BioMed speeds commercialization process

BOULDER – Boulder BioMed LLC accelerates the commercialization of innovative technologies and spins them off to larger companies.

Jim Kasic and the anonymous angel investors who recently formed the venture hope to help make Colorado a hotbed for the medical device industry.

“Inventors often don’t know how to commercialize their technologies,” Kasic noted. “They may have a platform, but they haven’t identified a market. The temptation is to try to solve lots of problems poorly instead of solving one problem well.”

SPONSORED CONTENT

Select your Republic Services residential cart now!

In preparation for Republic Services becoming the primary provider of residential recycling, yard trimmings, and trash, residents should now select the best cart size and service schedule for their household needs.

Boulder BioMed, like an incubator, is “a warm, fuzzy place where businesses go to find direction,” Kasic said. It accelerates the commercialization process by applying two principles: planning and focus.

Established in late 2009, the company has earned about half a million dollars so far. Kasic expects annual revenue of $5 million within three years.

In considering a technology, he said, “We look first of all for novel approaches to a treatment regimen. We also want to be able to define a clear market niche.” Boulder BioMed emphasizes devices that aim for class 2 ranking by the U.S. Food and Drug Administration. “It’s easier to get them to market,” Kasic explained.

A device’s intended use and the risk to patients determine its FDA ranking. Elastic bandages fall into class 1 while implantable pacemakers are in class 3.

Boulder BioMed hopes to tap funds available through the recently launched Colorado Institute for Drug, Device and Diagnostic Development, a nonprofit devoted to bridging the gap between laboratory science and commercialization. Another possibility is venture capital firms, which the PricewaterhouseCoopers MoneyTree report said invested $2.5 billion in the U.S. medical device industry during 2009. Kasic also expects to enter development agreements with larger medical device companies.

Currently, Boulder BioMed’s primary client or “daughter company” is Sophono Inc. Kasic is president and chief executive of both firms.

In April, Sophono’s Alpha 1 magnetic bone-anchored hearing device earned the CE mark, a consumer health and safety requirement in European markets. The product, which is suitable for those not helped by in-the-ear or behind-the-ear hearing aids, has already been surgically implanted in about 100 patients ranging in age from five to 65. It is available in Germany, Switzerland, the Netherlands, the United Kingdom and Russia.

FDA approval for the device is pending. “We’re close,” Kasic said. “They just have a few more questions.”

Vancouver, B.C.-based iData Research expects bone-anchored hearing devices to be the fastest growing segment of the U.S. hearing aid industry, achieving a tenfold increase by 2016. In a statement announcing its findings, iData CEO Kamran Zamanian said, “Bone-anchored-hearing-aids created a treatment option for a portion of the hearing impaired population who could not be treated with standard hearing aids. Because there are hundreds of thousands of untreated patients market growth will be rapid.”

Kasic is more conservative. He projects that the market will double during the next five or six years.

Once the Alpha 1 achieves FDA approval, Sophono plans to shift manufacturing operations from Germany to Colorado, creating new jobs in production, assembly, quality control, research and development, administration, marketing and sales management. It plans to have 20 to 30 employees by the end of 2011.

Boulder BioMed is negotiating agreements that cover four other new technologies: a treatment for obesity, an orthopedic device, a urinary catheter and a respiratory device. “The fundamentals of product development are the same across different biomedical areas,” Kasic noted.

In Colorado, the medical device and instrument segment has more employees than pharmaceuticals and biotechnology, 9,480 versus 5,610. According to the Metro Denver Economic Development Corp.’s 2010 Bioscience Industry Cluster profile, most of the 270 medical device companies in the nine-county Metro Denver and Northern Colorado region employ fewer than 10 people each.

The region ranks 11th among the 50-largest metropolitan areas for jobs in the medical device and instrument industry. It saw employment increase by 5.3 percent per year between 2004 and 2009. Nationally, the growth rate was 4.6 percent.

Boulder BioMed, which currently has three employees and operates from a shared office, expects to expand its local staff by the end of the year. Likely hires include experts in engineering, manufacturing, quality, sales and marketing. “We look for depth and breadth of knowledge,” Kasic said, “and the ability to transfer that knowledge to different technologies.” He expects BioMed employees to “drift in and out of ‘daughter’ companies.”

By summer, Boulder BioMed will probably be in the market for larger quarters. “We want to stay within a mile of our current location,” Kasic said. “Boulder has an abundance of talent.”