innovative medical devices targeting hospital...
TRANSCRIPT
MAY 2019
INNOVATIVE MEDICAL DEVICES
TARGETING HOSPITAL ACQUIRED INFECTIONS
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DISCLAIMER
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INTRODUCING CAMSTENTINNOVATIVE MEDICAL DEVICE COATINGS
Strong IP for materials and processes:
- Creates low-friction surfaces
- Resists attachment of biological substances
- Safe and biocompatible
Any silicone or latex device can be coated
with minimal additional development
Separate non-stick technology to resist
platelet attachment in blood stream
NON-STICK COATINGS AIM TO
REDUCE INFECTIONS CAUSED BY MEDICAL DEVICES
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300kHAI cases p.a
NHS
10k deaths p.a.¹
1.7mHAI cases p.a
USA
99k+ deaths p.a.²
¹ House of Commons, Reducing HAI in Hospitals in England, 2009; (2) Klevens, R Monina et al. "Estimating Health Care-associated Infections and Deaths in U.S. Hospitals, 2002." Public Health Reports 122.2 (2007): 160–166; Graphic courtesy of GE
² Pickard, R., Lam, T., MacLennan, G., Starr, K., Kilonzo, M., McPherson, G., ... & Glazener, C. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised
controlled trial. The lancet, 2012 380(9857), 1927-1935
³ Loveday H, Wilson J, Pratt R et al (2014) epic 3: National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England, Journal of Hospital Infection 86S1 (2014) S1-S70
TARGET MARKET: HOSPITAL ACQUIRED INFECTIONS (HAI) CAUSED BY MEDICAL DEVICES
Major cause: bacterial colonisation, as a layer of biofilm forming on
medical device surfaces
17.2% HAIs are caused urinary tract infections of which up to 56%
result from patient catheterisation³
5%chance of contracting
an HAI when admitted
to hospital
4
5
10% reduction of
HAI cases
NHS
£93.1msaved pa¹
¹ House of Commons, Reducing HAI in Hospitals in England, 2009; (2) Klevens, R Monina et al. "Estimating Health Care-associated Infections and Deaths in U.S. Hospitals, 2002." Public Health Reports 122.2 (2007): 160–166; Graphic courtesy of GE
² Pickard, R., Lam, T., MacLennan, G., Starr, K., Kilonzo, M., McPherson, G., ... & Glazener, C. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a
multicentre randomised controlled trial. The lancet, 2012 380(9857), 1927-1935
STRONG FINANCIAL INCENTIVES TO TACKLE HAI
9.4% of total in
patient costs
USA
$35bcost of treating HAI²
17.6 days
average increase in
hospital stay if you
get an HAI
Current approach: to impregnate medical device surfaces with antibiotics or silver.
This is ineffective as it kills bacteria, but has little impact on infection rates²
SIGNIFICANT PROGRESS IN LAST 18 MONTHS
PRODUCTS
First Product: market available Foley catheter to combat CAUTI*
MANUFACTURING
Doubled HQ / Mfg space
Capacity of 2000 catheters/month
Readily and cheaply scalablemanufacturing facility
Backed by an integrated supply chain
EXPERTISE
Established Team/Board with in-depth device and healthcare expertise
Lean operating model: small team of permanent staff
Focus on early stage revenues
Fielding a full range of standard and specialty Foleys
Driving clinical studies with positive results
Building awareness: press coverage, KOL &, conferences
High value devices being coated for other applications
* Catheter acquired urinary infections
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Safe in contact with tissues
Secure vs. rubbing and cracking
Stable for over 2 years
Flexible to bending and stretching
Economical to create and apply
Competitive performance vs.
commercial alternatives
CAMSTENT CATHETERS PERFORM BETTER ON EACH AND EVERY OCCASION WITHOUT EXCEPTION²
Biofilm was significantly suppressed all along the inner
drainage lumen¹
Added clinical benefit: Customers cite the ease of
insertion and removal because of the silky smooth
surface created by the coating
BUILDING CLINICAL EVIDENCE FOR ‘BACTERIA-PHOBIC’ CLAIM
Patients receive a Camstent coated catheter or
hospital standard uncoated
Patients usually surgical, providing a greater challenge
to the coating from handling, bacteria, duration, cell
debris etc.
Devices analysed after use at an independent lab for
biofilm density
Follow-on study will measure patient benefit and
health economics
¹Jeffery, N., Kalenderski, K., Dubern, J., Lomiteng, A., Dragova, M., Frost, A., ... & Andrich, D. (2019). A new
bacterial resistant polymer catheter coating to reduce catheter associated urinary tract infection (CAUTI): A
first-in-man pilot study. European Urology Supplements, 18(1), e377.
