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Research: Healthcare
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.
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Ondine Biomedical |
Steriwave initiates UK pilot study with NHS
Pharma and biotech |
Spotlight – Flash
11 August 2023 |
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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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Research: Healthcare
SIGA has reported Q223 results, which came in largely as expected, and management has provided key operational highlights. Activity in the second half of the year has started to firm up with upcoming TPOXX deliveries (for H223) and better-than-expected international orders (offsetting IV orders that will likely be received in FY24). We maintain our FY23 product revenue estimate of $155m and note H223 management sales guidance of $143–158m. We await further clarity on PEP immunogenicity trials, which we believe are the next material catalyst. As we incorporate the reported quarterly results and slight shift in revenue mix for the balance of the year, our valuation adjusts to $1.24bn or $17.46 per share (vs $1.25bn or $17.53 per share previously).