Cardiovascular Systems, Inc. Announces First In-Human Experience With Company’s Propel™ Percutaneous Ventricular Assist Device

Below, we are re-publishing with permission the press-release issued by Cardiovascular Systems, Inc. on March 16, 2022

ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the first in-human experience with Propel™, its first-generation percutaneous ventricular assist device (pVAD), offering hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (HR-PCI).

The first series of patients was treated by Dr. David E. Kandzari, MD, FACC, FSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Atlanta, Ga., performed in Tbilisi, Georgia. Propel performed as intended, providing uninterrupted hemodynamic support leading to successful revascularization.

Propel is designed to meet the needs of the HR-PCI patient by providing clinically meaningful hemodynamic support while minimizing access site and procedural complications due to a small profile pump and smaller catheter body versus the current pVAD systems that are commercially available. Propel is percutaneously inserted, and the blood inlet portion of the device is positioned within the left ventricle below the aortic valve, and the outlet positioned above the aortic valve.

Propel was used at multiple support levels, with a hemodynamic power output and duration sufficient to maintain the stability of patients during their HR-PCI.

As one of the study investigators, Dr. Kandzari said, “This is a novel pVAD system that enables a 12 French in-body pump with a 7 French in-body catheter. This reduction in size may reduce the clinical complications associated with high-risk procedures while providing the clinically necessary cardiac support for the patient. The lower catheter profile may also increase the potential for use in patients with challenging anatomy that exclude treatment with current therapies.”

“Today’s announcement is another important milestone for CSI as we seek to develop an exciting pipeline of new products designed to improve the outcomes for patients with coronary artery disease,” said Scott R. Ward, Chairman, President and Chief Executive Officer of CSI. “We appreciate Dr. Kandzari’s commitment and willingness to participate in these first cases. Conducting the first in-human cases outside the U.S. increases the confidence we have in Propel and furthers the development of this program. We continue to work closely with FDA, and the data from these cases will inform the design and conduct of an early feasibility study in the U.S.”

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, arterial calcium is present in 38 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit http://www.csi360.com and connect on Twitter @csi360.

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding (i) the development of Propel; (ii) future clinical studies and regulatory submissions relating to Propel; and (iii) CSI’s product pipeline, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the ability of CSI to develop Propel; technical challenges; regulatory developments; clinical trial requirements and results; FDA clearances and approvals; the experience of physicians regarding the effectiveness and reliability of products sold by CSI; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

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Maxwell Biomedical Initiates First-in-Human Trial to Assess the Safety and Efficacy of а Novel Pacing Intervention in Patients with Atrial Fibrillation

Spatial Resynchronization Therapy™ (SR ™Т) Successfully Terminated Atrial Fibrillation

Below, we are re-publishing with permission the press-release issued by Maxwell Biomedical on July 14, 2022

SAN DIEGO, Calif., July 14, 2022. Maxwell Biomedical announced today that it has initiated its First-ln­ Human Clinical Trial “Initial Experience with Spatial Resynchronization Therapy in Patients with Atrial Fibrillation (SR-TheAF)” at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. The study is designed to test the acute safety and efficacy of Spatial Resynchronization™ Therapy (SR™T) in patients with а history of atrial fibrillation (AF). The study will enroll up to 30 patients. During the initial studies, AF was successfully detected and termination with SRT pacing was demonstrated.

Spatial Resynchronization Therapy (SRT) is а Maxwell’s proprietary algorithm designed specifically to treat AF. Once AF is detected, SRT delivers pacing stimuli across а spatially distributed array of electrodes placed on the pericardial wall of the left atrium. Pacing stimuli, which are imperceptible to the patient, are precisely delivered to restore normal rhythm.

“We are very excited about the acute performance of SRT in this first series of patients,” stated Randy Werneth, СЕО of Maxwell Biomedical, “This represents а major milestone in our development pathway to bring а device-based treatment option to patients with AF.” Working alongside the surgical team in Tbilisi was Mehdi Razavi, MD, an entrepreneurial electrophysiologist from the Texas Heart Institute in Houston Texas, who has been working closely with the Maxwell Biomedical team to develop and pre­ clinically test the SRT concept. “In the past, pacing was tried with limited success to convert AF to а normal rhythm,” said Dr. Razavi, “SRT is а new methodology, based on insights gained from past experiences and rooted in the underlying biophysics of human fibrillatory conduction.”

