Wenzel Spine acquires OsteoMed's spine assets

Wenzel Spine Announces Acquisition of Interspinous & Facet Fixation Product Platforms (press release)
Read all Mergers & Acquisitions here
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of the PrimaLOK™ SP Interspinous Fusion System and PrimaLOK™ FF Facet Fixation System from OsteoMed, LLC.
The PrimaLOK SP & FF platforms include a polyaxial interspinous process device and percutaneous facet screw system designed for MIS applications in treatment of lumbar spinal disorders. These patented technologies are designed to provide surgeons an expanded MIS solution when used in conjunction with the stand-alone, expandable, VariLift-LX interbody fusion device.
“This acquisition provides our distributors and surgeons a powerful combination of MIS solutions. When paired with our VariLift-LX stand-alone, expandable, interbody technology, surgeons now have the ability to provide supplemental fixation, when needed, without having to revert to pedicle screw constructs,” said Chad Neely, President and Chief Executive Officer of Wenzel Spine. “In addition, this expands our current product portfolio while strengthening our development pipeline and demonstrating our commitment to the development of innovative MIS solutions to our distribution and surgeon partners.”
Dr. Charles Gordon, the inventor of the PrimaLOK SP System, and founder of the Texas Spine & Joint Hospital, commented, “I am pleased that Wenzel Spine has added the PrimaLOK Systems to their product portfolio. We are very happy to be partnered with a Spine focused company and believe Wenzel Spine is the ideal partner to bring the full potential of the PrimaLOK Systems to market.” Dr. Gordon further commented, “There are tremendous MIS innovation opportunities in combining the advantages of the PrimaLOK and VariLift-LX technologies.”
Wenzel Spine plans to integrate the PrimaLOK platforms into the pipeline of innovative MIS solutions currently being developed. The company has completed a limited US release of the PrimaLOK SP & FF Systems and expects to offer wide US release of the products in the second quarter of 2017.
About Wenzel Spine, Inc.
Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients. For more information about the company and our products, visit www.wenzelspine.com
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View source version on businesswire.com: http://www.businesswire.com/news/home/20170222005421/en/

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The Medical Tourism trend is on the move in Orthopedics

This year, hundreds of thousands of Americans will travel outside the United States for health care. The rising cost of medical treatment in the U.S. sends Americans abroad in record numbers. Around 500,000 Americans leave the country each year for some sort of elective medical procedure, including Orthopedic procedures.
Medical tourism originated in the 1990’s with cosmetic procedures. Today, a large percentage of patients travel for common Orthopedic procedures—total hips, total knees, spine fusions, etc. There is no rule of thumb, but a total joint procedure outside the US typically costs the patient 25%-75% less than in the US.
This trend is driven by economics, demographics, globalization and technology, and cannot be ignored. The huge scale and logistics become as simple as calling your travel agent. If you don’t believe it, just take a look at WorldMedAssist http://www.worldmedassist.com/ or PassportMedical http://www.passportmedical.com/ as examples.
Choose a procedure, choose a country, and book your trip.  One, two, three.
Articles about Medical Tourism

In Need of a New Hip, but Priced Out of the U.S – A case study for Medical Tourism
Here’s a new twist – Medical Tourism in the United States
Las Vegas is becoming a Medical Tourism destination for Spine surgery
Medical Tourism is a Growing Orthopedic Trend
Cheaper surgeries drive patients to Medical Tourism – Baton Rouge woman goes to Belgium for Total Hip Replacement
Healthbase Facilitates Medical Tourism Spine Fusion Surgery for Uninsured American in India

 AAOS: 3 changes coming to your orthopedic practice

Indians return home to India for the great value of a $15,000 Total Knee procedure
13 Orthopedic Trends observed by Tiger

Jamaican doctor pioneers disc replacement procedure (Jamaican Observer)
A group of doctors has high hopes that an artificial disc, owned exclusively by a Jamaican-born doctor, can be used as a tool to drive medical tourism in Jamaica.
The technology was used for the first time in a four-level disc replacement procedure at the Andrews Memorial Hospital in St Andrew on February 1. The surgical procedure was performed by orthopaedic spinal surgeon Dr Kingsley Chin, who was born in Buff Bay, Portland.
Chin is CEO of KIC Ventures, a venture capital firm focused on the health technology sector and the owner of AxioMed, a health tech company that has developed the technology known as the Freedom Cervical disc. AxioMed was founded to advance the standard of care for patients with degenerative spine conditions and has now successfully developed the artificial disc that most closely mimics the normal disc using viscoelastic polymer technology.
In disc replacement, worn or damaged disc material between the small bones in the spine (vertebrae) is removed and replaced with a synthetic or ‘artificial’ disc. The goal of the procedure is to relieve back pain while maintaining more normal motion than is allowed with some other procedures, such as spinal fusion. The Freedom Cervical disc is said to most closely mimic the natural properties of a healthy human disc and has been proven to withstand the forces and wear of decades of use.

