Aatru Medical Announces Latin America Distribution Agreement for Their Innovative NPSIMS™ Negative Pressure Surgical Incision Management System

 As part of Aatru Medical, LLC (“Aatru”) commercial planning, the company is pleased to announce a Latin America distribution agreement with Salus Biomedical, for the NPSIMS product. The product received recent FDA 510(k) clearance, and Aatru is in the process of finalizing market introduction plans. Initial markets include Latin America, with U.S. and additional global markets to follow.

“We are very excited about this next phase of Aatru development, as we bring the product to market, providing access for clinicians and patients to this truly innovative product,” stated Edward Armstrong, President, Aatru Medical.

The patented NPSIMS utilizes a safe and innovative solid-state chemical reaction to create and apply negative pressure in the therapeutic range to closed incision sites for up to 7 days. The unique mode-of-action, which contains no moving parts or electromechanical components, delivers similar clinical performance to other available Negative Pressure Wound Therapy (NPWT) devices, while providing substantial advantages in patient quality of life, ease of use, and price.

Salus Biomedical is a medical device distributor across Latin America, focusing on hospital use devices. Israel Vierma, Managing Director of Salus Biomedical, stated, “We are proud to be at the forefront of incision care with this simple, most innovative and useful product. Aatru Medical is breaking new ground on ease-of-use for the clinicians and in helping us address a growing need in Latin America.”

Aatru COO Tom Lash noted, “Market analysis and voice-of-customer feedback identified that users value the role of NPWT products in helping manage the risk of surgical site infections (SSI), although product complexity and the high cost of currently-available NPWT products is restricting use to mainly higher-risk incisions only. The NPSIMS product provides similar clinical performance while providing significant cost improvement over existing devices, creating a more scalable standard of care to treat the vast majority of low-exudate surgical incisions.”

About NPWT for closed surgical incisions:

Several post-operative wound complications are common following surgical procedures. Negative pressure wound therapy (NPWT) is well recognized for the management of open wounds, and in the last several years has been applied to closed surgical incisions. Compared with standard postoperative dressings, NPWT has been clinically shown to significantly reduce the rate of surgical site infection and seroma.

About Aatru Medical:

Aatru is a privately held medical device technology company focused on disrupting the surgical incision market with its FDA-cleared NPSIMS, a simple, disposable, single-use, patented, low-cost NPWT device, uniquely designed to require no electromechanical pump, battery or canister.

Introductory videos of the NPSIMS product can be found on the Aatru Medical, LLC website: www.aatru.com.

Aatru Medical, LLC

Tom Lash

216-303-6063

www.aatru.com

ContactContact

Categories

  • Business
  • Medical & Health
  • Medical Products
  • Surgery

Aatru Medical Announces FDA Clearance and Commercial Launch of the NPSIMS™

 Aatru Medical, LLC (“Aatru”) today announced U.S. Food and Drug Administration (FDA) 510(k) Class II clearance of the NPSIMS™ Negative Pressure Surgical Incision Management System.

The NPSIMS utilizes an innovative mode-of-action that eliminates the expensive electro-mechanical pump, battery, and electronics found in most other negative pressure wound therapy (NPWT) systems being deployed for closed surgical incision applications. The single-use, disposable NPSIMS is easily activated and operates silently during therapy delivery. A patented preassembled dressing provides ease-of-application with exceptional “sealing” capability while providing patient comfort and ergonometric appeal.

The FDA effort was led by Aatru President and Board member Edward Armstrong who leveraged his extensive professional prior experience with NPWT and medical device companies. “This innovative NPWT technology allows the NPSIMS product to provide clinical, patient and economic benefits in an elegant presentation, which we look forward to making available to users in the near future,” said Mr. Armstrong.

“In spite of the significant challenges posed by the global pandemic, the Aatru team with the support of our regulatory partners successfully received FDA Class II clearance for the NPSIMS. We believe that we are now well-positioned to commercially launch in multiple countries that have expressed immediate interest in our NPWT platform. We have filed more than 60 patents globally to protect our innovative technology, and we have identified manufacturing partners who can immediately scale to meet global demand,” said Aatru’s CEO and Chairman, Timothy Wojciechowski.

About NPWT for closed surgical incisions:

Several post-operative wound complications are common following surgical procedures. Negative pressure wound therapy (NPWT) is well recognized for the management of open wounds, and in the last several years has been applied to closed surgical incisions. Compared with standard postoperative dressings, NPWT significantly reduces the rate of wound infection and seroma. The global market opportunity for NPWT in the closed surgical incision market is approximately $12B annually with low single-digit market penetration to date.

About Aatru Medical:

Aatru is a privately held medical device technology company focused on disrupting the surgical incision market with its NPSIMS, a simple, disposable, single-use, patented, low-cost NPWT device, uniquely designed to require no electromechanical pump, battery or canister.

An introductory video of the NPSIMS product can be found on the Aatru Medical, LLC website: www.aatru.com.

Contact: Tom Lash

Aatru Medical, LLC Chief Operating Officer

216-303-6063

tlash@aatru.com

Aatru Medical, LLC

Tom Lash

216-303-6063

www.aatru.com

ContactContact

Categories

  • Licensing
  • Medical & Health
  • Medical Products
  • Plastic Surgery
  • Surgery