Below, we are re-publishing with permission the press-release issued by Argá Medtech on Octobe 26, 2022
Acute procedural success achieved in all patients using a novel pulsed field ablation (PFA) sine waveform and configurable catheter.
EPALINGES, Switzerland, Oct. 26, 2022 (GLOBE NEWSWIRE) — Argá Medtech announced today that it has begun enrollment in their First-in-Human Clinical Trial “Coherent Sine Burst Electroporation (CSE) System Pilot Study in Patients with Atrial Fibrillation (BURST-AF)”. The study is designed to test the acute safety and efficiency of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation (AFib). The first five patients, four with paroxysmal and one with persistent AFib, were successfully treated by Dr. Giorgi Papiashvili with support from Dr. Ante Anic, at the Healthycore Medical Center in Tbilisi, Georgia.
The CSE system consists of a configurable (circular, linear, and focal) ablation catheter and pulsed field ablation (PFA) generator. In contrast to all other PFA waveforms, CSE employs a unique sinusoidal wave instead of a square wave. CSE is designed to minimize muscle stimulation, decrease bubble formation, and increase targeted energy delivery to create transmural lesions in tissue of any thickness. CSE offers unmatched flexibility to deliver bipolar, unipolar, or a combination of both waveforms that enables the user to titrate the width and depth of the ablation lesion.
“We are very pleased with the performance of our CSE System in this initial group of patients,” stated David Neale, CEO of Argá Medtech. “The ability to deliver three different lesion sets with a single catheter, combined with a generator that titrates lesion depth and width, enables electrophysiologists to safely and efficiently treat any location in the heart.” The physicians and lab staff were excited to provide this new therapy option to their AFib patients. “It was easy to change the ablation catheter from circular to linear,” said Dr. Papiashvili, “and not having to exchange catheters for each lesion set is a game changer.” Visiting physician Dr. Ante Anic (University Hospital Split, Croatia) added, “Energy delivery was very impressive, with no muscle stimulation, no bubbles and very adaptable to the patient’s needs. The catheter flexibility allowed the pulmonary veins to be quickly isolated using the circular configuration and then easily changed to deliver a ‘linear single-shot’ roof line.”
Atrial Fibrillation and PFA Ablation AFib is the most common heart arrhythmia affecting over 33 million patients worldwide and makes them 5 times more likely to have a stroke.1 Patients with AFib have a significantly poorer quality of life when compared to healthy individuals, experiencing a variety of symptoms including lethargy, palpitations, dyspnea, chest tightness, sleeping difficulties, and psychosocial distress. Ablation using thermal energy (radiofrequency or cryogenic) has proven to be an effective treatment in alleviating AFib associated symptoms and improving quality-of-life. However, there are risks associated with the use of thermal energy that include the potential to damage critical structures such as the esophagus or nerves that surround the heart. Pulsed field ablation energy delivery is tissue selective, ablating the selected heart tissue, while sparing nearby tissues.
About Argá Medtech We are a venture-capital backed development stage company developing the next generation of pulsed field ablation and irreversible electroporation for the safe and effective treatment of patients with cardiac arrhythmias. Founded in 2020, Argá Medtech is based in Switzerland with research and development facilities in San Diego, CA.
Chugh SS et al. Worldwide epidemiology of atrial fibrillation. A global burden of disease study 2010. Circulation;129:2014.
Below, we are re-publishing with permission the press-release issued by Medcura, Inc. on January 12, 2023
January 12, 2023·3 min read
COLLEGE PARK, Md., Jan. 12, 2023 /PRNewswire/ — Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGel™ Absorbable Surgical Hemostat. LifeGel™ is the first and only hemostatic agent to receive Breakthrough Device Designation seeking a new and highly differentiated indication: in surgical procedures (except in ophthalmic and urological) as an adjunctive hemostatic device when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical. Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.
The FDA’s Breakthrough Devices Program is available to therapeutic devices that establish they have the potential to provide more effective treatment of life threatening or irreversibly debilitating diseases or conditions. Breakthrough designation provides several important benefits, including quicker and more collaborative review of future regulatory submissions with greater opportunity to interact with FDA experts throughout the review process.
