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Aspect Biosystems uses proprietary bioprinting and cell culture technologies to create high quality living 3D human tissues.  We aim to improve the pre-clinical drug discovery process by providing pharmaceutical companies and researchers with functional living tissues that better predict the human response to drugs.  Our testing platforms will enable pharmaceutical customers to identify failed drugs earlier in the development pipeline, before expensive clinical trials begin.  Aspect Biosystem’s long-term vision is to create human tissues on demand for multiple applications including cosmetics-testing, personalized medicine, diagnostics and regenerative medicine.

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.

Kineta® is a nationally-recognized biotechnology company focused on developing leading edge therapeutics in three large high need therapeutic areas: autoimmune disease, viral disease and chronic pain. Our company is focused on the development of novel drug candidates each the outcome of years of scientific exploration and supported by an extensive body of peer-reviewed NIH-supported research.

 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.

Regulating Nitrosylation for Multi-Disease Therapies

SAJE Pharma’s S‑nitrosoglutathione reductase (GSNOR) inhibition technology regulates nitric oxide signal transduction pathways that are critical for multiple therapeutic benefits.  SAJE’s small molecule drugs regulate nitrosylation by inhibiting GSNOR.  Many biologists consider that “Nitrosylation is the new phosphorylation”, meaning that nitrosylation regulates cell pathways as directly as does phosphorylation.  The big advantage for SAJE is that there is only one human GSNOR to inhibit as compared to 100’s of phosphorylation targets, making it a much more “druggable” target with less possibility for off-target toxicity.  SAJE and its collaborators have discovered that GSNOR inhibition reduces: inflammation, oxidant damage, fibrosis, mucus accumulation, and bronchoconstriction.  Such multiple therapeutic efficacies by inhibiting only one enzyme with small molecules is unprecedented in pharmacology.  SAJE is focused on idiopathic pulmonary fibrosis and asthma as its first clinical applications, although there is animal data for efficacy in other diseases including cardiovascular, metabolic, inflammatory, liver, kidney, and other respiratory.  One GSNOR inhibitor has shown Clinical Proof of Concept for GSNOR as a target in a Phase IIa trial in asthma.

SAJE Pharma’s executive team consists of experienced drug development scientists and serial entrepreneurs whose backgrounds include FDA, large pharma, start-up companies, and the CRO industry.

SAJE has licensed one patent app that is nearing issuance in the EU and the US.  It protects SPL-334, SAJE’s lead molecule, and other related molecules.  In addition, SAJE is close to filing 3 more patent apps on its novel compositions that inhibit GSNOR.  A clear advantage for our drugs compared to many novel therapies  is the cost of goods.  Our drugs will cost pennies per dose.

SAJE would like to raise $15 MM to take SPL-334 through a Phase IIa trial in IPF.  The drug is ready for IND-enabling studies.  The company’s exit strategy is to out-license each of its drugs and their accompanying data set, one at a time, for different diseases in different categories.