AF is the most common heart arrhythmia affecting over ЗЗ million patients worldwide.1 It occurs when the upper chambers beat uncontrollably and are out of synchronization with the lower chambers of the heart. The lack of coordinated contractions during prolonged episodes of AF increases the likelihood of blood clot formation and reduces the amount of blood available to pump to the body. AF increases stroke risk five times2, increases mortality rates two-fold in heart failure patients3 and costs the United States healthcare system $26В annually1. Current AF treatment options include outpatient cardioversion, rate or rhythm control medications and catheter ablation. SRT would offer patients а non-destructive, minimally invasive option to treat  their AF.

About Maxwell Biomedical

We are а development stage, science driven, innovative medical technology company with outstanding people dedicated to advancing long-term solutions for patients with Atrial Fibrillation.

Maxwell is developing а first of its kind, non-ablative, atrial pacing device that automatically detects AF and imperceptibly delivers Spatial Resynchronization Therapy (SRT) to restore and maintain а normal heart rhythm. Device monitoring and cloud connectivity ensures active and continuous patient care and management. Founded in 2019, Maxwell Biomedical is based in San Diego, СА.

  1. Chugh SS et al. Worldwide epidemiology of atrial fibrillation. А global burden of disease study 2010.Circulation; 129:2014.
  2. Virani SS et al. Heart disease and stroke statistics 2021 update: а report from the American Heart Association. Circulation;143:2021.
  3. Chamberlain АМ et al. Atria/ Fibrillation and Mortality in Heart Failure. Circ: Heart Failure;4(6):2011.
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Clinical Accelerator announces collaboration with Argá Medtech – developers of a novel cardiac ablation system for the treatment of cardiac arrhythmias

Clinical Accelerator, a full-service, medical device focused contract research organization, is excited to announce a new collaboration with Argá Medtech, on their feasibility study exploring the safety and efficacy of Argá’s non-thermal cardiac ablation system targeting Atrial Fibrillation (AF)

The system is a next generation of Pulsed Field Ablation and Irreversible Electroporation, offering an alternative to RF and Cryo – the most commonly used sources of energy for cardiac ablation. The system is hoped to result in a safer and faster procedure with improved clinical outcomes for AF patients.

The study is planned to enrol 10 patients and will be managed by Clinical Accelerator at our partner sites. It is currently in the set-up phase, and we are very excited to see its progression!

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.

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BetaGlue announces the treatment of the first patient with BAT-90, taking radiotherapy inside solid tumours

Below, we are re-publishing with permission the press-release issued by BetaGlue Technologies on July 11, 2022

BetaGlue Technologies, a highly innovative company working in the Life Sciences sector, is glad to announce that the first patient has been treated in a clinical trial with BAT-90, the company’s cancer radiotherapy platform. The first clinical results have shown that BAT-90 makes it possible to treat only the area where the tumour is located, while avoiding the surrounding tissues, so as to combine treatment efficacy and patient safety.
 
The clinical trial in liver cancer patient has been coordinated by Professor Malkhaz Mizandari at the New Hospitals in Tbilisi (Georgia), an international centre of excellence affiliated with Thomas Jefferson University in Philadelphia (USA).
 
BAT-90 (‘Beta Ablation Therapy with Yttrium-90’) consists of a β radiation-emitting biocompatible matrix, delivered to patients via percutaneous injection: the Yttrium-90-labelled microspheres present inside the matrix are injected into the tumour and, as the carrier takes only 120 seconds to reach full polymerisation, they are retained exclusively in the injected area. This prevents the microspheres from spreading to surrounding tissues or organs, so as to release their radiation energy only to the target tumour. In this way, a very low radioactive dose is needed, much lower than the one used with conventional radio-metabolic treatments, thus enhancing treatment efficacy and patient safety.
 
BAT-90 opens up important horizons in oncology, bringing benefits to both patients and the healthcare systems. Indeed, BAT-90 is a therapeutic nuclear medicine solution that is extremely precise (it only targets the tumour area), personalised (calibrated to the patient’s clinical situation), rapid (a single injection reaching full polymerisation in just a few minutes) and safe (the radiation energy is released where needed, avoiding exposure of surrounding tissues and organs, thus minimizing any risk to either patients or healthcare professionals).

BetaGlue Technologies SpA
BetaGlue Technologies is a highly innovative company working in the Life Sciences sector.  The Company has developed BAT-90, an advanced radiotherapy platform targeting inoperable solid tumors and/or surgical resection margins. BetaGlue is also patenting a medical device that enables safe biopsies in oncology, preventing even severe complications after lung or liver procedures. BetaGlue enjoys the support of a highly qualified Scientific Advisory Board, as well as of leading national and international advisers, in the development of its solutions.
Web site: www.betaglue.com

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Clinical Accelerator announces collaboration with CryoTherapuetics – a medical device company focused on treating coronary artery disease

Clinical Accelerator, a full-service, medical device focused contract research organization, is pleased to announce a new partnership with CryoTherapeutics – an early-stage European medical device company which has developed a novel cryoenergy therapy for the treatment of inflamed atherosclerotic plaque, a major cause of heart attack.