“We’re very pleased for the opportunity to continue working closely with the FDA to improve a surgeon’s ability to control and stop the wide range of bleeding scenarios for which the Breakthrough Designation was awarded,” said Medcura President and CEO Jim Buck. “This designation provides for a more collaborative partnership with the FDA which should expedite patient access to LifeGel as a game-changing new solution to surgical bleeding management.”
Other hemostatic agents swell after application. When used in confined spaces like the spinal canal, where up to 60% of these products are applied, hemostatic agents have been documented to cause nerve compression that can lead to severe adverse events including paralysis. Medcura’s proprietary and patented formulation was designed not to swell upon application, eliminating the chance of spinal cord compression caused by swelling hemostatic agents. Unlike many other hemostatic agents, LifeGel contains no human or animal proteins, including thrombin, and requires no pre-mixing, preparation or cold chain storage. Being ready to use, LifeGel can help avoid costly delays, risks and complications associated with uncontrolled bleeding and reduce wastage of expensive hemostatic materials in the operating room. These differentiating features, along with the platform’s disruptive cost advantage, positions Medcura’s LifeGel to become a future standard of care for surgical bleeding management.
“Over the past decade, there have not been meaningful advancements in the safe control of surgical bleeding using flowable technologies which are routinely used in many high-volume and high-value procedures,” said Medcura’s Chief Medical Officer, neurosurgeon Dr. Ken Renkens. “With the experience we’ve gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control the wide range of challenging bleeding situations a surgeon often confronts.”
About the Company
Medcura, Inc. is a commercial-stage medical device company developing versatile hemostatic products serving large surgical, medical, and consumer market opportunities. The Company’s proprietary technology platform combines the use of safe, inert ingredients with patented chemistries, all aimed at introducing disruptively lower cost products capable of safely and effectively controlling bleeding across a broad spectrum of clinical applications. Learn more about Medcura’s growing product line at www.medcurainc.com.
Clinical Accelerator, a full-service, medical device focused contract research organization, is pleased to announce a partnership with Airiver Medical, to evaluate the safety and efficacy of Airiver’s pulmonary Drug-Coated Balloon in the FIM treatment of benign Central Airway Stenosis.
Central airway obstruction leads to a significant level of morbidity due to dyspnea and greatly reduced quality of life. Airiver’s DCB is hypothesised to improve patient outcome through the endoscopic treatment. Airiver’s balloon is coated with the Paclitaxel drug, similar to the Urotronic Optilume drug-coated balloon for urinary strictures which was recently approved by FDA.
Patients will be followed up for a year and we are very excited to take responsibility for the implementation and management of this study at our partner institution.
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.
Below, we are re-publishing with permission the press-release issued by Cardiovascular Systems Inc. on September 02, 2022
Cardiovascular Systems has an acquisition option agreement with the balloon’s developer, Chansu Vascular Technologies.
Cardiovascular Systems Inc. (CSI) has begun enrolling patients in its coronary everolimus drug-coated balloon study.
The first patient was treated by Dr. Iraki Gogorishvili, head of the Interventional Cardiology Department at the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi, Georgia. “The crossability and deliverability of the CVT DCB is excellent and I am very excited to participate in this research project evaluating this new class of DCBs,” Gogorishvili said.
The coronary DCB was used to treat in-stent restenosis (ISR) located in the left anterior descending artery. The balloon involved in this first-in-human trial was developed by Chansu Vascular Technologies LLC (CVT). CSI is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. Under an acquisition option agreement, CSI has exclusive rights to acquire CVT upon completion of certain technical and clinical milestones in the development program.
DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease, and are increasingly recognized for their potential in complex coronary artery disease, ISR, small vessels, and bifurcation lesions. Everolimus, the active drug in CVT’s DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.
“The CVT DCBs are designed to capitalize on the proven long-standing anti-restenotic benefits of everolimus for the treatment of patients with cardiovascular lesions. CVT intends to enroll 50 patients at up to 15 sites in France, Georgia, Lithuania, and Spain to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study,” said Ryan Egeland, M.D., Ph.D., CSI’s chief medical officer.
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, 18.2 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, significant arterial calcium is present in about 30 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).
Based in St. Paul, Minn., CSI develops and commercializes 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.
