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 

TriNet

Robin Engstrom
Regional Sales Consultant, Life Sciences and Biotech 
Glenn Harvin
Regional Sales Consultant, Life Sciences and Biotech 
Caleb Monticalvo
Field Marketing Coordinator 
Jeff Nedved
Regional Sales Consultant, Life Sciences and Biotech 

Tutela Industries, LLC. United States

Tutela Industries is a Health IT startup developing patient-centric mHealth solutions to reduce readmissions and significantly enhance patient engagement. Tutela has developed a proprietary and breakthrough low cost, secure framework, TutelaConnect™, for hospital-based clinicians to communicate (voice, video, and data) securely to remote caregivers, both outside and inside the hospital environment. Even though a majority of hospitals have implemented electronic health records for identifiable patient data exchange within the hospital, the secure HIPAA compliant capture and exchange of unstructured patient information outside the hospital remains a challenge, impacting decision making, care coordination and informed consent.

In a recent benchmark data security report, over 90% report that their number one security risk is the unsecure exchange of patient information (phone, text. email) initiated from inside the hospital. 88% of hospitals attribute data breaches to employee negligence and the lack of mobile device security. The cost of these breaches exceeds $5.6 Billion per year, averaging $1M per year per hospital. Most hospitals are still struggling to create a unified communication strategy that meets stringent security, HIPAA compliance requirements while meeting clinical workflow and ease of use demands. Ubiquitous solutions are not cloud-based which makes the use case for patient engagement costly, complicated and difficult to scale. Ultimately, restricting the use to the few and not the many. The worldwide available market for interactive patient engagement solutions exceeds $2.3B and the initial target market, the high-risk Neonatal Intensive Care is estimated at $160 Million. The TutelaConnect™ Platform, can enter the market within current reimbursement and regulatory environments, and is ready to launch H2 2015 through sales to the first  pilot hospitals.

The competitive landscape includes large players in adjacent markets; Cisco/PolyCom for enterprise video solutions; Phillips, medical device manufacturer for remote monitoring, and electronic health record companies, Cerner and EPIC. Small niche players, Mommy’s Ear, Angels Eye and NICView offer limited pieces of a unified patient engagement communication tool.  None to date provide a cloud-based, platform agnostic, secure and HIPAA compliant method that eliminates costly licenses, expensive hardware and ongoing endpoint configuration and IT support requirements.

A strong competive position, highly differentiated use cases, a clear Freedom to Operate and patent potential, as well as, a highly experienced management team, early traction and favourable regulatory trends provide a great opportunity for success.

Website:
www.itutela.com
Year Founded
2010
Main Sector
Medtech Subsector
Indication
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

In 2010, Tutela company founders observed that a great need existed in intensive care areas for clinicians to communicate with patient’s circle of care; family members, advocates and aids to streamline discharge processes, prevent readmissions and provide a better experience. After 1000+ technical, economic and user interviews, a minimally viable prototype was developed for use in high risk areas, such as the neonatal intensive care unit (NICU). Three of the more novel components of the system include a secure access distribution mechanism; role-based mechanism to authenticate all users (both inside and outside the hospital) and their relationship to a third-party(patient), a method in which the capture of all the information including users, 3rd party (patients), clinical notes, electronic health record information, and any voice, video or audio transmission is secured at rest and in transit fulfilling compliance regulations, and a method to capture, store, forward and assign all relevant data from each engagement session to a  3rd party (patient) eliminating licenses and user accounts. The TutelaConnect Platform provides the first multi-platformed, cloud-based interactive patient engagement system that securely connects remote care givers to the bedside of critically ill patients using a platform agnostic video conferencing technology.

Alliance & Collaborations
First three pilots and customers include; Johns Hopkins Hospital, University of Pennsylvania Children's Hospital, Georgetown University Hospital NICU. Discussions are underway with seed investors TEDCO(follow-on), Maryland Ventures and Gulf Ventures.
Supporting Metrics or Evidence

Strong evidentiary support that patient and family engagement plays a vital role in experience and outcomes exist including a direct correlation with patient satisfaction, discharge planning and reduced readmissions; Fairview, Cope and CMS studies. The ongoing clinical trial and the voice of customer data (1000+ technical, economic and user interviews) have shown a technical deployment in less than 15 hours at an academic medical center, an improvement in clinical efficiency in the record of unstructured communications, an increase in patient satisfaction that impacts reimbursement and a slight reduction in length of stay that saved the hospital, $13,000. Hard numbers will be available at the completion of the trial in Q1 2015. The system is considered a Class One Exempt device. The FDA requires only that the NICULink, mobile device and the TutelaConnect Platform be registered 30 days prior to commercialization.

Current Financing Needs

$800,000. Amount can be staged to support product development completion, headcount and pilot costs.

Current Timeline

6-9 months away from commercialization.

Current Investors

TEDCO($100k), Founders Capital ($300k) and Gulf Ventures(GVC)committed ($200k)

IP Status

Freedom to Operate Analysis and Provisional Patent was filed in December 2014.

Recent Milestones

To date, 90% of the first product platform has been developed. Technical and clinical workflow usability and feasability testing is complete. In December 2014, beta testing of a portable mobile device connected to the platform began in the NICU at Georgetown University Hospital. Over 500 clinician-to-family interactive video sessions have been completed with 97% "game changer" endorsement. A small reduction in length of stay, 3.9 days, equated to savings of $13,000 during a 3 week period. Additional pilots are lined up at Johns Hopkins and UPENN in the adult and pediatric service lines, which will lead to first sales A committment for $200k was received in December. A pipeline and contact with other interested hospitals including Loma Linda, Stanford, University of Tennessee has been initiated. Soft product launch is targeted for October 2015 at a national neonatal conference.  

Management Team Highlights

We have an experienced and well rounded team with 80+ years expereince in network security, medical device and software product development and clinical data support sales and marketing. Brad Pollard, CTO, has 15+ years in startup expereince. His last position prior to Cisco was with Source Fire, sold to Cisco for $2.3B. Karen Alder, CEO, has 20+ years in sales and accounting with health IT startups. Her last position was with TheraDoc, which was sold to Premier for $117M. Richard Smith, COO, 25+years experience in medical device product development. Led successful product launches at GE and Brainz. Brainz was successfuly exited in 2008. Clinical advisors are well recognized leaders in neonatology and the adult critical care space.

Karen Alder
Co-Founder/CEO 

Twin Cities Angels Fund II, LLC United States

Twin Cities Angels is an angel group that was founded in 2006 that is based in Minnesota. The group has raised two funds that are The Twin Cities Angels Fund I and II. The second fund is currently looking to invest in emerging companies. The group typically provides seed and venture capital ranging from $ 25.000 to $2 million to life science companies. The group plans to invest in 4 to 6 companies per year. Twin Cities Angels seeks to invest in companies based in the Twin Cities Area of Minneapolis/St. Paul, the state of Minnesota and within a reasonable distance, such as Western Wisconsin, Northern Iowa, and Eastern Dakotas.

Year Founded
2006
Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
John Alexander
Chairman & Founder 

TYLT Lab

TYLT Lab was founded in 213 and has offices in Santa Monica CA and in Hong Kong. TYLT Lab invests across a variety of sectors including biotech and medical technology and will be raising a second fund in 215. TYLT Lab typically invests $5-$1 million and prefers to invest in seed or Series A rounds. The firm makes up to 12 allocations per year and is interested in opportunities globally, companies developing products that can impact healthcare delivery in emerging markets such as China or India are of particular interest.
Gerard Casale
Managing Director