REG - Ondine Biomedical - Corporate and Trading Update

Ondine BiomedicalAnnouncement

24/04/2024 07:00

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RNS Number : 8359L  Ondine Biomedical Inc.  24 April 2024

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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.
 Carolyn Cross, CEO                        +001 (604) 665 0555

 Singer Capital Markets

(Nominated Adviser and Joint Broker)
 Aubrey Powell, Sam Butcher                +44 (0)20 7496 3000

 RBC Capital Markets (Joint Broker)
 Rupert Walford, Kathryn Deegan            +44 (0)20 7653 4000

 Vane Percy & Roberts (Media Contact)
 Simon Vane Percy, Amanda Bernard          +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  (#_edn1) )-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  (#_edn2) ) and the Society for
Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023,
recommend nasal decolonization for major surgical procedures.( iii  (#_edn3) )

 

 i  (#_ednref1) Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance:
clinical implications and potential alternatives for the eradication of
MRSA. J Antimicrob Chemother. 2015;70(10):2681-2692. doi:10.1093/jac/dkv169

 ii  (#_ednref2)
https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

 iii  (#_ednref3) Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies
to prevent surgical site infections in acute-care hospitals: 2022 Update.
Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67

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