Alphatec Spine Launches Battalion™ Lateral System with Squadron™ Retractor to support Minimally Invasive Lateral Access Procedures

CARLSBAD, Calif., April 07, 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 that the Company has launched its new Battalion Lateral System with the Alphatec Squadron Lateral Retractor, and successfully completed initial patient surgeries including degenerative, multilevel and L4/L5 spinal segment cases.  With the launch of the Battalion Lateral System, the Company is well positioned to begin to compete in the $500M U.S. Lateral market.

“The launch of Battalion Lateral represents a significant milestone for Alphatec, opening up new commercial opportunities for us.  With this launch, we are now able to compete in the MIS Lateral market—one of the fastest growing markets in spine,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “The Battalion Lateral System includes our proprietary Squadron Retractor that is designed to enhance the surgeon’s experience and improve clinical outcomes.  Early feedback from surgeon customers has been very positive regarding the system performance, differentiated feature set and ability to successfully treat even the most complex patient cases with a minimally invasive approach.  The launch of Battalion Lateral also enables Alphatec to access new distributors with strong surgeon relationships in the Lateral space. We look forward to expanding into this new market and increasing surgeon adoption.”

Battalion Lateral System Overview

The Battalion Lateral System with the Alphatec Squadron Lateral Retractor provides surgeons with a next-generation Lateral system with innovative, unique functionality designed to improve clinical outcomes by reducing tissue creep, minimizing psoas retraction time, and achieving alignment and fusion objectives.  The Battalion Lateral System includes numerous proprietary features, including the Squadron Lateral Retractor.  The system is designed to allow surgeons to customize the access to match the patient’s unique anatomy through independent retraction of the cranial/caudal blades, DepthControl™ technology that provides in-situ height adjustment for the low-profile blades, and LevelToe™ mechanics to ensure that the blades maintain a parallel plane when toed up to 15°.  The Squadron Retractor is also fully compatible with most neuromonitoring platforms enabling access safely through the psoas. The Battalion Lateral Spacer is available in 0° and 15° lordosis with a variety of width and height options for lumbar and thoracic approaches as well as angled and offset instrumentation to provide access to the L4/L5 segment.

“Alphatec’s Battalion Lateral System provides great options for accessing and preparing the space via the retractor, but the retractor itself completes the procedure,” said Dr. Frank K. Kuwamura, a board-certified orthopedic spine surgeon, in San Antonio, Texas.  “The ability to independently raise and lower blades to accommodate the anatomy really separates this retractor from other retractors available on the market.  It saves time in the psoas and that supports better patient outcomes.”  Dr. Kuwamura was one of the first surgeons to use the system and completed the case with Alphatec’s Illico® percutaneous pedicle screws.  The patient had a previous fusion and had developed adjacent disc disease.

Michael E. Russell, II, M.D., a board-certified orthopedic surgeon in Tyler, Texas, was also one of the first surgeons to use the Battalion Lateral System in a clinical setting.  He used the system to perform a Lateral procedure at L3/L4 and instrumented posteriorly using Alphatec’s Arsenal™ Spinal Fixation System. The Squadron Lateral Retractor allowed Dr. Russell to access the disc space from an offset trajectory.

Dr. Russell commented, “The Squadron Retractor enabled me to attach to multiple attachment points giving me the flexibility to use my preferred Lateral technique.  The combination of the level toeing and the ability to lower the low-profile blades individually allowed me to successfully navigate osteophytes without the need for blade extenders.”

Battalion Lateral to be Featured at Upcoming Surgeon Conferences

The Battalion Lateral System and Squadron Retractor will be featured at the International Society for the Advancement of Spine Surgery, ISASS, April 12th through April 14th in Boca Raton, Florida and at the Annual Meeting of the American Association of Neurological Surgeons, AANS, April 24th through April 26th in Los Angeles, California for surgeon review.

