SAUSALITO -- Sanovas Inc. plans to expand its corporate headquarters in Marin County's southernmost city to include a manufacturing operation for early production of key components for its microsurgical devices, used in diagnosing and treating cancer and other chronic diseases.
[caption id="attachment_47573" align="alignright" width="415"] Sanovas' first product is the Vas Zeppelin catheter-based microsurgery system.[/caption]
The expansion comes just ahead the company's plans to file for approval from the U.S. Food and Drug Administration. The new facility ultimately would produce Sanovas' commercial products. The privately held company said it has more than 25 multinational patents pending.
The new plant will be at 30 Liberty Ship Way, which is adjacent to its existing offices in Suite 110-B at 85 Liberty Ship. The total expansion will consist of 4,700 total square feet, including 3,500 square feet that will accommodate the manufacturing site and additional office space, according to Sanovas.
“Sanovas’ headquarters is a natural choice for our manufacturing site, as it allows us to maintain the highest level of quality control over the most proprietary components of our technology platform,” Chief Executive Officer Larry Gerrans said. “These facilities will provide us with the ability to attract the very best talent from within the life sciences community right here in the Bay Area.”
Mr. Gerrans said numerous factors make Sausalito the ideal location for a company seeking to find treatments for pulmonary diseases such as lung cancer, emphysema and tuberculosis.
Mr. Gerrans said "there is an urgent need" for technology in this area, and that, compared to other forms cancer and chronic illness, lung cancer receives relatively scant attention, likely because of its association with smoking. Accordingly, Sausalito's proximity to the Pacific Ocean means better air quality for patients of pulmonary disease.
"Salinity in the air is good for those pulmonary diseases," he said, adding that Sanovas had explored San Francisco and South San Francisco for space, but it became clear those locales were not ideal.
Sanovas is moving into the new location now and expects to have the manufacturing space built out in the next few weeks, Mr. Gerrans said. The expansion includes plans to hire at least 20 new employees in 2012 across multiple platforms, particularly in engineering and regulatory.
Initially, Sanovas will manufacture core components of its technology. It will be preproduction until the company can go into full production upon FDA approval. The company said it expects to continue manufacturing those components in Sausalito as it ramps up for commercialization. Sanovas is currently seeking investment to take its Clear Vessel technology to market.
Mr. Gerrans said he could foresee another expansion of between 10,000 and 15,000 square feet in the near future, depending on when full production begins.
Sanovas’ microsurgery platform is designed to give surgeons the ability to access and understand previously inaccessible areas of the body, enabling them to diagnose, treat and deliver drug and immune therapies to small-diameter anatomy in what are said to be entirely new ways.
Sanovas sees particular potential and new ground with lung cancer, given the lungs comparative inaccessibility.
"We quickly learned that the lungs are the last front of innovation because you can't turn them off to operate on them," Mr, Gerrans said. The technology is small enough to go through other bodily tubes as well as the lung passages, he added.
The technology was developed by veterans of the minimally invasive devices field, according to the company. The microsurgical technology utilizes what Sanovas says is the world’s smallest surgical camera to visualize and treat difficult-to-reach areas of the body.
The camera is connected to the end of a steerable catheter, which is used to deliver additional tools for collecting tissue samples, analyzing and removing tumors and delivering drug and immune therapies to targeted locations within the deepest reaches of the body.
Sanovas plans to file a 510(K) premarket notification with the FDA in the first half of 2012. If approved, the company would begin full-scale manufacturing by the end of the year. Initially, Sanovas intends to market its tools for the treatment of lung cancer and pulmonary disease.
Lung cancer is the leading cause of cancer death among men and women worldwide. Nearly 400,000 people in the U.S. die from lung disease each year, according to the American Lung Association. Mr. Gerrans, citing data from the Association, said women in particular are vulnerable to lung cancer -- even if they have never smoked -- and that the minimally invasive technology could help identify treatments and spur further research and dialogue.
"Lung cancer is not an affliction associated with just smoking," he said. About 18 percent of women with lung cancer never smoked, while only about 2.3 percent of men with lung cancer never smoked, Mr. Gerrans said.
“With nearly 1 in 7 Americans currently suffering from a chronic pulmonary disease and another 96 million at risk, there is an urgent humanitarian need for these next-generation solutions,” Mr. Gerrans said.
Mr. Gerrans and Chief Technology Officer Erhan Gunday started Sanovasin Walnut Creek in 2010 and relocated the company to Sausalito last year.
