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May 24, 2018 OrthoSpineNews

KIRKLAND, QCMay 23, 2018 /CNW/ – Ortho Regenerative Technologies Inc. (CSE: ORTH.CN) (“Ortho RTi” or the “Corporation“), an emerging Orthopaedic and Sports Medicine Technology company, today announced it has received a Notice of Allowance from the European Patent Office for European Patent Application Number 10831011.1 entitled, “Soluble Physiological Chitosan Formulations Combined with Platelet-Rich Plasma (PRP) for Tissue Repair.”

Once the administrative process is complete, the European Patent that issues from this application will provide intellectual property protection for the formulation of Ortho RTi’s ‘Ortho-R’ for the biologic repair of tissue.

“This allowance adds to the formidable intellectual property estate that we are building to cover our game-changing propriety biopolymer platform around the globe,” said Ortho RTi’s Executive Chairman and CEO, Dr. Brent Norton.  “We believe that Ortho-R holds great promise for improving the repair of soft tissue injuries, including rotator cuff tears, the meniscus in knees and articular cartilage.  As such, it is important to ensure that the potential market opportunity we see ahead is well protected.”

About Ortho Regenerative Technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic tissue repair devices to dramatically improve the success rate of sports medicine surgeries.  Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage.  The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention.  Visit us on the internet at www.orthorti.com.

Forward-Looking Statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events.  Such expectations are based on certain assumptions that are founded on currently available information.  If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks.  The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

SOURCE Ortho Regenerative Technologies Inc.

For further information: Stephen Kilmer, Investor & Media Relations, 647.872.4849, kilmer@orthorti.com


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May 24, 2018 OrthoSpineNews

May 24, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, today announced the release of its Clutch interspinous process device. This new product further enhances the breadth of Spinal Elements’ thoracolumbar portfolio and offers surgeons more options for treatment of various posterior thoracolumbar pathologies.

Clutch has been in use since shortly after its FDA 510(k) clearance in 2017 and with this expanded commercial release, Spinal Elements again sets the new standard with a unique and clinically relevant feature: The Clutch interspinous process device’s proprietary spring-activated mechanism is designed to maintain active compression against the spinous processes to resist loosening and migration. Additionally, the device’s bone opposing surfaces are enhanced with clinically proven Ti-Bond® technology, designed to provide immediate stability and long-term fixation.

“I have found interspinous process devices to be a very useful surgical option in my practice. Clutch has an ideal anatomic design that lets me confidently place the device in a more anterior position, fixating securely into the best quality bone,” said Dr. Burak Ozgur, a nationally recognized neurosurgeon in Newport Beach, California. Jason Blain, President and CEO of Spinal Elements added, “Creating procedural solutions for improved patient outcomes is a critical requirement for every system we design and market. Clutch meets this need with what we believe to be a best-in-class design. I am excited for how this addition complements and expands our product portfolio.”

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.spinalelements.com.

Contacts

For interviews or more information:
for Spinal Elements
Laura Charlton (formerly Johnson)
laurajohnsonpr@yahoo.com
(760) 450-7749 cell


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May 24, 2018 OrthoSpineNews

SAN DIEGOMay 22, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the new PRECICE STRYDE™ system from NuVasive Specialized Orthopedics™ (NSO) was used in the first set of patients by internationally recognized limb lengthening and reconstruction expert Dr. Dror Paley. Built on five years of clinical experience, PRECICE STRYDE is a market-leading internal system available for stature lengthening and limb reconstruction.

PRECICE STRYDE is NSO’s third-generation limb lengthening system and includes an implantable intramedullary nail, locking screws, reusable instruments and a hand-held External Remote Controller (ERC). STRYDE was recently cleared by the U.S. Food and Drug Administration in April for use in both the tibia and femur. Patients are now able to non-invasively lengthen or shorten the implant to a prescribed length utilizing the ERC post-surgery from their own home versus lengthy hospital stays. When used for stature lengthening for cosmetic purposes, STRYDE can increase a patient’s height by more than three inches.

