Clinical Evaluation conducted in partnership with Regional One Health’s Center for Innovation featured in Wounds, a leading clinical journal

Feb 14, 2023

The Healthcare Startup Access Incubator at Regional One Health’s Center for Innovation is designed to help inventors evaluate their medical innovations in a real-world setting.

One of those clinical evaluations, of a new Manuka honey-based wound care product, is now published in the journal Wounds.

Wounds shares how the product, created by SweetBio, Inc., helps stubborn wounds heal more quickly compared to standard procedures.

In 2019, the Regional One Health Center for Innovation’s Healthcare Startup Access Incubator partnered with Memphis-based medical device company SweetBio, Inc. to evaluate APIS, SweetBio’s Manuka honey-based wound care product. Now, the clinical case summary has been published in a leading clinical journal.

Wounds, the most widely read, peer-reviewed journal focusing on wound care and research, features results and observations regarding APIS’ ability to improve wound closure.

The Center for Innovation was created to help health care innovators and entrepreneurs validate new ideas at Regional One Health in hopes of improving health care outcomes and experiences for patients here and all over the world. Alejandra Alvarez, Center for Innovation director, said it is exciting to share results from the center’s work in a major publication.

“We are not only helping a company validate their business model or clinical use case and giving our community access to the latest technological advancements in wound care, but now we get to share it with a much larger audience, advancing health and wellbeing of people across the nation and, maybe, globally!” Alvarez said.

The APIS evaluation was led by providers in Regional One Health’s Wound Care Center, which uses state-of-the-art therapies and whole-person care to help heal stubborn wounds.

Providers there were trained to use APIS, an FDA-cleared product that harnesses the healing properties of Manuka honey in a membrane that can be applied to wounds in clinical settings.

Eligible patients were required to be at least 18 years old with a type 1 or 2 diabetes diagnosis. They had to be ambulatory and have adequate circulation, and their wounds had to be non-healing, have a surface area of 9 centimeters or less, and show no clinical signs of an infection.

Over the course of the evaluation, providers identified 43 patients and 47 wounds, including diabetic foot ulcers, pressure wounds and venous leg ulcers.

To create a control group, they used standard care to treat 20 of the wounds. Then, they used the APIS membrane to treat the other 27.

In the end, the average time of closure for wounds that healed with the APIS product was twice as fast – 7.4 weeks compared to 14.8 weeks with standard care.

In one case, a patient even served as their own control – they presented with diabetic ulcers on each foot, and one was treated with standard procedures and the other with APIS. After six weeks, the foot treated with APIS healed, while the other did not. Physicians then used the APIS product on the unhealed wound, and it closed after another two weeks.

The findings confirm previous studies of APIS, which showed its ability to heal wounds in 4-6 weeks. The report notes the clinical evaluation done at Regional One Health was specifically designed to challenge the product by using it in an urban hospital setting where patients may face difficulties accessing comprehensive care and complying with wound care guidelines.

To that end, the analysis also documented patient compliance issues like missing appointments, poor diet, and failing to rest the area of the wound. It found that noncompliance was the top reason patients’ wounds did not heal, followed by challenges posed by other comorbidities.

Read the full publication here: 

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