Enivo pilot clinical study shows promise for reducing mastectomy complications

AROA’s Enivo system shows promise in management of dead space following mastectomy
All enrolled patients so far have successfully undergone a unilateral mastectomy and follow-up, with no major complications
Hopes Enivo could pave way for new standard of care in wide range of surgeries where managing dead space is difficult

 

Special Report: Aroa Biosurgery’s Enivo system may reduce secondary complications in mastectomies, with positive results emerging from its pilot clinical trial of the device showing promise in the all-important management of dead space.

Soft tissue repair company Aroa Biosurgery (ASX:ARX) has announced the first clinical study of its trademarked Enivo system is showing encouraging results in the management of dead space after a mastectomy.

To date, six patients have undergone unilateral mastectomy surgery and had the device implanted during the trial, which began in Auckland in July 2023.

ARX says the study has grown to incorporate an additional research location in Whangarei, New Zealand, with 10 patients expected to be rolled across both sides.

In medical terms, dead space refers to the open space created by surgical separation or excision of soft tissue.

It can lead to a range of secondary complications, such as seromas and haematomas.

A seroma is an accumulation of fluid that can lead to infection, discomfort, unsatisfactory cosmetic results and prolonged hospital stays.

ARX says seromas are the most frequent complication that arises after a mastectomy surgery.

 

Managing the problem of dead space

ARX says, at present, to control dead space and avert fluid build-up, surgeons must employ methods such as surgical drains, adhesives or quilting stitches.

However, these approaches can often be inconsistent, and the persistence of post-surgical complications remains a substantial issue.

The Enivo system – developed by ARX – applies vacuum pressure to a surgical site to eliminate surgical dead space and reduce fluid accumulation following surgery.

 

Focus on trauma, cancer surgery and complex wounds

ARX was founded in 2008 by its CEO and veterinarian Dr Brian Ward following his discovery that the extracellular matrix (ECM) – a tissue scaffold located in the forestomach of sheep – not only closely mimics human tissue structure, but also contains over 150 essential proteins vital for healing.

Headquartered in New Zealand, ARX made its debut on the ASX in July 2020 and stands as part of a small group of Australian-listed soft tissue repair companies, alongside Polynovo (ASX:PNV) and Avita Medical (ASX:AVH).

The company’s flagship product, AROA ECM, is a proprietary extracellular matrix biomaterial.

It comprises a complex assortment of biological molecules, serving as the foundational element for ARX’s variety of soft tissue repair products, including the Enivo System.

The company focuses on trauma, post-cancer surgery and chronic complex wounds.

In October 2023, ARX announced a new study highlighting positive outcomes using Myriad Matrix and Myriad Morcells in complex traumatic wounds.

The peer reviewed study was published in the September issue of leading industry journals ePlasty and outlines the clinical effectiveness of Myriad Matrix and Myriad Morcells in complex traumatic wound reconstruction procedures.

 

‘New standard of care in a wide range of surgeries’ 

Ward says the results emerging from the Enivo study were very encouraging.

“We have now treated six patients and overall, we are very pleased with the way the device has functioned, with no breast seromas forming,” he says.

“We are hopeful that Enivo could pave the way for a new standard of care in a wide range of surgeries where managing dead space is difficult and subsequent complications may lead to poor outcomes for patients and higher treatment costs.”

Leading the study, Associate Professor Michelle Locke says she hopes the study makes a real difference to breast cancer patients.

“I am delighted to be involved in the Enivo clinical study, and hopeful that this innovation will make a real difference to patient outcomes,” she says.

 

 

This article was developed in collaboration with Aroa Biosurgery, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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