RCS - Ondine Biomedical - C$4.91 raise supports ongoing commercialisation

Ondine BiomedicalAnnouncement

13/12/2023 07:15

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RNS Number : 5636W  Ondine Biomedical Inc.  13 December 2023

13 December 2023

 

ONDINE BIOMEDICAL INC.

 

("Ondine Biomedical", "Ondine" or the "Company")

 

Successful C$4.91 raise supports ongoing commercialisation

 

·  Ondine met its 2023 target and more than doubled the number of hospitals
using its groundbreaking photodisinfection technology to reduce
healthcare-associated infections (HAIs)

·   According to the NIH, HAIs affect more than 2 million patients a year
in the US, leading to over 90,000 deaths and incurring costs exceeding $30
billion a year. 1 

 

Following its successful fundraising of C$4.91 million (US$3.62), Canadian
life sciences company Ondine Biomedical Inc. (AIM: OBI)
will continue accelerating commercialisation of its proven
nasal photodisinfection technology. This cutting-edge technology replaces
topical antibiotics for the prevention
of healthcare-associated infections (HAIs) and kills all types of
pathogens - bacteria, viruses and fungi - without
causing antimicrobial resistance.

 

The Company has confirmed that it has more than doubled the number of
Steriwave® deployments in 2023 and is in discussions with more than
75 hospitals in the UK, Mexico, Spain, and Canada. The growing global
emphasis on preventing HAIs post-surgery, coupled with the escalating
challenge of antimicrobial resistance, has spurred heightened interest in
Ondine's photodisinfection technology.

 

The deployments are in areas of major surgery,
including spinal, orthopedic, and cardiovascular. The antibiotic mupirocin
has been used for nasal decolonization for the prevention of HAIs since the
1980s. However, mupirocin has resistance rates of up to 81%, 2  and very
poor compliance. 3 

 

Carolyn Cross, CEO of Ondine, commented, "We have put great efforts into
improving our commercial activity sales process, which has increased the
speed of the average sales cycle from contact to deployment by 50%. We have
appointed distributors in the UK, Spain, and Mexico and are gaining real
momentum. What is particularly encouraging is that many hospitals are
recommending Steriwave to other hospitals. We believe this momentum will
continue to increase, and commercial sales will become more significant in
2024."

 

The five-minute Steriwave nasal decolonization procedure is seamlessly
integrated into preoperative protocols, receiving positive feedback from
patients for its simplicity and comfort. There have been no reports
of serious side effects as a result of Steriwave usage. Steriwave has
been used by more than 150,000 patients, including at Vancouver General
Hospital where its use has been associated with a significant reduction in
HAIs across major surgeries. 4 (,) 5 

 

As well as growing its commercial activities, the Company continues to work
closely with HCA - the largest hospital group in the United States - to
prepare for the Phase 3 trial in circa 14 HCA hospitals as part of its
Ondine's submission to the FDA for approval. The Company already has
approval for Steriwave in Canada, the UK, the EU, and Mexico.

 

Implementing nasal decolonization prior to major surgery to reduce HAIs is
recommended by leading medical bodies, including the World Health
Organization,(( 6 ))  the Society for Healthcare Epidemiology of America
(SHEA),(( 7 ))  and NICE. 8  The nose is the major reservoir of pathogens
and the majority of surgical site infections (SSIs) and bloodstream
infections have been traced back to bacteria in the patient's nose. 9  A
patient with a surgical site infection (SSI) will, on average, spend 7 to 11
days longer in the hospital, significantly increasing costs and lengthening
patients' recovery.(( 10 ))

 

While currently focusing on nasal decolonization, Ondine's proprietary
photodisinfection technology holds promise for broader applications in
preventing and treating various topical infections.

 

 

Enquiries:

 

 Ondine Biomedical Inc.
 Angelika Vance, Corporate Communications                     +001 (604) 838 2702

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 Aubrey Powell, Asha Chotai, 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 science company pioneering the field
of photodisinfection therapies. Ondine has a pipeline of investigational
products, based on its proprietary photodisinfection platform, in various
stages of development. Products beyond nasal photodisinfection include
therapies for a variety of medical indications such as chronic sinusitis,
ventilator-associated pneumonia, burns, and other indications.

 

About Steriwave Nasal Photodisinfection

Nasal photodisinfection is a non-antibiotic method for nasal decolonization
using a proprietary light-activated agent (photosensitizer) to destroy
pathogens in minutes without causing resistance. 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 a localized oxidative burst
that is lethal to pathogens. In this single short treatment, Steriwave
eliminates infection-causing bacteria, viruses, and fungi in the nose - a
major reservoir of pathogens associated with healthcare-associated
infections. 11   The speed of application and broad-spectrum efficacy is of
great importance in enhancing hospital workflows.

