CE mark for five new devices

Key commercial milestone with launch of full suite of GI products

Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, has today announced a key commercial milestone, with the simultaneous CE marking of five new devices which form the Creo GI (gastro-intestinal) suite of advanced energy devices across four technology platforms. The CE marking of the full range of products provides EU and UK clearance ahead of their commercial launch. Creo expects to introduce the devices into clinical practice and prepare for commercialisation in the second half of the year.

The range is designed to be used with the CROMA™ Advanced Energy Platform (CROMA), powered by Kamaptive™ full-spectrum adaptive technology, a seamless, intuitive integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures.

The heavily patented devices are individually optimised to utilise Bipolar radiofrequency (RF) and High frequency microwave (MW) energy for the core tissue effects of dissection, resection, haemostasis and ablation, and form the basis of four individual device platforms. Creo has been anticipating this milestone and is launching the branding and brand hierarchy for these powerful technology platforms to coincide with the clearance of multiple devices alongside CROMA and Kamaptive Technology.

The individual device technology platforms each have multiple potential market applications in the roadmap including open surgical applications, several laparoscopic surgical and ablation markets as well as the core focus, initially, in the therapeutic flexible endoscopy markets. The device technology platforms are summarised below:

  1. Speedboat™ device technology – Range of unique bipolar RF blades with integrated MW coagulation, the first device technology launched by Creo.
  2. SpydrBlade™ device technology – Tissue resection devices combining Speedboat resection capability with precise microwave coagulation – the only bipolar RF resection structure we know of.
  3. MicroBlate™ device technology – Tissue ablation devices including MicroBlate™ Fine and MicroBlate™ Flex – the smallest microwave ablation devices we know of.
  4. SlypSeal™ device technology – Range of haemostasis devices leveraging Creo’s unique “Non-stick” haemostasis technology – the only non-stick advanced energy haemostasis technology we know of.

 The newly CE marked products are:

  • Speedboat™ Slim
  • SpydrBlade™ Flex
  • MicroBlate™ Fine 
  • MicroBlate™ Flex
  • SlypSeal™ Flex

Creo’s first product, Speedboat™ Inject (previously called Speedboat) is already CE marked, FDA cleared, and is being used by clinicians in the UK, EU, US, Africa and APAC. SlypSeal™ Flex (previously referred to as HS1) received US FDA 510k clearance in March 2020.

The full Creo GI suite of technology platforms and products is described below:

1. Speedboat device technology

Speedboat device technology is another unique device technology with the only known bipolar surgical dissection blade in any form of surgery. Additionally, Speedboat integrates MW technology allowing for precise control of bleeding during surgery. These features can also be uniquely integrated with irrigation and injection capability. As with all the CREO device families, the Speedboat device technology has applications in many different areas of clinical therapy and surgery.

Speedboat Inject – (the original Speedboat™)
The first device launched by Creo along with CROMA with EU and US clearance, has been used in numerous clinical cases worldwide, is supported by excellent clinical publications, and with strong health economic data already established. Speedboat Inject is a flexible device aimed at the endoscopist enabling them to lift tissue with viscous fluid injection via a retractable needle, cut tissue precisely using bipolar RF energy delivered along the edge of the instrument for localised energy transfer, reducing the risks associated with monopolar tissue resection, and deliver high frequency controlled and focused  coagulation, all within a single instrument. Initial data from the UK’s leading clinical user of Speedboat demonstrates that its use can save NHS hospitals nearly £5,000 per procedure versus a traditional surgical outcome for patients. Overall costs savings could be higher when the additional costs associated with surgery are factored in.

Speedboat Slim
The second device in the Speedboat family of devices, with a “slim” profile, Speedboat  Slim enables endoscopists to access more indications in patients where narrower and more flexible devices are required to gain access to even more indications.

 

2.  SpydrBlade device technology

SpydrBlade device technology optimises the power of the CROMA platform, where advanced bipolar RF energy is used to cut tissue and precisely controlled MW energy is used for the coagulation and sealing of tissue during surgery. The SpydrBlade  jaw structure utilises the unique blade technology of Creo’s Speedboat technology which allows the surgeon to cut tissue as the jaws close, with the jaws of the device open as well as while the jaws are closed as a blade. No other laparoscopic surgical device is known to have these fundamental resection features. The patented combination with microwave energy for the sealing and coagulation of tissue adds up to a game-changing device technology platform.

