2017 – Page 27 – Selby Spine

SAN DIEGO, Oct. 10, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has filed a lawsuit in the Delaware Chancery Court against Patrick S. Miles, former vice chairman of the Company and a member of NuVasive’s Board of Directors. The lawsuit asserts that before abruptly resigning from the Company to join Alphatec Holdings, Inc. (NASDAQ: ATEC), Mr. Miles engaged in a scheme for over a year to divert corporate opportunities and then announced he would join Alphatec in violation of his contractual obligations to NuVasive. In the lawsuit, NuVasive argues Mr. Miles’ divided loyalties constituted a clear breach of his fiduciary duties to NuVasive and its stakeholders, and that he violated his non-competition and non-solicitation obligations to the Company.

NuVasive issued the following statement:

This step was not taken lightly, particularly given Mr. Miles’ history with NuVasive. Yet it is this history and Mr. Miles’ intimate knowledge of the Company and our proprietary information that makes his breach of fiduciary duties and contractual obligations so egregious and this litigation necessary.

It is not the Company’s preference to proceed down a litigation path, but it would be contrary to our own responsibilities to ignore Mr. Miles’ actions. To be clear, Mr. Miles’ conduct has precipitated this lawsuit, which we believe is necessary to protect NuVasive’s rights and interests and the interests of our stakeholders. We will continue to take all appropriate steps in this regard.

As detailed in the complaint:

In January 2016, NuVasive was contacted by UBS Financial Services Inc. to explore NuVasive’s interest in acquiring Alphatec. Miles was NuVasive’s president and chief operating officer at the time. Miles advised NuVasive that pursuing such acquisition was “a waste of time,” and that Alphatec had an “aged, undifferentiated portfolio.” Consistent with Miles’ comments, NuVasive passed on the opportunity.
Then, on March 22, 2017, Miles secretly executed a securities purchase agreement to purchase $500,000 of Alphatec stock in a private placement. Miles and Alphatec concealed this investment by purchasing shares in Alphatec through an entity called “MOM” and failing to disclose that Miles was the beneficial owner of the shares. While still an employee and a member of the NuVasive Board, Miles negotiated an offer from Alphatec to serve as its executive chairman. As part of that offer, as an inducement to his employment, Alphatec granted Miles 1,000,000 Restricted Stock Units (a market value of $3,220,000 at Alphatec’s closing price as of October 2, 2017). Miles also agreed to purchase 1.3 million shares at $2.26 per share (a $2,938,000 investment) and is to be granted warrants to purchase up to an additional 1.3 million shares of Alphatec stock upon the closing of his purchase. Miles will own about 15% of the outstanding shares of Alphatec’s stock and, with the warrants he has been granted, could potentially own up to 23% of Alphatec’s outstanding stock.
On Sunday, October 1, 2017, Miles notified NuVasive that he was resigning his position as vice chairman and a member of the Board effective immediately. He planned to commence employment as Alphatec’s executive chairman the next day, and he did not intend to honor his contractual commitments to refrain from: 1) working for a competitor, 2) soliciting NuVasive’s customers and 3) recruiting NuVasive’s employees.

A full copy of the complaint will be available at NuVasive’s website.

NuVasive stated it is continuing to investigate and will file further claims if warranted.

DLA Piper is serving as legal counsel to NuVasive in connection with this matter.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with the acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

10 Oct 2017 – By Nextremity

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, is announcing the limited release of its newest product, the Axi+Line™ Proximal Bunion Correction System for the treatment of hallux valgus deformity, also known as a bunion. This announcement comes shortly after Nextremity Solutions announced the limited release of another new product, the PiroVue™ Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a 2015 study in Foot & Ankle International^® entitled, “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans”, patients with hallux valgus deformities (bunions) had a “more pronated first metatarsal than the control group”. The study showed that 87.3% of the patients sampled with hallux valgus deformity also had abnormal frontal plane rotation of the first ray.