Dr. Paley is the founder and director of the Paley Orthopedic & Spine Institute in West Palm Beach, Fla., and is recognized as one of the most experienced surgeons in the United States and world in limb lengthening and deformity correction.

“The PRECICE STRYDE technology advances how I am able to treat patients requiring limb reconstruction or those seeking to increase their height, and I am excited to incorporate this into my practice,” said Dr. Paley, a board-certified orthopedic surgeon specializing in limb lengthening and deformity correction. “I continually seek to offer better clinical solutions to my patients, and I am proud to have collaborated with NuVasive in the development of this latest orthopedic advancement.”

This new system aims to provide better and more tolerable post-operative outcomes for patients undergoing limb lengthening. Prior to this technology, a patient was only permitted to apply 30-50 pounds of weight on each leg, leading to a slow and lengthy return to daily life and activities. With STRYDE’s unique stainless steel composition, patients are now able to apply 150-250 pounds of weight on each leg depending on the device chosen and post-operative care recommended by their physician. This offers patients a potential for 200 percent or greater post-operative weight-bearing activity compared to previous systems, and studies have shown earlier weight bearing may lead to quicker healing times in patients using the PRECICE system1. Next launch steps include partnering with leading global limb lengthening surgeons to demonstrate cosmetic stature lengthening viability with plans for a limited launch in mid-2018 and the product more broadly available in 2019.

“At NSO, we are excited to introduce PRECICE STRYDE to the market, which is just the start of a long line of PRECICE products in the next 18-months to further transform the orthopedic space and offer better clinical outcomes for patients,” said Massimo Calafiore, president of NSO. “There is so much opportunity for us to address unmet clinical needs in the orthopedic market—from limb reconstruction to stature lengthening—this latest technology has the ability to drastically improve how our surgeon partners treat their patients.”

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA® platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1 Laubscher M, Mitchell C, Timms A, et al. Outcomes following femoral lengthening: An initial comparison of the PRECICE intramedullary lengthening nail and the LRS external fixator monorail system. Bone Joint J 2016;98-B:1382–8.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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May 24, 2018 OrthoSpineNews

MEMPHIS, Tenn.May 22, 2018 /PRNewswire/ — CrossRoads® Extremity Systems, the Global Leader in Active Stabilization™, offering innovative foot & ankle fixation implant systems and services, announced that the Company has received FDA clearance for the DynaFORCE® Active Stabilization™ MPJ Implant System. CrossRoads® Extremity Systems has the only MPJ Implant system on the market that combines stability of an anatomic plate with active compression of a nitinol clip, delivered to the operating room completely sterile packed.

Scott Shawen, MD, from Charlotte, NC, one of the first users of the MPJ Active Stabilization™ system states, “CrossRoads provides a comprehensive Active Stabilization™ system that is easy to use. After more than 30 cases, I have found that the instrumentation is the most ergonomic on the market, making drilling and deployment of the compression clip and plate quick and simple.” He continued to say, “Anecdotally, my midfoot fusion times have been cut in half. Additionally, my patients have earlier initiation of weight bearing. I look forward to using DynaFORCE® Active Stabilization™ constructs on additional applications in the future.”

About CrossRoads® Extremity Systems

CrossRoads was founded in 2014 and is headquartered in Memphis, TN. CrossRoads has experienced rapid growth through creative product development and a strong distributorship network. CrossRoads’ goal is to provide a steady rhythm of novel and clinically relevant new products that distinguish it from other companies.

In addition to providing novel products, CrossRoads strives to find ways to help hospitals save money and improve efficiency. CrossRoads believes that as customers experience the EcoSMART® model of using high quality, surgical grade instruments in sterile kits, EcoSMART® Service will become the preferred model of surgeons, O.R. staff, and materials management.