SpydrBlade Flex
This is the first SpydrBlade device in the family and is described as “the holy grail of interventional endoscopy” by Rob Hawes MD, a world-renowned pioneer in the field of therapeutic endoscopy at the Florida Hospital in Orlando. Designed to operate in flexible endoscopes commonly used around the world, SpydrBlade Flex puts advanced laparoscopic capability into the hands of the endoscopist for the first time. Building on the Speedboat blade technology, SpydrBlade Flex enables the clinician to grasp, cut and coagulate highly perfused tissue (such as in the colon, stomach, liver or spleen). The ability to alternate between cutting and coagulating using RF and MW energy across the ‘jaws’ of SpydrBlade  Flex gives the clinician significantly more control providing a gliding cut using a fixed bipolar RF field as well as a conventional bipolar RF cutting between two jaws at opposite polarities. It offers great utility to bloodlessly resect/dissect and coagulate in a wide range of organs within the human body by sequentially applying the microwave field followed by the RF field to coagulate and then cut.

 

3. MicroBlate device technology

Creo’s MicroBlate tissue ablation technology brings very high frequency 5.8Ghz microwave energy into clinical practice for the first time. Operating at such a high frequency offers unrivalled levels of control and feedback via the CROMA platform allowing physicians to precisely ablate diseased tissue in multiple tissue types and many different clinical access methods. Creo is launching the first two devices in the MicroBlate  range which allow unique levels of minimally invasive access due the size, design and technology in the MicroBlate  range.

MicroBlate Fine
Brings fine needle microwave ablation into clinical practice for the first time and is believed to be the smallest diameter MW ablation needle antenna in the world. With a diameter of less than 1mm, the MicroBlate Fine device can be used in a variety of ablation procedures such as open, laparoscopic and flexible endoscopic procedures. Designed to be the same form and dimensions as a standard biopsy needle, MicroBlate Fine is designed for the ablation of a wide range of tissue types (such as pancreas, liver, kidney, lung and muscle). Due to the small diameter of the device, it can be used to ablate tumours in highly perfused organs without the risk of bleeding prior to energy delivery due to the sub-mm insertion tract.

MicroBlate Flex
A new soft tissue ablation device, designed with the aim of being able to ablate nodules and tumours in several tissue types including lung (in particular the airways), using the highest frequency MW energy used for tumour ablation. This device also has potential to be used to treat a number of other conditions, where a small diameter flexible device enables access into otherwise inaccessible regions of the body. The device could be particularly useful to treat a range of ENT indications, including nasopharyngeal cancer and nasal polyps. Due to its small size and flexibility, MicroBlate Flex has the potential to reach deep into the lung where, once in position, the device can be inserted through a catheter and into the tumour.

 

4. SlypSeal device technology

SlypSeal device technology is believed to be the only “non-stick” electrosurgical haemostasis device technology in the market. This key feature overcomes the perennial challenge in surgery and transforms the surgeons’ ability to precisely manage bleeding with the unique ability to reapply with the “non-stick” feature addressing the risk of “re-bleeds”. This combined with the precision and control of MW coagulation, opens up many different device structures in the future.

SlypSeal Flex
The first device in this family of devices targeting GI bleeds which is one of the most common clinical indications in the GI tract. The SlypSeal Flex will target the treatment of upper and lower GI bleeds, such as stomach ulcers or bleeding polyps.

 

Full details of Creo CE marked product range can be found here:
http://www.rns-pdf.londonstockexchange.com/rns/8918P_1-2020-6-14.pdf

 

Craig Gulliford, Chief Executive Officer of Creo, commented:

We are delighted to announce the CE Mark and European clearance for our wider suite of GI products. Since their first demonstration at the UEG Week Congress in October 2019 the Creo team have been gearing up for first clinical use in various markets. Procedures utilising our products have, for the right reasons, been delayed during the Coronavirus Pandemic as routine diagnostics have been stopped to free up resources. However, we are now poised with a wider range of devices than originally planned, that will allow the Company to re-emerge from lock-down stronger and more confident in our medium and long-term prospects.

“It’s difficult to articulate how the whole Company feels about achieving this amazing milestone. Bringing any medical device to market is very challenging especially if they are truly novel medical devices, powered by cutting edge technology. So, bringing five individual and game-changing devices to market at the same time is a phenomenal achievement for the entire Creo team and completes phase one of our big ambition which underpinned our IPO and was supported by such a great group of investors.

“More importantly, this heralds the next phase of the business development as we take advanced laparoscopic surgical technology to the flexible endoscopy community worldwide. The whole Company is gearing up for enabling doctors across Europe, India and beyond to treat patients with these new device families for the first time over the coming months.

“We already have multiple devices in the market within the MicroBlate™ and Speedboat™ Device Technology platforms. The continuing development programme we are running at Creo will be generating many devices within each of these device platforms in the coming months and years enabling us to evolve as a business into many different clinical areas.

“Our heavily patented Speedboat™  Technology, SpydrBlade™  Technology, SlypSeal™  Technology and MicroBlate™  Technology powered by the CROMA™  platform provide a tremendous foundation from which we can build the business.

Posted 06/15/20

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