Simplify Medical Announces First Patient Treated in U.S. Pivotal Trial Of MRI-Optimized Cervical Artificial Spinal Disc at Two Adjacent Levels

April 12, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical, Inc., maker of the Simplify® cervical artificial disc, today announced that the first patient has been treated in the device’s pivotal clinical trial studying its use in two adjacent levels of the spine as a treatment for cervical degenerative disc disease. The Simplify Disc is designed to be clearly viewed on magnetic resonance imaging (MRI) without the artifact that can result from metal used in typical spine implants, potentially protecting patients from radiation associated with computed tomography (CT) scans.

Following the first case at Texas Back Institute, Simplify Disc IDE study investigator John Peloza, MD said, “Disc implantation went smoothly and the patient is doing quite well.” Dr. Peloza, medical director of the Center for Spine Care, continued, “I look forward to studying the use of the Simplify Disc at two levels, in collaboration with the Texas Back Institute team. I believe the Simplify Disc’s anatomic design with lower heights can help minimize overdistraction, which may improve outcomes in multi-level procedures.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “We are excited to start the Simplify Disc Two-Level IDE study. The device is made of materials designed to optimize its viewing and viewing of the adjacent spinal canal on MRI without artifact. This may eliminate or minimize the use of post-operative CT scans and reduce the risk of the associated radiation to the patient.”

The prospective, randomized controlled Simplify Disc pivotal trial will encompass up to 215 patients at up to 15 centers and will compare cervical implantation of two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The composite primary endpoint includes functional improvement, pain relief and safety. The national co-principal investigators are Domagoj Coric, MD, chief of the department of neurosurgery, Carolinas Medical Center, and Dr. Guyer. For information about eligibility or enrollment in the two-level pivotal trial, please visit http://www.simplifytrial.com/.

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimize patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability. Implantation of the Simplify Disc is accomplished in a simple, three-step procedure. The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.

“We have designed the Simplify Disc to be responsive to surgeons’ needs, providing them with the potential to improve patient outcomes,” said David Hovda, Simplify Medical Chief Executive Officer. “We are enthusiastic about moving forward with the pivotal trial.”

The Simplify Disc is also enrolling patients in a second pivotal trial comparing one-level cervical implantation of the disc between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. More information about the one-level clinical trial is available at www.SimplifyTrial.com.

The Simplify Disc has received the CE Mark and has been used to treat more than 600 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an Investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications, Inc.
Michelle McAdam, (949) 545-6654
michelle@chronic-comm.com

Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform

April 12, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR)(NASDAQGM: MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.

Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.

According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”

Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.

During AANS, Mazor Robotics will be hosting the following special presentations at booth #1423:

Presentation: Clinical Experience with Mazor Robotics Guidance Systems
Presenter: Dr. Jae Y. Lim
Date: Monday, April 24
Time: 1:00 – 2:00 pm

Presentation: Initial Case Series with Mazor Robotics’ Next Gen System: Mazor X™
Presenter: Dr. Donald M. Whiting
Date: Monday, April 24
Time: 3:30 – 4:00 pm

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the benefits of the Company’s products, the timing of release of Mazor X Align, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Brian May Joins Spine Wave as Executive Vice President, Research and Development

SHELTON, CT–(Marketwired – April 12, 2017) – Spine Wave, Inc. is a fast growing, privately held company committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that Brian May has joined the Company as Executive Vice President, Research and Development.

Mr. May brings extensive experience in the orthopedics market and was most recently at Zimmer Biomet where he was one of the two directors running Product Development for the Zimmer Biomet Knee Reconstruction business. Brian is a seasoned leader with a proven track record in orthopedic product development. He joined Zimmer in 2015 via the Biomet acquisition where he spent the previous 13 years of his career. Mr. May holds a Bachelor of Science degree from University of Illinois and a Master of Science in Bioengineering from Clemson University.