On February 1, Dr Chin operated on a female patient with a prolapsed disc who would’ve been in need of several surgical procedures with sequential disc replacement or a fusion of the discs, which would’ve limited her neck motion.
For the procedure, he worked with his team of University of the West Indies (UWI) and Oxford-trained Rhodes Scholar Dr David Walcott, UWI & Yale-trained neurosurgeon Dr J Geoffrey Liburd, and anaesthesiologist Dr Patrick Toppin.
Andrews chief executive officer Dr Marvin Rouhoutas and Keith Shakespeare were instrumental in facilitating the procedure, along with theatre manager Nurse Roxanne Shaw-Edwards and her staff nurses.
Dr Chin’s colleague and president of AxioMed, Jake Lubinski, also witnessed the historic launch of his company’s product that was used in the surgical procedure and, which Dr Walcott has described as “unprecedented”.
Live feeds from the operating theatre are said to have generated much excitement in the USA. An exclusive technology never before pioneered in the USA, Dr Chin plans to expand and brand it within Jamaica.
He is confident that it will strengthen Jamaica’s medical tourism industry, a sentiment echoed by Dr Walcott.
“With this technology, she (the patient) was able to get all discs replaced, and within the operation, that is intraoperatively and postoperatively, we assessed the flexibility of her neck and confirmed it to be good,” Dr Walcott told the
Jamaica Observer in a recent interview.
He contended that the sort of standard four-level procedure that would’ve been required would’ve limited her flexibility.
Upon successfully completing the surgery recently, Dr Chin pronounced that there’s nothing like pioneering something.
“It could change the face of the profession in Jamaica and the rest of the globe,” he said.
The doctors believe that Jamaica is ideally poised to attract investments in medical tourism given the availability of quality medical professionals and the island’s proximity to the United States. The team aims to brand the technology within Jamaica and use it as an engine to drive the development of the health tourism sector, using it as a strategic gateway to penetrate the international health market and drive health tourism within the Caribbean.

 

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STUDY: No Way to Predict Risk in Joint Replacements

Study: No Way to Predict Risk in Joint Replacements (Orthopedics This Week)

Despite testing three different risk adjustment indices, researchers have found that none of them were useful in predicting readmissions among osteoarthritis (OA) patients who underwent joint replacement. The study, which appears in the January 2017 edition of Arthritis Care & Research, was led by Amit Kumar, Ph.D., a postdoctoral research associate at the Brown University School of Public Health. It is entitled, “Current Risk Adjustment and Comorbidity Index Underperforms in Predicting Post-Acute Utilization and Hospital Readmissions after Joint Replacements: Implications for Comprehensive Care for Joint Replacement Model.”

One of the reasons for the study, as stated in the January 25, 2017 news release, is the new outcome based reimbursement environment. “To compel hospitals to do better, the Centers for Medicare and Medicaid Services (CMS) launched the Comprehensive Care for Joint Replacement (CJR) program in April 2016, which penalizes hospitals for readmission of joint replacement patients within 90 days.”
“In the absence of that risk adjustment, when sick patients have worse outcomes, hospitals will be penalized,” said Dr. Kumar. “If we could find an index that was working for this population, we could recommend that—but unfortunately none of them are working very well.”
Again, quoting directly from the press announcement; “Dr. Kumar and former colleagues at the University of Texas Medical Branch tested the applicability of the three industry-leading indices for predicting mortality and health care utilization: the Charlson Comorbidity Index, the Elixhauser Comorbidity Index and CMS’s Hierarchical Condition Category.”
“Dr. Kumar analyzed Medicare data on every beneficiary who survived for 90 days after a total knee or total hip replacement performed because of osteoarthritis between January 2009 and September 2011. In all, the study covered a total of 605,417 patients. The data showed that 46.3% of patients were discharged home, 40.9% went to skilled nursing facilities and 12.7% stayed in inpatient rehabilitation.”
Amit Kumar told OTW, “Studies have shown that poor functional status is strongly associated with increased used of post-acute care services and hospital readmission. Current risk adjustment models contain extensive information on medical diagnoses, but not function-related measures. The missing information on physical functional status in claims data of older hospitalized patients can affect the decision-making process on discharge destination and continuity of care.”
“Orthopedic surgeons may improve service delivery by developing appropriate risk adjustment model and care transition plans based on patient functional status and initiating an intervention to prevent specific comorbid conditions associated with greater risk of readmission. The preventive measure can be initiated before and after surgery to address the medical needs of patients with high-risk of readmission.

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The Artificial Meniscus, a "game-changer" for early OA, is being tested in US clinical trials

TWO TRIALS TEST POLY URETHANE MENISCUS (Orthopedics This Week)
website Active Implants

One of the more troublesome parts of the body is the meniscus, the pad of tissue that rests between the thigh and shin bones. The meniscus tears easily both from physical activity and excess weight. And once torn, it does not heal readily. More than one million partial meniscectomies, intended to remove or repair a torn meniscus, are performed in the U.S. every year. This is about the same as the total number of hip and knee replacement surgeries combined. While most joint replacement surgeries are successful and patients become pain free, that is not the case with meniscus surgery. Many patients still experience persistent knee pain following surgery on their damaged meniscus.

