Abiomed Acquires preCARDIA, a Breakthrough Medical Device Company, to Improve Outcomes for Heart Failure Patients

June 1, 2021 8:03 AM

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) has acquired preCARDIA, developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function.

“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started”

Annually, more than one million patients are admitted to hospitals in the United States with ADHF. Despite available pharmaceutical treatments, heart failure is the leading cause of hospitalization in patients older than 65 years of age. preCARDIA provides heart failure specialists a minimally invasive solution with the potential to improve patient outcomes and lower the cost of care by providing early intervention with this new technology.

preCARDIA’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced re-hospitalizations and improved quality of life. The system is based on an invention by Navin Kapur, MD, and Richard Karas, MD, PhD, at the Molecular Cardiology Research Institute at Tufts Medical Center in Boston.

The design of the preCARDIA system allows for straightforward placement by physicians and hemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” said Lisa Wipperman Heine, president and chief executive officer at preCARDIA. “I am confident that the addition of our technology into Abiomed’s product portfolio will further improve outcomes for heart failure patients.”

preCARDIA completed enrollment of 30 patients in an FDA early feasibility study (EFS), which demonstrated acute technical success and significant reduction in cardiac filling pressures and rapid diuresis. Additionally, all patients were free of device- or procedure-related major adverse events through 30 days.

“Heart failure is a devastating condition associated with excess fluid overload known as congestion. preCARDIA is a breakthrough technology that regulates blood flowing into the heart known as preload, thereby reducing congestion and improving heart and kidney function,” said Navin Kapur, MD, physician-scientist and investigator in the Molecular Cardiology Research Institute at Tufts Medical Center, and the chief medical advisor and chair of preCARDIA’s Scientific Advisory Board. “This novel approach has the potential to be a revolutionary tool for the treatment of millions of patients suffering from acute heart failure worldwide.”

“We look forward to advancing preCARDIA’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early stage acute decompensated heart failure patients, a new patient population for Abiomed,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “This acquisition aligns with Abiomed’s principles of leading in technology and innovation and putting patients first.”

The preCARDIA system is available for investigational use only and is not approved for use outside of clinical studies. A projected timeline for commercialization will be announced later this fiscal year.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit: www.abiomed.com.

ABOUT preCARDIA

preCARDIA is dedicated to improving patients’ quality of life through pioneering clinically advanced technology that offers an alternative solution for physicians and their patients suffering from ADHF. preCARDIA’s current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF through cardio-renal volume unloading via intermittent superior vena cava (SVC) occlusion.

The company was founded & incubated by MD Start and is headquartered in St. Paul, Minnesota, USA.

CAUTION: The preCARDIA System is an investigational device and is limited by Federal (or United States) Law to investigational use. For more information, please visit: www.precardia.com.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Minimally-invasive, implant-free technology for heart failure patients studied at 1 and 3 months

Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

May 17, 2021 09:36 AM Eastern Daylight Time

AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF).

“Due to the limited medical or device options to treat heart failure with preserved ejection fraction, providers have few tools for helping patients manage the resulting shortness of breath and reduced quality of life”

The Alleviant System is a novel transcatheter device for the creation of a therapeutic interatrial shunt without a permanent cardiac implant. Results were presented at the American College of Cardiology Scientific Session (ACC.21) and at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) by Colin Barker, MD, Director of Interventional Cardiology at Vanderbilt University, Nashville, TN and Jacob Kriegel, MD, Chief Medical Officer of Alleviant Medical.

The reported results of this ongoing first in human study include safety and objective clinical and quality of life outcome measures at one and three-months post-procedure in ten subjects. Data highlights include:

  • Confirmed shunt patency in all subjects at 3 months;
  • Reduction in mean peak exercise pulmonary capillary wedge pressure (PCWP) by 20% (8 mmHg, p=.026) at 1 month;
  • Reduction in mean NT-proBNP by 48% (582 pg/ml, p<.001) at 3 months;
  • Increase in mean 6-minute walk distance by 50% (110 meters, p<.001) at 3 months;
  • Increase in mean Kansas City Cardiomyopathy Questionnaire overall summary score by 87% (23 points, p<.001, consistent with a large clinical improvement) at 3 months;
  • No device-related or procedure-related adverse events through 3 months

“Due to the limited medical or device options to treat heart failure with preserved ejection fraction, providers have few tools for helping patients manage the resulting shortness of breath and reduced quality of life,” commented James Udelson, MD, Chief, Division of Cardiology, Tufts Medical Center, an advisor to the company. “We are encouraged by these early data highlighting outcomes for a no-implant interatrial shunt procedure and look forward to collaborating on further clinical evidence development with the Alleviant technology.”

“Our focus and mission at Alleviant Medical is to deliver a simple, reproducible no-implant interatrial shunt technology to heart failure patients and healthcare providers,” said Adam Berman, CEO of Alleviant Medical. “We are very pleased with the investigator-presented data at these two prestigious cardiology conferences and look forward to subsequent data releases from the ongoing clinical studies with our technology over the upcoming months.”

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 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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Clinical Accelerator announces collaboration with InterVene for developing an endovascular device for deep vein valve failure

Clinical Accelerator announces collaboration with InterVene for developing an endovascular device for deep vein valve failure

Clinical Accelerator is pleased to announce that is has begun a collaboration with InterVene, to run an early human feasibility study (EHFS) on their novel endovascular device – BlueLeaf Endovenous Valve Formation System – for deep vein valve failure.

Currently, there is no minimally invasive therapy to treat deep vein valve failure and many patients require open surgery. InterVene’s system directly addresses this issue by being the first ever non-implantable, endovenous product which can be used to form new vein valves from layers of tissues that derive from the patient’s vein wall. The system allows for several valves to be formed after only one procedure, thus greatly reducing the burden and medical risk that patients otherwise face.  

The team at Clinical Accelerator are all delighted to have the opportunity to participate in this exciting project. We greatly look forward to advancing this device and attaining quality data.

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 InterVene

InterVene is a medical device start-up company based in San Francisco, USA, focused on improving treatment for deep vein valve failure. InterVene is a product of the Stanford Biodesign Fellowship program and is a former Company-In-Residence at the Fogarty Institute for Innovation. For more information, please see their website: https://www.intervene-med.com/

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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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