Nextremity Solutions currently offers the Re+Line^® Bunion Correction System, which specifically focuses on the treatment of hallux valgus deformities of lesser angles. However, the Axi+Line Proximal Bunion Correction System addresses treatment of deformities of larger angles and addresses correction in the frontal plane.

READ THE REST HERE

MARIETTA, Ga., Oct. 10, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today its preliminary revenue results for the third quarter of 2017.

Third Quarter 2017 Revenue Highlights

Q3 2017 revenue of $84.6 million exceeded MiMedx guidance range of $79 to $80 million
Q3 2017 revenue grew 31% over Q3 2016 revenue
First nine months of 2017 revenue grew 33% over first nine months of 2016
Distributor and OEM revenue was below 5%
Accounts receivable DSO down to mid-60s

The Company recorded record revenue for the 2017 third quarter of $84.6 million, a $20.2 million or 31% increase over 2016 third quarter revenue of $64.4 million. Revenue for the nine months ended September 30, 2017 was $233.6 million, a $58.5 million or 33% increase over revenue for the nine months ended September 30, 2016 of $175.1 million.

Parker H. “Pete” Petit, Chairman and CEO stated, “Our third quarter revenue performance was very strong, and we are very pleased with the robust momentum that our sales organization is building. It became evident to us in early September that this momentum would produce third quarter revenue in excess of our earlier expectations. Despite the disruption from Hurricane Harvey and Hurricane Irma, we were confident that our strong performance throughout the country would more than make up for the impact of these natural disasters. We are particularly pleased with the exceptionally strong revenue performance from our commercial accounts. Over the years, we have concentrated on developing a customer base with a very wide breadth, both geographically and functionally. We are extremely pleased with the span of the customer base that we have built now in ‘secondary markets’. Revenue from our commercial accounts is leading our robust growth. Revenue from our direct sales force is currently in excess of 95% of our total revenue with revenue from distributors and Original Equipment Manufacturer (OEM) accounts below 5% of our total revenue.”

Speaking to other aspects of third quarter performance, Petit added, “We had very strong cash flow from operations and expect to report continued progress in our Days Sales Outstanding (DSO). We anticipate that our DSO as of the end of the third quarter will be improved into the mid-60s. I would have to state that our other operations are also working quite efficiently. These financial metrics indicate that our shipped products are being utilized by our customers at an efficient rate.”

Bill Taylor, President and COO, said, “Our revenue performance for the third quarter marks 27 consecutive quarters of sequential revenue growth and 26 of the last 27 quarters of meeting or exceeding our revenue guidance. We are gratified to have exceeded our guidance by more than $4 million. The asset base we have built in our sales force and other critical functions of our organization are performing very effectively. Throughout the organization, the enthusiasm for our excellent potential in the biopharma market is very high, and this is being reflected in the momentum our sales force is building in the market place. We could not be more pleased with the results our organization is producing and the respect we have garnered in the market.”

Taylor continued, “During the quarter, we announced the results of a number of clinical studies that should be important catalysts in driving revenue performance in various applications. With the momentum our sales force has built and these types of compelling study results, we are looking forward to continuing our robust sales growth. It is also important to mention that we had a number of our sales force and their customers heavily impacted by the natural disasters that occurred during the quarter. I am especially proud of how the members of the sales team in the affected areas, who endured the impact of these disasters, and yet gave so much support to their customers to get their patients the care they needed.”

Petit noted, “Adding to the effectiveness and results our sales force is generating are the many sales efficiencies we have implemented. Our Sales Management System (SMS) and advanced territory analytics have made solid contributions to our growth capabilities. We have been highly successful in our market expansion initiatives, one of which is our strategy to dedicate resources in ‘secondary markets’. Our sales force has now grown to the size that we are working very efficiently in the ‘secondary markets’. Utilizing our SMS and territory management capabilities, we have been pleased with our success in opening these secondary markets and gaining incremental revenue.”

“We are going through the natural maturation processes that well-run businesses achieve at various stages in their growth. Combined with our exceptional product offerings, this maturation should continue to produce an impressive growth trajectory,” added Taylor.

