Top Stories – Page 41

MARIETTA, Ga., Aug. 31, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that their latest peer-reviewed clinical study of the MiMedx dehydrated human amnion/chorion membrane (“dHACM”) allografts was accepted for publication in the International Wound Journal.

The paper entitled “A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers,” was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O’Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH. The electronic publication of the article in the International Wound Journal is expected to be made in the next few weeks. At that time, MiMedx expects to issue a follow-up press release with the detailed study results and link to the article.

Parker H. Petit, Chairman and CEO, stated, “This is the first large scale successful Venous Leg Ulcer (VLU) study to be completed in nearly 20 years, and the first large randomized controlled trial (RCT) of this quality on a biological allograft. No other organization has completed such a VLU study and achieved such compelling results. Our EpiFix bilayer allograft is the first and only biologic with these confirmed clinical results. This study is evidence that MiMedx continues to distance itself from our competitors.”

Bill Taylor, President and COO, said, “The 16 week randomized, fifteen-center, clinical trial evaluated the efficacy of MiMedx EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. The 109 subjects were randomized to receive EpiFix in addition to moist dressings and compression or moist dressings and compression alone. The primary endpoint was time to complete healing. Secondary endpoints were the proportion of subjects with complete healing by 12 and 16 weeks.”

Taylor continued, “The study results for the patients treated with EpiFix showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing. These results are vastly superior to VLU healing rates reported in studies of other advanced wound care products. In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix reported in this study. The healing results observed with EpiFix within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm²for Apligraf treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm².”

“While we have achieved Medicare reimbursement coverage for both VLU’s and Diabetic Foot Ulcers (DFUs), our breadth of reimbursement coverage with commercial payers is primarily for DFUs. Commercial health insurance plans are heavily influenced by the results of published clinical studies, and numerous clinical studies have been conducted and published that confirm the healing effects of EpiFix on DFUs. With the publication of this study and its compelling results in VLU healing rates, we expect a significant revenue opportunity will develop for MiMedx as commercial payers see this body of evidence demonstrating the clinical efficacy of EpiFix in the treatment of VLUs. We have used very conservative parameters to calculate the impact of gaining additional VLU coverage with payers. We estimate with the impact of this study, MiMedx can obtain VLU coverage for approximately 133 million additional commercial lives,” noted Petit.

Taylor added, “Published data indicates that the prevalence rate of VLUs in the commercial population is 0.183 percent. Assuming three to four EpiFix applications for a VLU, which is a very moderate assumption, and assuming an extremely conservative market penetration rate of 10 to 15 percent, we believe our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance will be between approximately $75 million and $150 million.”

Chris Cashman, EVP and Chief Commercialization Officer, commented, “We are extremely confident in our ability to achieve and exceed our VLU market penetration estimates if additional commercial insurance coverage is gained. Currently, only about 30% of the commercial plans that cover EpiFix for DFUs also cover EpiFix for VLUs as well. This study should dramatically increase that ratio. We now have approximately 350 sales professionals focused on the commercial wound care market, and we anticipate that number to grow to approximately 375 sales professionals by year-end. Given the VLU market opportunity, without even considering the approximate one million acute pressure ulcers that could also benefit from EpiFix applications, we are very excited about the revenue opportunities that this landmark clinical study can facilitate for MiMedx.”

“We are looking forward to soon reporting the full details of this study when the article is electronically published,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; the potential safety and efficacy, and additional approved uses and markets for our products; our expectations of how insurers will respond to this data and the size and timing of additional revenue opportunities; the estimated number of sales professionals by year-end; and the advantage over competitors that will be conferred by this result. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; insurance coverage decisions may not occur as anticipated or coverage requirements may change; that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated; and we may be unable to hire sufficient qualified sales persons in a timely manner. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

joimax_Training_Education_Center_Irvine_FINAL_VERSION.jpg

August 31, 2017

IRVINE, Calif.–(BUSINESS WIRE)–joimax^® announces the grand opening of its new state-of-the-art Training and Education Center in Irvine, California. The company will be holding its first workshop at the Center on September 8-9th.

As the market leader in endoscopic spine surgery, joimax^® is fully dedicated to outstanding physician education, training and services worldwide. Due to the newly released US CPT reimbursement code, valid since January 1^st, 2017, the demand for joimax^® endoscopic procedures are growing monthly in the USA among patients as well as the physician community. This fast growing demand creates major needs which joimax^®, Inc. is addressing with fast expansion of its US organization.

