Wearable Device for Continuous Hemodialysis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,949,759.00
Award Year:
2011
Program:
STTR
Phase:
Phase II
Contract:
2R42DK072646-02A1
Award Id:
n/a
Agency Tracking Number:
R42DK072646
Solicitation Year:
2011
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA10-051
Small Business Information
303 BEAR HILL RD, WALTHAM, MA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
004627316
Principal Investigator:
ANNAGALEA
(781) 890-1338
agalea@infoscitex.com
Business Contact:
STEPHENMATTOX
(781) 890-1338
smattox@infoscitex.com
Research Institute:
COLUMBIA UNIVERSITY

COLUMBIA UNIV NEW YORK MORNINGSIDE
Sponsored Projects Administration 615 West 131st Street Room 254, Mail Code 8725
NEW YORK, NY, 10027-7922
() -

Abstract
DESCRIPTION: The fundamental goal of this program is to develop a microfluidics-based artificial kidney that minimizes exposure of blood to artificial surfaces and provides continuous perfusion in a compact, wearable device. This device will provide treatment at low flow rates over long times, greatly reducing concentration and volume transient in body fluids. The key element is a primary separator that enables transport of water and solutes from the blood to a plasma-like solution (sheath fluid). The sheath fluid carries these compounds to a secondary separator where they are transferred to an external dialysate for disposal. The secondary separator is similar to a conventional membrane hemodialyzer or hemodiafilter, but is substantially smaller. It acts only on the sheath fluid to remove water and solutes and recycle purified sheath fluid to the primary separator. The nature of the system allows the majority of the components (the primary and secondary separators) to be worn in a small package approximately60 cm3 in size. Thus far we have demonstrated the essential parameters of the primary and secondary separators and begun the design of other system components. We have worked closely with a commercial partner and present this proposal as a direct development path to the first product in an identified family of related medical devices. In the proposed Phase II program, we will finalize the design of all components of the system and perform preliminary testing such that by the end of the Phase II program wewill be prepared to apply for an IDE for full clinical trials. PUBLIC HEALTH RELEVANCE: Standard treatment for End Stage Renal Disease (ESRD) is dialysis. Annual clinical costs for treatment of ESRD approach 10 billion, and market estimates indicate that almost 90% of patients are treated by hemodialysis. Hemodialysis, however, is far from a perfect solution, in that it requires thrice-weekly visits to a clinic, and leaves the patient feeling ill for a good portion of the time prior and immediatelyfollowing these treatments. Our device will enable the maintenance of volume between treatments, and eventually replace clinical treatments, improving patient quality of life by virtue of providing slow treatment over many hours instead of a few relativelyshort sessions a week. By eliminating the need for frequent clinic visits, the patient is more able to lead a normal life. In summary, the device proposed here will serve the portion of that market that can be much more fully rehabilitated when freed fromthe regimen and deficiencies of in-clinic dialysis.

* information listed above is at the time of submission.

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