Chansu Vascular Technologies is located in Sunnyvale, Calif. CVT was founded by Philippe Marco, M.D., to develop peripheral and coronary DCBs using everolimus. Marco is a 25-year medical technology veteran who has spent his entire career focused on cardiovascular device development. He was president and chief operating officer (COO) of Epix Therapeutics (acquired by Medtronic), and president and COO at CV Ingenuity (acquired by Covidien), where he was responsible for the development of the Stellarex DCB. Marco started working on drug delivery cardiovascular devices while in charge of Medical Affairs for Abbott Vascular where, following the Perclose Inc. acquisition, he led the franchise expansion into a diversified portfolio from closure devices to drug-coated coronary stents, embolic protection devices, and peripheral catheters and stents.
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 myocardial infraction.
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.
Below, we are re-publishing with permission the press-release issued by Vascular Dynamics, Inc. on October 18, 2022
Vascular Dynamics, Inc. (VDI), a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that a study assessing its MobiusHD device to treat patients with chronic heart failure has been published in the peer-reviewed journal, Structural Heart.
The authors conclude that the MobiusHD device implantation in progressive heart failure patients, who had previously remained highly symptomatic despite guideline-directed medical therapy, was safe and resulted in clinically meaningful improvements in health status, functional exercise capacity, NT-proBNP levels, and left ventricular ejection fraction (LVEF) changes that emerged within three months after device implantation and were sustained through 12 months follow-up in the feasibility clinical trial.
“The clinical results of this feasibility study have shown impressive efficacy,” said JoAnn Lindenfeld, MD, a heart failure specialist at Vanderbilt University Medical Center, and one of the study’s co-authors. “That all patients underwent successful and uneventful device implantation and experienced positive changes in quality of life and exercise capacity is encouraging, and we look forward to learning more in the forthcoming pivotal study further examining this promising technology.”
The endovascular baroreflex amplification (EVBA) procedure enables placement of the MobiusHD implant in the targeted site within the carotid sinus. After identifying the preferred target location using pre-procedure imaging, the procedure is typically completed in less than 30 minutes.
The unique MobiusHD device mechanically stimulates the arterial baroreceptor reflex by changing the geometric shape of the carotid sinus to increase local arterial wall stretch while preserving pulsatility. The resulting amplified nerve signaling triggers decreasing sympathetic activity and increasing parasympathetic activity. This rebalancing of the autonomic nervous system is believed to improve symptoms and prevent progression of HFrEF. In this way, the MobiusHD offers a potential device-based solution for symptomatic heart failure patients who are not responding to drug treatment.
“The results from this published study further validate and add to the evidence supporting the potential value of the MobiusHD technology, as a potential game-changer for chronic heart failure sufferers who have not responded well to traditional treatments, despite being well-medicated” commented Ed Roschak, CEO of Vascular Dynamics. “We look forward to advancing our evaluations in this ongoing study including patients from Canada, Australia, and Germany. Also, a pivotal clinical trial is planned and will include a sham-controlled, randomized study protocol.”
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“MobiusHD” is a registered trademark of Vascular Dynamics, Inc.
CAUTION: In the United States, the MobiusHD® device is limited by law to investigational use only.
About Vascular Dynamics, Inc.
Vascular Dynamics develops innovative, endovascular platform technologies to offer compelling treatment options for patients at risk of life-threatening conditions underserved by conventional treatments. The company’s MobiusHD technology features the first endovascular device to use the body’s natural baroreflex mechanism to modulate the autonomic nervous system and help restore sympathetic balance. Clinical evaluations are in progress. More information is available at http://www.vasculardynamics.com.
Below, we are re-publishing with permission the press-release issued by Miracor Medical on August 23, 2022
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with TIMI flow 0, 1, and 2 within 12 hours of symptom onset. The primary efficacy endpoint of the study will be infarct size measured by cardiac magnetic resonance imaging (CMR) at 5 days. The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. Major adverse cardiac events and heart failure endpoints will be captured acutely and for up to 3 years.
PiCSO-AMI-II will be the second major randomized trial to evaluate the role of PiCSO in improving coronary microvascular function and reducing infarct size in patients presenting with anterior STEMI. Miracor is currently recruiting 144 patients in PiCSO-AMI-I, a landmark European randomized controlled trial, with comparable endpoints as the approved US trial. Recruitment in the European study is expected to end this summer. It is anticipated that a future patient-level pooled meta-analysis of the two studies will demonstrate a hard clinical endpoint improvement in heart failure hospitalization.
