WhiteSwell

A fundamental shift in the treatment of acute decompensated heart failure

ADHF is an episode of worsening heart failure symptoms in which patients experience difficulty breathing, fatigue, and swelling due to fluid back-up in the lungs and other parts of the body. Efficient and complete removal of excess fluid from the body’s tissues is vital to improve patient outcomes. WhiteSwell’s therapy is designed to leverage the impressive drainage capabilities of the lymphatic system to shift fluids out of the interstitial compartment, the fluid-filled spaces in connective tissue throughout the body, and into the vascular compartment (blood vessels). From there, excess fluid is removed through diuresis.

Leveraging the Lymphatic System to Treat ADHF

WhiteSwell is a science-driven company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. The quest to address this significant clinical need led the WhiteSwell team to explore the therapeutic potential of the lymphatic system. WhiteSwell’s solution is uniquely designed to facilitate removal of fluid from both the interstitial and intravascular compartments.

ADHF results in millions of hospitalizations worldwide each year, including nearly 2 million in the US.²

Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires immediate treatment to remove excess fluid in a process called decongestion.

Complete decongestion is the goal of ADHF treatment, as residual congestion at hospital discharge is the strongest predictor of rehospitalization and death.^4,5,6As many as half of ADHF patients are discharged from the hospital not fully decongested,⁷about 25% of ADHF patients are readmitted to the hospital within one month and 50% are readmitted in 6 months.^7,8,9

Targeting Tissue Fluid

The goal of WhiteSwell’s therapy is to accomplish complete decongestion with preservation of renal function.

The aim is to keep patients out of the hospital for longer periods of time, and to slow the cycle of rehospitalization and deterioration typically associated with heart failure patients.

Complete decongestion is difficult to achieve with current ADHF treatments, which focus on removal of excess fluid from the vascular system. WhiteSwell is taking a different approach, targeting removal of excess fluid in the interstitial system, the fluid-filled spaces in connective tissue all over the body that are outside of the vascular system.

Through in-depth research into the fluid dynamics that occur during acute decompensated heart failure, the company came to appreciate the incredible potential of the lymphatic system. Each person has an estimated 100,000 miles of lymphatic network which reaches throughout the body to drain and filter fluid from the tissues.

The lymphatic vessels reach deep into the body’s tissues and can be as small as 50 microns in diameter (the size of a human hair) with microscopic openings for fluid.¹⁰ The breadth and depth of lymphatic drainage facilitates its ability to effectively drain fluid throughout the body.

Normally, the lymphatic system collects fluid that has nourished the tissues and returns it to the veins via the thoracic and lymphatic ducts.¹⁰ In ADHF patients, high venous blood pressure reduces or stops lymphatic drainage at these ducts, hindering the lymphatic’s ability to shift fluid from the interstitial system to the intravascular system.

Currently there is no effective treatment to directly remove excess fluid from lung and other interstitial tissues. WhiteSwell’s innovative technology enhances the natural fluid removal process of the lymphatic system by creating a low-pressure zone at the main lymphatic drainage site, the thoracic duct, in order to effectively decongest the interstitial system.

The WhiteSwell Therapy System is an investigational device not currently approved in the United States or in the European Union.
Its use is limited to investigational use in clinical trials.

Breadth of Lymphatic System

Eamon Brady

Chief Executive Officer

Bio

Eamon Brady

Chief Executive Officer

Eamon Brady is the CEO of WhiteSwell, leading the charge to develop an innovative new therapy for Acute Decompensated Heart Failure by drawing upon the tissue drainage power of the body’s own lymphatic system. He honed his experience in science-driven device development as founder and CEO of Neuravi, where he built a company which treated over 5,000 acute ischemic stroke patients before it was acquired by Johnson and Johnson. He was also a founding member and head of R&D at MedNova Ltd, a company that pioneered carotid stenting and was acquired by Abbott Vascular. Eamon is passionate about bringing medical therapies to market that impact patients with poor prognostic outlook and he sees team building and technological innovation as critical to better patient outcomes. When he isn’t encouraging his team to challenge themselves to continuously improve, Eamon relaxes by working the land in his home near Galway.

