A newly published multicentre RCT demonstrates Smith+Nephew PICO◊ single use NPWT as superior to traditional NPWT in reducing wound area, depth and volume in DFUs and VLUs

LONDON--(BUSINESS WIRE)--Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, is excited to announce the publication of results from a new randomised controlled trial (RCT) demonstrating that the use of PICO^◊ Single Use Negative Pressure Wound Therapy System (sNPWT) significantly reduced wound area, depth and volume compared with traditional negative pressure wound therapy (tNPWT) in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs).^1*

Chronic wounds cause substantial morbidity and mortality and can lead to significant medical costs.² In the United States alone, chronic wounds affect 6 million people, with increasing numbers anticipated in growing elderly and diabetic populations.² One study showed that in a single year, chronic wounds cost ~$9.7 billion in the USA.³ Venous or arterial insufficiency, diabetes, and local-pressure effects are the most common causes of chronic wounds.⁴ Chronic wounds can be managed with traditional negative pressure wound therapy (tNPWT),⁵ but it can be complex to use and limit patient mobility.⁶

The randomised, controlled, multicentre study was conducted at 16 centres in the USA and two centres in Canada, comparing the efficacy and safety of PICO sNPWT with tNPWT in the management of patients with lower extremity ulcers with a longer than 4 weeks duration over 12 weeks.¹ In total, 164 patients were randomised to receive either PICO sNPWT or tNPWT.

A greater average reduction in wound area of 39.1%, depth of 32.5% and volume of 91.1% versus tNPWT was observed with PICO sNPWT.^1* There was a 51% relative increase in the number of patients achieving wound closure at 12 weeks with PICO sNPWT versus tNPWT. Dressing changes were less frequent with PICO sNPWT than with tNPWT, mean reported 6.8 fewer changes and 3.4 days longer wear time. Overall satisfaction was also greater with PICO sNPWT, and fewer patients had adverse events with PICO sNPWT than with tNPWT.

“I decided to use PICO Single Use Negative Pressure Wound Therapy System to treat a diabetic foot ulcer, after achieving excellent results using the therapy on skin flaps and full thickness skin grafts” said, Rosemary Hill, Wound Ostomy Nurse at Lions Gate Hospital, Vancouver. “By introducing PICO as an early intervention for lower extremity ulcers, we’ve been able to help kick-start wound healing and ultimately improve the quality of life for patients who experience a faster and more predictable healing trajectory, as well as being mobile and able to resume treatment at home.”

The unique PICO^◊ sNPWT dressing includes the proprietary AIRLOCK^◊ Technology for uniform and consistent delivery of therapeutic NPWT across a wound and the surrounding zone of injury.⁷ By minimising the need for fillers and reducing dressing change frequency compared with traditional NPWT¹, PICO sNPWT helps healing to progress undisturbed, contributing to faster time to healing, improved quality and distribution of granulation tissue and more consistent re-epithelialisation.⁸

PICO sNPWT has a strong evidence base with 103 published papers of which 21 are published RCTs and 65 are unique clinical studies.^1,9

To learn more about PICO sNPWT see https://www.smith-nephew.com/kirsner

- ends -

* n=161; p<0.001 for area; p=0.014 for depth; p=0.013 for volume

References

1. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A Prospective, Randomized, Controlled Clinical Trial on the Efficacy of a Single‐use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Treatment of Chronic Ulcers of the Lower Extremities. Wound Rep Regen. 2019. [Epub ahead of print];. https://doi.org/10.1111/wrr.12727.
2. Powers JG, Higham C, Broussard K, Phillips TJ. Wound healing and treating wounds: Chronic wound care and management. J Am Acad Dermatol. 2016;74(4):607-25.
3. Bickers DR, Lim HW, Margolis D, et al. The burden of skin diseases: 2004. A joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. J Am Acad Dermatol. 2006;55(3):490-500.
4. Werdin F, Tenenhaus M, Rennekampff HO. Chronic wound care. Lancet. 2008 29;372(9653):1860-1862.
5. Birke-Sorensen H, Malmsjo M, Rome P, et al. Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011;64 Suppl:S1-16.
6. Hurd T, Trueman P, Rossington A. Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: a case series. Ostomy Wound Manage. 2014;60(3):30-36.
7. Smith & Nephew October 2017. Project Opal PICO 7 System Stability Testing, Initial Time Point. Internal Report. DS/17/253/R.
8. Brownhill R, Bell A, Hart J, Webster I & Huddleston E. Pre-clinical Assessment of a No-canister, Ultra-portable, Single use Negative Pressure Wound Therapy (sNPWT) System* in a Porcine Model of Wound Healing: Unlocking its Mode of Action. Poster presented at the Advanced Wound Care (SAWC) Conference, 7-11 May 2019, San Antonio, Texas.
9. Smith & Nephew. Analysis by Dr Vicki Strugala. January 2019.

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business that exists to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 16,000+ employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $4.9 billion in 2018. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, Instagram or Facebook.

To learn more about how we can help you get CLOSER TO ZERO^◊ delay in wound healing, 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.

AWM-AWD-19806 December 2019