PiCSO is used as an adjunctive procedure after epicardial flow has been restored during the primary percutaneous coronary intervention (PCI) procedure. The unique mechanism of action, of intermittently occluding the coronary sinus outflow, redistributes venous blood-flow to the peri-infarct zone and enhances the coronary microcirculation viability by washing-out debris and other noxious agents of the infarct process. Early non-randomized European studies have suggested that this leads to reduced incidence of coronary microvascular obstruction (MVO) [3,4] and smaller infarct size, which are both strongly correlated to improvement in heart failure hospitalizations and reduced mortality following primary PCI [5]. Despite improvements in patient care pathways, widespread use of reperfusion strategies, and adjuvant pharmacological therapies, the one-year mortality rate after STEMI in high-risk patients has plateaued over the past decade at 14% [1]. Also, heart failure development after hospital discharge is very prevalent, being diagnosed in approximately 13% of patients at 30 days and 20–30% at 1 year after discharge [2].
“Reducing infarct size and MVO is a key factor in improving survival and reducing the risk of heart failure among patients with heart attack. PiCSO therapy is a promising new therapy to reduce infarct size and improve outcomes in anterior STEMI patients. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” said Prof. Gregg W. Stone, (Director of Academic Affairs for the Mount Sinai Heart Health System, New York, NY, USA) who will be study principal investigator, with Prof. Marco Valgimigli of Istituto Cardiocentro Ticino in Lugano, Switzerland, as the study co-principal investigator.
“In addition to the ICD-10-PCS code that was granted by the Centers for Medicare and Medicaid Services (CMS) in April 2022, the Investigational Device Exemption marks a key milestone in the company’s lifecycle and speaks to the positive evolution of the company. We look forward to conducting a meticulous study with our clinical investigators to bring PiCSO to American patients.” said Olivier Delporte, CEO. The company plans to raise funds later this year to execute this important study, support company operations and assess potential partnerships for Asia.
The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020. The development of Miracor’s PiCSO technology is supported by a reimbursable cash advance from the Walloon Region since August 2017.
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 was originally founded by a cardiac surgeon at the Medical University of Vienna, Austria, Professor emeritus Werner Mohl. Prof. Mohl has worked and published about coronary sinus occlusion and interventions for decades, and invented the PiCSO therapy concept. Miracor Medical has developed the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.
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NOTE: The PiCSO® Impulse System is limited to investigational use in the United States.
Szummer, K., et al., Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. European Heart Journal, 2017. 38(41): p. 3056-3065.
Jenča, D., et al., Heart failure after myocardial infarction: incidence and predictors. ESC Heart Failure, 2021. 8(1): p. 222-237
Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. IJC Heart & Vasculature, 2020. 28: p. 100526.
De Maria et al. 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.
Stone et al. 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.
Below, we are re-publishing with permission the press-release issued by Sequana Medical on November 15, 2022
15 November 2022, 07:00 am CET
Data from SAHARA with first-generation DSR product (DSR 1.0) confirm:
Safe, effective and rapid elimination of persistent congestion following intensive DSR therapy
Considerable benefit in cardio-renal status maintained till end of study (16 weeks post-intensive DSR therapy)
Dramatic and sustained improvement in diuretic response up to 15 months post intensive DSR therapy
No congestion-related heart failure re-hospitalizations during entire study
One class improvement of NYHA status and 75% reduction in predicted one-year mortality based on Seattle Heart Failure model
First patient dosed successfully in YUKON, Ph. 1 study of second-generation DSR product (DSR 2.0)
MOJAVE, US Ph. 1/2a randomized controlled multi-center study of DSR 2.0, on track to start in H1 2023
Company presentation with webcast at Jefferies Healthcare Conference on 17 November 2022
Ghent, Belgium – 15 November 2022– Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “SequanaMedical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces positive top-line results from SAHARA, the Phase 2a study using its first-generation DSR (Direct Sodium Removal) product (DSR 1.0). Data from ten[i] evaluable diuretic-resistant heart failure patients with persistent congestion who have completed the 16-week follow-up period after intensive DSR therapy confirm the previously reported strong interim data[ii] showing important and long-lasting clinical benefits.
