Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
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Certainly someone needs to fund their mooted very large phase 3 trial in the US, that what was presumably what the now departed JP Errico was brought in to try and arrange. A trial of that size (4,400 patients) would normally cost the best part of 200 million dollars and is many times the size of a typical Phase 3. It is not clear how much having HCA as partner will help with this. Meantime they seem to be raisng funds on a quarterly basis.
I think the approval of Steriwave, after recent trials, into the NHS has now primed Ondine for takeover by a big provider with the size to scale it. Ondine has 7 applications for Steriwave in its sights and pending Ph3 approval into the USA market.
Hospital acquired infections cost the NHS a fortune.
SSIs are one of the most common healthcare-associated infections (HAIs) and affect one in every 20 patients who undergo a surgical procedure in the NHS. SSIs can cost up to £100,000 per patient, and the overall cost of HAIs to NHS England is over £2 billion a year.
Operating results for the first half year were in line with management expectations despite a challenging economic backdrop and unfavorable stock markets which contributed to the deferral of 2023 fundraising plans. The Company has made solid progress toward its two key 2023 corporate objectives:
· Preparing for the upcoming Phase 3 clinical study-a critical component for US market approval of the Company's nasal photodisinfection. ( Steriwave)
· Advancing commercial efforts and geographic footprint into the Canadian, British, Spanish, and Mexican markets.
Financial highlights
· Loss from operations in H1 2023 of $8.03 million (H1 2022:
Observations:
JP Errico resingned from electroCore Board in May 2023.
Joined Ondine in January 2024.
LinkedIn profile (Experience) does not mention Ondine
Steriwave® is a broad-spectrum antimicrobial providing targeted decolonization safely, effectively, quickly.
Broad-spectrum: Kills all pathogens (bacterial, viral, fungal).
Non-resistance forming.
Safe and painless treatment for patients within 5 minutes.
High compliance, clinician administered.
Suitable for repetitive use (e.g. healthcare workers, frequent hospital visitors, long-term care facilities, outpatients, dialysis patients).
Should be out soon
Not a good sign and fund raise looks likely. Very small holding here just for interest. Just see how holders of SND have been wiped out. Lucky to have made £k`s in this but could have also lost a lot of cash. Both Companies have great products, but are vulnerable to progress without any liquid cash flows. This is an high risk Company to invest in so be careful how much You want to risk.
I have only just found this stock and am going through my research as i always do before investing.
the cfo leaving in such a short time is a red flag to me.
also that they will almost certainly have to do another fund raise in the near future.
anyway i will continue my research.
Matt Ross joined Proactive's Stephen Gunnion after the company sealed its first commercial deal with an NHS trust, starting with the Pontefract and Pinderfields hospitals. This follows a successful 500-patient elective hip and knee surgical quality initiative at Pontefract, leading to its adoption across the two hospitals.
The company aims to develop a business case with York health economics group and Mid Yorkshire for broader NHS adoption, based on the successful outcomes and health economics work.
Ross also highlighted Ondine's commercial momentum, including the deployment of Steriwave in eight new healthcare facilities and a growing international presence, now spanning 22 facilities in Canada and expanding in the UK and Spain.
The success is attributed partly to Steriwave's effectiveness in reducing the need for antibiotics, as demonstrated in a UK study, and its alignment with antimicrobial resistance efforts. Ondine plans to continue expanding in European markets, capitalize on its success in Canada, and explore potential in the United States through FDA phase three trials.
William (Bill) Kanz has been appointed as Senior Vice President, Engineering and Operations. In this role, Mr. Kanz will lead the engineering, operations and manufacturing teams, supporting Ondine's rapid commercial growth. Mr. Kanz is a certified quality engineer and lean six-sigma black belt, and brings a wealth of product management, manufacturing, and product development expertise to the company. Building on his operational management capabilities, he has developed some of the world's leading atherectomy devices, ultrasound catheters and blood pumps, and has 47 patents to his name.
Caetano Sabino, Ph.D. has been appointed as Ondine's Director of Research and Development, building on his extensive pharmaceutical sciences background and many years of development of light-activated therapeutics. Dr. Sabino is an expert in photodynamic disinfection, and has authored numerous important publications, textbooks, and patents in the field. He most recently held the position of CEO, BioLambda, Científica e Comercial LTDA, Sao Paulo, Brazil manufacturing industrial equipment for light-based disinfection in hospitals, clinics, and the food industry.
