Anti-Inflammatory Cardiovascular Device

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HL097512-01
Agency Tracking Number: HL097512
Amount: $273,190.00
Phase: Phase I
Program: SBIR
Awards Year: 2009
Solicitation Year: 2009
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Small Business Information
DUNS: 190155171
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (440) 477-9874
Business Contact
Phone: (440) 477-9874
Research Institution
DESCRIPTION (provided by applicant): NovelMed is developing an extracorporeal device which can be used to prevent complications associated with cardiac procedures where the patients' blood is exposed to artificial surfaces and ischemic/dead tissues. It is well known that the surfaces of plastics and other artificial synthetic materials in extracorporeal devices activate the alternative complement pathway (AP) causing post-surgical pathology (including bleeding complications). The effects of the AP activation are linked to cellular activation and the release of potent mediators of inflammation. Our cardiovascular device, InflamminTM causes the blood to resist AP activation during cardiac procedures. Preliminary data has demonstrated that our system is a target-specific inhibitor of the alternative complement pathway. Downstream events of the AP activation are linked to massive cellular activation and inflammation. Inflammin binds proteins which blocks the AP pathway upstream and prevents activation of neutrophils, monocytes and platelets. The bound protein is a component of the alternative complement pathway and is a killer protein that is indirectly responsible for the activation of neutrophils, monocytes and platelets. Based on the unique properties of the Inflammin system, we are developing a single use affinity cartridge/ filter that binds the killer protein present in blood. As a result, the blood is depleted of this protein. Serum depleted of the specific protein cannot activate the AP. Our preliminary data strongly suggest that Inflammin will remove the protein from serum rendering the serum incapable of activating the AP. Proposed studies will replace serum with whole blood. The whole blood - before and after the cartridge - will be evaluated for serological and cellular activation markers. NovelMed has filed a provisional patent on this device and other similar devices that can be made using our affinity system. . PUBLIC HEALTH RELEVANCE: NovelMed has the potential of providing improved quality of life to those that currently suffer from the side effects of cardiac surgeries. NovelMed is developing an anti-inflammatory and anti-platelet cardiovascular device to address this unmet medical need. The device will absorb the protein that plays a role in cellular activation and inflammation. Removal of this protein will render the blood incapable of adversely responding to the CPB unit, thus, preventing complications that result from inflammation and platelet activation that occurs during cardiac surgeries. If this device becomes successful, it will be used in nearly all cardiac surgeries. .

* Information listed above is at the time of submission. *

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