Positive Preliminary Clinical Trial Results Reported for Vascular Dynamics’ Novel Heart Failure Treatment Technology

Endovascular baroreflex modulation data presented


Feb 9, 2021

IRVINE, CALIF – (February 9, 2021) – Vascular Dynamics, Inc., a privately held medical device company focused on innovative, endovascular device-based solutions for cardiovascular conditions, has announced positive preliminary results from its clinical trial, “A Feasibility Study Exploring the Effect of the MobiusHD® Device in Patients with Heart Failure.”

Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, Germany and Tamaz Shaburishvili, MD, Head of the Cardiovascular Clinic at Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia shared preliminary results of the clinical trial as part of a CSI Focus D-HF webinar presented last week.

Baroreceptors are specialized nerve endings that respond to stretch and are located along the carotid arteries in the neck. These stretch receptors are essential to the body’s natural control of the cardiovascular system and its performance. The MobiusHD device is a carotid endovascular implant designed to amplify this natural baroreflex mechanism, signaling the brain to produce autonomic modulation for improved heart function.

EndoVascular Baroreflex Amplification (EVBA) is the procedure used to implant the MobiusHD device. EVBA has been previously evaluated successfully in the treatment of 89 hypertension patients. EVBA using the MobiusHD device is now being investigated as a treatment to help patients suffering with heart failure.

Prof. Sievert reported that 19 heart failure patients with reduced ejection fraction (HFrEF) were safely and successfully treated using the EVBA procedure with the MobiusHD device. Preliminary data from the three-month follow up were presented for the first 13 of these patients. Every patient demonstrated clinical improvement. Statistically significant changes in averages of Kansas City Cardiomyopathy Questionnaire scores, six-minute hallway walk distances, NT-proBNP levels, and left ventricular ejection fractions were reported.

“We are very excited about such positive initial results,” said Sievert. “The procedure is straightforward, using conventional carotid access techniques, and is very safe. The early results are impressive and point to a potential solution for appropriate heart failure patients. Further evaluation is recommended.”

“Preliminary results from this feasibility study in heart failure patients are very promising,” commented Ed Roschak, CEO of Vascular Dynamics. “We look forward to expanding these efforts to multiple clinical centers around the world. We will report additional results as they become available.”

About Vascular Dynamics, Inc.
Vascular Dynamics develops innovative, endovascular platform technologies to offer compelling treatment options for patients at risk of life-threatening conditions and 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 of this unique baroreflex modulation therapy for heart failure and high-risk hypertensive patients are in progress. More information is available at http://www.vasculardynamics.com.

CAUTION: In the United States, the MobiusHD® device is limited by law to investigational use only.

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Clinical Accelerator collaborates with Metavention on a study of a novel medical device for hypertension

Clinical Accelerator collaborates with Metavention on a study of a novel medical device for hypertension

Clinical Accelerator and Metavention have recently entered into a collaboration allowing Clinical Accelerator to join the program of feasibility studies already under way in the United States, New Zealand and Australia. Our organization will participate in the renal denervation trial of Metavention’s novel device to evaluate safety and effectiveness in patients with hypertension. With Clinical Accelerator’s strong focus on advancing cardiovascular medical devices, this is a very exciting project for our team to participate in and attain quality data for.

Metavention has developed a unique Integrated Radio Frequency (iRF) Denervation System, which is currently under investigation for renal, hepatic and multi-organ denervation – a novel intravascular procedure.  Designed to be a one time, minimally invasive procedure, the device uses radio frequency energy to disrupt over active sympathetic nerves. The use of this advanced technology in conditions like hypertension and type 2 diabetes is hypothesized to reduce blood pressure, improve blood sugar control and improve other metabolic disease such as non-alcoholic fatty liver disease (NAFLD).

About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization has a strong emphasis on cardiovascular indications and performs clinical investigations of novel cardiac devices. 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 Metavention

Metavention, Inc. is a privately-held medical device company headquartered in Minneapolis, Minnesota and the developer of the iRF Denervation System, a novel technology designed to disrupt the sympathetic nerves that contribute to type 2 diabetes, high blood pressure, and other metabolic diseases.

CAUTION: The iRF Denervation System is not approved for sale in any region and is limited by Federal (US) Law to investigational use only.