For more information, please visit www.crextremity.com or www.activestabilization.com

©2018 CrossRoads Extremity Systems, LLC.  All Rights Reserved

Vernon Hartdegen
President & CEO of CrossRoads Extremity Systems, LLC
pr@crextremity.com

SOURCE CrossRoads Extremity Systems

Related Links

http://www.crextremity.com


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May 24, 2018 OrthoSpineNews

WARSAW, Ind.May 22, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announces the U.S. launch of the GLOBAL UNITE Reverse Fracture Shoulder, an innovative implant solution for shoulder reconstruction following complex fractures in patients with a grossly deficient rotator cuff. The new system is designed to provide increased flexibility for securely reattaching the bone to the implant, which is important for healing and function, and allowing biological fixation to the stem of the implant with a porous coating to help deliver a consistent surgical outcome. This new offering adds to DePuy Synthes’ commitment to innovative shoulder solutions that address the full continuum of shoulder disorders.

Shoulder fractures are the second most common fracture of the upper extremity, representing 10 percent of all fractures in those older than 65 years and are increasing in frequency as the elderly population grows.When patients with grossly deficient rotator cuffs suffer 3- or 4-part fractures in the upper arm bone (proximal humerus), it is often challenging to provide consistent treatment that helps healing and restores motion. Increasingly, surgeons are shifting to a reverse shoulder implant for more consistent and predictable outcomes for these patients.2

“I find that especially in my older patients whose bone quality doesn’t allow me to use the plates and screws typically used in a shoulder fracture procedure, fixation is an issue often due to weak rotator cuffs,” said Dr. Carl Basamania***, Orthopaedic Surgeon. “In my experience with the GLOBAL UNITE Reverse Fracture Shoulder System I get strong fixation and I feel a lot more confident about moving patients early so they get better motion and a quicker return to function.”

In a reverse total shoulder replacement, the ball and socket anatomy is reversed. A metal ball is fixed to the shoulder socket and a cup is fixed to the upper end of the humerus. Instead of using the rotator cuff to power the shoulder, the implant uses the deltoid muscle, which is the muscle at the top of the arm and shoulder.

The GLOBAL UNITE Reverse Fracture Shoulder provides:

  • Numerous suture holes, designed in the collar on top of the implant, and suture pockets around the backside of the implant to enhance bone fixation around the implant.
  • POROCOAT Porous Coating, a proprietary technology that consists of microscopic titanium beads. The porous structure supports biological fixation at the bone-implant interface.3
  • Backside pockets specially designed for bone graft, which may help promote bone growth and healing.
  • A streamlined instrumentation kit that is designed to improve cross compatibility across DePuy Synthes’ shoulder offerings.

“DePuy Synthes’ broad portfolio of shoulder solutions helps surgeons address a wide range of conditions from traumatic shoulder fractures to rotator cuff tears and instability,” said Stephanie Chamberlain, Global Platform Leader Mitek Sports Medicine and Shoulder. “We offer solutions for minimally invasive surgery and complete shoulder reconstruction, all designed to restore mobility for patients.”

The GLOBAL UNITE Reverse Fracture Shoulder is the latest implant offering under our GLOBAL UNITE Platform Shoulder System and builds on the company’s long history in innovative shoulder reconstruction. This includes the DELTA XTEND Reverse Shoulder System and most recently the launch of TRUMATCH Personalized Solutions Shoulder System pre-surgical planning software for shoulder reconstruction, which can be used in both reverse and anatomic total shoulder arthroplasty to optimize implant positioning and placement.

The GLOBAL UNITE Reverse Fracture Shoulder will launch in the U.S. beginning in the 2018 second quarter. For more information click here.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional solutions and specialty surgery with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and DePuy Orthopaedics, Inc.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

***Dr. Carl Basamania is a consultant to DePuy Synthes Joint Reconstruction.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements,” as defined in the Private Securities Litigation Reform Act of 1995, regarding the roll out of the GLOBAL UNITE™ Reverse Fracture Epiphysis (FX) Shoulder System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Stanbury, SJ, Voloshin, I. Reverse Shoulder Arthroplasty for Acute Proximal Humeral Fractures in the Geriatric Patient Geriatr Orthop Surg Rehabil. 2011 Sep-Nov; 2(5-6): 181–186.

