EIT Emerging Implant Technologies Announces Agreement with HCA

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now successfully completed the contracting process with HealthTrust related to an HCA contract and is now able to offer all interbody products for Cervical, ALIF, TLIF and PLIF procedures in the 177 hospitals and 119 freestanding surgery centers located throughout the United States.

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth.

With the addition of this contract, EIT is poised to continue its aggressive growth pattern in the United States. EIT believes that this will create more unique opportunities to work with HCA surgeons to evaluate and take advantage of the validated structure and many other unique features that differentiate EIT from other 3D printed products.

The contract approval was pursued and successfully completed by Ortho Sales Partners. Josh Sandberg, President of OSP said, “This is a huge milestone that we have been able to help achieve at an unusually early stage in EIT’s development. That is a credit to the strength of this product offering and we are excited about the opportunity to work with HCA facilities in helping them lower the overall cost of these spine procedures.”

“EIT´s goal is to improve spine care using the advantages of 3D printing technology and cope with given pricing and reimbursement structures. We are delighted that HCA/HealthTrust is interested in working with EIT. This will help us to get quicker market access in the United States” said Guntmar Eisen, cofounder and CEO of EIT.

In addition to the contract, EIT is currently finalizing an action plan with HCA leadership to understand the economic impact this novel technology will have on fusion rates, implant costs and the need for high cost osteobiologics. Further details of this proposal will be announced at a later time.
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About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 12.000 EIT cases have been performed in over 15 markets globally.

Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market

‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA™ HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopaedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK.

Robert Gewirtz, MD – Neurosurgeon, Columbus, Ohio, comments on the innovative orthopaedic product: “Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes.I am happy that I was able to partner in this collaboration to help bring the product to market.”

The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis using spacers and endplates. It features a hollow center and holes to accommodate autograft or allograft while encouraging formation of new bone and includes anti-migration features.

In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated into the polymer matrix, and not simply coated. Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK OPTIMA Natural including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. It has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at 4 weeks and 12 weeks,(1) and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks.(2) In addition, as observed by surgeons, early clinical results have shown solid fusions with dense bone apposition at 6 months and beneficial clinical outcomes for patients, revealing specific improvements in overall pain and neurological function,(3) when a PEEK-OPTIMA HA Enhanced interbody fusion device was used.

Steve Anderson, Vice President of Marketing at Omnia Medical concludes: “We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced biomaterial. This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with JALEX Medical and Invibio Biomaterial Solutions was an excellent experience – and will hopefully enable surgeons and patients to benefit from the new solutions.”

For more information please visit http://www.omniamedical.comhttp://www.jalexmedical.com and https://invibio.com.

REFERENCES
1.    Study evaluated the in vivo response to PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a large animal model. Data on file at Invibio. This has not been correlated with human clinical experience.
2.    Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.
3.    Testimonials presented have been provided by participating orthopaedic surgeons. Their view and experience are their own and do not necessarily reflect those of others. “Invibio” disclaims any liabilities or loss in connection with the information herein

Next-Generation High-Definition Visualization System for Minimally Invasive Surgery Introduced by DePuy Synthes

LAS VEGASDec. 6, 2017 /PRNewswire/ — Today, the PUREVUE™ Visualization System was unveiled at the Orthopaedic Summit 2017: Evolving Techniques. This new offering from DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, is a state-of-the-art imaging platform for minimally invasive endoscopic surgery.

Approximately 18.6 million endoscopic procedures are performed each year in the United States.1 In these procedures, case efficiency and patient outcomes are often linked to how well the surgeon can see the targeted anatomy.

The PUREVUE Visualization System combines a light source, image processer and local image management for a reduced operating room (OR) footprint, and includes intuitive touch-screen navigation and customizable settings for many minimally invasive surgery (MIS) applications. The autoclavable camera head features a proprietary sensor designed for endoscopy, that delivers native HD image acquisition for a clear view throughout the procedure that is further enhanced by multiple monitor options, including ultra-high-definition 4K. The forward-compatible system is also augmented by a wide range of visualization accessories.