Seán Mac Réamoinn

Chief Financial Officer

Bio

Seán Mac Réamoinn

Chief Financial Officer

Seán Mac Réamoinn is the CFO of WhiteSwell, guiding the investment in the company to create value and drive growth. An experienced business leader with a specific interest in delivering outstanding shareholder returns for ambitious, high-growth businesses, Seán has led more than 20 corporate transactions from financings, through to business sales and initial public offerings. Seán was most recently CFO of Neuravi, closing series B and debt financing rounds prior to acquisition by Johnson & Johnson, whilst also playing a central role in the company’s successful commercial evolution. A fellow of the Institute of Chartered Accountants, he previously worked in high growth technology ventures in IT Services and co-founded a mobile technology provider which he ultimately led to a successful listing on the London Stock Exchange. When not balancing the books, Seán is guiding young athletes with their own balancing skills as a coach for a local hurling team in Galway.

Ann Marie Cannon

VP Quality & Regulatory Affairs

Bio

Ann Marie Cannon

VP Quality & Regulatory Affairs

Ann Marie Cannon is the VP of Quality and Regulatory Affairs, dedicated to delivering a high quality WhiteSwell system for treating ADHF patients. With extensive experience in developing medical device quality systems and regulatory strategies, she most recently was Director of Quality and Regulatory Affairs at Marvao Medical where she built an ISO 13485 and QSR compliant quality system, created a regulatory strategy, and led clinical trials, culminating with both CE Mark and FDA clearance. Ann Marie believes that doing things the right way with a commitment to the highest standard is vital when bringing new therapies to market. She holds a Bachelors degree in Biochemistry and a Masters degree in Biotechnology from the National University of Ireland in Galway. To facilitate clarity of thought, Ann Marie enjoys walking in the bracing air of the rugged coastline of the west of Ireland.

Ronan Keating

VP Research & Development

Bio

Ronan Keating

VP Research & Development

Ronan Keating is the VP of R&D at WhiteSwell, guiding development of an innovative treatment to target interstitial decongestion in Acute Decompensated Heart Failure patients. Ronan is an experienced R&D leader, having most recently served as CTO and founder at neoSurgical where his team developed a first of its kind absorbable tissue approximation implant, taking it from concept to regulatory approval to commercialization. Prior to this Ronan led EmboShield Embolic Protection R&D programs at Abbott Vascular and Mednova. He strongly advocates Design from First Principles and Design for Manufacture as essential for groundbreaking innovation and he strives to create products that address complex performance requirements with robust engineering and streamlined design. A Biomedical Engineer with a portfolio of circa 30 patents, he also holds a Masters Degree in Computational Fluid Dynamics. Ronan is an avid off-road cyclist who enjoys spending his free time crisscrossing the rocky landscapes of the west of Ireland and further afield whenever possible.

Linda Nelson

VP Clinical Affairs

Bio

Linda Nelson

VP Clinical Affairs

Linda Nelson is the VP Clinical at WhiteSwell, guiding clinical strategy to demonstrate the potential for WhiteSwell’s endovenous decongestion therapy leveraging the lymphatics to target interstitial decongestion in ADHF patients. Linda has directed numerous clinical teams at Medtronic and served as VP Clinical Affairs at Respicardia. She leverages over 20 years of experience in global clinical research to develop innovative strategies for evidence collection. She enjoys building and strengthening high- performing teams and is energized by continual learning in complex environments. Linda holds both a Bachelor’s degree in nursing and an MBA. Between world travels supporting clinical studies, Linda finds time to get outdoors to kayak, hike and garden.

