Texas Medical Center Innovation Fund

James Graham
LinkedIn logo Associate Director 
BIO

Jim Graham joined the Texas Medical Center Innovation Institute in 2014.  Jim brings more than a decade of experience in life science finance, entrepreneurship and commercialization.  Jim began his career in the West Coast office of Alex.Brown, the U.S. investment banking division of Deutsche Bank.  In 2003, he worked for Biogen Idec before moving to the Boston Office of McKinsey & Co.  At McKinsey, Jim served leading pharmaceutical, biotechnology and medical device clients as a member of the Pharmaceutical and Medical Products practice.  In 2009, Jim joined Sante Ventures, an early stage life sciences venture capital firm, where he led a number of investments in medical technologies. He holds a B.S. in Biological Sciences with Honors from Stanford, an S.M. in Biomedical Sciences from the Harvard-MIT Division of Health Sciences and Technology and an MBA from the MIT Sloan School of Management. Jim also holds the Chartered Financial Analyst designation.

Texo Ventures United States

TEXO Ventures is a healthcare venture capital firm that was founded in 29 and is based in Austin Texas. The firm operates as a hybrid of angel and venture capital. The recent fund closed at $15.4 million in 212. The firm focuses on making equity investments in the Medical Technology and Healthcare IT spaces at near commercialization or early commercialization stage. The firm typically invests ranging from $3 million to $5 million into a company. The firm plans to make 2-3 investments over the next 6-9 month. TEXO Ventures is open to consider companies across the US. The firm primarily focuses on healthcare which includes Health IT Technology  enabled Health Services Chronic Disease Management Managed Care and Benefit Design. Although medical devices and functional diagnostics are considered for investment purposes Texo Ventures must see a clear regulatory pathway and obvious synergies with healthcare reform within a company. The firm's current investment portfolio includes companies in the area of medical technology. Within this field they are in areas such as diagnostic and therapeutic radiation devices electro mechanical medical devices re-usable instruments biomaterials and non-active implantable.

Philip Sanger
Managing Partner 

The Angels' Forum

Carol Sands
Managing Member 

Thermalin Diabetes LLC United States

Year Founded
2009
Biotech Subsector
Indication
Biotech Phase of Development
Technology Overview
The first rapid acting U500 insulin for high-dose patients and miniaturizing patch pumps ($3.2B 2025 market). The first never-needs-refrigeration, biphasic and basal insulins for China, India, the Middle East, and Europe. ($12B 2025 market) Ultra-rapid acting (2 hour duration) insulin to enable next generation, “artificial pancreas” pumps. ($5B 2025 market). Plus several more in development.
Management Team Highlights
Michael Weiss, M.D. PhD, Founder and CSO Richard Berenson, CEO Bruce H. Frank, PhD, Vice President of Development Thomas Hattier, PhD, Vice President of R&D Gregory Dube, PhD, Senior Director of Pre-Clinical & Clinical Programs Janine Roberge, Vice President, Finance
Rick Berenson
CEO 

Thetis Pharmaceutcals United States

Year Founded
2011
Biotech Subsector
Biotech Phase of Development
Technology Overview

Thetis has discovered and is in the early stages of developing several compounds in the omega-3 arena that are quite differentiated from existing agents based on its proprietary HEALER Technology. 

  • TP-252 is an ionic derivative of eicosapentaenoic acid that delivers EPA with remarkable bioavailability in animal models. Unlike anything known in the omega-3 arena, TP-252 is a solid, stable, free-flowing drug substance that is suitable for tablet formulations and for potential use in fixed dose combination products with statins.
  • TP-113 (bis-metformin glutamate DHA) is a novel oral agent for treatment of T2DM as a 2nd generation metformin product with substantial differentiating pharmacological attributes and intellectual property protection. Its PPP targets significant HbA1c reduction as its primary clinical endpoint with enhanced pharmacological benefits that include insulin resistance resolution, multiple mechanistic effects on hepatic gluconeogenesis that could translate into lower metformin dosing requirements, and reduced serum triglyceride (TG) levels.
  • TP-352, an ionic derivative of docosahexaenoic acid that delivers DHA with remarkable bioavailability in animal models, has prospects for treatment of NASH based on the anti-fibrotic, metabolic and TG lowering effects of DHA.
  • TP-110 (bis-metformin glutamate EPA) has prospects as a first in class agent for treatment of PCOS based on the clinically established effects of its active moeties for ovulation restoration, reduced insulin resistance and enhanced anti-androgenic effects.  
Alliance & Collaborations
Marette Laboratory
Supporting Metrics or Evidence

HEALER Technology applied to already approved APIs with established safety records.

