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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.

Precision NanoSystems Inc. (“PNI”) has developed proprietary technology (NanoAssemblr) and companion Reagent Kits (SUB9KITS) that enable the simple manufacture of novel nanoparticles that are used to delivery genetic and small molecule medicines (nanomedicines). Nanomedicines are the "FedEx" of the health-care industry and are used for cell-specific delivery of research tools, diagnostic imaging agents and drugs to study, diagnose and treat disease. PNI's products are commercialized and in high demand from many of leading RNA and small molecule therapeutic biotechnology and pharmaceutical companies.  http://www.precisionnanosystems.com/products/

EmbraceHer is the women's reproductive health club developed by clinicians. We support the lifetime reproductive health of every woman from menstruation, fertility preservation, conception, infertility/IVF, maternity, postpartum, lactation, sexual health and menopause. Our digital platform provides targeted, clinically-sound health education, subscription-based telehealth services, and doctor-curated medical and health products for women. 

Our maternity product is the only mobile digital health offering developed and prescribed by Board-certified obstetricians, used by over half a million pregnant mothers.

Orphagen’s focus is small molecule discovery at novel drug targets. We create programs leading to first-in-class drugs. Our goal is to partner these with development stage pharmaceutical companies.

We have been first mover in creating three discovery programs for novel targets, including one program that initiated Phase 1 clinical trials with a strategic partner (JT Pharma) in 2013 for autoimmune disease.

We work with novel drug targets from a very productive target class, the nuclear receptors.

Our work has so far been funded by $15 M in federal grants and partnership revenue. Orphagen is in the process of raising equity funding to accelerate current programs.

Orphagen’s lead internal program is for retinitis pigmentosa, the major form of hereditary blindness. Closely following are antagonists to SF-1, a promising target for treatment of Cushing’s syndrome, a life-threatening endocrine disorder, and two cancers with an endocrine connection: prostate cancer and adrenocortical cancer. New target screening may lead to first-in-class programs for glioblastoma, sickle cell anemia, and cancer immunotherapy.

Ventac Partners is a dedicated life science investment and consulting firm with offices in Europe, USA and Asia. Ventac Partners has a strong track record in founding new innovative companies, fund raising and supporting M&A transactions.

All partners are experienced and hands-on life science entrepreneurs with proven track-record in successfully starting, funding, growing and expanding international life science companies.

Amorphex Therapeutics is an early clinical stage company that was founded to develop products for sustained ophthalmic drug delivery using patented TODDD™ technology. Topical ophthalmic pharmaceuticals are a $5+Billion market, but inaccurate and inefficient delivery systems, poor compliance and excessive side effects undermine their clinical benefits and true sales potential. TODDD™ is a soft, non-invasive device that is completely concealed under the eyelid and continuously delivers therapeutic levels of drug 24/7 over several months. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t contain appreciable water and avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health (NIH-SBIR) grants for the TODDD™ technology totaling $2.5 million.

TODDD™ has issued patents in major markets and has been successfully tested in safety studies, animal trials with drugs and without drug in humans.

Amorphex is seeking to fund small, 30 - 40 subject, human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications.  These milestones will drive dramatic increases in valuation and corporate partner interest.

Armune BioScience is a medical diagnostics company formed to develop and commercialize unique technology for diagnostic and prognostic tests for prostate, lung and breast cancers. The technology is unique because it utilizes autoantibodies created by the body’s own immune system to detect cancer at an early stage. When the immune system recognizes a cancer antigen it creates an autoantibody to the antigen which is replicated by the immune system. Armune’s technology can be used to detect these autoantibodies in serum.

Early detection and prognosis of cancer is critical not only in selecting appropriate treatment protocols, but also in increasing 5-year survival rates among cancer patients. Cancer detection in early stages is typically performed by detecting cancer-specific serum antigens. Unfortunately, cancer serum antigens are present at very low levels in early stage disease. Also, a single detectable cancer antigen may not be present in all patients due to heterogeneity of the disease and therefore multiple biomarkers are needed. Detection of serum autoantibody responses to tumor antigens provides more reliable serum marker(s) for cancer diagnosis. Serum autoantibodies are more stable than serum antigens and may be more abundant than antigens, especially at low tumor burdens characteristic of early stage cancer. The technology does not detect cancer per se, but looks for the immune response to cancer.

Armune’s initial focus is on a prostate cancer diagnostic test. The PSA (Prostate Specific Antigen) test is currently used as a prostate cancer diagnostic test and it has good sensitivity (~86%), but very poor specificity (20 to 30%) resulting in high false positive rates (70 to 80%) and many unnecessary biopsies and costs.

PxRadia is applying its HD-mAb technology platform to provide increased therapeutic potency to biosimiliar monoclonal antibodies. These antibodies are directed to validated targets such as Her-2, CD-20 and PD-1/PD-L.  We and our partners will share new IP and rights and differentiation from current products in the marketplace.

We are an Australian Biotechnology Company nearing completion on five year R&D programme into new, novel compounds from natural rare Australian extracts for both the prophylactic and treatment of giardiasis.

Current R&D programmes in both Australia and Boston, MA.

World’s first alternative natural treatment to antibiotic strength drugs of choice against bacteria and protozoa for animals envisages enormous market potential, including human, organic, veterinary and husbandry sectors   

Fast kill rate ‘within 5 minutes’  

Non-Toxic and safe for human and animal consumption.

No antibiotic resistance problems that plague current treatment modalities [due to multiple compounds]

Kills all the life cycle – Pluripotent and treats both the disease and the pathogenesis of the disease in multiple ways

MOA established and known [several]