April 19, 2017

Roswell, GA, April 7, 2017 – Z-Medical LP, subsidiary of Z-Medical GmbH + Co. KG, a privately financed and held medical device company that designs, develops, manufactures, and markets innovative implants and surgical instruments, announced today that it has appointed René Rothacker as Chief Commercial Officer and Jim Talbert as Vice President Sales USA.

Z-Medical received FDA 510(k) clearance to market the MIS Z-Pedicle Screw System in 1Q15, and established a U.S. subsidiary later that year to support launch with logistic partner WebOps, LCC and GlobalMed Logistix, LLC. In 4Q16, the company entered into an agreement with InterMed Resources tn, LLC to distribute the MIS Z-Pedicle Screw to HealthTrust’s ~1,600 acute care facilities in the U.S.

Mr. Rothacker will report directly to Alexander Henninger, CEO of Z-Medical LP and shareholder of Z- Medical GmbH + Co. KG. René Rothacker is responsible for leading the commercialization of Z-Medical’s MIS Z-Pedicle Screw System including sales and product promotion to drive US business growth.

He has over 15 years of experience in Marketing and Product Management in the medical device industry with an expertise in pharmaceutical packaging and spinal implants. Prior to joining the company, he was Consultant for Z-Medical and provided technical expertise and training in support of product development. Prior to this role he worked as Product Marketing Manager at joimax® GmbH, the leading developer and provider of complete systems for minimally invasive endoscopic spinal surgery and as Senior Product Manager at Paradigm Spine GmbH, a leader in the field of non-fusion spinal implant technology. He was responsible for defining product marketing strategies including preparation of international product launches as well as developing and implementing training programs for sales representatives, global distribution partners and surgeons. From 1999 to 2008, he was employed by Aptar Pharma (former Ing. Erich Pfeiffer GmbH) and was responsible for coordination of international customer projects, product training and support of the global distribution network. 2002, he received his Diploma in Business Administration and Engineering at the University of Cooperative Education at DHBW Stuttgart Campus Horb.

In his previous position as Director International Business Development at Z-Medical he was responsible and the main driver in setting up Z-Medical’s US Operation including the strategic partnership with WebOps, LCC and GlobalMed Logistix, LLC who provide Z-Medical with a comprehensive set of operational processes, tools and services for the US commercialization of MIS Z-Pedicle Screw System.

In this position he has worked in close cooperation with Mr. Talbert who is renowned within the Orthopedic, Neurosurgical, and Spine Industries as a decisive leader and a formidable force in international and regional markets. He formerly was Z-Medical’s USA National Distributor and supported Z-Medical in the start-up phase with his proven history of success in sales and product promotion, with a unique talent for building and maintaining business relationships. He will report to René Rothacker.

The strategic partnership with InterMed Resources tn, LLC who distributes spinal implants manufactured by Z-Medical to HealthTrust Purchasing Group, L.P., a leading group purchasing and total cost management organization that serves nearly 1,600 acute care facilities nationwide was initiated by Jim Talbert. Under the agreement, Z-Medical sells its MIS Z-Pedicle Screw System at a contracted price for distribution to HealthTrust member facilities throughout the United States.

Jim Talbert has extensive experience in training medical professionals in the proper application of surgical equipment and medical devices and is a driven individual committed to developing professional and personal skills to their greatest potential.

His history as a dedicated and organized professional, committed to providing exceptional customer care and support to clients with industry leaders such as Amedica Corp., Exactech, Inc., Globus Medical, Inc., Johnson & Johnson, DePuy, Medtronic, Pfizer, Smith & Nephew, Stryker Corporation, Zimmer, and Zimmer Spine equipped Jim with an expansive knowledge in the surgical device industry.

“We are delighted to have René Rothacker as our CCO and Jim Talbert as VP Sales USA on board of our US team. Their combined expertise and experience in Marketing & Sales will drive our business growth in the US to continue the success in our direct markets.” Alexander Henninger, CEO Z-Medical LP.

“The Innovative Simplicity and high versatility of our MIS Z-Pedicle Screw System can be a game changer, in a technical but also in an economical aspect. It was designed for a straight forward approach and to reduce surgical steps. The preloaded set-screw makes it faster and easier with fewer problems (no cross- threading or tulip splay). The multifunctional system and innovative implant design reduces the OR time, minimizes potential risks and offers a wide range of treatment options.”

About the MIS Z-Pedicle Screw System 

The MIS Z-Pedicle Screw System with only one instrument tray offers surgeons an ideal solution for their indication specific needs. The high versatility of the system, the pre-sterilized implants as well as the innovative screw design enables them to efficiently and cost effectively address the most common pathologies. It was specifically designed for a minimally-invasive approach but can also be used in open procedures. It is approved for Degenerative, Trauma, Tumor and Deformity application. Alignment after surgical correction of spondylolisthesis, reduction in fracture- and the derotation in scoliosis treatments are achieved directly with the pre-assembled set-screw, the long reduction thread and the especially designed uniplanar fracture- and deformity screws.

About Z-Medical 

Based and founded in Tuttlingen in 2010, Z-Medical® GmbH + Co. KG is a privately financed and held medical device company that designs, develops, manufactures and markets innovative implants and surgical instruments in the section of Spine, Hand & Foot and Arthroscopy. The company’s U.S. subsidiary was established in Atlanta, Georgia, in August 2015. Z-Medical implants stand for precision, innovative simplicity and ready for surgery.

