Surgical Innovations Share Discussion Threads

[buywell3] 30/4/2018 13:32

Advanced Medical Solutions (AMS) annual report out ... re the Hernia Mesh Fixation device – LiquiBand® Fix8™ that SUN developed and now manufacture for AMS and own the IP.

Further growth now on track

The AMS annual report said ''We expect to see a return to sales growth this year.''

and

''In R&D, we are also working on broadening the claims on the use of the device for hernia mesh fixation as well as for a number of other laparoscopic surgical applications and developing a device suitable for hernia mesh fixation in open surgery which we expect to launch in Europe in the first half of 2019. ''

plus AMS are to spend £3M getting LiquiBand® Fix8™ approval for sales in the USA

''At present, the device is approved for use within Europe and those markets that accept European approval standards.
We have started the process to get LiquiBand® Fix8™ approved in the US market.
This necessitates a full Pre Market Approval (PMA) involving clinical trials with patient enrolment expected to start in mid 2018 and enrolment completing by the end of the year. We expect the total cost of completing the approval process will be around £3 million with the majority of the spend being incurred in 2018 and 2019.''



Hernia Mesh Fixation device – LiquiBand® Fix8™

LiquiBand® Fix 8™ is used to hold hernia meshes in place within the body instead of tacks and staples. This accurate laparoscopic application of adhesive is expected to both reduce surgical complications and reduce the potential pain associated with the use of tacks and staples. It also provides the ability to attach mesh in areas
where tacks and staples cannot be applied, helping to improve the patient experience and surgical outcomes.

As reported at the half year, sales growth of LiquiBand® Fix8™ has been restricted due to design enhancements we have made following surgeon feedback. Further feedback has been received on the updated device and modifications have been completed.
We have chosen not to actively promote the device while the modifications were ongoing, nevertheless sales increased by 3% to £1.7 million (2016: £1.7 million) and 1% at constant currency.

We expect to see a return to sales growth this year.

At present, the device is approved for use within Europe and those markets that accept European approval standards. We have started the process to get LiquiBand® Fix8™ approved in the US market.
This necessitates a full Pre Market Approval (PMA) involving clinical trials with patient enrolment expected to start in mid 2018 and enrolment completing by the end of the year. We expect the total cost of completing the approval process will be around £3 million with the majority of the spend being incurred in 2018 and 2019.

In R&D, we are also working on broadening the claims on the use of the device for hernia mesh fixation as well as for a number of other laparoscopic surgical applications and developing a device suitable for hernia mesh fixation in open surgery which we expect to launch in Europe in the first half of 2019.

[buywell3] 27/4/2018 11:58

Friday 13 April 2018

''NHS obesity-related workload, which totaled 617,000 admissions in the last year: a 18 per cent rise from the previous year and a 334 per cent rise from 2009/10.

The first stream, around 10,705 admissions, is directly treating obesity.
For example, bariatric surgery – at cost to the NHS but with the forward view that it will offset longer term costs had obesity been left untreated.

The larger second stream is managing the obesity-related conditions.''


buywell3 Note: or better put IMO


The larger number of operations performed in the last year related TO obesity related conditions was 606,295

In that year there were also 10,705 operations directly treating obesity eg bariatric surgery



What an utter disgusting treatment of human beings and in addition what a waste waste of public monies.o

Remember

Prevention is BETTER than cure ... many of those 606,295 people could have avoided their medical condition/s resulting from obesity IF they had undergone bariatric surgery.

''Approximately 20 per cent of 10-year-olds are obese. And sadly, obese children are likely to grow up to be obese adults. This means the pressure from obesity on NHS services will receive a generational drip-feed that is likely to accrue until the NHS truly blows its breeches.''

[meijiman] 27/4/2018 11:28

Surely you have to be a bit dim not to realise that lifestyle changes will help you lose weight or not get fat in the first place. Trouble is self denial seems to have gone out of the window (I was born in the 1950s)and sport was very very compulsory at my school-forget you kit and you do it in your underwear. Ah the good old days.
What time is Nigel on today?

