Stryker Crosses The 95% Thresholds in VEXIM and Announces Its Intention to File a Proposed Public Buy-out Offer Followed by a Squeeze-out for the Outstanding Shares of VEXIM

Posted On February 14, 2018 By OrthoSpineNews In Financial /

February 14, 2018 – BALMA, France–(BUSINESS WIRE)–Regulatory News:

Stryker Corporation (NYSE:SYK) announced that it has crossed the 95% thresholds in VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM) and intends to file a proposed public buy-out offer followed by a squeeze-out for the outstanding shares of VEXIM, in accordance with French tender offer laws and regulations.

After the acquisition of 92.19% of the share capital and 91.56% of the voting rights of VEXIM following a simplified public tender offer opened from November 16, 2017 to December 6, 2017, Stryker acquired 300,016 additional shares on the market (at a maximum price of EUR 20, i.e., the price paid in the simplified public tender offer) and crossed upwards the 95% thresholds in share capital and voting rights of VEXIM. Stryker now holds indirectly, through its French subsidiary Stryker France MM Holdings SAS, 8,716,415 shares and voting rights of VEXIM, representing 95.48% of the share capital and at least 95.14% of the voting rights.

As a result, Stryker intends to file, within the coming weeks, a proposed public buy-out offer for all the outstanding shares it does not own for a price per share of EUR 20, which will be followed automatically by a squeeze-out of all the remaining non-tendered shares. The public buy-out offer followed by a squeeze-out will be subject to the clearance decision of the French stock market authority (the “AMF”).

In accordance with Article 261-1, I and II of the general regulation of the AMF, the board of directors of VEXIM will appoint an independent expert to issue a report regarding the fairness of the financial conditions of the proposed public buy-out offer followed by a squeeze-out.

The squeeze-out is expected to occur during Q2 2018.

The suspension of trading of VEXIM shares will be maintained until the filing of the proposed offer.

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column, and the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 61 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Euronext Growth Paris since May 2012. Following the simplified tender offer carried out in December 2017, the global leader in medical technology, Stryker, held 92,19% of VEXIM’s capital at the end of year 2017. For further information, please visit www.vexim.com

SpineJack®¹, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

About STRYKER
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

¹ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès
CEO
José Da Gloria
Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com

Fibroblast_cells_by_Dr._Torsten_Wittmann-1.jpg

Phase 1/2 Clinical Trial Results Positive for SpinalCyte’s CybroCell™ Dermal Fibroblasts

Posted On February 14, 2018 By OrthoSpineNews In Biologics /

February 13, 2018

HOUSTON–(BUSINESS WIRE)–Degenerative disc disease has long been considered an inevitable part of aging, but new breakthrough research from SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs), suggests a new cell-based therapy could provide a cure for millions of sufferers. SpinalCyte has completed the first double blind, placebo-controlled human trial using HDF injections to treat sufferers of degenerative disc disease.

Almost 70 percent of patients who were treated with the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease, called CybroCell, reported significant therapeutic improvement. Prior research has shown that intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine¹.

“CybroCell, in my opinion is the future of cell therapy,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “The current data suggests that CybroCell has the ability to significantly reduce pain, improve patient quality of life and be more effective than conventional stem cells. It has the added benefit of being more economical to produce and easier to acquire. Compared to all of the stem cells that I have worked with in my career, fibroblasts used in CybroCell are much superior.”

The landmark Phase 1/2 trial included 16 patients with chronic lower back pain caused by degenerative disc disease. The patients were randomly assigned to one of three groups. The first group received a placebo in the form of saline only; the second group received a single intradiscal injection of 10 million cells of CybroCell and the third group received a single intradiscal injection of 10 million cells of CybroCell in combination with platelet-rich plasma (PRP).

Using the Oswestry Disability Index (ODI), a widely used questionnaire measuring the intensity and disabling effect of lower back pain on daily activities, researchers determined that the ODI of four of the six patients (67 percent) treated with CybroCell decreased by more than 15 points, which is considered a significant therapeutic improvement. One of the four patients (25 percent) treated with CybroCell in combination with platelet-rich plasma (PRP) reported an ODI decrease of more than 15 points while one of six patients (17 percent) in the placebo group reported an ODI decrease of more than 15 points.