The NUsurface Meniscus Implant is among the first “artificial meniscus” designed to replace the damaged one. Active Implants LLC makes the implant and has offices in Memphis, Tennessee, the Netherlands and Israel. “There are limited options for patients who experience persistent knee pain following meniscus surgery,” says Richard Alfred, M.D., orthopedic surgeon at Capital Region Orthopaedic Associates and VENUS study investigator. “It is our hope that the NUsurface implant alleviates pain in these patients, allowing them to return to their previous levels of activity.”

The NUsurface Meniscus Implant, which is made of medical-grade plastic, is an investigational device that is inserted into the knee in a minimally invasive procedure through a small incision. It has been used in Europe since 2008 and in Israel since 2011.

Two clinical trials are currently underway, labeled SUN and VENUS. The stated goals of the trials are to assess the safety and effectiveness of the NUsurface Meniscus Implant in restoring function like that of a natural, healthy meniscus. “It is important to note that NUsurface is an investigational device that is limited by United States law to investigational use,” Alfred said. “Responses to the NUsurface can and do vary with each patient, so those interested in the trial should discuss their individual situations with a clinical trial physician.”

To be eligible for the clinical studies, patients must be between the ages of 30 and 75, have pain after remedial meniscus surgery and have had meniscus surgery at least six months ago. To find a study site, visit www.activeimplants.com/kneepaintrial.

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POD Spine Surgeon Sabit Gets 20 Years in Prison

POD SPINE SURGEON SABIT GETS 20 YEARS IN PRISON (Orthopedics This Week)
Aria Sabit, M.D. is going to jail for almost 20 years if he completes a sentence imposed in January by a federal judge in Michigan.
Sabit pled guilty back in May 2015 to a $2.8 million healthcare fraud scheme for filing false claims that the government said, “caused serious bodily harm to patients by performing unnecessary invasive spinal surgeries.”
Sabit came to light in September 2014 when the Department of Justice (DOJ) sued Utah-based Reliance Medical Systems, LLC and Sabit, among others, in California federal court over an alleged kickback scheme involving physician owned distributors (PODs) and physician investors. The physicians were allegedly being paid based on the number of Reliance Medical spinal implants they used. Sabit was one of the surgeons named in that complaint through a Reliance Medical POD named Apex Medical Technologies, Inc.
Although Sabit’s prosecution, guilty plea and sentencing in Michigan were not directly related to his involvement in a POD in California, the government went to great lengths in the announcement of the sentencing to say that Sabit agreed to convince his California hospital to buy spinal implant devices from Apex and to use a substantial number Apex spinal implant devices in his surgical procedures. Sabit further admitted that he and Apex’s co-owners concealed Sabit’s involvement in Apex from the hospitals and surgical centers.
On November 12, 2012, as part of a federal investigation in California, Sabit testified that he never had been paid any compensation by a medical device manufacturer and that he didn’t know of any device company in Bountiful, Utah, the headquarters of Reliance Medical.
By January 2014, Sabit began invoking his Fifth Amendment right to not testify against himself.
After a detention hearing on December 4, 2014, a magistrate ordered Sabit held in jail. Prosecutors told the judge they fear he was a flight risk and would try to return to his native Afghanistan to start a hospital and drill for oil. They said he is a member of a politically prominent family.
After his detention, a federal grand jury indicted him on December 9, 2014 on 18 counts of fraud and 1 count of “unlawful procurement of naturalization” in a 20-page indictment.
In connection with the guilty plea, the government stated in a press release that Sabit, “admitted that he derived significant profits by convincing patients to undergo spinal fusion surgeries with “instrumentation” that he never performed and billed public and private healthcare benefit programs for those fraudulent services. Sabit further admitted that, in some instances, he operated on patients and dictated in his operative reports—which he knew would later be used to support fraudulent insurance claims—that he had performed spinal fusion with instrumentation, when he had not. Specifically, Sabit fraudulently billed public and private health care programs for instrumentation when, in fact, he used cortical bone dowels made of tissue. Sabit failed to render services in relation to lumbar and thoracic fusion surgeries, including in certain instances, billing for implants that were not provided.”
Sabit also is a defendant in two civil False Claims Act cases brought by the DOJ in the Central District of California. These cases remain pending.
Between 2009 and 2010, Sabit was the subject of more than two dozen medical malpractice lawsuits in California. An FBI agent testified at Sabit’s detention hearing in Michigan that Sabit performed over 200 spinal fusion surgeries in California from June 2009 to December 2010 and that the DOJ had filed a Civil Complaint against him in September 2014.

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