Jill Amstutz

VP Strategic Marketing

Bio

Jill Amstutz

VP Strategic Marketing

Jill Amstutz is the VP of Strategic Marketing for WhiteSwell, where she is inspired by the opportunity to provide a valuable new approach to heart failure therapy that will help patients and clinicians. She strongly believes in the importance of developing the scientific support for new innovation. Most recently, as VP of Global Marketing at Neuravi, she launched programs including the Clot Summit which sought to advance the treatment of acute ischemic stroke through scientific research on stroke-causing thrombi. She has worked on a number of cardiovascular products at start-ups like Sadra Medical and larger corporations such as Guidant and Abbott Vascular. She has an MBA from the Stanford Graduate School of Business and a Bachelor’s degree from Princeton University. When she is not asking why, Jill enjoys hiking and being immersed in the sights, sounds and scents of nature.

Martin Keegan

VP Technical Operations

Bio

Martin Keegan

VP Technical Operations

As the VP of Technical Operations, Martin Keegan oversees a world-wide network of suppliers to deliver high quality precision-engineered products. Most recently as Technical Operations Director at Boston Scientific, he was responsible for manufacturing, process optimization and validation, and led a successful technology transfer program. He brings to WhiteSwell a breadth of experience spanning endovascular medical devices to electronics, including hardware and software development. Martin delights in building cross-functional trans-national teams with an eye to excellence. He holds both a Bachelor’s and Master’s in Mechanical Engineering from National University of Ireland, Galway and is a Chartered Engineer. Fueled by fast-paced coordinated action and healthy competition, Martin dedicates time to two local water polo clubs as Team Manager.

Sagi Raz

Director Advanced Technology

Paul Frehill

Senior Engineering Manager

Ronald Kelly

Senior Technology Manager

Board of Directors

Andrew Levin

Managing Director, RA Capital

Bio

Andrew Levin

Managing Director, RA Capital

Andrew Levin is Chairman of the Board of Directors at WhiteSwell, providing guidance to help the company develop what he believes will be a potentially game-changing therapy. He is passionate about developing new therapies as a Managing Director at RA Capital Management where he spearheads a drug discovery effort that has led to the formation of several new companies. Previously he served as Vice President at H.I.G. Bioventures and as Director of Pharmaceutical Sciences at the Clinton Health Access Initiative. He holds a BSE in Mechanical Engineering from Princeton University, a PhD in Biomedical Engineering from the Massachusetts Institute of Technology, and an MD from Harvard Medical School. When he isn’t growing companies, he spends time with his growing family.

Andrew Farquharson

Managing Director & Co-Founder, InCube Ventures

Bio

Andrew Farquharson

Managing Director & Co-Founder, InCube Ventures

Andrew Farquharson is a Board member at WhiteSwell, facilitating connections, providing strategic perspective and supporting innovation. His strategic insights come from two decades of experience building, restructuring and acquiring life science companies as a founding member of InCube’s venture fund and as an advisor to InCube Labs, LLC. Andrew built a global sales force from scratch, grew revenues of synthetic DNA products to $40M in two years, and helped to negotiate a sale of Operon Technologies to QIAGEN for $150M. He holds a Masters of Business Administration from Harvard University and a Bachelor’s degree from the University of California at Berkeley. A connoisseur of craft beers, Andrew’s passion for innovation and appreciation of complexity imbue both his ventures and his leisure pursuits.

Doug Evans

Chief Executive Officer, Lungpacer Medical Inc.

Bio

Doug Evans

Chief Executive Officer, Lungpacer Medical Inc.

Doug Evans is on the Board of Directors at WhiteSwell, providing counsel, deep R&D experience and support to the leadership team. As CEO of Lungpacer, a company that helps protect the lungs and respiratory muscles of critically ill patients, he is devoted to addressing underserved clinical needs. His 30 years of experience includes serving as COO for Kensey Nash Corporation which was acquired for $360M by Royal DSM in 2012. He has authored over 175 patents and commercialized multiple leading-edge products in cardiology, orthopedics and general surgery. Doug holds a Bioengineering degree and MBA from Penn State, and a Master’s in Electrical Engineering and Photonics from the University of Pennsylvania. His commitment to addressing clinical challenges with improved therapy extends to his personal life, with his work as co-founder of the Cure4Cam Childhood Cancer Foundation.

