The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Small Business concern that possesses the research and development (R&D) expertise to conduct innovative research that will contribute toward meeting the program objectives of the NHLBI Transcatheter Cerclage Mitral Valve Annuloplasty for Secondary Mitral Regurgitation. The purpose of this announcement is to provide a Presolicitation Notice for the release of the Small Business Innovative Research Technology Transfer (SBIR TT) Contract Proposals Solicitation: NHLBI-HL-13-15. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.



The purposes of the SBIR TT program are to: (1) stimulate technological innovation in the private sector; (2) strengthen the use of small businesses to meet Federal Research/Research & Development (R/R&D) needs; (3) foster and encourage participation by socially and economically disadvantaged small business concerns and by small business concerns that are 51 percent owned and controlled by women, in technological innovation; and (4) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity, and economic growth. This is an SBIR TT (Technology Transfer) contract topic from the NHLBI. This is a program whereby inventions from the NHLBI Division of Intramural Research are licensed to qualified small businesses with the intent that those businesses develop these inventions into commercial products that benefit the public.



For purposes of the SBIR TT program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials, or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture; (3) is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; or is owned and controlled by another (one) small business concern that is itself at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; AND (4) has, including its affiliates, no more than 500 employees.



Secondary mitral valve regurgitation is a common contributor to heart failure, and is caused by annular expansion and papillary muscle traction. Secondary mitral valve regurgitation may be amenable to surgical annuloplasty, which reduces mitral valve annular size to enhance coaptation of the otherwise normal leaflets.



NHLBI labs have developed a novel non-surgical catheter-based approach to annuloplasty called “cerclage annuloplasty.” Using enhanced image guidance, catheter tools traverse a trajectory including the coronary sinus, a basal septal perforator vein, a short transmyocardial pathway through the interventricular septum, and the right ventricular inflow tract. Once this pathway is established, circumferential tension is applied to reduce annular dimensions. Serendipitous features of cerclage annuloplasty include preservation of mitral annular deformation throughout the cardiac cycle, and reciprocal entrapment of the left ventricular outflow tract to enhance coaptation of the anterior mitral leaflet during systole.



We have established the potential utility of cerclage annuloplasty in a porcine model of ischemic cardiomyopathy. To translate the project into humans will require development of commercial-grade interventional tools to make a clinical procedure simple and safe, including device and regulatory development, followed by early clinical testing. NHLBI has four patent applications filed related to cerclage annuloplasty.



A catheter-based annuloplasty like cerclage may have value as a primary therapy for secondary mitral regurgitation. Alternatively cerclage annuloplasty may have value as an adjunctive therapy combined, for example, with leaflet clip procedures. It may also have value in less-severe disease not justifying surgical morbidity, or to relieve symptoms accompanied by severe comorbidity precluding surgical therapy.



The NHLBI anticipates one award under this SBIR TT solicitation.



This is an SBIR TT (Technology Transfer) contract topic from the NHLBI. This is a new program whereby inventions from the NHLBI Division of Intramural Research are licensed to qualified small businesses with the intent that those businesses develop these inventions into commercial products that benefit the public. The contractor funded under this NHLBI SBIR TT contract topic shall work closely with the NHLBI inventor(s) of this technology, who will assist in pre-clinical experiments and will perform a clinical trial using offeror’s product. The NHLBI inventor(s) will provide assistance in a collaborative manner with catheter designs, procedure techniques, clinical considerations, and discussions during the entire award period.



An SBIR TT contractor will automatically be granted a royalty-free, non-exclusive license to use NIH-owned and patented background invention(s) only within the scope and term of the award. However, an SBIR offeror or SBIR contractor can apply for an exclusive or non-exclusive commercialization license to make, use, and sell products or services incorporating the NIH background invention(s). Offerors submitting an SBIR contract proposal in response to this solicitation are strongly encouraged to submit concurrently an application for a commercialization license to such background invention(s). Under the NHLBI SBIR TT program, the SBIR contract award process will be conducted in parallel with, but distinct from, the review of any applications for a commercialization license.



Relevant NIH Publications and Patent applications



• Kim JH, Kocaturk O, Ozturk C, Faranesh AZ, Sonmez M, Sampath S, Saikus C, Kim AH, Raman VK, Derbyshire JA Schenke WH, Wright VJ, Berry C, McVeigh ER, Lederman RJ, Journal of the American College of Cardiology. 2009;54(7):638-651, Pubmed ID 19660696, posted at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3034128.

• Device for protecting coronary arteries against compression during transcatheter mitral valve annuloplasty (“Transcatheter Coronary Sinus Mitral Valve Annuloplasty Procedure and Coronary Artery and Myocardial Protection Device”). JH Kim, RJ Lederman, O Kocaturk. Assignee: The United States of America. U.S. Provisional Patent Applications 60/858,716 and 60/932,611 filed November 14, 2006 and May 31, 2007 respectively (expired); International Patent Application PCT/US2007/023876 filed November 13, 2007 (expired), U.S. Patent Application 12/514,990 filed May 15, 2009, European Patent Application 07861997. NIH reference no. E-249-2006.

• Cerclage locking device and delivery system (“Tensioning Device and Methods of Use“). O Kocaturk. Assignee: The United States of America. U.S. Provisional Patent Application 61/157,267 filed March 4, 2009 (expired), International Patent Application PCT/US2010/026245 filed March 4, 2010 (expired), U.S. Patent Application 13/254,160 filed August 31, 2011. NIH reference no. E-048-2009.

• An expandable mesh target and capture device for transcatheter cerclage annuloplasty. (“Method and Devices for Transcatheter Cerclage Annuloplasty”). RJ Lederman, O Kocaturk. Assignee: The United States of America. U.S. Provisional Patent Application 61/383,061 filed September 15, 2010 (expired), International Patent Application PCT/US2011/51748 filed September 15, 2011. NIH reference no. E-108-2010.



NHLBI will share any unpublished patent applications with offerers willing to sign confidential disclosure agreements.



This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about May 11, 2012. This advertisement does not commit the Government to award a contract.