Objective Pain Measurement “ If you can’t measure it,

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Presentation transcript:

Objective Pain Measurement “ If you can’t measure it, you can’t improve it ” Lord Kelvin Frank A. Minella Founder & CEO fminella@painqx.com 610.348.9153 www.painqx.com

Problem: Subjective Pain Measurement Patient Self-Report Inadequate Current Standard of Care Relies on patient self report Not verifiable or replicable Patients struggle to differentiate pain mid scale (3 to 7) Unreliable for pain base-line or follow up

Problem for Clinicians: Over/Under Treatment of Patients Result Over-treatment Adverse Affects (e.g. Addiction) Issue Creates Leads to Incomplete Understanding of Patient’s Pain (Baseline & Follow up) Uncertainty in Dosing & Treatment Subjective Pain Measurement Under-treatment Unnecessary Pain and Suffering Source: Hospital & Physician Survey, Mass General Hospital Consultants, 2016

Analysis / Neural Processing Solution Objective Pain Measurement PainQx Neuro-analytic SaaS Platform 1 2 3 Cloud Based Analysis / Neural Processing $$ Time Per Patient Under 5 Minutes Cost $65 per assessment Processing Time Real-time Hardware Off-the-shelf EEG Headset Pain Score 6.0

Clinical & Software Development Plan Month: 6 12 18 24 30 CLINICAL DEVELOPMENT Refine MVP (N=100) Algorithm Optimization (N=200) FDA Validation Study (N=400) FDA Filing Review R&D COSTS $178,250 $1,896,000 $105,000 SOFTWARE DEVELOPMENT Artifact Automation Forehead System (Improve Clinical Utility) Commercial Launch Preparation R&D COSTS $330,000 $960,000 INVESTMENT $1,000,000 $7,000,000 Notes: PainQx has 2 sponsored studies that will be completed in 6 months PainQx has already completed the recruitment of 100 patients Total additional patients required for development & FDA Clearance N=700 Total Development cost $8M = Value Inflection

The Team  Mission Focused, Execution Driven Frank A. Minella Founder, CEO Leslie Prichep PhD. Founder, Inventor William Koppes MSEE. VP of R&D Alex Ruckdaeschel Founder, CFO Alejandro Zamorano VP of BD Serial Entrepreneur Business Management Consultant: Accenture Pharma Industry Group 28 yrs. experience in Commercial Business Management & Military Command Leadership U.S. Army Officer and Aviator Founder, Brain Research Lab NYU School of Medicine Serial entrepreneur, whose patents have been successfully commercialized 3 times Professor of Psychiatry, NYU Medical School Neuroscience world leader, expert in QEEG 35 yrs. experience Medical Device Product Development, Implementation VP, Global R&D Siemens Healthcare VP, Global Engineering Siemens Healthcare CTO, Director of R&D BrainScope 20 yrs. experience Business Financial Management worldwide Partner of Alpha Plus Advisors, LLC. Co-Founder and Principal of Blue Rock - AG, Investment Advisor, Nanostart Founder of Life Science Nation Employee 6 at Abpro Inc. 8 yrs. experience in the business development and start up experience specific to Life Sciences Add bullet bios

Team Positions Needed Signal Processing Engineer Database Manager Development of algorithms for objective assessment of pain based on EEG waveforms. Responsible for artifact detection algorithm development for identifying and flagging artifacts in EEG waveforms Development of EEG feature selection strategies, feature formulations, regression equations, discriminant functions, and performance metrics in support of algorithm development / optimization. Statistical analysis of clinical data Database Manager Maintain a relational database containing study data. Set up initial structure of the database and maintain it as new QEEG features are defined and derived. Assist in the selection of the appropriate database technology for the PQx SaaS. Archive the database on a regular basis and perform data integrity checks as appropriate. Develop programs to query the database.

Team Positions Needed Clinical Study Manager EEG Technologist Oversee data acquisition and entry at multiple research sites following study protocols. Work with PQx Database Mgr. and development personnel to ensure that data is efficiently transferred and meets data integrity/quality. Responsible for feedback to clinical sites on data quality and completion of electronic data capture forms (eCRFs). Assist in identifying qualified sites for study participation. Track key study metrics using tracking tools. Implement Data Verification Monitoring Plans. EEG Technologist Acquire EEG data using International 10/20 electrode placement system. Extract EEG information from EDF files. Artifact identification in raw EEG recordings. Clinical and electrophysiological data acquisition, database entry and querying. Utilize data analysis programs, such as EEG source localization.