The CEO’s Perspective: SANUWAVE^® Acquires UltraMIST^® System and Licensing Rights for Wound Care Biologics Products

SANUWAVE’s recently completed acquisition (August 2020) of UltraMIST System assets — along with securing premium licensing terms for two important biologics, BIOVANCE^® Human Amniotic Membrane Allograft and Interfyl^® Human Connective Tissue Matrix — further strengthens the SANUWAVE product portfolio. These FDA-cleared additions create a platform of scale with end-to-end product offerings that reimagine the standard of care for advanced wounds.

The SANUWAVE Energy First Approach

It is SANUWAVE’s mission to further what we know to be the best way to treat certain wounds: the Energy First approach. Clinical research has proven that application of energy modalities — as a line of treatment before introducing biologics — improves patient outcomes.

UltraMIST therapy delivers low frequency ultrasound energy to the treatment site using a noncontact fluid (e.g., saline). This low energy ultrasound-generated mist promotes wound healing. In fact, in a meta-analysis of preclinical and clinical evidence* for advanced wound closure, UltraMIST therapy achieved an 85% area reduction in seven weeks across a wide range of chronic and acute wounds.

UltraMIST Acquisition: An Overview

Fundamentally, the immediate impact of the UltraMIST System acquisition for SANUWAVE:

• Broadens our wound care platform with a noncontact ultrasound device that is complementary to SANUWAVE’s high-energy dermaPACE^® System.
• Contributes to end-to-end wound care offerings that address the entire care pathway for advanced wounds through wound closure.

In short, the combination of SANUWAVE’s dermaPACE System and UltraMIST System creates a market-leading wound care solution likely to improve clinical outcomes across the continuum of care.

Let’s drill down a bit and explain why we found this acquisition to be such a compelling opportunity and why we’re so excited about it going forward.

As we reviewed UltraMIST therapy capabilities, it seemed likely that combining them with those of SANUWAVE’s dermaPACE System would result in significant therapeutic synergies. We felt that the sum could be significantly more powerful, resulting in greater combined efficacy than either of the technologies on their own. Together, they:

• Uniquely position SANUWAVE to address the entire wound care patient pathway from the initial stages of treatment for advanced wounds to closure.
• May result in improved patient outcomes via the treatment combination of UltraMIST and dermaPACE, compared with the current standard of care, in wound indications such as diabetic foot ulcers (DFUs).

Biologics Licensed Additions: BIOVANCE and Interfyl

Helping to complete our end-to-end solution, BIOVANCE and Interfyl biologics offer advanced and differentiated treatment options when used in conjunction with SANUWAVE’s Energy First approach:

BIOVANCE Human Amniotic Membrane Allograft

• Provides a natural foundation for wound healing
• Enables key cells and proteins to move into the BIOVANCE material, promoting tissue regeneration
• Serves as intact extracellular matrix required for appropriate healing

Interfyl Human Connective Tissue Matrix

• Replaces damaged integumental soft tissue
• Augments/supplements inadequate connective tissue
• Repairs small surgical defects including exposed vital structures (e.g., bone, tendon, ligament, or nerve)

A Giant Step for SANUWAVE

SANUWAVE’s acquisition of the UltraMIST System and the licensing rights for biologics, BIOVANCE and Interfyl, mark a new chapter in our company’s mission and growth. As we evolve from our position of initial strength as a medical device company with FDA-cleared wound care products, such as dermaPACE, we now move forward with a portfolio of assets that position us to provide care for patients with advanced wounds all the way to wound closure and healing.

This is a transformative event for SANUWAVE, and we look forward to sharing our progress as we execute our industry vision: the Energy First approach.

*Data was compiled utilizing MIST System Therapy. The UltraMIST System is the successor, but maintains the same mechanism of action. For more, see our clinical summary.

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