Aatru Medical, LLC (Aatru) is a privately-held medical device company specializing in technology development in negative pressure wound therapy for surgical incisions and chronic wounds.

The Aatru NPSIMS™ represents a new and advanced technology in ultraportable devices that are designed for use on closed surgical incisions that produce low exudate.

 

A 510(k) premarket notification submission was filed in June 2020 with the US FDA.

The NPSIMS™ product does not have FDA Clearance and is not for sale at this time. All information on this website is for educational purposes only.

 

 

Negative Pressure Wound Therapy (NPWT)

NPWT use over closed surgical incisions has been shown in a substantial number of studies to be beneficial in reducing rates of surgical site infection (SSI), seroma/hematoma and dehiscence, and improving scar quality.

Negative pressure wound therapy (NPWT) has been in use for more than 20 years for the management of a wide range of different wound types. More recently, NPWT systems have been used to manage closed surgical incisions in patients at high risk of surgical site complications.

Some simplified and advanced NPWT systems no longer employ a fluid-collection canister, but allow any exudate produced by the wound to evaporate through a high moisture vapor transmission rate (MVTR) dressing or to be collected in the super-absorbent pad in the dressing.

The ultraportable, discreet versions of NPWT are ideally suited for use on closed surgical incisions that are not expected to produce large volumes of exudate.

NPWT has been used on closed surgical incisions following a variety of different types of surgery, including abdominal, cardiothoracic, colorectal, obstetric, orthopedic, pediatric, plastic/breast, trauma and vascular surgery. (Source: World Union of Wound Healing Societies Consensus Document)

In the US, SSIs affect about 500,000 surgical patients each year and lead to about 8,000 deaths annually. (Source: Najjar PA, Smink DS. Prophylactic antibiotics and prevention of surgical site infections. Surg Clin N Am 2015; 95: 269-83.) A patient with an SSI has a 2–11-fold increase in mortality compared with a post-surgical patient without an SSI. (Source: Anderson DJ, Podgorny K, Berris-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Inf Control Hosp Epidemiol 2014; 35(6): 605-27.)

Negative Pressure Wound Therapy (NPWT)

NPWT is an established practice in wound care to treat acute wounds, chronic wounds, and surgical incisions. The therapy consists of a suction pump that delivers -80mmHg +/- 20mmHg connected to a sealed dressing that is applied to the wound site. During the therapy, the edges of the wound bed are pulled closer together, exudate is removed, and the wound or surgical incision is protected from outside contaminants.

The NPWT category can be divided into two types of devices:

Traditional NPWT devices consist of large pumps with disposable dressings that are purchased or rented for repeated patient use.
Single Use NPWT devices consist of small disposable pumps and dressings that are designed for single patient use.

Surgical Site Infections (SSI)

Any infection that occurs in the part of the body where a surgery took place is called an Surgical Site Infections. (Source: https://www.cdc.gov/HAI/ssi/ssi.html) Due to high financial burdens, healthcare systems have put an emphasis on the prevention of SSIs. Single Use NPWT has gained acceptance as a preventative strategy.

NPWT therapy is recognized for lowering SSIs, reducing hospital readmission rates, and shortening the length of hospital stays for many surgery patients.

Avoidance of surgical site complications may:

 

  • Reduce morbidity (including systemic complications, long–term sequelae/after-effect, pain, patient/caregiver anxiety) and mortality

  • Reduce length of hospital stay and unplanned readmission

  • Improve hospital efficiency, e.g. by preventing delays in follow-on treatment (such as chemotherapy) and allowing greater patient throughput

  • Reduce indirect and direct healthcare costs

  • Reduce social and psychological costs for patients, their families and caregivers

  • Enhance oncological survival

  • Enhance patient satisfaction and departmental/institutional standing

Sourced from the WUWHS Consensus Document: Closed Surgical Incision Management: Understanding the role of NPWT 

All information on this website is for educational purposes only. Any statements related to safety or effectiveness are attributed generally to NPWT, and not specifically to the NPSIMS™ device.

 

Negative pressure is a proven therapy for reduction of SSIs. (Source: Hyldig N, Birke-Sorensen H, Kruse M, et al. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg 2016; 103; 477-86.) Unfortunately, the products on the market that consistently deliver results have expensive electromechanical pumps that are often cost prohibitive in today’s healthcare system.

NPSIMS™

An Affordable Negative Pressure Solution for Closed Surgical Incisions that is Designed to Deliver Results.