Currently  there is no approved interventional treatment for this indication, but CryoTherapeutics hopes to change that with their therapy which will target areas of the coronary artery where there is inflammatory disease. The system consists of a console delivering a cryogen to the tip of a catheter which then delivers cryotherapy at below zero temperatures to the specific site in the coronary artery. The procedure is conducted with the assistance of invasive of non-invasive imaging to ensure precise placement

CryoTherapeutics’s feasibility study will be managed by Clinical Accelerator and we are thrilled to be a part of this project. We are looking forward to using our expertise in clinical trial management of FIH and early feasibility studies to result in a successful study.

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.

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Axon Therapies Announces Positive Early Clinical Data from REBALANCE-HF Randomized Clinical Trial

Axon Therapies

Below, we are re-publishing with permission the press-release issued by Axon Therapies on May 23, 2022

Late-breaking results presented at the European Society of Cardiology’s Heart Failure Association annual conference and simultaneously published online in the European Journal of Heart Failure

SANTA CLARA, Calif., May 23, 2022 /PRNewswire/ — Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced positive early results from a roll-in cohort for their feasibility IDE trial, REBALANCE-HF. The study is evaluating a novel frontline therapy called Splanchnic Ablation for Volume Management (SAVM) that aims to rebalance volume distribution in heart failure patients with preserved ejection fraction (HFpEF). The results support safety and efficacy of the SAVM procedure and signaled clinical improvements in key data including pulmonary capillary wedge pressure (PCWP) with exercise and patient quality of life metrics. Data was presented at the European Society of Cardiology’s Heart Failure Association 2022 annual conference in Madrid, Spain and simultaneously published online in the European Journal of Heart Failure.

“It is very promising to see the positive early dataset and improvement in key clinical outcomes.  HFpEF patients have few treatment options today, and SAVM offers a minimally invasive, implant-free procedure designed to treat a root cause of their symptoms and hopefully slow down or stop disease progression – it has the potential to be a very exciting approach,” commented Marat Fudim, MD, Advanced Heart Failure Specialist at Duke University Medical Center. “I’m eager to see the longer-term results and patient outcomes from the study as they become available.”

The REBALANCE-HF study is a prospective, multi-center, randomized, sham controlled, double-blinded study enrolling 80 patients at up to 20 U.S. sites and is designed to assess the safety and efficacy of the SAVM procedure. The trial included a cohort of 18 single-arm, open-label roll-in patients for interim analysis that provided early data on the SAVM procedure using the Axon Ablation Catheter. While the findings require additional confirmation, early results are very promising. The therapy had a solid safety profile—all patients were successfully treated and three non-serious device-related adverse events were reported (heart failure decompensation requiring an ER visit, transient hypertension during the procedure, and back pain following the procedure). Patients showed improvement in PCWP with exercise as well as improvements in functional capacity, symptoms, and overall health status.

Key Results

  • Significant reduction in PCWP at 20 watts and peak exercise at 1-month (p=0.007 and p=0.013, respectively)
  • 33% of patients experienced improvement of at least one New York Heart Association (NYHA) class compared to baseline at 1-month (p<0.01)
  • Significant improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) (22.1 pts at 1-month, p <0.01; 18.3 pts at 3-months, p<0.01)

Sanjiv Shah, MD, who is the National Principal Investigator of the REBALANCE-HF trial, stated, “The SAVM procedure offers a novel approach to potentially improving outcomes in patients suffering from heart failure by reducing sympathetic nerve activity to restore volume balance within the circulation. The early data from the REBALANCE-HF trial, demonstrates the potential promise and importance of managing volume shifts in this underserved patient population.” Dr. Shah is Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

“The data for this first cohort of patients is very encouraging. We anticipate completing enrollment in REBALANCE-HF later this year and sharing the full results next year,” stated Chad Hoskins, CEO of Axon Therapies. “The data builds on the results of our pilot studies, which demonstrated a durable effect of SAVM at 1 year. We’re grateful for the work of our investigators, and we look forward to the culmination of these efforts in a pivotal trial beginning in 2023.”

