Harvey Homan, president and CEO of medical device company Urovalve, says that the best way for an early stage medical device company to obtain funding is to “turn over every stone possible.”

Urovalve’s product, a remote-activated intra-urethral catheter for men who suffer urinary retention, was developed by an engineer working in his basement after he broke his back in 1986. By 2003, when Homan joined the company, it had a lab prototype, and exactly two years later the company had completed its first in-man clinical study. Urovalve (www.urovalve.com) is housed in the NJIT Economic Development Enterprise Center in Newark.

Homan speaks at the Life Science Business Development Forum of the New Jersey Technology Council’s Life Sciences Network on Wednesday, June 28, at 2 p.m. at University Heights in Newark. The forum’s purpose is to bring together New Jersey life science companies and interested corporate development and licensing professionals, researchers, and investors. Register at www.njtc.org or call 856-787-9700 for more information.

Holman is now busy following his own funding advice. He has taken the company through the present with initial funding of about $1 million from private investors and a National Institutes of Health grant. Recently Urovalve received an Incubator Seed Fund Grant from the New Jersey Commission on Science and Technology, and the company is in the final stages of due diligence for a Techniuum loan for early-stage technology businesses from the New Jersey Economic Development Authority. Urovalve has also received a commitment for a grant from the Ontario Neurotrauma Foundation to fund a clinical study.

One funding strategy Homan uses is presentations about Urovalve at select meetings with investors, like the recent Biotechnology Industry Organization’s Venture Forum. He then follows up through contacts and networking in order to “identify investors who are interested in early-stage medical device companies.”

Homan 20 years of experience in large pharmaceuticals to Urovalve. He worked at Sterling Pharmaceuticals for 13 years, and spent seven years at Boots company in England. When he left Boots in 2000 and returned to the United States, he decided he wanted to work in early-stage companies and was hired as CEO for Linguagen, a Cranbury-based company that discovers and develops flavor modifiers and sweeteners for pharmaceuticals, foods, and beverages. Homan’s academic credentials include a B.A. in biology from the University of Buffalo, an M.A. in biology from Hofstra University, an MBA in marketing from the Stern School at NYU, and a Ph.D. in pharmacology from the University of Georgia.

Urovalve is currently working on some design refinements to address needs identified in the clinical study. The company is aiming to complete the regulatory process and get 510k device approval in time to launch by the end of 2007.

Urovalve believes that its product is unique, and a vast improvement over current devices. On its website, it states that “simple, low-cost valves have been developed that can be activated remotely by a user to self-regulate flow. Proprietary catheters have been developed to retain a valve in place, without exposure to the external environment, and introducers and extractors have been developed to enable easy and rapid placement without the need for surgery.

“A valved-catheter has been developed that will free users from reliance on a Foley catheter and bag, frequent intermittent catheterization, or surgery followed by need for a condom catheter. These low-technology devices limit activities, impose dependence on others, damage the self-image of users, and cause a high incidence of serious urinary tract infections. Catheter-associated UTIs affect approximately 840,000 U. S. patients annually and cost approximately $1,300 to test and treat each catheter-associated UTI.

“At the other end of the spectrum are very expensive, high technology devices, such as the nerve stimulator or the artificial sphincter that require irreversible, extensive surgery. No devices currently available or known to be in development combine the utility, ease of use, and cost benefits of the valved-catheter that has been developed and patented by Urovalve.”

The device that Urovalve is developing could have wide application, and could, therefore, be an important part of a larger company’s product portfolio. The goal, says Homan, is to develop into an attractive acquisition for Bard or another large medical device company active in the urology field. “We anticipate a fairly short period of staying independent,” he says, “less than five years.”

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