Collaboration advances Steriwave for ICU Market

Ondine Biomedical Inc.

25 September 2024

 

ONDINE BIOMEDICAL INC.

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

Collaboration advances Steriwave for ICU Market

Royal Columbian Hospital Foundation's Advancing Innovation in Medicine (AIM) division supports Steriwave ICU use with clinical trials at Royal Columbian Hospital

·    Treatment of patients in intensive care units (ICUs) would significantly expand Ondine's market opportunity.

·    Infection prevention is a top priority in ICUs as they face higher infection rates, more fragile and sicker patients, and bed capacity shortages.

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company at the forefront of light-activated antimicrobial treatments, is pleased to announce a research collaboration with the Royal Columbian Hospital (RCH) Foundation's Advancing Innovation in Medicine (AIM) division. 

This research collaboration, in support of Steriwave^® use in the intensive care unit (ICU), is investigating Steriwave's impact on infection prevention and patient outcomes in critical care settings. It initially involves a 320-patient pilot with the potential for a subsequent multicentre trial with up to 2,000 patients depending on the results of the initial phase. The C$855,000 study will be funded by the RCH Foundation's AIM division which will support the ICU clinical development work in a services-for-shares collaboration to help accelerate the use of photodisinfection in the ICU.

Royal Columbian Hospital, a hospital within BC's Fraser Health Authority, will be the first to trial Ondine's Steriwave nasal decolonization technology to prevent infections in ICUs. The study will be led by ICU physician Dr. Steven Reynolds and his research team at RCH. The purpose of this strategic initiative is to integrate Ondine's Steriwave, a proven nasal decolonization therapy, into ICU infection control and workflow protocols to determine the impact of rapid broad spectrum nasal decolonization on ICU infection rates, impact on length of stay and mortality rates.

Dr. Steven Reynolds, founder and executive lead of the RCH AIM division, stated:

"By eradicating bacteria in the nose without harming the nasal epithelium, we can help prevent the rapid colonization of ICU patients with multidrug-resistant bacteria. This is crucial because the nose is one of the primary reservoirs of bacteria that lead to serious infections, such as ventilator-associated and hospital-acquired pneumonia, both of which can be fatal. AIM is excited to partner with Ondine to rigorously evaluate nasal photodisinfection through ICU clinical trials, recognizing its potential as a promising intervention to reduce both costs and patient suffering."

This clinical work sets the stage to unlock the expansive global ICU market. Nasal decolonization, relying on topical antibiotics which can lead to resistance, is already recognized as a key infection prevention strategy in the USA having already demonstrated significant reductions in ICU infection rates in US hospitals.

It is the Board's opinion that the potential cost savings for hospitals using Steriwave are substantial. Infections in ICUs, where patients are sicker and more fragile, are common and costly, impacting 1 in 8 patients (12-13%).² One study found that the length of stay for patients who develop an HAI in the ICU increases by 9 days as a direct result of the HAI.^[1]  Given the average daily cost for an ICU bed in Canada is $3,592^[2], the additional cost can exceed $32,300 per HAI. Moreover, significant bed day capacity is being used up by these infections given the extended stays resulting from HAIs. The financial impact of reducing ICU HAIs therefore can be significant. Ondine anticipates that Steriwave will deliver both improved patient outcomes and considerable cost savings, echoing the successful results seen in pre-operative nasal decolonization of surgical patients. Steriwave is approved for nasal decolonization in Canada, Mexico, the UK, and Europe.

Carolyn Cross, CEO of Ondine Biomedical, highlighted the strategic importance of the study:

"Our collaboration with Dr. Reynolds and his team at RCH is an important strategic initiative accelerating our ability to address the needs of the critical care market. Steriwave has the potential to revolutionize infection control in critical care settings globally, and this study is key to demonstrating its impact."

Cost and Funding

The study will be funded by the RCH AIM Foundation, with an estimated cost of $855,000. In return, Ondine will issue new common shares of no par value in the capital of the Company ("Common Shares") at the following milestones:

·    25% upfront;

·    25% at first patient enrolment;

·    25% at last patient enrolment; and

·    the final 25% upon release of final data results and submission of a draft manuscript to a peer-reviewed journal for publication.