About Axon Therapies, Inc.
Axon Therapies, a private medtech company, is developing a minimally invasive therapy that aims to address a root cause of heart failure by restoring balance to the sympathetic nervous system. Derived from an existing clinical procedure, splanchnic ablation for volume management (SAVM) using the Axon Ablation System enables targeted ablation of the overactive sympathetic nervous system, a key driver of worsening heart failure. The implant-free, catheter-based procedure aims to restore volume balance, stop disease progression and improve patient heart failure symptoms. Axon was founded by proven medtech incubator Coridea, and is backed by leading healthcare investors, including Deerfield ManagementAction Potential Venture Capital, and an undisclosed strategic investor. Learn more at axontherapies.com.

SOURCE: Axon Therapies, Inc.

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Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®

Below, we are re-publishing with permission the press-release issued by Miracor Medical on March 29, 2022

AWANS, Belgium, March 29, 2022 /PRNewswire/ — Miracor Medical SA (Miracor Medical) today announced the first patient enrolled in the PICSO-AMI-V study to evaluate the benefits of PiCSO® (Pressure Controlled Intermittent Coronary Sinus Occlusion) therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-Elevation Myocardial Infarction (STEMI).

The first patient enrolled was treated at the University Hospital of Toulouse, France by the team of Professor Didier Carrié (Drs T. Lhermusier and F. Campelo). “Our team started using the PiCSO therapy for anterior STEMI patients in 2021. We are delighted to explore new indications and now start using PiCSO for inferior STEMI patients in the context of the PiCSO-AMI-V study,” says Prof. Carrié.

Improving outcomes for patients with large heart attacks remains an important unmet need

The principal investigator of the study is Professor Adrian Banning, Oxford Heart Center, Oxford, UK. “We are pleased to be initiating the PiCSO-AMI-V study. It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart. The study builds upon the data from the First-In-Man study that we published in 20213. We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure.” says Prof. Banning.

PICSO-AMI-V is a prospective, randomized, multicenter feasibility study and will enroll 75 inferior STEMI patients presenting with TIMI 0 & 1 flow, at up to 10 clinical sites in Europe. In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone. Adverse Device Effect (ADE) rate at 30 days post index procedure will be assessed as the primary endpoint. In addition, cardiac function and clinical safety endpoints – including death, heart failure-related hospitalization, new onset or worsening of heart failure – will be assessed. The patients will be followed for 1 year.

PiCSO therapy has demonstrated positive results in several clinical studies. Data from two recent studies (“PiCSO in ACS” and “OxAMI-PICSO”) showed that the use of the PiCSO Impulse System is associated with a significant infarct size reduction in anterior STEMI patients 1,2. Furthermore, OxAMI-PICSO3 showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients. PiCSO therapy accelerates the microcirculatory recovery resulting in significantly lower IMR (Index of Microcirculatory Resistance) and RRR (Resistive Reserve Ratio) post procedure when compared with controls.

We are thrilled to start this second randomized clinical trial in Europe, and to progress our strategy to expand indications beyond our initial indication of anterior STEMI. The PiCSO-AMI-V Inferior STEMI study will complement the ongoing PiCSO-AMI-I (Anterior STEMI) study, which has enrolled more than 100 anterior STEMI patients and is anticipated to complete enrollment during the second semester of this year. We also recently treated the 300th patient with the PiCSO therapy, illustrating the acceleration of usage and experience with the therapy,” says Olivier Delporte, CEO of Miracor Medical.

PiCSO therapy is used during the primary PCI procedure in acute myocardial infarct (AMI). Via its unique differentiated mechanism of action the PiCSO Impulse System clears the coronary microcirculation by intermittently occluding the coronary sinus outflow. The use of the PiCSO Impulse System has been associated with a reduction in infarct size after STEMI, which has been shown to lead to reductions in heart failure hospitalizations and reduced mortality4. Heart Failure develops in 18-28% of patients 90 days after their STEMI 5.

The PiCSO-AMI-V Inferior STEMI study is partially funded by a recoverable cash advance granted by the Walloon Region to Miracor Medical.

About Miracor Medical
Miracor Medical (www.miracormedical.com), located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.

Miracor Medical develops the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function and potentially reduce the onset of heart failure following acute myocardial infarction.

NOTE: The PiCSO® Impulse System is commercially available for anterior STEMI patients in EU, UK and EFTA. It is not commercially available for inferior STEMI patients.