“This new wet lab facility provides a major base for supporting our fast growing education needs for both our new sales and clinical associates, but moreover it’s a place for physicians to be trained,” states Bob Wolownik, National Director of Sales for joimax^® Inc.

joimax^® also announced that they are taking the lead in supporting this years’ workshops and educational sessions at:

SMISS Sept 14-16, 2017 – Las Vegas, NV
Sole Supporter of the Endoscopic Lab Session

ISASS Sept 22-23, 2017 – Long Beach, CA
Endoscopic Lab Supporter

NASS Oct. 25-28, 2017 – Orlando, FL
Endoscopic Spine Surgery Session Sponsor
and Endoscopic Lab Supporter

joimax^® has also made significant strides in reimbursement support for endoscopic spine procedures via a new external coding support hotline that it manages along with a payor correspondence package. joimax’s Vice President of Operations & Reimbursement, Brian Schneider, recently stated, “We have seen a significant rise in interest from both payors and physicians asking to receive information and streamline communication regarding the new endoscopic spine code.”

“As we received a first CPT reimbursement code for endoscopic spine surgery earlier this year and now invest wisely for future growth, joimax^® will continue to write a major success story in the US, similar to what it has accomplished in Europe and Asia,” states Maximilian Ries, General Manager for joimax^®, Inc. He announced that the company is continuing to post record sales by nearly doubling its year to date US revenues, which is in line with the company’s budget plan.

Overall joimax^® is very pleased with the great strides achieved in the US market and sees continued sustainable growth globally. “All this is an important step towards the full acceptance of endoscopic minimally invasive spine surgery techniques and their benefits to both the physician and their patients in the US now as well,” echoes Wolfgang Ries, Founder and CEO of joimax^®.

The company’s European and Asian sales also show record numbers. Earlier this year, joimax^® also received multiple new product registrations in Asia and recently in Brazil to fully access this new market.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® (for facet and sacroiliac joint therapy) or with EndoLIF^® and Percusys^® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”).

Contacts

Press contact USA:
joimax^® Inc.
Melissa Brumley, +1 949 859 3472
Melissa.brumley@joimaxusa.com
or
Press contact Int.:
joimax^® GmbH
Sabine Jarosch, +49 721 25514, ext.213
sabine.jarosch@joimax.com

DENVER, Aug. 31, 2017 /PRNewswire/ — Fifty-six of Colorado’s top orthopedic physicians, across seven practices, have united under a common vision of improving outcomes, efficiency, cost, and quality to form Orthopedic Centers of Colorado, LLC (OCC). With 19 offices across the Denver metro area, the combined practice is the largest provider of orthopedic and musculoskeletal care in the state.

The seven practices coming together as Orthopedic Centers of Colorado, LLC are:

Advanced Orthopedic & Sports Medicine Specialists P.C.
Colorado Orthopedic Consultants, P.C.
Denver Spine Surgeons, LLC
Denver-Vail Orthopedics, P.C.
Hand Surgery Associates, P.C.
Orthopedic Associates, LLC
Peak Orthopedics & Spine, PLLC

In a market where just 33 percent of physicians work in independent practice, down from 48 percent in 2012, this formation represents a physician-driven commitment to the private-practice model of medicine.

“The private-practice model has proven to deliver a higher level of quality at a more competitive price,” said Davis Hurley, MD, president of Orthopedic Centers of Colorado. “Patients will continue to benefit from the more personalized approach that private practice delivers to accommodate each patient’s needs.”

As a physician-driven organization, OCC will remain nimble enough to adapt to the ever-changing healthcare landscape, and emerge as pioneers in improved patient outcomes and reduced costs, while maintaining strong personal relationships with the patients from the communities we serve.

The seven practices will begin operating as Orthopedic Centers of Colorado on September 1, 2017. Patients of the practices will see no interruption in their care and services and will begin to see the OCC name on patient communications.

About Orthopedic Centers of Colorado, LLC
The number one choice for orthopedic, hand and spine health in Colorado and the Rocky Mountains, Orthopedic Centers of Colorado is an independent group of 56 physicians focused on patient specific care, quality outcomes, value and continuous improvement. We’ve assembled the best doctors across nearly 30 areas of expertise including Colorado’s best sports medicine and orthopedic physicians. Patients can visit any of our 19 convenient locations for care from doctors who believe quality patient care starts with a great patient experience. Learn more at orthocentersco.com

SOURCE Orthopedic Centers of Colorado, LLC

CAESAREA, Israel–(BUSINESS WIRE)– Mazor Robotics Ltd. (MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced that it has entered the next phase of its strategic partnership with Medtronic earlier than planned and their existing agreements have been amended accordingly. The agreements provide for the conversion of the commercial relationship between the parties, with Medtronic assuming exclusive worldwide distribution of the Mazor X system, and Medtronic making a $40 million third tranche investment in Mazor. These developments are a result of the early achievement of certain sales and marketing milestones by both companies, as well as higher than expected global market acceptance and demand for the Mazor X system. Medtronic and Mazor originally entered into a strategic agreement in May 2016.

