BiOM has named Dr. Charles Carignan as its next CEO, replacing Tim McCarthy, who left the company this past spring.
Carignan is a 20-year medtech veteran who has held several key positions in the medical device industry, including most recently at NinePoint Medical, where he was the founder and CEO.
In addition, Carignan has served as executive vice president and chief medical officer of Novasys Medical and held the same role at Boston Scientific (NYSE:BSX). He was also the vice president of clinical research and medical affairs at Conceptus (NSDQ:CPTS), where he oversaw the clinical development of the Essure device for female sterilization.
Bedford, Mass.-based BiOM (formerly known as iWalk) is a driving force in the bionics revolution. The company’s BiOM T2 bionic ankles are part of a new generation of "smart" prosthetics that seek to restore normalized function of human limbs to amputees. The company’s bionic ankle emulates the muscle function of a human ankle using computer processors that are able to "adjust the ankle’s stiffness and propulsive torque 500 times a second," the company says. The result is a prosthetic that can mimic a person’s natural gait, reducing many of the long-term health problems associated with prosthetic limbs. The company was founded by MIT robotics guru Hugh Herr.
The BiOM is one of the costlier prosthetics on the market – up until January of this year insurance companies reimbursed physicians anywhere from $50,000 to $150,000 for the devices, according to BiOM. Although the device is covered by the U.S. Defense Dept., the Veterans Affairs Dept. and various private worker’s compensation plans, the device remains in reimbursement limbo at the Centers for Medicare & Medicaid Services.
Former BiOM CEO Tim McCarthy told MassDevice.com that even though CMS issued a specific reimbursement code for the BiOM prosthesis and set a reimbursement rate, it ultimately determined that Medicare would not cover the device.
"Even though they’ve given us the code, given us the fee, it’s a non-Medicare covered item, so any Medicare covered patient who wants the BiOM would either have to get supplemental insurance or pay out of pocket. Medicare is not paying for the BiOM at this stage," McCarthy told us. "They didn’t do us any favors."
Company officials said in a prepared release that Carignan’s vast experience with cutting-edge technology should help the company with its reimbursement challenges.
"Chuck has deep experience navigating the clinical, regulatory and reimbursement challenges that disruptive technologies face in order to achieve widespread growth," chairman Geoff Pardo said in a prepared release. "The BiOM T2 System has a transformative effect on the lives of patients, and Chuck’s experience in demonstrating cost-effectiveness of new technologies will be invaluable as we seek to make this broadly available to patients."
"I’ve joined this company because I believe that the BiOM T2, and future products that we have in development, can redefine the lives of many people who have suffered the loss of mobility due to illness or trauma," Carignan said prepared remarks. "I see a team that includes the BiOM staff, Dr. Herr and his lab, and the board of directors, with the passion to do what it takes to get these products to patients. It is a meaningful challenge that I am looking forward to very much."