“With Americans living longer and seeking shorter recovery times, the call for minimally invasive procedures is accelerating,” said Stephanie Chamberlain, Vice President and Global Platform Leader, DePuy Synthes Mitek Sports Medicine. “We are committed to bringing forward innovation that responds to evolving patient needs and the PUREVUE Visualization System is an example of how our advanced technologies enable high quality patient care.”

The PUREVUE Visualization System also completes the company’s capital equipment offering in arthroscopy, a type of endoscopic surgery focused on joint anatomy, which includes the VAPR VUE™ Radiofrequency System and the FMS VUE™ Fluid Management and Tissue Debridement System. Together, these solutions bolster Mitek Sport Medicine’s portfolio of implants and instrumentation used for a wide spectrum of arthroscopic soft tissue procedures.

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.

1 Perry, Anne F., et al. “Burden of Gastrointestinal Disease in the United States: 2012 Update” Gastroenterology. 2012 November; 143(5): 1179–1187.e3. doi:10.1053/j.gastro.2012.08.002 Update.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

DSUS/MTK/1117/1100(1)
December 2017

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

WishBone Medical Inc. Names Jean-Pierre Capdevielle as Chief Strategy Officer and Board Member

Warsaw, Indiana, December 6, 2017 – WishBone Medical, Inc., a new pediatric orthopedic company in Warsaw, Indiana, announced that Jean-Pierre “JP” Capdevielle has taken on the role of Chief Strategy Officer.  Mr. Capdevielle has also been elected unanimously by the Board of Directors to serve as a Director for WishBone Medical, Inc. As CSO, he will work closely with the Chairman of the Board and CEO, Nick Deeter to grow WishBone Medical’s strategic initiatives.

Mr. Capdevielle is a seasoned executive with over 37 years of international experience and has a successful track record of helping startup companies. His knowledge of the orthopedic industry has lead him to the top of major International Medical Device Companies like, Smith & Nephew and Sofamor Danek/Medtronic to name a few. Mr. Capdevielle has lead multiple teams to the successful launches of sophisticated and innovative devices and systems throughout his years of experience.

Jean-Pierre Capdevielle has an extensive professional resume. In 1979 Mr. Capdevielle founded his first company Medical Hospital Products Ltd in Malta, upon leaving in 1982 he had a team of over 240 employees. In 1988 Mr. Capdevielle joined Smith & Nephew to become their Senior Director of Continental Europe and Managing director of French, German and Spanish Operations. Upon joining Smith & Nephew, Mr. Capdevielle lead to a sales growth of 35% a year from 1989-1992 and contributed in the successful introduction of the GENESIS Modular Knee system across EU.

Upon his resignation from Smith & Nephew in 1993, Mr. Capdevielle joined and worked directly with Ron Pickard, CEO and Chairman of Sofamor Danek. At Sofamor Danek Mr. Capdevielle helped bring in revenue of up to $350 million. From 1993-2006 Mr. Capdevielle was a part of many successful business ventures before starting his current business in 2006: Isortho & ICS Consulting Group. Just within the past 4 years, Mr. Capdevielle has contributed to the success of over 22 companies.

WishBone Medical was founded by Nick Deeter, a leader in Pediatric Orthopedics. WishBone is a pediatric orthopedic company focused on the unmet needs of children suffering from orthopedic issues. WishBone’s commitment is to provide anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits with an emphasis to minimize disease, prevent infection, reduce overall costs for our customers and to achieve the best outcomes for children who are still growing, because kids are not just little adults.

“JP brings an incredible amount of medical device industry experience to our team,” says Nick Deeter, Chairman of the Board and CEO of WishBone Medical.  “We are very glad to have him at WishBone Medical to serve as our Chief Strategy Officer and newly elected Board Member.  We are eager for him to work with the WishBone Medical Team as we take the company into a successful second year of operations.”

