Aytu Bioscience Inc (NASDAQ:AYTU) has seen a severe slump in price over the last few days, even as the company continues to inch closer to full acceptance of its MiOXSYS system. AYTU is down over 25% for the last five sessions and volume is cresting above 4M for the last 10 days.
The drivers in this action has come from a number of different news updates, but, overall, AYTU’s product offering just continues to inch closer to industry acceptance. The main product from AYTU is its male infertility offering, the aforementioned MiOXSYS system. The product recently was cleared for use in Mexico and has already been cleared in Canada.
Aytu Bioscience Inc (NASDAQ:AYTU) is a commercial-stage specialty life sciences company focused on global commercialization of novel products in the field of urology, with a focus on products addressing vitality, sexual wellness, and reproductive health. The Company currently markets two prescription products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or ”Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS® is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within growing markets.
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Josh Disbrow, Chief Executive Officer of AYTU, commented, “Regulatory licenses and registrations are critical to our efforts of effectively penetrating these new markets. MiOXSYS continues to gain traction with its international commercial expansion as regulatory bodies, like Mexico’s COFEPRIS, approve the product for clinical use in the assessment of male infertility.”
According to the release, Mexico is one of the top ten largest countries in the world, with a population of over 127 million. Approximately one in six couples suffer from infertility, and almost half of these cases can be attributed to male factor infertility. Male infertility assessment remains a significant area of clinical need around the world.
Mr. Disbrow added, “We recently appointed IMP Medica, headquartered in Mexico City, Mexico, as exclusive distributor of the MiOXSYS System in Mexico. We are pleased to now be able to offer MiOXSYS to clinicians and laboratories throughout Mexico who seek to better identify and treat men with suspected infertility and for which oxidative stress may be implicated.”
Furthermore, AYTU also completed a $12M public offering. The Company intends to use the net proceeds from the offering for sales and marketing expenses to further advance the commercialization of Natesto, and for working capital and general corporate purposes.
Aytu Bioscience Inc (NASDAQ: AYTU) has a market cap of $16.29M and a float of 3.59M. The 10-day volume is above 4M and there is reason to be optimistic for AYTU as the company looks to reverse a rather sour 2017. We will write more updates as news breaks. Sign-up for continuing coverage on shares of $AYTU stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $AYTU, either long or short, and we have not been compensated for this article.