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InterWest Partners
Doug Fisher
PartnerIR2Dx
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.
Lesli Fellman
Founder / VP FinanceRobert Maurer
CEO
Iron Horse Diagnostics
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.
Robert Bowser
CEOAndreas Jeromin
CSO
Ischemia Care
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.