Eden Prairie, Minnesota-based ProUroCare Medical Inc. is seeking $1 million, according to a filing with the U.S. Securities and Exchange Commission.
ProUroCare has developed an elasticity imaging technology that can be used to document abnormalities of the prostate. The technology would serve as an adjunct to a digital rectal image, the current standard by which prostate health is determined.
The company appears to have raised $100,000 based on the regulatory filing. A call to the Rick Carlson, the company’s CEO, wasn’t immediately returned. According to the company’s website, more than $23 million has been invested in developing the ProUroScan System. The technology was developed in collaboration with Artann Laboratories.
The public company that trades over the counter seems to have run into some trouble in getting market clearance.
An application for a 510(k) clearance was filed back in November 2009. In March 2010, ProUroCare said that a letter from the U.S. Food and Drug Administration said that the agency had not finished reviewing the application because a predicate device could not be identified. A 510(k) application for a new product has to demonstrate substantial equivalence to another product already on the market, known as a predicate.
In May 2010, a de novo application was filed with the FDA. A de novo application asks for market clearance for low-risk devices that have no predicate device in the market. It appears that the FDA has not made a final determination on the fate of the ProUroScan imaging system.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Last July, the company named Larry Getlin, whom a news release described as having 19 years of urology regulatory, clinical affairs, quality and compliance experience, to its board. Getlin, who was already assisting the company as a consultant, was formerly senior vice president of Corporate Compliance, Legal and Quality at American Medical Systems, which has been acquired by Endo Pharmaceuticals.
ProUroCare has no revenue and in 2011 narrowed its loss to $2.1 million from $6 million in the previous year.
An earlier version of the story incorrectly stated that ProUroScan would replace the digital rectal examination to screen men for prostate cancer. ProUroScan is an adjunct to the DRE.
