Shantanu Gaur
Allurion Technologies was founded in 2009 to develop an intragastric balloon for weight loss that can be administered without surgery, endoscopy, or anesthesia. Obesity is a worldwide epidemic, yet only 2% of patients who qualify for bariatric surgery go on to be treated. Several endoscopic weight loss techniques are under development for the overweight and obese population, but they are restricted to the gastroenterologist call point and more expensive due to the costs associated with endoscopy and anesthesia.
Allurion's Elipse intragastric balloon is swallowed and excreted and can be delivered without endoscopy or anesthesia, thereby making it accessible to non-endoscopists and to consumers at a lower price point.
Allurion is currently a clinical-stage company seeking funds for further clinical work and OUS commercialization.
Allurion Technologies
Sergio Gazic
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:
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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.
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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).
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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
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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.
AZ Commerce Authority
Bioscience Portfolio ManagerMaurits Geerlings
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.
Formula Pharma
CEOCarl Genberg
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.
N8 Medical
CTODr Chris Gibson
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.
Amanda Gillon
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.
BioScience Managers
Investment AnalystNorm Gitis
Lymo Investments is a multi-family venture fund based in Silicon Valley, CA. The firm is an active investor in the medical device sector, and is interested in opportunities worldwide. Initial investments are typically about $50,000 with the potential for follow-on investments totaling $500,000, and may be structured as equity or as debt. Lymo Ventures does not invest in seed rounds. In the recent past Lymo Investments has allocated new investments at a rate of approximately one every two months. The firm offers support and expertise to portfolio companies but does not seek a board seat.
Lymo Investments
FounderAnton Gopka
ATEM Capital
CEO General PartnerEric Goslau
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.