TransEnterix Acquires Assets, Intellectual Property and Retains R&D Team from MST Medical Surgery Technologies

September 23, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has acquired substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israel medical technology company, in a cash and stock transaction with a total consideration, further described below. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

“Adding innovative, novel technological capabilities to Senhance is a critical part of our long-term strategy as we work towards digitizing the interface between the surgeon and the patient,” said Todd M. Pope, President and CEO of TransEnterix. “The addition of the MST technology to our Senhance platform will increase the effectiveness of surgeons, making procedures quicker and less error-prone, leading to better outcomes for the patient.”

“We are very excited to be partnering with TransEnterix, one of the leaders in surgical robotics who is pioneering the industry with their Senhance platform,” said Motti Frimer, CEO of MST. “The Senhance is a fantastic product with incredible potential, and we have a shared vision with TransEnterix of providing digital laparoscopy to better equip surgeons with innovative technologies that enhance their abilities, providing better quality, more consistent outcomes.”

Strategic Rationale

The addition of MST’s technology, IP portfolio, and R&D team supports and accelerates TransEnterix’s vision to leverage its Senhance Surgical System to deliver digital laparoscopy, thereby increasing control in the surgical environment and reducing surgical variability.

  • Innovative Surgical Technology Portfolio: MST’s technology and software engine will help accelerate Senhance platform innovation to meaningfully advance the benefits of digital laparoscopy to patients, surgeons and operating rooms globally. Key components of MST’s technology include advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.
  • Established R&D Center: Provides immediate access to an established R&D center in Israel, with a core team of experienced engineers. In addition, the R&D center allows the Company to tap into talent from one of the world’s top technology hubs.

Transaction Structure

TransEnterix acquired from MST substantially all of its assets, which includes technology and intellectual property, and will transfer MST’s Israeli-based R&D team to a newly formed subsidiary, TransEnterix Israel, Ltd.

The transaction will be financed with a combination of cash and stock, delivered in two separate tranches. At the closing of the transaction, MST will receive approximately $5.8 million in cash and 3,150,000 shares of TransEnterix common stock. The second tranche of $6.6 million, payable in cash or stock, is to be paid within one year of closing. The timing and form of payment of the second tranche is at TransEnterix’s sole discretion.

Conference Call

TransEnterix, Inc. will host a conference call tomorrow, Monday, September 24, 2018 at 8:00 AM ET to discuss this acquisition. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers, and reference the “Acquisition of Medical Surgical Technologies Ltd” conference call, approximately ten minutes prior to the start time. To access the live audio webcast with presentation slides or archived recording, use the following link http://ir.transenterix.com/events.cfm. The presentation materials for the conference call will be available for download at 7:00 AM ET at http://ir.transenterix.com/events.cfm. The replay will be available on TransEnterix’s website for approximately 90 days after the conference call.

About TransEnterix

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

Forward Looking Statements

This press release includes statements relating to the acquisition of the assets and R&D team of MST and the anticipated uses of such assets by TransEnterix in the future, including related to the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the reported transaction with MST is successfully consummated, our ability to use the acquired assets as intended, and our commercial success related to such assets. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

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

MiMedx Provides Update on Previously Announced Senior Executive Separations

MARIETTA, Ga.Sept. 20, 2018 /PRNewswire/ — The Board of Directors (the “Board”) of MiMedx Group, Inc. (Nasdaq :MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that it has determined that the previously announced separations of four senior MiMedx executives – Parker H. PetitWilliam C. TaylorMichael J. Senken, and John E. Cranston (collectively, the “Separated Employees”) – be treated as terminations “for cause”. The Compensation Committee separately reached this determination as well.  These determinations are based on information identified as part of the Audit Committee’s ongoing independent investigation.

Mr. Petit is the Company’s former Chairman and Chief Executive Officer; Mr. Taylor is the Company’s former President and Chief Operating Officer and a former member of the Board; Mr. Senken is the Company’s former Chief Financial Officer and principal accounting officer; and Mr. Cranston is the Company’s former Vice President, Corporate Controller and Treasurer. Messrs. Petit and Taylor resigned as officers of the Company effective June 30, 2018, and Messrs. Senken and Cranston stepped down from their positions on June 6, 2018.  Mr. Taylor resigned from the Board effective June 30, 2018.

