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Arizona’s bioscience and health care industry benefits from strong relationships with major institutions, hospitals, private firms and the state's public universities. CNBC ranks the state second nationwide in availability of skilled workforce, and biomedical jobs are growing three times faster than the national average.  In addition to our aggressive incentive programs, Arizona is committed to attracting and supporting quality companies through competitive tax policies and has demonstrated a continued trend of reducing property, individual sales and corporate income tax rates.  An example of some of the key programs and incentives for the biosciences includes:

• AZ Innovation Challenge – $3 million ($1.5 million twice yearly) for technology commercialization to the world’s most promising technology ventures. Awards range from $100,000 to $250,000 per company.

• Angel Investment Tax Credit - provides tax credits up to 35% for investors who make capital investment in small businesses certified by the Arizona Commerce Authority (ACA).   

• Arizona Innovation Accelerator Fund - an $18.2 million loan participation program to stimulate financing of small businesses and manufacturers by providing debt financing up to $2 million.  Recognized by the US Treasury as a Best Practice model of its kind

• R&D Tax Credit/Refund – refundable and non-refundable programs for increased R&D activities.  Income tax credits up to 34% for qualified expenses. Up to 75% of the excess tax credit can be refunded.

Formula Pharmaceuticals is a US-based oncology focused biotech company, developing Chimeric Antigen Receptor (CAR) based therapies using a proprietary platform.

Formula's CAR therapies involve allogeneic immune effector cells and a NON-viral transfection method for highly efficient cell expansion and differentiation. Additionally, Formula's target effector cells primarily involve Cytokine Induced Killer cells, instead of T-cells or Natural Killer cells. These various characteristics offer distinct practical, clinical, regulatory and commercial benefits over other CAR approaches that involve autologous cells and viral transfection methods. Although not yet in clinical stage development, Formula believes that its CAR based development program will catch up with competing clinical-stage development programs, based on the significant CMC and regulatory advantages that Formula's CAR approach offers.

Formula is interested in meeting with investors and prospective pharmaceutical/biotech partners. Near-term value driving milestones (including clinical trial results) are expected within the next 2-3 years.

Significant industry and investor interest in CAR based therapies have been established over the past 12 months, with 4 leading industry players (Pfizer; Novartis; Celgene and Juno Therapeutics). Formula's CAR therapy is distinctive, and is believed to offer significant advantages of the aforementioned CAR technologies. CARs represent a new and important paradigm for cancer therapy, with the leading pharmaceutical players expected to acquire and develop their own position into this space.

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.  

The Problem: Pharmaceutical development has traditionally focused on intense study of an explicit molecular target related to a specific disease of interest. This strategy is costly and inefficient.

The Solution: We have developed technology that can be scaled to quickly, precisely, reliably, and simultaneously model thousands of genetic diseases in human cells and evaluate the effect of thousands of individual drugs on those disease models. We've built a computational platform that recognizes structural changes in millions of diseased cells and then identifies drugs that return those diseased cells to a healthy state.

Proof of Concept: We have already used an early version of this platform to discover a potential treatment for one genetic disease. We have IP for this drug, and have already been approached about licensing.  We are scaling our platform now to enable us to achieve our goal of discovering and partnering to bring to market treatments for at least 100 genetic diseases in 10 years.

TRANSVERSE MEDICAL INC is an early stage medical device company focused on the development of innovative technologies addressing the market of aortic embolic protection for Transcatheter Aortic Valve Replacement (TAVR), cardiovascular percutaneous interventions and surgical procedures. TMI’s proprietary Point-Guard™ technology is uniquely designed with the capability to conform to the aortic arch anatomy, deflect and filter embolic material from entering the major cerebrovascular arteries, collateral and adjacent arteries, and upon completion of procedure, safely and effectively remove the system with captured embolic debris.

Stroke rate is substantial in many established and emerging cardiovascular procedures.  Of particular interest in the field are the new Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Aortic Valve Implantation (TAVI) procedures.  There clearly exists an unmet need for an embolic protection and capture device that can be utilized during the procedures to significantly reduce acute strokes and adverse ischemic events, particularly in heart valve implantation & repair.

The risk of cerebral events and the need for protection during Transcatheter Aortic Valve Replacement is well documented in the literature and discussed by highly recognized key opinion leaders at major medical conferences around the world.  Stroke and the incidence of silent embolic events during TAVR are associated with high patient morbidity and mortaility.  This awareness of stroke, reported early on in the range of 2% to 11% prior to standardized endpoint definitions, is a concerning complication during TAVR and may have been attributed to early generation devices.  However, stroke continues to be reported in TAVR with rates in the range of 0.6% to as high as 7%, remaining roughly double those associated with surgical aortic valve replacment (SAVR). While the clinical and technical challenges of TAVR will continue to be addressed through lower profile devices and operator experience, the risk of stroke remains a major concern.