“The U.S. opioid crisis is a national emergency, so we consider the development of CybroCell, which may reduce or eliminate the need for opioids among patients suffering from chronic back pain as a result of degenerative disc disease, to be an urgent public health priority,” said Pete O’Heeron, Chief Executive Officer, SpinalCyte. “Chronic lower back pain effects nearly 33 million Americans and over 7 million are related to degenerative disc disease ². This creates a national crisis for their quality of life. Our human trials exceeded our most optimistic projections and we believe it will ultimately lead to a cure for degenerative disc disease. On behalf of everyone at SpinalCyte, I would like to thank the patients and physicians who participated in our Phase 1/Phase 2 trial and let them know we are committed to advancing this novel approach so all patients can benefit.”

SpinalCyte’s Phase 1/2 trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.

Photo available for download: https://www.dpkpr.com/files/701/

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in biologics.

¹Chee et al. Cell Therapy with Human Dermal Fibroblasts Enhances Intervertebral Disk Repair and Decreases Inflammation in the Rabbit Model. Global Spine J. 2016 Dec;6(8):771-779. https://0201.nccdn.net/1_2/000/000/18d/7d6/Global-Spine-Journal.pdf

²https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12809

(Photo: Dr. Torsten Wittmann/Science Photo Library/Getty Images)

Contacts

SpinalCyte, LLC
Investor Contact:
281.461.6211
info@spinalcyte.com
or
Media Contact:
Daniel Keeney, APR, 832.467.2904
dan@dpkpr.com

Mazor Robotics Reports Record Fourth Quarter & Full Year 2017 Financial Results

Posted On February 14, 2018 By OrthoSpineNews In Financial /

CAESAREA, Israel, Feb. 14, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of robotic guidance systems, reported record fourth quarter and full year revenues of $19.1 million and $64.9 million, respectively. As previously announced, the Company received purchase orders for 27 systems in the 2017 fourth quarter, including 24 Mazor X systems. For the 2017 full year, the Company received 73 system orders, of which 64 were for the Mazor X system and nine were for the Renaissance system.

“Our effective execution during 2017 continued to strengthen our global leadership position in spine robotics and led to record systems sales and recurring revenue,” commented Ori Hadomi, Chief Executive Officer. “2018 will be a year of transition during which we will emphasize synergy with Medtronic as well as procedure growth. Mazor is well positioned to benefit from the accelerating adoption of robotics for spine surgeries.”

FOURTH QUARTER 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended December 31, 2017 increased 36% to $19.1 million compared to $14.0 million in the year-ago fourth quarter. U.S. revenue increased 38% to $17.4 million compared to $12.6 million in the year-ago fourth quarter, as the Company recognized revenue from 21 Mazor X systems, compared to 13 Mazor X and two Renaissance systems in the fourth quarter of 2016. International revenue was $1.7 million compared to $1.4 million in the year-ago fourth quarter. Recurring revenue from kit sales, services and other increased 107% to $9.3 million in the fourth quarter of 2017 compared to $4.5 million in the year-ago fourth quarter, which is primarily attributed to the higher system installed base. The Company ended the quarter with a backlog of 16 systems (14 Mazor X and two Renaissance systems).

The Company’s gross margin for the three months ended December 31, 2017 was 59.3% compared to 70.5% in the year-ago fourth quarter. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X system compared to the Renaissance system and the pricing terms with Medtronic. Total operating expenses were $11.4 millioncompared to $14.2 million in the year-ago fourth quarter, mainly due to lower operating expenses, following the transition to the global distribution phase of the Medtronic partnership. Operating loss was $0.1 million compared to an operating loss of $4.3 million in the year-ago fourth quarter. Net income for the fourth quarter of 2017 was $0.4 million, or $0.01 per share, compared to a net loss of $4.3 million, or $0.09 per share, for the year-ago fourth quarter.