About Battalion Lateral System and Squadron Retractor Lateral Access System

The Battalion Lateral System features a full array of access and disc preparation instrumentation in straight, angled, and offset orientations.  The system is recommended for use with the Arsenal Spinal Fixation System or the Illico MIS Posterior Fixation System. The Battalion Lateral implant is also cleared for use with both autograft and allograft biologic materials.
For more information, please visit:   http://alphatecspine.com/Battalion-Lateral.

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 compete and expand its presence within the U.S. MIS Lateral market and the size of such market; the Company accessing new distributors with strong surgeon relationships in the Lateral space and increasing surgeon adoption; and the ability of Battalion™ Lateral System to enhance the surgeon’s experience and improve clinical outcomes.  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 uncertainty of success in developing and launching new products, including without limitation the products discussed in this press release; the Company’s ability to compete directly with the market leaders in the U.S. MIS Lateral market; the Company’s ability to gain market share in the U.S. MIS Lateral market and to benefit a vast number patients in such market; and the acceptance of the Company’s products by the surgeon community and the success of procedures by spine surgeons, including without limitation the products and procedures discussed in this press release.  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 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

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

Exclusive: Cardinal Health nears $6 billion deal for Medtronic unit – sources

By Carl O’Donnell – Wed Apr 5, 2017

U.S. drug distributor Cardinal Health Inc (CAH.N) is nearing a deal to acquire medical device maker Medtronic Plc’s (MDT.N) medical supplies business for close to $6 billion, people familiar with the matter said on Wednesday.

The sale would streamline Medtronic’s portfolio after its $42.9 billion acquisition of Covidien Plc in 2014. In that deal, it inherited most of the company’s medical supplies business, which sells everything from syringes to surgical instruments.

Medtronic and Cardinal Health have entered into exclusive talks over the sale of the business, and a deal could be announced later this month, the sources said, cautioning that there was always a chance that the negotiations could end unsuccessfully.

The sources asked not to be identified because the negotiations are confidential. Medtronic and Cardinal Health declined to comment.

For Cardinal Health, the deal would boost efforts to build out its medical products business, which it has highlighted as a priority for dealmaking.

 

READ THE REST HERE

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

KFx Medical, LLC Announces Another and Third License of its Knotless Double Row Patents

April 06, 2017

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC announced that it has entered into a license agreement with CONMED Corporation – CNMD (NASDAQ) relating to its patents used in knotless double row rotator cuff repair.

Under the agreement, CONMED and its affiliates will have the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents. Approximately one-third of more than 400,000 rotator cuff repairs in the United States utilize the technique to achieve an anatomic reattachment of tendon.

Terms of the licensing agreement were not disclosed.

“We are proud to have our innovation recognized by CONMED. Previously we announced our licensing agreements with Smith & Nephew, Inc. and Mitek, a Johnson & Johnson Company for the same patents. I am pleased with the licensing arrangement with these three world leaders and knowing KFx’s valuable double row knotless rotator cuff technology will reach even more patients,” indicated Tate Scott, President and Chief Executive Officer.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical
W. Tate Scott, 619-742-2010
Tate.Scott@KFxmed.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

SI-BONE, Inc. Announces Published Guidance Recommendation for Minimally Invasive SI Joint Fusion from NICE

SAN JOSE, Calif., April 7, 2017 — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the U.K.’s National Institute for Health and Care Excellence (NICE) has published their Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain.1 The guidance recommends that MIS SI joint fusion be available to properly diagnosed patients in the U.K. National Health System (NHS).

NICE develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations. NICE’s role is to improve outcomes for people using the NHS and other public health services.2

The recommendation states that the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery, based primarily on the strong clinical evidence from the iFuse Implant, is adequate provided that standard arrangements are in place.  They also recommend that the procedure be performed by trained surgeons using a lateral transarticular approach, and that patients have been properly diagnosed with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion.  Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients,” according to W. Carlton Reckling, MD, MBA, Chief Medical Officer and Vice President Medical Affairs at SI-BONE.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth3, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9868.040617

  1. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. NICE Interventional Procedures Guidance [IPG578]. April 2017. https://www.nice.org.uk/guidance/IPG578/chapter/1-recommendations

  2. https://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf

  3. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

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