²Representative difference in biofilm / mineral accumulation in a Camstent Coated Foley (left) and standard
uncoated Foley (right) catheter surface, used for similar durations.
CAMSTENT FOLEY STANDARD FOLEY
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PILOT STUDIES AT SIX UK CENTRES RESULTS
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PRIORITY IN HOUSE DEVELOP PARTNERSHIPS
Pursue sales & routes to market for first
products
Direct in to UK and small scale via website
Apply for FDA 510(k) – Pre-Sub meeting
Build marketing & PR efforts
Hire experienced commercial director
EU via distributors
US via partners / distributors
Increase product diversity Basic development easily scalable in current
facilities
Introduce wholly owned Camstent coating
and IP – already advanced
Develop indwelling products using second
patented technology e.g. cannulas, giving
sets, PIC lines
Pursue technology license / co-development
agreements to develop new products
Consider sale of individual product
categories
Seek clinical and regulatory leverage for
new product introductions
Manufacturing For UK and EU sales
First manufacture of new product types
Larger scale manufacturing (>2000/mo)
Support product sales in the US
Clinical studies Build body of evidence to support claims
Continue Small scale pilot studies
Large scale clinical studies to reduce costs
and accelerate market acceptance
Assistance with health economics study
PARTNERSHIP GOALS
LOOKING AHEAD: 3 YEAR MILESTONES
MILESTONE 2019 2020 2021
Hospital introduction and pilot study
Evidence for outcome / cost impact
Expand clinical access (care homes)
Build awareness
(trade shows / peer review/ press)
Distributor / partnership / licensing
Manufacturing to match sales volumes
New product introductions
Resource additions (linked to growth)
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PRODUCT
(% INCIDENCE OF INFECTION)
ANNUAL
SALESANNUAL GLOBAL VALUE
(Units) Uncoated Coated
Foley Catheter 38% 100 million92m @ £3
£276m8m @ £12 £96m
Ureteral Stent 76% 92,00084k @ £12
£1.0m
8k @ £160
£1.3m
Endotracheal
tubes15-25% 50 million
46m @ £5
£230m
4m @ £150
£600m
Other tubes,
drains, shunts
4.0 –
30%++ -- ++
LOOKING AHEAD: DEVELOPING NEW PRODUCT LINES
ALL PRODUCTS:
HIGH VALUE
HIGH MARGIN
PREMIUM
PERFORMANCE
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LOOKING AHEAD
- Build leadership team and market-facing capability; secure new funding
- Building brand of ‘bacteria-phobic’ products / expanding EU approved claims and products
- New product launch – a second high-margin product within 18 months, partnership for selection, manufacture, and market entry
- Technology licenses granted for applications outside of core markets
- Expand results from clinical studies for first product, building evidence for clinical and economic impact
- Peer-reviewed results published in high-impact journals from ongoing clinical trials
- Expand accessible patient populations – Out of hospital, home care, and geographies
- Submission for US regulatory approval
- Participation in major and regional trade shows and clinical events, with allied abstracts
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- Funding via revenue, partnerships, and investment provides resources to:
- Support innovation and new Intellectual Property for materials and processes
- Fund exploitation of Camstent technologies generating new products
- Options to automate / partner / license manufacture for customer inventory
- Contribute as required to large scale in-market clinical studies and pre-market trials
- Facilitate testing to expand regulatory claim and approve new products
- Increase the geographic reach of the company, especially towards the US
- Add depth to the operating organization, especially in recruiting customer-facing leaders
- Build value towards potential exit via multiple routes in a meaningful time frame
USE OF FUNDS
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- Unmet need: many patient groups and devices will benefit from Camstent’s single platform innovation
- Unique proven technology: ‘non-stick’ coating material, with growing body of clinical evidence for
preventing build up of infectious organisms, lowering costs and improving patient outcomes. Low friction
surface enhances patient comfort and minimises adhesions
- Low product risk: approved for sale in EU and manufacturing approval complete. Strong clinical and
business partnership interest as commercialisation gets underway
- Strong IP position: strong patent protection, exclusive technology license, proprietary process knowhow
- New product opportunities: entering new fields of medicine de-risks current offering. Targeting new
products that are high value, high margin and high performance
- Clear development path: leveraging materials and processes will enable company to meet opportunities
for customer sales, new product lines, and global partnerships
SUMMARY
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MAY 2019
INNOVATIVE MEDICAL DEVICES
TARGETING HOSPITAL ACQUIRED INFECTIONS
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Dr. Paul Harper, CEO
Dr David Hampton, Founder, CTO
+44 786 055 9492
www.camstent.com