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New Needle for Two-Needle Hemodialysis

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60869
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
DK059062
Solicitation Year:
N/A
Solicitation Topic Code:
NIDDK
Solicitation Number:
N/A
Small Business Information
BIOMEDICAL ENTERPRISES, INC.
BIOMEDICAL ENTERPRISES, INC. 8128 HAMILTON SPRING RD BETHESDA, MD -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2010
Title: New Needle for Two-Needle Hemodialysis
Agency: HHS
Contract: 2R44DK059062-05
Award Amount: $502,342.00
 

Abstract:

DESCRIPTION (provided by applicant): Studies performed with phase I SBIR grants 1R43DK55385-01A1 and 1 R43 DK59062-01A1 and phase II SBIR grants 2R44DK059062-02A1 and 5R44DK059062-04 have demonstrated the following: a) A new hemodialysis(HD) venous needle (NVN) with three jets is hemodynamically  superior to the current venous needle (CVN) because it decreases the velocity of the  vascular access flow by 3.5 times and the turbulence by 6 times when compared with  the currently used venous needle (CVN), and unlike the CVN, it does not form an area of  annular recirculation. b) The NVN is more efficient than the CVN in the removal of BUN, it is safe(it causes equal  or less damage to cells, it does not form clots and does not cause prolonged bleeding at  puncture sites), and it is as effective as the CVN to fulfills the function of conduit to  transport blood. c) More importantly, the data from HD in sheep and patients suggest that the NVN is  clinically superior to the CVN because it causes less damage to circulating blood cells  and less generation and release of cytokines and oxidants. However, the data did not  show statistically significant superiority because the sample size was small. The proposed phase II competing renewal grant will demonstrate clinical superiority of the NVN by studying a larger number of HD patients and obtaining statistically significant data. Seventy stable HD patients will be studied. Each patient will receive one mid-week HD using the CVN and one mid-week HD using the NVN the following week. Pre and post HD plasma and intracellular IL-1 and IL-6, intracellular IL-6 soluble receptor, IL-6 gp130, superoxide and hydrogen peroxide and plasma Mandenyldealdehyde(MDA) and advanced oxidation protein products(AOPP) will be measured. Each patient will use the same HD prescription during both HD including length of dialysis, type of dialyzer non-reused, size of needles (15g), heparin, dialysate composition, and blood and dialysate flow rate. The outcomes to be compared are net changes in blood levels of all the markers in the NVN and CVN groups. Demonstrating that the NVN is clinically superior will have great significance:  a) It will show that the NVN is more useful than the CVN: The NVN would decrease the complications caused by inflammation and oxidative stress, the mortality of patients and the cost of care,  b) It will allow claiming clinical superiority of the NVN in the application for pre-market approval to be submitted to the FDA. This will facilitate marketing and sales and is necessary to obtain investments to commercialize the needle. The NVN fills a technological gap and a clinical need: the CVN is not fit for use with the 400-500 ml/min blood flow rates currently used in HD. The NVN is protected by several patents and the process to obtain a 510K from the FDA has been started.        PUBLIC HEALTH RELEVANCE:   This project will demonstrate that the new venous needle (NVN) is a product that will  help hemodialysis patients unlike the current venous needle (CVN) that is harmful to  patients. The NVN will decrease medical complications, mortality and the cost of care of  hemodialysis patients.   The NVN fills a technological gap and a clinical need: The current venous needle (CVN)  fulfills the needs of hemodialysis with low blood flow rates but it is not fit for use with the  high blood flow rate currently used of 400-500 ml/min.   This study will enhance scientific knowledge to improve the delivery of dialysis and the  design of devices used on dialysis.

Principal Investigator:

Alfredo R. Zarate
3014695112
ARZBME@AOL.COM

Business Contact:

Alfredo R. Xarate
3014695112
Small Business Information at Submission:

BIOMEDICAL ENTERPRISES, INC.
BIOMEDICAL ENTERPRISES, INC. 8128 HAMILTON SPRING RD BETHESDA, MD 20817

EIN/Tax ID: 522093162
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No