Cash generated by operating activities was $3.8 million compared to cash used in operating activities of $1.9 million in last year’s fourth quarter. The change is primarily a result of strong collections in the fourth quarter of 2017. As of December 31, 2017, cash, cash equivalents and investments totaled $108.3 million.

FOURTH QUARTER 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliations of the Company’s GAAP results to non-GAAP results. The reconciliations relate to non-cash expenses in the amount of $1.5 million with respect to share-based payments and amortization of intangible assets recorded in the fourth quarter of 2017. On a non-GAAP basis, the net income in the fourth quarter of 2017 was $1.9 million, or $0.03 per share, compared to net loss of $3.1 million, or $0.07 per share, for the year-ago fourth quarter.

FULL YEAR ENDED DECEMBER 31, 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

For the full year ended December 31, 2017, revenue increased 78% and totaled $64.9 million compared to $36.4 millionfor the full year ended December 31, 2016, due to higher system sales and an increase in recurring revenue. Recurring revenue totaled $27.8 million, an increase of 65% compared to $16.8 million in the full year ended December 31, 2016. The growth in recurring revenue is attributed to the increase in the installed base and high utilization of the Company’s robotic guidance systems. Gross margin for the full year ended December 31, 2017 was 63.5% compared with 71.6% for the full year ended December 31, 2016. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X system compared to the Renaissance system and to the pricing terms with Medtronic. Operating expenses for the full year ended December 31, 2017 were $55.1 million, compared to $45.1 million for the full year ended December 31, 2016. The Company’s sales and marketing expenses are now expected to decrease, as Medtronic assumed commercial responsibility for the Mazor X, effective September 18, 2017. Net loss for the full year ended December 31, 2017 was $12.4 million, or $0.25 per share, compared to a net loss of $18.7 million, or $0.42 per share for the full year ended December 31, 2016.

FULL YEAR ENDED DECEMBER 31, 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

On a non-GAAP basis, the net loss for the full year ended December 31, 2017 was $5.7 million, or $0.12 per share, compared to a net loss of $16.1 million, or $0.36 per share for the full year ended December 31, 2016.

ADJUSTMENTS TO REPORTED THIRD QUARTER 2017 FINANCIAL RESULTS

As previously disclosed on January 8, 2018, the Company’s revenue for the third quarter ended September 30, 2017 was adjusted from $17.2 million to $18.6 million. The corresponding cost of goods sold was also adjusted from $5.3 million to $5.9 million. The increase is due to system deliveries to Medtronic which were incorrectly recorded as delivered after the third quarter ended September 30, 2017.

Following an additional analysis of the 2017 third quarter results, the Company is further adjusting its cost of goods sold by $1.1 million to $7.0 million due to the inaccurate recording of purchase of goods.

As a result of these adjustments, the gross margins for the three and nine months ended September 30, 2017 were adjusted from 69.2% and 68.0% to 62.3% and 65.3%, respectively. The net loss for the same periods was increased by $0.3 million to $3.9 million and $12.9 million, respectively.

The amended financial results for three and nine months ended September 30, 2017 are available through the Company’s website at

https://www.mazorrobotics.com/index.php/investors-relations/financial-reports.

CONFERENCE CALL INFORMATION

The company will host a conference call to discuss these results on Wednesday, February 14, 2018, at 8:30 AM EST (3:30 PM IST). Investors within the United States interested in participating are invited to call 800-289-0438. Participants in Israel can use the toll-free dial-in number 1809 212 883. All other international participants can use the dial-in number +1 323-794-2423.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-888-203-1112 and reference the Replay Access Code: 5797376. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.comand select ‘Investor Relations.’

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating profit (loss), net income (loss) and basic and diluted earnings per share that exclude the effects of capitalization of development costs, non-cash expense of amortization of intangible assets and share-based payments. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income and earnings per share and to compare them to historical net income and earnings per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding that 2018 will be a year of transition for Mazor, Mazor benefitting from the accelerating adoption of robotics for spine surgery, the expected decrease in sales and marketing expenses, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

READ THE REST HERE

Simplify Medical Completes Enrollment in IDE Trial Studying Simplify Disc in One Level of Spine for Cervical Disc Replacement

Posted On February 14, 2018 By OrthoSpineNews In Spine, Top Stories /

February 14, 2018

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced completion of enrollment in its U.S. IDE trial studying the Simplify Disc used for one-level cervical implantation of the device between C3 to C7 compared with a historical control group. The trial enrolled 166 patients at 16 U.S. sites.

