A fundamental shift in the treatment of acute decompensated heart failure

WhiteSwell is dedicated to advancing treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits.

 

Leveraging the Lymphatic System to Treat ADHF 

 

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 in tissues is vital. Unlike current approaches, which remove fluid from the vascular system, WhiteSwell’s solution leverages the natural process of the lymphatic system to remove fluid from the interstitial system, the fluid-filled spaces in connective tissue throughout the body where most of the excess fluid caused by ADHF is located.

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,about 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.

Depth of Lymphatic Drainage

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 the lymphatic system facilitate its ability to effectively drain fluid from 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 aim is through more complete decongestion 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 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.

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.

Ronan Keating

VP Technical Operations

Bio

Ronan Keating

VP Technical Operations

Ronan Keating is the VP of Technical Operations at WhiteSwell, where he is focused on creating a robust and responsive supply chain with the breadth and scope needed to meet WhiteSwell quality and commercial demands while advancing the technology. He is experienced at scaling operations, having most recently served as CTO and founder at neoSurgical where his team developed the product from concept and commercialized it, ramping production capabilities to 200,000 units annually to meet Medtronic’s requirements as their distribution partner. Ronan is a strong advocate of Design for Manufacture and Assembly to build simplicity and repeatability into products with complex performance requirements. A biomedical engineer with a portfolio of circa 30 patents, he also holds a Masters Degree in Computational Fluid Dynamics. Always ready to take on a challenge, 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.

Yaacov Nitzan

Founder

Bio

Yaacov Nitzan

Founder

Yaacov Nitzan is the founder of WhiteSwell and is passionate about finding new approaches to addressing the significant clinical need in treating patients with Acute Decompensated Heart Failure. Yaacov’s curiosity and research led him to more fully understand the significant therapeutic potential of the lymphatic system in these patients. He has built his understanding of heart failure working on a wide variety of cardiovascular devices; most recently before WhiteSwell he co-founded V-Wave to develop an interatrial shunt to achieve left atrial decompression. Prior to that, he was Director of R&D at Edwards Lifesciences with responsibility for percutaneous aortic heart valve projects. A named inventor on numerous patents, Yaacov holds a Bachelor’s degree in Mechanical Engineering from Technion Institute and a Master’s degree in Biomedical Engineering from Tel-Aviv University. Yaacov finds that swimming and surfing are excellent sources of creative inspiration.

Sagi Raz

Director Advanced Technology

Gerry McCaffrey

Senior Process Technology Manager

Sophia Nash

R&D Project Manager

Or Inbar

R&D Project 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

Daniel Burkhoff, MD PhD

Director, Heart Failure, Hemodynamics and MCS Research

Cardiovascular Research Foundation (CRF)

New York, New York

Michael Jonas, MD

Director, Structural Heart Disease, Cardiac Catheterization Services

Kaplan Medical Center, Heart Institute

Rehovot, Israel

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.

Contact us about career opportunities by sending a resume / CV to challenges@whiteswell.com

Quality Engineer

The position reports to the VP of Quality and Regulatory Affairs. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development and maintenance of the quality systems and design assurance activities to support product development projects.

R&D Engineer

The Engineer will work as part of the engineering team and be responsible for tasks that are related to new product development projects. Initially, the Engineer will be focused on catheter component, process, and supplier development.

WhiteSwell Logo

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 – 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

2225 E. Bayshore Road, Suite 200
Palo Alto, CA 94303-3220
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