transforming fertility treatment with precision medicine 1 · transforming fertility treatment with...
Post on 12-Aug-2020
0 Views
Preview:
TRANSCRIPT
Transforming fertility treatment with precision medicine 1
www.VivoPlex.com
A revolutionary digital health company in human fertility
With a novel approach to monitoring the uterine environment, VivoPlex can drastically change the dynamics of the fertility
treatment sector
2CONFIDENTIAL
3
Transforming fertility treatment with precision medicine
- Large global market with significant growth potential – currently 660,000 pts/yr in 6 initial markets
- Strong IP protection and first mover advantage
- First time clinicians can monitor the uterine environment for specialist fertility intervention, driven by clinical data
- Compelling preclinical data validates novel approach to monitoring of uterine variables
- Targeting improved patient outcomes and significant cost savings
- Novel digital health platform, applicable in other settings such as animal health
2013 20182015 2019 2020 2021
Early in vivo & proof of concept data
Human feasibility data & company
founded
Series A funding
Clinical study First commercial launch –product portfolio in
development
Preclinical data
CONFIDENTIAL
IVF laboratories strive to match embryo culture conditions to the natural uterine environment
Evidence confirms pH, oxygen and temperature are critical factors in embryo development
50MFertility Issues
= =2MIVF Cycles
0.6MSuccessful
1.4MUnsuccessful
Clinical focus is shifting to understanding the endometrium (lining of the uterus)
*Literature search results from Medline, using key words ‘the role of endometrium in fertility’, years 2014-2018
Current standard of careThe opportunity
Addressing a global unmet clinical need
The number of publications in endometrium and fertility*
Number of publications
Lack of accurate data on the real conditions in the uterus – our device can have a major impact 4
High impact - concentrated market, poor success rates
Patients & clinics are highly motivated to adopt
new technologies
~ £4bnWith success rates so low and costs so high,
global cost of failed IVF cycles
Private
NHS
59%
41%
UK IVF cycles
Global market for IVF treatments to
exceed $36bn by 202610% CAGR
~46% of global IVF cycles performed in our 6
primary target markets
UK, Spain, France, AUS/NZ, USA, Japan
5
Growth drivers combine demographic and economic factors
Global growth of the middle class
Devices and consumables segment 16% CAGR
Unique opportunity to revolutionise the market with better data to drive outcomes
Revolutionising IVF market with evidence-based approach
VivoPlex in IVF ecosystem Innovation &
research focused
Influencers
Key opinion
leader clinicians
Large network
& Scientific Advisory Board
Open to new
technology
Willing to self fund
Patients
Working with
patient groups
High volume
Research
experience
Clinics
Know all key clinics
Public healthcare
services
Private clinics
Payers
Building reimbursement
knowledge
High volume
Dominant groups
Permissive laws
Funding
6 key markets
Markets
Driving improved success rates
6
Working in partnership with all key stakeholders, leveraging our reach into the IVF market to develop a deep understanding of their needs and drive adoption of our technology
The VivoPlex solution
Sensor head continuously monitors pH, oxygen and temperature
Microelectronic driving circuit controls the sensor head and data transfer
Antenna charges and transmits data
Wireless and battery-free device, inserted using the same outpatient procedure as a standard IUD
Garment provides wireless power and data transmission
Proprietary software platform integrates with existing clinical software to store, process & display data to fertility specialist
2
3
1
7CONFIDENTIAL
A personalised approach to fertility treatment O
2/T
emp
erat
ure
/pH
Time
Abnormal
Normal
‘Normal’ ranges are defined
Cyclical variation is monitored
Individual patient data is collected
Subsequent fertility interventions monitored for effectiveness
Correlation with diseasesDiagnostic algorithms
1
2
3
4
4
Daytime Night time
VivoPlex technology provides unique insight into uterine health and fertility, enabling clinicians to optimize and personalize fertility treatments
Interventions could include change to IVF stimulation regime, embryo transfer timing, addition of probiotics to diet, personalized embryo culture conditions
8CONFIDENTIAL
Proof of concept validated by new data
2013 study in 5 rabbits continuously for 14 days showed:
Successful proof of wireless power technology and data communication protocols
Good safety data: no inflammatory response and good biocompatibility
Strong in vivo study results Compelling new data validates our novel approach
Confirms earlier technical proof of concept & safety studies with temperature only
prototype
Data to be published
Tem
per
atu
re
Time
In vivo study at Northwick Park Institute for Medical Research (NPIMR) Daytime
Night time
