Surgical Innovations Share Discussion Threads

[buywell2] 03/12/2024 18:34

CMR Surgical look set to soon be carrying out several other procedures in the US


Mark Slack the co-founder and chief medical officer of CMR Surgical has very recently stated:

"we chose to go in the most efficient route possible, both financially and time-wise, which is to do a de novo and therefore only chose limited clinical indications.

The idea being, once we get that, we’ll then [submit 510(k) applications] on multiple other clinical scenarios.

We’ll start by upgrading the system, and then we’ll do colorectal, thoracic and all the other specialties, one after the other.

The real achievement was getting the system past a full FDA approval for the system and for all our instruments, because then doing the 510(k) is altogether much easier.

So we do small, limited clinical trials and expand it across to the other specialties here."






Google


AI Overview

On October 15, 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization for CMR Surgical's Versius surgical system:

What it means

The FDA's de novo clearance allows CMR Surgical to introduce the Versius robot in the U.S. for gallbladder removal procedures in patients aged 22 and up.

What it is

The Versius is a portable, cart-based, laparoscopic robot that assists surgeons with minimally invasive procedures:
It has collaborative arms and bedside units for direct patient access.
It offers port placement options to suit each patient's needs.
It's designed to biomimic the human arm.

How it works

The Versius can be wheeled around health facilities and put into place in about seven minutes. Surgeons can use it to do the entire procedure or parts laparoscopically.

Next steps

CMR Surgical plans to initially partner with a select number of U.S. hospitals before expanding nationwide. The company expects the total cost to be "favorable".

Other highlights

The Versius is the second most utilized surgical robotic system globally, with over 26,000 surgical procedures completed.













CMR Surgical & Surgical Innovations Develop New Surgical Hybrid Port Access System




CMR Surgical & Surgical Innovations develop new surgical hybrid port access system
• Surgical Innovations’ new YelloPort Elite™ 5mm, with reusable trocar and cannula, reduces cost and waste generated when compared with traditional fully single use Port Access Systems

• Developed with CMR Surgical, the port access system is the latest addition to Surgical Innovation’s Resposable® range of products and is designed specifically for the Versius® Surgical Robotic System

Cambridge, United Kingdom. 23 March 2022 00:01 (GMT). CMR Surgical – the global surgical robotics business – announces that it has worked with Surgical Innovations – a company specialising in the design, manufacture, sale and distribution of medical products – to develop YelloPort™ Elite 5mm, a new surgical port access system.

The surgical port is made up of a reusable trocar and cannula, with single use valve, which minimises clinical waste and reduces the cost for hospitals when compared to traditional single-use surgical ports(1).

YelloPort Elite™ 5mm was designed specifically for CMR’s surgical robot Versius®,though it is universal in nature and can be used in combination with a wider range of laparoscopic instrumentation.

YelloPort Elite™ 5mm received its CE Mark in February 2022 and will launch in Europe in April 2022 followed by a global rollout.

It is the first venture that Surgical Innovations and CMR Surgical have collaborated on.

David Marsh, Chief Executive Officer, Surgical Innovations, said: “We’re delighted to partner with CMR Surgical, a fellow British medical device company, to develop this new surgical Port Access System. Our ResposableTM products provide a high-quality hybrid instrument concept, with the clinical benefits of a small disposable element, reducing waste by at least 70% compared to fully disposable alternatives.”

Mark Slack, Chief Medical Officer, CMR Surgical, said: “When we talk to hospitals and clinical teams, we hear how important it is for them to reduce the environmental impact of the surgical products and instruments they use. We want to partner with hospitals to reduce waste and cost, whilst advancing performance. Working with Surgical Innovations to develop this new port, we’ve been able to do just that.”






In a typical Versius MIS operation 3 of the above trocars are used

After an operation the seals of each Trocar are removed and the Trocars sent for special hospital based cleaning procedure

Then new seals are fitted for the next patient --- Surgical Innovations make these seals .



