SANTA ROSA – Medical-device startup Medlogics has received promising data from the first stage of a post-market study being performed in Europe and South America on its cardiac stent.
The first patient trials of its Cobra bare-metal stent show comparable results to drug-eluting stents in preventing major adverse cardiac events during the first 30 days after implant, the company announced today.
According to Nicholas Chronos, M.D., president and CEO of Saint Joseph’s Translational Research Institute and a Medlogics director, the data represents a potential breakthrough in bare-metal stents and underscores results that had been obtained in animal trials.
“It was surprising then but required confirmation in clinic. So it is that much more exciting now to see these types of clinical outcomes confirm our cautious optimism from the pre-clinical observations,” he said.
Medlogics was founded by Richard Klein, formerly vice president and chief patent council for AVE, and James Peacock, a medical device entrepreneur. The company has received about $30 million in venture and private funding.
The company has grown to 74 employees and currently occupies about 14,000 square feet on Westwind Boulevard near the Charles M. Schulz-Sonoma County Airport.
The six-month patient trial now under way has enrolled 99 people in various sites in what is known as a “real-world” setting that represents the range of patients a doctor would see, including those with diabetes and other complications.
“Achieving positive outcomes in such a difficult setting make the results even more impressive,” said company Marketing Director Kalei Hampson.
If the long-term data continues to be this favorable, Cobra has the potential to reduce the need for drug-eluting stents with some patients, he said.
Results from the completed trial will be used as preliminary data when Medlogics applies for FDA approval – perhaps as early as next year – he said.
In addition to Cobra, Medlogics is also developing a drug-eluting stent. A major difference from existing drug-eluting stents is that the Medlogics drug-eluting stent uses a silica gel coating that is absorbed by the body rather than polymers associated with complications.
Medlogics does not disclose revenues but expects results of the current study, if they prove as positive as the initial data indicates, will drive significant adoption of the Cobra bare-metal stent and have a significant impact on the way heart disease is treated with stents, said Mr. Hampson.
For more information, visit www.medlogicsdc.com.