As a result of findings related to the conduct of the Separated Employees, the Board and the Compensation Committee, as the administrators of the MiMedx Group, Inc. Assumed 2006 Stock Incentive Plan (the “2006 Plan”) and the MiMedx Group, Inc. 2016 Equity and Cash Incentive Plan (together with the 2006 Plan, the “Plans”), have taken all required action to cause all equity and incentive awards outstanding under the Plans held by the Separated Employees to be forfeited.  The Board and Compensation Committee action was based on findings that the Separated Employees engaged in, among other things, conduct detrimental to the business or reputation of the Company.

In addition, the Board and the Compensation Committee have determined that action shall be taken to recover compensation previously paid to the Separated Employees pursuant to the Plans and the Company’s Compensation Recoupment Policy, based upon the final results of the Company’s restatement of its previously issued consolidated financial statements and financial information.

Additionally, the Board announced that Mr. Petit has resigned as a member of the MiMedx Board, effective immediately.

“The Board is taking the necessary steps to prepare MiMedx for its next chapter and a stronger future,” said Charles R. Evans, Chairman of the Board. “The Board is committed to taking the decisive actions necessary to develop enhanced systems and controls. Meanwhile, the Board and management team remain focused on executing the Company’s strategy to deliver operational and clinical successes to improve the lives of patients around the world and drive long-term business success and value creation.”

The Audit Committee is working with its advisors to complete the investigation expeditiously and has made significant progress. The investigation is ongoing, and there may be other actions taken based, at least in part, on information from the investigation. The Company is also working to prepare its financial statements for audit and regain compliance with its Securities and Exchange Commission reporting obligations as soon as practicable.

About MiMedx  
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million 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.

Safe Harbor Statement
This press release includes forward-looking statements including statements regarding the Audit Committee’s independent investigation and any actions that may arise in connection therewith.  Forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors, including, without limitation, uncertainties relating to the outcome of the Audit Committee’s investigation.  For more detailed information on the risks and uncertainties that may apply to the Company’s business and the ownership of Company common stock, please review the Risk Factors section of the Company’s most recent annual report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15

September 21, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink Surgical today announces the expanded commercial launch for the FLXfit®15 articulating-expandable intervertebral body fusion device.

FLXfit15 is a posterior lumbar expandable interbody device that offers up to 15 degrees of controlled and continuous expansion and is one of the only expandable cages on the market that offers articulation, providing ease in precise anterior placement. FLXfit15’s open device architecture enables ample space for graft material and its bulleted-nose and single-instrument inserter/expander are designed to streamline insertion. FLXfit15 is offered in 2 lengths – 32mm and 40mm, and in heights from 8-13mm to accommodate diversity in anatomical need.

“The FLXfit15 Interbody device offers the surface area contact and lordosis often desired in an ALIF procedure but obtained with a less complicated posterior approach – this implant is inserted as a PL, deploys as a TL, and expands to gain lordosis of up to 15 degrees. It saves me time, is less invasive and offers optimal sagittal balance correction. In my opinion, it’s the best posterior interbody cage on the market,” said Grant Skidmore MD, Neurosurgeon, Norfolk, VA.

Jay Bartling, CEO, said, “The surgeon and distributor interest in FLXfit15 has far exceeded expectations in a very short period. CoreLink is committed to providing advanced technology with world class quality.”

“Last year, expandable devices grew to over 20% of the overall interbody market- expandable devices are clearly here to stay. CoreLink’s offering FLXfit15 is a great compliment to our growing product offering and positions us well to meet the increasing needs of surgeons and patients,” said Derek Kuyper, VP of Sales at CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, booth #2038, where a full display of FLXfit15 and our family of Foundation 3D Products will be featured. Private appointments available.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

Photo: Business Wire

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808
www.corelinksurgical.com

Surgeons call for ban on pedicle screw reuse and demand two-step asepsis process

14th September 2018

Contaminated pedicle screws cost hundreds of thousands of US dollars a year, and through an increase in surgical site infections result in additional and avoidable patient morbidity. Anand Agarwal (University of Toledo, Toledo, USA) and colleagues are calling for a change in the standard of care revolving around implant handling and delivery, cutting costs and improving patient safety.

