Author: Ken Dropiewski

Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)

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Niagara Falls, NY, June 14, 2024 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical services, is pleased to announce its membership in the national alliance “Cardiac PET Industry Coalition” (CPIC), an organization at the forefront of quality of patient care, advocacy and innovation to advance the field of cardiovascular PET imaging. Positron joins forces with the coalitions founding members, Bracco Diagnostics, CDL Nuclear Technologies and Siemens Healthcare who have come together to promote federal policies that advance health outcomes for patients with cardiovascular disease and improve the availability of cardiac PET diagnostics throughout the United States. The CPIC will be a leading advocate for fair and transparent coverage and reimbursement policies that facilitate access to cardiac PET, align practitioners with regard to research opportunities, highlight the clinical and economic benefit of the modality, and provide expanded opportunities to educate healthcare providers and policymakers on the overall value of cardiac PET. CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda. Adel Abdullah, President of Positron stated, “Positron welcomed the opportunity to join the coalition, and personally, and I am honored to be part of current and future CPIC committees focused on the education, availability and advancement of the PET modality for cardiac studies. We believe Positron’s PET/PET-CT technology and ability to deliver the best value in the industry will play a key role in the adoption and growth of cardiac PET.  Positron and our team will support and serve the coalition as best as possible for the future of the industry, concluded Mr. Abdullah.”  Cardiac PET Industry Coalition CPIC passionately advocates for and protects the reimbursement of Cardiac PET, ensuring equitable access to innovative and life-saving technologies for healthcare providers and patients. For more information please visit www.cpicoalition.com About Positron Corporation Positron Corporation is a medical technology company that co-develops, manufactures, and sells  state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers throughout North America. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging, the gold standard in cardiac diagnostics. Positron’s innovative PET/PET-CT technologies, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron’s Attrius® PET and NeuSight PET-CT imaging systems and distinct market position are substantial advantages unique to Positron that will facilitate the adoption of cardiac PET and the growth of the nuclear imaging market. Positron will soon offer a state-of-the-art PET-CT 4D molecular imaging device in the Affinity PET-CT 4D 64-Slice. Positron’s PET-CT(s) will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT systems will also enable the Company to fully service and meet the demands of the vast oncology imaging segment of nuclear medicine.  Positron is committed to expanding the cardiac and oncology PET modality by delivering the best technology and value to imaging specialists and will continue to advance its technology through its co-developer, supplier, and R&D venture with Shenyang Intelligent Neuclear Technology Co. a subsidiary of Neusoft Medical Systems.   For more information please visit www.positron.com Forward-Looking Statements This press release contains statements which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results even if new information becomes available in the future. FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: investor@positron.com

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Mineralys Therapeutics Appoints Biopharmaceutical Executive Alexander M. Gold, M.D. to its Board of Directors

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RADNOR, Pa., June 14, 2024 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced that Alexander M. Gold, M.D. has been appointed to the Company’s Board of Directors (the Board), effective June 13, 2024. “We are delighted to welcome Alex to our Board of Directors as we advance the late-stage clinical development of lorundrostat for the treatment of hypertension and related cardiorenal metabolic disorders,” stated Jon Congleton, Chief Executive Officer of Mineralys. “As a cardiologist and accomplished biopharmaceutical clinical development executive, Alex brings tremendous experience driving value for biopharmaceutical companies. We believe Alex’s track record of successful pipeline development, regulatory approvals, and joint ventures will make him be a valuable director and resource for the Company’s team.” “I am honored to join the Mineralys Board of Directors,” stated Dr. Gold. “I look forward to working with the Company’s executive team and fellow Board members to advance the treatment of cardiorenal metabolic disorders. There is significant potential with lorundrostat in offering a targeted treatment approach for hypertension and other diseases driven by dysregulated aldosterone.” Dr. Gold is a cardiologist with more than 20 years of experience leading the development, approval, and commercialization of new therapies. He has held executive positions at several biopharmaceutical companies that targeted numerous therapeutic areas, including cardiometabolic, renal, and inflammation. Currently, Dr. Gold is the Chief Medical Officer of a clinical-stage biotech company. Prior to his current role, he held the role of Head Medical Officer at Sanifit-CSL. He originally joined as Chief Medical Officer and President of Sanifit Inc. in 2017, which was then acquired by Vifor Pharma in January 2022 and subsequently by CSL Ltd. in August 2022. Prior to Sanifit, Dr. Gold held the role of Senior Vice President and Head of Clinical Development at Portola Pharmaceuticals. Prior to Portola Pharmaceuticals, Dr. Gold was Head of Clinical Development at Reata Pharmaceuticals. For 11 years he held multiple leadership positions at AstraZeneca, including the Executive Director and Development Leader for BRILINTA, CRESTOR and ONGLYZA. Dr. Gold is currently an Adjunct Professor at Stanford University School of Medicine. Dr. Gold completed his residency in internal medicine and fellowship in cardiology at the Beth Israel Deaconess Medical Center / Harvard Medical School in Boston and conducted translational and clinical research as a fellow in cardiovascular research at the Harvard Clinical Research Institute and was a Scholar in Clinical Science. Dr. Gold received his M.D. from Harvard Medical School and his B.A in Biology from Brandeis University. In addition, the Company announced the resignation of Olivier Litzka, Ph.D. from its Board, effective June 13, 2024. Dr. Litzka stated: “It was an honor for me to serve on the Mineralys Board since the Company’s final private financing round prior to the initial public offering. The Company has shown tremendous progress, which is due to its exceptionally talented and hard working team. As a venture capital investor, I’ve decided to step down in order to make room for new, well-suited board members like Alex Gold to support the Company going forward. I wish Mineralys all the best on its path forward.” “The Board and I would like to express our collective gratitude to Olivier for his contributions and dedication to the Board. We wish him future success as he turns his attention to other venture investments at Andera Partners,” stated Mr. Congleton. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension, in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com

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Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.