Moving towards human clinical application
Encouraging human feasibility data
2015 study in 15 women for up to 3 days showed:
• Safety and tolerability of a larger, temperature-only prototype
• Successful wireless power and data transmission
• Patterns of temperature variation within and between patients that gave early validation of our novel approach
Planning for first human study well advanced
Clinical feasibility study to confirm previous preclinical data
• Study in 2020
• Part funded by UK NIHR
• Continued interaction with KOLs, major clinics and insurers to run in parallel
10
Results provide gateway to launch
Tem
per
atu
re
Time
Individual temperature data from 3 hours to 3 days
Daytime Night timeCONFIDENTIAL
11
Building data capability to capture full digital health opportunity
Animal health biosensor and digital health capabilities broaden our opportunity and validate our technology platform
Establishing architecture ready for data capture from device trials from 2020,
using state of the art technology to hold and analyze data in a secure
environment
Understanding & driving evolving regulatory landscapefor AI and machine learning, in step with regulatory framework
Unique and proprietary digital health platform with clean
data sets, making an impact on clinical decisions with novel data
Delivering additional revenue by leveraging big data for true digital health
Fertility Clinic
Pharma Company
Diagnostic Company
Health Insurance
National Health System
Smoking
Medical Conditions
Pregnancy History Body composition
ExerciseNutrition
Family history
IVF Equipment Company
12CONFIDENTIAL
13
Launch strategy
Device monitors oxygen, pH and temperature continuously for a
multi-day period
First commercial launch
2021
Comparing individual patient data against normal values and known
causes of uterine dysfunction
Algorithms used to optimise IVF treatment, drug regimen and
demonstrate improved reproductive outcomes
(~100k patients’ data)
Second commercial launch
2023
Global expansion
2025
CONFIDENTIAL
Clinical feasibility study
SAB and KOL network
Publications
CE Mark
Clinical trials
Big Data analytics
Improved outcomes
IP protection
Market launch
Clinical phase fundingenables CE mark to unlock future value
Realising market potential
Early market penetration
Commerciallaunch2021
Results drive value creation
Preclinical studies
Shar
e P
rice
(G
BP
)*
2019 2020 2021
CE Mark & Launch
15
Series Afunding
*For illustrative purposes
Near term value inflection points for the company combine continuous risk reduction with a robust, long term growth strategy
MHRA approval for clinical feasibility
study
Leveraging novel technology for additional growth in animal health
By leveraging closely related opportunities, we can use our animal health subsidiary to
build a business with strategic synergies but a different business model
Livestock monitoringProject MORPH
Small animal welfare monitoring
Project ARTEMIS
Partners and non-dilutive funding identified
16
Led by a world class team
Dr. Chris Dickson Chairman
Chris has had a long career in health information, holding senior positions at Bupa (Head for Healthcare Services), Ascribe PLC and EMIS Group (Director of International Strategy). He is a
qualified medical doctor
Prof. Hywel MorganCofounder
Hywel is Professor of Bioelectronics at the University of Southampton, specialising in bio-sensors and lab-on-a-chip technologies. He has been awarded a Royal Society- Leverhulme Senior Research
Fellowship at the University of Oxford and the Desty innovation Prize for separation science
Prof Ying Cheong Cofounder
Ying is Professor in Reproductive Medicine at the University of Southampton and a practicing consultant, treating thousands of patients with fertility problems. Her expertise centres on unravelling
the impact of reproductive disorders on implantation and reproductive health
Charles Dickson Executive DirectorAfter a career in corporate finance, Charles moved to lead family office, Tarncourt Group in 2008. He completed a leadership programme at Harvard Business School in 2009. and has been NXD of Apache Capital Partners since 2010
Joanna Smart CEOJo has over 20 years experience in the healthcare sector in Europe and the US. She studied Natural Sciences at Cambridge before joining Nomura Intl. Jo has held senior roles for Onyx Pharmaceuticals and Chiron Corporation and is Deputy Chair of the NIHR i4i Challenge Award Panel
David WilkinsonNon-Executive DirectorDavid is a non-executive Chairman and NED at a range of public and private businesses. He was previously a senior partner at Ernst & Young (EY), working for over 30 years with growth and entrepreneurial companies on corporate development, mergers and acquisitions, financing, IPOs and other exits. 17
CONFIDENTIAL
For more information please contact us at E: j.smart@vivoplex.com T: +44 (0)2380 111 555 www.VivoPlex.com
A revolutionary digital health company in human fertility
18
top related