Woundchek Laboratories

Products

First in class wound diagnostics
Diagnostic tests for better wound healing
Point of care testing in wound diagnostics

News FDA clears WOUNDCHEK™ Bacterial Status for use by wound care professionals

Events

General Overview

WOUNDCHEK™ Laboratories is focused on the development of novel wound diagnostic products to help improve outcomes in wound care. Currently, the cost of ineffective treatment is estimated to be more than $20-25 billion¹Data based on savings calculated with the WOUNDCHEK economic model, UK version, with AQP VLU data inputs. – Nherera L. et al. Quantifying the economic value of diagnostics in wound care in the UK. Poster, EWMA 2013. annually. Clinical experts agree the use of point of care wound diagnostic devices could reduce the cost of ineffective treatment and delayed healing by being able to target the right therapy, on the right patient, at the right time, and for the right length of time²World Union of Wound Healing Societies (WUWHS). Principles of best practice: Diagnostics and wounds. A consensus document. London: MEP Ltd, 2008.. A resulting financial benefit to health care systems can be achieved through significant reduction of the expenses associated with poor targeting of treatment, delayed healing, and avoidable complications. WOUNDCHEK™ Laboratories launched the world’s first and only point of care test to detect EPA (elevated protease activity) in chronic wounds in 2012, and over the past several years has become a recognized leader in wound diagnostics.

Mission

The company’s vision is to provide clinicians with better, accurate, timely, actionable, and easy to access information, leading to improved outcomes through point of care wound diagnostics. WOUNDCHEK™ Laboratories aims to be the leading and dominant enterprise in wound diagnostics by providing medical professionals with the diagnostic information to:

Identify wounds which are not healing
Intercept issues and early warnings that cause poor wound healing or initiate wounds
Aid in determination of best therapeutic routes
Monitor the effectiveness of a course of treatment

Activities

Based in the UK and the USA, WOUNDCHEK™ Laboratories' staff are focused on product development, clinical research, and working with its distribution partners to develop the emerging wound diagnostics market.

Our research is centred on two critical questions, identified by clinical experts as primary pieces of diagnostic information needed to direct treatment pathways in the majority of chronic wounds:

Does the wound have chronic inflammation?
Is there an active bacterial pathogenesis?

ISO 13485:2016 certified quality management system.

WOUNDCHEK™ Protease Status

Bacterial Virulence

Bacterial proteases have been described as the most important class of virulence factors and play a key role in the establishment of wound infections, ultimately impeding the healing response and keeping the wound in a chronic state¹Koziel J, Potempa J. Protease-armed bacteria in the skin. Cell Tissue Res. 2013; 351(2): 325-37.. They are produced by both Gram-negative and Gram-positive bacteria associated with chronic wound colonization²Wysocki AB, Bhalla-Regev SK, Tierno PM, Steven-Riley M, Wiygul R. Proteolytic Activity by Multiple Bacterial Species Isolated from Chronic Venous Leg Ulcers Degrades Matrix Substrates. Biol Res Nurs. 2012; 15(4): 407-415..

The detection of bacterial protease activity in a chronic wound would be indicative of the presence of bacterial virulence which is a precursor to clinical signs and symptoms of infection³Thomson PD, Smith DJ. What is infection? Am. J. Surg. 1994; 167(No. 1A): 7S-10S.^,⁴Dow G, Browne A, Sibbald RG. Infection in chronic wounds: Controversies in diagnosis and treatment. Ostomy Wound Management 1999; 45 (8): 23-40. .

Bacterial virulence is undesirable since, at this stage, the wound is in a part of the wound infection continuum that typically requires intervention.

WOUNDCHEK™ Bacterial Status — Now available in countries accepting CE mark or FDA clearance!

PRODUCT CODE	DESCRIPTION	CONTAINS
360006	WOUNDCHEK™ Bacterial Status Test Kit	6 tests (all material needed)
360010	WOUNDCHEK™ Bacterial Status Control Kit	3 positive & 3 negative control swabs

The Only Test to Detect EPA

Developed to aid wound assessment and help clinicians target advanced wound care therapies more effectively, WOUNDCHEK™ Protease Status is able to detect EPA (elevated protease activity). As there are no visual cues for EPA, wounds with EPA have so far gone undetected¹Snyder R. et al. A survey: The importance of proteases in wound healing and wound assessment. Poster, Wounds UK 2011..

WOUNDCHEK™ Protease Status will help clinicians establish within minutes which wounds may most benefit from a protease modulating therapy, ensuring appropriate and targeted use of these therapies.

WOUNDCHEK™ Protease Status product sizes — Now available in countries accepting CE mark!

