Tag: MolecuLight

Is Your Wound Bioburdened? Case 4

Dot Weir, RN, CWON, CWS

 

• A 94-year-old male, active and in overall good health, with chronic venous leg insufficiency and hypertension.

• Treated regularly in our clinic for bilateral venous leg ulcers with good wound hygiene, absorptive dressings and compression bandaging.

• On one of these visits the patient complained of an area of discomfort on a callus located on the medial aspect of his right second toe including the interdigital area between toes 1 and 2.

 

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Is Your Wound Bioburdened? Case 3

A 77-year-old, non-smoking female with diabetes came into the clinic for a postoperative assessment … The patient presented with a non-healing surgical wound resulting from a great toe amputation 3 weeks prior … She had poor vascularity, normal blood sugar levels, and there were no signs or symptoms of infection (no malodor, purulent drainage, or cellulitis) … read more

Latest Clinical Evidence Presented at SAWC 2021 Illustrates the Significant Clinical Utility of the MolecuLight Point-of-Care …

Imaging Platform
7 Clinical Posters and Presentations Highlight the Breadth of Clinical Benefits
of the MolecuLight Device for Wound Care Applications

TORONTO and LAS VEGASOct. 28, 2021 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces the presentation of 7 clinical posters and presentations at the Symposium of Wound Care (SAWC) Fall 2021, held from October 29 – 31, 2021 in Las Vegas, Nevada. SAWC is one of the largest multidisciplinary meetings of wound care professionals.

“We are thrilled to have so many customers presenting their impressive clinical findings at this year’s SAWC Fall conference”, says Anil Amlani, MolecuLight’s CEO. “The clinical topics being presented span the wound care continuum, from improved wound assessment and treatment planning, to monitoring of wound cleaning and debridement efficacy, and the resulting improvement in wound healing rates. Presenters will also describe detection and treatment of wound-related cellulitis, and findings from the recently published Delphi consensus-based guidelines for the use of the MolecuLight platform. The outcomes presented in these studies illustrate the significant clinical improvements to wound care provided to clinicians by the MolecuLight i:X“.

A submission on MolecuLight by Dr. Charles A. Andersen was one of the top scoring abstracts out of more than 200 submissions. This is the fifth consecutive SAWC meeting at which an abstract on improved patient care achieved through use of the MolecuLight i:X has received this honour.

The 5 clinical posters and 2 presentations featuring the MolecuLight i:X from SAWC Fall 2021 are as follows:

Poster #CR-005
12-Week RCT Evaluating Impact of Routine Fluorescence Imaging of Bacteria on DFU Healing Rates
Alisha Oropallo, MD¹, Scott Gawlik DPM¹, Dean Vayser, MD²
¹Northwell Comprehensive Wound Health Center and Hyperbarics, Lake Success NY,
²ILD Research Centre, San Diego, CA
 Download poster

Poster #CR-006
Cleansing Techniques for Wound Hygiene: Which Are Most Effective?
Alisha Oropallo, MD1Amit Rao MD1Jai Joshi1
1Northwell Comprehensive Wound Health Center and Hyperbarics, Lake Success NY 
 Download poster

Poster #LR-025
Detection of bacterial fluorescence from in vivo wound biofilms using a point-of-care
fluorescence imaging device
Andrea J. Lopez1Laura M. Jones2, Landrye Reynolds1Rachel C. Diaz1Isaiah K. George1William Little1Derek Fleming3,4Anna D’souza2Kendra Rumbaugh3Allie Clinton Smith1Monique Y. Rennie2
1Department of Honors Studies, Texas Tech UniversityLubbock TX, USA; 2MolecuLight Inc. Toronto, ON Canada3Department of Surgery, Texas Tech University Health Sciences Center4Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA 
 Download poster

