HOLLISTON, Mass., Nov. 30, 2015 /PRNewswire/ -- Harvard Apparatus Regenerative Technology, Inc. (HART) (Nasdaq: HART), a biotechnology company developing bioengineered organ implants for life-threatening conditions, today announced it has received written notification from The NASDAQ Stock Market that it has regained compliance with the minimum bid price requirements. The letter noted that as a result of the closing bid price of HART's common stock having exceeded $1.00 per share for more than ten consecutive business days, the company has regained compliance and the matter is now closed.
HART's CEO, Jim McGorry, commented, "Maintaining our NASDAQ listing is fundamental to our corporate strategy. We are gratified by the investment community's response to our recent progress, including the positive animal research results on HART's second generation (Gen2) bioengineered esophageal, tracheal and bronchial implants."
Mr. McGorry continued, "Going forward, our development plan is focused on getting our technology back into humans on a compassionate use basis and filing our first clinical trial application with the FDA during 2016. We are confident that we will meet these goals given the results of our recent studies using our Gen2 technology across all three applications, our strong scientific team and our collaborations with translational partners. We have initiated confirmatory large-animal studies of our Gen2 implants with Mayo Clinic. The study design has been completed, prerequisite tests are underway, and we expect the animal surgeries to occur in December."
About HART (www.hartregen.com)
Harvard Apparatus Regenerative Technology (HART) makes bioengineered organ implants for life-threatening conditions. Our technology platform is to be used to restore function in the esophagus and the airways (trachea and bronchus). HART is completing further large-animal studies to refine our technology platform with the goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in 2016, seeking to initiate clinical trials for one of our three product candidates. Our first-generation trachea technology was used in five adult human trachea transplants approved under compassionate use exemptions, but none of our products are yet approved for marketing by a government regulatory authority.
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any HART products by the FDA, EMA, MHRA or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of HART products, including those pertaining to the airway or esophagus, which such success may not be achieved or obtained on a timely basis or at all . These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the our implant products, bioreactors, scaffolds and other devices and product candidates we pursue; plus other factors described under the heading "Item 1A. Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor and Media Contact:
David Collins, Tanya Kamatu
212 924 9800
SOURCE Harvard Apparatus Regenerative Technology, Inc.