients with this challenging subtype of heart failure.

This is the only artificial intelligence CPT code specific to supporting HFpEF diagnosis through echocardiography and was released on July 1st this year on the AMA’s website, becoming effective January 1st, 2025. The new CPT code, 0923T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786.  EchoGo® Heart Failure is also covered in the hospital inpatient setting, using the New Technology Add-on Payment (NTAP) code XXE2X19.
Ross Upton, PhD, Chief Executive Officer and founder of Ultromics, stated, “This recognition by the AMA underscores the significant impact our technology is having in the field of heart failure care. HFpEF represents a significant and growing patient population, accounting for 50% of heart failure cases worldwide, and may go undiagnosed in up to 64% of cases.1  We believe that EchoGo® Heart Failure will transform diagnostic pathways for these patients, enable earlier intervention, improve quality of life, and deliver benefits to payors and healthcare systems.”In the US, CPT codes are used by public and private health insurance programs and offer doctors and healthcare professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures, and services.Additional Data on EchoGo® Heart FailureEchoGo® Heart Failure was granted FDA 510(k) clearance in December 2022 and has been awarded FDA Breakthrough Device Designation.2Recent data on the tool was published last year in JACC: Advances, showing superior efficacy of EchoGo® Heart Failure in identifying HFpEF over the current clinical standard.Specifically, the AI-based system was able to correctly assign a diagnosis to 74% of patients who had returned non-diagnostic results on the commonly used HFA-PEFF and H2FPEF clinical scores.3 This improvement could translate to more patients receiving accurate and timely diagnoses and management.EchoGo® Heart Failure demonstrated high sensitivity and specificity, detecting 88% of patients who had HFpEF, and 82% of patients that did not.3 These results exceed what is usually observed in routine clinical practice.For the study, investigators retrospectively assessed independent data on 6,756 patients who underwent a comprehensive TTE at Mayo Clinic in Rochester, Minnesota, between January 2009 and December 2020. It was then independently tested in geographically distinct areas within Mayo Clinic Enterprise sites across the United States on a dataset that included 1,284 patients.The authors concluded, “EchoGo® Heart Failure’s exceptional discrimination capabilities, combined with its ability to identify patients with higher mortality risks, hold great promise for improving patient outcomes and enabling faster access to treatment.”References:1. Borlaug et al., Heart Failure With Preserved Ejection Fraction: JACC Scientific Statement. J Am Coll Cardiol 2023;81:1810–1834.2. Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction. News release. Ultromics. December 2, 2022.3. Akerman AP, et al. Automated Echocardiographic Detection of Heart Failure with Preserved Ejection Fraction Using Artificial Intelligence. JACC Adv. 2023:1;2(6):100452–2.About Ultromics:Ultromics is a pioneer in precision heart failure detection. Our ground-breaking platform, EchoGo®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality.  The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease dataset in echocardiography. The model was trained on thousands of patients to accurately detect disease and was validated against 5-year patient outcomes.  The technology has been built in collaboration with Mayo Clinic and the NHS England. Ultromics’ mission is to stop heart failure in its tracks with its precision detection platform.Photo – https://mma.prnewswire.com/media/2452704/Ultromics.jpgSOURCE Ultromics

Continue Reading →

Valcare Medical, Inc. Announces Formation of Scientific Advisory Board with Renowned Mitral Valve Experts