1 De Maria, et al. (2018). Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction – Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352-e359

2 Egred, et al. (2020). Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. Int J Cardiol Heart Vasc, 28, 100526. https://doi.org/10.1016/j.ijcha.2020.100526

3Scarsini, et.all. (2021), Oxford Acute Myocardial Infarction, S., Kharbanda, R., Ferreira, V. M., Channon, K. M., De Maria, G. L., & Banning, A. P. (2021). Pressure-controlled intermittent coronary sinus occlusion improves the vasodilatory microvascular capacity and reduces myocardial injury in patients with STEMI. Catheter Cardiovasc Interv, Epub ahead of print(doi: 10.1002/ccd.29793). https://doi.org/10.1002/ccd.29793

4 Stone, et al. (2016). Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.

5 Cahill, et al. (2017). Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.

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Sequana Medical receives certification under MDR, the new European Medical Device Regulation

Below, we are re-publishing with permission the press-release issued by Sequana Medical on February 14, 2022

  • alfapump® is one of the first novel Class III active implantable medical devices to be certified

Ghent, Belgium – 14 February 2022 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the alfapump system in the European Union (EU).

Sequana Medical was granted the EU Quality Management System (QMS) Certificate and the EU Technical Documentation Assessment Certificate confirming that the Company’s QMS and the alfapump system are compliant with the latest regulatory standards required for medical devices in Europe. The Company’s proprietary DirectLink technology built into the alfapump system has been classified as medical device under the MDR, clearly demonstrating the relevance and importance of alfapump performance data monitoring, allowing physicians to closer follow-up on their patients. This announcement follows the recent QMS certification under the Medical Device Single Audit Program (MDSAP), demonstrating Sequana Medical’s compliance to the high standards of medical device regulations internationally.

Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: Achieving MDR certification is another major milestone and the result of our early adaption to the new and more stringent regulatory requirements in Europe. This achievement would not have been possible without the extensive and diligent work of the entire Sequana Medical team. We are also very thankful for the longstanding relationship with BSI, our competent Notified Body, and we look forward to continuing working with them.”

Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “Without doubt, MDR has raised the standards for medical device regulation and we are excited to be one of the first novel Class III active implantable medical device companies to receive this certification. It shows our strong commitment to complying with the highest regulatory standards for medical devices and is a demonstration of our progress to meeting the standards required for approval of the alfapump in the U.S.”

About European Medical Device Regulation (MDR)

The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. MDR has significantly increased the requirements in respect of technical documentation, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical data and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.

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Clinical Accelerator announces collaboration with Deerfield Catalyst, a medtech incubator committed to developing transformational solutions to improve patient outcomes and streamline care

Clinical Accelerator, a full-service, medical device focused contract research organization, is pleased to announce a collaboration with Deerfield Catalyst. The company combines the resources of two established health pioneers: Coridea, a New-York based, premier Medical Device Incubator; and Deerfield, an investment management firm focused on healthcare. The plan is to launch 10 companies over the next five years developing innovative medical devices.

Clinical Accelerator is excited to be joining this collaboration, offering our extensive expertise in management of medical device investigations with a special focus on early human feasibility studies. Our ability to accelerate the timelines of clinical studies and reduce the capital required, allows R&D programs to advance faster, bringing novel medical devices to patients earlier.

The first collaborative project with Deerfield Catalyst will be a pilot study for a novel device treating Obstructive Sleep Apnea and we look forward to many more studies in the future.

About Deerfield  

Deerfield Device Design and Development Catalyst (Deerfield Catalyst) is a medtech incubator that aims to support and advance transformational innovation into commercial products and successful enterprises. A collaboration between Deerfield and the Coridea team, Deerfield Catalyst is focused on developing medtech solutions that improve outcomes and streamline patient care. The incubator plans to launch 10 companies over the next five years. 

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries. Clinical Accelerator’s model of operation is designed to achieve significant cost savings for its clients and to guarantee compact timelines for patient enrolment with a firm focus on the quality of clinical trial data.

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Clinical Accelerator announces collaboration with Verve Medical to conduct an early human feasibility study for treatment-resistant hypertension

Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Verve Medical, to conduct an early human feasibility study of their novel medical device for patients with treatment-resistant hypertension.

World-wide, there are over a billion patients who suffer from hypertension and it is directly responsible for millions of deaths annually. Many patients with hypertension are either inadequately identified or treated and medications can be expensive and have side effects. Verve Medical is focused on proving an effective peri-pelvic renal denervation approach to hypertension which, unlike the peri-arterial approach, avoids the possibility of arterial restenosis and does not require anticoagulation or antiplatelet agents. This device has the ability to achieve an immediate blood pressure drop in patients that is comparable to open sympathectomy.

Clinical Accelerator is very excited to partner in this project and will be working closely with Verve Medical, running their early human feasibility study in our region of operation. We look forward to developing this product and achieving positive data on this potentially life-changing device.

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging medtech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.

About Verve Medical

Verve Medical is an early-stage medical device company, based in the United States and focused on developing novel non-vascular renal denervation devices for treatment-resistant hypertension.

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