“We believe our sales organization will continue to produce robust revenue growth, and we should continue our trend of exceeding expectations. We look forward to discussing with our shareholders later this month many other positive details along with our full third quarter results,” concluded Petit.

Dates for Release of Third Quarter 2017 Results and Two Live Broadcast Conference Calls
The Company also announced today that it plans to release its full results for the third quarter ended September 30, 2017, before the opening of the market on Friday, October 27, 2017. The Company also announced that it will provide revenue guidance for the fourth quarter of 2017 in that quarterly earnings release.

MiMedx will host its standard live broadcast of the Company’s third quarter conference call on Friday, October 27, 2017at 10:30 a.m. eastern time. A listen-only simulcast of the MiMedx conference call will be available online at the Company’s website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company’s website at www.mimedx.com.

Please note that MiMedx will host a live broadcast of a conference call this Wednesday, October 11, 2017 at 10:30 a.m. eastern time to discuss the topics included in this press release. A listen-only simulcast of the MiMedx conference call will be available online at the Company’s website at www.mimedx.com. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company’s website at www.mimedx.com.

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

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding sales momentum, future revenues, the future level of days sales outstanding, and the potential contribution of pending clinical studies. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that the actual third quarter of 2017 final revenue number may differ from the preliminary number, the results of clinical studies may be delayed or below expectations; that sales momentum and revenue growth may moderate; and that days sales outstanding may increase. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Enquiries

Investors
Ingeborg Øie	+44 (0) 20 7960 2285
Smith & Nephew

Media
Charles Reynolds	+44 (0) 1923 477314
Smith & Nephew

Ben Atwell / Debbie Scott	+44 (0) 20 3727 1000
FTI Consulting

Forward calendar

The Q3 Trading Report will be released on 3 November 2017.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

^{Forward-looking Statements}

^{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.}

MARIETTA, Ga., Oct. 9, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today the decision of its Board of Directors to authorize a $10 million increase in the Company’s Share Repurchase Program.

This action by the MiMedx Board of Directors authorizing the additional $10 million to the Company’s Share Repurchase Program brings the total authorized to $110 million since the Share Repurchase Program commenced in May 2014. The Company reported that in light of the short seller attacks and its strong balance sheet and cash flows, the MiMedx Board of Directors believes the stock repurchases continue to be an extremely positive investment for MiMedx. The Board also agreed to review this program again at its scheduled meeting on October 26, 2017, and to consider an additional commitment at that time.

Parker H. “Pete” Petit, Chairman and CEO, stated, “To date, we have utilized virtually all of the $100 million previously authorized by the Board. This program has been particularly beneficial for the Company, as we have acquired shares at very low prices for a company with our level of sustained growth, biopharma strategy, outstanding clinical trials, the consistent pattern of physician and payer reception in the market place and our robust pipeline of future products. The recent deceptive and contrived attacks on our stock have caused the MiMedx shares to become very undervalued in my opinion. I believe it is a very prudent use of our capital to acquire our shares at this point, and our high growth profile in both revenues and profits should produce an extremely anti-dilutive result from our stock repurchases.”

“We share the frustration from the short selling activity with all of our shareholders, and we are aggressively pursuing avenues that will expose these illegal activities,” concluded Petit.

About MiMedx

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

Important Cautionary Statement

This press release includes forward-looking statements, including statements regarding the Company’s stock repurchases are a positive investment for the Company and a prudent use of the Company’s capital, the belief that the Company’s stock price is very undervalued at present, the Company’s expectations to continue the use of the share repurchase program to enhance shareholder value. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the stock repurchases may not be a positive investment or a prudent use of the Company’s capital, the Board may not consider a substantial new commitment to the share repurchase program at its October 26, 2017 meeting, the Company’s stock price may not be undervalued, the Company’s continued use of the share repurchase program may not enhance shareholder value or the Company may not continue to use the share repurchase program. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Contacts

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

Nanovis Spine CEO Matt Hedrick recently sat down to speak with ODT about our commitment to developing innovative products to improve patient care and outcomes (full article attached).

https://www.odtmag.com/issues/2017-10-01/view_features/distinguished-support-a-review-of-spinal-orthopedic-technologies/?sthash.APN1XgvK.mjjo

“With an approximately 10 percent rate of lumbar non-fusions, we feel this area is where we can do the most good. Nanovis’ deeply porous titanium scaffolded FortiCore implant systems provide high fixation strength in a short timespan compared to PEEK, plasma-sprayed PEEK, or allograft…” Hedrick said.