PRODUCT CODE	DESCRIPTION	CONTAINS
350006	WOUNDCHEK™ Protease Status 6 Test Kit	6 tests (all material needed)
350010	WOUNDCHEK™ Protease Status Control Kit	3 elevated result and 3 low result control swabs

Videos

Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States

Evidence

Posters & Articles

Serena TE, et al, 2016. Defining a new diagnostic assessment parameter for wound care: Elevated protease activity, an indicator of nonhealing, for targeted protease-modulating treatment

Lazaro J., et al, 2016. Elevated levels of matrix metalloproteinases and chronic wound healing: an updated review of clinical evidence

Izzo I., et al, 2014. High matrix metalloproteinase levels are associated with dermal graph failure in diabetic foot ulcers

Frenthoff, E. et al. 2015. Testing and treating for elevated protease activity (EPA) in wound care clinics improves clinical outcome at no additional cost

Uccioli, L. et al. 2014. The presence of elevated protease activity (EPA) influences the integration of dermal grafts in diabetic foot ulcers

Gibson, M. et al. 2013. Testing chronic wounds for EPA. The benefits of testing all wounds, whether assessed as healing or non-healing

Ivory, 2013. The cost implications of implementing Woundchek Protease Status into clinical practice

Ivory, 2013. Assessing chronic non healing wounds for elevated protease activity

Anichini, R. et al. 2013. Detecting and treating Elevated Protease Activity (EPA) in chronic diabetic wounds

Duteille, F. 2013. Evaluation of the use of point-of-care test for proteases to identify patients with increased risk of skin graft failure

Nherera, L. et al. 2013. Quantifying the economic value of diagnostics in wound care in the UK

International case series: Using Promogran/Promogran Prisma on wounds with elevated protease activity: case studies. London: Wounds International, 2013.

Young, T. 2012. Using a protease test to inform wound care treatment decisions

Haycocks, 2012. Assessing chronic diabetic foot wounds for elevated protease levels

Hodgson, 2012. Clinical skills of tissue viability nurse versus Woundchek to detect elevated protease activity (EPA)

Serena, T. et al. 2012 Preliminary results: Testing for elevated protease activity in clinical practice

Johnstone, 2012. Case Studies: Testing for and treating EPA

Cullen, B. et al 2012. Targeted use of Collagen/ORC improves clinical outcome

Serena, T. et al. 2011. Protease activity levels associated with healing status of chronic wounds

Snyder, R. et al. 2011.The importance of proteases in wound healing and wound assessment

Consensus Documents

Diabetic Foot Ulcers: Prevention, Care and Treatment Spanish Diabetes Foundation, 2014

Die tolle eines proteasen schnelltests in der wunddiagnostik DACH, 2013

Using a diagnostic tool to identify elevated protease activity levels in chronic and stalled wounds USA, 2013

EPA made easy, Wounds International, 2013.

Protease diagnostic in wound care UK, 2012

Role of proteases in wound diagnostics International, 2012

Significato e valutazione delle proeasi nel processo di riparazione tessutale Italy, 2012

The role of a point-of-care protease activity diagnostic test in Canadian clinical practice Canada, 2012

World Union of wound healing societies consensus document International 2012

Symposia

Dr. Läuchli, Dr. Anichini, Dr. Dowsett, and Prof. Duteille, EWMA 2013 EPA, guiding treatment decisions for improved clinical results and cost effective care

Dr. Serena, Dr. Fletcher, and Dr. Läuchli, EWMA 2012 Testing for EPA, the arrival of wound diagnostics

Dr. Thoms, Training Event 2012 Proteases: Background, Assessment, and Treatment of EPA in chronic wounds (in German)

Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States

Evidence

Posters & Articles

Serena, T. et al. 2017. A Rapid Point of Care Test for Bacterial Protease in Chronic Wounds is Predictive of Amputation Risk

Serena, T. et al. 2015. Bacterial proteases: A marker for a 'state of pathogenesis' in chronic wounds

Serena, T. et al. 2015. Bacterial protease activity in chronic wound fluid, a potential indicator of pathogenicity even in the absence of overt signs of infection.

Benson, R. et al. 2013. Bacterial protease activity, an indicator of bacterial pathogenicity in chronic wounds even in the absence of overt clinical signs.

Consensus Documents

Wound Infection in Clinical Practice, International Wound Infection Institute, 2016

BPA Made Easy Wounds International, Serena T., et al, 2016

The Use of a point-of-care test for bacterial protease activity in chronic wounds Wounds International 2015, Vol 6 Issue 4

Symposia

content coming soon.

Disclaimer:
The product information on this page is not intended for, or to be used by health care professionals or users in the United States

Videos

Areas of Interest

The strategy of WOUNDCHEK™ Laboratories is to be the leading and dominant enterprise in wound care diagnostics by providing medical professionals with the diagnostic information to:

Identify wounds which are not healing
Intercept issues and early warnings that cause poor wound healing or initiate wounds
Aid in determination of best therapeutic routes
Monitor the effectiveness of a course of treatment

Clinical experts identified numerous markers that could form the basis of new diagnostic tools for use in wound care¹World Union of Wound Healing Societies (WUWHS). Principles of best practice: Diagnosis and wounds. A consensus document. London: MEP Ltd, 2008.(see slide above).

