Ted Tarasow United States

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.

Year Founded
2011
Main Sector
Medtech Subsector
Indication
Medtech Phase of Development
Technology Overview
TMI is currently developing the POINT-GUARD™ Cerebral Embolic Protection System with VARIFLEX™ Conforming Technology.
Current Financing Needs
Seed & Series A Funding
Current Timeline
Pre-Clinical Development
Current Investors
Private Investors & Founders
IP Status
US/PCT Applications Filed; US and WO Publications
Transverse Medical, Inc.
Director 

James Taylor

MidCap Financial is a commercial finance firm that was founded in 28 with offices in Bethesda MD Chicago IL and Los Angeles CA. The firm focuses on providing debt financing solutions to healthcare companies. The firm generally provides loans of around $15 million and is involved in approximately 15 new deals each year. The firm considers companies located around globe.
MidCap Financial LLC
Director 

James Taylor Canada

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/

Year Founded
2010
Biotech Phase of Development
Current Financing Needs
PNI is currently raising Series A financing.
Recent Milestones
PNI launched its flagship NanoAssemblr Benchtop and SUB9KIT products in H2 2013. Since that time, PNI has seen significant latent demand for its products and is rapid expanding product manufacturing to satisfy market need. Additionally, PNI has achieved important technical milestones in it's large-scale nanomedicine platform and SUB9KIT products.
Management Team Highlights
PNI’s management, directors & advisors have collectively contributed to over 100 patents and 500 papers, started over 20 biotech companies, raised over $1B in financing/deals and have brought 4 drugs to market. PNI’s CEO, Dr. James Taylor has over 10 years of experience in commercializing biotech and has lead PNI since invention. PNI’s COO, Dr. Euan Ramsay, has 13 years commercializing biotech, has secured over $40M in leveraged financing, and has developed nanomedicines to clinical trials.
Precision NanoSystems
CEO 

Denise Terry United States

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.

Year Founded
2012
Main Sector
Medtech Subsector
Medtech Phase of Development
Technology Overview
mobile, Web, iOS, Android
Supporting Metrics or Evidence
550,000 users
Current Financing Needs
$1M seed stage
Current Investors
Astia angel
Recent Milestones
6-figure revenues, over 550K registered users
Management Team Highlights
Denise Terry, CEO (8x startup veteran, 3 exits); Jan Rydfors, MD, FACOG - Author of Clinical Handbook of Obstetrics, Gynecology, Infertility
EmbraceHer Innovations, Inc.
Cofounder & CEO 

Dr Scott Thacher United States

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.

