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Presentation given at GAIN luncheon 5/26/10. Gainesville, FL. Presenter: Eric Buffkin President, eTect, LLC 4817 SW 34th St, Suite 4 Gainesville FL 32608 352-367-8328 x102 phone [email protected]
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Company Overview
What is eTect?
Batteryless In-Body communications and diagnostics
Multiple medical and non-medical applications
Who are we?
Exceptional team consisting of:• Wireless IC Design• In Vivo communication R&D• Materials Science and Physics• Biomedical devices and signal processing• Pharmacokinetics/dynamics• Entrepreneurial experience
Adherence
eTect has developed an innovative solution to collecting vital information sought by the pharmaceutical industry for many years.
No one knows
Billions of dollars are spent yearly developing new drugs.
The average cost of a clinical trial is nearly $8000 per participant.
Over 8 million people are estimated to have participated in a clinical trial of a new drug in 2009.
How many participants took the new drugs as prescribed?
In real time
eTect’s ID-Cap system will detect and report when a trial participant ingests a pill or capsule
What this
means
Increased AwarenessIncreased Adherence Increased Quality of DataEasier Trial Conduct
Compliance Study Duration Required Subjects Cost of Trial-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
94%
-60% -50% -45%
Effects of Improved Adherence
McKenzie, S., Paty, J., Grogan, D., Rosano M., Curry, L.., Sciarappa, K., & Hufford, M., (2004), Proving the eDiary Dividend. Applied Clinical Trials, June 2006; 54-68.
The Solution
ID-Cap
Data collection and deliveryMobile user interface
Pill Detecte
d
Ingestible wireless tagsTag reader worn by patient
ID-Cap in
Action
When time to take a pill, the user is prompted by the mobile device.
ID-Cap in
Action
Once the pill is ingested, the tag is interrogated by a signal from the reader. The tag responds indicating it has been ingested.
The tag then safely dissolves in the digestive system with no effect on the medication.
ID-Cap in
Action
Data collected by the reader is immediately uploaded to the adherence database and is available in near real-time.
ID-Cap
Benefits
Built in reminder system with real-time verification improves medication adherence.
Immediate notification of missed dose available to physicians or administrators.
Exact dose and timing information allows for better assessment of pharmacokinetics.
Real-time tracking of adherence trends available to administrator or sponsor without unblinding data.
Business
Model
eTect collects and provides real time adherence information
Trial Spons
or
eTect
Trial Administra
torID-Cap Deployment
AdherenceData
Database
ID-Cap meds
Readers,Mobile InterfaceID-Cap
Tags orCapsules
ID-Cap tags or capsules are supplied to trial sponsors
Readers and mobile devices are shipped to trial administratorsAdministrators deploy ID-Cap to participants
eTect collects a fee to enable each participant in the trial
$$Adherence
Reports
Market Size (US
TAM)
20102011
20122013
2014
0
1,000,000
2,000,000
3,000,000
4,000,000
5,000,000
6,000,000
7,000,000
8,000,000
9,000,000
10,000,000
Estimated Participants – IND Clinical TrialsBased on analysis of data from "State of the Clinical Trials Industry" CenterWatch (2008)
and Clinicaltrials.gov
Phase I Phase II Phase III Phase IV
Tota
l Enro
llees
Competition
Current methods of determining adherencePaper & electronic diaries, smart drug packaging, patient support programsNone provide verificationID-Cap provides real-time verification
Emerging competitorsOther “smart-pill” companiesID-Cap key advantages
no batterytwo-way communicationslow-cost RFID-like implementation
Intellectual
Property
Electronic Pills for Medication CompliancePatent Allowed, May 2010
In vivo Communications MethodPatent Pending, filed 2009
Biocompatible Conductive Inks and Tag SubstratePatent Pending, filed 2010
Proprietary Integrated Circuits and other trade secrets
Platform
Technology
eBurst serves multiple in vivo applicationsEnergy harvesting eliminates or minimizes the need for a batteryProtocol and signaling optimized for in vivo communications
Clinical Trials
Patient AssistancePrograms
Pharmacy Dispensation Compliance
Implant Identification
Implant Monitoring
Disposable sensors for
med / surgical devices
Additional Orthopedic Applications
Home Healthcare, Assist Living
ID-Cap
OrthoTag
invivoTag Long-term implantable
sensors
Leadership
Neil Euliano, Ph.D. – CEOFounder and President of Convergent Engineering Inc., a Biomedical Engineering firm specializing in signal processing algorithms. Published over forty times, currently holds nine issued patents with approximately twenty pending patents, and has been the principal investigator for multiple programs for the National Institutes for Health, National Science Foundation, and industry sponsors. Ph.D. EE, University of Florida
Eric Buffkin – PresidentFounder of Pelagic Group, Identity Stronghold, Indian River Silicon. Former executive with Intellon Corp. and consulting executive to Entropic Communications. Over 20 years experience in integrated circuits market. BSEE, University of Florida; MBA, Rollins College
Rizwan Bashirullah, Ph.D. – Chief Science OfficerAssistant Professor, Electrical and Computer Engineering, University of Florida. Holds four issued patents. Fields of research include biomedical circuits, in vivo wireless interfaces and low power analog/digital VLSI. Ph.D. EE, North Carolina State University
Brent Myers, Ph.D. – Technical LeadWireless communications integrated circuits pioneer. Leader of development teams responsible for shipment of over 400 million integrated circuits while at Harris Semiconductor, Intersil, and Conexant.Ph.D. EE, Florida Institute of Technology
Dan Robinson, Pharm.D., Chief Pharma OfficerDeveloper of multiple applications for improved pharmacy health care outcomes, pharmacoeconomics, pharmaceutical care reimbursement, adverse drug reactions, drug usage evaluation, disease state management, adherence improvement, and clinical monitoring. BS in Pharmacy from the University of Georgia and a Ph.D. in Pharmacy from the University of Cincinnati.
Current Status
Over $1 million invested to dateCore technologies developed
Biocompatible conductive ink and tag substrate – g.inkIn vivo communication system and proof-of-concept IC – eBurstInitial safety and dissolution testing completed
Experienced technical team assembledProduct development in process
Press Coverage
TV20 News.Read about eTect in the Gainesville Sun.Antenna Pill video — University of Florida NewsCNET NewsBusiness WeekDaily News IndiaCBC CanadaTom’s GuideUberGizmoDVICEPopular ScienceMeridian InstituteItalian AGI SaluteAustrian pressetextDiscovery Channel Daily PlanetTimeeTect-referenced Blogs
Confidential and Proprietary
Live links at www.etectbio.com/news
Contact Info
Additional information is available at our private website – www.etectbio.com. Login credentials may be obtained upon request.
Eric BuffkinPresident
eTect, LLC4817 SW 34th St,Suite 4Gainesville FL 32608352-367-8328 x102 phone352-262-8947 [email protected]