The NPSIMS™ System leverages a non-mechanical pump and innovative dressing design

NPSIMS™ System includes:
  • 4.5” x 9” (approx.) Sterile Dressing with connected tubing (pad is 1.35” x 5.5”)
    (Can accommodate multiple dressing sizes)
  • One Vacuum chamber
The NPSIMS™ System leverages a non-mechanical pump and innovative dressing that is unlike anything currently on the market
  • Single Use – Designed for a single use, the NPSIMS™ vacuum chamber and dressing are disposed of after each use
  • Lightweight & Portable – Weighing just 3 ounces, the NPSIMS™ vacuum chamber is designed to enable discreet patient portability
  • Delivers Continuous Negative Pressure Generates and maintains an average negative pressure of -80mmHg +/- 20mmHg at the wound surface
  • 7-day Duration – The dressing is designed to remain on the patient for the duration of the treatment dependent upon the recommendation of the treating physician, up to 7 days
  • Canister Free – Designed for closed surgical incisions with up to 10ml of exudate, the NPSIMS™ has no need for a bulky canister
  • Super Absorptive Dressing – Designed to manage surgical site exudate with the super absorbent pad
  • Visible Indicators – There are no audible alarms but the NPSIMS™ exhibits two visible indicators for the delivery of NPWT
  • Quiet Operation – The Vacuum chamber is designed to function silently and requires no batteries or electrical power source

 

Downloadable PDF Documents
The NPSIMS™ product does not have FDA Clearance and is not for sale at this time. All information on this website is for educational purposes only.
Aatru has more than 40 patent filings in process globally for the NPSIMS™ product, with 5 US patents and 1 Japan patent granted to date.

Clinical Evidence:

Aatru NPSIMS™ Product Validation through Testing & Reporting

 

Usability/Human Factors Study

Usability and Human Factors validation tests were conducted to assess the design of the Aatru NPSIMS™ with respect to user input to the Design Specification and Requirements.

The Usability Test is intended to be a summative evaluation of qualitative investigations that are reported from observations of User interactions with the device’s user interfaces and the description of their experiences.

Incisional Porcine Wound Model – Animal Trial

To establish in-vivo validation of the Aatru negative pressure wound therapy O2 scavenger mode of action, an animal study was conducted at University of Miami, Miller School of Medicine, Department of Dermatology and Cutaneous Surgery, Wound Healing Research Laboratory. Testing for:

  • Pressure Maintenance
  • Bacterial Count Assessment
  • Exudate Quantity Data
  • Observational Data

The European Wound Management Association | Symposium on Advanced Wound Care

 

Aatru Abstracts of Porcine Results accepted at EWMA 2020 and SAWC-Spring 2020

  • Abstract accepted at both Conferences
  • e-Posters to be presented
  • Live Presentation by Aatru at Conferences

European Wound Management Association, EWMA 2020 Poster Session

Presented by Robin Martin, PhD – November, 2020

The NPSIMS™ product does not have FDA Clearance and is not for sale at this time. All information on this website is for educational purposes only.

Aatru Leadership Team

Aatru is a purpose driven organization comprised of a management team with extensive experience in invention, design, medical devices, and thought leadership. The team is supported by a seasoned Board of Directors and Medical Advisory Board.

TIMOTHY WOJCIECHOWSKI
Chief Executive Officer and Co-Inventor

Mr. Wojciechowski is the Chief Executive Officer of Aatru. He brings 20 years of demonstrated start-up and technology development expertise in the areas of NPWT and LCD optical films . Mr. Wojciechowski held leadership positions at Micros Chip, served as CEO at Concast Standard, Trivium Technologies, Executive GM at Oglebay-Norton Advanced Materials, and is a co-inventor on more than 15 patents in NPWT and optical films.

Mr. Wojciechowski holds a Bachelor of Arts in Economics from Cleveland State University.

THOMAS LASH
Chief Operating Officer and Co-Inventor

Mr. Lash is the Chief Operating Officer of Aatru. He brings over 30 years of technology consultative sales and marketing with large corporations and start-ups, including serving as CEO for Micros Chip and COO at Trivium Technologies, Inc. Prior to his executive leadership roles, Mr. Lash had a variety of senior sales and marketing at EMC Corporation, Teradata, NCR Corporation, and AT&T.

Mr. Lash holds a Bachelor of Arts in Urban Affairs and Communications from Cleveland State University.

EDWARD ARMSTRONG
President

Mr. Armstrong is the President and a Director of Aatru.  He has more than 30 years of medical device leadership experience driving global commercial growth, transforming organizational effectiveness, and leading innovation in new product development and business models, including 20 years in wound management with 12 years in NPWT.  Most recently, Mr. Armstrong was the Vice President Business Unit Leader for Post Acute Care & Respiratory Business at Invacare. He previously held many upstream and downstream executive positions within Smith & Nephew Wound Management, and he spent the early years of his career at Bristol Myers Squibb.

Mr. Armstrong holds a Bachelor of Engineering, Computer Science from the University of Pennsylvania, and an MBA from the University of Michigan.

