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

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/

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

Paragon 28 announces launch of 12 unique titanium wedges to address flatfoot deformities-TITAN 3-D™ Wedge System

ENGLEWOOD, Colo., April 6, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The TITAN 3-D™ Wedge System builds on Paragon 28’s portfolio of osteotomy wedges and uses the same patented shapes as the PRESERVE™ Evans and Cotton Wedges.  These porous titanium wedges offer surgeons an alternative to autograft and allograft bone.

The TITAN 3-D™ Wedges have an open geometry with a three-dimensional scaffold that allows for blood entry, bone through growth, and the incorporation of biologics if used. Each wedge has a central opening which allows for passage of a 3.5 or 4.0mm screw across the osteotomy to help increase stability of the construct.  In order to ensure accurate and consistent placement of this crossing screw, both wedge families leverage the patented PRECISION GUIDE™ System. Unlike many competitive implants, Titan 3-D™ Wedges do not require the use of an ancillary surface plate. To increase the coefficient of friction and minimize the chance of implant expulsion, the TITAN 3-D™ wedges are built with spikes which interface with bony surfaces.  To facilitate accurate implantation, the system includes product specific inserters which thread onto the back of each wedge and have a strike plate to aid in final seating. The system also includes resection guides which limit excessive bone removal if explanation is required.

Paragon 28 is grateful for the significant contributions Dr. Thomas Chang, DPM Sutter Health, Santa Rosa, CA, made as surgeon designer of this system.

About Paragon 28 Inc.

Paragon 28, Inc was established in 2010 to address the unmet and under-served needs of the foot and ankle community. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

www.paragon28.com

 

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com

Alphatec Spine Adds Experienced Spine Executives to Sales Leadership Team

CARLSBAD, Calif., April 05, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC), and a provider of spinal fusion technologies, announced today the addition of two new sales executives with proven track records in the spine industry, naming James (Jim) Duffy as Area Vice President, U.S. Sales, South, and Greg Rhinehart as Area Vice President, U.S. Sales, East.  Drawing on their deep commercial spine experience, Messrs. Duffy and Rhinehart will be responsible for expanding the Company’s presence in the Southern and Eastern United States, respectively, including continuing to build dedicated sales agent relationships, targeting new customer and market opportunities, and providing service and support for existing surgeon customers.

“I’m excited to welcome Jim and Greg to the Alphatec family as we continue to build out a strong sales leadership team that is focused on driving sustainable growth and improving patient outcomes,” said Terry Rich, Alphatec Spine’s Chief Executive Officer. “Jim and Greg bring tremendous track records to Alphatec and they will be instrumental in recruiting and developing top distributors and sales talent to deepen our engagement with surgeons and build greater awareness and adoption of our differentiated products.  I look forward to working with both leaders as we accelerate our sales strategy and aggressively work to become the fastest growing company in spine.”

Jim Duffy Named AVP Sales, South Region

Mr. Duffy brings over 25 years of progressive spine and orthopedic sales leadership experience to Alphatec, including a proven history of building strong distributor relationships and dedicated distribution channels.  Mr. Duffy joins Alphatec from Zimmer Biomet Spine, where he was the Sales Vice President for the East region of the United States following Zimmer’s merger with Biomet, and was responsible for the strategic integration and management of the distribution channel.   Prior to Zimmer Biomet, Mr. Duffy served as the Area Vice President of Sales for Zimmer Spine.  Earlier in his career, Mr. Duffy served in a number of district and regional sales leadership roles, including at KARL STORZ Endoscopy-America, Medtronic Spinal and Biologics, and at Synthes Spine.

Mr. Duffy holds a Bachelor of Science in Business Management from Westfield State University.

Greg Rhinehart Named AVP Sales, East Region

With over two decades of spine and orthopedic sales leadership experience, Mr. Rhinehart brings significant expertise to Alphatec in developing high-performing sales organizations, and driving expansion and revenue growth.  Prior to joining Alphatec, Mr. Rhinehart was the Vice President of Sales at Medicrea.  Before that, Mr. Rhinehart held senior sales leadership roles at Globus Medical, Inc., where he most recently served as the Vice President of Sales for the Central U.S. region—a position he held for nine years.  Under his leadership at Globus, Mr. Rhinehart successfully built a new sales organization to continue Globus’ expansion in the Central U.S., significantly growing annual revenues.  Prior to joining Globus, Mr. Rhinehart held multiple sales leadership roles in spine and orthopedics at DePuy Spine, Medtronic, Sulzer-Spinetech and DePuy Orthotech.

