Markets General Healthcare Primary & Secondary care, - - PowerPoint PPT Presentation

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Vitalograph

Founded in Buckingham in 1963 Privately owned ≈350 employees

– Buckingham – Ireland – US – Germany – Hong Kong – Japan

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Markets

General Healthcare

– Primary & Secondary care, – Spirometers, – ECG etc

Home Markets

– Peak Flow meters – Electronic lung monitors

Clinical Trials

– Spirometry & Lung FuncNon measurement – Cardiac Safety – Over-reading – Data & Project Management – Services

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Product Range

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Inhaler Compliance History

IniNated by Prof Richard Costello of RCSI and Beaumont Hospital & Prof Richard Reilly of TCD Licensed by Vitalograph in 2011

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Background

Two Types Of Inhaler;

– Dry Power Inhalers (DPI) & – Metered Dose Inhalers (MDI)

Market is forecast to be $44Bn in 2016 at a CAGR of 16% MDI sales forecast to be $29Bn in 2016 and DPIs $15Bn

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The Problem Up to 85% of Inhaled Drugs are wasted Lavorini SystemaNc review of DPI literature - between 4 & 92% of user had incorrect Technique NHS study showed that 91% of HCPs could not demonstrate correct technique Two dimensions to correct technique- Temporal & Technique Adherence- Correct Technique

– DPI; Exhale, Prime, Inhale sharply, Breathhold, Exhale – MDI; Inhale slowly, Fire, Inhale, Breathhold, Exhale

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INCA Architecture

Automated Analysis Semi- Automated Analysis FTP Server SQL DB & Web Portal Clinic PC

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INCA Inhaler Compliance

• Measures Temporal & Technique Inhaler

Compliance

• Audio Analysis Methodology
• Exact Nme and date of usage
• Dosage
• Correct Technique

– ExhalaNon – Inhaler acNvaNon or Priming – InhalaNon Nme – Breath hold Nme – ExpiraNon

• Deployed in several current & upcoming

studies

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Semi-Automated Analysis

Prime InhalaNon ExhalaNon Breath Hold

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Recording Device

• MKI is single use, MK II can be reused up to six Nmes
• MK II is much smaller
• Plans in place to add BT to transmit from home

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Overview

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Detailed Data

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Combined with other Data

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Licensing Process

• Went very smoothly despite being a 3 way agreement
• Dr Gordon Elliot of TCD led the Colleges iniNaNve
• No major issues along the way
• Plenty conversaNons and phone calls
• Overall process took about six months

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Progress since then

Redesigned the hardware twice

– Added a true RTC, SS Memory – Made smaller

Third iteraNon in the pipeline Put the design through a medical device design process for MDD & FDA CE approved FDA Pending Developed a Web ApplicaNon Spent €450K in further development Sponsored a PhD in TCD in the area of acousNc analysis with SFI Provided hardware and soeware for clinical trials, total of 1500 devices Commenced an InnovaNon Partnership Program (IPP)

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Regulatory Market Route

Three Hurdles to get a medical device to the market

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The two benefits of licensing

• You get the InnovaNon
• Adding on regulatory compliance & market route is essenNal
• More importantly (oeen unseen), Create the market pull
• Respected clinicians/academics behind the innovaNon
• Clinical validaNon
• Papers & PublicaNons
• Tradeshows and conferences
• Speaking OpportuniNes
• Present to Customers
• Don’t license and walk away, you need to stay engaged and partner with

the inventors

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Summary

• We sNll have work to do on commercialisaNon
• Incredibly difficult problem we’re trying to solve
• Fully commiked to being successful
• Licensing works if the innovaNon is truly innovaNve and differenNated
• Engage with the inventors early and stay engaged
• Use them to create the market pull