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ONDINE BIOMEDICAL INC.
("Ondine Biomedical",
"Ondine" or the "Company")
Corporate and Trading
Update
Significant revenue growth
and commercial momentum
Ondine Biomedical (LON: OBI), a leading provider of
light-activated antimicrobial technology to treat and prevent
hospital infections, provides an update on its recent developments,
strategic priorities and 2024 corporate plans.
Commercial
In 2023, revenues nearly doubled to $1.2 million
($0.6 million in 2022), driven by significant growth in the number
of hospitals deploying Steriwave®. Ondine ended the year with 16
hospital deployments, up from six at the prior year end. This
momentum has continued with eight additional hospital deployments
in Q1 2024, bringing the total to 24 hospitals, 50% up from the
previous year-end and four times the number at the beginning of
2023.
During the last quarter, several hospitals announced
expansions to include other surgical indications. The Company
is also benefitting from significantly reduced sales cycle times,
lower new client acquisition costs and improved margins resulting
from lower cost of goods and higher product pricing. Retention of
hospital accounts added to date is at 100%.
Of the eight new hospital placements in the first
quarter of 2024, five of these were located internationally:
·
In the UK, strategic
inroads were made into the NHS in England with the accelerated
adoption by two hospitals in the Mid Yorkshire NHS Teaching Trust
(the "Trust") for orthopedic surgeries as a result of a strong
early pilot data in one of them, and high levels of enthusiasm for
the new technology by both healthcare professionals and patients.
The Trust created a 12-month budget for the use of Steriwave for
patients undergoing hip and knee surgery. Ondine is now partnering
with the Trust and Health Innovation Yorkshire and Humber to
conduct a health economic analysis to further support Steriwave
adoption across the NHS. In the private sector, HCA Healthcare UK
has approved Steriwave for use in its UK-based private hospitals,
at the discretion of the clinician. HCA UK, a leading private
healthcare provider in the UK with 30 facilities, is a subsidiary
of HCA Healthcare (USA).
·
In Spain, the first three
hospitals are now implementing Steriwave, including the prestigious
Hospital Universitario La Paz (HULP). HULP is a large tertiary
hospital in Madrid with 1,308 beds. The Hospital Universitario La
Paz is recognized as a centre of reference and health excellence
and is considered one of the top three public hospitals with the
best reputation in Spain.
·
In Australia, Ondine has
achieved its first hospital deployment in Australia at Mater
Hospital, North Sydney, a 233-bed private hospital in New South
Wales. The hospital is part of the St. Vincent's Health Australia
Group, Australia's largest not-for-profit provider of health and
aged care services. This follows the recent Australian Spine
Society Conference held from 5-7 April 2024, at which Dr. John
Street, Co-Medical Director of the Complex Spine Program at
Vancouver General Hospital, presented his research study findings
on Steriwave as keynote speaker.
Distribution
Partnership(s) to accelerate growth: As a result of Ondine's
positive clinical data, growing sales momentum and recent
commercial success, the Company has been approached by several
multinational companies in the hospital supply, wound care, and
infection control industries. The Company is currently in a process
of progressing discussions on distribution collaborations with
potential partners. While these discussions have been constructive,
there is no certainty that a distribution agreement will
materialize from any of these discussions. Management believes that
distribution partnerships have the potential to generate earlier
income for Ondine in the form of time-based territorial license
payments and to accelerate sales and income generation for the
Company through faster market penetration and greater geographical
reach. The Company's 2023 investments in manufacturing
capacity upgrades combined with a significant COGS reduction
program support larger-scale rollout and increased gross margins
required by any potential partners. The latest generation light
diffuser is reducing the cost of goods for our Steriwave testing
kits by 46 per cent.
Expansion into
Intensive Care Units (ICU): Ondine is accelerating its plans
to enter the ICU market to take advantage of interest by hospitals
to replace the commonly used antibiotic mupirocin. Mupirocin, the
topically applied antibiotic used in the nose over 5 days, requires
lengthy administration times and generates antibiotic resistance.
