Contact: Liz Dowling, (415) 388-2794
Dowling & Dennis PR
CHICAGO, July 28, 2021 /PRNewswire/ — Novian Health Inc. (Novian), a clinical stage medical device company focused on the development of image-guided laser therapy for the focal destruction of malignant and benign breast tumors, announced today the first closing of a private placement financing, raising total proceeds of over $5 million. National Securities Corporation, a B. Riley Financial company, is acting as the exclusive placement agent. Additional closings are anticipated.
The Company generally intends to use the net proceeds of the Offering for general working capital purposes, the initiation of its confirmatory pivotal trial (BR-003) for the evaluation of Novilase® Breast Therapy for the focal destruction of malignant breast tumors (≤15 mm), and initiation of commercialization and post-marketing surveillance in Europe, among other uses. The Company intends to use data from the execution of the BR-003 trial to support a submission to FDA for marketing clearance. In Europe, Novilase has received a CE Mark (approval) for focal destruction of malignant and benign breast tumors, the only ablation device to have this approval.
The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Novian Health Inc.
Novian Health, based in Chicago, is a privately held medical device company with proprietary technology for the focal destruction of tumors using Interstitial Laser Therapy (ILT). The company has developed, tested, and patented a minimally invasive percutaneous procedure that uses controlled heating for the focal destruction of breast tumors as an alternative to lumpectomy.
Novian has received a CE Mark, European approval, for focal destruction of malignant and benign breast tumors. Novilase is the first thermal ablation device with a major market approval for focal destruction of breast cancer. Multicenter clinical trials have been conducted in the U.S. and Europe. FDA-510(k) clearance has been received for the treatment of benign breast tumors and a post-marketing study is collecting outcomes to support reimbursement coverage. FDA has granted an Investigational Device Exemption (IDE) to conduct a confirmatory 510(k) pivotal trial to obtain clearance for focal destruction of malignant breast tumors. It is anticipated that the trial can be completed within two years. For more information on Novian, please visit www.NovianHealth.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Novian cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. These risks include, but are not limited to, risks relating to the timing of the consummation of the private placement and the expected receipt and use of proceeds from the private placement: the timing, costs, conduct, and success of our clinical trial activities for Novilase, including but not limited to the timing, costs, conduct and outcome of our clinical studies; the anticipated treatment of future clinical data by the FDA, or other regulatory authorities, including whether such data will be sufficient for approval; the availability of substantial additional funding for the Company to continue its operations and achieve its goals; the potential impact that COVID-19 variants may have on us, our suppliers, vendors, regulatory agencies, our employees, and the global economy as a whole; and the expected duration over which the Company’s balance will fund us.