Colorado-based BioFusionary, a medical technology company focused on developing a proprietary electromagnetic induction platform with aesthetic and surgical applications, has entered into an agreement under which BioFusionary will merge with Australia-based Continuation Investments in an all-stock transaction.
Continuation Investments will conduct a minimum $5 million capital fund raise. Proceeds will be used to manufacture and market BioFusionary's flagship product BioFusionary Bebe in the U.S. The company's operations will remain in the U.S.
The BioFusionary Bebe received 510(K) clearance from the FDA on March 10. The device uses high frequency electromagnetic induction (EMI) to generate deep heat within body tissues and is indicated for the treatment of medical conditions such as relief of pain, muscle spasms and joint contractures.
The BioFusionary Bebe is a non-invasive system intended for use in medical settings. Evidence suggests the device creates heat in the dermal plane, a one-to-four millimeter thin layer of tissue rich in collagen structural fibers. BioFusionary scientists believe the heat and subsequent cooling cause collagen and other tissue proteins to re-associate and entangle, which appears as tightening and improved appearance of the skin surface. In clinical studies, the initial tightening occurred almost immediately with continued improvement weeks later.
BioFusionary recently entered into a manufacturing agreement with a U.S.-based specialty medical device manufacturer to produce the BioFusionary Bebe. The company will focus on a targeted local launch in select U.S. cities in the fall of 2014 prior to a worldwide launch in 2015.