Less widely recognised is the fact that contamination of pedicle screws still occurs in the sterile field, with intraoperative bacterial contamination needing an urgent solution.

So the issue of contamination is two-fold: outside of the operating room, concerning the reprocessing of pedicle screws, and inside the operating room, when pedicle screws are left exposed on trays and are infected with several common bacterial strains.

Reprocessed pedicle screws have been shown to still have residual microbial and non-microbial contaminants on them. In a study conducted by Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) and colleagues, published in the Global Spine Journal, traces of saccharides (including biofilm, endotoxins and fatty tissue), soap residue, and salt residue were identified on six pedicle screws randomly selected from four different trays of cleaned, wrapped and purportedly sterilised implants. In fact, there is evidence that the amount of carbohydrate residue increases following reprocessing. The investigators also found corrosion stains present on the outer surface of the implants.

The screws were retrieved using clean gloves, and immediately placed inside of clean zip-lock polybags before undergoing optical microscopy, scanning electron microscopy with energy dispersive spectroscopy, and Fourier transform infrared spectroscopy.

That reprocessed pedicle screws are not always fully sterile has already influenced policy decisions in some nations. Japan and Scotland have banned the reprocessing of spinal implants used for spinal surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.

Burns wrote: “Most orthopaedic units in NHS Scotland use screws, small plates and other small orthopaedic implants which have been repeatedly reprocessed (cleaned and sterilised) by the local Central Decontamination Unit in racks or trays. Concerns have been raised that these implants cannot be properly cleaned, and we have photomicroscopic evidence that they retain or acquire organic and/or chemical residues during reprocessing. Legally, many of these devices are classified as ‘single use’, which means they must not be re-used following contact with a patient, but also that they should only be cleaned and sterilised once, prior to first use. We suspect many of these devices have been recirculating for many years, some perhaps for over two decades. Besides generic concerns over infection and CJD [Creutzfeldt-Jakob Disease] contamination, there is evidence to suggest that reprocessed steel implants can cause inflammatory reactions to a much greater degree than ‘pristine’ devices as delivered by the manufacturer, and there are also issues of corrosion and weakening caused by repeated processing. This has clear implications for reducing implant failures, and we have no option but to address the legal, regulatory and governance issues this practice raises.”

 

READ THE REST HERE

 

Biedermann Motech to launch iMAS 360™ procedure at NASS

Miami, FL – September 24, 2018 / Business Wire / – Biedermann Motech will launch the iMAS 360™ procedure at NASS 2018 in Los Angeles, September 26-28, 2018.

Biedermann Motech, the developer of the world’s first polyaxial pedicle screw (MOSS System) and pioneer in the spinal market for more than 30 years, announced today the launch of the iMAS 360™ procedure at the North American Spine Society (NASS) meeting in Los Angeles, September 26-28, 2018.

The iMAS 360 is a mini-open, microsurgical 360 fusion procedure for the lumbar spine developed by spinal surgeon Robert L. Masson, M.D., Orlando. It incorporates many of the traditional fusion techniques combined with advanced implants and instruments to create a less invasive muscle sparing procedural solution. The key takeaway of the iMAS 360 is the ability to treat any level of the lumbar spine between L2 and S1 with one small posterior midline skin incision.

“iMAS 360 is a lumbar fusion technique that is tissue sparing, has an optimized surgical field, allows for bilateral direct decompression and restoration of lordosis. The MOSS 100™ modular pedicle screw system and the TELIX K™ steerable interbody system have been specifically designed with the iMAS 360 procedure in mind,” says Ray Oktavec, Biedermann Motech’s Director of US Sales & Marketing, Spine.

Robert L. Masson, M.D., said, “The iMAS 360 evolved over time to optimize accuracy, strategy, sequence and ultimately systems. It is an advanced procedural solution integrating technologically sophisticated equipment and techniques focusing on a specific 3D reconstructive plan…”

There will be presentations for surgeons discussing the clinical value of the iMAS 360 procedure at the Biedermann Motech booth # 2435 all three days during NASS with Robert L. Masson, M.D., Tim Keenen, M.D., Syed Aftab, FRCS, and PD Dr. med. Ali Reza Fathi.