[buywell3] 27/4/2018 11:14

worth a look

[bashor] 26/4/2018 23:12

I hope Nigel sells the growth story well tomorrow

[davidosh] 23/4/2018 16:53

Just to mention that Surgical Innovations are presenting at the huge Mello2018 investor event at the end of this month so good timing if you would like to come

They have never presented at a Mello event before and Nigel Rogers is scheduled to present on Friday 27th April when the company also has a stand for the day. Here is the link if any of you would like to come along and meet them....

[meijiman] 19/4/2018 08:56

Good find -comes across as a compelling argument. That's over 7 stone above your ideal weight. These people must be enormous. Give me a double cheeseburger with a side order of fries and a gallon of sugary fizz to wash it down.

[buywell3] 19/4/2018 07:04

Somebody get this under Mr Hunts hooter



Study looks at weight loss surgery for teens

Participants in the study had to be at least 100 pounds over their ideal body weight to enter the program.

Author: Dr. Comilla Sasson
Published: April 11, 2018


A new study from Children’s Hospital Colorado compared obese adolescents who received traditional treatments for diabetes and obesity with those who received bariatric surgery.

Participants in the study had to be at least 100 pounds over their ideal body weight to enter the program.

At the two year mark, the adolescents in the bariatric surgery group lost on average 97 pounds, decreased their body mass index by 28 percent, and 94 percent improved their hemoglobin A1c levels to non-diabetic ranges.


In comparison, those teens in the medical treatment group at two years experienced an average increase in body weight by 13 pounds, increase in body mass index by 3.5 percent and mean increase in their hemoglobin A1c levels from 6.3 percent to 7.6 percent.

The conclusions are surprising and potentially controversial.

Lead study author Dr. Inge, who also serves as the Director of the Bariatric Surgery Center at Children's Hospital Colorado, has seen dramatic results for his severely obese adolescent patients who have had surgical procedures.

These adolescents are referred after failing to lose weight with nutrition counseling, exercise programs, psychological support, and behavioral interventions.

There are two main types of bariatric (weight loss) surgery, the gastric sleeve and the Roux-en-Y procedure.

Both decrease the size of the stomach and/or reroute the way in which food is digested by the stomach and small intestine.

These procedures are done using laparoscopic techniques with small incisions.

This new study raises the question, with such dramatic results, is the surgical option a treatment that should be considered more often in an effort to reverse type 2 diabetes for severely obese adolescents?

Surgery does have its complications, and each procedure has its risks and benefits. Twenty-three percent of the adolescents in the bariatric surgery group had to go back to the operating room for additional surgical procedures.

Surgery, although potentially considered an extreme option, could be an important part of a comprehensive treatment plan for caring for adolescents who are obese.

If surgery can reduce the severe complications that diabetes has on the body, such as future heart attacks, strokes, kidney issues, and amputations, then these minimally invasive procedures might significantly reduce healthcare costs and lead to better health and productivity for these teens.

Future research, including following patients for longer time periods, will continue to provide answers to these questions.


It's a ''no brainer'' Mr Hunt

Pay around £8k for MIS obesity surgery ... now : save £180k down the road over the next 5 years as the other diseases and health issues kick in

[buywell3] 19/4/2018 06:49

............................ Surgery needed for 80,000 obese kids .............................


Thursday, April 19, 2018

Some 80,000 obese children in Ireland need surgical intervention to tackle their weight issues or they may not make it to adulthood, a doctor has warned.








... Weight-loss surgery beats meds for obese, diabetic teens, study says ...

March 21st 2018


Weight-loss surgery may help severely obese teens with Type 2 diabetes far more than medication and lifestyle changes alone, new research suggests.









Before, I couldn't walk 200m'​ – why surgery can be life-changing ...

The Guardian-25 Mar 2018

''Last week, the new president of the Royal College of Paediatrics and Child Health, Prof Russell Viner, said that the NHS could be doing up to 100 times more obesity surgery, or bariatric surgery, on the most obese children and teenagers.''