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Clinical Accelerator receives ISO 9001:2015 quality certification

Clinical Accelerator has reached a new milestone by being awarded the ISO 9001:2015 certification.

The 2015 edition of ISO 9001, created by the International Organization Standardization (ISO), provides the latest standards that must be followed in order to demonstrate the quality of products and services that are offered. Being ISO certified, customers can have the utmost confidence and trust that the Clinical Accelerator team will take a pro-active, professional and structured approach to the organization and management of our clinical trials. 

Established in 2006, the company offers a large range of services to support all stages and phases of clinical trials with pharmaceutical products and medical devices. Such services include but are not limited to: clinical trial design and protocol development; study feasibility and site selection; clinical trial authorizations (IRB/EC and CA); project and site management, site monitoring; data management; biostatistics; safety monitoring; study logistics; medical writing; quality assurance and other regulatory affairs. This certification is just one demonstration of how Clinical Accelerator has developed into a respected and competitive member of the CRO industry. For more information on how we could help assist your clinical trial, please see our website: clinicalaccelerator.com, and get in touch!

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Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Innovative technology offers an implant-free approach for individuals with chronic heart failure

January 25, 2021 10:16 AM Eastern Standard Time

AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline directed medical therapy.

“Chronic heart failure affects more than 26 million patients globally and HFpEF patients in particular have limited treatment options”

The Breakthrough Device Program creates a pathway for patients to have more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval. The Centers for Medicare and Medicaid Services (CMS) recently finalized a new coverage pathway for Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT). The MCIT coverage policy facilitates patient access to Breakthrough Devices by providing up to 4 years of Medicare coverage beginning on the date that FDA clears or approves a Breakthrough Device.

“Chronic heart failure affects more than 26 million patients globally and HFpEF patients in particular have limited treatment options,” said Adam L. Berman, CEO of Alleviant Medical. “By utilizing a no-implant interatrial shunt approach, the Alleviant Medical technology offers the option for a simple, minimally-invasive procedure for heart failure patients. We appreciate the rigorous review by the FDA and their designation of our technology as a Breakthrough Device. We look forward to the ongoing constructive collaboration as we continue to develop clinical evidence.”

Chief Medical Officer and co-Founder Jacob Kriegel, MD commented, “Current pharmaceutical options for treating HFpEF/HFmrEF are limited, and patients stand to benefit from additional innovative device therapies. Our technology enables the creation of a therapeutic interatrial shunt, intended to offload elevated left atrial pressure in properly indicated HFpEF/HFmrEF patients, without the need for a permanent cardiac implant. We are currently developing robust clinical evidence through investigational use of this novel therapy and look forward to reporting outcomes from our initial patient series later this year.”

About Alleviant Medical:

Alleviant Medical is a privately held medical device company that is dedicated to developing novel therapies for patients suffering from heart failure. The company has developed a transcatheter technology intended to decompress the left atrium without a permanent cardiac implant or open-heart surgery. The procedure is designed to be performed under fluoroscopy (x-ray) and ultrasound guidance using a minimally-invasive approach and leverages standard interventional cardiology techniques. The company’s mission is to alleviate the significant clinical and economic burden of heart failure and to improve the lives of millions of patients suffering from this debilitating disease. Alleviant Medical’s investment partners include Vensana Capital, Broadview and Longview Ventures, TMC Venture Fund, S3 Ventures and an undisclosed strategic investor.

The Alleviant Medical technology is under investigational use only and not available for commercial distribution in the United States or any other market.

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Replicor publishes its REP 301-LTF study achieving durable functional cure of HDV and HBV, inactivation of cccDNA and elimination of integrated HBV DNA

Replicor publishes its REP 301-LTF study achieving durable functional cure of HDV and HBV, inactivation of cccDNA and elimination of integrated HBV DNA

Below, we are re-publishing with permission the press-release issued by Replicor Inc. on November 16, 2020

MONTREAL, November 16th, 2020 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the final results of the long term follow-up of its REP 301 study (REP 301-LTF study) in Hepatology Communications.

The article, entitled “Persistent control of HBV and HDV infection following REP 2139-Ca and pegIFN therapy in chronic HBV/HDV co-infection”, presents the analysis of 3.5 years of follow-up on the safety and efficacy of a suboptimal regimen of REP 2139 and pegIFN in chronic HBV / HDV co-infection and can be accessed here.

