OrthoPediatrics Corp. (Nasdaq: KIDS) to Ring The Nasdaq Stock Market Opening Bell in Celebration of Its IPO

ADVISORY, Oct. 13, 2017 (GLOBE NEWSWIRE)

What:
OrthoPediatrics Corp. (Nasdaq:KIDS), the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions, will visit the Nasdaq MarketSite in Times Square in celebration of its initial public offering (IPO) on October 12, 2017.

In honor of the occasion, Mark Throdahl, President & Chief Executive Officer, will ring the Opening Bell.

Where:
Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio

When:
Friday, October 13, 2017 – 9:15 a.m. to 9:30 a.m. ET

OrthoPediatrics Corp. Media Contact:
Zack Kubow, The Ruth Group
646-536-7020
zkubow@theruthgroup.com

Nasdaq MarketSite Media Contact:
Emily Pan
(646) 441-5120
emily.pan@nasdaq.com

Feed Information:
Fiber Line (Encompass Waterfront): 4463

Gal 3C/06C 95.05 degrees West
18 mhz Lower
DL 3811 Vertical
FEC 3/4
SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK

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Webcast:
A live stream of the Nasdaq Opening Bell will be available at:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

Photos:
To obtain a hi-resolution photograph of the Market Open, please go to http://business.nasdaq.com/discover/market-bell-ceremonies and click on the market open of your choice.

About OrthoPediatrics Corp
Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 21 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products to 35 countries outside the United States.

About Nasdaq
Nasdaq (Nasdaq:NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 90 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to approximately 3,900 total listings with a market value of approximately $12 trillion. To learn more, visit: http://business.nasdaq.com

-NDAQA-

The Big Squeeze – Reps are ditching Big Ortho bags to build their own. Why it’s happening, and how to be successful.

I have seen a lot of tenured ortho sales people leave the comfort of “Big Ortho” and take on the role of Distributor or rep for much smaller start-ups. I want to deconstruct the forces driving this change and the dynamics between all the players. Then, we will explore what drives the variability in results of this new model. Finally, I will leave you with some ideas on how you can become a high caliber distributor prepared to thrive in a new role.

Big Ortho vs The Rep

As pricing pressures continue to push profits down, manufacturers are looking for more ways to improve their bottom line. As referenced in my previous article The Unsung Hero of the Orthopedic Industry – The Rep, the distributors and reps bear the brunt of much of the pricing compression. It seems as though the easy target for the squeezing is the one furthest from the boardroom – the Sales Reps and Distributors.

We have seen large companies’ commission rates fall well below 20%. At the same time, ASP’s (Average Selling Prices) continue to fall with corporate negotiated hospital or GPO contracts. The result is an inverse relationship where reps have to do more cases to make the same amount of money as last year. Increasing business 20-30% is a more difficult challenge than ever before due to increased consolidation and competition in the marketplace.

We are left with a dynamic where Small Ortho can capitalize on the inverse relationship Big Ortho reps face. By offering significantly higher commission and the ability to be their own boss, small ortho is attracting experienced representation that can leverage established relationships and navigate familiar approval processes.

“The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.The Ortho Startup & The Rep”

The orthopedic start up market continues to attract venture and private equity funding as forecasts like, “OrthoBiologics market to reach $6.06B by 2022” present fertile ground. Additionally, as Big Ortho seems more comfortable investing in M&A rather than R&D, start-ups have a clear exit strategy.

As the device market matures and patents expire, new doors open for clever copycats. This phenomenon presents opportunity for smaller, more nimble competitors to gain a strategic advantage and capture business that was once securely owned by Big Ortho. Innovative technology or even just novel improvements to antiquated systems can lead to profitable acquisitions.

This is not to say it is an easy endeavor for start-ups to break into orthopedic implants. R&D, Regulatory affairs, and the rapidly evolving landscapes of hospitals and GPO requirements present evermore complex and time-consuming barriers for small companies. As with any new venture, more time translates into more money and that unknown timeline can be very detrimental to a small company. Finding representatives and distributors capable of steering through this “mine field” is a critical driver of their success.