Mr. Capdevielle received his M.B.A in International Marketing and Finance programs from Hautes Etudes Commerciales Jouy-en-Josas in 1974 and in 1992 completed the Marketing Executive Program from Columbia University in New York. Mr. Capdevielle currently resides in France and is fluent in over 3 languages. He served in the Military from 1974-1976. Mr. Capdevielle is married with two children and enjoys playing/watching rugby and golf in his free time.

To learn more about WishBone Medical, visit www.WishBoneMedical.com. 

About WishBone Medical, Inc.

WishBone Medical, Inc. is a privately held pediatric orthopedic company offering anatomically-appropriate innovative implants and instrument solutions to pediatric patients and surgeons worldwide.

For further information, visit www.wishbonemedical.com or call Allison McSherry, General Manager at (574)306-4006

Antibacterial Benefits of PEKK for Orthopedic Applications Detailed in Study of 3D-Printed OsteoFab® Structures

SOUTH WINDSOR, Conn., Dec. 05, 2017 (GLOBE NEWSWIRE) — Oxford Performance Materials, Inc. (OPM), a leader in advanced materials science and high performance additive manufacturing (HPAM™), today announced the results of an independent scientific study that reveals superior antibacterial properties of 3D printed PEKK (poly-ether-ketone-ketone) structures vs. conventional PEEK (poly-ether-ether-ketone) surfaces for orthopedic applications. The September 2017 study1 examined 3D printed PEKK samples produced by OPM’s proprietary OsteoFab® process and “demonstrated for the first time the promise that nanostructured2 PEKK has for numerous anti-infection orthopedic implant applications.”

OPM’s OsteoFab® technology was first commercialized in 2013 and utilizes the Company’s exclusive OXPEKK® material, a high performance PEKK polymer formulation that meets FDA and EU requirements for long-term implantable medical device applications. The properties of OPM’s OXPEKK polymer and OsteoFab 3D printing technology combine to form an inherently rough, nanostructured surface that has been demonstrated to enhance bone attachment.3

The antibacterial attributes of 3D printed PEKK are significant, since they address two areas of growing concern in medicine. “Orthopedic implant infections have been steadily increasing while, at the same time, antibiotics developed to kill such bacteria have proven less and less effective with every passing day,” according to the researchers. “It is clear that new approaches that do not rely on the use of antibiotics are needed to decrease medical device infections.”  As a result, the antibacterial properties detailed in this new study that apply to OsteoFab devices will provide another important layer of differentiation for the performance of OPM medical devices in the marketplace.

Dr. Gregory Chotkowski, Board Certified Oral and Maxillofacial surgeon, commented on the comparative benefits of OsteoFab devices: “I am excited that there is another option available for custom facial bony augmentation. The products currently available are porous and have a high incidence of infection when placed through a transoral surgical approach,” Dr. Chotkowski stated, “I had the opportunity to use OPM’s 3D printed PEKK mandibular angle implants on several occasions and feel that this material is far superior.  The bacteriostatic properties – combined with custom fabrication – makes this an ideal material for facial augmentation through a transoral approach.”

Five FDA 510(k) clearances have been obtained for OsteoFab devices.  OPM is the only company with FDA clearances for 3D printed polymeric implants, and the Company was granted a patent from the European Patent Office for its “Customized Implant for Bone Replacement” manufacturing process. In addition to obtaining its own clearances, OPM has customers that have obtained regulatory approvals for devices made from OXPEKK polymer in Asia, Europe, and South America. The Company is an OEM of its craniomaxillofacial (CMF) OsteoFab implant line, which is exclusively distributed worldwide by Zimmer Biomet. Over 1,700 patient specific cranial and facial devices have been shipped to date, and the OsteoFab facial line was officially launched earlier this year.

