ClarkKant
13年前
New Hires With FDA Approval
Approach to Market Entry
We have delayed the hiring of key staff positions and making certain preparations for market entry prior to FDA approval of the ProUroScan System in order to conserve cash during the prolonged FDA review period. Once we have obtained FDA approval and sufficient funding (see “Management’ Discussion and Analysis”), we plan to take the following actions over the next few months in advance of our product rollout.
· Hire the key staff needed to execute our commercialization plans. We have identified outstanding candidates in the marketing, operations, engineering, and medical reimbursement fields.
· Install ProUroScan Systems in the facilities of approximately six members of our Scientific Advisory Board to begin formal training in the use of the system, and to perform studies. We expect the work done by these respected scientists to provide the important market validation of key opinion leaders that will help facilitate market acceptance.
· Establish the internal quality control systems and capabilities required to enter the highly regulated U.S. medical device market.
ClarkKant
13年前
Testing Done @ Mayo Clinic!
http://ih.advfn.com/p.php?pid=nmona&article=52019521
Plus many other reputable clinics!
Veterans Affairs Medical Center, Minneapolis, MN;
Robert Wood Johnson Medical School Division of Urology, New Brunswick, NJ;
Mayo Clinic, Rochester, MN;
AccuMed Research Associates, Garden City, NY; and
Urological Associates of Lancaster, Lancaster, PA.
ClarkKant
13年前
Manufacturer Already Contracted!
http://www.logicpd.com/
http://ih.advfn.com/p.php?pid=nmona&article=52019521
Manufacturing
We have contracted with Logic PD (Minneapolis, MN), a contract engineering and manufacturing firm that is Quality Systems Regulation (“QSR”) compliant, to initiate production on the first commercial ProUroScan Systems. The QSR requires manufacturers, including certain third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process. Logic has successfully completed pre-production manufacturing of three ProUroScan Systems. The tactile pressure sensors used in the ProUroScan’s probe are supplied by Pressure Profile Systems, Inc. (“PPS”) (Los Angeles, CA), which designs and develops the world’s most advanced tactile pressure measurement systems
Because of the unique nature of the two major proprietary components of the ProUroScan System, it is likely that one or more additional third-party manufacturers will be chosen to assemble the certain components or sub-assemblies. Our goal is to reduce the cost of producing systems over the first two years, taking advantage of manufacturing scale and purchasing discounts, as well as engineering changes designed to eliminate components and reduce component costs.
TKnight28
15年前
A provider of proprietary imaging products, said that it has closed on a $885,000 private placement of debt financing.
According to ProUroCare, the funding was provided by a small group of existing investors closely aligned with the company.
ProUroCare said it will use the proceeds to fund manufacturing and marketing scale-up activities, expand the company's existing intellectual property portfolio and form a scientific advisory board.
It added that a portion of the funding will also be used to pay existing debt obligations and for general corporate purposes.
Company CEO Rick Carlson said, "This additional funding brings the total amount raised by the company since 2007 to more than $9.3 million."
Minnesota-based ProUroCare Medical is engaged in the business of developing innovative medical imaging products. The company's current focus is the ProUroScan prostate imaging system, which is used to document abnormalities of the prostate detected by a Digital Rectal Exam.