Financial by Comments are Disabled

TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the AMEND mitral valve repair device. The AMEND mitral annuloplasty ring has been designed to treat patients suffering from severe mitral regurgitation not deemed suitable for surgery.
“We are excited to be joined and supported by some of the world’s leading pioneers in mitral valve therapies,” said Dr. David Meerkin, Valcare Medical CMO. “Their combined experience and collective insights will greatly assist Valcare at this critical point as we significantly broaden and deepen our clinical experience.”
Members of the Valcare Medical Scientific Advisory Board include:
Dr. Isaac George, MD joined New York Presbyterian/Columbia University Medical Center in the Department of Surgery in July of 2001 as a resident in general surgery following his graduation from Duke University School of Medicine. Prior to receiving his MD, Dr. George completed a B.S. in Mechanical Engineering at Massachusetts Institute of Technology in 1997. Dr. George also completed a fellowship program in cardiothoracic surgery in 2011 as well as a fellowship program in interventional cardiology in 2012. Dr. George is an Associate Professor of Surgery and Medicine, and the Surgical Director of Structural Heart of the NYP health system. He is one of the few physicians in the world trained in both cardiac surgery and interventional cardiology. He is an expert in the most current and innovative procedures including Transcatheter Aortic Valve Replacement (TAVR), transcatheter valvular mitral valve repair (Mitraclip, Edge to Edge), transcatheter mitral and tricuspid valve replacement and surgical TAVR removal/explantation.
Dr. Scott Lim, MD, is a Professor of Medicine & Pediatrics at the University of Virginia and the University of British Columbia. He has developed a career focusing on novel therapies for heart valve, structural, congenital, and heart failure therapies. He has served as national primary investigator on transcatheter aortic, mitral, and pulmonary valve trials, as well as worked with multiple early-stage novel cardiac device therapies, particularly in mitral and tricuspid valve disease. In addition to authoring more than 250 scientific publications, 500 presentations, and 50 book chapters, Dr. Lim has been the founding editor through 5 editions of the most popular textbook on congenital heart disease, the Field Guide to Congenital Heart Disease & Repair. He has also spent more than two decades leading a charitable organization to teach cardiac disease care to physicians in developing countries.
Dr. Paul Sorajja, MD is the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center at the Minneapolis Heart Institute Foundation, and a cardiologist at Minneapolis Heart Institute® where he serves as the Director of the Center for Valve and Structural Heart Disease. Dr. Sorajja’s expertise is interventional cardiology, with a focus on bringing the latest innovative technologies to patients with valvular and structural heart disease. He was part of the team that performed the first transcatheter mitral valve replacement (TMVR) in the US and has the largest worldwide experience with the therapy. Dr. Sorajja currently serves as a national investigator for TMVR and for clinical trials in percutaneous treatment for tricuspid regurgitation. He has served on multiple national practice committees for valvular heart disease and hypertrophic cardiomyopathy. Dr. Sorajja has published more than 250 manuscripts as well as several books. He routinely lectures at national and international medical conferences and has received awards for his expertise in medical education. Dr. Sorajja is also highly active in developing intellectual property in these areas.
Dr. Azeem Latib, MD, Director of Structural Heart Interventions, Montefiore Health System, New York. Azeem is a world-leading expert in interventional cardiology, with a clinical focus on complex coronary interventions as well as transcatheter aortic, mitral, and tricuspid interventions. Following his clinical interests, Dr. Latib’s research centers on transcatheter aortic, mitral, and tricuspid interventions with a focus on device innovation. In addition, he performs research on drug-coated balloons, drug-eluting stents, and challenging lesion subsets.
Dr. Federico DeMarco, MD, PhD is the head of the Structural Heart Program and of the Interventional, Valvular and Structural Heart Interventions Unit in Centro Cardiologico Monzino in Milan. He trained in Interventional Cardiology at the Institut Cardiovasculaire Paris Sud in Massy, France, between 2005 and 2007, and until 2015 he worked as a senior staff interventional cardiologist at Niguarda Hospital in Milan. From 2015 to 2022 he helped build the largest Structural Heart Interventions program in Italy in Policlinico San Donato in Milan. His interventional experience is extensive, spacing from complex coronary interventions to TAVR, transcatheter mitral and tricuspid valve repair and replacement, PFO and LAA occlusion, peripheral interventions, and a wide variety of other endovascular interventions. He has been collaborating with multiple companies since 2012, both on product design and development with engineers and on early clinical experience with various device trials and first in man procedures. He authored and co-authored over 150 peer-reviewed publications and book chapters on coronary, aortic and mitral interventions and has a strong interest in new endovascular technology.
“We are honored to have these accomplished mitral valve experts join Valcare Medical’s Scientific Advisory Board,” said Steve Sandweg, Valcare Medical CEO. “Each of these individuals has made significant contributions and helped pioneer breakthroughs in the treatment of mitral valve disease. We look forward to leveraging the vast expertise of our SAB to help drive Valcare’s clinical and regulatory strategy.”
The innovative AMEND mitral valve repair device is a closed, D-shaped semi-rigid annuloplasty ring with proprietary anchoring capabilities. AMEND has been designed to replicate the efficacy of the traditional annuloplasty rings used to treat mitral regurgitation during open-heart surgery, but is implanted via a less invasive, percutaneous approach.
The AMEND device is investigational and limited to investigational use only. The products are not available for sale or commercial distribution.
About Valcare Medical
At Valcare Medical, our mission is to transform mitral valve therapy through the development of advanced, minimally invasive solutions. Our goal is to eliminate the need for open-heart surgery in patients with severe mitral regurgitation. We aim to minimize patient risk and maximize procedural outcomes by providing strong clinical evidence for the effectiveness of our technologies. We aspire to improve patients’ quality of life while increasing life expectancy by offering a safer and more effective alternative to traditional surgical methods.
Contact: [email protected]
SOURCE Valcare Medical