OPM recently introduced its OsteoFab technology to the spinal device market through its partnership with U.S.-based RTI Surgical.  RTI announced last month the commercial launch of Fortilink-C IBF System with TETRAfuse® 3D Technology. The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device to incorporate macro, micro and nano-rough features beyond the endplate surfaces to the entire implant surface. Today, OPM is well positioned to produce a full range of standard sizes in spine, providing OPM with the first high volume, mass application for its OsteoFab 3D printing technology using its proprietary OXPEKK polymer.

About Oxford Performance Materials, Inc.

A recognized leader in advanced materials science, Oxford Performance Materials Inc. (OPM) was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastics, with a focus on poly-ether-ketone-ketone (PEKK).  OPM develops proprietary material, process, and application technologies and applies high performance additive manufacturing (HPAM™) to produce fully functional, end-use structural parts. The Company has three strategic business units: OPM Materials develops proprietary OXPEKK® thermoplastic products and other materials for biomedical, aerospace, and industrial applications. OPM Biomedical is a pioneer in personalized medicine, 3D printing OsteoFab® cranial and facial implants as an OEM, and additional products on a contract manufacturing basis. OPM Biomedical is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has a total of four 510(k) clearances in its portfolio. OPM Aerospace & Industrial produces 3D printed OXFAB® production parts for highly demanding aerospace, satellite, and defense applications. OXFAB® structures offer significant weight, cost, and time-to-market reductions that are defined in a set of specified performance attributes in the exhaustive OPM B-Basis database, developed in conjunction with NASA. For more information, please visit: www.oxfordpm.com

Company Contact:
Bernie Plishtin
Oxford Performance Materials
860-656-9446
bplishtin@oxfordpm.com

1 “Antibacterial Properties of PEKK for Orthopedic Applications,” International Journal of Nanomedicine, Dovepress 15-Sep-2017, Mian Wang, Garima Bhardwaj (Department of Chemical Engineering, Northeastern University, Boston MA) and Thomas J. Webster (Department of Chemical Engineering, Northeastern University, Boston MA and Wenzhou Institute of Biomaterials and Engineering, Wenzhou Medical University, Wenzhou, China). The full study by Mian Wang, et al. may be viewed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5592909/
2 Nanostructured materials are those having properties defined by features smaller than 100 nanometers.
3 Hacking, Adam, “The Tissue Response to PEKK Femoral Rods Implanted in the Medullary Canal of the Rabbit Femur”. OPM Internal Report, January 23, 2013.

In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System

December 05, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for an addition to its CoLink® Forefoot Bone Plating System used to stabilize bones during the post-surgical healing process. The addition will be marketed under the CoLink View brand name.

CoLink View Bone Plates incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK). The CoLink View Plates include an X-ray transparent PEEK hub that allows the surgeon to literally watch the patient’s bone heal. This cannot be done with traditional metal plates because metal absorbs X-rays and blocks the image below. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.

In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.

The CoLink View is the sixth In2Bones PEEK-related implant system that has received FDA clearance; others are expected to be cleared in 2018.

In August 2016, In2Bones USA, LLC and In2Bones, SAS, Lyon, France, merged to form In2Bones Global, Inc, a Delaware Corporation headquartered in Memphis. Since the merger and in addition to the aforementioned product, the company has launched several innovative products including the NeoView® PEEK Distal Radius Plate, the NeoSpan® SuperElastic Compression Staple, the Reference Toe System®AlloAid® PIPAlloAid® Nail, the 5MS® fifth metatarsal fracture repair system, the CoLag® Screw System, an ankle fusion plate system and the PitStop™ PEEK subtalar implant.

For more information about In2Bones Global, Inc. extremity products in the U.S. and France, please visit www.i2b-USA.com or www.In2Bones.com.

About In2Bones USA, LLC

Located in Memphis, Tennessee, In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-USA.com.

About In2Bones, SAS

Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.