Having established a solid safety and efficacy profile in over
150,000 patients in pre-surgical and industrial settings, the
Company estimates that the ICU application represents an
opportunity to expand the total addressable market for Steriwave
significantly. As ICUs have the highest hospital rates of
infection and mortality, they represent an opportunity to
accelerate new hospital adoption at a point of major unmet need
both in terms of improving patient outcomes and reducing cost of
care and length of stay. Further announcements will be made in due
course.
US Phase
3 Clinical Trial Plans
Following a Type C meeting with the US Food &
Drug Administration ("FDA") last September, the design and budget
for the clinical trial program has been finalized in close
collaboration with HCA Healthcare ("HCA"), Ondine's US clinical
trial partner. The trial will run at 14 HCA hospital sites
with a circa 5,000-patient group-randomized crossover study,
comparing Ondine's nasal photodisinfection added to
standard-of-care infection prevention practices versus
standard-of-care alone. The Company is targeting to commence the
trial in the third quarter of this year. Data from the trial will
inform the Company's planned FDA submission and approval would
facilitate adoption of Steriwave in the US.
Funding Position and
Support
The Company has received indications of support from
its founder CEO and substantial shareholder, Carolyn Cross, and
from other existing shareholders, to provide near-term funding to
extend the Company's runway. Discussions are currently underway
with HCA's investment arm, Health Insight Capital, for its funding
support of the key Phase 3 clinical trial. The Company is confident
in its ability to secure longer-term financing to execute on the
growth opportunities described above. Further announcements will be
made in due course.
**ENDS**
Enquiries:
Ondine Biomedical
Inc.
|
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Carolyn Cross, CEO
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+001 (604) 665 0555
|
|
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Singer Capital Markets
(Nominated Adviser and Joint Broker)
|
|
Aubrey Powell, Sam
Butcher
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+44 (0)20 7496 3000
|
|
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RBC
Capital Markets (Joint Broker)
|
|
Rupert Walford, Kathryn
Deegan
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+44 (0)20 7653 4000
|
|
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Vane Percy & Roberts (Media Contact)
|
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Simon Vane Percy, Amanda
Bernard
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+44 (0)77 1000 5910
|
About Ondine
Biomedical Inc.
Ondine Biomedical Inc. is a Canadian life sciences
company and leader innovating light-activated antimicrobial
therapies (also known as 'photodisinfection'). Ondine has a
pipeline of investigational products, based on its proprietary
photodisinfection technology, in various stages of development.
Ondine's nasal photodisinfection system has a CE mark
in Europe and the UK and is approved in Canada and several other
countries under the name Steriwave®. In the US, it has been granted
Qualified Infectious Disease Product designation and Fast Track
status by the FDA and is currently undergoing clinical trials for
regulatory approval. Products beyond nasal photodisinfection
include therapies for a variety of medical indications such as
chronic sinusitis, ventilator-associated pneumonia, burns, and many
other indications.
About
Steriwave®
Ondine's Steriwave® nasal photodisinfection system is
a patented technology using a proprietary light-activated
antimicrobial (photosensitizer) to destroy bacteria, viruses, and
fungi colonizing the nose. The photodisinfection treatment is
carried out by a trained healthcare professional and is an easy to
use, painless, two-step process. The photosensitizer is applied to
each nostril using a nasal swab, followed by illumination of the
area with a specific wavelength of red laser light for less than
five minutes. The light activates the photosensitizer, causing an
oxidative burst that is lethal to all types of pathogens without
causing long-term adverse effects on the nasal microbiome. A key
benefit of this approach-unlike with antibiotics, which have
resistance rates reported as high as 81%[i]-is
that pathogens do not develop resistance to the therapy.
Nasal decolonization is recommended in the 2016 WHO
Global guidelines for the prevention of surgical site
infections,[ii] and the Society
for Healthcare Epidemiology of America (SHEA) guidelines, published
in May 2023, recommend nasal decolonization for major surgical
procedures.[iii]