So when Versius is installed at a new hospital in each country CMR Surgical are selling into --- the pace of which is increasing --- then that hospital has to hold and order new Trocars from Surgical Innovations plus spare seals ( 3 used per operation per patient )

During transaction involving ordering , Surgical Innovations sales people have the opportunity to showcase other MIS surgical instruments and products that they make , that also save a hospital money and reduce plastic waste together with a carbon footprint reduction.


The recent FDA clearance for Versius in the US , for Gallbladder removals thus presents the opportunity for the number of Versius operations to double IMO in 2025 IF CMR Surgical Sales can capture 1% of the market.


Google AI Question

how many MIS gallbladder removals in the US in 2023 ?


AI Overview


In the United States, surgeons perform around 1.2 million gallbladder removals each year, including: 605,000 ambulatory laparoscopic procedures, 280,000 inpatient laparoscopic procedures, and 49,000 inpatient open procedures.

The most common reason for gallbladder removal is repeated attacks of biliary colic. Gallbladder removal is often the safest and most effective treatment for symptoms or complications associated with gallbladder disorders.

The gallbladder is not an essential organ, and the body can adjust and function normally without it. However, surgery is usually carried out if you have painful gallstones, which can form in the gallbladder due to an imbalance in bile.

If you are experiencing symptoms of gallstones or think you are at risk for gallbladder disease, you should talk to your primary care provider about getting an ultrasound. Early detection of gallbladder disease can help save your life.


Amazing eh


Take Germany for example


how many MIS gallbladder removals in Germany 2023


AI Overview

According to available information, around 175,000 gallbladder removals are performed in Germany each year, making it one of the most common surgeries in the country due to the high prevalence of gallstone disease; most of these are likely to be minimally invasive (MIS) procedures




how many MIS gallbladder removals in France 2023


AI Overview

According to available research, in France, over 115,000 MIS (minimally invasive surgery) gallbladder removals, also known as cholecystectomies, are performed annually, primarily for symptomatic gallbladder stones; this data is considered fairly current and likely applies to 2023 as well.




See where I'm going


MIS Gallbladder removal is the most common MIS operation in the world



Google AI question

Is MIS gallbladder removal the most common operation in the world ?


AI Overview


Yes, minimally invasive gallbladder removal, also called a laparoscopic cholecystectomy, is considered one of the most common operations performed worldwide, making it a strong contender for the title of "most common operation" globally; this is primarily due to the high prevalence of gallstones, which often necessitate gallbladder removal

dyor

[buywell3] 25/11/2024 07:25

October 15th 2024

Marketing Authorization for next-generation Versius Surgical System

Versius was granted marketing authorization through FDA’s De Novo process which establishes initial indication for adults undergoing cholecystectomy





24th November 2024

CMR Surgical is a global surgical robotics company. Its ground breaking next-generation surgical robot Versius performed its 20,000th surgical case in 2024.

The unicorn company’s small robot offers portability and unique design features that enable surgeons worldwide to provide minimal access surgery (MAS) to more people and across more specialities, such as thoracic surgery.

Over 75 per cent of hospitals that perform surgeries with Versius now use the system across at least two specialities, which has increased adoption uptake. Versius’s small V-wristed instruments and 3D HD vision support precise and accurate surgical performance across common- and complex elective procedures.

The robotic system biomimics the human arm with benefits such as optimised port placement, fully-wristed instruments that enhance dexterity and accuracy, and multiple ergonomic working positions — all of which can help reduce surgeons’ stress and fatigue and improve overall surgical efficacy. In 2023, CMR Surgical achieved over 50 per cent growth in its global install base.

In October 2024, CMR Surgical secured FDA approval for Versius in the US market. It now seeks to address the strong demand for surgical robotics across key territories including Asia Pacific, the Middle East and Africa, to help patients access optimal surgical care. CMR boasts the only global surgical robotics manufacturing facility in the UK.