Pre-operative nasal decolonization has been found to significantly decrease
SSIs caused by the infection-causing pathogen Staphylococcus aureus. 12  The
Society for Healthcare Epidemiology of America (SHEA) recently updated
guidelines to elevate nasal decolonization from a recommended practice to an
essential requirement for orthopaedic (including spine) and cardiothoracic
surgical procedures.6

According to the Centers for Disease Control and Prevention (CDC)
(https://www.cdc.gov/drugresistance/biggest-threats.html) and the World Health
Organization (WHO)
(https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed)
, rising rates of antimicrobial resistance are of serious worldwide concern.
The reported resistance rates for the antibiotic commonly used for nasal
decolonization, mupirocin, are as high as 81%.2 SSIs involving resistant
pathogens are associated with significant increases in the length of
hospitalization and costs. 13  Unlike currently used topical antibiotics,
Steriwave can eradicate pathogens including extensively drug-resistant (XDR)
bacteria, viruses (including coronaviruses such as SARS-CoV-2), and fungi such
as Candida auris. 14 

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®.
It has been used in Canada for over ten years, with no serious adverse events
reported. In the US, it is currently undergoing clinical trials for regulatory
approval.

 

 1  Stone PW. Economic burden of healthcare-associated infections: an American
perspective. Expert Rev Pharmacoecon Outcomes Res. 2009 Oct;9(5):417-22. doi:
10.1586/erp.09.53. PMID: 19817525; PMCID: PMC2827870.

 2  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

 3  Hansen D, Patzke PI, Werfel U, Benner D, Brauksiepe A, Popp W. Success of
MRSA eradication in hospital routine: depends on compliance. Infection. 2007
Jun;35(4):260-4. doi: 10.1007/s15010-007-6273-y. Epub 2007 Jul 23. PMID:
17646910.

 4  Bryce E, Wong T, Forrester L, Masri B, Jeske D, Barr K, Errico S, Roscoe
D. Nasal photodisinfection and chlorhexidine wipes decrease surgical site
infections: a historical control study and propensity analysis. J Hosp Infect.
2014 Oct;88(2):89-95. doi: 10.1016/j.jhin.2014.06.017. Epub 2014 Aug 1.
Erratum in: J Hosp Infect. 2015 Sep;91(1):93. PMID: 25171975.

 5  Moskven E, Banaszek D, Sayre E, Gara A, Bryce E, Wong T, Ailon T,
Charest-Morin R, Dea N., Dvorak M, Fisher C, Kwon B, Paquette S, Street J.
Effectiveness of prophylactic intranasal photodynamic disinfection therapy and
chlorhexidine gluconate body wipes for surgical site infection prophylaxis in
adult spine surgery. Can J Surg. 2023 Nov;66(6), E550-E560.
https://doi.org/10.1503/cjs.016922

 6  World Health Organization. Global Guidelines for the Prevention of
Surgical Site Infection. World Health Organization; 2016. Available at:
https://www.who.int/publications/i/item/9789241550475
(https://www.who.int/publications/i/item/9789241550475) . Accessed December
12, 2023.

 7  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

 8  National Institute for Health and Care Excellence (NICE). NICE Surgical
Site Infections: Prevention and Treatment. NICE; 2019. Available at:
https://www.nice.org.uk/guidance/ng125
(https://www.nice.org.uk/guidance/ng125) . Accessed December 12, 2023.

 9  von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a
source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001
Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102. PMID: 11136954.

 10  Seidelman JL, Mantyh CR, Anderson DJ. Surgical Site Infection Prevention:
A Review. JAMA. 2023;329(3):244-252. doi:10.1001/jama.2022.24075

 11  Liu Z, Norman G, Iheozor-Ejiofor Z, Wong JK, Crosbie EJ, Wilson P. Nasal
decontamination for the prevention of surgical site infection in
Staphylococcus aureus carriers. Cochrane Database Syst Rev. 2017 May
18;5(5):CD012462. doi: 10.1002/14651858.CD012462.pub2. PMID: 28516472; PMCID:
PMC6481881.

 12  Lemaignen A, Armand-Lefevre L, Birgand G, et al. Thirteen-year experience
with universal Staphylococcus aureus nasal decolonization prior to cardiac
surgery: a quasi-experimental study. J Hosp Infect. 2018;100(3):322-328.
doi:10.1016/j.jhin.2018.04.023.

 13  Weigelt JA, Lipsky BA, Tabak YP, Derby KG, Kim M, Gupta V (2010) Surgical
site infections: causative pathogens and associated outcomes. Am J Infect
Control 38:112-120. https://doi.org/10.1016/j.ajic.2009.06.010

 14  Ondine Biomedical Inc. (2023, September 14). Steriwave proven highly
effective against XDR bacteria [Press release].
https://www.londonstockexchange.com/news-article/OBI/steriwave-proven-effective-against-xdr-bacteria/16124940
(https://www.londonstockexchange.com/news-article/OBI/steriwave-proven-effective-against-xdr-bacteria/16124940)

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