Daily Mail-23 Mar 2018

Obese teens were at an eight percent risk of heart disease before surgery; After bariatric operations, like gastric bypass, their risks dropped to four percent; Their health improvements were sustained for five years after surgery, according to new research from the University of Minnesota




Weight loss surgery widely underutilized among young patients with ...

News-Medical.net-20 Mar 2018

Among U.S. teenagers and young adults with severe obesity, a new study finds that only a small percentage undergo weight loss surgery, even though it is broadly considered the most effective long-term weight loss therapy.


It's a ''no brainer'' Mr Hunt

[buywell3] 14/4/2018 11:30

Mr Hunt needs to start getting proactive regarding introducing more preventive surgery on obese patients to help them lose weight before other diseases related to being obese bankrupt the NHS completely and stop it from functioning in a meaningful way.

Today obesity now being linked as the prime cause of Liver disease over booze

''Britain has the highest obesity rates in the EU and the warning came after an analysis of MRI scans of 2,895 people on the UK Biobank database revealed 12 per cent suffer from the most severe type of liver disease, known as non-alcoholic steatohepatitis (NASH).''


I have posted re Obesity now also being linked as the main cause of several types of cancers, Type 1 and 2 Diabetes , Stokes and cardiac problems.

The Dept Of Health needs to act ... now ... more bariatric surgery operations on the NHS NOW

14 April 2018




Our liver disease timebomb: Britain is facing a health crisis fuelled by obesity which is set to take over alcohol as the main cause of the condition

Obesity is set to become the leading cause of liver disease, replacing alcohol

The alarming change will occur in the next five years according to researchers

The study discovered that 12 per cent of Brits thought to have fatty liver disease


£8k on an op now ... saves £180K on loads of other problems in the following 5 to 10 years

Common sense please ... the NHS must stop being a political football Mr Hunt

[meijiman] 03/4/2018 15:03

Sounds great..5p here we come..at least when the market picks up.

[buywell3] 03/4/2018 15:02

In the last 12 months Surgical Innovations have designed a new ''end piece'' for Liquiband Fix8 that should satisfy surgeons re the new applications that AMS now seek



2 weeks ago Advanced Medical Solutions said this regarding Liquiband Fix8

Taken from latest AMS results

''In R&D, we are also working on broadening the claims on the use of the device for hernia mesh fixation as well as for a number of other laparoscopic surgical applications''


Also since then we have heard about Microline France coming into the frame following the £7M deal with Elemental Healthcare (SUN), announced a few weeks agao


Plus AMS are now spending £3M on obtaining USA approval for Liquiband Fix8 which should go on sale late 2019 / early 2020


One can again surmise that AMS will be seeking USA approvals for a VARIETY of applications for the Liquiband Fix8 device

See my earlier posts re cash projections ... which now could be on the low side





Hernia Mesh Fixation device - LiquiBand(R) Fix8(TM)

LiquiBand(R) Fix 8(TM) is used to hold hernia meshes in place within the body instead of tacks and staples. This accurate laparoscopic application of adhesive is expected to both reduce surgical complications and reduce the potential pain associated with the use of tacks and staples. It also provides the ability to attach mesh in areas where tacks and staples cannot be applied, helping to improve the patient experience and surgical outcomes.

As reported at the half year, sales growth of LiquiBand(R) Fix8(TM) has been restricted due to design enhancements we have made following surgeon feedback. Further feedback has been received on the updated device and modifications have been completed. We have chosen not to actively promote the device while the modifications were ongoing, nevertheless sales increased by 3% to GBP1.7 million (2016: GBP1.7 million) and 1% at constant currency. We expect to see a return to sales growth this year.

At present, the device is approved for use within Europe and those markets that accept European approval standards. We have started the process to get LiquiBand(R) Fix8(TM) approved in the US market. This necessitates a full Pre Market Approval (PMA) involving clinical trials with patient enrolment expected to start in mid 2018 and enrolment completing by the end of the year. We expect the total cost of completing the approval process will be around GBP3 million with the majority of the spend being incurred in 2018 and 2019.