The Challenge

The challenge for many smaller orthopedic companies is that the caliber of distributor that they are able to attract tend to be limited to a Sales Rep who decided to bail out of a larger company for the reasons described above. They require very little support or training and they can hit the ground running to achieve some success fairly quickly. But, for what these reps bring in strong relationships and technical know-how, they often lack in infrastructure and leadership experience. As a result, what the company ends up with is little more than what we call a “Super Rep” who’s sales plateau sooner than expected.

The reason most plateau quickly is that they don’t have any of the infrastructure that a seasoned distributor typically does. No one can blame them since they are essentially a rep who now enjoys the full distributor commission rather than a split. Rather than owning a business, they effectively only own a job and want to keep overhead low and profits high. This is a short-sighted solution and the distributors who are in this category are quite vulnerable. Without a team and support infrastructure, they are little more than the sum value of the surgeon relationships.

For the manufacturer, this poses a problem of scalability. If these Super Reps don’t begin to take on the responsibilities of a true distributor or agent, they will struggle to capture more geography and build a valuable and sustainable business. While it may satisfy some, manufacturers don’t see these players as long-term partners. The success of Big Ortho came from having strong, long-term partnerships with distributors and agents who invested in their businesses and built sustainable enterprises that were able to scale.

Where many of these new distributors are failing is in building a foundation of scalability and making the necessary investments into their company’s future sustainability. Setting the right foundation for success early in the scaling process is paramount. It’s not necessary to make large capital investments, but setting up the right foundation is paramount to prolonged success.

“As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers.”

Data-driven Distribution

Where does one start? First, start with the basics: as a distributor, you need to have a legitimate company website if you want to be seen and prospected by companies looking for new distributors. You and I both know the surgeons and hospitals don’t give much thought to that. But, if you’re successful, M&A will eventually impact the lines you carry. Continually prospecting and being visible to companies with new technologies is a key part of remaining relevant and positioning yourself for success in your local market. Having a website enables you to project the image that you take your business seriously and are taking steps to be professional. Manufacturers want to see that you work ON your business and not merely in it.

Having a website also enables you to use an email address with your company’s name on it rather than a gmail, or worse: your AOL address. Nothing says “mom & pop” like a distributor using a internet service provider’s email address. The quality of your website is also important as it projects the image of your company. If it is too “1990’s,” people will draw the conclusion that you are still back in the dark ages and not availing yourself of the latest technologies. This can be an impediment to attracting some of the companies with newer innovations that are seeking representation. A website can be done very inexpensively and deliver the right message and image.

Another inexpensive way to differentiate your distributorship is by leveraging technology to manage your business. Using a whiteboard, Google Calendar and group text messages to manage inventory presents you as a risky proposition when it comes to companies allocating valuable assets to you. As margins continue to tighten, operational efficiencies achieved through smarter distribution and sales will separate winners from losers. Technology should impact your business in several ways: coordinate your team’s schedules, quickly schedule cases, manage day to day sales activities, track your inventory from multiple manufacturers, consolidate your manufacturer’s invoices and open PO’s. In other words, run your business in the 21st century.

While I am biased in believing our platform, Surg.io, is the best solution for reps and distributors, any electronic system is better than none. Keep in mind that manufacturers entrust a great deal of money into your hands by way of implant and instrument inventories. Your existing and future partners want to see that your utilization brings about a healthy return on investment. Nothing is more compelling than efficient infrastructure and solid data to support your request for additional inventory or even, data to support keeping the inventory you currently have. Equally, nothing more undermines your partnership with a manufacturer than inefficient use and tracking of their inventory.

