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Pin to quick picksCreo Medical Regulatory News (CREO)

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Market Cap: £71.66m
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Market Update

2 Jul 2018 07:00

RNS Number : 1665T
Creo Medical Group PLC
02 July 2018
 

 

Creo Medical Group plc

("Creo" or the "Company")

 

Market Update

 

Since the Company was admitted to trading on AIM in December 2016 (the "IPO") it has made significant progress against all of the strategic objectives set out at that time and continues to execute against its plans with a view to a full commercial launch in 2019. In particular, since the IPO, the Company has:

· Gained FDA clearance and CE Mark for its CROMA advanced energy electrosurgery platform and Speedboat RS2 device (with FDA clearance being received ahead of schedule);

· Trained 34 clinicians to date with some trainees being trained in collaboration with a developing global network of distribution partners ahead of commercial launch in 2019

· Placed its CROMA advanced energy electrosurgery platform and Speedboat RS2 device with EU key opinion leaders;

· Commenced the generation of clinical data through in-human use, with physicians utilising Creo's Speedboat device in multiple procedures with no reported complications, including procedures with patients under mild conscious sedation with same day discharge for routine follow up rather than surgery under general aesthetic and a prolonged hospital stay as would otherwise have been the case; and

· Undertaken a FDA pre-submission meeting with the FDA for its flexible ablation device confirming that it will make a Pre-Market Notification (via the 510(k) pathway).

 

Following speculation and in light of this progress and consultation with shareholders, the Board confirms that it has been considering its future funding in order to capitalise on the Company's current momentum and exploit the opportunities, it believes are, available to the Company at this time. Accordingly, the Board can confirm that it has instructed advisers to commence work on a proposed placing of new ordinary shares to institutional and other investors (the "Proposed Placing"). Initial Board consideration was to raise in the region of £15-20 million but given investor feedback to date the Board may choose to raise a higher amount than this. Amongst other things the net proceeds of the Proposed Placing would enable the Group to continue to extend its training programme for clinicians; complete its development of the Gastro Intestinal suite of products; continue to fund research and development into further applications of products; add distribution partners on a worldwide basis and accelerate Creo's product roll out by scaling up the current manufacturing capabilities and accelerating a USA roll out. The Board believes that additional funds would make the Company an increasingly attractive prospect for strategic partners and allow the exploration of possible strategic M&A.

 

Whilst there can be no certainty that the Proposed Placing will proceed, nor as to the quantum, pricing, or timing of any such placing the Board would seek to conduct any placing as near as practicable to the Company's closing mid price on 27 June 2018 (being the latest practicable date prior to this announcement).

 

Further announcements will be made as appropriate.

 

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Upon the publication of this announcement via Regulatory Information Service, this inside information is now considered to be in the public domain.

 

Contacts

 

Creo Medical:

Cenkos:

FTI Consulting:

Richard Rees

+44 (0)129 160 6005

 

Camilla Hume/Mark Connelly (NOMAD)

Michael Johnson / Russell Kerr (Sales)

+44 (0)207 397 8900

Brett Pollard / Mo Noonan

+44 (0)203 727 1000

creo@fticonsulting.com

 

 

About Creo Medical

 

Creo Medical, founded in 2003, is a medical device company focused on the development and commercialisation of minimally invasive surgical devices, by bringing advanced energy to endoscopy. The Company's mission is to improve patient outcomes by applying microwave and radiowave energy to surgical endoscopy. Creo has developed CROMA, an electrosurgical platform that combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation. This technology provides physicians with flexible, accurate and controlled surgical solutions.

 

The Company's strategy is to bring its CROMA platform to market through a suite of medical devices which the Company has designed, initially for the emerging field of GI therapeutic endoscopy, an area with high unmet needs. The CROMA platform will be developed further for bronchoscopy and laparoscopy procedures. The Company believes its technology can impact the landscape of surgery and endoscopy by providing safer, less-invasive and more cost-efficient option of treatment.

 

For more information about Creo Medical please see our website, www.creomedical.com.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
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Date   Source Headline
6th Jun 20191:23 pmRNSResult of AGM
13th May 201910:50 amRNSAnnual Reports & Accounts & Notice of AGM
10th May 20197:00 amRNSMello 2019
24th Apr 20197:00 amRNSNew video abstract featuring Speedboat published
5th Apr 20197:00 amRNSFinal Results
28th Mar 20197:00 amRNSUpdate on US Clinical Education Programme
21st Mar 20192:34 pmRNSExercise of Options
21st Mar 20197:00 amRNSNotice of results and investor briefing
18th Mar 20197:00 amRNSCreo founder in Sunday Times 100 UK entrepreneurs
14th Mar 20195:17 pmRNSHolding(s) in Company
12th Mar 20199:19 amRNSSpeedboat in BSG Endoscopy best video abstract
6th Mar 201912:58 pmRNSExercise of Options
11th Feb 20197:00 amRNSDistribution agreement for France, Germany, Italy
24th Jan 201911:17 amRNSGrowth & Innovation Forum 2019
16th Jan 20197:00 amRNSFirst use of Speedboat in the US
17th Dec 20184:28 pmRNSExercise of Options
3rd Dec 20187:00 amRNSFirst placement and use of Speedboat in Europe
23rd Nov 201810:43 amRNSDirector/PDMR Shareholding
19th Nov 20181:30 pmRNSExercise of Options
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17th Oct 20187:00 amRNSSpain & Benelux Framework Distribution Agreements
12th Oct 20187:00 amRNSHolding(s) in Company
8th Oct 20187:00 amRNSInvestor Open Event at Chepstow
3rd Oct 201812:14 pmRNSHolding(s) in Company
28th Sep 20187:00 amRNSInterim results for six months ended 30 June 2018
17th Sep 20187:04 amRNSExtension of Distribution Agreement with Pentax
13th Sep 20187:00 amRNSFirst use of Speedboat in South Africa
3rd Sep 20181:34 pmRNSHolding(s) in Company
31st Aug 201811:32 amRNSHolding(s) in Company
31st Aug 201811:30 amRNSDirector/PDMR Shareholding
21st Aug 20183:59 pmRNSIssue of Equity Update - Amendment
21st Aug 20181:48 pmRNSIssue of Equity Update
20th Aug 201810:13 amRNSDirector/PDMR Shareholding
1st Aug 20181:24 pmRNSResult of General Meeting
18th Jul 20184:44 pmRNSHolding(s) in Company
13th Jul 20187:00 amRNSConditional Placing of New Ordinary Shares
9th Jul 20187:00 amRNSAgreement with First Medical Company
4th Jul 20187:00 amRNSUK Distribution Agreement with Diagmed Healthcare
2nd Jul 20187:00 amRNSMarket Update
10th May 201811:25 amRNSExercise of Options
20th Apr 20184:38 pmRNSChange of accounting reference date
20th Mar 20187:00 amRNSInterim results for six months to 31 December 2017
28th Feb 20184:32 pmRNSChange of Registered Office
12th Feb 20187:00 amRNSExercise of Options
9th Jan 20185:43 pmRNSDirector/PDMR Shareholding
22nd Dec 201712:10 pmRNSDirector/PDMR Shareholding
22nd Dec 20179:24 amRNSDirector/PDMR Shareholding
20th Dec 20171:32 pmRNSResult of AGM
29th Nov 20177:00 amRNSSpeedboat RS2 advances beyond initial pilot centre

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