Scientific Advisors

William Abraham, MD

Professor of Medicine, Physiology, and Cell Biology

College of Medicine Distinguished Professor

The Ohio State University, Columbus, Ohio

Michael Jonas, MD

Director, Structural Heart Disease, Cardiac Catheterization Services

Kaplan Medical Center, Heart Institute

Rehovot, Israel

Daniel Burkhoff, MD PhD

Director, Heart Failure, Hemodynamics and MCS Research

Cardiovascular Research Foundation (CRF)

New York, New York

Join WhiteSwell as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

Culture

We’re looking for committed, curious, creative people with a thirst for knowledge and a desire to make a significant impact on healthcare, improving therapy for ADHF.

Diversity

We work in teams – in Israel, Ireland, and the US. We respect the importance of bringing different skill sets and perspectives together to generate the best solutions.

Innovation

We value self-starters who are willing to go the extra mile, seek out what is needed, and take pride in the quality of their work.

Senior Regulatory Specialist

An experienced regulatory professional, you will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new treatment for acute decompensated heart failure patients. You hold a bachelor’s or master’s degree in a scientific or engineering discipline and have 7+ years’ of experience in the medical device industry in a Quality Assurance or Regulatory Affairs role. Explore the opportunity here.

R&D Manager

As leader of a diverse team of engineers, you will guide technical innovation and collaborative problem-solving in order to deliver and support a system for clinical evaluation and commercialization worldwide. Leading by example, you will promote a passion for innovation, a science-driven culture, and a commitment to meeting key milestones and executing project plans. You hold a BSc in biomedical, mechanical, electrical or materials engineering, and have 10+ years’ of experience in the medical device industry. If this intrigues you, please find out more here.

Research & Development Engineer

You are motivated by innovation that impacts lives. You excel when dealing with complex challenges, able to dive into the details while keeping an eye on the overarching objectives. You have a BSc, MSc or PhD in in Biomedical, Mechanical, Polymer, Materials, or Industrial Engineering and 1-3 years of experience in a technical role. If you want to explore this opportunity, Click here.

WhiteSwell Adds Experienced Executives to its Senior Management Team

With VP Clinical and VP Technical Operations, Company is Well Positioned for Next Phase of Growth

WhiteSwell Announces $30 Million Financing for New Therapeutic Approach to Acute Decompensated Heart Failure

Funds Will Support Product Development and Clinical Studies of Novel Catheter-Based Technology

WhiteSwell Strengthens Patent Portfolio for Treatment of Acute Decompensated Heart
Failure with Newly Issued U.S. Patent

Adds to Portfolio of 40 Patents for Catheter-Based Technology That Leverages Power of Body’s
Natural Fluid Removal Process

Catheter Stimulates Lymphatic Drainage for Heart Failure Treatment: Interview with Eamon Brady, CEO of WhiteSwell
Conn Hastings

Clinical journal publications of interest on the role of lymphatics and interstitial fluid in ADHF

Direct Interstitial Decongestion in an Animal Model of Acute-on-Chronic Ischemic Heart Failure
William T. Abraham, Michael Jonas, Ranjeet M. Dongaonkar, Beth Geist, Yukie Ueyama, Kevin Render, Brad Youngblood, William Muir, Robert Hamlin, and Carlos L. del Rio

Pathophysiology of the Lymphatic System in Patients With Heart Failure: JACC State-of-the-Art Review
Maxim Itkin, Stanley G. Rockson, and Daniel Burkhoff

Lymphatic Dysregulation in Patients With Heart Failure: JACC Review Topic of the Week
Marat Fudim, Husam M. Salah, Janarthanan Sathananthan, Mathieu Bernier, Waleska Pabon-Ramos, Robert S. Schwartz, Josep Rodés-Cabau, François Côté, Abubaker Khalifa, Sean A. Virani, Manesh R. Patel

Reduced Lymphatic Reserve in Heart Failure With Preserved Ejection Fraction
Giacomo Rossitto, Sheon Mary, Christine McAllister, Karla Bianca Neves, Laura Haddow, John Paul Rocchiccioli, Ninian Nicholas Lang, Clare Louise Murphy, Rhian Merry Touyz, Mark Colquhoun Petrie, Christian Delles