“We want to thank the surgeon investigators, their staffs and the patients participating in the Simplify trial for their time and tremendous support,” said David Hovda, chief executive officer of Simplify Medical. “Recognizing that most of the devices used in disc replacement today require patients to be exposed to substantial ionizing radiation from CT scans post-operatively, it’s important for patients and physicians to have an alternative that minimizes that risk.”

The trial’s national co-primary investigator Domagoj Coric, MD, with Carolina Neurosurgery and Spine Associates, said, “The Simplify Disc is straightforward to implant, with materials designed to optimize biocompatibility and lower disc heights to better match cervical anatomy. We are pleased with the positive early clinical outcomes and look forward to seeing the longer-term study results, anticipating that they will validate the promise seen to date.”

Richard Guyer, MD, chairman of the Texas Back Institute Foundation and national co-primary investigator for the study, said, “The Simplify Disc is made of materials designed to optimize MRI imaging of the disc space and adjacent spinal canal without artifact. This can minimize or eliminate the use of post-operative CT scans and their risk of radiation to patients, and we look forward to having this capability as an option for treating our patients with cervical disc disease.”

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

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

The Simplify Disc used in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled and enrollment is expected to be completed by the end of 2018. The prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level clinical trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

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

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

Contacts

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

Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant

Posted On February 14, 2018 By OrthoSpineNews In Spine, Top Stories /

February 14, 2018

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

Spineology’s OptiMesh^® deployable graft containment implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data to support a regulatory submission for expanded indications, allowing the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

Dr. Stéphane Lavoie of DeLand, Florida enrolled the first SCOUT subject. As one of the top enrolling sites, Dr. Lavoie also enrolled the final study subject. “The Spineology interbody fusion system allows me to efficiently prepare the disc space for fusion through a very small access, reducing surgical time and trauma to the surrounding tissues. It has been exciting to participate in the clinical trial for this unique fusion system and I have been pleased with my patient outcomes.”

“The unique deployable mesh allows me to create a confirming bone graft pack to support new bone growth,” added Dr. Martin Krag, Professor of Orthopaedics at the University of Vermont Larner College of Medicine. “Importantly, patient satisfaction is very good. At our institution we have observed rapid and substantial improvements in pain and function scores for study subjects post-surgery.”

Early results in the SCOUT trial have been encouraging. Dr. John Chi will be formally presenting interim SCOUT results at the upcoming meeting of the International Society for the Advancement of Spine Surgery (ISASS) to be held this April in Toronto, Canada. Dr. Chi is an Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital, the top enrolling site in the SCOUT IDE trial.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients will be followed for 24 months minimum and the company is gathering data on hospital parameters, pain and function, patient satisfaction, safety and radiographic fusion. The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Subsequent to appropriate follow-up, the clinical outcomes data collected will allow Spineology to submit a De Novo application to the FDA to seek marketing clearance for interbody mesh fusion indications in the U.S.

About Spineology Inc.
Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com

Medovex Corporation Presents Initial Data on the DenerveX® System During NSpine 2nd Platinum Course in Arosa, Switzerland

Posted On February 14, 2018 By OrthoSpineNews In Spine /

ATLANTA, Feb. 13, 2018 (GLOBE NEWSWIRE) — Medovex Corp. (OTCQB:MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that the Company participated at the NSpine Platinum Small Group Educational Event in Arosa, Switzerland, held January 29^th through February 3^rd, 2018.

