WHEAT RIDGE, Colo., July 29, 2014 /PRNewswire/ -- The BioFusionary Corporation, Inc. (TBC), a medical technology company focused on developing a proprietary electromagnetic induction platform with aesthetic and surgical applications, today announced it entered into an agreement under which TBC will merge with Australia-based Continuation Investments Limited (COT) in an all-stock transaction.
Upon completion of the transaction, the Company will initially trade on the Australian Stock Exchange under the code COT. Concurrent with the execution of the agreement, COT will conduct a minimum $A5.0 million capital fund raise. Proceeds will be used to manufacture and market TBC's flagship product, the 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 U.S. Food and Drug Administration (FDA) on 10 March 2014. 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 that the device creates heat in the dermal plane, a one-to-four mm thin layer of tissue rich in collagen structural fibers. TBC 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.
TBC 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.
"This is a tremendously exciting time to bring a new technology to the U.S. market. We're confident our collaboration with Continuation Investments Ltd will support our robust clinical program and ambitious commercial growth plans," said Damon Cox, TBC's President and Chief Executive Officer. "We're encouraged by the strong reception we've received from the medical community here as well as from potential global business collaborators."
Cox was named president and CEO of TBC in April 2014 following two years at Pinnacle Life Sciences, an independent consultancy he founded and directed. Prior to that, he was involved in the commercialization of several multi-million dollar products with leading Fortune 500 public and private companies. Cox brings an extensive history of contracting, pricing negotiating and policy development to his new role at TBC. Cox additionally served as an U.S. Army officer in the elite 82nd Airborne and as a Ranger Company Commander.
TBC Chairman Kevin Marchitto, PhD and TBC Director Stephen Flock, PhD are co-founders of the Company and co-inventors of the Company's technology. They have co-authored 28 issued patents with more than 20 patents pending. TBC holds multi-jurisdictional patents and patent applications to protect its core intellectual property covering its EMI technology platform and other novel products.
About The BioFusionary Corporation, Inc.
TBC has a product pipeline based on its proprietary EMI technology. Potential follow-on applications for the BioFusionary technology include use in urinary incontinence and cartilage reshaping. Pre-clinical research suggests the technology may be efficacious in tightening ligaments in the pelvic region and intestinal track as well as in cartilage reshaping for individuals with airway blockage (e.g., deviated septum, stenotic trachea) and for ear and nose reconstructions. Additionally, TBC has developed a curable synthetic medical adhesive based on elastic polymers. The adhesive, which is "cured" using TBC's EMI technology, has potential surgical applications such as sealing lung tissue after resection and wound closure in soft tissues.
This information includes "forward-looking statements" of The BioFusionary Corporation ("TBC") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this information that address activities, events or developments TBC believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors TBC believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond TBC's control. Investors are cautioned any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to obtain further FDA clearances or approvals, obtain CE Marking, cost effectively manufacture and generate revenues from the BioFusionary Bebe at a profitable price point, execute agreements required to successfully advance the Company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, TBC does not intend (and is not obligated) to update publicly any forward-looking statements.
|SOURCE The BioFusionary Corporation, Inc.|
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