CHARLESTON -- During his career as a cardiovascular surgeon, Dr. Mark Bates has encountered a lot of problems for which there was no readily available solution.
Instead of waiting for somebody else to develop answers to those problems, Bates took it upon himself to do so.
"He put pen to paper and came up with a solution," said Gardiner Smith, president of Paragon Intellectual Properties LLC, a Charleston-based firm that designs medical devices.
Bates started the company in 2004, and after years of research and development, it nearly is ready to start marketing its products.
At the time he founded the company, Bates already had several patents to his name and was a "prolific inventor of devices," most of which are related to coronary procedures, Smith said.
"He wanted to base a medical technology company in West Virginia," Smith said. "He felt that he could add value to (other patents) through medical testing procedures."
Today, Paragon has seven portfolio companies. Each one focuses on developing a specific medical device.
Early Research
The first project undertaken by Paragon was designing and developing a hybrid stent for peripheral and carotid applications, Smith said. The job of developing the stent belongs to Biflex Hybrid Stent Systems LLC, one of Paragon's portfolio companies.
The new stent is unique in two ways, he said. First, it is an ultra-low profile device designed to be less invasive. The stent also is easier to use and requires fewer steps to deploy. As a result, patients and doctors are exposed to radiation for less time.
In addition to the stent being less invasive, it also is more accurate, Smith said.
The second way in which the stent is unique is that it has a biological coating, which was developed by another Paragon company, Apollo Therapeutics LLC.
"There is a very thin coating of collagen on the metal of the stent," Smith said.
The biological coating helps prevent restenosis, in which the artery becomes inflamed around a stent, causing it to become restricted once again, he said. Some other stents are coated with drugs that prevent restenosis, but they also can prevent healing. The Biflex and Apollo stent does not have that disadvantage, Smith said.
The new stent was developed and tested at Paragon's Innovation Center laboratory in Carlsbad, Calif., Smith said. Company officials plan to begin human testing soon.
"We will begin testing on humans in the spring of 2008 in Europe, followed by trials in the U.S. in 2009 or 2010," he said. "Then we'll apply for marketing approval in Europe and the U.S."
Other Devices
But the stent is only the beginning, Smith said. Paragon's other companies are working on other innovative devices.
- Global Stem Cell Solutions LLC is developing a system to evenly distribute stem cells and other biological materials into organs. Smith said the company is three to four years away from marketing the project.
- Nanotechnology has opened doors in a number of fields. Nanotech Catheter Solutions LLC hopes to use the microscopic technology to produce smaller catheters and other less invasive medical devices. As promising as the technology is, it also is new. Paragon does not expect it will be ready for another five or six years.
- Renal artery atherosclerosis is a condition normally treated with a complicated angioplasty procedure. Renal Protection Solutions LLC is developing new methods for treating the condition.
- Patients with spinal cord injuries might some day benefit from the work conducted by Spinal Cord Injury Solutions LLC. That Paragon company is developing a phased array cell delivery platform designed to promote long-term cell growth.
- One problem with some types of drug treatments is that healthy cells are adversely affected by medication. Temporary Intravascular Drug Delivery Systems LLC, however, is working on a device that will precisely target medicines to sick cells. Called a "drug cage," it is expected to be ready for marketing in three to four years.
For now, Paragon will focus on the seven portfolio companies it has, Smith said.
Patience Required
Investing in a life sciences company is not for the impatient, Smith said.
"Life sciences startup companies have a longer development cycle," he said. "The reward can be high sales."
Because of the long initial phase, life sciences startups typically receive a period of patent protection during which only they can sell the new product, Smith said. Paragon will have patent protection for 15 years starting when the patent is granted, he said. After that period, other medical device manufacturers may sell products based on the patent.
Just getting to the selling phase, however, takes time and patience, he said. Investors looking for fast returns on their investments might not be suited for the life sciences sector.
Smith, who has been with Paragon for about one year, has a background in senior management for biopharmaceutical companies. He is confident in Paragon because of the leadership team. The company has a diverse board of directors and, although it is a relatively new company, experienced department leaders.
As Paragon prepares to expand into marketing its first product, it will expand, Smith said. Company officials have no plans for moving the headquarters from Charleston as it grows.
"It's very easy to do business here on a global scale," Smith said. "With the Internet, air travel ... I believe West Virginia can compete in global business."