As Spine Wave continues to expand its portfolio with differentiated products, Mr. May will lead the extensive research and development efforts. “I am pleased to have someone with Brian’s proven leadership ability join the Spine Wave team,” said Mark LoGuidice, Spine Wave’s Chief Executive Officer. “Biomet grew nearly tenfold during Brian’s tenure and that firsthand experience will prove invaluable to Spine Wave as we position ourselves for the next phase of significant growth.”

“I am excited to join Spine Wave, a company with a proven history of developing and commercializing innovative products,” said Mr. May. “Spine Wave has several important product launches scheduled for 2017 which will significantly broaden the company’s offering and which have the potential to generate robust and sustainable growth for the foreseeable future. I look forward to contributing to Spine Wave’s continued growth and evolution.”

About Spine Wave
Spine Wave’s vision is to leverage our intellectual property portfolio and engineering expertise to deliver a steady stream of highly differentiated spinal technologies with a particular emphasis on expandable interbody devices. Spine Wave’s portfolio of expandable products now includes the Velocity® Interbody Device, the Leva® Interbody Device and the StaXx® family of products, of which over 50,000 devices have been implanted. Other novel products in the portfolio include the Annex® Adjacent Level System, the Sniper® Spine System, which has developed a reputation as a leading MIS screw system, and the recently acquired True Position® Pivoting Spacer System which is comprised of a “crescent-style” interbody device and a unique delivery mechanism which simplifies accurate and reproducible placement of the implant. Spine Wave is committed to delivering a robust pipeline in 2017 and 2018 that will allow the company to address every major spine market segment with a highly differentiated offering.

For further information on all the Spine Wave products please visit the Company’s website at www.SpineWave.com.

Contact:
Terry Brennan
Chief Financial Officer
Email contact

203-712-1810

Texas Back Institute first in the US to provide herniated disc repair using Anchor Orthopedics’ Technology

PLANO, TX, April 11, 2017 /PRNewswire/ – Texas Back Institute continues to lead the way in spine surgery by being the first in the US to use the AnchorKnot® Tissue Approximation Kit, a novel technology for use in herniated disc repair.

Dr. Scott L. Blumenthal, board-certified orthopedic spine surgeon, physician executive with Texas Back Institute and Co-Medical Director of Center for Disc Replacement, performed a discectomy procedure on a young patient in February 2017. This patient was the first in the US to undergo herniated disc repair using the AnchorKnot® Kit.

Lumbar disc herniation is one of the most common causes for back surgery, and can occur from injury or disc degeneration.  In both cases, material from a damaged disc presses on the spinal nerve, causing many patients to experience pain, which can significantly decrease their quality of life.  A standard discectomy procedure offers effective relief; however, it commonly results in a defect that until now, has been difficult to repair without specific tools. Studies have shown that 10-15% of patients could suffer a reherniation through this defect.

The Texas Back Institute completed nearly 500 discectomy cases in 2016. Dr. Blumenthal comments that “most discectomy procedures are left to heal through the body’s scar tissue which could take 6 weeks or more, so if approximating the tissue can return patients to function and to rehab earlier then this could be a real benefit to patients.”  Dr. Blumenthal indicates that there has been literature and commercial attempts in the past and “with appropriate studies and follow-up this could be a game changer for patient outcomes.”

“As an experienced medical device company, we have worked closely for numerous years with surgeons to design the AnchorKnot®Tissue Approximation Kit for use in herniated disc repair.  It is a tremendous honor for Anchor Orthopedics to have our first US clinical partner at the Texas Back Institute,” said Neil Godara, General Manager. “Our goal is to design clinically meaningful products that improve the lives of patients around the world. We look forward to offering the AnchorKnot® Tissue Approximation Kit to patients in need of a discectomy procedure, and continuing to collaborate with Dr. Blumenthal and his team at the Texas Back Institute.”