In R&D, we are also working on broadening the claims on the use of the device for hernia mesh fixation as well as for a number of other laparoscopic surgical applications and developing a device suitable for hernia mesh fixation in open surgery which we expect to launch in Europe in the first half of 2019.




note

''We expect to see a return to sales growth this year.''

[buywell3] 03/4/2018 14:52

Been doing a bit more digging re other uses for Liquiband Fix8, first of all for newbes.

Liquiband Fix8 is this


And Surgical Innovations designed it for Advanced Medical Solutions (AMS) and then manufactured it.

Currently Surgical Innovations own the IP and AMS have the sales rights worldwide till May 2024 when they revert back to Surgical Innovations.



We know ''LiquiBand® Fix 8™ received CE approval in May 2014, allowing the product to be used for the laparoscopic repair of hernias occurring in the groin, which account for 75% of all hernias. The device has been marketed and distributed by the Group’s direct sales teams in the UK and Germany and through various distributor partners across the EU. The applications of LiquiBand® Fix 8™ have now been extended for the laparoscopic repair of all abdominal hernias and for the closure of the membrane lining of the abdominal wall which may need repairing as a result of the hernia repair procedure.''


We can now recently surmise from just over a week ago that Advanced Medical Solutions (AMS) have appointed Microline France ( part of the Japanese multi $ Billion company HOYA) , to pave the way for the use of Liquiband Fix8 with Cellis biologic implants for stomach wall repair Laparoscopic surgery.


I also just read this

9 FEBRUARY 2017

''Aim-listed AMS is now working with surgeons in the UK to test the glue in other areas of surgery – general, orthopaedics and obstetrics and gynaecology.''

Never saw the above before .... so now it would seem that Liquiband Fix8 could soon get approval for several completely new areas of Laparoscopic surgery ie general, orthopaedics and obstetrics and gynaecology.


The CEO has never made secret of the fact that Liquiband Fix8 figured large in his plans

''
Chris Meredith, Chief Executive Officer of AMS, commented: “LiquiBand®; Fix 8™ is an important product for AMS and demonstrates our innovation and market agility. We are delighted with the response we have received following the launch from surgeons who have been extremely positive about the ease of use of this device and the benefit it brings to patients, reducing the pain that can be experienced when tacks or staples are used. This is the first extension of the claims of LiquiBand® Fix 8™ and we expect to develop further opportunities for this kind of application, broadening the market for the use of adhesives internally. This is an important part of our strategy to increase our penetration of the Operating Theatre segment of the wound closure market.”

[buywell3] 28/3/2018 13:48

Recap re other uses for Fix8 which were added in 2015

1 May 2015



Expanded indications for LiquiBand® Fix 8™



Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS.L), the surgical and advanced woundcare specialist company, today announces that additional clinical work has been completed to allow for expanded indications of LiquiBand® Fix 8™, the Group’s newly developed cyanoacrylate adhesive device for hernia mesh fixation.

The device is now able to be used for the laparoscopic surgical mesh fixation for all types of abdominal hernia as well as for the closure of the membrane lining the abdominal wall (peritoneum).



LiquiBand® Fix 8™, an innovative device which augments AMS’s existing LiquiBand® range of topical tissue adhesive products, was developed by AMS to enable the laparoscopic attachment of hernia meshes within the body through the accurate delivery of individual drops of cyanoacrylate adhesive. This accurate laparoscopic application of adhesive is expected to reduce surgical complications, in particular the potential pain associated with the use of tacks and staples, thereby improving the patient experience and reducing healthcare costs overall.



LiquiBand® Fix 8™ received CE approval in May 2014, allowing the product to be used for the laparoscopic repair of hernias occurring in the groin, which account for 75% of all hernias. The device has been marketed and distributed by the Group’s direct sales teams in the UK and Germany and through various distributor partners across the EU. The applications of LiquiBand® Fix 8™ have now been extended for the laparoscopic repair of all abdominal hernias and for the closure of the membrane lining of the abdominal wall which may need repairing as a result of the hernia repair procedure.