JOHN BUAN, Ph.D.
Chief Technology Officer and Co-Inventor

Dr. Buan is the Chief Technology Officer and a Director of Aatru. He has more than 20 years of medical device leadership experience in R&D, engineering, quality, and operations/logistics, including 13 years in wound management and 9 years in NPWT. He previously held leadership positions and/or medical device product development consulting services for Biodaptive, LLC, Smith & Nephew, Kalypto Medical, and Surmodics.

Dr. Buan holds Bachelors degrees in Physics and Math from the University of Minnesota – Twin Cities, a Ph.D. in Condensed Matter Physics from the University of Minnesota – Twin Cities.

JEFF USTIN, M.D.
Chief Medical Officer

Dr. Ustin is the Chief Medical Officer of Aatru. He has worked in device design for start up medical companies for almost 20 years. Dr. Ustin is a practicing trauma surgeon in Cleveland, Ohio with a strong background in engineering and entrepreneurship.  After completing an undergraduate degree in engineering at Dartmouth College, Dr. Ustin received his medical degree from Stanford University School of Medicine.  He began his training in general surgery at Case Western Reserve and in lieu of traditional research time obtained a Masters in Electrical Engineering from University California, Berkeley.  Dr. Ustin then completed his general surgery training at Emory University and did a fellowship in Acute Care Surgery, comprising trauma, emergency surgery, and surgical critical care at Harvard University and the Massachusetts General Hospital.

He has also served on oversight and advisory committees at MetroHealth, Cleveland Clinic, University Hospitals of Cleveland, and through Case Western Reserve University Department of Biomedical Engineering.  He holds faculty appointments in surgery and biomedical engineering at Case.

RICHARD MIDDAUGH, Ph.D.
Chief Scientific Officer and Co-Inventor

Dr. Middaugh is the Chief Scientific Officer and a Director of Aatru. He held scientific positions of increasing management and leadership for 26 years at Energizer Battery. Dr. Middaugh was an Associate Professor of Chemistry at Northeastern University and the University of Kansas and previously served as a consultant to RBC Technologies and Revolt Technology, LTD.

Mr. Middaugh holds a Bachelor of Arts in Chemistry from Harvard University and received a Ph.D. in Chemistry from the University of Illinois at Urbana-Champaign.

 

WILLIAM EVO, J.D.
Chief Strategy Officer and General Counsel

Mr. Evo is the Chief Strategy Officer and General Counsel for Aatru. He has over 35 years as a licensed business and transaction attorney and has worked as an executive and consultant in many business sectors. After a career in professional hockey, he served as the President of the Detroit Red Wings, senior management at Ideal Technologies and co-founder, partner and president of the Capital Centre, LLC.

Mr. Evo holds a Liberal Arts Bachelor degree from the University of Western Ontario and received a J.D. from the University of Detroit.

ROBIN MARTIN, Ph.D.
Senior Scientific Consultant

Robin Martin, Ph.D. has held a variety of global senior clinical scientific roles over 15 years at Smith & Nephew Advanced Wound Management. Beginning in 2002, Doctor Martin has worked in large multi-disciplinary global teams designing, launching and marketing medical devices such as: VERSAJET™ hydrosurgery debridement system, BIOBRANE™ temporary biosynthetic skin replacement, and negative pressure wound therapy (NPWT) systems such as RENASYS™ and PICO™ and building clinical evidence to support their use. He is widely published and is considered an expert in his field.

BOARD OF DIRECTORS

TIMOTHY WOJCIECHOWSKI
Chairman

Mr. Wojciechowski is the Chief Executive Officer of Aatru. He brings 20 years of demonstrated start-up and technology development expertise in the areas of NPWT and LCD optical films . Mr. Wojciechowski held leadership positions at Micros Chip, served as CEO at Concast Standard, Trivium Technologies, Executive GM at Oglebay-Norton Advanced Materials, and is a co-inventor on more than 15 patents in NPWT and optical films.

Mr. Wojciechowski holds a Bachelor of Arts in Economics from Cleveland State University.

RICHARD MIDDAUGH, Ph.D.

Dr. Middaugh is the Chief Scientific Officer and a Director of Aatru. He held scientific positions of increasing management and leadership for 26 years at Energizer Battery. Dr. Middaugh was an Associate Professor of Chemistry at Northeastern University and the University of Kansas and previously served as a consultant to RBC Technologies and Revolt Technology, LTD.

Mr. Middaugh holds a Bachelor of Arts in Chemistry from Harvard University and received a Ph.D. in Chemistry from the University of Illinois at Urbana-Champaign.

