Innavirvax

Moneesh Chatterjee

Innovation in Medtech

David Cassak
Managing Director 

Intellijoint Surgical

Mr Armen Bakirtzian
LinkedIn logo CEO 

InterWest Partners

InterWest Partners founded in 1979 is a venture capital firm based in Menlo Park California. The firm?s primary focus is providing venture capital to early-stage healthcare and information technology companies. The firm has raised 1 funds to date with over $2.8 billion in committed capital. The firm?s tenth fund closed in 29 at $65 million. The firm generally invests in the Series A and B rounds, initially allocating $8-12 million and up to $2 million over the life of the investment. The firm primarily invests in US-based companies but will also selectively consider opportunities abroad. The firm is actively seeking new investment opportunities.
Doug Fisher
Partner 

IR2Dx United States

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. 

Year Founded
2008
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

In 2002, IR2Dx company founders observed that anti-diabetic therapies reduced adverse cardiology events across multiple drug classes, while at the same time, cardiovascular drugs were reducing diabetes conversions. Further, it has long been recognized that cardiovascular disease is a comorbidity of diabetes. IR2Dx founders concluded that cardiovascular disease and Type 2 diabetes are manifestations of the same underlying conditions, and by analyzing information on relevant markers, treating physicians could be provided with information to help guide drug selection and assess drug response, making improved treatment possible. The research identified pathway biomarkers that significantly elucidate the evolution, and optimal treatment, of the disease while continuing to provide glucose control, throughout the treatment process with a patient. These biomarkers are: high-sensitivity C-reactive protein (hsCRP), intact proinsulin, insulin, adiponectin and C-peptide. Through the IR2Dx patented methods and systems of evaluating the baseline and subsequent levels of these markers, the physician is given a previously unavailable, cost effective window into the pathways and causes of his/her patient’s specific disease, with the opportunity to intervene therapeutically before the disease state progresses further. Specifically, the IR2Dx platform, for the first time in diabetes, provides physicians with easily accessible clinical information to aid in: • Assessment of the current state of a patient’s metabolic pathways; • Determination of the likely further progression of disease; and, • Determination of optimal treatment strategies for the patient.

Alliance & Collaborations
Discussions are underway with commercial laboratory and kit development partners.
Supporting Metrics or Evidence

To date, the IR2Dx diagnostic panel markers have been used prospectively on over 14,000 patients across 35 clinical trials, with over 40 publications. These studies validated the use of the panel markers, and covered patients at all stages of disease including prediabetes, across the range of anti-diabetic drug- classes. These studies demonstrated improvements in group mean HbA1c levels, the present standard for clinical success in the diabetes field.

Current Financing Needs

$12 million, can be staged to support commercial laboratory rollout and kit development ($5 million), and further clinical studies ($7 million).

Current Timeline

At commercialization

Current Investors

Friends & Family, Founders, Physicians

IP Status

Patents issued in US and Europe

Management Team Highlights

Highly Experienced Team. CEO has over 40 years in the diagnostics field (including 17 years at Abbott Diagnostics), and all management team members have over 30 years in biotech. Many of our key advisors are well recognized world leaders in diagnostics, diabetes and cancer.

Lesli Fellman
Founder / VP Finance 
Robert Maurer
CEO 

Iron Horse Diagnostics United States

 

 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.

Year Founded
2012
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Alliance & Collaborations
Biogen Idec
Current Financing Needs
$1,000,000
IP Status
4 issued patents
Robert Bowser
CEO 
Andreas Jeromin
CSO 

Ischemia Care United States

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.

Website:
www.iscdx.com
Year Founded
2009
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
Blood test for cause of stroke. The test (called ISCDX) detects immune responses by RNA expression related to causes of stroke, including AF, within minutes of event. ISCDX is ordered by a clinician at a hospital after a stroke has occurred, a tube of blood is drawn, sent to the ISC CLIA laboratory, results are reported to the physician during patient hospitalization , and paid through the hospital under existing reimbursement (DRG) codes. ISCDX may reduce cost by $7,000 per patient and increase hospital revenue.
Alliance & Collaborations
Medronic, Affymetric, Cleveland Clinic, MUSC, Allegahany Health Network, Albert Einstein Medical Center, UCLA.
Supporting Metrics or Evidence
14+ years, 600+ patients of data, 5 patents, $5M Federal Funding (pre licensing by ISC), and publications in major peer reviewed journals. Previous research has demonstrated sensitivity/ specificity > 95%. ISC reached milestones faster and with less investment than comparable exits.
Current Financing Needs
ISC is raising a $5M series C at $6.5M pre money, with $2.5M closed. ISC previously raised $2.3M in equity and $1.4M in non dilutive funding, further demonstrating commercial and technical merit.
Current Timeline
ISC is following proven commercial pathway. The BASE clinical trial will serve as a final clinical validation and build sales channel to commercially offer the ISCDX test through the company CLIA laboratory. This strategy is similar to companies such as Veracyte and Foundation Medicine (both 2013 IPOs).
Current Investors
Broadview Ventures, Cleveland Clinic (GCIC grant), Queen City Angels, Ohio Third Frontier, Accelerant Fund, and private individuals.
IP Status
5 patents in various stages of prosecution, international filings as well.
Management Team Highlights
Proven management team and board (2 IPOs, multiple exits, past president of AHA, chief of cardiology at Stanford, 4 VC directors), KOLs in the field of stroke (including author of the Stroke Guidelines), strategic support (Affymetrix, Medtronics), and leading stroke center directors.
Jeff June
Jeff June
LinkedIn logo CEO & Founder