Previously:



CMR Surgical announced that its Versius robot had performed over 10,000 cases on March 27th 2023


CMR Surgical announced on Sept 21st 2023 that its Verius robot had been used in more than 15,000 procedures across seven surgical specialties



Seems that with FDA approvals now coming 40,000 operations in 2025 is likely


Some related news from Surgical Innovations would perhaps IMO be welcomed by the market

dyor

[ebitda3] 20/11/2024 16:36

How dead can this stock get? One or two trades per day (if you're lucky).Come on SI, give us something positive!!

[ebitda3] 23/10/2024 12:36

I see HealthInvest AB sold their holding in August. It's on the RNS feed. They hold 0% now.

[mr macgregor] 15/10/2024 15:52

Zombie company kept alive by repeated placings. Another one incoming.

[justiceforthemany] 14/10/2024 15:57

Placing coming. Directors not buying any stock.

[bmcollins] 14/10/2024 15:51

Well having just finished watching the presentation I feel more comfortable, sure there is risk but the team seem to have made good progress, interestingly especially in Israel & India, both being countries which could likely have companies who deal with SUN and could buy it up and scale up with a cash injection, imho.

[bmcollins] 14/10/2024 13:10

@ebitda
Precisely so, I was alrady signed up and await the webinar with interest !

[ebitda3] 14/10/2024 13:01

Business half year update on Investor Meet Company at 16:00 today

[fillipe] 08/10/2024 15:23

SUN - 0.645p paid at 1545hrs today.

f

[ebitda3] 02/10/2024 10:17

Walbrook PR have referred to HR results on LinkedIn. Are these results public?

[justiceforthemany] 30/9/2024 14:10

Despite inflation falling and a new Labour government can't even turn a profit and UK market in trouble.

[gbh2] 30/9/2024 12:56

AS I commented many times in the past, the directors are the only ones to make a profit out of this dog.

[mandate] 30/9/2024 11:43

Sounds reasonably positive to me

[justiceforthemany] 30/9/2024 11:20

Continue in operational existence for the 'foreseeable future'....yikes.
Presentation today also cancelled.

[justiceforthemany] 30/9/2024 10:45

Several references to going concern and whether or not the company will still be functioning going forward.
Concerning.

[justiceforthemany] 30/9/2024 07:21

Cash down.
Not good.

[justiceforthemany] 25/9/2024 07:46

Results + call on Monday.

[buywell3] 18/9/2024 07:17

Surgical Innovations make Liquiband Fix8 and Liquifix Fix8 for AMS

2025 imo looks set to be a very big year in the USA for sales of these products






Advanced Medical Solutions results today



Internal Fixation and Sealants

AMS's hernia mesh fixation device, sold under the LiquiBandFix8® brand ex-US and as LIQUIFIXTM in the US, secures meshes inside the body with accurately delivered individual drops of cyanoacrylate adhesive instead of traditional tacks and staples.

Revenues increased by 75% on a reported basis to £3.8 million (2023 H1: £2.2 million) and 79% on a constant currency basis.



The US launch of LIQUIFIXTM is progressing well with significant launch orders received.

The GPO approval process has proven to be more prolonged than anticipated and consequently limited orders are expected in the second half of 2024.

Progress has been made in two major US GPOs, with approval in Premier GPO, leveraging our distribution partners existing Premier mesh approvals, and pending approval in HealthTrust GPO from 1 November.

Following the HealthTrust GPO approval, significant orders are anticipated from H1 2025.




AI Overview
Learn more
…
Both open and laparoscopic surgery are used to repair inguinal hernias, and the best approach depends on the patient's circumstances:

Laparoscopic surgery

This approach is becoming the primary method for treating adult inguinal hernias. It can result in less pain, shorter hospital stays, and a faster return to normal activities than open surgery. However, it requires general anesthesia and can be more expensive. Laparoscopic surgery might be a good choice for patients with a small belly button hernia who are active sportspeople.




