Smith & Nephew signs exclusive worldwide distribution agreement for the revolutionary MolecuLight i:XTM imaging device

3 May 2017

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces it has signed a worldwide distribution agreement with MolecuLight®, Inc., a developer of innovative imaging technology for the clinical assessment of wounds.

This agreement supports Smith & Nephew’s strategic priority to innovate for value by delivering solutions that help healthcare professionals better improve the lives of their patients.

“Smith & Nephew, through products such as ACTICOAT^◊  antimicrobial silver dressings and IODOSORB^◊  cadexomer gel ,has long been committed to helping customers manage infection in chronic and acute wounds,” said Andy Weymann, MD, Chief Medical Officer at Smith & Nephew.  “The MolecuLight i:X imaging device enables healthcare professionals to see what they have never been able to see before, the actual accumulation of several common bacteria in a wound, even when not visible to the naked eye.  Moleculight  i:X enhances clinicians’ ability to choose the right therapy, at the right time for their patient ^1,2 In addition, it has also the potential to enhance other areas of current wound care practice such as helping to guide wound sampling and debridement, monitoring of  wound progression, providing more insight in conversation between the clinician and the patient, and greater detail when documenting treatment decisions.”

Rosemary Hill, BSN, CWOCN, CETN(C), of Lions Gate Hospital (Vancouver, Canada) added ‘’The MolecuLight i:X is more than a bacteria visualization device. The information it is providing is positively impacting our antimicrobial stewardship program and empowering my overall wound treatment decision making.’’

The MolecuLight i:X  is a handheld point-of-care imaging device that uses fluorescence imaging to display potentially harmful concentrations of bacteria that fluoresce in violet light on screen, in real-time.  Clinicians can capture and view still images and video, as well as measure the surface area of a wound and then save and add those images to the patient’s electronic health record ^2,3.

“When combined with clinical best practice, the information provided by the MolecuLight i:X on bacterial presence and distribution can guide early interventions to potentially reduce bioburden and promote wound healing²,” said Craig Kennedy, CEO MolecuLight.  “Partnering with Smith & Nephew, a world leader in advanced wound care, allows this revolutionary technology to rapidly reach a worldwide customer base and begin the process of becoming a routine step in wound assessment.”

The MolecuLight i:X is currently available in Canada and the European Union with regulatory clearance in the U.S. pending.

Enquiries

About MolecuLight Inc. 

MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions^{1,2,4,5,6,7,8,9,10}.  The company was founded in 2012 by Dr. Ralph DaCosta, Principal Investigator and Scientist at the Princess Margaret Cancer Center, University Health Network (Toronto, Canada), currently the company’s Chief Scientific Officer and Director. MolecuLight’s premiere product – the MolecuLight i:X is a Wound imaging Device that allows clinicians to quickly, safely and easily visualize  bacteria that fluoresce in violet light and measure wound surface area at the point of care so they have maximum insights for accurate treatment and accelerated healing ².

The MolecuLight i:X™ Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X™ Imaging Device is pending US FDA De Novo approval and is not available in the US.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce wound infections, please visit www.closertozero.com.

^{Forward-looking Statements}

^{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

^{◊ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.}

 References:

1. _{Wu YC, Smith M, Chu A, Lindvere-Teene L, Starr D, Tapang K, Wong O, Linden R, DaCosta RS. Handheld fluorescence imaging device detects subclinical wound infection in an asymptomatic patient with chronic diabetic foot ulcer: a case report. Int Wound J. 2016 Aug;13(4):449-53.}
2. _{DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).}
3. _{Hill R and Douglas JJ. Effect of bacterial fluorescence imaging on patient care and wound management in a hospital setting: a pilot study. Proceedings of the Annual Symposium on Advanced Wound Care (SAWC); 2017 Apr 5-9; San Diego, CA. (accepted poster)}
4. _{Ottolino-Perry K, Chamma E, Blackmore KM, Lindvere-Teene L, Starr D, Tapang K, Rosen CF, Pitcher B, Panzarella T, Linden R, DaCosta RS. Improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers. Int Wound J. 2017; doi: 10.1111/iwj.12717.}
5. _{MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.}
6. _{Rennie MY. A prospective, single-blind evaluation of the positive predictive value (PPV) of the MolecuLight i:X device to predict the presence of porphyrin-producing bacteria in chronic wounds. MolecuLight final report TR054. 2017 Jan.}
7. _{MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.}
8. _{Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the 22nd Annual Canadian Association of Wound Care Conference; 2016 Nov 3-6, Niagara Falls, ON.}
9. _{Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.}
10. _{Hoeflok J, Teene L, Chamma E, Chu A, DaCosta RS. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18-21; Fort Lauderdale, FL.}