Key Highlights Include:

Medtronic assumes exclusive global spine market commercial responsibility for the Mazor X Surgical Assurance Platform and its accessories.
The implementation of annual minimums for purchase of Mazor X systems by Medtronic with a cumulative potential of hundreds of Mazor X systems over a four and a half-year period.
Approximately 30 members of the current Mazor sales organization are expected to join Medtronic to assure continuation of the current momentum.
Co-development of future products for the spine market that combine Mazor Robotics’ core expertise in surgical planning and precision-guided surgical systems with Medtronic’s navigation capabilities and implant systems. The first results of this combined and synergistic effort are expected to be demonstrated this fall.
Mazor will continue to provide service to the global installed base of the Mazor X.
A shared economic incentive to continue developing products and services that maintain innovation leadership and utilization of Mazor Robotics clinical solutions.
Medtronic will invest $40 million in Mazor Robotics’ American Depository Shares (ADS) at a price of $38.46 per ADS, which represents the weighted average of the closing price of Mazor’s ADS on Nasdaq over the past 20 trading days. This third tranche of investment in Mazor by Medtronic will bring Medtronic’s total investment in Mazor to $72 million, representing approximately 11.9% of the outstanding shares post investment and 10.6% of the fully diluted shares outstanding post investment. Mazor will also issue to Medtronic warrants to purchase an additional 1.21 million Mazor ADSs at an exercise price of $44.23 per ADS. The exercise price represents a 15% premium over the per share price for the $40 million equity investment. Medtronic has the right to exercise the warrants immediately in whole or in part, for cash, and they expire after 18 months. Assuming the full exercise of the warrants, Medtronic’s investment in Mazor will reach $125 million and its ownership could increase to 4.2 million ADSs, or 14.2%, based on the current number of ADSs outstanding on a fully diluted basis. Closing of the $40 million equity investment is expected to take place on or around September 12, 2017.

“Medtronic is our valued strategic partner and together we have achieved the desired outcome for Phase I well ahead of our original plan,” commented Ori Hadomi, Chief Executive Officer. “I believe that the move to this next phase reinforces our significant leadership position in the growing market for surgical guidance systems for spine procedures. Our strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers.

“The strategic partnership between Mazor and Medtronic has already resulted in 59 Mazor X system orders since the October 2016 launch and reflects an accelerated sales cycle due to customers’ eagerness to adopt our solutions for the spine market,” added Mr. Hadomi. “Now, as commercial responsibility for the Mazor X in the spine market shifts to Medtronic, the annual minimums for sale of Mazor X systems agreed to by the two companies are expected to drive substantial improvement in Mazor’s financial results during the next several years. Together we will be able to further advance our robust jointly-developed product pipeline for the spine market, to make a difference for patients while Mazor also pursues new opportunities to apply our innovative technologies to other medical needs.”

“Moving to the next phase of our strategic partnership demonstrates our shared passion for transforming how spine surgery is done,” said Doug King, senior vice president & president of the Medtronic Spine division, which is part of Medtronic’s Restorative Therapies Group. “Mazor Robotics’ technology and Medtronic’s navigation capabilities and implant systems provide spine surgeons with complete procedural solutions that advance the standard of care and will help surgeons maximize predictability and efficiency.”

Mazor will continue to manufacture and recognize revenues for Mazor X system sales, disposable kits and service fees all of which will be sold at contractual pricing agreed with Medtronic. The contracted pricing is at a lower rate than Mazor realized through its direct sales channel. In addition, Mazor will be entitled to certain synergy fees associated with the use of Medtronic implants in Mazor Robotics’ installed base. Moving from direct sales to a strategic distribution model is expected to immediately reduce Mazor’s annual operating expenses by approximately $13 million. Trailing 12-month operating expenses for Mazor totaled $52.7 million.

The proceeds from the investment will further strengthen Mazor’s balance sheet and provide the resources to continue to collaborate with Medtronic to develop innovative solutions for the spine market, as well as develop innovative solutions for other potential markets.

