An open-heart surgery is an invasive procedure that calls for the rib cage to be spread open — even under the best circumstances, that process can damage nerves, tear ligaments and fracture ribs. But medical device developer Physcient aims to improve on such open-chest procedures with a new approach to old surgical techniques that date back more than 70 years.

Physcient is bringing biomechanical analysis to the conventional thoracic retractor. Hugh Crenshaw, CEO and cofounder of Durham-based Physcient, said that the company isn’t radically overhauling the device used for decades on heart surgeries and other open-chest operations. Rather, the company is taking existing surgical technology and improving it.

“The function of the instrument is unchanged,” Crenshaw said. “But now it works better.

An estimated 600,000 open-chest surgeries are conducted annually in the United States. A similar number of such surgeries are conducted in Europe each year. The majority of those procedures are open-chest surgeries using thoracic retractors. Originally developed in the 1930s, the device essentially cranks open a patient’s ribcage. Thoracic retractors are often referred to descriptively as “rib spreaders” and they do their work with tremendous force to bone and tissue. Rib fractures are common. For patients, the trauma means long and painful post-surgery recovery times.

Physcient’s technology was originally developed at North Carolina State University. Researchers there were researching surgical instruments that would cause less trauma to patients. Physcient was founded in 2007 to further develop the research. The company’s technology combines software and automation to provide an analysis of the bones and tissue as the ribs are being spread. The device, dubbed the Assuage, still spreads the ribs. But it does it in a smoother, gentler manner, not the jerking motion that comes with thoracic retractors. Assuage stops short of causing trauma to tissue and bone.

Crenshaw said that when he started researching new surgical technologies, he thought he would pursue minimally invasive surgical devices. But while such products work well in the abdomen, the chest provides a greater challenge. Most surgeons don’t do minimally invasive surgery for heart and lung procedures because minimally invasive instruments don’t give them the access to the organs that they need.

Crenshaw says the Assuage gives surgeons the same access as conventional rib spreaders and allows them to conduct surgeries in the same amount of time. At least, that’s the plan. Assuage has been tested on pigs. So far, no human trials have been done.

Physcient’s R&D has been financed primarily by grant funding, including support from Durham-based nonprofit NC IDEA and the National Heart, Lung and Blood Institute. In 2010, the National Science Foundation awarded Physcient a $499,986 phase 2 small business innovation research grant for continued development of Assuage.

The company is now aiming to raise $4 million to develop a late-stage prototype of the device and for a 510(k) submission to the U.S. Food and Drug Administration. Assuage could reach the market in 16 to 18 months.

Clinical trials will be conducted at some point but they are not required for a 510(k) filing and might be done after receiving FDA clearance. That work could also be done with a partner. Crenshaw said that he is in talks with companies interested in striking a deal with Physcient on Assuage or its pipeline technologies. Crenshaw said it’s too soon to discuss the pipeline technologies in detail, but he said they have potential applications in orthopedic and back surgeries. For now, Physcient’s focus is on Assuage, a device the company chose as its first product because of the large unmet medical need addressing surgeries done with thoracic retractors.

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