Included for the first time in this publication is analysis of experimental markers of HBV infection from an ongoing collaboration with Abbott Diagnostics, demonstrating that HBsAg reduction to < 0.005 IU/mL during therapy does not appear driven by antibody mediated clearance.  Importantly, the persistence of undetectable HDV RNA, normal liver function with improving fibrosis status continues for 3.5 years after removal of all therapy.  Many of these patients also maintain functional cure of HBV with no detectable HBV pgRNA and HBcrAg < LLOQ.  Importantly, in participants with functional cure of HBV, HBsAg was maintained < 0.005 IU/mL in the absence of antibody mediated HBsAg clearance, indicating the loss of HBsAg producing capacity in the liver and removal of integrated HBV DNA.  

Dr. Andrew Vaillant, CSO of Replicor commented, “Our clinical experience with NAPs highlights their unique ability to achieve long term durable control of both HDV and HBV infection, restoration of normal liver function and progressive reversal of liver inflammation and fibrosis.  We are very excited by the new experimental marker data indicating the efficient inactivation of cccDNA and removal of integrated HBV DNA, the latter likely signaled by the strong host mediated transaminase flares observed during and common with profound HBsAg reduction unique to NAP therapy.  These new observations suggest that very long-term control of both HBV and HDV infection are achieved with NAP-based therapy.  We look forward to evaluating the optimized NAP-based combination therapy used in the REP 401 study in co-infected subjects, which promises much higher rates of functional cure of HDV and HBV’’.

About Replicor Replicor is a privately held biopharmaceutical company with the most advanced animal and human clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV co-infection. For further information about Replicor please visit our website at www.replicor.com.

* The study is conducted by Clinical Accelerator

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Clinical Accelerator announces collaboration with Noxopharm to advance idronoxil (NOX66), a novel treatment for COVID-19

Clinical Accelerator is pleased to announce a new collaboration with Noxopharm, a leading Australian drug development company. Noxopharm’s NOX66 therapy has received trial approval and is now in a Phase Ib, open-label trial by Clinical Accelerator in Eastern Europe. The trial will evaluate the safety, tolerability and preliminary efficacy of NOX66 over a 4.5-fold dose-range in COVID-19 patients. We aim to establish the recommended Phase 2 dosage and also collect information on NOX66’s effect on several variables related to COVID-19 infection. For the study, the therapy is being given to hospitalized patients with moderate systemic illness due to COVID-19 infection at a high risk of developing severe sepsis/septic shock.

Idronoxil, the active ingredient in NOX66/Veyonda, is a multiple signal transduction regulator and immunomodulator via cancer specific inhibition of sphingosine1-phosphate and suppression of stimulator of interferon genes (STING)-mediated inflammatory cytokine pathways. In non-clinical studies, it has been shown that idronoxil can suppress a broad range of cytokines due to its capacity to strongly inhibit STING signalling, a cellular pathway associated with the onset of ‘cytokine storms’. Since COVID-19 patients can develop a ‘cytokine storm’ which may result in multiple organ failure and potentially death, is hypothesized that NOX66 can reduce this risk.

Another benefit of NOX66 is its potential to reduce  blood clotting events in COVID-19 patients, a condition that is being increasingly reported in some critically ill patients. This benefit is based on recent evidence which suggests that STING activation in immune cells may trigger aberrant blood coagulation.

Although many COVID-19 patients do not progress to severe disease, the frequency of severe disease in hospitalised patients in areas with significant community transmission can be as high as 30%. This highlights the urgent need for an effective therapy against this novel coronavirus-induced disease. We are hopeful that this trial can contribute to the discovery of a beneficial treatment for COVID-19 patients.

About Noxopharm

Noxopharm is an Australian clinical stage drug development company with a focus on developing a treatment for COVID-19 and also cancer. The company is run by a strong team of experts in the field including: CEO Graham Kelly; CMO Dr Gisela Mautner; COO Jeanette Bell; CFO Shawn Van Boheemen; CSO Dr John Wilkinson and Director of Drug Discovery and Research Olivier Laczka.