Uncategorized by Comments are Disabled

HANGZHOU, China, June 14, 2024 /PRNewswire/ — Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine. This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center.

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This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.

The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve’s registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.”We’re honored to be part of the VenusP-Valve PROTEUS trial,” said Prof. Scott Lim after the procedure. “We’ve just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.” “That went really smoothly in this teenage patient with free pulmonary insufficiency”, commented Prof. Michael Hainstock. “I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.””The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, General Manager and CEO of Venus Medtech. “The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”About VenusP-ValveAs the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.About Venus MedtechVenus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.For more information, please visit https://www.venusmedtech.com

*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.

*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.

*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.

Copyright 2024. Venus Medtech (Hangzhou) Inc. All Rights Reserved.

Contacts:Jill Liu  Public Relations [email protected]Ophelia ChenInvestor Relations[email protected]SOURCE Venus Medtech (Hangzhou) Inc.

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New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation

Peripheral/Endo by Comments are Disabled

Temporary vessel occlusion a growing practice for trauma patients.
SALT LAKE CITY, June 13, 2024 /PRNewswire/ — Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.
REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.
“Landmark was easy to use and easy to deliver with a smooth insertion,” said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. “REBOA can be an important tool to aid in patient resuscitation.” It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2
“We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage,” said Ryan Murri, Emergency Scientific’s Chief Executive Officer. “With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options.”
The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.

Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023). 
Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.

SOURCE Emergency Scientific

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CARMAT Announces the Start of the Equitization of the First Tranche of Its EIB Loan

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June 13, 2024 12:00 PM Eastern Daylight Time PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR): On February 14, 2023, the French financial markets authority (Autorité des marchés financiers) invited companies issuing equity securities or securities giving access to capital on a staggered basis to adopt a standard communication and warning on the […]

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Viz.ai Collaborates with Hypertrophic Cardiomyopathy Association to Improve Care for Hypertrophic Cardiomyopathy Patients

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SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with the Hypertrophic Cardiomyopathy Association (HCMA), the preeminent organization improving the lives of those with hypertrophic cardiomyopathy (HCM), to support, educate and advance research for HCM. “We’re thrilled to collaborate with the HCMA […]

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Anteris Provides Update on DurAVR™ THV Valve-in-Valve Experience Presented at New York Valves 2024

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DurAVR ViV restores similar aortic valve gradients to initial post-surgical results June 13, 2024 06:00 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 […]

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FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

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With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for lead wires while maintaining high-quality data collection and accelerating trial timelines.

PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.
“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”
Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model. With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”
This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.
About ClarioClario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.
For more information, go to Clario.com or follow us on LinkedIn.
Media Contact:Alexis NavratilCommunications Manager[email protected] 
SOURCE Clario

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXess™, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel

EINDHOVEN, The Netherlands, June 13, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) submission to begin enrolling patients into a pivotal study for aXess.
aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for hemodialysis vascular access, combining the safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG). The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients.
Xeltis’ groundbreaking implants platform is an important development in vascular replacement technology as, over time, its implants are gradually replaced by the patients’ own living healthy tissue. Xeltis’ novel technology has already treated over 100 patients across different clinical trials.   
Eliane Schutte, Chief Executive Officer, Xeltis commented: “We have already shown outstanding 12-month data from our first-in-human study in Europe and are looking forward to starting this pivotal trial in the US. We are very proud of the potential for aXess to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to hemodialysis patients worldwide.”
Paulo Neves, Chief Medical Officer, Xeltis said: “Our focus is on improving the outcomes for patients on dialysis. aXess offers this potential through its avoidance of the reinterventions and complications associated with other vascular access solutions. This pivotal study is important in assessing and demonstrating this and marks a significant milestone in our clinical strategy in the US.”
The US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine EU countries.
About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis’ most advanced product currently under clinical development is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. 
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors.
About aXessaXess is a restorative conduit which enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of a fistula with the speed to treatment of an AV graft. The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by renal disease patients.
A first-in-human trial of aXess demonstrated a significant improvement in performance compared to hemodialysis vascular access solutions. A pivotal trial of aXess is currently enrolling up to 110 patients in nine EU countries.
Go to axesspivotal.com for more details.
SOURCE Xeltis

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Simpson Interventions Announces Appointment of Dr. Joseph Knight as CEO

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June 12, 2024 10:00 AM Eastern Daylight Time CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced the appointment of Dr. Joseph Knight to the role of Chief Executive Officer, effective May 1st, 2024. He replaces Simpson Interventions’ Founder and previous CEO, […]

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