More information is available at www.biedermann.com or call 866-622-6082.

Follow us on LinkedIn https://www.linkedin.com/company/biedermann-motech/

About Biedermann Motech

Biedermann Motech is a mid-sized, family owned group of companies with headquarters in Germany (Villingen-Schwenningen) and the USA (Miami). Since 1916 we have been working in synergy with world-class surgeons to solve significant clinical challenges through the development of next-generation technology. Our core competence is the development, production, and distribution of innovative implants and instruments for spinal and extremity surgery. We research, develop, manufacture and distribute high-quality implant systems in collaboration with healthcare professionals, technology partners, scientific institutions and specialized companies with the goal of achieving improved clinical outcomes.

Contact:  Serina Prado

305-722-5310 x132

sprado@biedermann.com

Biedermann Motech, Inc – USA

7620 NW 25th Street, Unit 3 & 4

Miami, FL 33122

Biedermann Motech GmbH & Co. KG
Bertha-von-Suttner-Str. 23
78054 Villingen-Schwenningen

Germany

Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY

September 21, 2018

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance and is proceeding with a full commercial launch of BIOSPHERE® MIS PUTTY. BIOSPHERE® MIS PUTTY utilizes a pre-loaded bone graft cannula and trigger-based delivery system specifically designed for the unique challenges of minimally invasive surgery (MIS). The system permits controlled placement of Synergy’s proven, next-generation bone graft product (BIOSPHERE®PUTTY) in open, mini-open, and percutaneous minimally invasive settings.

“BIOSPHERE® MIS PUTTY was engineered to create a functionally ergonomic and easy to use bone graft delivery system,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “With the launch of BIOSPHERE® MIS, surgeons now have the means to precisely deliver BIOSPHERE®PUTTY to the surgical location.”

The BIOSPHERE® MIS PUTTY bone graft delivery system consists of a hand-held dispenser and cannula pre-loaded with BIOSPHERE® PUTTY. The system is easy-to-use and has a one-step assembly process that is achieved by attaching the cannula to the dispenser. As the trigger is engaged during delivery, a metered amount of BIOSPHERE® PUTTY is extruded from the cannula. By design, BIOSPHERE® MIS PUTTY can be extruded around implanted hardware or to remote anatomic locations in a targeted fashion. Delivery is controlled and stops as soon as the trigger is released. The dispenser and cannula were specifically engineered with a narrow sight line profile that maximize the surgeon’s view during graft placement. BIOSPHERE® MIS PUTTY is available in a kit (that includes a dispenser and putty-filled cannula), and also individual replacement cannulas to reload the delivery system, if additional bone graft is needed.

“The BIOSPHERE® MIS PUTTY delivery system improves the ability of a surgeon to place a bone graft material at a desired location. The system is significantly easier to use than standard graft funnels and allows for increased graft delivery due to the targeted placement,” stated Dr. Derek Thomas, MD. “The BIOSPHERE® MIS PUTTY delivery system is not only useful for MIS procedures, but also for open procedures with hard to reach graft areas.”

BIOSPHERE® MIS PUTTY utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a moldable bone graft material that has one of the highest bioactive glass contents on the market.

Synergy will be showcasing BIOSPHERE® MIS PUTTY and other products at Booth 2555 at the 2018 North American Spine Society Meeting in Los Angeles (September 26th – 28th).

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141
www.synergybiomedical.com
info@synergybiomedical.com

Medtronic to Acquire Mazor Robotics

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depository Share, or $29.25 (104.80 ILS) per ordinary share, in cash, for a total of approximately $1.64 billion, or $1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Medtronic’s acquisition of Mazor strengthens Medtronic’s position as a global leader in enabling technologies for spine surgery, and drives Mazor Robotics’ vision to bring its core technology to the forefront of the global market. Mazor’s proprietary core platform technology, including the Mazor X(TM) Robotic Guidance System (Mazor X), and the Renaissance® Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s market-leading spine implants, navigation, and intra-operative imaging technology with Mazor’s robotic-assisted surgery (RAS) systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies plan to showcase this technology integration at the upcoming NASS (North American Spine Society) 2018 Annual Meeting in Los Angeles.