For more information, please see https://www.noxopharm.com/site/content/

About Clinical Accelerator

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe, Russia, Ukraine and CIS countries. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological, nutraceutical 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 Results From First-In-Human Clinical Study in Late-Breaking Clinical Trial Session At 2020 Virtual HFSA Conference

Below, we are re-publishing with permission the press-release issued by Axon Therapies, Inc. on October 09, 2020

Satera™ Ablation System demonstrates success as a frontline treatment of heart failure

Interim results from Axon Therapies’ First-in-Human Trial of the Satera Ablation System (11 HFpEF patients at 1- and 3-month follow-up)

NEW YORK, Oct. 9, 2020 /PRNewswire/ — Axon Therapies, a Coridea portfolio company focused on addressing one of the root causes of heart failure, today announced positive interim results from their first-in-human (FIH) trial of splanchnic ablation for volume management, or SAVM, using the Satera™ Ablation System.  Dr. Sanjiv Shah, Director of the HFpEF program at Northwestern University Feinberg School of Medicine in Chicago, IL presented the results during the Late Breaking Clinical Trial session at the annual Heart Failure Society of America (HFSA) meeting.

“As physicians, we are often limited in our ability to adequately decongest heart failure patients and prevent excessive increases in pressure during exertion. Although research has shown that inappropriate volume redistribution is a major contributor to functional limitations and outcomes, no interventions targeting this mechanism have existed until now,” stated cardiologist Dr. Sanjiv Shah.  “I’m very excited about the positive first-in-human results from Axon’s innovative ablation technology. The SAVM procedure selectively blocks the neural pathway carrying signals from the chronically active sympathetic system to the splanchnic vascular bed, causing selective venodilation, improved venous compliance, and ultimately restoring appropriate volume balance within the circulation.”

A total of 11 heart failure patients with preserved ejection fraction (HFpEF) were successfully treated using Axon’s Satera™ Ablation System. Interim data was presented on 1- and 3-month follow-up post-procedure. Endpoints included a composite safety index, New York Heart Association (NYHA) Heart Failure classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and 6-minute walk test.

Study highlights include:

  • Achieved procedural success in all 11 patients with no device or procedural-related serious adverse events (SAEs)
  • Significant improvement in NYHA classification (p<0.05) at both 1-month and 3-month follow-up
  • Significant improvement in KCCQ score (p<0.05) at both 1-month (43 vs. 64) and 3-month (43 vs. 79) follow-up
  • Significant improvement in 6-minute walk test (p<0.05) at both 1-month (293 vs. 342 meters) and 3-month (293 vs. 347 meters) follow-up
  • Significant reduction in NT-proBNP (p<0.05) at 3-month (1,292 vs. 627 pg/mL) follow-up

Building on the FIH results, Axon is initiating REBALANCE-HF, a prospective, randomized, sham controlled, double-blinded feasibility IDE trial in early 2021. The study will enroll 80 patients at up to 20 sites to assess the safety and efficacy of SAVM using the Satera Ablation System in HFpEF patients. Learn more at www.axontherapies.com.

“The SAVM procedure is a frontline heart failure therapy that restores volume balance, stops disease progression and improves outcomes in heart failure patients,” commented Howard Levin MD, CEO of Axon Therapies. “In addition, the outpatient, transvenous procedure is implant-free, which preserves future options for the patient. We are initially focusing on the underserved HFpEF patient population, but believe SAVM, with the Satera Ablation System, may have applications for all heart failure patients in the future.” 

About Axon Therapies, Inc.
Axon Therapies, a portfolio company of proven medtech incubator Coridea, is focused on solutions to address one of the root causes of heart failure. Developed from a known surgical procedure, splanchnic ablation for volume management (SAVM) using the Satera™ Ablation System enables selective and sustained venodilation of the splanchnic bed. During the procedure the right greater splanchnic nerve is ablated and signals to the chronically hyperactive sympathetic nervous system (SNS) are disrupted. This allows the body to restore normal volume balance, stop disease progression and improve symptoms in heart failure patients. Learn more at axontherapies.com.