Safe-Harbor Statement:

This press release contains “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. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Contacts

Element-R Partners
Susan Duensing, CBC
847.639.8300
susan@rurelevant.com

ChoiceSpine™ Announces First Clinical Use of HAWKEYE Ti Device

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announces the first clinical use of HAWKEYE Ti, a 3D-printed, titanium Vertebral Body Replacement (VBR) device. The first surgery was performed by Joe Ordonez, MD, Neurosurgical Associates, Norfolk, VA at Sentara Norfolk General also in Norfolk, VA.

“ChoiceSpine has always been dedicated to patient care and innovation,” said Dr. Ordonez. “The HAWKEYE Ti device offers the perfect combination of both.”

The HAWKEYE Ti device was designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. Its 3D printed architecture combines unique geometry with multiple coarse nano surfaces to encourage bony growth all around the implant and allowing for seamless integration with the vertebral endplates. The HAWKEYE Ti product portfolio provides a favorable environment for spinal fusion with its small and large footprints that range in size from 10 to 60 mm in height in either 0° or 8° lordosis.

“ChoiceSpine is on a journey to develop and market a vast portfolio of products that meet the surgical needs of our customers and their patients,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “HAWKEYE Ti is just one example of the spinal device and biologic solutions that we deliver with exceptional service to our distributor partners and healthcare customers.”

ChoiceSpine received FDA clearance for the HAWKEYE Ti device in October of this year. HAWKEYE Ti is the first of many 3D printed devices being developed and commercialized by ChoiceSpine.

About ChoiceSpine 
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

Amplitude Surgical: Commercial Launch of the ACLip®, an Innovation in (ACL) Reconstruction Knee Surgery

December 04, 2017

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible) (Paris:AMPLI), a leading French player on the global surgical technology market for lower-limb orthopedics, announces the commercial launch of the AClip®, its innovation in anterior cruciate ligament (ACL) reconstruction knee surgery.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: Following its hip and knee joint prosthetics and its foot surgery implants, Amplitude Surgical’s offering is being expanded to sports surgery. Repairing the anterior cruciate ligament is one of the most frequent knee pathologies, with almost 250,000 operations performed each year in Europe. The AClip® is a highly differentiating innovation resulting from our R&D activity, after over 6 years of development and a number of patents. Like Novastep, and in synergy with our innovative offering for lower limbs, the AClip® should provide a significant contribution to the Group’s future growth.

Following the successful implantation of more than 850 AClip® implantsin surgical assessment center, Amplitude Surgical can now begin the widespread distribution of this ACL repair device. This innovation is unique to the market, and will be presented at the annual congress of the Société Francophone d’Arthroscopie (Francophone Arthroscopy Society) in Marseille.

The Aclip implant for anterior cruciate ligament repair provides surgeons with an unique, simple, and reproduceable repair device. The insertion of the AClip® is achieved under arthroscopic surgery, typically as an outpatient procedure. The rigidity of this fixation boosts the integration of the implant and could accelerate the patient’s rehabilitation and return to activity. Since the ACLip® received CE marking in Europe, the registration process has been ongoing in the United States and the registration application is due to be filed with the FDA shortly.

The implant is characterized by a two-part fixation system (cage & endobutton), which is extremely resistant to traction and has a unique set of instruments featuring a dual-level reamer. This allows for two bone tunnels of different diameters to be drilled at the same time.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
finances@amplitude-surgical.com
+33 (0)4 75 41 87 41
or
NewCap
Investor Relations
Marc Willaume
amplitude@newcap.eu
+33 (0)1 44 71 00 13
or
NewCap
Media Relations
Nicolas Merigeau
amplitude@newcap.eu
+33 (0)1 44 71 94 98

Exactech and TPG Capital Announce Amended Merger Agreement Providing for Increase in Merger Consideration to $49.25 per share

December 04, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, announced today that it has entered into an amendment to its merger agreement with TPG Capital and certain of its affiliates which was previously announced on October 23, 2017. Pursuant to the amended merger agreement, the Company’s common stock outstanding immediately prior to the effective time of the merger (other than certain shares held by the Company’s founders and certain management shareholders) will be converted into the right to receive $49.25 per share in cash. This represents an increase of approximately 17.3% over the $42.00 of per share merger consideration previously agreed to by Exactech and TPG Capital. TPG Capital has also increased its equity financing commitment to $737 million for purposes of consummating the merger.