Implementing one of these platforms doesn’t need to be onerous. While there is always a bit of a learning curve when starting up, once you get through the on-boarding process and everyone is using it, it will be a lifesaver. In addition to better organization and inventory utilization, using Surg.io, or a similar platform, helps you create margin in your day for more selling by streamlining all your processes. It enables you to better communicate as well as ensure that everyone is singing from the same sheet of music. If all you’re using is Google Calendar, you’re missing a whole host of features and analytics that can take your business to the next level.

Looking Ahead

As challenges continue to mount and the odds continue to stack against orthopedic distributors, only those who embrace technology and figure out how to leverage it will be able to thrive through the next 10 years of the evolution of the industry. Doing more with less will continue to be the pressure and will require a strategic approach to supply chain management. Projecting a “no tech” business to manufacturers poses a profound risk to distributors and with how easy and inexpensive as it is, seems to be a very risky proposition. The days of only courting your surgeons and hospitals is passing away along with paper-only records and whiteboard logistics.

To learn more about Surg.io and how to leverage it for growth and scalability, visit www.Surg.io and request a demo.

Medacta Makes the MiniMAX™ Hip Stem Available to U.S. Surgeons Following Successful First Stateside Surgery

October 12, 2017

CHICAGO–(BUSINESS WIRE)–Orthopedics leader Medacta International today announced the introduction of the MiniMAX Hip System into its U.S. product portfolio. The MiniMAX is an anatomical cementless stem that is engineered to provide enhanced fit and fill in the metaphyseal femur by following the natural shape of the femoral canal with a unique curved design, ideal for both minimally invasive anterior and posterior hip replacement procedures. The launch follows the successful first stateside surgery utilizing the stem, which was performed by David Scott, M.D., of Spokane, Washington, on September 12.

“The MiniMAX Hip Stem is a very versatile product. It was built as an addition to the product range of stems and instruments dedicated to our AMIS (Anterior Minimally Invasive Surgical) approach to hip replacement, but it also works with posterior techniques, providing surgeons with even more flexibility,” said Francesco Siccardi, Executive Vice President of Medacta International. “Our partners in Europe and Australia have had extremely positive experiences with the implant, and we’re excited to offer it as another option for surgeons in the United States.”

The MiniMAX Hip Stem aims to reduce risk and postoperative pain for patients while making it easier for surgeons to introduce it into the femur. The MiniMAX’s lateral flare design minimizes fracture, and its nine degrees of neck anteversion can provide more joint stability and reduce the risk of dislocation. The short, thin tip with five degrees of curvature lowers the risk of thigh pain caused by distal interference. The implant’s proximal titanium plasma spray and hydroxyapatite coating provide enhanced proximal fixation.

“I was impressed with how well the MiniMAX Hip Stem replicates the natural anatomy of the human hip, rather than having the patient’s anatomy conform to the shape of the implant, like many other popular models,” said Dr. Scott. “Pairing the MiniMAX with a minimally invasive approach made for an efficient, effective procedure and my patient is recovering well.”

First introduced in Europe in 2007, the MiniMAX Hip Stem is associated with proven clinical results, obtaining a survival rate at 5 years of 97.5 percent considering revision for any reason and 100 percent considering aseptic loosening as endpoint, according to internal Medacta research.

John Masonis, M.D., of Charlotte, North Carolina, will perform a live surgery using Medacta’s AMIS platform to implant the MiniMAX Hip Stem at the 6th Annual ICJR Anterior Approach Hip Course on Thursday, Oct. 19 at noon Central.

“Surgeons attending the live surgery will receive education on the surgical and patient processes associated with the anterior approach to hip replacement and while doing so, will be able to see the MiniMAX stem and AMIS platform in clinical practice for themselves,” said Dr. Masonis.

The live surgery will be webcast and may be accessed on the day of the event at http://www.icjr.net/livesurgery/masonis. For more information on the event, please visit ICJR at https://icjr.net/meeting/2017-6th-annual-direct-anterior-approach-hip-course. For more information on the MiniMAX Hip Stem, visit https://www.medacta.com/EN/minimax.