The Team
Board of Directors

Jack Wilkens

Chief Executive Officer
Simon Bayliff

Vice President, R&D
Malcolm Williams

Chief Financial Officer
Patrick Brosnan

Scientist
Gill Witherington

Administrator
Richard Collette

Commercial

Jack Wilkens

Chief Executive Officer
Leon Okurowski
Bill Umphrey

Jack Wilkens
Chief Executive Officer

Former Systagenix Vice President of Diagnostics Development, CEO of RevDia, which specializes in infectious disease point of care diagnostic testing. Prior to RevDia, he was Chief Operating Officer for Inverness Medical Innovations (now Alere - ALR-NYSE), a world leader in point of care rapid diagnostics. He has also held senior management positions with Unipath, IMI, Sterling Diagnostics / AGFA and Polaroid Corporation. Mr. Wilkens has a BS in Chemical Engineering and an MBA.

Simon Bayliff
Vice President, Research & Development

Simon is a Biochemistry & Physiology graduate with nearly 30 years' experience developing products in the Medical Device and In-Vitro Diagnostic fields. He has worked in 'start-up' environments and for companies including Abbott Laboratories and Johnson & Johnson.

Patrick Brosnan, BSc
Scientist

Patrick has worked in wound care for the past five years, with Systagenix. He worked for four years as an R&D scientist and more recently has moved into the clinical side of the company, helping run, monitor and analyse trials in USA. Patrick graduated from The University of Manchester in 2008 with a BSc (hons) in Biology.

Gill Witherington
Administrator

Gill has worked in admin for 13 years in Gargrave, firstly for Johnson & Johnson, which then became Systagenix Wound Management for the Research & Development Department and has to be able to deal with a vast range of tasks.

Malcolm Williams
Chief Financial Officer

Malcolm is a fellow of the chartered institute of management accountants (UK) as well as having an honours degree in accountancy and finance. He spent 22 years with Johnson and Johnson working mainly in medical devices and diagnostics. Latterly he was the international finance director for Ortho Clinical Diagnostics covering Europe, Africa and Asia. He now works for several start up businesses.

Bob Dicheck
Regulatory

Bob Dicheck is an experienced regulatory and quality management professional, who has been involved in U.S. and international regulated industries for more than 30 years.

Previously he was Vice President of Quality & Regulatory Affairs for Osmetech Molecular Diagnostics and Vice President Worldwide QA/RA at Unipath, Inverness Medical Innovations. Prior to that Bob held a variety of corporate and global franchise executive level QA/RA positions over 14 years within the Johnson & Johnson family of companies.

Richard Collette
Commercial

Richard Collette is an experienced Commercial Business Leader in international business development for medical products such as diagnostic imaging equipment, tele-care for chronic wound management, IVDs, and implantable devices covering the past 20 years.

Most recently, he was President of the USA and Canada marketing, sales, distribution, and service operation for one of the leading suppliers of implants that restore hearing to those challenged with profound hearing loss.

Jack Wilkens
Chief Executive Officer

Former Systagenix Vice President of Diagnostics Development, CEO of RevDia, which specializes in infectious disease point of care diagnostic testing. Prior to RevDia, he was Chief Operating Officer for Inverness Medical Innovations (now Alere - ALR-NYSE), a world leader in point of care rapid diagnostics. He has also held senior management positions with Unipath, IMI, Sterling Diagnostics / AGFA and Polaroid Corporation. Mr. Wilkens has a BS in Chemical Engineering and an MBA.

Leon Okurowski

Mr. Okurowski is the Vice President of Pear Tree Advisors and the co-founder and Vice-President of the Pear Tree Funds. He is also Vice President and Treasurer for various U.S. Boston entities. Mr. Okurowski has over forty years experience in the finance and investment management business.

Mr. Okurowski obtained his MBA from the Whittemore School of Business at the Univerity of New Hampshire, his MS in taxation from Bentley College, and a BS from the United States Naval Academy.

He has served on the boards of several high-tech companies. He was a co-founder and served on theboard of Atlantic Bank and Trust
Company, a public company.

Prior to joining U.S. Boston,
Mr. Okurowski served in the
United States Navy as a
submarine officer.

Bill Umphrey

Mr. Umphrey is the Chairman and co-founder of the Pear Tree Funds, the President of Pear Tree Advisors, Inc., and the Chairman of U.S. Boston Capital Corporation. Mr. Umphrey founded the U.S. Boston's predecessor in 1969 and has over forty years of experience in the finance and investment management business.

Mr. Umphrey obtained his JD from Harvard Law School, an LLM in taxation from Boston University of Law, a Masters in Personnel Administration fron George Washington Univeristy, and a BS with distiction from the United States Naval Academy in Annapolis, Maryland.

Prior to founding U.S. Boston,
Mr. Umphrey served in the
United States Navy as a
submarine officer.

Events

News

Date: Dec 2, 2019

FDA clears WOUNDCHEK™ Bacterial Status for use by wound care professionals

Date: Oct 1, 2019

Patients recruited for WOUNDCHEK™ Bacterial Status UK Clinical Trial

Date: Apr 4, 2017

New CE Mark for WOUNDCHEK™ Bacterial Status

News archive

Date: Dec 2, 2019

FDA clears WOUNDCHEK™ Bacterial Status for use by wound care professionals

Woundchek Laboratories are excited to announce that the FDA has cleared Bacterial Status for use in the USA by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds. Bacterial Status results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the assessment of risk for non-healing chronic wounds such as wound age, wound size, and vascular status.