Current Financing Needs

$25 million to fund TP-113 through Phase IIa

Current Timeline

INDs can be opened on lead candidates within 12 months due to non-clinical safety efficiencies based on prototype candidate already vetted by FDA

Current Investors

Connecticut Innovations and Angel Investors

IP Status

Issued patents (US8765811, US8993124, US8901107) and non-provisional patent applications under petition to make special 

Recent Milestones
  • TP-113 preclinical studies in mice showing PDX formation
  • IND allowance establishing non-clinical safety of Thetis compounds
  • Extensive rodent pharmacokinetic studies demonstrating unique PK properties
  • Pre-formulation feasibility studies completed on lead candidates
  • Issued composition of matter patents on metformin compounds (TP-113/110)
Management Team Highlights

Frank Sciavolino, PhD, Chief Scientific Officer

  • former Pfizer R&D executive (Zithromax) and in-licensing (Celebrex)
  • PhD, Organic Chemistry, University of Michigan
  • Over 30 issued patents

Gary Mathias, MBA, Chief Financial Officer

  • Over 25 years as healthcare investment banking and entrepreneur
  • Former SVP, GE Equity, Healthcare
  • MBA, Yale University; BA Economics, Harvard College

Alexander Fleming, MD, Senior Clinical & Regulatory Officer

  • Former supervisory physician, DMEP, FDA
  • Expert in metabolic disease
  • MD, Board Certified, Endocrinology, Emory University

Andre Marette, PhD, Lead Investigator and Scientific Advisor

  • Professor of Medicine, Institute for Heart & Lung Research, Laval University
  • Pfizer Research Chair, Pathogenesis of Insulin Resistance and CVD
  • Recent publication on PDX effect on insulin resistance (Nat. Med. 5/11/2014)

Michael Van Zandt, PhD, Director, Discovery Chemistry

  • Former Director, Institute for Pharmaceutical Discovery (1996-2012)
  • PhD, Organic Chemistry, Wayne State University

Robert Lipper, PhD, Technical Consultant, Formulation

  • VP, Biopharmaceutics, BMS (1984-2008)
  • PhD, Pharmaceutical Chemistry, University of Michigan

Mehar Manku, PhD, Scientific Advisory

  • former Chief Scientific Officer, Amarin Corp.
  • Executive editor, PLEFAs
  • Inventory on 61 patents in polyunsaturated fatty acids
Gary Mathias
CFO 
Frank Sciavolino
CSO 

Thrive Bioscience, Inc. United States

Thrive Bioscience is commercializing automated, analytical cell management laboratory instruments with integrated disposables. Thrive systems target the existing manual cell culture market ($8B), the cell-based assay market ($14B) and multi-billion dollar emerging markets for cell therapeutics. Thrive systems monitor, maintain, and passage cell lines, as well as run assays and generate large amounts of previously unavailable data.

Current methods of cell culture, developed more than 50 years ago, are now a major bottleneck holding back research and medicine, and cost society billions of dollars annually in waste and lost opportunity. Thrive Bioscience is the first company to wholly automate cell culture in research, diagnostic, and therapeutic markets.

Cell culture, especially the growth of human and other mammalian cells, is a fundamental tool used in science and medicine. As an example, the market for cell-based assays used in drug discovery accounts for $14B annually. One of the most rapidly growing and emerging segments requiring automated cell culture is the personal cell-based therapeutics market, for which human cells are genetically engineered, and then re-implanted into a patient.

Website:
thrivebio.com
Year Founded
2014
Main Sector
Medtech Subsector
Medtech Phase of Development
Current Financing Needs

Have raised $3M of a $4M round and seeking investors to complete the round.

Current Investors

Life Science Angels, Finney Capital and several seed investors.

Management Team Highlights

Management Team

·       CEO, Gary Paul Magnant -- Serial bio-tools entrepreneur; 3 prior successful exits; formerly Sage Science, MJ Research, ThermoCeramix, Owl Scientific

·       COO/CFO, Thomas Forest Farb -- Serial healthcare-centric entrepreneur; numerous successful exits and IPOs; formerly MedicaMetrix, Indevus Pharma, Interneuron Pharma, Cytyc

·       CSO, Alan Blanchard, PhD -- Numerous commercial instrumentation successes in DNA sequencing & DNA microarrays at Agencourt Personal Genomics and Lilly

·       VP Engineering & Manufacturing, Brian Foley -- Former Head of Technology & Engineering at Merck Millipore; numerous products developed and launched

Board of Directors

·       Guy Broadbent -- Former President of Laboratory Products Division of Thermo-Fisher Scientific; former CEO of XcellerX (acquired by GE Healthcare)

·        Michael Finney, PhD -- Managing Director of Finney Capital; former Co-Founder and CSO of MJ Research; Board Member of Sage Science

Tom Farb
Chief Operating Officer 

Torrey Pines Investment

Torrey Pines Investment (TPI) was founded in 22 and is based in San Diego CA. The firm has raised two funds and also invests in drug development via a partnership with BioMotiv. TPI makes venture-stage minority equity investments and prefers act as a co-investor but also leads rounds on occasion. The firm invests internationally.

Ron Demuth
President 

Transverse Medical, Inc. 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
Eric Goslau
CEO 
Larry Blankenship
Director 
Ted Tarasow
Director 

Trigemina

Michael Leonard
CFO 
Charles Yeomans
President