Website:
www.orphagen.com
Year Founded
2000
Biotech Subsector
Biotech Phase of Development
Technology Overview
Orphagen targets unexplored or “orphan” nuclear receptors (NRs), members of a receptor family that includes targets for major breast and prostate cancer drugs and for anti-inflammatory glucocorticoids. Approximately half of the 48 known NRs are targets for drugs on the market or new compounds approaching FDA approval. These marketed drugs generate in excess of $10 billion in annual U.S. sales alone. The remaining nuclear receptors, the orphans, have potential for design of first-in-class drugs. Orphagen has proprietary methodology, experience and knowhow for identifying drug-like small molecules that turn these receptors on and off. Orphagen’s work with these orphans is based on close relationships with academic laboratories.
Alliance & Collaborations
In 2003-6, Orphagen developed a first-in-class drug discovery program for ROR-gamma, a new target for autoimmune diseases such as psoriasis, rheumatoid arthritis and steroid-resistant asthma. Orphagen licensed its discovery-phase ROR-gamma program to JT Pharma in 2008. In 2013, JT Pharma initiated the first Phase 1 clinical trial for this target. BMS, Merck, Pfizer, Janssen, and Amgen also started biotech partnerships for the same target, but not until 2 to 5 years after JT-Pharma and Orphagen. Orphagen has demonstrated ability as a first mover for novel drug targets.
Supporting Metrics or Evidence
Approximately 50% of all industry partnership deals are done early, at a preclinical stage. Upfront payments for first-in-class drugs can reach $10-15 M and have grown substantially in the last 15 years. Combined later milestones are greater: $100 M to $300 M. First-in-class programs, such as Orphagen’s, are likely candidates for accelerated approval by the FDA, which markedly increases their potential for appreciated value. Orphagen plans to partner its discovery and development programs one by one as they mature. Partnership revenue will be used to expand R&D in Orphagen’s discovery pipeline and, when sufficient, to return capital to investors.
Current Financing Needs
$3 M to accelerate the Orphagen program for retinitis pigmentosa and to support a backup program (SF-1). Orphagen continues to receive significant non-dilutive funding from its ongoing partnership, from grants, and from sale of non-proprietary assay services.
Current Timeline
Orphagen expects to have advanced preclinical proof-of-principle data for retinitis pigmentosa and to execute a value-generating partnership for this indication in 2016. This is Orphagen’s most advanced internal program. Additional lead stage partnerships are anticipated in 2017 and beyond. Orphagen is also exploring revenue-generating partnerships in 2015-2016 for new target screening.
Current Investors
Friends and family, only. Orphagen has a single class of stock, Common stock.
IP Status
Orphagen has filed broad use patents for all ligands to two of its major targets where it has been the first to identify small molecule agonists or antagonists. Its screening technology and lead compounds, which are new chemical entities, are maintained as trade secrets.
Recent Milestones
2010-14 Phase 1 SBIRs for: (i) prostate cancer; (ii) endometriosis; (iii) glioblastoma; (iv) retinitis pigmentosa (RP); and (v) Cushing’s syndrome. 2013 File broad use provisional patent application on novel target for RP. 2013 JT Pharma starts Phase 1 clinical trial based on Orphagen strategic partnership. 2014 Structural biology collaboration for SF-1 with pharmaceutical partner. 2014 Initial proof-of-principle for treatment of RP in an animal model of disease. Identification of target co-crystal structure.
Management Team Highlights
Scott Thacher, Ph.D. Founder, CEO and CSO. Investigator for 15 SBIR grants to Orphagen. Concluded Orphagen’s licensing deal with Japan Tobacco. Previous: Investigator at Allergan. Co-founder: Io Therapeutics. Judy Blakemore. Director Business Development. Former interim COO at Onyx. Business development and transactional advisor for small to mid-size biotechnology companies since 1993. Paul Crowe, Ph.D. Director of Biology, Former Senior Director Pharmacology at Neurocrine. Ruo Steensma, Ph.D. Director of Chemistry, Former Director at Structural Genomix.
Orphagen Pharmaceuticals
LinkedIn logo CEO 
BIO

Scott Thacher, Ph.D., CEO and Director, founded Orphagen in 2001.  He has 30 years of experience in life sciences research and pharmaceutical R&D and led Orphagen to its first partnership in 2008. Prior to founding Orphagen, Scott directed programs in acne, psoriasis, hyperlipidemia, and diabetes at Allergan. Scott was previously on the biochemistry faculty at the Texas A&M College of Medicine (1986-1993) and was a Staff Fellow at the NIH. He holds a Ph.D. in biophysics from Harvard University and a B.S. in physics (Stanford).

Neil Thomas United States

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.

Neil Thomas
Ventac Partners
LinkedIn logo Partner 

Mr Robert Thompson United States

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.

Year Founded
2010
Main Sector
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Supporting Metrics or Evidence
Successful safety studies, animal trials and human proof of concept studies.
Current Financing Needs
$1.1M to regulatory milestone, $2.1M to clinical milestone, $4.6+ M to complete plan
IP Status
Patents issued in US, Europe, Japan and Canada
Amorphex Therapeutics
CEO 

Eli Thomssen United States

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.

Website:
www.armune.com
Year Founded
2008
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
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.
Current Financing Needs
Completing a Series A syndicate of $2.5 million.
Current Timeline
Launching the prostate cancer diagnostic assay as a LDT (Laboratory Developed Test) under the CLIA guidelines beginning Q1 '15.
Current Investors
Angels, MEDC (Michigan Economic Development Corporation), BRCC (Bioscience Research Commercialization Center) and grants.
IP Status
3 patents issues and 6 pending
Recent Milestones
We have developed and validated the prostate cancer diagnostic assay.
Management Team Highlights
Extensive life science experience in both large companies as well as start-ups.
Armune BioScience
President & CEO 

Ms Gail Thurston United States

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.

Website:
www. pxradia.com
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
HD-mAb Technology Platform Potentiates Therapeutic Efficacy of Monoclonal Antibodies
Alliance & Collaborations
Pending
Current Financing Needs
$2M
Current Investors
LH Financial, NYC
IP Status
Files
Recent Milestones
Seed Round Financing
Management Team Highlights
Alton C. Morgan, Serial Entrepreneur & world renown Expert in Monoclonal Antibodies
PxRadia Inc.
VP Corporate Development 

Giles Tilley Australia

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]

Website:
TBA
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
Giardia
Current Financing Needs
seed angel to $1 million
Current Investors
Private
Medifruit Pty Ltd
Director