Development of a New Technique for Ultrasound Imaging of the Innominate Vein and the Venous Angle
Dan Haberman, Lana Rizhamadze, Giorgi Shaburishvili, Gerry O’Sullivan, Ortal Tuvali, Michael Jonas, Jacob George, Sara Shimoni, William Abraham

WhiteSwell – Ireland

Parkmore Business Park West
Parkmore, Galway, H91 PTT8
Ireland

+353 91 394 110

WhiteSwell – Israel

Hutsot Shefayim Commercial Center
Shefayim 6099000
Israel

+972 98 331 151

WhiteSwell – USA

1900 S. Norfolk St., Suite 350
San Mateo, CA 94403
USA

info@whiteswell.com

Citations
1 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-473
2 Agarwal et al, Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998– 2011, Am J Epidemiol. 2016;183(5):462–470
3 Westenbrink et al, Heart failure specialization in Europe, European Journal of Heart Failure (2016) 18, 347–349
4 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-473
5 Arrigo et al, Optimising Heart Failure Therapies in the Acute Setting, Cardiac Failure Review 2018;4(1):38-42
6 Chioncel et al, Cardiac Failure Review 2017;3(2):122-9
7 Girerd et al, Integrative Assessment of Congestion in Heart Failure Throughout the Patient Journey, J Am Coll Cardiol HF 2018;6:273–85
8 Gheorghiade, M, Vaduganathan, M, Fonarow, G, Bonow, R, Rehospitalization for Heart Failure: Problems and Perspectives, J Am Coll Cardiol 2013;61:391–403.
9 Farmakis et al, Acute heart failure: Epidemiology and socioeconomic burden, Continuing Cardiology Education 2017;3(3)
10 Moore & Bertram, Lymphatic System Flows, Annu. Rev. Fluid Mech. 2018. 50:459–82

A fundamental shift in the treatment of acute decompensated heart failure

ADHF results in millions of hospitalizations worldwide each year, including nearly 2 million in the US.2

Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires immediate treatment to remove excess fluid in a process called decongestion.

Targeting Tissue Fluid

The goal of WhiteSwell’s therapy is to accomplish complete decongestion with preservation of renal function.

The aim is to keep patients out of the hospital for longer periods of time, and to slow the cycle of rehospitalization and deterioration typically associated with heart failure patients.

The lymphatic vessels reach deep into the body’s tissues and can be as small as 50 microns in diameter (the size of a human hair) with microscopic openings for fluid.10 The breadth and depth of lymphatic drainage facilitates its ability to effectively drain fluid throughout the body.

Eamon Brady

Eamon Brady

Chief Executive Officer

Seán Mac Réamoinn

Seán Mac Réamoinn

Chief Financial Officer

Ann Marie Cannon

Ann Marie Cannon

VP Quality & Regulatory Affairs

Ronan Keating

Ronan Keating

VP Research & Development

Linda Nelson

Linda Nelson

VP Clinical Affairs

Jill Amstutz

Jill Amstutz

VP Strategic Marketing

Martin Keegan

Martin Keegan

VP Technical Operations

Sagi Raz

Paul Frehill

Ronald Kelly

Board of Directors

Andrew Levin

Andrew Levin

Managing Director, RA Capital

Andrew Farquharson

Andrew Farquharson

Managing Director & Co-Founder, InCube Ventures

Doug Evans

Doug Evans

Chief Executive Officer, Lungpacer Medical Inc.

Scientific Advisors

William Abraham, MD

Michael Jonas, MD

Daniel Burkhoff, MD PhD

Join WhiteSwell as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.

Culture

Diversity

Innovation

ADHF results in millions of hospitalizations worldwide each year, including nearly 2 million in the US.²

The lymphatic vessels reach deep into the body’s tissues and can be as small as 50 microns in diameter (the size of a human hair) with microscopic openings for fluid.¹⁰ The breadth and depth of lymphatic drainage facilitates its ability to effectively drain fluid throughout the body.