Dear OTW Reader:
An anonymous spine surgeon muses, “Are the side effects of InFuse over or under stated?”… Mike Franz discusses the International Spine and Orthopedic Institute …Dr. Scott Levin, the Chair at Penn, reports on the region’s first bilateral arm and hand transplant…and more.
Carragee Out to Make a Name for Himself?
A spine surgeon who requested anonymity told OTW, “First of all, is the increased retrograde ejaculation related to Infuse, to surgical exposure, or to the technique? In many people’s minds, Infuse is not at fault; and there is increasing data to suggest that this problem is not related to Infuse. The other issue is the increased incidence of malignancy that Dr. Carragee raised. There is some concern that he based his conclusions on incomplete data that was publicly available—rather than on the full data set. The information from the statistics at the company suggests no increased risk related to Infuse. There is some concern whether a higher dose amplifies the incidence or is just a spike. The fundamental issue is, ‘Are you going to believe the company or Dr. Carragee, who many think is on a mission to make a name for himself?’ The FDA has found Infuse to be safe and effective…and they have access to all of the data. There is just not enough data at present to change practice.”
David Veino, Tom Kennedy New VPs at Globus
Globus Medical, Inc. has added two new vice presidents to its executive team: David Veino, vice president of Marketing, and Tom Kennedy, vice president of Surgeon Relations and Education. David Veino will lead Globus’ worldwide marketing efforts. Prior to joining Globus, he spent five years as global director of sales and marketing for the Interventional Spine division of Stryker. Prior to Stryker, Veino spent five years in sales with Atherotech culminating as vice president of sales. Prior to that, he held roles of increasing responsibility in sales and marketing at HeartGen Centers, Philips Medical Systems, Cor Therapeutics, and Parke Davis Pharmaceuticals. Tom Kennedy will be responsible for Globus’ Musculoskeletal Education and Research Center (MERC) as well as the Surgeon Relations Group. Previously Tom was vice president of professional affairs and medical education for Smith + Nephew’s Biologics and Clinical Therapies Division. Prior to that he was director, Professional Programs with Stryker Spine. Additionally, Tom has over 15 years experience in various sales and marketing positions, including those with C.R. Bard, Maxxim Medical and Johnson and Johnson Medical.
“Marrying” Chinese and Western Surgeons
MikeFranz is CEO of the International Spine and Orthopedic Institute (ISOI), a high-level, unprecedented cultural exchange of sorts. Franz, who is also CEO Emeritus and Chief Strategy Officer of the Texas Back Institute (TBI), tells OTW, “The Kerlan Jobe Clinic and TBI have jointly founded the International Spine and Orthopedic Institute (ISOI) with a goal of establishing orthopedic surgery hospitals in China. We are focusing on affluent Chinese patients, expatriates, and medical tourists. We have a unique partnering of Western and Chinese surgeons; to access the surgeons in China, we are relying on our existing relationships with senior orthopedic professors in that country. Through their introductions we are meeting skilled Chinese surgeons and are conducting training programs here and in China. Having established these relationships, we can thereby seek out affluent Chinese patients. The perception in China is that Western medicine is in a more advanced state than Chinese medicine, so there is quite a demand for what we are offering. Our U.S. training hubs are TBI (for spine), and Kerlan Jobe (for sports medicine and total joints). We are proud to have already created a partnership with the First Affiliated Hospital of Suzhou University last March, whereby we renovated a VIP orthopedic center and now send U.S. surgeons there. The next project is a private hospital where we have ownership in the orthopedic department and we will put our model into it. Our ultimate objective will be for ISOI to have majority ownership in standalone orthopedic surgery hospitals in China, something we expect will start to occur in 2013.”
Spine Wave Has New Product Developer
Spine Wave, Inc. has announced that it has entered into an agreement with MB Innovations (MBI), a newly formed product development company based in Memphis, Tennessee. MBI will initially develop products exclusively for Spine Wave while they expand their infrastructure in anticipation of taking on additional medical device clients. MBI will assemble an accomplished team of engineers and advisors who have experience in developing commercially successful medical devices. The team will be led by Troy Drewry, President of MBI, who began his career in product development at Medtronic Sofamor Danek and most recently held the position as VP of U.S. Operations for Paradigm Spine. Mike Sherman, a partner at MB Venture Partners, will serve as executive chairman of MBI. Mike’s product development career spans over 20 years at Synthes, Smith + Nephew and Medtronic Sofamor Danek where he generated over 90 issued U.S. patents.
$50, 000 to Develop MI Bone Tissue Device
Jay Khanna, M.D., associate professor of orthopedic surgery and biomedical engineering at Johns Hopkins University, has been awarded $50, 000 to develop a minimally-invasive bone tissue harvesting device with a softer drill. Dr. Khanna’s device allows for the collection of more bone tissue, a safer autograft, reduction of pain and better grafting. This technology is the core of a startup company, BOSS Medical, LLC.
Vascularized Composite Allograft Transplantation—Opportunity for Orthopedics?
L. Scott Levin, M.D., FACS chair of Orthopaedic Surgery at the University of Pennsylvania, is pleased with the progress they are making with transplantation. Dr. Levin, professor of surgery (plastic surgery), is the only orthopedic surgeon to direct a university-based transplant team. He tells OTW, “We did the first bilateral arm and hand transplant in the region two months ago; the patient is doing extremely well, and is regaining the functions of daily living that she didn’t have before transplant. This complex procedure involved orthopedic surgeons, plastic surgeons, hand surgeons, etc. From an orthopedic perspective vascularized composite allograft transplantation represents a future opportunity for living joint repair and replacement of other body parts that until now were impossible or relied on prosthetics that have limited life expectancy as a device. We are moving forward, and have several patients who have undergone evaluation and will be listed for surgery in early 2012.”
Luke Faulstick Leaves DJO
Luke Faulstick has moved on from DJO Global. The former executive vice president and chief operating officer will leave the company in early February, 2012 to join Power Partners, Inc., a privately-owned power transmission manufacturer, as Co-owner, President and CEO. Faulstick has served as a member of the board of advisors of Power Partners, Inc. since 2003.
Closer Than Ever to Arresting Degeneration
Dr. Isador Lieberman of the Texas Back Institute has “no doubt” that biologics is the future of spine surgery. He tells OTW, “We are seeing more information these days on regeneration and alteration of the degenerative cascade—and the reversal of the degenerative cascade. This is stuff that will put us heavy metal spine surgeons out of business…and that is a good thing. The FDA has already starting shaking the trees with companies, and having them come out with stem cell possibilities. But the slowness of the regulatory process will ultimately delay the availability of this technology for patients. The good news is that we are closer than ever to arresting the degenerative process so that we’ll be able to manipulate that process with targeted therapeutics like growth proteins or something that is part of the BMP group. Many researchers are looking at various applications and trying to reassign them to another application. As for the regulators, somebody has to step up and point the FDA in the right direction. We need a point person who will say, ‘This is what you need to do; this is how to handle this opportunity. Why are they so hesitant?’ Because they look at this stuff and say, ‘We don’t know how to categorize it…is it a pill, an implant, or a procedure’… and no one wants take responsibility for this process.”
