Creo Medical Share Discussion Threads

[mesquida] 19/6/2023 07:13

Should see us up another 10% today surely.

[someuwin] 19/6/2023 07:10

19 June 2023

Creo Medical Group plc

("Creo" the "Company" or the "Group")

Speedboat Inject cleared for upper GI use in Europe

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that Speedboat Inject is now CE marked according to the Medical Device Regulation ("MDR") for use throughout the entire gastrointestinal ("GI") tract, having received upper GI clearance.

Until now, Speedboat Inject has been CE marked for lower GI tract use only within European markets. Clearance for upper GI procedures mean that the device can now be used for endoscopic procedures through the whole of the GI tract, from the mouth down to the stomach (upper GI tract) as well as within the lower GI tract. Speedboat Inject is already cleared and used in the full GI tract for the cutting and coagulation of soft tissue using radiofrequency (RF) and microwave energy in the US, APAC and elsewhere.

When used as indicated for the cutting and coagulation of soft tissue, Speedboat Inject has been used to perform procedures such as:

-- Oesophagus per-oral endoscopic myotomy ("POEM") to treat achalasia (a swallowing disorder), where typically a heller myotomy (surgery) would be required;

-- Gastric per-oral endoscopic myotomy ( G-POEM) to treat delayed gastric emptying (gastroparesis);

-- Z-POEM to treat Zenkers diverticulum, where a pouch or pocket that forms in the wall of the oesophagus, affecting the throat and swallowing process, and is a prominent procedure for ear, nose, throat (ENT) and foregut surgeons;

-- F-POEM, a derivative of Oesophagus POEM, to reduce reflux - typically this has required an invasive upper GI surgical procedure; and

-- Speedboat Submucosal Dissections ("SSD") in the stomach and oesophagus, to endoscopically resect certain cancerous and pre-cancerous lesions.

In FDA regions, upper GI cases account for over 40% of global Speedboat procedures to date. Creo Medical already has a healthy pipeline of clinicians ready to use the device for upper GI procedures across Europe, with demonstrations, training and procedures already planned in.

Craig Gulliford, Chief Executive Officer of Creo Medical, commented: " We are really excited by this extension to the clearance in Europe which opens up increases in case volume for a significant number of our customers with usage to treat a wide number of additional indications. This clearance opens up possibilities not only to increase the caseloads of existing users, but primarily to introduce Speedboat to a large base of new users.

"Training doctors for Speedboat use in upper GI procedures has proven to be efficient in the USA. With our Pioneer programme now well established, and with some of the world's finest upper GI endoscopic practitioners championing the device and providing mentoring, we have great capacity now to transition doctors through our Pioneer training programme and for them to become high users with training opportunities in multiple procedures with many different types of patients.

"I'm also delighted that this clearance has been done under the significantly changed regulatory framework (MDR) which has been a significant challenge for the team. This successful approval for Speedboat Inject according to the MDR represents a significant achievement for the Company and the team who have been working hard to secure this, building on the success we've already achieved in the US and APAC where Speedboat has been treating a wide range of upper GI procedures with excellent outcomes."

Dr Zaheer Nabi, a frequent user of Speedboat Inject for upper GI procedures at AIG Hyderabad Hospital in India said: "The advanced bipolar energy makes cutting and tunneling during POEM procedures very precise, providing me with improvements in efficacy and efficiency. I've also found that the design of the device significantly lowers the risk of perforation during such 3rd Space Endoscopic procedures, with the microwave energy effective in minimising bleeds and thermal damage. The slimmer device in particular is excellent for performing upper GI procedures."

Another prominent user, Dr Jawaid from Baylor College of Medicine Medical Center in the US, added: "Speedboat is effective in POEMs in particular because it can speed up the tunneling process and prevents inadvertent thermal

injury. It may also help with post-procedural pain."
Dr. Yip, from the Division of Upper GI and Metabolic Surgery at the Faculty of Medicine, Chinese University of Hong Kong said: "The Speedboat device is a new revolution to the field of third space endoscopy and advanced tissue resection. With the novel bipolar and microwave energy platform, upper GI ESD/SSD and tunnelling procedures can be performed safely and efficiently, thus benefitting patients worldwide by enabling easier adoption of the technique."

[hatfullofsky] 19/6/2023 07:09

Wow ! Great RNS

[dr biotech] 17/6/2023 19:09

May be worth keeping an eye on this page. I think they would have to RNS any significant news though.


hxxps://www.nice.org.uk/guidance/awaiting-development/gid-mt602

[idomeneo] 16/6/2023 16:56

Pedantic I know but: "Timings are approximate and may change for some topics.".