Poster #CR-020
Are Semi-quantitative Clinical Cultures Inadequate? Comparison to Quantitative Analysis of 1053 Bacterial Isolates from 350 Wounds
Thomas E. Serena1Phil Bowler2Gregory Schultz3Anna D’souza4Monique Rennie4
1
SerenaGroup Research Foundation, Cambridge MA USA; 2Phil Bowler Consulting, Warrington UK3Department of Obstetrics and Gynecology, University of Florida, FL, USA; 4MolecuLight Inc. Toronto 
 Download poster

Poster #PI-003
Guidelines for point-of-care fluorescence imaging for detection of wound bacterial burden based on Delphi consensus
Charles A. Andersen¹, Alisha R. Oropallo², Raymond Abdo³, Jenny Hurlow⁴, Martha R Kelso⁵, M. Mark Melin⁶ and Thomas E. Serena⁷
1Madigan Army Medical Center, Renton WA2. Zucker School of Medicine Hofstra/Northwell, Hempstead, NY3St. Louis Foot & Ankle LLC, St. Louis MO4Consultant Wound Care Practitioner, Memphis TN5Wound Care Plus LLC, Blue Springs MO6M Health Fairview, Edina MN7SerenaGroup Research Foundation, Cambridge MA
 
 Download poster

Oral Presentation & Poster #PI-002
Diagnosis and Treatment of the Invasive Extension of Bacteria (Cellulitis) from Chronic Wounds Utilizing Point-of-Care Fluorescence Imaging
Charles Andersen¹, Katherine McLeod¹, Rowena Steffan¹
¹Vascular/Endovascular/Limb Preservation Surgery Service, Madigan Army Medical Center, Joint base Lewis-McChord, WA USA
 Download poster

Podium Presentation
Innovation Spotlight: Shining a Light on Bold Ideas in Wound Care
Charles Andersen¹
¹Vascular/Endovascular/Limb Preservation Surgery Service, Madigan Army Medical Center, Joint base Lewis-McChord, WA USA

In additional to the clinical posters and presentations at SAWC (Symposium on Advanced Wound Care) Fall 2021, the recently launched MolecuLightDX will be available for demonstration in the MolecuLight booth #439 in the Exhibit Hall at Caesars Palace in Las Vegas, Nevada.

About MolecuLight Inc.

MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s suite of commercially released devices, including the MolecuLight i: and DX™ fluorescence imaging systems and their accessories, provide point-of-care handheld imaging devices for the global wound care market for the real-time detection of wounds containing elevated bacterial burden (when used with clinical signs and symptoms) and for digital wound measurement. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant, unmet needs including food safety, consumer cosmetics and other key industrial markets.

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SOURCE MolecuLight

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www.moleculight.com

Joerns Healthcare Introduces Point-of-Care Imaging to Wound Care Portfolio Through MolecuLight Partnership

CHARLOTTE, N.C. and PITTSBURGH, Oct. 19, 2021 /PRNewswire/ — Joerns Healthcare, a healthcare technology and equipment services company, announces the addition of the MolecuLight i:X® and DX™ wound imaging platforms to its wound management portfolio through an exclusive agreement with MolecuLight Corp. to provide MolecuLight’s fluorescence imaging technology for point-of-care detection of the bacterial burden in wounds. The MolecuLight i:X and DX devices are the first-of-their-kind handheld imaging devices that help clinicians quickly and easily visualize the bioburden of wounds as part of the standard clinical examination. The device can be used on all wounds, in all care settings and provides invaluable information in real-time to inform and support clinician decision-making. The automated wound measurement and assessment platform simplifies wound management to maximize healing and patient satisfaction.