The advantages of FortiCore® include:

#deeply porous interconnected titanium scaffold

#intermolded PEEK-Optima® core by InVibio with benefits of modulus and imaging

#resistance to abrasion and delamination (rebar in concrete concept)

#published pre-clinical data showing statistically significant superiority vs. PEEK, Allograft, and Plasma Spray https://lnkd.in/eDjfMaR

“Our next technology upgrade for this market is a patented nanotube surface that offers the potential to further enhance the interface with bone that our entire line of spinal implants offers surgeons. Combining these technologies provides Nanovis and our distributor partners an entire portfolio of highly-advanced and highly-differentiated products.”

Nanovis is actively recruiting independent distributors to give more patients, physicians, and providers access to our science enhanced, meaningfully differentiated technology platforms.

To learn more, please contact jeff.shepherd@nanovistechnology.com, or visit us at Booth# 762 at the North American Spine Society meeting October 25-28, 2017 in Orlando.

October 09, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will demonstrate its new 3D-printed Tritanium C Anterior Cervical Cage, an interbody fusion device designed for use in the cervical spine, at the Congress of Neurological Surgeons (CNS) Annual Meeting, Oct. 7-11, 2017, in Boston (booth No. 311).

The Tritanium C Anterior Cervical Cage is the latest spinal fusion implant constructed from Stryker’s proprietary Tritanium In-Growth Technology,¹ a novel, highly porous titanium material designed for bone in-growth and biological fixation.¹

The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study.²* The Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium.³ Tritanium is inspired by the microstructure of cancellous bone⁴ and enabled by AMagine™, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing.

“We look forward to showcasing the Tritanium C Anterior Cervical Cage and demonstrating its advanced capabilities at the CNS meeting,” said Bradley Paddock, President of Stryker’s Spine division. “Stryker’s Tritanium Technology is ‘engineered for bone.’ Our growing line of Tritanium implants reflects our commitment to being at the forefront of technology advances in spinal surgery, and to providing our surgeon customers with a range of options to address their preferences and meet the needs of their patients.”

According to Mohammed Faraz Khan, M.D., Hackensack University Medical Center, N.J., one of the first surgeons to use the new cage, the benefits of the Tritanium C Anterior Cervical Cage are clear. “In my opinion, this new addition is going to make all the difference in this space,” Khan said. “The inserter used with the system was super sleek and easy to use.”

The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017 and will be available to surgeons in Q4 2017. It features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability,⁵ the cage has serrations on the superior and inferior surfaces designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges help to facilitate insertion and to protect soft tissue and anatomy. The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to adapt to a variety of patient anatomies.

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.

References

1.		PROJ43909 Tritanium technology claim support memo
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.		Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5475-5491
5.		PROJ44960: Coefficient of friction memo

Content ID: TRICC-PR-2_15699

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.

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374-6174
bsullivan@sullivanpr.com

October 9, 2017

TORONTO–(BUSINESS WIRE)–Synaptive Medical Inc., a medical device and technology company, today released Modus V™. This second-generation, high-powered digital microscope with a surgical robotic arm is derived from Canadarm technology used on the International Space Station. Designed with feedback from Synaptive’s clinical partners, Modus V is the new cornerstone of its integrated BrightMatter™ platform.

Modus V sets the new standard for robot-assisted neurosurgery with the most powerful optics available on the market that give unprecedented views of patient anatomy and may allow surgeons to perform less invasive procedures with more precision. For patients, less invasive procedures may lead to faster recovery times, reduced complications and, in some cases, may render an inoperable diagnosis operable.