Carolyn Cross, CEO, Ondine Biomedical commented. "We will be providing an update on our upcoming dual priorities of continued significant commercial expansion and initiation of Phase 3 clinical trial in the USA with our partner, HCA Healthcare."
8.6651-9.34p
Should be our primary focus
Steve305 - I think we should avoid trying to guess the reasons for a resignation. Personally, I believe we should consider the overall situation: the developments re the NHS trials, the progress towards the FDA phase 3 trial and the ramping up of production capability are worthy of a positive outlook.
Ondine Biomedical Inc on Thursday appointed a new interim chief financial officer, following the resignation of former CFO Joseph Errico.
The Vancouver-based life sciences company named Kwong Choo as interim successor. It noted Choo "brings more than 15 years of experience in international public companies on NASDAQ, the Toronto Stock Exchange, and the TSX Venture Exchange", as well as with "a number of private biotechnology and pharmaceutical companies".
Choo has been working with Ondine since 2022, while former CFO Errico was appointed to the role two months ago.
In other appointments, Ondine promoted Nikita Parkhaev to vice president, finance, having most recently held the position of controller.
It also appointed William Kanz as senior vice president, engineering and operations. In this role, Ondone said Kanz will lead the engineering, operations and manufacturing teams, supporting Ondine's rapid commercial growth.
Lastly, Ondine appointed Caetano Sabino as director of research and development, which it said "build[s] his extensive pharmaceutical sciences background and many years of development of light-activated therapeutics".
Looking ahead on an operations front, Chief Executive Officer Carolyn Cross commented: "We will be providing an update on our upcoming dual priorities of continued significant commercial expansion and initiation of phase 3 clinical trial in the US with our partner, HCA Healthcare."
Shares in Ondine Biomedical were down 2.5% to 9.51 pence each in London on Thursday aft
So the cfo described as a big hitter only stays at the company for 2 months why is this i ask ???
There's a fine line between dismissing a share at this level and FOMO as appraisal and adoption snowballs. It really screams the perfect juncture for a player like J&J to take this on and scale it exponentially. The proof of effectiveness is out there and rapidly gaining surgeon comment.
Proactive Investors interview:
"The company aims to develop a business case with York health economics group and Mid Yorkshire for broader NHS adoption, based on the successful outcomes and health economics work."
There are 195 NHS trusts, excluding Ambulance and Mental Health trusts, many with more than one site. If Steriwave is widely adopted after the preparation of the business case, the potential number of applications is considerable. There are also private hospitals to consider.
This extract is from the Ondine news update 25/03/24:
"SSIs are one of the most common healthcare-associated infections (HAIs) and affect one in every 20 patients who undergo a surgical procedure in the NHS. SSIs can cost up to £100,000 per patient, and the overall cost of HAIs to NHS England is over £2 billion a year. These costs are expected to rise as growing rates of antimicrobial resistance (AMR) make the current standard of care – the antibiotic mupirocin – less effective."
There is a massive opportunity for Ondine IMO.
Carol Cross CEO has take this from concept, thorough R&D and proving, trialled and accepted by surgeons and now on the cusp of large commercial rollout. At 62yrs of age and with her background and stature I am sure that she sees the best exit strategy is to sell to a big player who can scale up. The huge degree of success in reducing the need for antibiotics in post operative hospital care is evident and becoming globally 'viral' as surgeons and care teams communicate the savings. Steriwave is simple, quick, non-invasive and safe as it does not compromise the nasal biome weeks after the operation. A 75% reduction in the use of antibiotics to treat post op hospital acquired infections seems to be universal when Steriwave is used. That saves hospitals millions of pounds and thousands of days post op intervention and bed-blocking. It's a total no-brainer and just needs a major [probably US] Healthcare company to make her an offer and immediately scale it globally. As she holds 50% or so of the shares it would be a done deal. I mentioned 20p but I personally see it worth a lot more. Hopefully Carol Cross thinks likewise. I really cannot see any other direction than north from here.
Commercialised in Canada, yet no proof of revenues from these many hospitals
Hazbeen - the prouf in in the pudding
Adastra - do we expext to double like IMM?
RBC says target 60p
Given the raft of positive news now coming out from surgeons in all quarters of the profession, oropharyngeal, orthopaedics etc I have written to the company to request that they give possible financial projections of uptake. The recent NHS news must have huge potential and it would be great to see some meat on the bones.