Continue Reading →

Pulnovo Medical Announces First Enrollment in Portugal for Global Clinical Study of PADN Technology in Treating Pulmonary Hypertension Associated with Left Heart Disease

Coronary/Structural Heart by Comments are Disabled

SHANGHAI, July 2, 2024 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), is pleased to announce the successful initiation and first two patients enrollment for its global multicenter clinical study exploring the percutaneous pulmonary artery denervation (PADN) treatment for pulmonary hypertension associated with left heart disease. This landmark event took place at Centro Hospitalar Universitário de Lisboa Central – Hospital de Santa Marta in Portugal, marking the beginning of Pulnovo Medical’s innovative product deployment on a global scale.
Under the guidance of Professor Hang Zhang from Nanjing Medical University Affiliated Nanjing Hospital, Prof. Ruben Ramos and his team successfully performed the PADN procedure on two patients. The procedure was smooth, the devices easy to operate, and the results were excellent. The Portuguese medical team was impressed by the PADN technology’s safety and efficacy, as demonstrated by many years of data. Clinical parameters showed promising results when using PADN technology. The products’ comprehensive design and high-precision algorithm control significantly ensured stable energy output and effective surgical results.
Prof. Ruben Ramos said, “PADN technology shows great potential in treating pulmonary hypertension associated with left heart disease. We are delighted to be the first in Europe to participate in this global clinical study. Our team is confident in this project and looks forward to bringing more treatment options to European pulmonary hypertension patients through this study. PADN is not only a new treatment method but also brings new hope to patients suffering from pulmonary hypertension.”
Jessie Lian，Pulnovo Medical’s CEO said, “The PADN global multicenter clinical study is one of our key projects dedicated to innovative treatment technologies in the cardiovascular field. As an emerging treatment, PADN has enormous potential and prospects. The post-operative results of the first overseas application of PADN reflect the academic borderlessness of the moment. In the future, we will continue to firmly advance our global business, steadily promoting the teaching and learning of PADN technology. ”
Cynthia Chen, Pulnovo Medical’s Chairlady said, “We are proud to have successfully completed the first enrollment in the European multicenter clinical study of PADN in Portugal, marking the acceleration of our technology’s global progress. We will continue to promote the global application of PADN, allowing more patients to benefit from this innovative therapy.”

Continue Reading →

Artivion Amends Agreements with Endospan

Financial by Comments are Disabled

Provides Endospan with $25 million of Additional Debt Funding to Obtain FDA Approval for NEXUS
Upfront Payment Associated with Purchase Option Reduced to $135 million, inclusive of loan off-set, and $100 million earnout minimum eliminated 
ATLANTA, July 1, 2024 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced it has amended its credit facility and option purchase agreements with Endospan Ltd. (“Endospan”), an Israeli-based, privately-held developer of the NEXUS® Stent Graft System (“NEXUS”). In 2019, the Company provided a credit facility to Endospan and entered into an option agreement to purchase Endospan upon U.S. Food and Drug Administration (“FDA”) approval of NEXUS. The amendments announced today result in three major changes to the original credit facility and option purchase agreements:

Artivion will provide additional loans to Endospan of up to $25 million in three tranches and anticipates funding the loans with free cash flow;
The upfront payment associated with the purchase option is reduced from $250 million to $175 million, resulting in an upfront acquisition purchase price of $135 million, inclusive of loan off-set; and
The $100 million minimum payout for the earnout is eliminated.

