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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. 

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.

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.

Jump Capital was founded in 2012 and is based in Chicago, with an additional office in San Francisco. The firm is investing from a $250m fund, and is interested in a variety of sectors including the life science field. For life science investments, Jump Capital typically allocates $2-15 million, and prefers to invest in Series B-C rounds. Jump Capital invests in the USA and Canada, and has previously invested in 6 healthcare companies.

Jump Capital invests in medical devices, diagnostics, digital and mobile health, and healthcare services. The firm is open to opportunities in any clinical indication. Jump Capital is only interested in devices and diagnostics that have in-human data.

JVC Investment Partners is a private investment firm that was founded in 2000 and is based in Chicago, Illinois. The firm focuses on investments in the healthcare industry. The investment size can vary greatly and is very flexible depending on each company’s needs. The firm provides venture capital and growth capital to healthcare companies. For early-stage investments, the firm targets companies that provide solutions for hospital acquired infections, medication errors, healthcare system operational efficiency enhancements and cost reductions, and chronic disease management, and it typically invests equity or convertible preferred equity in post series A rounds. For growth investments, the firm targets companies with compelling products and strong position in niche markets and with an EBITDA in excess of $2 million. The firm primarily invests in companies based in US.

Life Science Angels Inc was founded in 2004 and is based in Sunnyvale CA. The group makes early-stage equity investments in a wide range of life science companies. Life Science Angels invests primarily in California but is open to investing out of state provided a round is being syndicated with a local angel group. Life Science Angels does not rule out investing outside the USA but has yet to do so. The group invests as individuals and allocation sizes are therefore highly varied but are usually of about $2-$6, Life Science Angels usually invests in rounds seeking $3 million or less. The group is interested in syndicating rounds with other angel groups.

Life Science Nation (LSN) is the premier sourcing platform for market intelligence and prospect pipeline development in the life science arena. LSN enables life science professionals to generate a list of qualified global targets that are a fit for their company’s products, services, and fundraising efforts. The ability to generate these Global Target Lists (GTLs) makes life science professionals more effective and efficient.