Gallinet D, et al. Improvement in shoulder rotation in complex shoulder fractures treated by reverse shoulder arthroplasty. J Shoulder Elbow Surg (2013) 22, 38-44.

Karageorgiou V, et al. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials 2005;26:5474-91.

© DePuy Synthes 2018. All rights reserved.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com


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May 24, 2018 OrthoSpineNews

Lund, Sweden, 13.00 CET, 24 May 2018 – BONESUPPORT, announces an agreement with Collagen Matrix, Inc. that will allow it to expand its US offering with products that are complementary to CERAMENT BVF. BONESUPPORT will start selling and marketing selected Collagen Matrix bone graft substitute products under its own brand name, and through its own US distribution network in Q4 2018.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with Collagen Matrix is important to our plans to build a larger, faster growing US business under our own control. The Collagen Matrix products can be osteoinductive and osteogenic when combined with bone marrow aspirate making them complementary to CERAMENT BVF, which is osteoconductive. We intend to launch these products under our own brand name later this year giving us a suite of products that will allow us to meet more of the bone graft substitute needs of the orthopedic surgeon. Establishing a broader portfolio of bone graft substitute technologies will also significantly improve our competitive position with payors including GPO/IDN’s (Group Purchasing Organization/Integrated Delivery Network), and help our new distribution channel to be more competitive.”

Collagen Matrix products, when combined with autogenous bone marrow, are both osteoinductive and osteogenic. They are used to fill bony voids or gaps of the skeletal system caused by surgery or traumatic injury.

On 17 May 2018, BONESUPPORT announced that it intended to create its own optimal US commercial platform by:

  • Building its own network of independent distributors that will be key in driving the sales of BONESUPPORT’s products, to a broad range of orthopedic indications.
  • Growing the size and capabilities of its own US commercial organization, which will increase from 14 to around 23 employees by the end of 2018
  • Extending its product offering based on new formulations of CERAMENT as well as synergistic bone graft substitute products via strategic collaborations such as the one announced with Collagen Matrix today.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir, Isabelle Andrews

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About Collagen Matrix Inc.

Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth.

More information about Collagen Matrix can be found at www.CollagenMatrix.com

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s marketed bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary CERAMENT technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of other drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only. CERAMENT V: Not available in the United States

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13.00 CET on 24 May 2018.


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May 23, 2018 OrthoSpineNews

May 23, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces the launch of JAZZ Evo, a new evolution of the JAZZ® implant developed to respond to the constraints of vertebral fusion indications in adults.

Developed primarily to facilitate the treatment of degenerative pathologies in adults, JAZZ Evo® is the first implant in a new range of JAZZ® connectors to be launched at a steady rate over the next two years. The implant benefits from the intellectual property protection of the JAZZ® range, a system for blocking the braid with a single screw, ensuring optimum clamping on the rod without damaging the braid. JAZZ Evo® is available in three diameters representing 90% of diameters used in degenerative spine surgery and can be used with the JAZZ Passer Band®, the braid specially designed for use in adults. Jazz Evo® has already obtained CE marking and 510(K) authorization, demonstrating Implanet’s know-how in an increasingly challenging regulatory climate, in particular with the reduction in the number of certification bodies.

Régis Le Couedic, Research and Development Director at Implanet, comments: “With the aim of permanent innovation, we work in close collaboration with surgeons to develop our range and optimize the design of the JAZZ® implant in order to make it even easier to use. JAZZ Evo® embodies Implanet’s approach of targeting the market of degenerative disease in adults. Surgeons are often concerned about the invasive aspect of implants and the reduced size of JAZZ Evo® means that its use makes surgery less invasive while also reducing the volume of metal implanted. Like all of our range, JAZZ Evo® is a snap-on, auto-stable implant, which makes it easier to position. These features are protected by existing patents.”