About Anchor Orthopedics

Anchor Orthopedics XT Inc., the developer of the AnchorKnot® Tissue Approximation Kit, aims to provide surgeons with novel solutions that optimize procedures in disc repair in an effort to preserve the biomechanics of the patient and improve surgical outcomes. Our mission is to work closely with surgeons on all aspects of development to create clinical solutions that serve to improve the lives of patients around the world. Anchor Orthopedics XT Inc., located in Mississauga, Canada, is a subsidiary of Baylis Medical Company Inc.

PRM-00194 EN J-1 V-1 © Anchor Orthopedics XT Inc., 2017. Anchor Orthopedics XT and AnchorKnot are trademarks and/or registered trademarks of Anchor Orthopedics XT Inc. in the USA and/or other countries. All other trademarks are the property of their respective owners. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use. The AnchorKnot Suture Passer (2-0) is an accessory of the Anchor System. The Anchor System is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the Anchor Endoscope and accessories are intended to aid the surgeon’s visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the Anchor System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). Patents pending and/or issued.

Media Contact Person:
Ester Kwok
Global Product Manager
ekwok@anchorortho.com
Tel: 647-484-0662 ext 388
Anchor Orthopedics XT Inc.
http://www.anchorortho.com

SOURCE Anchor Orthopedics

Intellijoint Surgical® Completes One Thousand Total Hip Replacement Procedures with intellijoint HIP®

WATERLOO, ON, April 11, 2017 /PRNewswire/ – Intellijoint Surgical® is proud to announce that intellijoint HIP® has now – only one year after commercial launch – been used in over 1,000 total hip replacement procedures in the United States, Canada and Australia.  intellijoint HIP® is a novel medical device providing 3D mini-optical navigation for orthopaedic surgeons.  The one thousandth case using intellijoint HIP was completed by Dr. Peter Sculco, Orthopaedic Surgeon, Hospital for Special Surgery in New York City. Surgeons who also performed a procedure using intellijoint HIP the day of this milestone include: Dr. Jeffrey Goldstein, Dr. Alejandro Gonzalez Della Valle, Dr. Ritesh Shah, and Dr. Jonathan Vigdorchik.

“All surgeons want to provide the best outcome for their patients.  A hip replacement should strive to replicate native anatomy as this best optimizes muscle function and overall recovery.  When it comes to a successful hip surgery, nature knows best and intellijoint HIP provides me with the real-time information I need to better replicate patient anatomy,” commented Dr. Peter Sculco. “Intellijoint empowers me to more accurately restore hip biomechanics which leads to satisfied patients and a rewarding clinical practice.”

To publicly acknowledge and thank the many healthcare professionals involved in early adoption of intellijoint HIP, Intellijoint Surgical has launched 1000 Thanks – a digital collage featuring those who were a part of the first 1,000 procedures. Each photo was taken using intellijoint HIP‘s novel 3D mini-optical camera in a “selfie” style to capture the individual in their work environment. Orthopaedic surgeons, nurses, physician assistants, surgical technicians, clinical coordinators, implant technicians and more from New York, Greater Chicago, Toronto, and surrounding area hospitals all volunteered to participate in this initiative.

“Reaching 1,000 procedures in year one of sales is a significant milestone for our company,” said Armen Bakirtzian, CEO and Co-Founder of Intellijoint Surgical. “We wouldn’t be here without the great teams of surgeons, nurses, OR staff and administrators focused on improving care for their patients.”

Intellijoint continues to grow aggressively within its existing markets and plans to expand to new markets early this summer.

About Intellijoint Surgical:

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

SOURCE Intellijoint Surgical Inc.

Related Links

https://www.intellijointsurgical.com/

Safe Orthopaedics Products Listed by AP-HP Paris Hospitals

April 10, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, is today announcing that its principal products for thoracolumbar spinal fusion have been listed by AP-HP (Assistance Publique – Hôpitaux de Paris, the main hospital authority serving Paris and its suburbs).

This listing with AP-HP means that Safe Orthopaedics products are available in 39 hospitals in Paris, including 15 active in spinal surgery, together accounting for around one-quarter of the French market.

