about us - company fact sheet
Overview
CHF Solutions, Inc. is a privately held manufacturer of innovative medical devices for cardiac care and the developer of the aquapheresis therapy and the Aquadex FlexFlow Fluid Removal system. Fluid overload is failure to eliminate excess fluid, primarily
water, from the body. While many conditions such as renal failure,
metabolic disease and post-surgical conditions may result in fluid-overload,
congestive heart failure (CHF) is a leading cause.
Aquapheresis therapy and the Aquadex FlexFlow Fluid Removal system are designed specifically for use by physicians to safely, effectively, and conveniently treat fluid-overloaded patients by removing excess salt and water. With aquaphereis, the physician specifies the amount of fluid to be removed from a patients blood at a controlled rate and the system does so in a highly controlled and effective way.
Mission
The Company's mission is to provide medical practitioners with innovative medical solutions that enable the treatment of patients with unmet clinical needs. Through its products, the Company strives to improve the quality of life, the medical outcomes, and the cost savings for patients and hospitals alike.
Market Opportunity
The market opportunity for CHF Solutions aquapheresis therapy is estimated at more than $2 billion in the treatment of fluid overloaded CHF patients in the United States alone.
- CHF Solutions sees an initial market potential of $1.65 billion for in-hospital treatment targeting fluid overloaded CHF patients. CHF leads to 2.2 million hospital admissions at an estimated $11 billion cost per year. The System 100 has the potential to dramatically reduce days in the hospital, saving the health care system as much as $3.2 billion.
- Medicare reimbursement only covers about half of the $10,000 cost of a hospital visit.
- The cost of the CHF Solutions therapy is under $1,000 and is currently assigned an ICD-9 code of 99.78 – aquapheresis, which falls under the classification of therapeutic apheresis.
- CHF Solutions plans to pursue the $960 million outpatient market as well.
History
Dr. Howard Levin, a cardiologist and biomedical engineer, had long been frustrated by the lengthy time and inefficiencies of existing fluid removal treatments. His vision was to develop a simplified solution that would allow medical practitioners to relieve fluid-overload more quickly, precisely and without the drawbacks or side effects of traditional treatments. Dr. Levin partnered with Mark Gelfand, an electrical engineer with 20 years of experience in developing computer-controlled medical devices for life support. Together, they founded CHF Solutions in July 1999 and developed the Companys first platform, the forerunner of the Aquadex FlexFlow system.
For a more detailed history, refer to the timeline (most recent first) listed below:
- In February 2007, Landmark UNLOAD Study Published In February
13th edition of the Journal Of American College Of Cardiology
- In January 2007, David B. Springer Promoted To President And
Chief Executive Officer
- In September 2006, Five Studies On Aquapheresis™ Therapy
Presented At Heart Failure Society Of America Annual Meeting.
- In June 2006, CHF Solutions, Inc. named one of “50 Companies
to Watch” in the June issue of Medical Device & Diagnostic
Industry magazine.
- In March 2006, Landmark UNLOAD trial results presented as Late
Breaking Clinical Trial at ACC 2006 Scientific Sessions.
- In December 200Data From Two Published Studies in JACC Show
Short- And Long- Term Benefits of Aquapheresis™ Therapy.
- In July 2005, CHF Solutions completed enrollment in UNLOAD trial.
Journal publications expected in first quarter of 2006.
- In April 2005, the System 100 is renamed Aquadex FlexFlow and
launched with several new features focused on expanding options
and improving customer satisfaction.
- In January 2005, CHF Solutions, Inc., closed a $22.9 million
Series E equity financing, led by MPM Capital and SV Life Sciences.
- In August 2004, aquapheresis therapy is awarded its own ICD-9
diagnostic code: 99.78
- In July 2004, CHF Solutions initiates 200 patient, multicenter
trial of aquapheresis therapy entitled UltrafiltratioN versus
IV Diuretics for Patients HospitaLized fOr Acute Decompensated
Congestive Heart Failure: A Prospective Randomized Clinical Trial
(UNLOAD).
- In June 2004, the System 100 wins the prestigious gold 2004
Medical Device Excellence Award (MDEA).
- In December 2003, CHF Solutions received marketing clearance
from the U.S. Food and Drug Administration for central venous
access with the System 100.
- In September 2002, Newark Beth Israel Hospital, Newark NJ, an
affiliate of Saint Barnabas Health Care System, became the first
hospital in the nation to adopt and begin treating patients with
the System 100. A national introduction of the System 100 is planned
for late in the third quarter of 2002.
- In July 2002, CHF Solutions, Inc., closed a $26.2 million Series
D equity financing, led by MPM Capital of San Francisco. Five
other firms also participated in the offering.
- In June 2002, CHF Solutions received marketing clearance for
the System 100 from the U.S. Food and Drug Administration.
- In March 2002, CHF Solutions moved its headquarters from New
York City to Brooklyn Park, Minn., to tap the wealth of medical
technology resources in the Minneapolis/St. Paul area.
- In December 2001, CHF Solutions completed the Simple Access
Fluid Extraction (SAFE) trial. The SAFE trial showed that the
System 100 successfully removed a targeted volume of excess fluid
as determined by the cardiologist.
- CHF Solutions (formerly known as Intellicardia) is incorporated
in July 1999 and takes up residence in Manhattan, NY.
Product Lines
CHF Solutions' Aquadex FlexFlow is a technologically sophisticated, yet easy-to-use mechanical pump/ultrafiltration system that can remove up to four liters (one gallon) of excess fluid from the blood of fluid-overloaded patients during an eight-hour treatment. It enables physicians the ability to precisely tailor the amount and rate of fluid removal per patient, resulting in a gradual reduction of fluid with no clinically significant effect on electrolyte balance or other hemodynamics.
Aquapheresis therapy can be used by the physician in conjunction with or as an alternative to diuretic or inotropic drug therapies to achieve the target fluid removal goal for the patient.
Whether its in an inpatient or outpatient clinical setting, whether the patient has peripheral or central venous access, the Aquadex FlexFlows low blood flow (10-40 mL/min), low extracorporeal blood volume (33 mL), and precise removal rates (10 to 500 mL/hr), allow physicians and nurses to remove the salt and water they need to, where and when they want to with no clinically significant impact on electrolytes, heart rate, or blood pressure. CHF Solutions aquapheresis therapy is comprised of the Aquadex
FlexFlow console, UF 500 filter circuit, and venous access catheters
and is indicated for ultrafiltration treatment of patients with
fluid-overload.
Executive Staff
John Erb, Chairman of the Board
Dave Springer, Chief Executive Officer, President
Ron Nelson, Chief Financial Officer
Pat Wethington, Vice President, Global Sales & Marketing
Robert Garee, Vice President, Operations
John O'Mahony, Vice President, Research & Development
Customers Aquapheresis and the Aquadex FlexFlow system have received positive
feedback from the heart failure, nephrology, and surgical communities.
As such, the therapy has been incorporated into the cardiac programs
of hundreds of hospitals across the United States, including some
of the nations top hospitals as rated by U.S. News & World Report.
Employees - 56
Headquarters
CHF Solutions, Inc.
7601 Northland Drive, Suite 170
Brooklyn Park, Minnesota 55428
(763) 463-4600 Phone
(763) 463-4606 Fax
Internet
http://www.chfsolutions.com
http://www.unloadstudy.com
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