Ludovic Lastennet, Chief Executive Officer of Implanet, comments: “JAZZ Evo® responds to the issues facing surgeons and patients as well as budgetary concerns, which should allow us to benefit from a major competitive advantage. It is with this in mind that JAZZ Evo® has been designed. As previously announced, we are maintaining our pace of innovation with the launch of one product per quarter in order to keep up with our more rapid growth in the US, French, German and UK markets, which we now target directly. Having demonstrated the medical value of JAZZ® in paediatric deformity, with JAZZ Evo® we have started to roll out our JAZZ® technology in the promising market of degenerative spine disease in adults. This implant represents the first link in a range of JAZZ® connectors dedicated exclusively to degenerative spine surgery in adults, a market worth $2.5 billion, four to five times the size of the deformity market1.”

Next press release: First-half 2018 sales on Wednesday, July 11, 2018

Implanet’s Combined General Meeting will be held at 10:00am on June 4, 2018 at the Company’s head office at Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac. You are cordially invited to this event. For further information. Please send your contact details to the following email address: implanet@newcap.eu

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 sources i-Data 2010; D. K. Chin and al. Osteoporos Int (2007) 18:1219–1224.; Company

Contacts

IMPLANET
Ludovic Lastennet, +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot,+33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, +1 917 385 21 60
implanet@alphabronze.net


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May 23, 2018 OrthoSpineNews

May 23, 2018

AUSTIN, Texas–(BUSINESS WIRE)–Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced a 24 Consecutive Patient Case Series detailing an endoscopic, stand-alone TLIF surgical technique used with the VariLift-LX System has been published in the Journal of Spine, Volume 7, Issue 2.

The Case Series, authored by Kai-Uwe Lewandrowski, M.D., details a novel endoscopic transforaminal lumbar interbody fusion technique using the VariLift-LX stand-alone expandable interbody fusion device. This surgical technique guide shows that it is feasible to perform a percutaneous endoscopically assisted transforaminal decompression and fusion surgery with the expandable stand-alone VariLift-LX System.

“The initial success of the VariLift-LX System when used with endoscopic techniques is very exciting,” said Chad Neely, CEO of Wenzel Spine. “The ability to successfully perform interbody lumbar fusion using endoscopic access and our stand-alone, expandable interbody device represents the new frontier in Minimally Invasive Spine Surgery. This endoscopic technique is the least invasive method to perform lumbar fusion available to surgeons and the VariLift-LX device is uniquely suited to be used in this application.” He further added, “Wenzel Spine is excited to be on the forefront of making Endoscopic Stand-Alone Lumbar Fusion a proven MIS solution for Spine.”

Wenzel Spine’s VariLift-LX Stand-Alone Expandable Interbody Fusion is commercially available in the U.S. and Europe.

About Wenzel Spine, Inc.

Wenzel Spine, Inc. is a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders. Headquartered in Austin, TX, Wenzel Spine is focused on delivering surgical solutions that improve the overall quality of spine care by simplifying procedures and reducing recovery time. Wenzel Spine seeks to improve patient quality of life by designing and producing devices of the highest quality to support our surgeon clients in the care and treatment of their patients. For more information about the company and our products, visit www.wenzelspine.com.

Contacts

Wenzel Spine, Inc.
Chad Neely, 512-469-0600
Chief Executive Officer


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May 23, 2018 OrthoSpineNews

May 23, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that it will enter into an accelerated share repurchase (ASR) program to repurchase $30 million of its outstanding common stock.