The market opportunity and adoption for TAVR continues to grow worldwide with a CAGR estimated at 19.8% (2014 to 2018) and worldwide market sales projection of $2.9 Billion in 2018. (Source: David Roman, Managing Dir., Global  Investment Research, Goldman, Sachs & Co.). The TMI Leadership Team estimates the Cerebral Embolic Protection Device (CPD) market to be at a conversion rate to CPD during TAVR at 50% by 2018, with worldwide market sales for CPD estimated at approx. $280 to $480 Million with an ASP of $3-5K. The Point-Guard™ advantages are expected to allow it to be used in 50% or more of such cases, projecting gross worldwide revenues of around $146 million by 2018.  Complications are limiting market growth (i.e., stroke) - - Controlling stroke (i.e., Point-Guard) can expand the markets and accelerate the expansion of TAVR use to lower risk patients, capture a larger portion of high/intermediate risk patients, set the "standard of care" (e.g 100% carotid filter use in US), and set the standard for other procedures (EP, AF, LAA, etc.).  Preliminary data presented at TCT 2014 by Dr. Axel Linke of University of Leipzig Heart Center in Leipzig, Germany showed significant reduction in early cerebrovascular accidents (CVA). Median Total Lesion Volume reported a 65% Reduction; Median Lesion Number reported a 57% Reduction; Rate of CVA reported a 67% Reduction. 

TMI is currently developing the POINT-GUARD™ Cerebral Embolic Protection System with VARIFLEX™ Conforming Technology. Point-Guard™ is the first complete embolic protection system engineered with VariFlex™ conforming technology, uniquely designed to conform to the aortic arch and branch artery ostia addressing the concern and possibility of residual flow redirecting around current embolic protection devices. The integration of VariFlex technology allows for maximum wall apposition to cover the aortic arch branch arteries with variable flexibilty and positioning. All other CPDs in the market have only met one or two areas of concern for CPD (Freeman, et al – “With all the embolic protection devices, potential limitations exist.”).  The Point-Guard is the only aortic embolic protection device designed to address all key features and functions of embolic protection during TAVR: conformity, deflection, filtration, and capture of emboli upon removal. Point-Guard will be the first cerebral embolic protection system to completely meet operator and procedural needs through ease of use, a low profile, safety and efficacy, compatible, and rapid delivery.

The Point-Guard™ is a class II product in the USA and can be cleared using the 510(k) process, with clinical trial results.  The number of clinical trial patients required is to be determined, but anticipated to be fewer than 100, including EU CE Mark clinical trial patients.  The CE Mark will be pursued first and is expected to require 50 or fewer patients with 30 day post-procedure follow-up.

TMI has raised $500K in private funding to date, is seeking additional seed funding of $1 million and series A funding of $6 million. 

Seed Funding will allow for completion of concept development & design freeze, pre-clinical development, testing, in vitro & in vivo studies, and first in human experience. Full Series A Funding will support European clinical trials (FDA Compatible), clinical product manufacturing & readiness, CE Mark approval & European pre-commercialization launch, strengthen IP and Filings, and general operation & administration.

Acumen Pharmaceuticals, Inc.

Direct to Brain Soluble Aβ Oligomer Selective Immunotherapy

First/Best in Class Therapy for Alzheimer’s Disease

Right Target - Right Patients - Right Delivery.  ACU-193 is Acumen’s monoclonal antibody drug candidate that targets soluble amyloid-beta oligomers (sAβo) with high affinity and selectivity.  Acumen is developing ACU-193 for direct intrathecal delivery to the brain via a device collaboration designed to increase the probability of early clinical success and enhance long term commercial potential.

The Only Alzheimer’s Immunotherapy Specifically Targeting Toxic sAβo Using Direct Brain Delivery.  ACU-193 is a late-preclinical, fully humanized monoclonal antibody that selectively targets sAβo, the primary pathologic agent in Alzheimer’s.  Composition of matter and use patents for ACU-193 run through 2030; and further IP protection is available.

Acumen is establishing an exclusive collaboration for access to FDA/CE approved chronic infusion pump systems for direct to brain drug delivery.  ACU-193 and direct brain delivery positions the program as a scientifically and clinically differentiated approach to Alzheimer’s with attractive long-term commercial and therapeutic potential.