“The revolutionary MolecuLight i:X and DX devices are the first point-of-care devices that simplify wound management and put immediate decision-making data at the clinician’s fingertips. The addition of this bedside imaging tool to our Connexio™ platform creates the first holistic system designed to enable immediate, evidence-based decisions for wound management. The device also eliminates the manual, administrative burden clinicians traditionally face by automating the data flows to their EMR platform of choice. The result is improved healing rates, reduced wound management costs, improved patient satisfaction and increased clinician efficiencies,” says Doug Ferguson, Chief Strategy Officer of Joerns Healthcare … read more

Launch of New MolecuLightDX™ Device to Enable Point-of-Care Imaging of Wounds in New Expanding Market Segments

MolecuLight Platform is Becoming the Standard-of-Care for Real-Time Imaging of Elevated Bacterial Burden in Wounds Across All Wound Care Settings

TORONTO, CANADA – (October 14, 2021) MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announced the launch of the MolecuLightDX™, a new point-of-care device model targeted at the unique needs of new expanding wound care market segments in the USA. The DX is an expansion of MolecuLight’s product line and compliments the MolecuLight i:X®, the “workhorse” wound imaging device that has quickly become a standard in wound care practices worldwide, with over 2,000 units sold.

“The i:X and DX are the only commercially-available point-of-care devices to enable real-time detection of elevated bacterial burden in wounds. With the introduction of the MolecuLightDX, we are thrilled to expand our product line and provide added functionality for these wound care market segments,” says Anil Amlani, MolecuLight’s CEO.

Specifically, the MolecuLightDX has the following new features frequently required in these segments:

  • Comprehensive EMR (electronic medical record) integration options for multiple EMR environments,
  • Patient-centric user interface and workflow to allow for easy patient and wound tracking,
  • An Administrator workflow and system configuration capability, and
  • Docking system for easier charging of the devive.

As with the i:X, the DX has the same accurate, rapid digital wound measurement for documentation of procedures and of wound progression. Newly available on the DX is a stickerless measurement capability which automatically measures wound area without the need for wound stickers.

Photo Legend: Select new features of the MolecuLightDX include a larger screen (top left), new Stickerless digital wound area measurement for documentation and monitoring of wound progression (top right), and integrated docking station (bottom right). As with the i:X, the DX is used for point-of-care imaging of elevated bacterial burden in wound to help inform clinical decision-making (bottom left).

“With the expansion of our product line, we can now offer clinicians in any care setting the unmatched capabilities of the MolecuLight platform, with a feature set and price point that matches their specific needs”, says Amlani. “MolecuLight customers will continue to receive our comprehensive activation and training support on both platforms, including on-site training with patients, e-Learning courses and certification and ongoing in-person and remote support by our Clinical Applications team.”

In addition, all MolecuLight procedures will be able to benefit from the reimbursement pathway available in the United States for the MolecuLight procedure, which is applicable to both the MolecuLight i:andDX devices. The reimbursement pathway includes two CPT® codes for physician work to perform “fluorescence wound imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment.

The MolecuLightDX has received FDA clearance for sale in the USA, as well as the CE Mark and Health Canada approval for commercial availability in Europe and Canada.

The MolecuLightDX will be displayed in the MolecuLight exhibit booth at the upcoming clinical conference, SAWC (Symposium on Advanced Wound Care) Fall 2021, on Sunday, October 31, 2021 at 9:00 am at Caesars Palace in Las Vegas, Nevada. To request an on-site clinical demonstration of the MolecuLightDX, please go to www.moleculight.com, or email info@moleculight.com.

 

About MolecuLight Inc.

MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s suite of commercially released devices, including the MolecuLight i: and DX™ fluorescence imaging systems and their accessories, provide point-of-care handheld imaging devices for the global wound care market for the real-time detection of wounds containing elevated bacterial burden (when used with clinical signs and symptoms) and for digital wound measurement. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant, unmet needs including food safety, consumer cosmetics and other key industrial markets.