Endospan has developed NEXUS, the first and only approved branched endovascular system to treat aortic arch disease, including both aortic aneurysms and dissections. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysms (TAA), aortic arch disease patients with aneurysms or dissections who receive treatment have previously had little choice but to undergo open-chest surgery with its associated invasiveness and risks, lengthy hospitalizations, and prolonged recuperation. NEXUS transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure and stands to address an annual global addressable market opportunity of $600 million according to latest estimates.
“Based on our experience with NEXUS in Europe since 2019, we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair,” said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. “We view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery. Should we exercise our option to acquire Endospan, we believe we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments.”
Terms of the Amendments Under the terms of the amended Endospan credit facility, Artivion will provide up to an additional $25 million in debt financing to Endospan over three tranches, with the first $7 million drawn at close and subsequent tranches subject to progress toward and achievement of the NEXUS PMA. The terms of the loan are nearly identical to the terms of the original $15 million loan, except that under the amended terms both original and new loans will benefit from a first priority lien in Endospan assets, pari passu with other first lien Endospan liabilities.
If Artivion elects to exercise its option to purchase Endospan as contemplated in the Securities Purchase Option Agreement, then the outstanding principal amount and all accrued interest on the original and new loans would be deducted from the acquisition proceeds paid at closing. Under the amended purchase option, Artivion has the right to acquire Endospan at any time up to 90 days after receiving notice of U.S. FDA approval of NEXUS, for an upfront payment of $175 million, less previously extended loans and accrued interest, and an additional payment in the form of an earnout at two years post exercise of two and one half times (2.5x) incremental year two revenue. There is no longer any minimum earnout payment, and the maximum payment is still $200 million. Additionally, Artivion at its sole discretion may use up to $12.5 million of Artivion equity as part of the upfront payment. 
The amendments to the credit facility and Securities Purchase Option Agreement have been approved by both companies’ boards of directors and Endospan’s Security Holders. There were no changes to the parties existing Exclusive Distribution Agreement. The purchase obligations of the Securities Purchase Option Agreement will become effective if, and only when, Artivion exercises its purchase option. Any purchase of Endospan by Artivion would be subject to customary closing conditions.
Financial CommentaryThe Company does not anticipate the amended agreement with Endospan to have a material impact on its full-year 2024 financial guidance.
About Artivion, Inc.Headquartered in suburban Atlanta, Georgia, Artivion is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.artivion.com.
About Endospan Ltd.Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has received CE-Mark to commercialize in Europe the NEXUS Stent Graft System, the first endovascular off-the-shelf system to treat Aortic Arch Disease which affects a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website, www.endospan.com. 
Forward Looking Statements Statements made in this press release and the accompanying presentation that look forward in time or that express management’s beliefs, expectations, or hope are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include those regarding our estimates for the total addressable annual global market for the NEXUS technology; and our beliefs that we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair; we view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery; and we believe that should we exercise our option to acquire Endospan, we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These risks and uncertainties include but are not limited to the risks that the TRIOMPHE clinical trial may not be completed or may fail, may not reach its endpoints, or may be completed on timeframes different than anticipated; that PMA approval for NEXUS may be not achieved at all or on the time frames anticipated or that there be developments in technology by competitors that reduce the total addressable market for the NEXUS technology. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2023, and our subsequent filings with the SEC. Artivion does not undertake to update its forward-looking statements.

Contacts:

Artivion, Inc.
Gilmartin Group LLC

Lance A. Berry
Brian Johnston / Laine Morgan

Executive Vice President & Chief Financial Officer
Phone: 332-895-3222

Phone: 770-419-3355
[email protected]

SOURCE Artivion, Inc.

Continue Reading →

Rejuvenate Bio Receives $4M in Funding from the California Institute for Regenerative Medicine (CIRM)

Financial by 0 comments

– Funding will advance development of Rejuvenate’s one-time gene therapy RJB-0402 for the treatment of desmoplakin gene variant arrhythmogenic cardiomyopathy July 01, 2024 08:00 AM Eastern Daylight Time SAN DIEGO–(BUSINESS WIRE)–Rejuvenate Bio, announced today that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $4M grant to […]

Continue Reading →

Anteris Technologies and v2vmedtech Announce Concept Lock of Next Generation Mitral and Tricuspid Repair System as VClip™ Passes Animal Study

Coronary/Structural Heart by 0 comments

VClip™ restores mitral valve function and overcomes limitations of current technologies July 01, 2024 05:30 AM Eastern Daylight Time BRISBANE, Australia & EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of TAVR and the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve […]

Continue Reading →
1 … 229 230 231 232 233 … 1,324