[networker] 16/6/2023 16:22

hatfullofsky. Many thanks for your helpful info.

[master investor] 16/6/2023 15:11

Friday afternoon sell off. Looks like we need the chart to cool down a little. Been a very good week.

[hatfullofsky] 16/6/2023 14:27

Apologies 38wkshttps://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/medical-technologies-guidance/how-we-develop

[hatfullofsky] 16/6/2023 14:23

It's a 36 week process

[networker] 16/6/2023 13:20

Does any one with scientific or medical knowledge have an insight into the likely timeframe for the NICE assessment? A quick look at their website seems to indicate that such a process could take about a year, but that seems longer than I might have expected as NICE initiated the process.

[someuwin] 16/6/2023 10:12

Better outcomes for patients. Better for surgeons. And saves time & money for the NHS (and healthcare systems throughout the world)

And the CREO tech (CROMA / Kamaptive) is being expanded with new devices to address a growing number of different procedures.

[parob] 16/6/2023 07:14

There was a huge 4M+ buy towards the end of last week and that seems to have cleared any loose stock and was the catalyst for the start of the rise. There's certainly some momentum now and the chart looks good so hopefully there's plenty more to come here. There's been some great news over the past couple of months.

[hatfullofsky] 16/6/2023 06:48

Keeps CREO out of the rope rises for another day, perhaps we'll see more buying today

[mesquida] 15/6/2023 19:51

Totally false closing price tonight , guaranteed to show a 3p rise at opening tomorrow , this is nonsensical. But whichever way you look at it today was a significant day for the share price. Looks like a line was cleared and buyers then saw that as a signal to get stuck in. Wiser to have bought when the line was on offer, but that's the way that investors operate nowadays.

[master investor] 15/6/2023 16:00

I can buy 20k on ig

[idomeneo] 15/6/2023 15:51

I was expecting this to bump around 25p for the rest of the summer with the market the way it is. The £2m collective buys at 20p by the directors at the raise was what sold it to me. These buys were an order of magnitude higher than anything they had done before and really support the idea that the products are being accepted by the profession. This may turn back for a bobble, but who wants to risk losing out?

[parob] 15/6/2023 15:29

Very aggressive buying today.

[someuwin] 15/6/2023 15:13

Can buy £3k. But not £4k.

[philly cheesesteak] 15/6/2023 12:12

Oh and re. Intuitive, I found this interview with their CEO discussing lung ablation;

hxxps://www.devicetalks.com/intuitive-ceo-guthart-shares-views-on-ion-ablation-rising-competition-and-robotic-surgerys-future/

Which ties into comments made in a couple of recent earnings calls;



"With regard to ablation, we are -- as we said last quarter, we're just at the early innings of engaging customers in Europe and looking at the trial data. We're excited by it. I think there are several indications in the lung that we'll pursue over time. We'll detail those more as we get more experience and more time.

There are opportunities outside the lung too, I want to be clear. We think those are interesting, but they're not areas of current focus. We really think finish the job we started. We have great engagement with pulmonologists and thoracic surgeons. We have opportunity to continue to support them to make our products ever easier, more robust and to move the margin structure where we want it to go. We're going to focus on that. And then we'll move to other indications in the lung. And then from after that, we'll have earned our opportunity to do the next step."

This then nicely ties back to the CREO RNS on 23rd May re. "First in-human milestone reached for MicroBlate™ Flex as part of Lung Tissue ablation clinical study"

and the March RNS where they announced the study;

"The Study is the first of a number of planned studies designed by Creo, in conjunction with Kamaptive partners, in respect of Creo's suite of ablation devices during 2023 and beyond. The Study will initially take place in the UK, and may expand to up to a total of six sites across Europe, with the potential to expand into the United States."

Pretty exciting stuff, for sure.

[philly cheesesteak] 15/6/2023 12:04

Great to see this continue to move higher. It appears that supply has run out at this level which is no surprise given the discount vs where it traded from 2017 through to early 2022 & the amount of commercial progress seen in the last 12 months. 100p seems a very realistic target.

[someuwin] 15/6/2023 12:02

Along with all the other compelling reasons to buy CREO, last year they signed a a long-term, multi-year collaboration agreement with Intuitive Surgical to optimise certain Creo products to be compatible with Intuitive's robotic technology.

Intuitive Surgical, Inc (NASDAQ:ISRG) is a $120bn leader in robotic surgery. Let that sink in!

[barbelsue] 15/6/2023 11:29

Just a post for me to get email updates on the postings on this thread. I think this looks very interesting and worth following