Z-Medical is actively recruiting regional distributors to capitalize on this expansion to its hospital network. For further information about Z-Medical, the MIS Z-Pedicle Screw System or distribution opportunities please contact,

Jim Talbert at j.talbert@z-medical.de

René Rothacker at r.rothacker@z-medical.de

or visit

www.z-medicalUSA.com

Z-Medical LP

1455 Old Alabama Road, East / Suite 115-A Roswell, GA 30076 / USA

Phone: (+1) 404 941 2022

Web: www.z-medicalUSA.com

By Chris Centeno, M.D., CEO at Regenexx – April 16, 2017

In 1897, Mark Twain was on a speaking tour in London when an American newspaper started a rumor that he was gravely ill. This was soon followed by an obituary. When asked by an American reporter in London about his death, Twain quipped, “The reports of my death have been greatly exaggerated.” I feel the same about C1-C2 facet injections. The radiofrequency mob has been trying hard to kill off cervical facet injections for years and C1-C2 is low hanging fruit, but like Twain, I have to report the death of this procedure has been greatly exaggerated.

What is a Facet Joint and how Does RFA Work?

Sometime around the turn of this last century, we began to see the use of radiofrequency ablation (RFA) for neck pain due to damaged facet joints take off. What is RFA and what is a damaged facet joint?

You have 14 joints in the back part of your spine (7 on each side). These joints help to control neck motion. These little articulations about the size of a finger joint are commonly called “facet joints”. They can become injured or can get arthritis like any other joint in your body. When this happens they can become chronically painful.

While the injection of anti-inflammatory steroid into these joints was the most common way to treat this pain, about 2000 or so we began to see the rise of another form of treatment called RFA. This procedure uses a probe that heats up to burn away nerves around the painful joint. The idea is that once these pain carrying “wires” are “cut”, the pain will stop because it’s no longer being transmitted to the brain. This works pretty well and has been well researched to help chronic neck pain caused by a damaged facet joint. However, as you might imagine, you can’t just burn nerves that carry pain signals and not have consequences. This procedure can cause the joint to become more damaged (a Charcot joint) and in my experience can cause a cycle where the patient needs to be treated every 5-18 months forever. In addition, my personal observation is that these patients get more “brittle” with time. By that, I mean that when their pain returns it’s worse and easier to provoke than before RFA was begun.

The RFA Biz Plan

Radiofrequency is a great medical business. Not only do these patients need to come back every so often for a repeat treatment, but insurance companies pay more for RFA than a simple facet injection. In addition, there’s a third party vendor who gets to charge outrageous prices for disposable needles and new RF probes, which means that there’s lots of moolah around to sponsor conferences, pay physician thought leaders, and medical directors. Hence, knowing that money talks in medicine, it’s not hard to figure out why those thought leaders have been trying to get rid of facet injections (i.e. injecting a substance into the joint rather than burning the nerves around the joint). as the idea competes with RFA. However, with the advent of orthobiologics like PRP and stem cells, everything changes.

READ THE REST HERE

April 18, 2017

MINNETONKA, Minn., April 13, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 24-month CT Fusion and Clinical Results for its SImmetry Sacroiliac Joint Fusion System. This prospective, multi-site study evaluated long-term fusion and pain reduction in patients receiving SImmetry^® Sacroiliac Joint Fusion.

The study evaluated 18 patients for radiographic evidence of fusion at 12 and 24 months following SI joint fusion with decortication and bone grafting. A systematic Computed Tomography (CT) review was predefined and performed by independent radiologists blinded to each other’s assessments. Fusion was defined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). Previously-reported results demonstrated that 79 percent of patients had evidence of bridging bone at 12 months. At 24 months post-op 94 percent of patients had evidence of bridging bone, with 83 percent categorized as Solid fusion across the SI joint. Of patients with Solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. There were no procedure- or device-related serious adverse events reported.

“Evidence is continually building to support sacroiliac (SI) joint fixation’s ability to effectively reduce pain in patients with SI joint disorders,” said Dr. William W. Cross III, an orthopedic surgeon specializing in pelvic disorders from Mayo Clinic in Rochester, MN who presented the data at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting. “This study demonstrates the ability of the SImmetry system to achieve pain reduction comparable to other systems, while providing radiographically evident fusion as early as 12 months and increased fusion rates at 24 months. By supplementing fixation with decortication and bone grafting, I can be confident that my patients have the best possible foundation for biological fusion, and long-term relief.”

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsⁱ. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointⁱⁱ.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. The Company is exhibiting at the 2017 ISASS meeting in Boca Raton, Fla. until April 14. For more information, visit zyga.com.

ⁱ Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ⁱⁱ Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com

MARIETTA, GA (PRWEB) APRIL 13, 2017

Leading spinal solutions provider Amendia, Inc. is pleased to announce the acquisition of Spinal Elements, Inc., a Carlsbad, California-based corporation.

“The acquisition of Spinal Elements brings a wealth of talent and a portfolio of exciting new products to the Amendia organization,” stated Chris Fair, CEO and President of Amendia, Inc. “The combination of these two companies solidifies our position as one of the fastest growing and most comprehensive spine companies in the marketplace today,” continued Fair.

Jason Blain, President of Spinal Elements, added, “Together, the company moving forward will provide a robust portfolio of spine products featuring titanium-coated PEEK interbody technology. We are thrilled about what lies ahead.”

Spinal Elements’ clinically proven Ti-Bond® porous titanium coating and upcoming product launches of the Lucent XP expandable cage and the Clutch interspinous process device, will complement Amendia’s recent launches of the Overwatch pedicle screw system, Syzygy reduction screw system and the Ceres cervical product lines.

Media inquiries should be directed to Steve McAllister, EVP and Chief Financial Officer at 770-575-5201.

About Amendia

Headquartered in a state-of-the-art manufacturing facility in Marietta, Georgia, Amendia is a leading designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Amendia’s mission is to exceed surgeon and patient expectations by creating balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders. For more information, please visit http://www.amendia.com.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefitting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit http://www.spinalelements.com.