Chris Meredith, Chief Executive Officer of AMS, commented: “LiquiBand®; Fix 8™ is an important product for AMS and demonstrates our innovation and market agility. We are delighted with the response we have received following the launch from surgeons who have been extremely positive about the ease of use of this device and the benefit it brings to patients, reducing the pain that can be experienced when tacks or staples are used. This is the first extension of the claims of LiquiBand® Fix 8™ and we expect to develop further opportunities for this kind of application, broadening the market for the use of adhesives internally. This is an important part of our strategy to increase our penetration of the Operating Theatre segment of the wound closure market.”










Now we have some new development re Fix8 and Microline in France



It would seem Fix8 in France is being used/going to be used to glue CELLIS® BIOLOGIC IMPLANTS in several different scenarious eg page 3 in following link , plus other applications of which we should hear of soon.

[buywell3] 27/3/2018 08:03

Yes it could indeed

This still would mean more sales of Fix8 possibly for abdominal wall repair and another application/s

So it looks like parastomal-hernias ( abdominal wall repair) are going to be one new application for Fix8 , these are also associated with Obesity and Colostomy operations.

Off out now will ... delve deeper soon

[jmf69] 26/3/2018 22:12

It could be that microline are simply acting as a distributor for the liquiband fix8 product on behalf of AMS.

[jmf69] 26/3/2018 22:09

Appear to have liquiband fix8 workshops this summer...https://www.linkedin.com/feed/update/urn:li:activity:6381482173073104896

[buywell3] 26/3/2018 12:03

On reflection further ... it looks like SUN/Elemental Healthcare are starting to develop a quickly growing working relationship with Microline

Which should be beneficial to both parties as the Elemental Healthcare new BOD members know shedloads about , and are greatly experienced in the Distribution Dept.

FWIW my thoughts are that Microline might well become the SUN Distributor for YelloPortElite and YelloPort+plus Trocars and seals plus the two new additions to the YelloPort family that I am expecting any day now.

If that happens and we get another RNS about it .... happy days are here again

[buywell3] 26/3/2018 08:24

Fist gut feelings are usually best

1. We know AMS have the rights to liquiband fix8 for sales SO AMS must be ok with Microline in France start to sound out/prepare their clients/french market for the use of liquiband fix8 for OTHER MIS applications.


2. This dovetails nicely with what AMS have said the other week in their results about seeking approvals for other laparoscopic MIS uses other than Hernia mesh application.

Notice the PLURAL applications

''
In R&D, we are also working on broadening the claims on the use of the device for hernia mesh fixation as well as for a number of other laparoscopic surgical applications''

So it looks like it is going to be abdominal wall repair and something else , which is what I was thinking as it happens.



However

The fact that AMS seems to have given the nod to SUN to prepare the way as it were for sales of liquiband fix8 in perhaps the EU (or selected countries like France) is a new development.

Since Elemental Healthcare just did a £7M 3 year deal with Microline , then this new development paves the way for future co-operation/deals between Microline and SUN in other countries ... and perhaps other products.

methinks an RNS soon

[buywell3] 26/3/2018 08:12

Thanks for that ... I shall have a think

Did you attend the Investors evening ? if so care to give us a brief precis of what was discussed

[jmf69] 26/3/2018 08:06

hTTps://www.linkedin.com/feed/update/urn:li:activity:6380501398903230464

[buywell3] 26/3/2018 07:44

JMF6925

I am a bit puzzled about what you have said in your last post ... below since Microline Group Founded in 1987, Microline is a wholly owned subsidiary of HOYA Corporation in Tokyo, Japan, a $6.3 billion company with approximately half of its revenue in medical business,

ie Microline is owned by Japan company HOYA Corporation



Advanced Medical Solutions (AMS) owns 100% sales rights to liquiband fix8 till 2024 when they revert back to SUN, SUN make the device liquiband fix8 and own the IP 100%.

''In return for the exclusive rights to this applicator for the internal application of adhesives and sealants, AMS has agreed to purchase all of its requirements for the approved new applicator from Surgical Innovations for a period of ten years.''

Elemental Healthcare act as a Distributor for Microline ie HOYA Corporation selling some of their MIS instruments into the NHS and private Healthcare.

