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Sofinnova Ventures was founded in 1974 and is based in Menlo Park, CA. The firm has approximately $1b of assets under management, and makes life science investments from two fund families; the main Sofinnova Ventures fund and Sofinnova HealthQuest Capital. Sofinnova Venture Partners IX closed at $500 million in 2014, and the debut HealthQuest fund closed at $110 million in 2014. The firm makes investments in the form of equity (preferred stock) and is an activist investor; the firm prefers to lead investments, take a board seat at its portfolio companies and be actively involved in company management. Sofinnova Ventures plans to make 4-6 new investments in life science companies in 2014. 

The Sofinnova Ventures main fund invests in biopharmaceuticals and typically makes initial investments of $5-15m, with the potential for a total investment of $15-30m. The fund invests in companies based in North America or Europe. 

HealthQuest Capital invests in non-biopharmaceutical life science and medtech companies and typically makes initial investments of $2-3m, with the potential for total investments of $5-6m. HealthQuest Capital is a venture growth fund focused on commercial-stage technologies, and only invests in companies headquartered in North America (particularly the US Southeast or West Coast).

Horizon Technology Finance is a venture lending, investment and financial services management company that was founded in 2003 and is headquartered in Farmington, Ct with additional offices in Walnut Creek, CA and Reston, VA. The firm controls approximately $200 million in assets under management and look to provide senior or subordinate loans to companies in the range of $2 to $20 million dollars, and often syndicates much larger deals. The firm prefers to lead or co-lead investments that they are involved in and looks to be involved in 15 deals in the next 6-9 months. The firm provides capital to companies located throughout the United States and Canada.

IR2Dx Company Overview:

IR2Dx has developed a proprietary, breakthrough analysis and reporting system for multi-marker diagnostic test panels, to provide highly personalized treatment strategies for patients with Type 2 diabetes.  While control of glucose levels remains an important factor in the treatment of the disease, the IR2Dx platform evaluates the individual disease pathways for each patient, providing critical information regarding multiple markers and their overall pattern, all of which contribute to management of underlying disease.  This information can then be used by physicians to guide treatment decisions to deliver precision medicine in diabetes. 

Today, there are approximately 382 million people with diabetes in the world, and this number is expected to grow to 592 million by 2035.  The worldwide available market for early detection and drug response diabetes diagnostics is greater than $20 billion.  IR2Dx can enter the market within the current reimbursement and regulatory environments, and is ready to launch its first products in H1 2015 through commercial laboratories.

The IR2Dx platform provides personalized treatment information and recommendations to physicians based on a proprietary decision tree algorithm, greatly enhancing the clinical utility of a laboratory report.  Existing reimbursement levels for the panel markers in the U.S. and key international markets adequately cover the addition of the IR2Dx analysis and reporting. 

The platform is a software-based decision analysis tool. The analysis is performed on results from commercially available diagnostic tests run using standard laboratory bench top systems, requiring no tailored equipment, no custom design of the test system itself, and no capital investment.  Lab technicians upload the multi-marker panel testing results to the IR2Dx proprietary web portal to access the company’s decision support tool analysis product. In the initial commercialization phase, each laboratory will have a specific customized software product, and will pay for each report on a per-use basis. 

In the current U.S. regulatory environment for such products, with “health management IT functionalities”, such as the IR2Dx analysis and reporting system, near-term requirements for premarket review are unlikely, though the FDA may give additional guidance at any time. The IR2Dx platform is protected by a strong and broad intellectual property portfolio combining substantial data and know-how with issued patents in the U.S. and Europe. The company’s issued patents carry claims for use of its analysis platform and combination of markers for treatment guidance “with all glucose lowering drugs.”

 The company anticipates launch of the proprietary IR2Dx platform in H1 2015, introducing its first clinical decision support products through commercial laboratories. 

 Iron Horse Diagnostics, Inc., founded in 2012, has developed breakthrough diagnostic tests in neurologic disorders where there is high-unmet medical need.  We generated and validated diagnostic tests for amyotrophic lateral sclerosis (ALS) and developed assays for traumatic brain injury (TBI) and concussion. Iron Horse Diagnostics has a significant  IP portfolio for these biomarkers in ALS and  TBI, which detects specific biomarker signatures in cerebrospinal fluid and blood in these disease states. We currently are performing a prospective validation of our ALS diagnostic in 4 sites in the US and 2 in Europe.

The ALS test will be commercially available by the end of 2015 anticipating over 300,000 test globally per year. TheTBI test is projected to be market-ready in 36-48 months with 8 Mill. concussion tests in the US alone per year.

Iron Horse Diagnostics has received a fast-track small business grant from the NIH  and funding from Biogen Idec to suppport the clinical validation and commerciliazation of the diagnostic tests in ALS.

Its management team  consists of a seasoned, internally recognized team of scientists, clinicians and business development/regulatory experts. Iron Horse is endorsed by the ALS Association and is working with an international network of clinicians to further the clinical adoption of the ALS test and support reimbursement strategies.

Iron Horse Diagnostics is seeking an investment of 1 Mill. USD to further support the commercialization of the ALS diagnostic test and product development of the TBI test.

Ischemia Care (ISC) is a clinical stage, capital efficient, venture capital backed, diagnostic laboratory company commercializing ISCDX, a blood test for cause of ischemic stroke (including atrial fibrillation or “AF”), leading to timely diagnosis and treatment, resulting in hospital cost savings and improved patient outcomes. ISC is executing on the Biomarkers of Acute Stroke Etiology (BASE) study , clinicaltrials.gov identifier NCT02014896 to support clinical adoption as an LDT through a company owned CLIA laboratory. ISC's initial focus is on the 40% (320K annually) ischemic strokes which are diagnosed as unkown cause (or "cryptogenic") as these patients typically are undertreaked and at a high risk for recurrence.

Stroke is the third leading cause of death worldwide with 20M annual events. In the US, there are 800K strokes, of which 195K are recurrent. Despite advances in imaging, cardiac monitoring, patient history assessment, and clinical examination, in 40% of ischemic strokes, the cause is unknown (or “cryptogenic”) leading to high recurrence and death.  There are no blood tests for cause of stroke. The identification of cause will change outcomes per Stroke Guidelines by adoption of “cause based” treatment regimen to prevent a more massive, debilitating, and costly recurrence. For example, identifying “undetected” AF in cryptogenic patients provides a 60% risk recurrence reduction.

Johnson & Johnson (J&J) was founded in 1886 and is based in New Brunswick NJ with an Innovation Center in Cambridge MA. The firm invests in a variety of fields within the life science sector including medical devices. J&J?s medical device investments are highly varied in both size and structure, the structure may involve milestone payments or may be an equity investment. J&J is interested in early stage medical device companies located globally.