Creo Medical Regulatory News (CREO)

Creo Medical Group plc

Extension of Distribution Agreement with Hoya Pentax Medical for the Asia-Pacific (APAC) region

Creo Medical Education Programme to be initiated in APAC alongside Market Seeding beginning in Australia.

Chepstow, Wales - 17 September 2018 - Creo Medical Group plc (AIM: CREO) ("Creo" or the "Company"), a medical device company focused on the emerging field of surgical endoscopy, today announces that it has entered into an addendum to its distribution agreement with Hoya Group, Pentax Medical ("Pentax").

Under the terms of the original distribution agreement, Creo granted Pentax the right to distribute Creo's Speedboat product and CROMA platform in the Asia Pacific region for 5 years subject to agreement of final terms by territory. The addendum further entrenches Creo's relationship with Pentax with firm commitment to roll out to various territories in conjunction with establishing Creo's Clinical Education Program and thereafter seeding the chosen markets.

Australia will be the first Asia Pacific territory in which Pentax will establish Creo's Clinical Education Program and subsequently seed the market. Pentax will purchase a minimum quantity of CROMA advance energy platforms and Speedboat instruments with the first products expected to be shipped within 3 months. Furthermore, Creo has agreed to extend the term of Pentax's distribution rights in each territory in which Pentax establishes Creo's Clinical Education Programme for a period of 5 years from the date on which Creo's products are registered in such territory.

Creo has commenced the regulatory registration process for its products in Australia and in conjunction with Pentax Creo has begun introducing doctors from Australia and other territories to the clinical education program here in Europe which will be rolled out into APAC in the coming months.

CROMA's electrosurgical platform combines bipolar radiofrequency for precise localised cutting and microwave for controlled coagulation. Speedboat is the first product approved in a suite of tools under development to aid the endoscopist in minimally invasive surgery. The Speedboat device helps reduce the risks associated with alternative laparoscopic procedures, reducing the length of hospital stays and transferring therapy from the operating room to the endoscopy room.

Craig Gulliford, Chief Executive Officer, commented:

"The extension of our agreement with Pentax marks a significant milestone in the commercialisation of Speedboat, our lead product. Creo is dedicated to improving patient outcomes and helping clinicians by bringing advanced energy to the emerging field of surgical endoscopy. Speedboat is paving the way for our suite of GI devices under development. Our products are rapidly gaining traction in the endoscopic field and with Pentax as our partner in the Asia Pacific region, their expertise and knowledge will prove invaluable to Creo in these important markets and as we build our reputation worldwide."

David Woods, President and CEO of Pentax Americas and M&A Director, commented:

"As a leading supplier of innovative and advanced medical products for minimally invasive procedures we recognise the great potential of the CROMA platform and Speedboat. I am pleased that we have been able to deepen our relationship with Creo. Ultimately, under this expanded commercial agreement more patients will benefit from the power of precise cutting and controlled coagulation, leading to better clinical outcomes in an outpatient setting."

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About Hoya Pentax Medical

HOYA is a global med-tech company based in Tokyo, Japan, and the leading supplier of innovative and indispensable high-tech products and advanced optical technologies. Hoya employs approximately 34,000 people in over 30 countries.

The medical endoscope business is one of HOYA's growth drivers.

Demand for minimally invasive treatment among medical professionals continues to grow quickly. HOYA develops medical endoscopes that enable early diagnosis and treatment under the PENTAX Medical brand. HOYA Group corporate website: http://www.hoya.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, investors.creomedical.com.