Mazor will continue to independently develop and market globally the Renaissance Surgical Guidance System, which was first launched in 2011. Efforts for Renaissance will be focused on certain market segments for which the Renaissance provides significant customer added value.

CONFERENCE CALL INFORMATION

The Company will host a conference call to discuss today’s announcement at 8:30 AM EDT (3:30 PM IDT). Investors within the United States interested in participating are invited to call 1-800-289-0498. Participants in Israel can use the toll-free dial-in number 1-80-925-8350. All other international participants can use the dial-in number 1-719-325-4818. For all callers, refer to Conference ID 1217133.

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 1-866-375-1919 and reference the Replay Access Code: 1217133. All international callers can dial 1-719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor

Mazor Robotics 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 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. For example, Mazor is using forward-looking statements in this press release when it discusses the outcome of the Phase II agreements with Medtronic, when it states that the results of combined development efforts are expected to be launched this fall, when it states that sales minimums are expected to drive substantial improvement in Mazor’s financial results during the next several years, when it discusses that the strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers, when benefits spine surgeons will get from the combination of Mazor’s technology and Medtronic’s navigation capabilities and implant systems are discussed, when it discusses advancing its robust, jointly-developed product pipeline for the spine market while pursuing exclusive efforts to apply its innovation to other medical needs, when it discusses that moving from direct sales to a strategic distribution model is expected to immediately reduce its annual operating expenses, when it discusses continuing to independently develop and market globally the Renaissance Surgical Guidance System and where it will focus its efforts with regard to this system, and when it discusses the timing of the closing of the Medtronic purchase of ADSs and the potential exercise of warrants as well as the use of proceeds from the sale of such securities. 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170829006252/en/

EVC Group
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Source: Mazor Robotics Ltd.

AUDUBON, Penn., Aug. 29, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that, the Board of Directors has named David M. Demski as the Company’s Chief Executive Officer, effective immediately. Mr. Demski will report to David C. Paul, the Company’s founder, Chairman of the Board, and Chief Executive Officer since its inception in 2003. Mr. Paul will remain in the role of Executive Chairman.

Mr. Demski has been a Globus Medical senior executive since 2003, serving initially as Chief Financial Officer from 2003 until 2008. In 2008, he became President and Chief Operating Officer of the Company, responsible for all of its domestic and international commercial operations, including sales, marketing, manufacturing, and finance. During Mr. Demski’s tenure as President and COO, Globus Medical consistently delivered above-category growth and profit margins, culminating in the Company’s successful initial public offering in 2012. In 2015, Mr. Demski became President, Emerging Technologies, and assumed responsibility for overseeing the Company’s expansion into the areas of imaging, navigation, and robotics, as well as orthopedic trauma, both of which are expected to contribute to the Company’s growth over the next decade.

Mr. Paul will continue to focus on strategic initiatives and will spend less time on day-to-day operational matters. The Company reported that the timing of these management changes was designed to allow Mr. Paul to recover from a health condition. Mr. Paul is expected to make a full recovery over the next several months and plans to remain actively involved with the Company both during his recovery and thereafter.

“No one is or could be more well suited to be CEO of Globus Medical than Dave,” said David Paul. “He has been with us since the very start of this Company, has led virtually every aspect of its operations, and has been a significant contributor to the Company’s success to date. During the seven years when Dave served as President, among his many responsibilities were direct leadership of both our domestic and international sales forces. During that time, and as he took over responsibility for our Emerging Technologies division, Dave honed a talent for optimizing sales team performance and developing and commercializing new products. His skill set is precisely what we need to continue our focus on profitable growth.

“With Dave taking over day-to-day management of the Company, I can focus on the things I am most passionate about and the areas in which I can bring the most value to our shareholders: strategy and technology innovation. Globus Medical was built on delivering groundbreaking solutions to surgeons and their patients, and we will not stray from our core mission. We have built a strong company and will move forward with the same vision and passion for which we are known. I look forward to being part of the Company’s continued success.”

Conference Call Details:
Globus Medical will hold a teleconference to discuss the press release with the investment community at 5:30 p.m. Eastern Time. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-216-562-0337 International Participants

There is no passcode for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at www.globusmedical.com/investors.

The call will be archived until Tuesday, September 5, 2017. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 7826-9364.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms and specifically include statements regarding Mr. Paul’s medical prognosis. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, changes in Mr. Paul’s medical condition, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

August 29, 2017

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics, a medical device company that develops and manufactures cutting-edge joint replacement implants and approaches, today announced the launch of its Procotyl® Prime Acetabular Cup System.