For surgeons, Modus V’s advanced instrument tracking with auto-focus, combined with a highly flexible arm, also allows for increased surgical efficiency through hands-free control, better ergonomics during procedures and greater versatility in the operating room. These innovations feed developments in precision medicine by creating more opportunity to capture, analyze and draw trends from patient data and build better decision-making tools for physicians, researchers and hospital administrators.

“This product release marks a major milestone in our evolution as a company,” says Peter Wehrly, Synaptive’s CEO. “Modus V is an integral part of our overall BrightMatter surgical solution. Conceptualized for the digital era as a fully integrated set of devices, our solution collects and delivers data—be it imaging, tractography or other patient information—when and where it’s most needed to drive surgical decision making. It’s part of our ongoing commitment to give surgeons the most advanced tools with which to treat their patients.”

Modus V is part of the BrightMatter product suite, which transforms surgical planning, patient data collection and intraoperative vision from disjointed analog methods to a fully integrated platform with navigation, robotic automation, digital microscopy and data analytics.

As the successor to BrightMatter Drive, Synaptive’s first generation robotic digital microscope, Modus V’s improved design was created to meet the complex needs of cutting-edge surgery, including:

The most powerful optics platform on the market fully integrated with the robotic arm, providing superior visualization of anatomy and allowing for better decision making when it matters most
Enhanced hands-free tracking of surgical instruments with auto-focus and programmable motions gives surgeons more control without disrupting workflow
Increased arm flexibility covers a larger volume of space, permitting more versatile positioning around the patient and ergonomic alignments of optics for the surgeon
Smaller unit footprint allows for greater maneuverability in the OR and enables faster deployment

“Collaboration is hardwired into Synaptive’s culture. Modus V’s improvements are grounded in the collaboration and extensive feedback from neurosurgeons in our customer community on both Modus V prototypes and BrightMatter Drive,” says Cameron Piron, Synaptive’s president and chief strategy officer. “We’re grateful for their support, and look forward to deeper commentary from the surgical community as Modus V enters the market.”

About Synaptive Medical | Synaptive Medical Inc., a Toronto-based medical device and technology company, collaborates with leading clinicians and healthcare systems to revolutionize products and services that cross traditional barriers to enable continuous improvement in care delivery in and beyond the operating room. Synaptive’s integrated BrightMatter™ solutions—including surgical planning, navigation and visualization, and an informatics platform—are designed to give clinicians the right information they need to ensure the best possible outcomes for patients.

Contacts

Synaptive Medical
Elizabeth Monier-Williams, 647-299-6429
Director, Marketing Communications
elizabeth.monierwilliams@synaptivemedical.com

SAN JOSE, Calif., Oct. 9, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that PEHP Health & Benefits of Utah, a nonprofit trust providing health benefits to Utah’s public sector employees and their families, has issued a positive coverage policy for MIS SI joint fusion with iFuse. The policy specifies positive coverage for MIS SI joint fusion using iFuse with prior authorization for CPT (current procedural terminology) code 27279 and considers open SI joint fusion with CPT 27280 experimental and investigational. In addition, the policy considers percutaneous radiofrequency ablation/denervation of the SI joint, including pulsed, non-pulsed and cooled, experimental and investigational.

“Minimally invasive SI joint fusion using the iFuse Implant has become the method of choice to treat patients who suffer from chronic pain resulting from degenerative sacroiliitis or sacroiliac joint disruption. With over 28,000 procedures performed and 54 peer-reviewed publications that include two Level 1 randomized controlled trials as well as numerous long-term studies including a 6-year study published in Neurosurgery, the iFuse Implant is the benchmark for SI joint fusion,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE. “It’s very encouraging to see health plans such as PEHP of Utah provide access to the iFuse Procedure™ for its health plan members who are suffering from chronic SI joint pain who’ve failed conservative care.”

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁵ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs. Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes. Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions. The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution. The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with sacroiliac joint dysfunction experience pain that can be debilitating. SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. iFuse Implant and iFuse Procedure are trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 10004.100917

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

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