To evaluate the safety, tolerability and efficacy of the Company’s second-generation DSR product (DSR 2.0), a single-arm, open-label, Phase 1 study has been initiated in Canada (YUKON) with up to 10 patients on peritoneal dialysis receiving a single treatment of DSR 2.0. The first patient has been dosed successfully and the results of this study will be used to determine dosing of DSR 2.0 in MOJAVE. Data from YUKON, together with CHIHUAHUA, a further Phase 1 study in Mexico intended to support the US IND[iii] filing of DSR 2.0, planned for Q1 2023. These replace the previously planned SAHARA extension study with DSR 2.0. Approval of the US IND will enable the Company to start MOJAVE, its randomized controlled multi-center Phase 1/2a US study of DSR 2.0, planned for H1 2023.
Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor to Sequana Medical, commented: “Congestion is a key driver of heart failure and remains the leading cause of morbidity and hospitalization in this large and growing patient population. Diuretic-resistance is widespread and the usual therapeutic approach is just adding more diuretics, further worsening the underlying issues. There are no therapies that seek to correct the cardio-renal pathophysiology causing the diuretic-resistance. The SAHARA results are highly encouraging and indicate the potential for DSR therapy to deliver clinically meaningful decongestion and durable improvements in cardio-renal function and thus diuretic response.”
Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, added: “These results are very positive and reinforce our view that DSR is a potential disease-modifying heart failure therapy. We are excited to have the first patient dosed with DSR 2.0 and we are confident that this second-generation product will deliver important therapeutic and safety benefits. I would like to thank the investigators, patients and care personnel involved in both SAHARA and YUKON, and we look forward to commencing MOJAVE, the first randomized controlled multi-center study in the US using DSR 2.0.”
SAHARA top-line results
At baseline, all teni evaluable patients with persistent congestion due to heart failure were on high dose loop diuretics (mean furosemide equivalent dose of 360 mg/day) and had an overall high disease severity, including a mean left ventricular ejection fraction of 23% and mean NT-proBNP of 6,628 pg/mL. At the start of the study treatment period, loop diuretics were withheld, and patients underwent intensive DSR therapy with DSR 1.0 for two weeks (phase 1) which was repeated up to two times depending on patients’ euvolemic state (i.e., normal amount of body fluids), diuretic response and stable DSR dosing at the end of phase 1. Patients who achieved euvolemia and had adequate diuretic response entered the maintenance DSR treatment phase with monthly DSR dosing for 16 weeks (phase 2).
All ten evaluable patients safely, effectively and rapidly eliminated the persistent congestion and achieved euvolemia within one week of commencing intensive DSR therapy, resulting in a mean weight loss of 7kg at the end of phase 1. During the intensive DSR period (phase 1), the diuretic response of the kidney was near-normalised, with mean six-hour excretion of sodium increasing more than 160% vs. baseline, as well as a considerable improvement in cardio-renal health, with a mean reduction in NT-proBNP[iv] of 38% vs. baseline and a mean improvement in eGFR[v] of 7% vs. baseline despite the dramatic fluid loss.
The improvement in cardio-renal health was broadly maintained at the end of phase 2 (16 weeks post intensive DSR period) demonstrated by a mean 33% reduction in NT-proBNP and a stable eGFR.
The need for loop diuretics was dramatically reduced for many months following completion of the intensive DSR therapy (see table below), which the Company believes is a demonstration of the durable improvement in cardio-renal health.
Evaluable patient
No. of months post intensive DSR period
Reduction in diuretic dose vs. baseline
01-01
15
90%
01-03
13
100%
01-04
12
90%
01-05
12
100%
01-06
10
100%
01-08
10
90%
01-09
9
67%
01-10
9
95%
01-11
6
93%
01-12
6
100%
No clinically relevant changes in serum sodium levels or progressive hyponatremia were observed in any of the evaluable patients. There were three serious adverse events in three of the evaluable patients, including two having a blocked peritoneal catheter (both during phase 2) and one with stable angina (started post phase 2, ongoing). The Data Monitoring Committee assessed both peritoneal catheter blockages as definitely related to the study device but unrelated to the implant procedure or study treatment, and the stable agina as unrelated to the study device, implant procedure, or treatment.
