Ondine Biomedical — Steriwave initiates UK pilot study with NHS

Ondine Biomedical (AIM: OBI)

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Research: Healthcare

Ondine Biomedical — Steriwave initiates UK pilot study with NHS

Ondine Biomedical has announced the initiation of its first NHS pilot study for Steriwave, the company’s lead product for nasal photodisinfection. The pilot is based at the Mid Yorkshire Teaching NHS Trust and will assess the effectiveness of Ondine’s technology in preventing surgical site infections (SSIs). The study will have a duration of six months and involve 500 hip and knee surgery patients using Steriwave for nasal decolonisation prior to surgery. With hospital-associated infections (HAIs) having an annual cost of around £2.1bn for the NHS, we believe there may be a significant opportunity for Steriwave in the UK and, therefore, the outcome of this pilot could represent an important catalyst Ondine.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Ondine Biomedical

Steriwave initiates UK pilot study with NHS

Pharma and biotech

Spotlight – Flash

11 August 2023

Price

16p

Market cap

£31m

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Share details

Code

OBI

Listing

AIM

Shares in issue

195.0m

Business description

Ondine Biomedical is a Canadian life sciences company specialising in photodisinfection-based therapies to prevent and/or treat a broad spectrum of infections, including those caused by drug-resistant pathogens. This patented technology aims to prevent the spread of infections across multiple therapeutic areas in healthcare and industry settings.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Ondine Biomedical is a research client of Edison Investment Research Limited

Ondine Biomedical has announced the initiation of its first NHS pilot study for Steriwave, the company’s lead product for nasal photodisinfection. The pilot is based at the Mid Yorkshire Teaching NHS Trust and will assess the effectiveness of Ondine’s technology in preventing surgical site infections (SSIs). The study will have a duration of six months and involve 500 hip and knee surgery patients using Steriwave for nasal decolonisation prior to surgery. With hospital-associated infections (HAIs) having an annual cost of around £2.1bn for the NHS, we believe there may be a significant opportunity for Steriwave in the UK and, therefore, the outcome of this pilot could represent an important catalyst Ondine.

Ondine has announced that its first UK-based NHS pilot study has commenced. This is being conducted with the Mid Yorkshire Teaching NHS Trust and being hosted by Pontefract Hospital, a relatively small hospital that provides emergency care for less serious medical conditions, as well as planned and day surgeries. Steriwave nasal photodisinfection uses a light-activated formulation to destroy bacteria, viruses and fungi in five minutes. This is a non-antibiotic treatment for infection prevention, positioning it as a novel approach to combat the global issue of antimicrobial resistance.

The UK pilot study will aim to demonstrate the efficacy of Steriwave in reducing SSIs across 500 hip and knee surgery patients. While infections in hip and knee replacements are uncommon (estimated prevalence of 1%), they can lengthen a patient’s stay in a hospital by 7–11 days and hamper recovery. With the NHS conducting around 12.5m surgeries per year, a 4.7% HAI rate for in-patients, and £2.1bn in corresponding costs, we believe there could be a significant opportunity for Steriwave to become a standard of care across NHS sites, if it can demonstrate a reduced rate of SSIs.

Ondine’s Steriwave nasal photodisinfection platform was first approved by Health Canada in 2009 and has shown a consistent track record of safety and efficacy to date. Since incorporating Steriwave in presurgical protocols in Vancouver General Hospital in 2011, an 84% overall reduction in SSI rates was observed by 2018. Steriwave received Fast Track designation from the FDA in 2019 and Ondine is currently engaged in US clinical trials in partnership with HCA Healthcare. In Q422, the company reported that its US Phase II nasal disinfection study met the primary endpoint of eliminating or significantly decreasing nasal Staphylococcus aureus in 86% of carriers. Ondine is planning to launch a larger Phase III clinical trial by end-2023, which will be conducted across 15 HCA hospital sites, and plans to involve c 10k surgical patients. Ondine hopes to expand into the US market, if successful with regulatory approval. Thus, the outcome of the upcoming US Phase III clinical trial may represent a major catalyst for the company, in our view.

We provided a more detailed assessment of Ondine’s Steriwave nasal photodisinfection platform and its commercialisation strategy in our Spotlight initiation note, which can be accessed here.

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General disclaimer and copyright

This report has been commissioned by Ondine Biomedical and prepared and issued by Edison, in consideration of a fee payable by Ondine Biomedical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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