Mr. Rhinehart holds a Bachelor of Science in Business Administration from Ohio State University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec Holdings Inc.’s 2016 Employment Inducement Award Plan (the “Plan”), on March 30, 2017, the Compensation Committee of the Board of Directors of Alphatec Holdings, Inc. approved the following inducement awards:

  • Mr. Duffy: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.
  • Mr. Rhinehart: 25,000 restricted stock units (RSUs) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan.  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, which was March 31, 2017 for Mr. Rhinehart and April 4, 2017 for Mr. Duffy, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (the first date of employment). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company markets products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to successfully expand in certain geographic regions, launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement.  Please refer to the risks detailed from time to time in Alphatec Holdings’ SEC reports, including its Annual Report Form 10-K, as well as its other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Aesculap Launches Novel Spine Device Warranty on its Plasmapore®XP Surface

CENTER VALLEY, Pa., April 6, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC, a medical device company with long-standing expertise in applying biocompatible surface treatments to orthopaedic implants, announced today a new warranty program on its established portfolio of surface-enhanced interbodies for spinal fusion. This warranty announcement coincides with the launch of the TSpace®XP interbody system, treated with PlasmaporeXP surface enhancing technology. The warranty offers participating facilities a device replacement in the instance of a reoperation because of clinically-relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician’s ability to visualize adjacent anatomy. This is the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine industry warranting against both delamination of a surface enhancement and the ability to visualize an implant without artifact.

This new Aesculap warranty on PlasmaporeXP devices differentiates the technology from other manufacturers who have less widely studied surface coated or otherwise enhanced spinal fusion interbodies. The current U.S. spine market favors PEEK, a medical grade plastic, for fusion. However, PEEK alone may lack the biocompatible characteristics necessary to stimulate a lasting fusion. For this reason, some spinal implant manufacturers are going back to all titanium implants; however, this structural material may create intraoperative and postoperative visualization issues which may jeopardize the safety profile for patients.

Aesculap began developing its expertise in surface enhancements with its BiContact™ Universal Hip System in 1986 and was first to the U.S. spine device market with surface-enhanced PEEK-OPTIMA®* interbodies for spinal fusion applications. Aesculap’s experience, with more than 20,000 PlasmaporeXP devices implanted to date plus results from over 20 clinical studies, provided the foundation to offer the device warranty.

According to Chuck DiNardo, President of Aesculap Implant Systems, LLC, “In the consumer market, if a product does not meet expectations, the purchaser expects a money-back type of guarantee. This has not been the norm in the device market. We created a program to demonstrate to healthcare providers that we believe in our product, our clinical data and our long-standing experience and ultimately share their goal of a lasting treatment for their patients’ chronic back issues.”

As a forerunner in surface enhancing technology, Aesculap’s proprietary process applies a pure titanium surface that is porous, osteoconductive and biocompatible to the core of each PlasmaporeXP implant on the top, bottom and lateral surfaces. Based on the global success of this surface enhancing technology, Aesculap has developed a full portfolio of PlasmaporeXP devices like the newest TSpace interbody to address a variety of degenerative spinal indications and approaches.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com/xp.

*PEEK-OPTIMA is a registered trademark of Invibio Limited.

SOURCE Aesculap Implant Systems, LLC

SpineGuard Raises €2Million of Fresh Equity Finance

April 06, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, has announced the completion of a €2 million round of fresh equity.

These proceeds will be used to support SpineGuard’s growth strategy: accelerate the adoption of its smart drilling devices for spine fusion and the development of innovations derived from its proprietary DSG™ technology platform.

There were two steps for this round of fresh equity finance:
i) Round 1 in favor of a limited number of European institutional investors
ii) Round 2 in favor of certain managers, directors or consultants of the Company

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “Following the successful launch of PediGuard Threaded and the first surgeries performed with our DSG™ integration module for ‘single-step’ screw insertion, these new proceeds will enable SpineGuard to reinforce DSG™ technology’s position as standard of care. I would like to warmly thank all those who subscribed to this equity round.

Terms of the equity funding

488,190 new ordinary shares with a nominal value of 0.20 Euros each have been created of which:

451,250 new ordinary shares issued in favor of a limited number of institutional investors in accordance with resolution #23 of the Extraordinary Shareholders meeting held on the 25th of June 2015 and in compliance with article L. 411-2 II of the French Monetary Code (Code monétaire et financier);

36,940 new ordinary shares issued in favor of certain managers, directors or consultants of the Company in compliance with the categories listed under resolution #10 of Extraordinary Shareholders meeting held on May 11, 2016, and in compliance with article L.225-138 of the French Code of commerce;

The issue price of the new shares is 4.00 euros per share, representing a discount of 9.37% to the weighted average share price of the last 20 days of trading prior to the funding;

The clearing and settlement (règlement-livraison) should take place by April 12, 2017.