Why would Microline promote the synergy between liquiband fix8 and the biological implants Cellis (which is sold in the UK by elemental healthcare) to the French market ?


Was this talked about at the recent investors evening ?




JMF6925 Mar '18 - 12:19 - 4458 of 4459
0 0 0
Microline have been promoting the synergy between liquiband fix8 and the biological implants Cellis (which is sold in the UK by elemental healthcare) to the French market last week.

Expecting the liquiband fix8 sales to show a significant uplift this year.

[buywell3] 25/3/2018 16:00

News today in the Sunday Times

May orders £4 Billion Brexit boost to save ailing NHS





Looks like more operations might now be done


All SUN need is for Mr Hunt to get proactive and realise that Obesity in the young needs NHS bariatric surgery BEFORE the onset of cancers, diabetes and cardiac problems follow on.

Spending around £7k to £8k now ... to save £107k to 108k plus 10 years later

Forward planning ... do UK government ministers do that ?

Are they responsible for the forward planning of the UK's Health and Wealth ?

[jmf69] 25/3/2018 12:19

Microline have been promoting the synergy between liquiband fix8 and the biological implants Cellis (which is sold in the UK by elemental healthcare) to the French market last week.Expecting the liquiband fix8 sales to show a significant uplift this year.

[buywell3] 24/3/2018 17:04

Elemental Healthcare are selling in effect as our own UK Distributor , the last newly released SUN product/s

YelloPort Plus
The YelloPort Plus Laparoscopic Trocar system is a high-quality, cost effective, semi-disposable alternative to expensive and wasteful Disposable Trocars. Read More...

YelloPort Elite
Universal Seal Trocar System




It would seem that this type of product has a place and a market in the USA and other countries





I was expecting some news of two additions to this range of products and perhaps the announcement of a Distributor or two perhaps for the USA and maybe Japan to sell them for us.


I realize for a small company like SUN getting the RIGHT Distributor signed up is absolutely KEY to success ... which is IMO one of the main reasons SUN bought Elemental Healthcare , another being to identify new product requirements that SUN could manufacture.


I wonder if the next SUN acquisition will be perhaps a foreign based Distributor ?

Higher margins could then be obtained for the sale of the SUN Trocar ranges plus new clients and other sales opportunities.

Instead of acquiring another manufacturer of the devices themselves which can be somewhat labour intensive headcount wise.

I reckon at this point my gut is lending more towards another Distributor by 60/40%

There could perhaps, then be some big advantages down the road from doing such an acquisition of a successful foreign Distributor , maybe one that SUN knew for example like they did Elemental Healthcare.

See my previous posts

So soon I hope to read an RNS regarding news related to :

13 September 2017

Half-year Report

Interim results for the six months ended 30 June 2017


''In the first half of the year, we progressed from beta trials to full product release of the initial stages of the YelloPort Elite port access range, and further follow-on products are now expected to be available around the end of the year. We have also met with added complexity in transferring and expanding our range of single use instruments arising from the acquisition of the laparoscopic business and assets of Surgical Dynamics Limited in November 2016. We have transferred all of the manufacturing equipment to Leeds and expect application to be made for CE mark at the end of 2017, with beta trials of the products commencing in early 2018.''


Surgical Innovations says trading in line
Mon, 26th June 2017 - 06:24

''"Product innovation continues to be a priority, with focus on the further development of the YelloPort Elite range, our next generation Resposable port access system and the launch of further products to enhance our ranges of retraction and ligation solutions.''




Final results for the year ended 31 December 2016
14 Mar 2017 07:00:10

''The greater emphasis placed on new product introduction culminated in the launch of the Yelloport ™ Elite range in the final quarter of 2016, this will be followed by further additions to this range in Q2 2017 as well as two more projects launching before the end of H1. The Group is excited to be able to offer these products to the market and remains committed to expanding the portfolio of products available further in 2017 and beyond. ''


The next news I trust will maintain the SUN Chart going ahead on its present course ; trajectory upwards towards 5.5p and beyond by the year end IMO