*The study is conducted by Clinical Accelerator

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Sequana Medical announces strong interim results from RED DESERT alfapump® DSR study and provides business update

Below, we are re-publishing with permission the press-release issued by Sequana Medical on October 22, 2020

RED DESERT:
 Results from first five patients indicate repeated dose alfa
pump DSR therapy to be safe and effective
 Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels
 No patients required loop diuretic therapy during the six-week alfa
pump DSR treatment period
 Following alfa
pump DSR treatment, loop diuretic responsiveness was restored to near normal levels; effect was durable for months post-treatment with majority of patients requiring little or no diuretic therapy
 Full RED DESERT data on track to report in H1 2021; first feasibility study (SAHARA DESERT) planned to start in H1 2021

BUSINESS UPDATE:
 Early interim data from POSEIDON study in recurrent and refractory liver ascites expected in Q4 2020
 European commercial supply of the alfa
pump temporarily interrupted in Q4 2020; no impact on POSEIDON and RED DESERT studies

Ghent, BELGIUM – 22 October 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from the first five patients enrolled in the RED DESERT study, evaluating repeated dose treatment of alfapump DSR (Direct Sodium Removal) in diuretic-resistant heart failure patients. Sequana Medical also provides a business update.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are hugely excited by these results from the first five RED DESERT patients and believe it is the first time ever that fluid balance in heart failure patients has been managed using repeated dose DSR therapy without the need for diuretics. These data support the underlying principle of DSR that after we remove sodium, the body will step in to quickly and accurately remove the free water necessary to restore the serum sodium concentration. Not only does these data suggest that by using alfapump DSR, we can manage the fluid and sodium balance of these patients, but also the restoration of diuretic response opens up further potential opportunities such as renal failure and haemodialysis. Following the allowance of our key patents in both the U.S. and Europe, we are confident that we will continue to lead the way in the use of alfapump DSR for the management of volume overload in a range of indications.”

Five heart failure patients (mean left ventricle ejection fraction in mid-20%’s and mean NT-proBNP of 2,500 – 3,000 pg/mL) on high dose diuretics (average furosemide equivalent dose of 150 – 200mg per day) underwent up to six weeks of alfapump DSR treatment. The alfapump DSR implant procedure and repeated dosing of DSR therapy were well tolerated in all patients with few adverse events.

There were no clinically significant changes in serum sodium levels or progressive hyponatremia (low concentration of sodium in the blood) in these patients after repeated DSR dosing. The results also show that during the course of the six-week therapy, no loop diuretics were required, demonstrating the ability of the alfapump DSR system to effectively remove sodium and fluid from these patients. Moreover, in the majority of patients, reduced doses of DSR therapy could be utilised and / or some DSR doses could be omitted while maintaining stable to lower weight and natriuretic peptides compared to baseline.

Restoration of diuretic response is an exploratory endpoint of RED DESERT, which is determined by the six-hour excretion of fluid and sodium following intravenous administration of 40mg of furosemide, evaluated serially throughout the study. All patients had an objectively poor diuretic response at baseline. After the six-week study, the diuretic response was restored to near normal levels with the six-hour sodium excretion more than doubled versus baseline. Furthermore, there was a significant durability to the improvement in diuretic responsiveness; in the majority of patients there was a dramatic reduction in loop diuretic requirements lasting months following the completion of alfapump DSR therapy.

“Diuretic-resistance is a nearly ubiquitous problem in heart failure patients resulting in untreated volume overload and high rates of hospitalisation. The results from these first five patients in the RED DESERT study are very promising and point to the potential use of the alfapump DSR in this difficult to treat patient population that has a clear unmet need,” said Dr. Jozef Bartunek, Interventional Cardiologist at Onze-Lieve-Vrouw Hospital in Aalst (Belgium) and Principal Investigator of the RED DESERT study.

“The durable improvement in diuretic responsiveness is particularly interesting. With additional confirmation of these encouraging results through continued study, I believe alfapump DSR has the potential to become a new therapy for the management of volume overload and diuretic resistance,” added Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical.

The RED DESERT study will enrol up to five additional patients, with top-line data expected in H1 2021.

Following the highly encouraging impact on diuretic responsiveness shown by the RED DESERT interim data, Sequana Medical plans to evaluate the dosing and frequency of alfapump DSR therapy in decompensated heart failure patients with residual congestion in a first feasibility study (SAHARA DESERT), expected to start in H1 2021. Based on the results of SAHARA DESERT, and other studies, Sequana Medical intends to commence a U.S. feasibility study in mid-2022 using a next generation proprietary DSR infusate comparing alfapump DSR therapy to standard of care.