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” said Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80 Mazor X systems since launch. With today’s announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of RAS in spine to the benefit of patients, providers, and the healthcare system more broadly.

“Today is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” said Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximize our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

Financial Highlights
The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Perella Weinberg Partners LP and Goldman Sachs & Co. LLC, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray LLP acting as legal advisors. Mazor’s financial advisor is J.P. Morgan Securities LLC, Duff & Phelps LLC, with Kirkland & Ellis LLP and Luchtenstein Levy Wiseman Law office acting as legal advisor.

About Mazor Robotics
Mazor, founded in 2001, pioneered the application of robotics technology and guidance for use during spinal procedures, and is the market segment’s leader. In 2011, the Company introduced the Renaissance system and in 2016 launched the next generation Mazor X system. To date, more than 200 Mazor systems are in clinical use on four continents and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 U.S. Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the spine robotics market on the evidence front. Mazor is the holder of more than fifty patents worldwide.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements, including, but not limited to, statements regarding the proposed transaction between Medtronic and Mazor, the expected timetable for completing the transaction, strategic and other potential benefits of the transaction, including meeting Medtronic’s long-term financial metrics for acquisitions, Mazor’s products and product candidates, and other statements about Medtronic or Mazor managements’ future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability and timing to satisfy conditions to closing including shareholder and regulatory approvals, the impact of the announcement of the transaction on the business, and other risks and uncertainties such as those described in Medtronic’s and Mazor’s reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic and Mazor caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic and Mazor undertake no obligation to update or revise any of these statements except to the extent required by law.

ADDITIONAL INFORMATION

In connection with the proposed transaction, Mazor intends to mail a proxy statement to its shareholders and furnish a copy of the proxy statement with the SEC on Form 6-K. Shareholders of Mazor are urged to read the proxy statement and the other relevant material when they become available because they will contain important information about Mazor, Medtronic, the proposed transaction and related matters. Shareholders are urged to carefully read the proxy statement and other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. The proxy statement (when available) may be obtained for free at the SEC’s website at www.sec.gov. In addition, the proxy statement will be available, without charge, at Mazor’s website at www.mazorrobotics.com.

-end-

Medtronic Contacts:
David T. Young
Public Relations
+1-774-284-2746

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

Mazor Contacts:
Eran Gabay – Gelbart Kahana
Israel Public Relations
+972-54-246378

Michael Polyviou – EVC Group
U.S. Public Relations
+1-732-232-6914

Stryker’s Spine Division To Showcase Tritanium® In-Growth Technology in Augmented Reality Experience at NASS 2018

September 20, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will feature its family of 3D-printed Tritanium interbody fusion cages and highlight its Tritanium In-Growth Technology1 in an augmented reality experience at the North American Spine Society Annual Meeting, Sept. 26–29, 2018, in Los Angeles (booth No. 1401).

The augmented reality “tour” combines objects in the real world with computer-augmented 3D animations. Using this augmented reality storyline, as well as a series of hands-on activities and scientific animations, the experience at the Stryker booth is designed to enhance understanding of the story behind Tritanium In-Growth Technology, as well as AMagine™, Stryker’s proprietary additive manufacturing (or 3D-printing) process, which assists in the creation of highly porous implants with a structure that is designed to mimic bone.

“Our augmented reality tour will demonstrate Tritanium’s characteristics, with the goal of helping surgeons better understand the differences of materials on the market,” said Michael Carter, vice president and general manager of Stryker’s Spine division. “Tritanium continues to receive terrific feedback as more surgeons become believers in the technology, validating our commitment to providing advanced and innovative products for our surgeon customers and their patients.”