Conclusion:

In terms of decreased post-operative discomfort, shorter hospitalization, and an earlier return to activities, laparoscopic hernia repair has been found to be superior to open hernia repair, which is also known as Lichtenstein surgery. However, there was no discernible difference among the two groups with regard to post-operative problems, including seroma development and wound infections. To assess chronic discomfort and recurrence rates after laparoscopic hernia surgery, additional studies and extended follow-up are required.





NOTE:

Less hospital stay = More patients treated in limited bed numbers = Quicker operations backlog clearance rates

[justiceforthemany] 13/9/2024 11:08

You've not answered my question.
Do you even hold any stock here?

[buywell3] 12/9/2024 06:01

One of the present NHS problems is lack of hospital beds , as under tory rule NHS beds in hospitals have been cut back resulting in be hospital bed usage rates of well over 90% in many hospitals ie FULL when we have an epidemic


Now IMO it makes sense in the absence of not enough beds to move to new surgeries and technologies that REDUCE THE LENGTH OF HOSPITAL STAY

Thus more patients can be treated in those same beds and the present backlog of operations tackled until newer hospitals can be built


The NHS SUPPLY CHAIN was created to save money for the NHS by arringing bulk purchases from suppliers of surgical consumables , instruments and equipment --- rather than letting individual NHS Trusts go their own way and order themselves in smaller numbers --- it has saved the NHS Billions of pounds since it was created


The NHS Supply Chain has concluded and now states:

" Minimally invasive surgery allows the surgeon to use techniques that limit the size and number of cuts, or incisions, that they need to make. This procedure is also known as Laparoscopy or keyhole surgery and it’s typically considered safer than open surgery. The surgeon uses small tools, cameras, and lights that fit through several tiny cuts in your skin.

The advantages of minimally invasive surgery include:

A shorter hospital stay and faster recovery time

Less pain and bleeding after the operation

Reduced scarring.



==========================================

So IMO Minimally invasive surgery (MIS) also known as Keyhole Surgery should be increasingly used as clear benefits exist compared to traditional olde open surgery --- many medical papers over recent years have shown this to be so

Also robotic Minimally invasive surgery should be increasingly used as medical papers also show this type of surgery achieves more operations performed and will increasingly better outcomes for patients.






Refer to

News 12th September 2024


PM pledges move to a ‘digital NHS’, following Lord Darzi report
AI and Data, Integrated Care, Leadership and Teams,


Lord Darzi’s independent investigation says the NHS is ‘in the foothills of digital transformation'
He calls on the NHS to make better of use of patient data, join up health records, improve the NHS App and harness AI to transform care
In response to the report, Prime minister Sir Keir Starmer pledged a move "from an analogue to a digital NHS"
Prime minister Sir Keir Starmer has pledged to move “from an analogue to a digital NHS”, following the publication of Lord Ara Darzi’s review into the state of the NHS in England.

The independent investigation, published on 12 September 2024, says that the service is in “serious trouble” and highlights “worrying health inequalities” and a deterioration in the health of the nation.

NHS surgeon and independent peer, Lord Darzi said that he was “shocked”; by what he found during his investigation, adding that “quality of care has gone backwards”.

Issues flagged in the report include patients struggling to see their GP, waiting lists for community and mental health services, the “awful” state of A&E, waiting times for hospital procedures, cancer care lagging behind other countries, and cardiovascular care “going in the wrong direction”.

Drivers for this performance include a £4.3 billion raid on capital budgets between 2014-15 and 2018-19 to cover in-year deficits, as well as a shortfall of £37 billion of capital investment meaning that “there are too many outdated scanners, too little automation, and parts of the NHS are yet to enter the digital era,” Lord Darzi says.

“Over the past 15 years, many sectors of the economy have been radically reshaped by digital technologies. Yet the NHS is in the foothills of digital transformation.