Medovex medical advisory board member Vik Kapoor MD, from Manchester, U.K. presented on two separate days at the N-Spine Platinum Small Group Educational Event. Dr. Kapoor presented initial data on his first 20 cases using the DenerveX System, which he considers very positive. The presentation was well received by approximately 50 European neuro, spinal, and orthopedic surgeons. Attending surgeons were granted 30 European CME credits (6 ECMEC® per day) by the European Accreditation Council for Continuing Medical Education (EACCME).

A third day marketing presentation focused on the DenerveX System including discussion related to reimbursement opportunities specific to individual countries, leading to expressed interest from many attendees to start performing DenerveX cases in their respective countries.

In an effort to enhance the value of the meeting, the third day of the event consisted of novel technologies identified by NSpine as improving the field of spine care. The Medovex team was pleased to have been selected.

The value of the Arosa meeting lies in its educational content – to gain a greater understanding of current trends and decision making in spinal surgery – and in the networking with senior decision makers in the world of spinal surgery.

Manfred Sablowski, Medovex Senior Vice President of Global Sales & Marketing stated, “We are pleased to have been selected for participation at The NSpine Platinum Small Group Educational Event. The professional networks built through these events are as valuable as the educational content itself. During this master’s course, Medovex had the privilege of meeting many of the world’s preeminent surgeons who we continue to draw on for advice in managing unusually complex cases.”

Sablowski continued, “Events like these are important milestones for Medovex, as well as a key inflection point gaining us leverage for our Company’s growth strategy focused in Europe, South America, and Australia. Importantly, it provides potential future customers the opportunity to experience firsthand the intuitive DenerveX System.”

Please also follow us on Facebook at https://www.facebook.com/medovex/.

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 System, 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 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

Medovex Corp.
Jason Assad
470-505-9905
Jassad@medovex.com

GLOBAL MEDIA CONTACTS

David Schull
Russo Partners LLC
212-845-4271 (office)
858-717-2310 (mobile)
David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
646-942-5627 (office)
917-547-0434 (mobile)
Karen.chase@russopartnersllc.com

Centric Medical™ Announces New Release of Sterile-Packed Rogue+™ Hammertoe Correction System Implants

Posted On February 13, 2018 By OrthoSpineNews In Extremities /

February 13, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the release of the ROGUE+ Hammertoe Correction System. This sterile-packed innovative system adds to the original implant design also available, while providing internal fixation via a dual threaded construct which is inserted between the proximal and middle phalanges so that the opposing threads fixate within the phalangeal canals of the toe to compress the proximal interphalangeal (PIP) joint.

“Centric Medical’s Rogue+ Hammertoe Correction System implant is a well-designed, patient focused, surgeon friendly device that allows for safe and predictable treatment of patients’ forefoot problems,” said Gregory G. Caronis, M.D. of Advocate Condell Medical Center in Libertyville, Illinois.

The sterile-packed ROGUE+ Hammertoe Correction implant is designed to have less implant extruding into the PIP Joint when reducing the joint, which allows for easier reduction of the joint and less bone removal, maintaining more of the original toe length. It offers benefits of strength, compression, internal bone fixation and simplicity. With streamlined instrumentation to reduce OR time, along with an improved technique, the implant can be consistently placed across the PIP Joint to optimize bone purchase in the proximal and middle phalanx.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

Contacts

Life Spine
Mr. Omar Faruqi, 847-884-6117
Chief Financial Officer
ofaruqi@lifespine.com

Exactech Shareholders Approve Merger Agreement with TPG Capital

Posted On February 13, 2018 By OrthoSpineNews In Financial /

February 13, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, today announced that at a Special Meeting of Shareholders held earlier today, Exactech’s shareholders approved the previously announced merger agreement with TPG Capital and certain of its affiliates, and approved the other two proposals described in Exactech’s proxy statement relating to today’s meeting.

Approximately 94.5% of voting Exactech shareholders cast their votes in favor of the merger, representing approximately 73.7% of Exactech’s outstanding common stock as of the record date for the special shareholder meeting. The final results will be available on a Current Report on Form 8-K, to be filed later this week by the company.