“At MicroPort Orthopedics, we embrace the constant advance in orthopedic medicine, and have a deep commitment to creating products that make patients’ lives better,” said Aurelio Sahagun, President. “The Procotyl^® Prime Acetabular Cup System, with its best-in-class features, is a great example of this commitment, as it not only strengthens our position as a leader in surgical joint replacement, but also complements our existing products and surgical approaches to help patients return to full function faster.”

The Procotyl® Prime Acetabular Cup System, which is the next step in the evolution of the successful Dynasty® Acetabular Cup System, received 510k Clearance from the U.S. Food & Drug Administration in late June.

“Procotyl® Prime’s design is a culmination of over 20 years of market experience coupled with intelligent design and engineering,” said Dr. James Chow, Director of Orthopedics Hip & Joint at Phoenix St. Luke’s Medical Center. “We set out to design an implant optimized for highly-crosslinked polyethylene and modern 3D fixation surfaces, allowing us to eliminate compromises. The result is a shell that is strong and flexible, has maximized poly thickness and robust pull-out strength, all while allowing the versatility of large head options in the smallest sizes.”

In addition to the benefits of the implant, the Procotyl® Prime system is the first on the market designed with simple, versatile instrumentation to support a variety of surgical approaches, including all of MicroPort’s soft-tissue sparing philosophies.

Dr. Brad Penenberg, Chief of Arthroplasty Service at Cedars-Sinai Hospital, said, “Procotyl® Prime is the first acetabular component adapted for MicroPort’s novel portal-assisted acetabular instrumentation. This unique approach facilitates preservation of soft tissue, fast patient recovery, and direct acetabular visualization.”

For more information about the Procotyl® Prime Acetabular Cup System or MicroPort Orthopedics, visit www.ortho.microport.com or follow the brand on Twitter and Facebook.

About MicroPort Orthopedics
Established in January 2014, MicroPort Orthopedics Inc. is the fifth largest multinational producer of hip and knee implants and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative OrthoRecon products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japanese, Latin American and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements
Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

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Contacts

LaVoieHealthScience
Sharon Correia
scorreia@lavoiehealthscience.com
617-412-8779

28 Aug 2017

Allegra Orthopaedics Ltd (ASX:AMT) is continuing to make significant progress with its unique bone substitute technology “Sr-HT-Gahnite” and is aiming to progress into the production phase.

The company is an orthopaedic manufacturer and has obtained the global license to the composite biocompatible ceramic material known as Sr-HT- Gahnite from the University of Sydney.

Allegra’s tests have indicated that all the samples containing the Sr-HT Gahnite scaffolds showed promising ingrowth of bone through the scaffold and in some cases completely bridged the defect.

Importantly, there was no evidence of inflammation or formation of fibrous tissue, indicating good biocompatibility of the Sr-HT Gahnite.

The company is also studying the various commercial applications of this unique bone substitute technology, before commencing with interbody cervical spinal cages as the initial product offering.

READ THE REST HERE

OR AKIVA, Israel and PRINCETON, New Jersey, August 28, 2017 /PRNewswire/ —

Regentis Biomaterials Ltd., a privately held company developing proprietary hydrogels for tissue regeneration, announced today it has received European CE mark approval for its GelrinC® biodegradable implant. The approval covers GelrinC manufactured using denatured human fibrinogen and expands upon the existing CE mark for a version containing denatured bovine-sourced fibrinogen. This latest approval enables Regentis to begin accessing new global markets, and helping more patients suffering from damaged articular knee cartilage.

“Since a CE mark is recognized internationally, this key approval opens the door to making the product available in many other territories,” said Regentis Biomaterial CEO Alastair Clemow, Ph.D.

GelrinC is designed to quickly and easily treat articular knee cartilage defects, both chondral and osteochondral. With a minimally invasive procedure, surgeons apply GelrinC into lesions as a liquid allowing it to fill any size and shape of defect. After a short exposure to ultra-violet light, GelrinC is converted into a solid implant which gradually degrades in a controlled manner. Over time, the implant is replaced with newly formed cartilage tissue that is similar to native cartilage, and fits within the surrounding cartilage and underlying bone.