Pursuant to a rollover and voting support agreement entered into at the time of the amended merger agreement, the Company’s founders, CEO and certain other management shareholders have agreed with TPG to exchange a portion of their shares in the transaction, representing approximately 18.8% of the Company’s outstanding common stock, for new equity securities in the post-closing ownership of the Company at a valuation equal to or less than $49.25 per share. Such founding and management shareholders have previously agreed to vote all of their shares for the approval of the amended merger agreement.

Exactech’s Board has approved the amended merger agreement with TPG and has determined that it is advisable, fair to and in the best interests of Exactech and its shareholders. Exactech’s Board hereby recommends to Exactech’s shareholders that they vote to approve the merger agreement and the merger with TPG.

TPG has arranged fully committed equity financing for the transaction and there is no financing condition to consummation of the merger with the Company. Early termination of the statutory waiting period under the Hart-Scott-Rodino Act was obtained on November 17, 2017 and, accordingly, there are no anti-competition or other regulatory approvals needed to consummate the merger with TPG Capital’s affiliate. The merger is expected to close during the first quarter of 2018, subject to customary closing conditions.

Advisors

J.P. Morgan Securities LLC is acting as financial advisor to Exactech. Greenberg Traurig, P.A. (Miami) and Greenberg Traurig, LLP (NYC) are acting as Exactech’s legal advisor. Ropes & Gray LLP is acting as legal advisor to TPG Capital.

About Exactech

Exactech was founded in 1985 by orthopedic surgeon Dr. Bill Petty, his wife Betty and biochemical engineer Gary Miller, PhD, with the purpose of improving the quality of care for patients suffering from joint injury or disease, such as arthritis. The company employs more than 700 individuals including engineers, researchers, manufacturing professionals and sales representatives, and distributes its products to more than 35 countries around the world.

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

About TPG

TPG is a leading global alternative asset firm founded in 1992 with more than $73 billion of assets under management and offices in Austin, Beijing, Boston, Dallas, Fort Worth, Hong Kong, Houston, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, San Francisco, Seoul, and Singapore. TPG’s investment platforms are across a wide range of asset classes, including private equity, growth venture, real estate, credit, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com.

Forward-Looking Statements

This press release includes 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 forward-looking statements include, but are not limited to, statements regarding Exactech’s proposed business combination transaction with TPG Capital, all statements regarding Exactech’s expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “would,” “should,” “will,” “intend,” “may,” “potential,” “upside,” and other similar expressions. All Statements in this press release that are not historical facts, are forward-looking statements that reflect the best judgment of Exactech based upon currently available information.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Exactech’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Exactech is unable to predict or control, that may cause its actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in Exactech’s filings with the Securities and Exchange Commission (the “SEC”).

Risks and uncertainties related to the proposed merger include, but are not limited to, the risk that Exactech’s shareholders do not approve the merger, potential adverse reactions or changes to business relationships resulting from the announcement of the amendment to the merger agreement or completion of the merger, uncertainties as to the timing of the merger, adverse effects on Exactech’s stock price resulting from the announcement of the merger or the failure of the merger to be completed, competitive responses to the announcement of the merger, the risk that regulatory, licensure or other approvals required for the consummation of the merger are not obtained or are obtained subject to terms and conditions that are not anticipated, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions.

In addition to the factors set forth above, other factors that may affect Exactech’s plans, results or stock price are set forth in its most recent Annual Report on Form 10-K and in its subsequently filed reports on Forms 10-Q and 8-K.

