Robert Maurer 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.

IR2Dx
CEO 

Allan May

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.

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Life Science Angels
Founder 

Ian McBeath Canada

Naegis, based in Vancouver, British Columbia, is developing novel, small-molecule leukotirene synthesis inhibitors (LTSIs) for serious inflammatory conditions.  The Company is currently focused on two proprietary programs: 

topical and oral therapy for Uveitis, a condition that is responsible for 10% of legal blindness in the US and for which there are limited therapeutic options. 

o oral therapy for Chronic Obstructive Pulmonary Disease (COPD),  a serious lung disease with increasing rates of mortality.

Naegis has developed a large library of LTSIs that are potent inhibitors of either 5-LO or LTA4H.  The Company is currently identifying a lead compound for selection for futher development for ocular disease, in particular Uveitis.

The Company is also advancing a series of compounds that are novel structures and highly selective and potent inhibitors of LTA4H, which are expected to be developed as new therpaies for COPD

Naegis is seeking pharmaceutical partners and capital investment to advance more rapidly their novel programs.

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Technology Overview
Leukotrienes are key inflammatory mediators implicated in many diseases. There is growing evidence of their central role in Uveitis. 5-LO inhibitors have been shown to reduce the clinical signs of uveitis in animal models. Naegis is developing potent 5-LO inhibitors that are both topically and orally active, with unique structures that are not expected to have the limitations of earlier 5-LO inhibitors. In COPD recent evidence has demonstrated the critical role for LTA4H in the progression and persistence of the disease. However it has recently been shown that LTA4H has a dual role and functions as both a pro and anti-inflammatory. Thus it is necessary to identify compounds that are active only against the pro-inflammatory function of the enzyme, whilst sparing its anti-inflammatory effects. Naegis is developing highly specific inhibitors of LTA4H that inhibit only the anti-inflammatory activity of LTA4H.
Alliance & Collaborations
In discussion
Current Financing Needs
$500,000 - $1,000,000
Current Timeline
Lead
Current Investors
Private.
IP Status
Proprietary compounds
Management Team Highlights
CEO - Dr. David Burgoyne an experienced medicinal chemist who has developed compounds that are in current human clinical trials. Also on the Board are Dr. Philip Davies, formerly Executive Director of Research and Area Head of Immunology at Merck, New Jersey. Also Dr Julia Levy, founder of QLT and developer of the first effective therapy for macular degeneration.
Ian McBeath
Naegis Pharmaceuticals Inc.
Corporate Development 

David McCaleb

Website:
www.susavion.com
Susavion Biosciences Inc.
Consultant 

Fred McCoy United States

NeuroTronik Limited is a development-stage, venture-backed medical device company pursuing a unique neuromodulation approach to improve cardac output for patients who come to the hospital with Acute Heart Failure Syndrome. With a seasoned team of engineers, advisors, and investors, NeuroTronik is on-track in project milestone achievement. Though a moderately-sized project, the market potential is exceptional.

NeuroTronik is planning a $20 million Series B preferred stock financing in late 2015. Those proceeds are designed to take the therapy through and into commercial sales in Europe.

Our named investors are Hatteras Venture Partners, Synergy Life Science Partners, Mountain Group Capital, and Lord Baltimore Capital.

The CEO is Fred McCoy. The CTO is Steve Masson.

Year Founded
2012
Main Sector
Indication
Medtech Phase of Development
Technology Overview
Neuromodulation independently engaging both cardiac parasympathetic and sympathetic nerves via electrical stimulation through a temporarily-placed electrode set, controled by a bedside NeuroModulator.
Alliance & Collaborations
Venture-backed.
Supporting Metrics or Evidence
Clearly demonstrated in canines. Early human work is positive.
Current Financing Needs
$20 million Series B late 2015.
Current Timeline
CE Mark and Europe launch 2017.
Current Investors
Hatteras Venture Partners, Synergy Life Science Partners, Mountain Group Capital, Lord Baltimore Capital
IP Status
Licensed and owned. Allowances have started.
Recent Milestones
Series A second tranche earned September 2014
Management Team Highlights
Fred McCoy, CEO: 30+ years experience, former Guidant and Eli Lilly. Steve Masson, CTO: 30+ years experience, former Cordis, Ventritex
NeuroTronik Limited
CEO 

Constance McKee

Manzanita Pharmaceuticals
CEO 

Ashley McMaster United States

The Advanced Medical Technology Association (AdvaMed), is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed represents 80 percent of medical technology firms in the United States and acts as the common voice for companies producing medical devices, diagnostic products and health information systems. AdvaMed members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 40 percent purchased annually around the world. AdvaMed's member companies range from the largest to the smallest medical technology innovators and companies.

AdvaMed 2015 - October 5-7, San Diego - is the leading MedTech Conference in North America, bringing more than 1,000 companies together in a uniquely multifaceted environment for business development, capital formation, innovative technology showcasing, world-class educational opportunities and networking. An event rich in international flavor and featuring a deep, diverse attendee list that includes influential policy-makers, business executives and media, AdvaMed 2015 seeks to advance industry discussion from key perspectives through detailed panel sessions, executive forums and more. It is a “must-attend” event for any MedTech company.

Service Provider Type
Sector Interest
Medtech Phase of Development
Unique Capabilities

AdvaMed 2015 is the place where medical technology leaders meet for business development and investment opportunities.  Emerging medical technology companies connect with top industry decision-makers at AdvaMed 2015 to explore strategic business development and capital formation.

Corporate business development professionals and investors will:

  • Discover the latest medical technologies and innovations during the Innovation Showcase and the MedTech Innovator competition;
  • Gain insights into the key investment issues and industry trends during the Funding Forums and Business Development & Finance Panels.

Innovators and early-stage companies will:

  • Learn how to develop an actionable strategic plan in the Entrepreneurship Boot Camp;
  • Pitch their technologies to investors during the Innovations Showcase and explore strategic business development opportunities through MedTech Partnering.
AdvaMed
Associate Vice President, Membership and Business Development 

Matt McNamara Australia

BioScience Managers is a venture capital life science investment firm headquartered in Melbourne, Australia. The group makes equity investments from $3M-5M and anticipates about 6 new investments this year. BioScience Managers invests globally. 

BioScience Managers will invest in companies across the life science space, including therapeutics, diagnostics and medical technology. The group does not invest in service providers. BioScience Managers considers all subsectors and indications, including orphan indications. The group will consider technology either in or prepared for human clinical trials and is open to all classes of devices. BioScience Managers seeks investments in novel technology and is not looking to gain share of an existing market. 

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
BioScience Managers
CIO 

David Mejia

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. 

Biotech Phase of Development
Medtech Phase of Development
Unique Capabilities

Life Science Investor Profiles, LSN has sourced validated and maintains the largest global database of investor profiles. LSN defined 10 categories of Life Science Investor;

·         Private Equity

·         Venture capital

·         Family Offices

·         Corporate VC

·         Angel Groups

·         Large Pharma/ Biotech

·         Alternative Institutional Investors: Pensions, Endowments

·         Endowments/Foundations

·         Hedge Funds

·         Government Grants

Marketing Services, LSN consults on branding, messaging, and outbound marketing strategies. This includes developing a tagline, elevator pitch, executive summary, corporate power point presentation, and new or updated website design to fit your brand and message. LSN will develop a Global Target List of prequalified candidates to target for marketing initiatives.

Life Science Nation