“The last decade was a missed opportunity to prepare the NHS for the future and to embrace the technologies that would enable a shift in the model from ‘diagnose
and treat’ to ‘predict and prevent’—;a shift I called for in High Quality Care for All, more than 15 years ago,” he writes.

Lord Darzi concludes that the NHS is in a “critical condition, but its vital signs are still strong”.

He highlights “low digital maturity” across the NHS and calls for a “major tilt towards technology to unlock productivity”, including digital systems for NHS staff working outside hospitals and using AI to transform care.

“There are many possible technologies that would support more efficient, higher quality, safer care in the community. But they are largely absent.

“Given the shift in the disease burden towards long-term conditions, there is a greater need for information systems that work across different settings,” he says.

Focus groups for the investigation found a strong perception among NHS staff that IT created an “additional burden”.

“It always seems to add to the workload of clinicians rather than releasing more time to care by simplifying the inevitable administrative tasks that arise,” Lord Darzi says.

He mentions the Federated Data Platform, as an example of significant NHS investments which “have great promise and have started to show some impact locally”.

Also he says that the NHS App has “huge potential”, but adds that it is “not currently living up to its potential impact given the vast scale of its registered user base”.

The report calls for the NHS to make better of use of patient data, which is “largely untapped either in clinical care, service planning or research”.

“With its deep and broad datasets, and the global AI hub that has emerged in the UK, the NHS could be at the forefront of this revolution, with NHS patients the first to see the benefits,” Lord Darzi says.

The report outlines the steps needed to provide integrated care, including “an understanding of the population and their needs using integrated datasets” and the whole team working to a shared care plan which incorporates preventative interventions.

In response to the investigation, Sir Starmer, said the government is creating a 10-year plan based around “moving from an analogue to a digital NHS”, as well as shifting from hospitals to communities and from “sickness to prevention”.

Amanda Pritchard, chief executive at NHS England said: “Our staff are treating record numbers of patients every day despite ageing equipment and crumbling buildings, a surge in multiple long-term illnesses, and managing the long-lasting effects of the pandemic.

“While teams are working hard to get services back on track, it is clear waiting times across many services are unacceptable and we need to address the underlying issues outlined in Lord Darzi’s report so we can deliver the care we all want for patients”.

Dr Jennifer Dixon, chief executive of the Health Foundation, said: “Darzi’s diagnosis points to some obvious priorities for NHS reform, including shifting the balance of resources towards primary care and community-based services, modernising NHS buildings and equipment, and harnessing the benefits of new technology to improve care for patients”.

She added that getting the NHS back on its feet will “require sustained investment”.

Secretary of state Wes Streeting, who commissioned the report in July 2024, said that the NHS “is broken, it’s not beaten”.

Digital health sector reactions to the report
We asked health tech leaders for their reactions to Lord Darzi’s investigation into the state of the NHS in England. Here’s what they had to say:

Dr Rachael Grimaldi, cofounder and chief executive at CardMedic:

“Darzi is right to point out that patient care is held back by outdated IT. There are still many areas in the NHS where technology is still a novelty; like language translation and communication.

“Using technology to break down communication barriers, especially in some of the most urgent or unplanned situations, is crucial. However, the existing barriers within the NHS must be dismantled to facilitate widespread adoption of technology as quite often change doesn’t filter down to the teams responsible for procurement, innovation, and digital transformation.

“It’ll be interesting to see how the new 10-year plan aims to solve the problems highlighted by Darzi and whether we’ll actually see real changes happening to tackle inequality and improve healthcare for everyone.”

Nick Wilson, chief executive at System C:

“Darzi has rightly pointed out about the untapped potential of NHS datasets that integrated care systems (ICSs) and trusts already have.

“A lot of suppliers also have an amazing opportunity to help with national and regional data sets for population health, maternity and pharmacy for example.

“Wes Streeting’s emphasis on a shift from sickness to prevention aligns with the need for well-integrated, technology-supported healthcare systems to maximise the potential of NHS datasets.