Upon completion of the transaction, Exactech shareholders will receive an amount in cash equal to $49.25 per share of Exactech common stock. The transaction remains subject to customary closing conditions and is expected to close on or around February 14, 2018, at which time Exactech will become a private company and its common stock will no longer trade on the NASDAQ. In addition, the company’s common stock will cease to be registered under Section 12 of the Securities Exchange Act of 1934, as amended.

Advisors

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

About Exactech

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 potential adverse reactions or changes to business relationships resulting from the announcement 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.

Contacts

TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Priscilla Bennett, 352-377-1140
media@exac.com

Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2018

Posted On February 13, 2018 By OrthoSpineNews In Financial /

DUBLIN – February 13, 2018 – Medtronic plc (NYSE: MDT) announced today that it will report financial results for the third quarter of fiscal year 2018 on Tuesday, February 20, 2018. A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at http://newsroom.medtronic.com. The news release will include summary financial information for the company’s third quarter of fiscal year 2018, which ended on Friday, January 26, 2018.

Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its third quarter of fiscal year 2018. The webcast can be accessed at http://investorrelations.medtronic.com on February 20, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at http://investorrelations.medtronic.com.

Looking ahead, Medtronic plans to report its fiscal 2018 fourth quarter financial results on Thursday, May 24, 2018, and for fiscal year 2019, the company plans to report its fiscal first and second quarter financial results on Tuesday, August 21, 2018, and Tuesday, November 20, 2018, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Orthofix Announces Initiation of Enrollment in Rotator Cuff Repair Study

Posted On February 13, 2018 By OrthoSpineNews In Extremities /

February 13, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced that enrollment has begun in a study that will evaluate the use of pulsed electromagnetic field (PEMF) technology for rotator cuff repair. This study will assess the efficacy and safety of the Company’s RCStim^™ device as an adjunctive treatment to surgical repair of full thickness rotator cuff tears.

The study will evaluate if PEMF technology that is currently used to promote bone growth can reduce the rate of repaired tendons being subsequently torn again and improve overall patient outcomes. The study will also gather data to see if there is a correlation between patients treated with PEMF and improvements in muscle strength and range of motion and a decrease in pain scores.

“Arthroscopic repair of rotator cuff tears can improve pain and functional use of the shoulder but a continuing challenge is the high retear rates after repair,” said Dr. Andrew Kuntz, an orthopedic shoulder surgeon at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and an investigator in the clinical study. “If PEMF therapy can prove effective in improving the patient’s ability to heal after repair surgery, this could provide us with a way to lower the number of revision surgeries and improve overall outcomes.”

The PEMF study for rotator cuff repair is a prospective, randomized, double-blind, placebo-controlled trial that will enroll approximately 538 patients who are between 21 and 80 years of age at up to 30 sites in the U.S. Study participants will be randomized in a two-to-one ratio to either an active or placebo control (inactive) device and followed for 24 months after initiation of treatment.

“PEMF technology has been used for many years to promote bone growth and the healing of nonunion fractures,” said James Ryaby, Ph.D., Chief Scientific Officer for Orthofix. “The rotator cuff clinical trial is based on our compelling pre-clinical research and it is our second ongoing study evaluating PEMF therapy for a soft tissue application. As we previously announced, we also have a study for Osteoarthritis of the Knee for providing symptomatic relief of OA pain, reducing cartilage breakdown and stimulating new cartilage formation. Ultimately, if results of these studies are positive, it could open the door to important new applications of this technology.”

The Orthofix RCStim device is an investigational device and use in the study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). More information about the study is available at ClinicalTrials.gov.

Orthofix PEMF technology devices are currently approved by the FDA for the treatment of nonunion fractures that have not healed or have difficulty healing and as an adjunct to cervical and lumbar spinal fusions. To learn more please visit bonegrowththerapy.com.

About Rotator Cuff Tears

According to the American Academy of Orthopaedic Surgeons, rotator cuff tears send as many as two million Americans to their physicians’ offices every year, many with a full-thickness or complete tear. A full-thickness tear means the tendon has separated from the bone. This common musculoskeletal injury often requires surgical intervention. An estimated 250,000 patients get rotator cuff surgery in the U.S. annually.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Investor Relations
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Month: February 2018

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