A shareholder holding 1% of the Company’s shares prior to the equity funding that would participate to it would end with 0.91%.

Use of proceeds

The net proceeds strengthen SpineGuard’s financial resources, open up additional sources of funding and with its already existing resources1 will fund the implementation of its strategy, in particular:

– To reinforce its primary commercial focus on the US market and support certain geographies with strong potential for sales of the DSG™ technology;

– Business Development activities to sign new partnerships with the spine industry for co-developing other DSG™ Smart Screws;

– To broaden its proprietary technology offerings to new applications and functions (combination with surgical robots, bone quality measurement, entry point determination) as well as new surgical fields beyond spine (joint reconstruction, trauma, maxilla facial or dental).

Listing of the new shares

The new shares will bear the same rights than existing shares. They will list on Alternext Paris under the same ISIN code as the existing shares FR0011464452. The new shares should be listed and available for trade on Alternext Paris on April 10, 2017.

Once the equity funding is complete, the total number of issued shares will be 5,601,215.

Pursuant article 211-3 of the General Regulations of the Autorité des Marches Financiers (AMF), this operation does not require a prospectus submitted to the approval of the AMF.

SwissLife Banque Privée acted as sole manager and book runner for this equity funding.

Next financial press release: 2016 Half-year revenue: July 6, 2017

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

1 The Company had €1,804k of cash at hand, is planning to receive €230k for French CIR 2016 and, under certain conditions starting 30 Sep.2017, can draw the third tranche of IPF loan for € 1,500k (refer to Note 17 of “2016 Rapport financier of the company)

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

EOS imaging Announces First Sale of EOS System in Israel

April 05, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the first sale of an EOS platform in Israel to Tel Aviv Sourasky Medical Center. The EOS platform has now been sold in 33 countries. The EOS platform is expected to be installed in April at The Dana-Dwek Hospital, one of the four main hospitals that make up the Tel Aviv Sourasky Medical Center.

Tel Aviv Sourasky Medical Center (TAMC) is the second largest and one of the most progressive full-service healthcare treatment and research institutions in Israel. As a premier multidisciplinary academic medical center, the Center serves the greater Tel Aviv metropolitan area population of 3.5 million people accounting for over 42% of the entire population of Israel. TAMC is a national referral center for many major primary and specialty care services.

Marie Meynadier, CEO of EOS imaging, said, “We are pleased that Tel Aviv Sourasky Medical Center is the first site in Israel to acquire an EOS platform. Given its status as a national reference site for orthopedic care, a large number of Israeli patients will now have access to our technology. In addition, this sale further expands our global installed base and provides incremental validation for the EOS system and associated services.”

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
+33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
Media Relations
Annie-Florence Loyer
+33 (0)1 44 71 00 12 / 6 88 20 35 59
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Medovex Corporation Partners with Technology Consult Berlin GmbH in Germany

ATLANTA, GA–(Marketwired – Apr 5, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has entered into a partnership with TCB – Technology Consult Berlin GmbH for distribution of its Denervex™ system throughout Germany. TCB is expected to provide sales, marketing and distribution services.

TCB, is a associated partner of Kalms & Partner Consulting (http://www.kalmsconsult.com/) based in Berlin, Germany offers a complete consultancy service for medical device manufacturers and selected services for pharmaceutical companies. The company offers sales and marketing, full distribution services, strategic and operational support in the fields of market access, health economics, reimbursement and business development.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “TCB – Berlin in Germany serves as a perfect call point fit for our mission to provide a successful distribution, sales and marketing foundation for our entry and expansion of our footprint of the DenerveX System in the most important market in Europe.”

On March 13, 2017, the Company previously announced that the reimbursement authority in Germany had renewed reimbursement payment coding for the DenerveX System technology for the treatment of the Facet Joint Syndrome for 2017.

The renewed reimbursement coding, effective immediately, was released in the Diagnosis-Related Group (DRG) system in 2017 in Germany. This new coding allows for hospitals and outpatient centers to receive reimbursement for the use of the DenerveX System for the treatment of the Facet Joint Syndrome in the spine.

According to Dennis Moon, Executive Vice President of Medovex, “The renewal of the reimbursement code for 2017 in Germany will be a significant driver for our European launch preparation for the DenerveX System. We look forward to targeting the German market through our new relationship with TCB – Berlin as the country is often recognized as a leader in early clinical adoption of new and cost effective technologies, being on the forefront of establishing reimbursement guidelines. Reimbursement is perhaps the most foundational element supporting adoption for a medical technology.”

The Company’s patented DenerveX System, is not yet commercially available in the EU and the U.S. The DenereX System is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

About Medovex:
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward- looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION