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Aligning Itself For Success

Founded in 2004 by a Massachusetts transplant, Boulder start-up iBalance Medical recently closed on an initial $4.8 million of an $8.24 million commitment in first-round venture financing.

The company is now ready to move into high gear on its new surgical product and procedure for knee reconstruction that focuses uniquely on treating malalignment of the joint, delaying or eliminating the need for total knee replacement surgery for many patients.

With millions of active people outliving their aging knees, the opportunity for iBalance Medical is significant. The most common threat to mobility for people aged 45 and over is knee osteoarthritis, a degenerative joint disease causing chronic pain and disability to more than 10 million Americans. The primary cause for progressing degeneration is a knee that is unstable and no longer transfers weight bearing forces normally. For many, the standard medical solution to years of wear and tear is total knee replacement surgery, which relieves pain and restores function but permanently restricts the patient's physical activity.

"Orthopedic surgeons know that degeneration worsens over time due to maIalignment of the knee's weight bearing surfaces," says Vince Novak, founder, president and CEO of iBalance Medical. "But the only solution currently available to correct malalignment and delay or avoid total knee replacement is knee osteotomy, which is difficult to perform and has a high rate of complications. We want to supplant knee osteotomy with an improved product and procedure."

The company's proprietary Axial Knee Realignment (AKR) technology consists of a guidance device and an implantable support device. The AKR system will enable surgeons to perform a simple, predictable procedure to achieve precise realignment of the joint, and to maintain the weight bearing surfaces in close contact in their proper alignment to promote regeneration of bone tissue. Patient benefits will include pain relief, restoration of knee function and a return to full physical activity. Improved tissue regeneration minimizes further joint damage.

iBalance Medical's first round of venture capital will fund the engineering and clinical groundwork to gain U.S. Food and Drug Administration (FDA) 510(k) market clearances in 2006. Then, according to Novak, "We plan to clinically validate the AKR procedure through a limited rollout to 12 or 15 surgical centers during 2007, followed by a full U.S. market launch in 2008."

Colorado's bioscience community compares favorably with Massachusetts, says Novak, "I haven't had any problem finding engineers and other folks with the right background. Prototyping costs half what it does in Boston, and office rent is about a third less.

Knowing how difficult it can be to get that first round of venture funding, Novak is grateful for the seed money he received from angel investors Steve Onody of Aurora and Tony Dimun of Short Hills, New Jersey. It's the first $250,000 to $500,000 that's crucial to getting the patent protections, proof-of-concept and initial prototyping you need to attract venture capital," he says. "Lack of seed money is why so many good ideas don't get funded."

First round venture capital for iBalance Medical came from Sutter HilI Ventures and Skyline Venture Partners of Palo Alto, California. With its development capital secured an a huge potential market eager for an alternative to joint replacement surgery, it looks like the stars are perfectly aligned for a bright future for iBalance Medical.

Note: This article is reprinted by permission from the Fall 2005 issue of The CBSA FOCUS newsletter. A link to a pdf of the entire issue is found below.

Malalignment of the joint

AKR implant

FOCUS is published quarterly by the Colorado BioScience Association, 1625 Broadway, Suite 950, Denver, CO 80202, with additional offices at Fitzsimons Bioscience Park and Fort Collins. Denise Brown, executive director. Phone 303-592-4072. A link to the CBSA website is found on the right.

Maggie Chamberlin Holben, owner of this website, is a memver of the Board of Directors for the Colorado BioScience Association and is making this page available to the CBSA to enhance media awareness of the association and its members.
Link to the iBalance Website
E-mail iBalance for Information
Link to the current CBSA Focus newsletter
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Link to a previous feature on PR Pharmaceuticals
Link to a previous feature on McKinley Medical
BIOSCIENCE: Metro Denver Industry Cluster Profile
Link to the Metro Denver EDC Bioscience Overview
Link to Colorado Bioscience Association Website
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