Early interim data from POSEIDON study expected in Q4 2020

Since data on the first 13 roll-in patients will soon be available, Sequana Medical will provide an update with early interim data for POSEIDON later this quarter. Interim data of the full roll-in cohort are expected in H1 2021 and primary endpoint read-out of the study cohort is expected in Q1 2022.

Update on alfapump manufacturing

As a result of problems with supply of a sub-component of the alfapump, Sequana Medical prioritised the supply of alfapump systems for the clinical studies and as such encounters a temporarily delay in the supply of the alfapump to commercial markets in Europe during Q4 2020. This is only temporarily impacting European commercial availability and the alfapump continues to be available for the POSEIDON and RED DESERT clinical studies. There is no impact on the quality of the alfapump system that has been supplied to the market and there is no regulatory impact. Normal supply is expected to return for Q1 2021.

About RED DESERT – Repeated dose alfapump DSR study for treatment of diuretic-resistant heart failure patients
This study is a multi-centre, prospective, single-arm, first-in-human study to evaluate the safety and feasibility of alfapump DSR. Up to 10 patients diagnosed with stable chronic heart failure on high dose oral diuretics are implanted with the alfapump DSR system (alfapump and implanted surgical port) across two centres in Belgium (Dr Bartunek at Cardiovascular Center Aalst) and Georgia (Dr Shaburishvili at Heart and Vascular Clinic Tbilisi). Following alfapump DSR system implantation, patients undergo a diuretic challenge with timed biospecimen collection. On day 14 post-implant (day 0), the patient is admitted for a 14-day in-patient period in which diuretics are withheld and patients are put on a strict low-sodium diet. During the first 14 days, patients are treated with DSR D10% infusate on Monday, Wednesday and Friday, administered through the implanted surgical port into the peritoneal cavity. The DSR infusate remains in the peritoneal cavity for a two-hour dwell time, after which all fluid is eliminated from the peritoneal cavity through the bladder using the alfapump system. Following the 14-day in-patient period, patients undergo a second diuretic challenge. Thereafter, diuretics continue to be withheld and patients come into the clinic for their DSR therapy over the subsequent four weeks. After completion of the study period, patients undergo a third diuretic challenge to quantify their response to diuretics.

The primary safety endpoints include absence of device, procedure and/or therapy related serious adverse events through day 14 and the rate of device, procedure and/or therapy related serious adverse event through day 42. Secondary feasibility endpoints include the ability of alfapump DSR to maintain a neutral sodium balance in the absence of diuretic therapy and the sustained effect of DSR to maintain euvolemia through week 6. Additional exploratory endpoints evaluate the potential impact of DSR to restore response to diuretics following DSR therapy. For more information about the study, please visit clinicaltrials.gov (NCT04116034).

About alfapump DSR (Direct Sodium Removal)
alfapump DSR is in clinical development as potential chronic therapy for patients with volume overload due to heart failure. Volume overload in heart failure is a major clinical problem and is the leading cause of hospitalisations for patients with heart failure. There are approximately one million hospitalisations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The treatment options are severely limited in those patients for whom diuretic therapy is no longer effective. This limitation is evident from the 24% hospital re-admission rate at 30 days from discharge. The estimated cost of heart failure-related hospitalisations in the U.S. alone is $13 billion per year.

DSR therapy is a breakthrough approach that involves removing sodium from the body using diffusion via the peritoneal cavity with the use of a sodium-free solution known as DSR infusate. Once the sodium has been removed, the body eliminates excess fluid naturally through urination. Studies have demonstrated that DSR therapy is capable of removing large quantities of sodium and fluid in a safe, tolerable and consistent manner and results were published in the high impact cardiovascular journal, Circulation.

About Sequana Medical
Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is currently underway, and is intended to support a commercial marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 800 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study (RED DESERT) in heart failure patients is currently underway.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers
The alfapump® system is not currently 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 http://www.poseidonstudy.com. The 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. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.

Forward-looking statements
This press release may contain predictions, estimates or other information that might be considered forwardlooking 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.

