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N8 Medical is a development-stage medical device company focused upon commercializing antimicrobial medical devices and coatings to address the multibillion dollar public health and economic burden associated with medical device-related hospital acquired infections and healthcare associated infections (HAIs).  N8 Medical’s key differentiator from competitors is the application of a novel, proprietary class of pharmaceutically active compounds known as ceragenins, Cationic Selective Antimicrobials, or CSAs (ceragenins or CSAs) to medical devices for the purpose of providing antifouling or anti-infective properties. N8 Medical believes that ceragenins offer unparalleled efficacy and cost advantages over other coatings and means of addressing HAIs. Further, the use of ceragenins as a platform technology under its CONTEGO™ brand across numerous device segments with multiple coating options provides N8 Medical with a unique, sustainable competitive advantage over other medical device companies.  

N8 Medical is seeking $6 million in investment capital, which it believes will be sufficient to fund development, FDA approval and CE Marking of its proprietary coated CONTEGO™ endotracheal tube (ETT), and initial commercialization activities. N8 Medical has designed its antimicrobial ETT to reduce ICU stays by a single day or more, thereby saving the hospital $3,000 to $5,000 in non-reimbursable costs per ICU patient, and, significantly, by freeing up an ICU bed one day earlier for a new revenue-generating patient and resulting in better profitability for providers and substantial opportunity cost savings.  Thus, N8’s CONTEGO™ ETT presents a compelling value proposition for hospitals.  N8's internal valuation model aligns with relevant market data and comparable companies, indicating a successful antimicrobial device company could achieve a value of over $100 million.  

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: 

o 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.

The Office of Translational Alliances and Coordination (OTAC) at the National Heart, Lung, and Blood Institute supports the development of innovative biomedical products to address unmet medical needs in the heart, lung, blood and sleep fields.  OTAC is home to the NHLBI's small business programs (SBIR and STTR) and the NIH Centers for Accelerated Innovations.

The NHLBI's SBIR and STTR programs comprise one of the largest sources of early-stage capital for U.S. small business, acting as engines of innovation for developing and commercializing novel technologies and products that aid in the prevention, diagnosis, and treatment of heart, lung, blood, and sleep diseases and disorders. The NHLBI provides grant and contract funding opportunities and resources to support small businesses performing research and development on technologies related to the mission of NHLBI. With an annual budget of $85M, the NHLBI funds about 200 companies each year through the Institute's small business programs.

The NIH Centers for Accelerated Innovations accelerate translation of scientific discovery into commercial products that improve health for patients. This unique public-private partnership is changing the way discoveries with scientific and commercial potential are identified and developed.

The National Research Council- Industrial Research Assistance Program (NRC-IRAP) is a Canadian federal government program that offers financial and advisory services to accelerate the growth of businesses through innovation and technology. Regarded worldwide as one of the most successful programs of its kind, NRC-IRAP is a vital component of Canada’s innovation system

Company

Navitas Pharma (Navitas) is developing a new class of cardiovascular drug for the US.  On the basis of recent, proprietary research, Navitas has filed patents for use of its drug platform in three disorders for which no drugs are currently approved in the US.  Each has over 1,000,000 patients in the US:

> Portal hypertension (PHTN; hypertension of the liver)

> Heart failure with preserved ejection fraction (HFpEF)

> Group II pulmonary hypertension (Group II PH; lung hypertension secondary to left-sided heart failure)

Technology Platform

Navitas’ main platform is a new chemical class of compounds, known as furopyridines.  Cicletanine (CIC), the lead drug from this platform, has been launched for hypertension in France, and introduces a new mechanism of action to the US.  The drug activates endothelial nitric oxide synthase (eNOS), thereby reversing endothelial dysfunction, a root cause of hypertension and heart failure.  As part of this eNOS-activation mechanism, CIC has recently been shown to activate protein kinase G (PKG), an enzyme whose inactivation is important in HFpEF.

CIC is significantly de-risked:

> Launched in France for general hypertension, in which the drug has a long-established track record of efficacy and safety.

> Extensive safety data from

   > Clinical trials in >10,000 patients

   > Post-launch pharmacovigilance of ~2 million patient-years in France and Germany

> Clinical proof-of-concept data in several disorders, including

   > Hypertension

   > Group II pulmonary hypertension

   > Hypertensive hypertrophy (relevant to HFpEF)

   > Angina

   > Diabetic claudication

   > Diabetic microalbuminuria (early-stage kidney disease)

> Proof of relevance in an established animal model of portal hypertension

> Extensive data supporting new mechanism of action via eNOS

Target Markets

Portal Hypertension (PHTN; high blood pressure in the liver) is a significant, unmet medical need, with over 1 million patients in the US.  Current treatments involve decreasing blood flow into the liver, either with drugs or with surgery, rather than getting at the core problem of blood-flow resistance in the liver itself.  Recent laboratory research shows cicletanine directly (within the liver) reversing an accepted, reliable animal model of portal hypertension.  CIC looks promising as the first direct treatment of portal hypertension.  Conservative forecast puts revenues at $3 billion. 