Tritanium cages are inspired by the microstructure of cancellous bone1 and enabled by AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing. The AMagine process allows the company to tackle previously difficult or impossible design complexities and address unmet surgeon needs with unique material characteristics. For example, Tritanium may be able to wick and retain fluid inside its porosity, compared to traditional titanium.1,2 Additionally, the unique porous structure of Tritanium Technology was designed to create a favorable environment for bone cells to attach and proliferate.3,4*

During the NASS conference, Stryker will also:

  • Feature results of a recent comparative animal study, which found significant differences in biomechanical and histologic performance among various interbody cage materials. The results showed that Tritanium cages achieved statistically significant increases in bone in-growth.4
  • Present a Solution Showcase titled “A Clinical Update on Tritanium—A Novel, Highly Porous Material Designed for Bone In-Growth and Biological Fixation,” by Scott Parker, M.D., assistant professor of neurological surgery, Vanderbilt University Medical Center, on Sept. 26, 2018, from 12–12:20 p.m. PT.
  • Preview its new Tritanium TL Curved Posterior Lumbar Cage, which received 510(k) clearance from the U.S. Food and Drug Administration in January 2018. Click here for the indications for use.

About Stryker

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

References

1. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26, 5475-5491.
2. RD0000053710: Tritanium cell infiltration and attachment experiment.
*No correlation to human clinical outcomes has been demonstrated or established.
3. RD0000050927: Tritanium material capillary evaluation.
4. McGilvray KC, Easley J, Seim HB, et al. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018;18(7):1250-1260.

CONTENT ID TRITA-PB-4

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Dr. Parker is a paid consultant of Stryker. His/her statements represent his/ her own opinions based on personal experience and are not necessarily those of Stryker. Individual results may vary.

Contacts

Stryker’s Spine Division
Jodie Morrow
Jodie.morrow@stryker.com
or
Sullivan & Associates
Andrea Sampson
asampson@sullivanpr.com, 714/374–6174

b-ONE Ortho Receives U.S. FDA 510(k) Clearance for Total Hip System

September 21, 2018

CEDAR KNOLLS, N.J.–(BUSINESS WIRE)–b-ONE Ortho Corp., an emerging orthopedic technology company dedicated to the development of innovative healthcare solutions, today announced it has received 510(k) clearance for its first device, the b-ONETM Total Hip System, from the U.S. Food and Drug Administration (FDA).

The b-ONETM Total Hip System is a cementless total hip system with advanced coating technology and intuitive instrumentation, designed to optimize patient fit in the modern patient demographic. The system comprises the JuvenoTMFemoral Hip, a bone-conserving femoral prosthesis, and the b-ONE Primary Acetabular System, which are compatible with b-ONETM 12/14 Taper Femoral Heads.

“This milestone for the company will officially introduce b-ONE’s product line to the U.S. market,” said Dr. Mark Kester, the Chief Scientific Officer. “With our first U.S. surgery quickly approaching, we are eager to provide surgeons with a versatile system designed to accommodate the majority of today’s expanding patient demographic. In addition, with the support of Dr. Richard Rothman, a prolific designer and developer in the orthopedic industry, our strong R&D team will continue the development and expansion of our product portfolio with a focus on quality, affordability and speed to market.”

The b-ONETM Total Hip System will have a limited launch in the first half of 2019, followed by a full commercial release in the second half of 2019.

This news follows b-ONE Ortho Corp.’s recent US$20 million Series A financing led by Eight Roads Ventures and F-Prime Capital Partners. Proceeds are being used to fund the growth of b-ONE Ortho Corp.’s product portfolio and expansion into international markets.

About b-ONE Ortho Corp.

Based in Cedar Knolls, New Jersey, b-ONE Ortho Corp. is an emerging orthopedic technology company dedicated to the development of innovative orthopedic healthcare solutions that restore patient mobility and improve surgical outcomes. Every day we are committed to becoming the most credible choice for orthopedic products worldwide.
www.b1.co

About Eight Roads

Eight Roads Ventures is a global venture capital firm that backs entrepreneurs with aspirations for greatness. As the proprietary investment arm of Fidelity International Limited, Eight Roads is committed to building bold and meaningful businesses and together with its associated funds has invested almost US$6bn globally into growing companies in the past 10 years.

