Entry into the med-tech industry was neither simple nor easy for former Navy Seal and current CEO of Biomagnetics Diagnostics (San Francisco) Clayton Hardman.
"While I was in service I saw so much pain," Hardman told Medical Device Daily. "Once I got out of the military I knew that I wanted to do something productive and something that would do some good."
Hardman would use his experience and personal finances to help develop devices in the diagnostics sector. One of his first attempts was in the late 90s and came to a halt almost immediately after it was initiated.
"It was an assay and it didn't work," he told MDD. "We never really found out why."
Hardman went on to say that he lost quite a bit of money from the assay, which he appropriated from another company at the time. The move forced him to put the company on the backburner until 2006.
"We found that we needed to have more user-friendly diagnostics that were more cost effective," he said.
Now the company is poised to launch a new assay called Integrated Optical Biosensor – or IOB for short. It entered into an agreement with the Los Alamos National Laboratory (Los Alamos, New Mexico) to develop the test, which is designed to quickly detect multiple viruses or diseases at any given time (Medical Device Daily, Dec. 7, 2009). The test is aimed more at developing countries than the U.S. Hardman said.
"IOB will allow us to do half a dozen tests with one sample," Hardman told MDD. "We can test for Malaria, HIV... and we can get the results back fairly quickly."
Hardman says that plans have changed somewhat for the test.
The company's initial strategy was to fully produce the handheld version of the IOBS platform and to then use that platform to develop all of the many different types of pathogen testing assay cartridges.
By taking a slightly different direction and developing desktop versions of the IOBS platform, which can be produced more quickly, the company will now be able to develop the single test assay cartridges for malaria, cholera, human tuberculosis, bovine tuberculosis and HIV/AIDS in parallel to the production of the handheld units.
Biomagnetic Diagnostics said that this approach will significantly reduce time-to-market and make the technology available to the world much sooner. The company said this move will also allow it to accelerate its revenue growth rate.
"It is important for us to accelerate assay test cartridge development as we are currently scheduling our malaria clinical trial with one of the most prestigious malaria research institutions in India with additional trials being organized in Kenya and Mexico," Hardman, said.
He added that the company was "anxious to begin demonstrating this technology in real world settings as we believe we will be able to lower the cost of malaria, tuberculosis, cholera and HIV/AIDS testing to unprecedented levels while at the same time reducing the time it takes to receive results from days or hours to a matter of a few minutes."
"While we believe the production of this device will yield significant returns for our shareholders, and this is clearly an important priority, we have never lost sight of the fact that there are tens of thousands of lives we may be able to save through our important endeavors in this area."
The company recently reported a significant financing to help further develop the product. Late last year, it completed an equity financing with cash commitments of about $1 million from several private investors and a single philanthropic organization (MDD, Oct. 20, 2009).
"We've made a very conscientious effort to keep costs down," he said. "We contract almost everything out and we have three full time positions with several part time positions."
The recent funding provides a much needed break for Hardman, who in the past, almost entirely funded the company.
"I had been funding most of this out of my own pocket," he said. "We put [the company] on the shelf and then brought it back in 2006. But now we're on a pretty [solid path]."
Omar Ford, 404-262-5546;