Program Profile & Positioning

Scientific Background & Program History.  SAβo are widely recognized as the primary neurotoxins responsible for the acute cognitive deficits and progressive neurodegeneration in Alzheimer’s disease.  SAβo are non-fibrillic assemblies of Aβ peptides, and are distinct from protofibrils, fibrillar Aβ, and β-amyloid plaques.  Brain levels of sAβo are 3-8 orders of magnitude lower than levels of β-amyloid plaques or monomeric Aβ.  They are elevated in the Alzheimer’s brain, and studies suggest a correlation between levels of sAβo and cognitive deficits in Alzheimer’s.  SAβo bind with high affinity to mature synapses, most likely to a small number of highly selective neuronal receptors.  Binding to these receptors interferes with normal neuronal function leading to memory loss and neurodegeneration.  Because sAβo are present at concentrations that are 3-8 orders of magnitude lower than non-toxic monomeric and fibrillar Aβ, they are an optimal immunotherapeutic target.  However, because only approximately 0.1-0.2% of peripherally administered antibodies cross the blood-brain-barrier and reach the brain, brain exposure of peripherally administered antibodies may limit their therapeutic efficacy.  Acumen is pursuing intrathecal delivery of ACU-193 to ensure therapeutic levels of the drug candidate reach the brain and achieve effects.

Effects of sAβo.

Acumen pioneered research on sAβo.  The company’s anti-sAβo antibody program was licensed to Merck & Co. in 2003 for significant upfront and milestone payments.  ACU-193 is a third generation product of the ~8 year/~$70M partnership with Merck.  Merck advanced the program to a late preclinical development stage.  In November 2011, as part of Merck’s restructuring following its merger with Schering Plough, Acumen reacquired all rights to the program including ACU-193, backup molecules, and substantial IP with no financial or take-back rights obligations to Merck.

ACU-193 Details.  

• Humanized, affinity-matured, IgG2 monoclonal antibody with uniquely high selectivity for sAβo.

• Prevents binding of sAβo to neurons and sAβo toxic effects at synapses.

• Brain penetration, target engagement and robust biochemical and behavioral efficacy demonstrated in mouse models of Alzheimer’s.

• Excellent pharmacokinetics, bio-distribution and brain penetration demonstrated in 4 animal species.

• Excellent safety profile in exploratory studies in rhesus monkeys.

• GMP production cell lines and the necessary analytics established.

• Drug delivery collaboration with Medtronic for direct brain delivery.

• Companion diagnostic biomarker assay established.

• Composition of matter and use patent protection through 2030.

Our clients are early-stage biotechnology, medical device, diagnostics and pharmaceutical service companies. When we begin working with a client they are frequently looking to complete proof-of-concept studies, secure intellectual property and other critical preliminary tasks. Typically we raise the first round ($1 - $5 million of capital) needed to accomplish these milestones, usually, but not always from angel investors. After key milestones have been achieved using that money, we generally follow by raising a second round of $5-20 million, usually institutional money, for development and growth

By working this way, we increase our clients' success rate raising capital and building their companies and the returns to the investors we bring into those companies. We have raised over $80 million in early stage funding for our clients (in Seed, Series A and Series B rounds) and delivered realized returns, so far, over $500 million—a realized return to date of over 6X—to the investors who provided that early stage capital, with a number of the companies still driving towards an exit that may increase that figure. Realized (cash-on-cash) internal rates of return for a hypothetical investor who participated in each round of financing offered by WG&A to date exceeds 65% annually.

Volcano Capital is a family office/venture capital firm based in New York. The firm manages an evergreen fund that operates free from the constraints of traditional venture capital funds. The firm seeks to make seed, venture, and growth equity investments in early to mid-stage medical device companies, but will also consider secured debt to help revenue generating companies with short term cash flow issues. The firm will also consider pre-seed investments. The firm can allocate anywhere from $1M to $10M per company, but generally allocates around $8M. The firm typically does 3 rounds of financing with an initial investment of around $3M. The firm is geographically agnostic, but highly prefers to invest in companies that are based in the US. The firm seeks to make about 3-4 allocations in the next 6-9 months.

Volcano Capital is currently looking for medical device companies with a strong emphasis on products with a 510(k) regulatory pathway. In terms of subsectors, the firm is looking for products specifically in the areas of interventional radiology and cardiology, spine/orthopedics and minimally invasive surgery. The firm is generally opportunistic in terms of indication.

NSF Health Sciences offers clinical, regulatory, and quality consulting services across the total product lifecycle for innovative medical device, pharmaceutical, and biotechnology companies.  We specialize in helping companies balance FDA and worldwide regulatory requirements with their business needs. 

BIOARRAY is a biotech company located at the Science park in New Haven. BIOARRAY is customizing treatments for patients to cure breast cancer the first time. BIOARRAY’s lead breast cancer test has been shown to reduce ineffective treatments by over 50% in proof of concept studies. BIOARRAY is a recipient of Avon Foundation and Connecticut Innovations funds. BIOARRAY is a MassChallenge Accelerator Winner.