To support the growing activity in the Paris region and capitalize on this listing from the outset, the Company has hired a sales manager for the Paris region, backing up the teams already covering largely south-east and south-west France.

Upon the introduction of its products, Safe Orthopaedics had initially decided to focus on development in the regions with the assistance of expert salespeople possessing very strong local roots in a bid to firmly establish its credibility. The addition of dedicated sales coverage for the Paris region represents another crucial stage in the Company’s development.

Aside from the AP-HP approval, the new sales manager for the Paris region will be able to build on the relationships already established with hospitals in the Paris region. These include Kremlin-Bicêtre teaching hospital where it has conducted a trial demonstrating the benefits of Safe Orthopaedics’ single-use instruments for spinal surgery2.

All the thoracolumbar ranges have been successfully listed with AP-HP. SteriSpine PS and SteriSpine LC can cover requirements for the bulk of trauma and degenerative surgeries performed at these hospital facilities.

“We are proud of the work done by our sales teams, which has resulted in our products being listed by AP-HP Paris hospitals. This represents a very important step forward in the expansion of our business. It will boost our sales not only in the Paris region but also in all the major public and private hospitals in France, given the value of such a listing.” said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics.

About AP-HP

AP-HP is a globally renowned and leading European hospital authority. Every year, its 39 hospitals treat 8 million sick people, providing consultations, emergency and scheduled in-patient treatment and in-home healthcare. It provides public healthcare services round-the-clock, which it regards both as a duty and a source of pride. AP-HP is the Paris region’s leading employer, with its workforce of 100,000 doctors, research scientists, paramedics, administrative and blue-collar staff. For further information: www.aphp.fr

Next Financial Release

Full-year 2016 results: April 28, 2017 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

1 Source: Safe Orthopaedics
2 See the “A Randomized Study Confirms the Benefits of Safe Orthopaedics’ Products in a Leading French Teaching Hospital” press release dated October 20, 2016.

Contacts

Safe Orthopaedics
Thierry Lambert, Tél.: +33-(0)1-34-21-50-00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél.: +33-(0)1-44-71-94-94
SafeOrtho@newcap.eu

IPG and DJO Announce Partnership to Deliver High Quality Affordable Care

April 11, 2017

ATLANTA–(BUSINESS WIRE)–IPG, the industry-leading provider of Device Benefit Management solutions, announced an innovative new partnership with DJO Global, Inc. and its Surgical Division. DJO Global is a leading global provider of medical technologies designed to get and keep people moving. With DJO’s broad range of products, used for rehabilitation, pain management, physical therapy and surgical reconstruction, the partnership further enables high quality, cost effective care and supports the delivery of value based care for high cost surgical procedures for IPG’s health plan clients and patients.

“As health plans look to set up the right structure that aligns incentives in support of value based reimbursement, the IPG program truly sets the stage to drive quality and affordability from optimal device selection and utilization, and site of care to truly impact surgical costs. DJO Surgical’s products contribute to lowering surgical costs and patient out of pocket costs. A true win-win,” said Mark Russell, Senior Vice President of Sales, Marketing and Commercial Logistics for DJO Surgical.

The IPG platform enables surgeons, facilities and device manufacturers to play an active role in the delivery of cost effective surgical care. DJO’s focus on value-driven implant systems and state-of-the-art technology strongly aligns with IPG’s mission of ensuring and enabling the delivery of high quality, cost effective surgical care.

“We are thrilled to work with innovative high quality manufacturers like DJO, who focus on lowering total episodic care through surgical efficiency for patients and health plans,” said Vince Coppola, President and CEO of IPG. “These partnerships continue to expand our ability to deliver on our cost and quality objectives for our health plan clients. Since our programs align incentives and goals between surgeons, facilities, health plans and manufacturers, DJO is now part of the team with the important mission of making health care more affordable.”