Eight Roads Ventures has led successful investments in China and across the world, including Wuxi PharmaTech, Hile, Innovent, Adagene, Hua Medicine, DeltaHealth, Denali, doctorlink, Laurus Labs, Alibaba, China PnR, AsiaInfo, iSoftStone, Wisers, GShopper, Rulai and PingPong. It launched a dedicated US$250m China Healthcare Fund in September 2017.
www.eightroads.com

About F-Prime Capital

F-Prime Capital Partners is a global venture capital firm investing in life sciences, healthcare, and technology. Since 1969, F-Prime has worked closely with entrepreneurs and academics to create innovative solutions to some of the world’s most significant challenges in healthcare and technology.
www.fprimecapital.com

Caution Concerning Forward-looking Statements

This press release may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the Corporation’s expectations for future events. Such statements are based on currently available information and current expectations. If these assumptions prove incorrect or inaccurate, or known or unknown risks occur, actual results could differ materially from the expectations and projections of b-ONETM Ortho Corp. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

Contacts

For press enquiries, please contact:
b-ONE Ortho Corp.
Corinne Zappacosta
+1 (917) 733-8088
CZappacosta@b1.co
Related Links
www.b1.co

Providence Medical Technology Secures $25 Million In Equity Financing

PLEASANTON, Calif.Sept. 20, 2018 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing surgical equipment and implants for cervical spine fusion surgery, today announced the closing of $25 million in new equity financing. Revelation Partners led the round with participation from the private equity investment team at BMO Global Asset Management (EMEA), MVM Life Science Partners, Medvest Capital, and Aphelion Capital. Inclusive of this new investment, Providence has raised a total of $53 million in equity financing since its 2008 inception.

The proceeds of the financing will be used to accelerate commercial expansion and clinical development of its DTRAX®line of cervical fusion instruments designed to help patients suffering from advanced cervical spine conditions.

“DTRAX is an important innovation in cervical spine treatment that addresses a large market with significant unmet clinical need,” said Zack Scott, Managing Partner of Revelation Partners. “We are pleased to back the Providence team during this pivotal stage of the Company’s growth.”

“We welcome Revelation Partners and BMO to our dedicated team of investors,” said Jeff Smith, CEO of Providence. “We are committed to improving the lives of patients suffering from cervical spine disorders. This funding enables Providence to increase our investment in clinical evidence development and bring our unique cervical fusion technology to more patients and surgeons. I am grateful for the new and continued support from our venture partners.”

Over 300,000 Americans receive cervical spine fusion annually for debilitating neck and arm pain. While many have successful results, roughly 20% of two-level anterior fusions fail.1,2 Additionally, 22% of patients are predicted to require reoperation for adjacent segment disease within ten years after surgery.3 Providence has developed a unique tissue-sparing approach to cervical fusion that is designed to address this unmet need. The company’s flagship DTRAX Spinal System was recently cleared by the FDA for use in posterior cervical fusion in patients with cervical degenerative disc disease and has been approved at over 1,800 hospitals in the United States.

About DTRAX Spinal System
The DTRAX Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion in patients with cervical degenerative disc disease. The system allows surgeons to perform posterior cervical fusion using a variety of surgical techniques including a tissue-sparing technique that reduces the dissection and stripping of muscles.4

About Providence
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative surgical solutions for cervical spine surgery. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market.

The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® bone and facet screws, and ENTRUS™ Allograft Bone. All products are sterile-packaged and single-use to maximize perioperative efficiency and ensure consistent quality and performance.

For more information, please visit www.providencemt.com.

MKT-PMT-308 Rev 0

References
1. Davis RJ, et al. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6. PubMed PMID: 24010901.

2. Fraser JF, et al. Anterior approaches to fusion of the cervical spine: a meta analysis of fusion rates. J Neurosurg Spine. 2007 Apr;6(4):298-303. PubMed PMID: 17436916.

3. Lee JC, et al. Adjacent segment pathology requiring reoperation after anterior cervical arthrodesis: the influence of smoking, sex, and number of operated levels. Spine (Phila Pa 1976). 2015 May 15;40(10):E571-7. doi: 10.1097/BRS.0000000000000846. PubMed PMID: 25705959.

4. McCormack BM, et al. Novel instrumentation and technique for tissue sparing posterior cervical fusion. J Clin Neurosci. 2016 Dec;34:299-302. doi: 10.1016/j.jocn.2016.08.008. Epub 2016 Aug 31. PubMed PMID: 27590864.

SOURCE Providence Medical Technology, Inc.

Related Links

http://www.providencemt.com