Many of these factors are beyond Exactech’s control. Exactech cautions investors that any forward-looking statements made by it are not guarantees of future performance. Exactech disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments.

Additional Information and Where to Find It

All references below to the “merger”, the “proposed merger” or the “merger agreement” refer to the Company’s previously announced merger and merger agreement with TPG Capital, as amended or supplemented from time to time.

The Company previously filed with the SEC a report on Form 8-K regarding the proposed transaction with TPG Capital, which included the amendment to the merger agreement. All parties desiring details regarding the merger are urged to review these documents, which are available at the SEC’s website (http://www.sec.gov).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, the Company will prepare and mail a proxy statement to its shareholders. In addition, certain participants in the merger will prepare and file with the SEC a Schedule 13E-3 transaction statement. These documents will be filed with or furnished to the SEC. Investors and shareholders are urged to read carefully and in their entirety these materials and other materials filed with or furnished to the SEC when they become available, as they will contain important information about the Company, the merger and related matters. In addition to receiving the proxy statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the merger and related matters, without charge, from the SEC’s website (http://www.sec.gov). In addition, these documents can be obtained, without charge, by sending an e-mail to investors@exac.com, along with complete contact details and a mailing address.

Participants in Solicitation

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from shareholders with respect to the merger. Information regarding the persons or entities who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the merger when it is filed with the SEC. Information regarding the directors and executive officers of the Company is set forth in the proxy statement for the Company’s 2017 Annual Meeting of Shareholders, which was filed with the SEC on March 24, 2017. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

Contacts

TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Exactech, Inc.
Donna Edwards, 352-377-1140
Donna.Edwards@exac.com

Dr. Adam Lewis to Adopt EOI’s FLXfit™ Articulated and Expandable Cages as His Treatment of Choice for MIS TLIF

OR AKIVA, IsraelDec. 4, 2017 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is proud to announce that Dr. Adam Lewis of Jackson MS is the first surgeon in Mississippi to adopt the FLXfit™ 3D Expandable Cage as his treatment of choice for MIS TLIF procedures. Dr. Lewis is a prominent neurosurgeon and founder of the Jackson Neurosurgery Clinic in Jackson MS.  He is a pioneer in MIS spine surgery and leads the shift to less invasive fusion procedures.

Dr. Lewis stated “The spine market is shifting towards MIS outpatient care. Instrumentation, implants, and techniques need to rapidly evolve to enable this revolution.” He commented, “I am a great believer in expandable cages, especially for MIS procedures where surgical access is limited. A low profile implant which can be easily inserted and expands in-situ is critical to obtain the best outcome.” Dr. Lewis noted, “Most expandable cages I have used provide only a partial solution as they have a small footprint and expand only in one plane. They don’t offer sufficient support and sagittal balance restoration.”

Dr. Lewis further explains, “The FLXfit™ family of expanding TLIF cages are ideal for MIS fusion surgery as they enable a best in class expandable cage through a small tube. The unique articulation feature allows me to place a traditional linear shape cage through a tube and achieve an ALIF like footprint.  This minimizes blood loss and surgical trauma while offering the best possible outcome.”  He concluded, “The initial observations on my first series of patients show very promising results. I now have the ability to dial-in up to 15 degrees of lordosis and significantly restore the natural lumbar curve.  Additionally, patients have a much larger, more stable implant which reduced pain and provide faster return to normal daily activities.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented “We are honored to work with Dr. Lewis.  Engaging with a leading MIS surgeon    like Dr. Lewis provides us with a collaborative expertise that enhances our ability to continuously improve the system”. Ofer noted “Dr. Lewis’ choice to employ FLXfit™ for his MIS fusion surgery helps validate our mission to restore and retain lumbar lordosis and be a prominent leader in addressing sagittal balance.

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347) 3219683

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