DJO’s surgical portfolio includes a full suite of advanced solutions for hip, knee and shoulder arthroplasty with an emphasis on incorporating modern technology while capturing both surgical and cost efficiencies that will be accessible to IPG’s expansive network of direct partnering facilities and surgeons.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

About IPG

IPG is the leading provider of Device Benefit Management solutions, working with health plans, manufacturers, providers, surgical facilities and patients across the country to improve quality and reduce costs for surgical procedures through optimization of the most effective site of care and device selection, resulting in more affordable high-quality care to consumers. For more information about IPG, call us at 866.753.0046, or visit us on the web at www.ipg.com.

Contacts

IPG
Kerry Lee Perry, 866-753-0046
kperry@ipg.com
or
DJO Surgical
A DJO Global Company
Kristin Barnebey, 512-826-5284
Kristin.Barnebey@DJOglobal.com

BONESUPPORT™ appoints Michael Diefenbeck as Chief Medical Officer

Lund, Sweden, 11th April, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the appointment of Michael Diefenbeck MD PhD as Chief Medical Officer.

Dr Diefenbeck founded Scientific Consulting in Orthopaedic Surgery in 2014 and has worked for BONESUPPORT on a range of clinical projects related to CERAMENT™ as an independent clinical advisor.

He is currently honorary consultant at Nuffield Orthopaedic Centre, Oxford University Hospitals. Dr. Diefenbeck studied medicine at Munich and was trained as an orthopaedic surgeon, specializing in trauma care and bone infections. He has 14 years’ clinical experience at different German hospitals (BG Unfallklinik Murnau, BG Kliniken Bergmannstrost Halle/Saale, University Hospital Jena and Schön Klinik Hamburg Eilbek). At University Hospital Jena he finished his PhD in 2011 and has since been involved in surgical education and training programs for students. He is author of 24 Pub-med listed research articles.

Dr Diefenbeck said: “I am excited to be joining BONESUPPORT at a particularly exciting time for the Company. I look forward to working with the BONESUPPORT team, to help shape the future development of the Company as it continues to develop and reinforce the clinical benefits that its CERAMENT based products deliver.”

Richard Davies, CEO of BONESUPPORT, said: “We are pleased to welcome Michael to the BONESUPPORT team. I have no doubt that his extensive medical experience in the orthopaedics field and his knowledge of our CERAMENT platform that he will be a real asset to BONESUPPORT as we look to grow our business and deliver value to all of our stakeholders.”

Dr Diefenbeck began his new role in April 2017 and reports to the CEO.

 

Contact Information

Citigate Dewe Rogerson

David Dible, Mark Swallow, Pip Batty

+44 (0)20 7282 2949/2948/1022

bonesupport@citigatedr.co.uk

 

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

 

Pip Batty

Account Manager

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922

Email: Pip.Batty@citigatedr.co.uk

 

Citigate Dewe Rogerson

3 London Wall Buildings

London Wall

London EC2M 5SY

 

Web: www.citigatedewerogerson.co.uk

Twitter: @CDRLifeSciences

LinkedIn: CitigateDeweRogerson / PipBatty

K2M Group Holdings, Inc. & LifeHealthcare Group Limited Announce New Distribution Agreement for Australia & New Zealand

LEESBURG, Va., April 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (“K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, and LifeHealthcare Group Limited (ASX:LHC) (“LifeHealthcare”), a leading independent provider of medical devices and healthcare solutions in Australia and New Zealand (ANZ), today announced that the two companies entered into a new supply agreement for the distribution of K2M’s innovative spinal technologies.

The K2M/LifeHealthcare distribution partnership, which dates back to 2010, has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare have entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.

Matt Muscio, LifeHealthcare’s CEO, stated, “I am very pleased to announce our new five-year contract with K2M through 2021. K2M is a globally recognized innovator in complex spine, having led the way in deformity and now minimally invasive and 3D-printed spine solutions. Through our partnership, we have delivered highly successful product initiatives, such as the EVEREST® MI XT and MESA® platforms, and market leading education forums, such as Deformity Down Under, to address the needs of Australian and New Zealand clinicians and their patients. We look forward to working with Eric Major and the K2M team over the coming years to reach our shared aspiration of the number one market share position in the Australian and New Zealand spine market.”