* In Georgia the study is conducted by Clinical Accelerator

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Clinical Accelerator to collaborate with Second Heart Assist on a Phase I study in Heart Failure

Clinical Accelerator and Second Heart Assist have recently entered into an exciting new collaboration, focused on developing a novel device for heart failure patients. An early feasibility trial will be conducted on Second Heart’s aortic stent based circulatory assist pump. The company is developing both a temporary use catheter-based device and a wireless powered chronic implant. The objective is to improve quality of life of heart failure patients by reducing the heart’s workload and improving organ perfusion. Renal function is also expected to be enhanced which reduces the risks that come with toxic contrasts used in percutaneous catheterization interventions (High Risk PCI). The product will also help patients to recover from cardiogenic shock and attain normal hemodynamics for acute decompensating heart failure patients.

Heart Failure is a severe problem that currently affects over 6 million people in the U.S. alone. Many patients cannot receive a heart transplant and therefore are instead reliant on cardiac assist devices. A major issue is that currently available circulatory assist devices have limitations such as device-associated thrombosis, and there are also risks and complications that can come with invasive implantation procedures that are often needed for many devices. Second Heart’s technology overcomes many of the limitations that are associated with other devices as it involves easy and secure placement in the aorta, provides high flow rates and minimizes risk of thrombosis with thrombosis-resistant material. The aortic stent design in this device is also currently the only one that is known to combine both high security of fixation stability and also maintenance of pulsatile aortic wall movement (which can potentially be essential to successful long-term chronic implant)

About Second Heart Assist

Second Heart Assist is a development stage company dedicated to developing the world’s first percutaneously placed true aortic stent based circulatory assist pumps. The company has two advanced platforms for three cardiovascular clinical endpoints and markets: (PCI, CRS, Class III HF). The platforms are a catheter-based device and a wireless power chronic device, both of which utilize their pulsatile-conforming aortic radial stent. Second Heart Assist is part of Leonhardt Ventures – a venture creation lab focused on advancing regenerative medtech innovations. It was founded by Howard J. Leonhardt, inventor and serial entrepreneur who has 21 U.S. patents and over 100 patent claims for products treating cardiovascular disease. Supervising the project is Dr. Les Miller, a prominent heart failure cardiologist and CMO of Second Heart Assist.

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.

 

Posted in Biotech, Central and Eastern Europe, Clinical Accelerator, Medical Devices | Leave a comment

Clinical Accelerator announces collaboration with LARRK Bio Inc

Clinical Accelerator is excited to announce that it has entered into a collaboration with LARRK Bio Inc, a US based biotech start-up company focusing on skin health and dermatology. The company is currently in “stealth mode”. LARRK Bio is led by Frederic Godderis, an experienced Pharma/Biotech executive and entrepreneur.

Clinical Accelerator has been conducting studies in the field of dermatology for over 10 years and has accumulated experience in many dermatologic indications, including: psoriasis; atopic dermatitis; skin cancer; burns and wounds. Our studies are placed in Central and Eastern Europe where we have extensive knowledge of specialist dermatology sites. Features of our sites include good access to patients and fast speed of patient enrolment. Members of our network of dermatologist are able to pre-screen and identify patients with all major dermatology conditions and refer them for enrolment into clinical trials at the selected specialist dermatology sites.

As a clinical CRO, Clinical Accelerator offers a full range of clinical trial services from protocol development and regulatory affairs through clinical conduct to data management, biostatistics and study reporting. As a patient enrolment organization, our strongest focus is on fast and efficient patient enrolment into our projects. Working closely with our network of investigators, we have developed an enhanced model of patient enrolment which allows us to accelerate clinical trials of any complexity and routinely rescue delayed and stalled studies.

We are looking forward to a productive collaboration with LARRK Bio and the successful completion of the trials under this agreement.

 

About Clinical Accelerator

Clinical Accelerator is a boutique clinical CRO, working predominantly with emerging Biotech and MedTech companies. The company has been running clinical studies in all main therapeutic areas, including dermatology, for over 14 years. Clinical Accelerator implements clinical studies in Central and Eastern Europe in a close collaboration with a fast-growing network of investigators who provide access to large patient populations in all main therapeutic areas.  The company is intent on fast and efficient patient enrolment even into most difficult clinical studies. Clinical Accelerator often participates in projects with patient enrolment challenges and routinely rescues delayed and stalled clinical trials.

Posted in Biotech, Central and Eastern Europe, Clinical Accelerator | Leave a comment