“Turning these insights into action would help teams make informed decisions at the point of care and ultimately deliver better outcomes.

“We would like to see the government prioritise the integration of care with existing technology systems to minimise significant delays and the substantial disruption often linked to introducing new and untested solutions across care settings.

“Unfortunately, the will to do the right thing hasn’t been strong enough to overcome the organisational, financial, and cultural barriers.

“Fundamental changes are needed in how funding flows between different care settings to incentivise true integration.”

Mindy Simon and Jack Porter, co-directors of NHS Innovation Accelerator:

“Lord Darzi’s review acknowledges extraordinary pressures facing the NHS and in turn emphasises the need for greater adaptability. At this crucial time, focusing on the healthcare solutions that are already available and ready for adoption is essential.

“Programmes like the NHS Innovation Accelerator are helping to identify and making these solutions accessible, reducing the burden on the NHS to find the capacity to source and assess them independently.

“By tapping into known evidence-based innovations, the NHS can create insights from one area of use, to improve patient care and address current challenges on a larger scale. This approach not only helps with immediate needs but also supports a positive and proactive perspective on advancing healthcare.”

Phil Bottle, managing director at SARD:

“Lord Darzi’s review, like others before it, highlights the significant challenges that our health and care system faces.

“It’s indisputable that a sustainable NHS needs to be more efficient, however, with such poor visibility of who is working in the NHS, and what they are expected to do it is impossible to right-size the workforce now, never mind for future demand.”

Richard Pugmire, chief exective at Answer Digital:

“The NHS is under immense pressure and the government has made it very clear in its early tenure that difficult financial decisions will need to be made in the forthcoming autumn budget.

“We’ve already seen budgets for AI deployment and virtual wards slashed to plug holes. However, if the Government is to deliver on its promise to move the NHS from ‘analogue to digital’, this will require funds directed in such a way that will help scale the technologies that have the biggest impact on enhancing productivity.

“Cuts and delays have already had an impact on digital initiatives across the board and I really feel for local NHS leaders who are trying to move their organisations forward with the resources available to them, but are required to rely on commitments previously built on sand.

“Lord Darzi’s assessment has been swift, and I hope for the sake of the NHS the prescribed reforms that follow in the anticipated 10-year plan are matched with the commitment required to make digital transformation possible, and quickly.”

Paul Tambeau, chief executive of Induction Healthcare said:

“Not surprisingly, the Darzi report highlights the role that digital tools can have in addressing key challenges in the NHS, especially in reducing waiting lists and improving productivity across the NHS.

“Induction customers have seen real evidence of how portals, integrated with video, can reduce waiting lists, make interactions with patients more efficient, and provide real cash savings for their trust.

“They also see how digital tools deliver a better patient experience as well as improved outcomes. It’s now time to act and ensure that funding models provide an incentive for trusts to procure longer term so that they can really embed tools in a way that is integrated with existing systems and drives value and efficiencies now, as well as longer term.”

Dr Hector Zenil, founder of Oxford Immune Algorithmics:

“It would be unfair to say the NHS is uniformly behind the private sector in terms of its adoption of technology. There are teams and leaders within the NHS who are at the forefront of innovation, such as AI and virtual wards.

“The challenge is one of implementation. Adopting emerging technologies requires far more checks and balances compared to the private sector, which is absolutely right given the need to prioritise patient safety.

“However, there is also a need to articulate a vision for the health service, which helps to educate the public, policy makers and clinicians on what is required to redefine the delivery of diagnosis and treatment.

“There are costs involved in embracing any new technology and in the current economic situation, there must be a discussion about where to prioritise investment because it is not possible to address every medical issue at once.”

[justiceforthemany] 10/9/2024 09:59

1.4M buy
Date set for results.

[justiceforthemany] 06/9/2024 12:51

Hope you have an actual holding here buywell.