All evaluable patients treated with DSR therapy in the RED DESERT and SAHARA clinical studies experienced no congestion-related heart failure hospital re-admissions during the entire study period and all patients improved their NYHA[vi] status by at least one class. The clinical benefits observed in RED DESERT and SAHARA resulted in a 75% reduction in predicted one-year mortality of patients pre- vs. post-intensive DSR therapy based on the Seattle Heart Failure Model[vii].
On track to start MOJAVE with DSR 2.0 in H1 2023
The Company is progressing development of its proprietary DSR 2.0 product, a sodium-free dextrose / icodextrin solution expected to have an improved therapeutic and favourable safety profile and with a robust intellectual property protection. Data from two interventional, single-centre, single-arm studies, one in Canada (YUKON) and one in Mexico (CHIHUAHUA) will evaluate the safety, tolerability and efficacy of DSR 2.0. Both studies will enroll up to ten stable peritoneal dialysis patients who will receive a single treatment of DSR 2.0, administered through their peritoneal dialysis catheter. The first patient has been treated successfully in YUKON and data from both studies intended to support the filing of the US IND, planned for Q1 2023. The choice of peritoneal dialysis patients is driven by their pre-existing peritoneal dialysis catheter.
Following initial discussions with the FDA, MOJAVE, a randomized controlled Phase 1/2a US study of DSR 2.0, is on track to start in H1 2023 assuming FDA approval of the US IND. The intention is to enrol 30 diuretic-resistant chronic heart failure patients with persistent congestion, with 20 patients randomised to DSR 2.0 administered via a peritoneal catheter on top of usual care for congestive heart failure (CHF) for up to four weeks and ten patients randomised to usual care for CHF alone. Following four weeks of DSR therapy there will be a three-month safety follow-up period. Prior to enrolment of these 30 patients, three additional patients will be enrolled in a non-randomized safety cohort and will receive DSR 2.0 administered via a peritoneal catheter on top of usual care for CHF for up to four weeks. Progression to the enrolment of the 30 randomized patients will be dependent upon DSMB[viii] approval following their review of the initial three patients. More details on the final study design will be announced following FDA approval of the US IND. Interim data of MOJAVE are planned for H2 2023 and top-line results are expected in mid 2024.
About fluid overload in heart failure (AKA congestion)
Heart failure is the leading cause of US hospitalizations in patients over 65 years old and 90% of these admissions are due to fluid overload, which is recognized as the primary driver of morbidity and hospitalization. Standard of care includes treatment with diuretic drugs, but these have well recognized toxicity and resistance issues. Half of the heart failure patients admitted for fluid overload are discharged with no clinically relevant loss of fluid and one in four is re-admitted to the hospital within 30 days of discharge. It is estimated that 200,000 US heart failure patients have drug-resistant congestion requiring repeated hospitalization, severely impacting their survival and quality of life and creating a heavy financial burden.
About DSR® (Direct Sodium Removal) in heart failure
Sequana Medical considers its proprietary DSR to be a disease modifying therapy for heart failure. Fluid accumulation in heart failure patients is caused by the retention of too much sodium. The DSR drug-based approach directly tackles this key clinical problem of sodium overload, and works in partnership with the kidneys to safely and rapidly eliminate the excess fluid. Complementary to existing heart failure therapies, clinical proof-of-concept studies using the Company’s first-generation DSR product (DSR 1.0) have shown that DSR can i) safely, effectively and rapidly eliminate fluid overload in heart failure patients, ii) improve the health of the heart and preserve renal function, and iii) restore the ability of the kidney to manage the fluid and sodium naturally, resulting in a large and long-lasting reduction in the need for diuretic drugs. In DSR treated patients, there have been no congestion-related re-hospitalizations during the study follow-up period, all patients improved their NYHA status by at least one class and the clinical benefits observed in the clinical studies resulted in a 75% reduction in predicted one-year mortality of patients pre- vs. post-intensive DSR therapy based on the Seattle Heart Failure Model. The Company is currently preparing an IND application for its second-generation DSR product (DSR 2.0) in the US and plans to begin a US randomized controlled Phase 1/2a clinical trial in H1 2023. Composition of matter and method patents have been granted for DSR therapy in the US and Europe.