A long-term European clinical study of GelrinC, focusing on patients with damaged articular knee cartilage, demonstrated sustained relief of symptoms with most patients regaining pain-free knees. MRI imaging further revealed that the regenerated cartilage had properties that were comparable to natural cartilage. Regentis is currently conducting an FDA-approved Phase III pivotal multi-site clinical trial on GelrinC in the U.S. and Europe to support a PMA application, a key step to having the product approved for patients in the U.S.

“The data from our European clinical study indicates that GelrinC provides surgeons with an effective one-step treatment. GelrinC is an off-the-shelf product that can be used at any time during surgery when a lesion is identified without the need for pre-planning or additional surgeries,” said Dr. Clemow. “This makes GelrinC an attractive treatment option that is as simple to perform as microfracture with superior clinical outcomes. With a potential yearly market of more than 150,000 procedures in the U.S. alone, the opportunities for GelrinC as the primary treatment for articular knee cartilage repair are very exciting.”

GelrinC is an investigational device and not available for sale in the U.S.

About Regentis Biomaterials
With offices in Israel and the U.S., Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company’s core technology platform is based on a series of hydrogels utilizing both polyethylene glycol diacrylate and denatured fibrinogen that combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance. This technology serves as the foundation for future clinical indications in osteoarthritis. The company’s flagship product, GelrinC® is designed for the treatment of articular cartilage lesions. For more information, please visit http://www.regentis.co.il.

For more information, please contact:
Alastair Clemow, Ph.D., President & CEO
Tel: +1-508-930-8865
aclemow@regentis.co.il

For media inquiries, please contact:
Josh Turner
Tel: +972-54-949-6526
josh@jtpublicrelations.com
SOURCE Regentis Biomaterials Ltd.

WARSAW, Ind., Aug. 24, 2017 /PRNewswire/ — Today, DePuy Synthes* announces an exclusive U.S. agreement with JointPoint, Inc. to co-market its proprietary software platform to provide an easy-to-use, surgeon-friendly navigation system that can help deliver improvements in surgical outcomes. JointPoint’s software provides non-invasive computer navigation, pre-surgical digital templating, case planning, and feedback while performing total hip replacement surgeries. JointPoint easily integrates with the Anterior Approach. The Anterior Approach is a minimally invasive surgical approach that allows a surgeon to work around the muscles, rather than cut through them, to get to the hip joint.

Adding the JointPoint software to a surgeon’s protocol may help reduce leg length discrepancy and complications related to inaccurate cup placement and final implant selection – two of the most important considerations in hip replacement surgery – by providing pre-surgical digital templating and real-time, data-driven surgical decision making in the operating room.

“We are thrilled to partner with JointPoint to help provide more predictive outcomes for surgeons and their patients,” said Aaron Villaruz, Global Hip Platform Leader, DePuy Synthes Joint Reconstruction. “By providing access to important information at key stages of the hip replacement process, together we can help surgeons streamline cases and allow for pre-surgical goals to be achieved more consistently.”

One of the important features of the JointPoint software is OneTrial™, which can predict optimal implant combinations based on pre-surgical goals using just two images during surgery. Unique to DePuy Synthes implants is the ability of OneTrial™ to also provide precise recommendations on implant size and position to enable more confident adjustments and reduce OR time and fluoroscopy by eliminating re-trialing. Additionally, the JointPoint software helps streamline communications through a JointPoint calendar, case sharing, and case planning/collaboration.

“During hip replacement surgery, physicians strive for optimal implant choices and positioning to improve patient satisfaction by achieving proper leg length, offset, and cup positioning. JointPoint Hip Navigation System gives surgeons the confidence with real time feedback so they can ultimately help restore patients back to their natural function efficiently while minimizing fluoroscopy,” said Dr. Andrew J. Cooper**, MD. “I’m excited about what JointPoint can offer those surgeons whose patients are good candidates for the Anterior Approach.”

DePuy Synthes will begin co-marketing the JointPoint software in the second half of 2017.

About DePuy Synthes Companies

DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies 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.

About JointPoint, Inc.

JointPoint, Inc. develops and markets software-driven medical technology for orthopaedics. The JointPoint software solution and OneTrial™ technology is a completely non-invasive navigation system for hip replacement surgery that provides intraoperative data and guides component selection while also optimizing efficiency within a surgical workflow. For more information, visit http://www.jointpoint.com

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**Consultant to DePuy Synthes Joint Reconstruction with an ownership interest in JointPoint, Inc.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

Photo courtesy of JointPoint, Inc.

The third-party trademarks used herein are the trademarks of their respective owners.

SOURCE DePuy Synthes

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