joimax®, Inc. Opens Its First Education & Training Center in Irvine, California, Posts Record Sales in the US and Continues to Make Gains with Endoscopic Reimbursement

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 1st, 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

Seven of Colorado’s Top Private Orthopedic Practices Come Together to Form Orthopedic Centers of Colorado, Now the State’s Largest Practice

DENVERAug. 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

Mazor Robotics and Medtronic Enter Next Phase of Strategic Partnership; Medtronic to Make a $40 million Third Tranche Investment in Mazor

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.

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20170829006252r1&sid=acqr7&distro=nx&lang=en

View source version on businesswire.comhttp://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.

Globus Medical Appoints David M. Demski as CEO

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

MicroPort Orthopedics Announces Launch of its Procotyl® Prime Acetabular Cup System for Total Hip Replacement Surgery

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.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

All rights reserved.

Copyright © 2017 MicroPort Scientific Corporation

Contacts

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

Allegra Orthopaedics making progress on bone substitute technology

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

Regentis Biomaterials Receives European CE Mark Approval for GelrinC

OR AKIVA, Israel and PRINCETON, New JerseyAugust 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.

Exclusive Agreement to Co-market Proprietary Software Platform to Aid in Total Hip Replacement Announced Between DePuy Synthes and JointPoint, Inc.

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.

©DePuy Synthes 2017. All rights reserved.

Photo courtesy of JointPoint, Inc.

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

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

Peninsula Orthopaedic Associates Announces First MACI Implant in the Region for the Treatment of Cartilage Defects of the Knee

SALISBURY, Md.Aug. 24, 2017 /PRNewswire/ — POA, a large regional orthopaedic specialty group, announced their first successful implant of MACI® (autologous cultured chondrocytes on a porcine collagen membrane) in the region. MACI is an FDA-approved product, in which a patient’s own cartilage cells from the knee are regrown in a laboratory and implanted back into the patient’s knee to repair the defect.

With the introduction of MACI, surgeons now have an FDA approved product in which the patient’s own cells can be reproduced in a controlled lab environment, embedded on a special collagen membrane, and then implanted in the knee using a minimally invasive technique. “Joint preservation surgery has undergone its next evolution.  With this new technology, we can use a patient’s own cells to grow new cartilage to preserve their joint.  The scaffold which delivers their cells allow for minimally invasive surgery and smaller incisions.  We are working on an all-arthroscopic technique, as well.  While this operation will not work for an arthritic knee, it has the promise of preserving a knee and potentially preventing future arthritis,” says Orthopaedic Surgeon Dr. Jason Scopp.

About MACI

MACI® (autologous cultured chondrocytes on a porcine collagen membrane) is an autologous cellular scaffold product that is used in the repair of symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement in adults. The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from a patient’s own cartilage for the manufacturing of MACI. The FDA approval of MACI was supported by the results of SUMMIT trial, a Phase 3 two-year trial.

About POA

Peninsula Orthopaedic Associates is a multi-specialty orthopaedic practice with offices in Berlin and Salisbury, Marylandand Millsboro and Seaford, Delaware. With over 50 years of providing comprehensive orthopaedic care, we provide expertise in foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine, joint replacement, joint preservation, orthopaedic trauma care, performance enhancement and rehabilitation, and biologic solutions, in order to offer an expansive continuum of care for our region.

For more information, please visit the MACI website at maci.com, or contact Jessica Ennis at
410-860-4506 or jennis@peninsulaortho.com.

SOURCE Peninsula Orthopaedic Associates

Bone Biologics Adds Osteoporosis and Trauma Indications to its Portfolio

August 23, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, today has announced that it has expanded its Field of Use definition of the license agreement with the UCLA Technology Development Group on behalf of UC Regents for NELL-1. Additionally, Bone Biologics has entered into an exclusive license agreement with the UCLA Technology Development Group on behalf of UC Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer.

“Following the completion of several key milestones, Bone Biologics is pleased to include two additional indications to its portfolio,” said Stephen LaNeve, CEO and President of Bone Biologics. “In addition to the company’s work in spine fusion, this exclusive license agreement for trauma and osteoporosis, further supports the possibility of NELL-1 becoming a proprietary platform technology.”

Most current osteoporosis therapies are designed to slow bone loss and prevent it from worsening but research involving NELL-1 is being examined to systemically restore bone and prevent further loss.

About Bone Biologics

Bone Biologics (OTC: BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work and building on unprecedented research on the NELL-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. NELL-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTC; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com