“Our ASR program reflects Anika’s strong financial position and underscores our confidence in the outlook for the Company,” said Joseph Darling, President and CEO, Anika Therapeutics. “This program demonstrates our commitment to a balanced capital allocation strategy, as we transform Anika into a fully-integrated commercial organization to accelerate future growth and create long-term value for our shareholders.”

The Company will enter into an accelerated stock repurchase agreement with Morgan Stanley & Co. LLC pursuant to a Fixed Dollar Accelerated Share Repurchase Transaction to purchase $30 million of shares of its common stock. The number of shares to be repurchased will be based generally on the volume-weighted average share price of Anika common stock over a valuation period. The Company plans to utilize existing cash on hand to fund the ASR program. Anika expects that the ASR program will commence in late May and that it will be completed in the fourth quarter of 2018.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s share repurchase program and future events pursuant to the ASR Agreement and any effects, results, or other matters related thereto. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. These statements can be affected by inaccurate assumptions and by known and unknown risks and uncertainties that are difficult to predict or beyond the Company’s control, including, among others, the terms of the ASR Agreement and factors affecting the final number and price of shares to be purchased under the ASR Agreement, including the volume-weighted average stock price of the Company’s common stock and actions taken by Morgan Stanley with respect to such arrangement, and events and transactions that could result in the termination of the ASR Agreement. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer


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May 23, 2018 OrthoSpineNews

May 23, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC) (the “Company”), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that it has entered into a debt financing agreement with Hercules Capital, Inc., as administrative agent and collateral agent (“Hercules”), and the banks and financial institutions entering into the loan agreement, to provide the Company with up to $40.0 million in term loans.

“We are pleased to partner with Hercules to refinance our debt and strengthen our balance sheet in a non-dilutive manner,” said Todd M. Pope, president and chief executive officer of TransEnterix. “Assuming the ability to borrow all tranches, we believe this refinancing, combined with cash on hand, provides us more than two years of cash runway and will support the continuing commercialization of our Senhance System.”

On May 23, 2018, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules pursuant to which Hercules has agreed to make certain term loans in the aggregate principal amount of up to $40 million, with funding of the first $20 million tranche occurring on May 23, 2018. The Company will be eligible to draw on the second tranche of $10 million upon achievement of certain Senhance System revenue-related milestones for its 2018 fiscal year, and a third tranche of $10 million upon achievement of designated trailing six months GAAP net revenue from Senhance sales. The Company is entitled to make interest-only payments until December 1, 2020, and at the end of the interest-only period, the Company will be required to repay the term loans over an eighteen-month period based on an eighteen-month amortization schedule, with a final maturity date occurring on June 1, 2022. The Company repaid all amounts owed under their previous loan agreement with Innovatus Life Sciences Lending Fund on May 23, 2018.

“Hercules is very pleased to partner with TransEnterix as they continue to expand the commercial adoption of Senhance,” said Scott Bluestein, Chief Investment Officer at Hercules. “The debt facility provides another example of our ability to creatively finance dynamic growth oriented Life Sciences companies through multiple stages of development and through various value inflection points.”

Armentum Partners acted as financial advisor to TransEnterix for the debt financing. Additional details regarding the Company’s financing are included in the Company’s Current Report on Form 8-K which is expected to be filed on May 23, 2018 by TransEnterix, Inc. with the Securities and Exchange Commission.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

About Hercules Capital

Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”) is a leading and largest specialty finance company focused on providing senior secured venture growth loans to high-growth, innovative venture capital-backed companies in a broad variety of technology, life sciences and sustainable and renewable technology industries. Since inception (December 2003), Hercules has committed more than $7.6 billion to over 420 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing.

Forward-Looking Statements

This press release includes statements relating to the Company’s May 2018 debt refinancing, that provides an opportunity to borrow up to $40.0 million assuming various milestones are met. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and includes whether this financing, combined with cash on hand, provides TransEnterix with more than two years of cash runway and will support the continued commercialization of the Senhance Surgical Robotic System . For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investors:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, +1-951-751-1858
joanna@greymattermarketing.com