Eric Major, K2M’s President and CEO, stated, “LifeHealthcare has been an important strategic partner of ours for many years and their established distribution presence and strong surgeon relationships have been instrumental in K2M’s strong market share growth in Australia and New Zealand. We are happy to announce our new agreement and look forward to offering innovative spinal technologies, such as our EVEREST MI XT Spinal System, our industry-leading 3D-printed CASCADIA™ Lateral Interbody System, and our comprehensive Balance ACS platform focused on achieving three-dimensional spinal balance, to surgeons in this important international spine market.”

For more information about K2M, visit www.K2M.com. For more information about LifeHealthcare, visit www.lifehealthcare.com.au.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™. Since its inception, K2M has designed, developed and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

About LifeHealthcare

LifeHealthcare Group Limited is a leading independent provider of healthcare solutions in Australia and New Zealand across clinically specialized therapeutic channels bringing Australian and New Zealand healthcare professionals innovative medical devices by partnering with world class companies who share the vision of innovation and making a real difference to people’s lives.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

K2M Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com 

LifeHealthcare Contact:
Kristine James				              
General Manager Corporate Development		  
+61 2 8114 1534					 
kristine.james@lifehealthcare.com.au

OMNIlife science™, Inc. And Global Orthopaedic Technology Enter into Licensing Agreement for APEX™ Knee System

RAYNHAM, Mass. and SYDNEY, April 7, 2017 /PRNewswire/ — OMNIlife science™, Inc. (“OMNI™”) and Global Orthopaedic Technology Pty Ltd. today announced an exclusive licensing agreement for OMNI’s ‘s APEX™ Knee Implants for Australia, New Zealand and South Africa.

Under the terms of the agreement, Global Orthopaedic Technology will acquire exclusive rights to manufacture, market and distribute the APEX™ Knee Implants in the three countries listed above. Global will continue to market OMNI’s OMNIBotics® robotic-assisted total knee and computer-assisted total hip replacement technology in the agreed markets under a separate distribution agreement. In addition, OMNI will continue to market Global’s Paragon Hip Implants in the United States also under a separate distribution agreement.

“The clinical performance of the APEX™ Knee in Australia, aided by OMNIBotics and other advanced implant delivery systems, continues to drive APEX™ knee growth in Australia,” said Rick Randall, OMNI CEO. “Licensing the knee implants to Global ensures the APEX™ Knee will continue to expand in the evidence-based Australian healthcare market and provide OMNI non-dilutive capital to support the demand for robotic-assisted total joint replacement products in the large U.S. orthopedics market.”

“Following six years of successful distribution of the APEX™ knee in Australia we believe the time is right for Global to secure the license and long term tenure for the product,” commented Andrew Fox-Smith, Global CEO. “The proven clinical success of the APEX™ Knee in conjunction with emerging technologies out of Australia, will provide Global with solid foundations for future development and growth.”

About OMNI
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

About Global
Global Orthopaedic Technology Is the largest Australian-owned orthopaedic implant designer and manufacturer.  Through strong engagement with some of Australia’s leading surgeons, universities and researchers, Global endeavours to lead the way in the distribution and development of new and innovative products   to meet the needs of both the surgeons and their patients. Global provides an extensive range of orthopaedic implant solutions from early intervention through to complex end stage surgery for both knee and hip replacement surgery. The hip and knee portfolio is also complimented by a suite of enabling technologies including robotics, patient specific instrumentation and planning tools, designed to improve efficiencies and optimise patient outcomes throughout the continuum of care. For more information about Global, please visit www.globalortho.com.au.

Forward-Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including statements using the terms “plans,” “believes” or similar expressions are “forward- looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI,  increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release

Contact
Cindy Holloway, Director of Marketing Communications Phone: (508) 824-2444

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com