Alsius Corporation: Change Takes Time
Medical Products
Written by Amanda Gaines   
Thursday, 31 January 2008
Alsius Corporation: Change Takes Time - Medical Devices - Health Solutions - RedCoat Publishing
This medical device company is changing the healthcare industry one hospital at a time.

In the medical device development industry, patience is a virtue. The birth of the X-ray, for example, began roughly 115 years ago and continues to advance. A similar spirit of continuing innovation lies in California-based Alsius Corporation. The venture capital-backed medical device company is responsible for the development and introduction of CoolGard 3000, a thermal regulation system reliant on temperature to produce desired results in critically ill patients.

Alsius Corporation: Change Takes Time - Medical Devices - Health Solutions - RedCoat Publishing
Bill Worthen, President and CEO
The company began with a focus in brain preservation and neurological protection, performing early stage clinical trials on patients with brain injuries. “Early on in the life cycle of the company, temperature as a key vital sign in very sick patients hit our radar screen,” said Bill Worthen, Alsius’ president and CEO since 1997. “As a result, we made a decision at the board level to reposition the company’s technological focus.”

Building momentum
Momentum has been building surrounding the importance of temperature and intervention based on patient temperature has been seen throughout the medical community for the past 10 to 15 years. After streamlining its vision in 1999, the management team at Alsius recognized a void in the technology available to manage patients’ temperature in critical care settings. “We stepped in and developed the CoolGard 3000 and the catheters that go with it. We now have the best temperature management system available.”

But Alsius did not develop the technology alone. In 1998, the European Union financed a trial to induce hypothermia in cardiac arrest patients for a group of unaffiliated physicians. Then, in 2003, the first randomized control trial in critically ill or neurological patients for fever reduction and maintaining “normal” thermia was completed stateside in top US healthcare centers, such as the University of Pittsburgh and UCLA. The combined success of these two trials transformed into the leading instrument in Alsius’ success.

The company initially focused on fever control in the neurological market, including patients with strokes and head traumas. Soon thereafter, it expanded to cardiac arrest patients, and within the past 12 months has expanded even further to include the benefits of for cardiac surgery patients. Earlier this year, NFL player Kevin Everett of the Buffalo Bills broke his neck during a game and was successfully treated with Alsius’ CoolGard 3000 product. His original prognosis was paralysis. But although the importance of temperature control gained a lot of media attention with the spinal cord injury, the company’s main focus continues to be brain-injured patients.

Market development mode
The benefits of thermal regulation in healing critically ill patients are clear, but presenting a new product to an overworked industry is challenging. Alsius is currently in market development mode, said Worthen, which means raising awareness of the product and its benefits. But raising awareness is only one piece of the puzzle. The next step is instigating the needed changes within the customer hospitals.

Alsius Corporation: Change Takes Time - Medical Devices - Health Solutions - RedCoat Publishing
“When doctors and nurses are introduced to a new product such as ours, it requires change within the hospital,” Worthen said. “They have to make a commitment to adopt the technology, and change takes time. These are busy people.”

Because the CoolGard 3000 product is so new (having gone through its final FDA approval clearance in late 2005), hospitals typically won’t have a budget for Alsius. But by following industry standard procedures for introducing a new product, including presenting specification sheets on performance, allowing physicians to take the equipment for a “test drive,” and having a solidly developed sales strategy, the company is seeing organic growth.


In 2006, Alsius sold roughly $5.9 million in products, and Worthen estimates a figure of between $8.5 million and $9.5 million for 2007. Of the 1,600 Level I, II, and III trauma centers and small community hospitals in the US handling patients who would most benefit from the CoolGard line of products, Alsius is in 100. But, said Worthen, that number only reflects the number of facilities, not the departments therein.

“One of our client hospitals has 10 of our systems. For cardiac arrest patients, CoolGard is in the coronary care unit. For neuro patients, it’s the neuro-ICU. Many times EDs have our equipment so they can induce cooling right away. If the cardiac surgery division takes off in the way we anticipate, we’ll also be in ORs.”

Focused execution
Right now, Alsius is in an execution phase. With a need to ramp up its manufacturing capabilities while maintaining consistent quality and reliable products, internal growth is also needed. And that is only on the current product supply side. As for new product development, Worthen is keeping mum about what is in the works but knows the company will continue in the same innovative footsteps that got it to the point it’s at today.

“It makes sense to look at synergistic technologies,” he said. “From time to time, that’s normal. But right now, we’re focused on execution and getting our products into the hands of the doctors and nurses that treat patients.”

 
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