About Sequana Medical
Sequana Medical NV is a pioneer in treating drug-resistant fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. Fluid overload is a well-recognized problem in these growing diseases, causing severe problems for the large number of patients for whom current medicines are no longer effective. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life.
alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to remove this excess fluid, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The Company has reported positive primary endpoint data from the North American pivotal POSEIDON study of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the Company is planning to commence MOJAVE, a US multi-centered randomized controlled Phase 1/2a clinical study of DSR 2.0, in H1 2023.
Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. DSR therapy is currently not approved for clinical research in the United States or Canada. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.
Note:alfapump® is a registered trademark. DSR® is a registered trademark in the Benelux, China, the EU, United Kingdom, and Hong Kong.
Forward-looking statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.
[i] In total, 12 patients were dosed in SAHARA but one patient died due to a cardiac arrest three days after study initiation and for one patient the study protocol was not correctly applied.
[ii] Interim data reported in Press release of 19 July 2022
[iv] NT-proBNP: N-terminal pro B-type natriuretic peptide, a key cardiac function parameter
[v] eGFR: estimated Glomerular Filtration Rate, a measure of kidney function
[vi] NYHA: New York Heart Association classification, data collected outside study protocols of RED DESERT and SAHARA
[vii] Predicted one-year survival analysis using Seattle Heart Failure Model of seven patients from RED DESERT and ten patients from SAHARA pre- and post-intensive DSR therapy. Analysis includes physician-assessed data collected post hoc.
Successful Spatial Resynchronization™ Therapy (SRT) conversion of AFib to normal rhythm
Below, we are re-publishing with permission the press-release issued by Maxwell Biomedical on October 20, 2022
Spatial Resynchronization Therapy (SR™T) demonstrates proof-of-concept in repeatedly terminating atrial fibrillation (AFib) and restoring sinus rhythm
SAN DIEGO, CALIFORNIA, UNITED STATES, October 20, 2022 /EINPresswire.com/ — Maxwell Biomedical announced today that it has successfully completed enrollment in its First-in-Human Clinical Trial “Initial Experience with Spatial Resynchronization Therapy in Patients with Atrial Fibrillation (NCT 05461612)” being conducted at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. SRT is a device-based approach that features a proprietary algorithm for diagnosing and treating AFib. The graphic is one of several successful conversions of AFib to normal rhythm demonstrated during the recent study.
The idea of imperceptible stimulation to gain control of the arrhythmia and restore sinus rhythm in AFib patients is not new. The methodology, timing, and location of stimulus delivery represent the unique aspects of the Maxwell System. Once AFib is detected, instead of delivering pacing to a single site, SRT determines where to deliver stimuli across a spatially distributed network of electrodes placed on the epicardial surface of the left atrium. Pacing stimuli are precisely timed to be delivered within the excitable gap, allowing the system to capture and control the atrial tissue and restore the normal rhythm.
“We are extremely encouraged by the results from this most recent study,” stated Randy Werneth, CEO of Maxwell Biomedical, “These latest results will further advance our System and SRT algorithm bringing us closer to delivering a device-based treatment for patients with all types of AFib.”
Atrial Fibrillation
Atrial fibrillation is the most common heart arrhythmia affecting over 33 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 AFib increases the likelihood of blood clot formation and reduces the amount of blood available to pump to the body. AFib increases stroke risk five times2 increases mortality rates two-fold in heart failure patients3 and costs the United States healthcare system $26B annually1. Current AFib treatment options include outpatient cardioversion, rate or rhythm control medications, and catheter ablation. SRT would offer patients a non-destructive, minimally invasive option to treat their AFib.
About Maxwell Biomedical
We are a 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 a first-of-its-kind atrial pacing device that automatically detects AFib and imperceptibly delivers SRT to restore and maintain a normal heart rhythm. Device monitoring and cloud connectivity ensure active and continuous patient care and management. Founded in 2019, Maxwell Biomedical is based in San Diego, CA. www.maxwellbiomed.com
Sources Maxwell Biomedical 1. Chugh SS et al. Worldwide epidemiology of atrial fibrillation. A global burden of disease study 2010. Circulation;129:2014. 2. Virani SS et al. Heart disease and stroke statistics – 2021 update: a report from the American Heart Association. Circulation;143:2021. 3. Chamberlain AM et al. Atrial Fibrillation and Mortality in Heart Failure. Circ: Heart Failure;4(6):2011.
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