 

SARA ANN MACKINLAY

Sara Ann MacKinlay is the President of Exsurco Medical Group, a medical device manufacturer of high precision products for tissue banks and healthcare professionals. Ms. MacKinlay has more than 25 years’ experience as a healthcare executive for companies such as Johnson & Johnson, Invacare and Smith & Nephew.

MICHAEL GAGLEARD, J.D.

At law firm Ishbia & Gagleard, P.C., attorney Mike Gagleard specializes in corporate, commercial, and individual litigation matters involving complex legal and substantive issues. His areas of practice include personal injury and contract and corporate law.

RUSS DONDA

Executive-in-Residence for biosensor and medical technologies at the Great Lakes Innovation & Development Enterprise, Russ Donda has over 25 years of management experience at very early stage companies. He was the founding CEO of ViewRay Incorporated, a founding manager at Regeneration Technologies and a founding member and co-chair of investment review for angel group the Emergent Growth Fund.

 

JAMES HINDMAN

James M. Hindman served in various positions at Allergan, Inc., a multi-specialty healthcare company, from 1984 to March 2015, including most recently as the Executive Vice President and Chief Financial Officer of Allergan from August 2014 to March 2015. Jim currently serves on the boards of Millendo Therapeutics, Inc. in addition to Aatru Medical, LLC. Jim currently serves as a member of the Board of Regents at Loyola Marymount University, Accuray Inc. and Urovant Sciences and serves as a member of the Dean’s Executive Council for the College of Business Administration at Loyola Marymount University.

JOHN BUAN, PH.D.

Dr. Buan is the Chief Technology Officer and a Director of Aatru. He has more than 20 years of medical device leadership experience in R&D, engineering, quality, and operations/logistics, including 13 years in wound management and 9 years in NPWT. He previously held leadership positions and/or medical device product development consulting services for Biodaptive, LLC, Smith & Nephew, Kalypto Medical, and Surmodics.

Dr. Buan holds Bachelors degrees in Physics and Math from the University of Minnesota – Twin Cities, a Ph.D. in Condensed Matter Physics from the University of Minnesota – Twin Cities.

EDWARD ARMSTRONG

Mr. Armstrong is the President and a Director of Aatru. He has more than 30 years of medical device leadership experience driving global commercial growth, transforming organizational effectiveness, and leading innovation in new product development and business models, including 20 years in wound management with 12 years in NPWT.  Most recently, Mr. Armstrong was the Vice President Business Unit Leader for Post Acute Care & Respiratory Business at Invacare. He previously held many upstream and downstream executive positions within Smith & Nephew Wound Management, and he spent the early years of his career at Bristol Myers Squibb.

Mr. Armstrong holds a Bachelor of Engineering, Computer Science from the University of Pennsylvania, and an MBA from the University of Michigan.

THOMAS LASH
Secretary

Mr. Lash is the Chief Operating Officer of Aatru. He brings over 30 years of technology consultative sales and marketing with large corporations and start-ups, including serving as CEO for Micros Chip and COO at Trivium Technologies, Inc. Prior to his executive leadership roles, Mr. Lash had a variety of senior sales and marketing at EMC Corporation, Teradata, NCR Corporation, and AT&T.

Mr. Lash holds a Bachelor of Arts in Urban Affairs and Communications from Cleveland State University.

MEDICAL BOARD OF ADVISORS

David A. Spivey
Chairman
Current: President & CEO, St. Mary Mercy Livonia

Jeff Ustin, M.D.
Current: University Hospitals, MGH 1811

Michael Schenden, M.D., P.C.
Current: Beaumont Hospitals

Philip Vierling, MBA
Former: Kalypto Medical

Arlette Palo
Former: Estee Lauder

Contact Us

 

 

 

Aatru News

 

Aatru Medical, LLC submits NPSIMS™ product to FDA for Class II Clearance and completes Series C funding

For Immediate Release: July 14, 2020

Aatru Medical Abstract Accepted for Presentation in Two Leading 2020 Wound Healing Conferences

For Immediate Release: August 18, 2020

Industry News & Information

 

WUWHS Report

An international group of surgical care experts discuss the challenges involved in closed surgical incision management and the interventions such as NPWT that can be used to reduce the risk of surgical site complications.

WHO Report

The World Health Organization has created a comprehensive set of global guidelines for the prevention of surgical site infection.

Journal of Tissue Viability

The Journal of Tissue Viability has published a paper that discusses how negative pressure wound therapy is thought to improve wound healing by altering capillary perfusion, entitled “Pressure distribution and flow characteristics during negative pressure wound therapy.”

American Journal of Obstetrics & Gynecology (AJOG)

“Closed Incision Negative Pressure Therapy Is Associated with Reduced Surgical Site Infections in Gynecologic Oncology Patients Undergoing Laparotomy” Chambers, et al.