The initial 25% tranche will be satisfied by the issue of 950,000 new Common Shares at an Issue Price of C$0.225 (12.5 pence) per share. The subsequent tranches will be issued at a price determined by the average closing price of the Company's Common Shares over the previous five days and the Royal Bank of Canada foreign exchange rate on the day each milestone is achieved.

Admission, Settlement and Dealings

Admission of the 950,000 new Common Shares will take place on or around 8.00 a.m. on 5 October 2024. The new Common Shares when issued, will be fully paid and will rank pari passu in all respects with the existing Common Shares, including the right to receive all dividends and other distributions declared, made or paid after the date of issue.

Total Voting Rights

Following admission of the new Common Shares, the Company's issued and fully paid share capital will consist of 278,235,759 Common Shares, each carrying one voting right per Common Share. The Company does not hold any Common Shares in treasury. Therefore, the total number of Common Shares and voting rights in the Company following Admission will be 278,235,759.

This figure may be used from the date of Admission until further notice by existing shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the FCA's Disclosure Guidance and Transparency Rules.

The Critical Importance of Infection Prevention in ICUs

ICUs are the epicenter of HAIs, with critically ill patients at high risk due to their weakened conditions and the frequent use of invasive procedures. In Canada alone, hundreds of thousands of patients are admitted to ICUs each year, with 12-13% developing infections unrelated to their primary medical condition.^[3] The rise of antimicrobial resistance (AMR) limits the effectiveness of traditional antibiotics, seriously complicating the ability to treat these infections.

A significant study conducted by HCA Healthcare in 2012 involving nearly 75,000 patients across 74 adult ICUs found that universal nasal decolonization using the antibiotic mupirocin reduced all-cause bloodstream infections by 44%.^[4] However, with rising mupirocin resistance rates as high as 80%,^[5] there is a critical need for new solutions. Ondine's Steriwave offers a promising alternative-broad-spectrum effectiveness without contributing to AMR.

Steriwave is a non-invasive, painless treatment that uses a proprietary antimicrobial agent activated by a specific wavelength of red light to destroy bacteria, viruses, and fungi in the nasal passages. The treatment is effective immediately, takes less than five minutes, and allows the normal nasal microbiome to recover swiftly. This innovative approach offers a potentially life-saving solution for ICU patients, who are particularly vulnerable to infections.

All references to C$ in this announcement are to Canadian Dollars. This Announcement uses a C$:£ exchange rate of 1 : 0.555041 as at 16:30 (GMT) on 23 September 2024.

Enquiries:

Ondine Biomedical Inc.
Carolyn Cross, CEO	+001 604 669 0555
Singer Capital Markets (Nominated Adviser, Joint Broker)
Phil Davies, Sam Butcher	[phone]
RBC Capital Markets (Joint Broker)
Rupert Walford, Kathryn Deegan	[phone]
Vane Percy & Roberts (Media Contact)	[phone]
Simon Vane Percy, Amanda Bernard

About the Royal Columbian Hospital Foundation (RCHF) and AIM

Royal Columbian Hospital (RCH) is a large tertiary care hospital in one of Canada's largest health authorities. It has a legacy of care since 1862 and serves 1.8 million people with unparalleled expertise in cardiac, trauma, neurosciences, and high-risk maternity, making it a vital lifeline for critical medical needs in British Columbia, Canada.

The hospital's foundation, a non-profit organization that supports RCH through public donations, is the largest external funder of research and innovation at RCH. Advancing Innovation in Medicine (AIM) is the research and innovation division of the Royal Columbian Hospital Foundation. AIM is dedicated to pioneering innovative clinical solutions that enhance patient outcomes, improve healthcare productivity, and create global impact through strategic partnerships. Find out more:  www.rchfoundation.com/aim-institute

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.

---

[1] Stewart S, Robertson C, Pan J, et al. Impact of healthcare-associated infection on length of stay. J Hosp Inf. 2021;114:23-31. (link)

[2] Canadian Institute for Health Information. Care in Canadian ICUs.;2016. (link)

[3] Johnstone J, Garber G, Muller M. Health care-associated infections in Canadian hospitals: still a major problem. CMAJ. 2019 Sep 9;191(36):E977-E978. (link)

[4] HCA Press Release: Studay at HCA Hospitals Shows "Universal Decolonization" of ICU Patients Reduces Bloodstream Infections by 44 Percent. 2012. (link)

[5] 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. (link)

 

END