Heart failure with preserved ejection fraction (HFpEF) accounted for a minority of diagnosed heart failure until recently.  With about 3 million US patients, it now accounts for 50 – 60% of heart failure diagnoses.   The increasing prevalence of HFpEF is driven to a large degree by metabolic syndrome (“pre-diabetes”) and diabetes.  This is important, as retrospective analysis of hypertension trials have associated CIC with significant decreases in glucose, cholesterol and triglycerides among patients in whom these were elevated.  Additionally, HFpEF is now thought to be driven by inactivation of protein kinase G (PKG), an enzyme recently shown to be activated by CIC.  Navitas therefore believes that CIC has the potential to reverse the root, molecular basis underlying much of the pathology of HFpEF.

Group II Pulmonary Hypertension (Group II PH) is hypertension of the lungs associated with left-sided heart failure.  A small CIC study showed marked improvements in functional status vs. placebo and significant improvement of pulmonary pressures.  The drug appears to have a dual action directly on both heart failure and hypertension within the lungs.  With over 1 million Group II PH patients in the US and no approved drugs, CIC has breakthrough-treatment potential.

Management

Glenn Cornett, MD, PhD (founder, CEO) has over 20 years of consulting and industry experience.  His work at Eli Lily included strategy and financial modeling, including work on licensing Cialis, establishment of a competitive-strategy unit in R&D and a corporation-wide assessment of new therapeutic targets.  At McKinsey, he consulted on engagements in health care, technology and manufacturing.  He also served on the Core Groups for Complexity and Business Dynamics at McKinsey.  While consulting at Los Alamos National Laboratory, Dr. Cornett authored a book on plutonium and public policy.

Running his own consulting firm, Glenn has done financial modeling and structuring for strategic transactions driving the addition of several hundred million dollars of market capitalization to his clients.  Dr. Cornett founded Navitas in 2004 and led it through its first liquidity event 3.5 years later in 2008.  He has run ten marathons (most recently: Cayman Islands in December 2014), and holds a black belt in karate.  He has a neuroscience PhD (UCLA) and an MD (Distinction in Research, U. Michigan).

Mark Alvino (corporate development) has extensive experience in investor relations, public relations and investment banking.  He held senior investment banking positions at Bradley Woods, Griffin and SCO Capital.  At the latter institution, he was responsible for over 20 transactions, driving in aggregate over $500 million of private financings in the biotech / pharma sector.  He was SVP at Ogilvy’s Feinstein Kean Healthcare, a pubic relations business focused on health care.   He was a Vice President at the investor relations firm Allen & Caron.  As an entrepreneur, he founded Advent Consumer Healthcare, where he holds multiple patents on a consumer-health product now available at 7200 CVS stores.  He remains active in competitive sailing.  He holds a degree form George Washington University.

Jim Page, MD, JD, MPH (founder, senior advisor) is a board-certified psychiatrist (residence: Stanford) and graduated first in his law school class.  Earlier, he was in natural resources, where he was a strategist and analyst for Fortune 500 corporations. 

Neurodyn Inc. (neurodyn.ca) is a Canadian biotechnology company using a portfolio approach to identifying, validating and developing natural bioactives into both prescription drugs and natural products for the early treatment of Alzheimer's Disease, Parkinson's Disease and other neurodegernative disorders. 

Memogain® is a patented pro-drug of an existing major Alzheimer's cognition enhancement drug, offering improved side effect profile and increased bioavailability. Initial Phase 1A results have been positive, showing no significant side effects and improved working memory in young and elderly volunteers. Memogain may qualify for a new US FDA accelterated pathway or Eu equivalent.

Cerbella™ is a treatment for early stage Parkinson's disease which has demonstrated in-vivo pre-clinical efficacy in acute models as well as Neurodyn's proprietary chronic model of Parkinson's disease. A product is expected to launch in Canada, USA or other countries in 2015.

NeuroPro® is a professionally-oriented supplement launched in October 2013, designed for neuroprotection and bansed on 5 years of animal model research.

Nerve Pain Treatment (PN34) is a rare first-in-class neuromodulator, being prepared for a topical orphan status nerve paincondition, with clinical trials to begin in 2015.

Progranulin (ND602) is a novel therapeutic demonstrating in-vivo pre-clinical efficacy in ALS, PD< Alzheimer's disease and Spinal Muscular Atrophy. The company is in its third year of collaboration (late stage pre-clinical evaluation) with the Michael J. Fox Foundation.