 

Rob Sandler
Chief Marketing Officer
MolecuLight Inc.
M. +1.647.362.4684
rsandler@moleculight.com
www.moleculight.com

MolecuLight i:X® Receives FDA 510(k) Clearance for the Device’s Ability to Detect Wounds Likely to Contain Pseudomonas aeruginosa (PA)

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New FDA Clearance Illustrates the Utility of the i:X to Reliably Predict Pseudomonas aeruginosa, a Bacterial Pathogen that Precludes Wound Healing and Often Evades Conventional Treatment Methods

 

TORONTO, CANADA – (September 23 2021) MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received FDA 510(k) clearance for the detection of wounds containing clinically significant levels (>104 CFU/g) of Pseudomonas aeruginosa (PA) for the previously cleared MolecuLight i:X imaging device.  The i:X device visualizes fluorescence, enabling the point-of-care detection of wounds containing elevated levels of bacteria. This new FDA clearance supports the ability of the i:X device to increase the clinician’s ability to detect the presence of Pseudomonas aeruginosa in wounds using the cyan fluorescence signal.  This augmented labeling is based on a detailed retrospective statistical analysis of over 350 patients.

 

Pseudomonas aeruginosa (PA) is a common bacterial pathogen that precludes wound healing. PA is notorious for its intrinsic resistance to many antibiotics and its tendency to form biofilm matrices that evade antibiotics and other conventional treatment methods1. The presence of PA in wounds is associated with rapid deterioration and more severe wound outcomes 2,3. The MolecuLight i:X is the only imaging device that provides real-time information on whether a wound is likely to contain elevated levels of PA (>104 CFU/g). The i:X is becoming an essential tool for assisting in clinician decision-making regarding the assessment and treatment of wounds.

 

Image and video courtesy of Dot Weir

“Bacterial removal is a critical component of wound care and wound healing. The ability of the MolecuLight i:X to detect and visualize wounds containing elevated bacterial burden while we are with the patient enables a proactive and objective approach to wound management”, says Dot Weir, RN, CWON, CWS, Clinician at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, Saratoga Springs, New York and Co-Chair of SAWC, the Symposium on Advanced Wound Care. “Wounds harboring Pseudomonas often require unique treatments. This new FDA clearance recognizes the added benefit of the i:X in visualizing and differentiating Pseudomonas aeruginosa in wounds through the cyan fluorescence signal it produces on the images. This is especially important because detecting the presence of Pseudomonas aeruginosa at the point-of-care allows wound care professionals to act immediately to tailor our cleaning, debridement, antimicrobial strategy and treatments accordingly.”

 

This video showing the cleansing of a diabetic foot ulcer is an example of the MolecuLight i:X’s cyan fluorescence signal indicating the likely presence of PA. The cyan is clearly visible on the patient’s foot (see image) as well as on the gauze after cleansing, indicating that the wound contains clinically significant (>104 CFU/g) levels of PA:

Video link: https://www.youtube.com/watch?v=X5YiT4zTUL8
References
1 Raizman et al., “Rapid Diagnosis of Pseudomonas aeruginosa in Wounds with Point-of-Care Fluorescence Imaging“, Diagnostics 2021, 11(2), 280

2Turner et al., “Requirements for Pseudomonas aeruginosa Acute Burn and Chronic Surgical Wound Infection”, PLoS Genet. 2014, 10, e1004518

3McManus et al., “Twenty-five-year review of Pseudomonas aeruginosa bacteremia in a burn center”, Eur. J. Clin. Microbiol. 1985, 4, 219–223

 

About MolecuLight Inc.

MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s first commercially released device, the MolecuLight i:X fluorescence imaging system and its accessories provide a point-of-care handheld imaging device for the global wound care market for the detection of wounds containing elevated bacterial burden (when used with clinical signs and symptoms) and for digital wound measurement. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant, unmet needs including food safety, consumer cosmetics and other key industrial markets.

 

For more information, contact:

Rob Sandler                                               

Chief Marketing Officer

MolecuLight Inc.
T. +1.647.362.4684

rsandler@moleculight.com

www.moleculight.com

 

Image: Download at: https://moleculight.box.com/s/b4d44tv25dq5wr834ilx7ldiqzl1orxi
Video: https://www.youtube.com/watch?v=X5YiT4zTUL8