About Medacta International

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

EOS imaging Reports 28% Sales Growth for the Third Quarter 2017

October 12, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of orthopaedic medical imaging, 2D/3D, today announced its (non-audited) consolidated sales for the third quarter ended September 30, 2017. The Company also announced the appointment of Eric Maulavé as Chief Operating Officer (COO) as part of its ongoing effort to develop its leadership team, and highlighted its participation at the Journées Francophones de Radiologie (JFR) meeting, which will take place from October 12 – 16, 2017 in Paris.

Marie Meynadier, Chief Executive Officer of EOS imaging, commented: “Sales in the third quarter grew 28%, reflecting strong performance in Europe and the stabilization of our North American business, which is beginning to benefit from new leadership and organizational structure. During the quarter we also had good growth in our recurring sales categories driven by our expanding installed base. Looking forward, we are confident that our North American team is building momentum that should bring a return to sustained growth in the region at the end of the year. We are also pleased to appoint Eric Maulavé to the new position of Chief Operating Officer, with responsibility for operations outside of North America. This is a natural expansion of the team to support our growth worldwide. Finally, our investments in developing new software applications continue to build the value of the EOS platform and we look forward to presenting our new connectivity solution at the JFR meeting, which is the largest radiology meeting in France.”

Third Quarter Sales by Product Line

€ millions Q3 2017 Q3 2016 variation
Equipment Sales 6,74 5,47 +23%
Sales of Maintenance 1,47 0,96 +52%
Sales of consumables and services 0,25 0,19 +39%
Total Sales 8,46 6,61 +28%

(unaudited)

In the third quarter of 2017, the Company generated revenue of €8.5 million, up 28% compared to the third quarter of 2016. The Company sold 17 EOS® systems during the third quarter of 2017, compared to 13 systems in the same period last year. Sales of maintenance contracts increased by 52% to €1.5 million, reflecting the continued growth of the installed base of EOS systems under contract. Recurring revenue in the third quarter of 2017 represented 20% of total sales, compared to 17% of total sales in the same period last year.

Third Quarter Sales by Geography

€ millions Q3 2017 Q3 2016 variation
EMEA 4,13 1,95

+111%

As % of total sales 49% 30%
North America 3,44 3,91

-12%

As % of total sales 41% 59%
Asia-Pacific 0,89 0,75

+19%

As % of total sales 11% 11%
Total Sales 8,46 6,61 +28%

(unaudited)

The increase in revenues over the third quarter of 2017 was mainly driven by strong sales in Europe. In North America, sales declined but were trending toward more stable results as the Company begins to benefit from new leadership and organizational structure.

Nine Month 2017 Sales by Product Line

€ millions September 30, 2017 September 30, 2016 variation
Equipment Sales 19,89 16,93

+18%

As % of total sales 80% 82%
Sales of Maintenance 4,29 3,18

+35%

As % of total sales 17% 15%
Sales of consumables and services 0,74 0,65

+15%

As % of total sales 3% 3%
Total Sales 24,93 20,75 +20%

(unaudited)

Nine Month 2017 Sales by Geography

€ millions September 30, 2017 September 30, 2016 variation
EMEA 11,52 7,27

+58%

As % of total sales 46% 35%
North America 9,18 11,57

-21%

As % of total sales 37% 56%
Asia-Pacific 4,23 1,92

+121%

As % of total sales 17% 9%
Total Sales 24,93 20,75 +20%

(unaudited)

In the first nine months of 2017, the Company sold 51 EOS® systems, compared to 41 systems in the same period last year.

Quarterly sales trend, by Product Line

Q1

2017

Q2

2017

Q3

2017

Q1

2016

Q2

2016

Q3

2016

ΔQ1 ΔQ2 ΔQ3
Equipment Sales 5,47 7,67 6,76 4,09 7,36 5,46 +34% +4% +23%

Sales of Maintenance

1,40 1,43 1,46 0,99 1,23 0,96 +41% +16% +52%
Other Sales 0,26 0,23 0,25 0,24 0,22 0,19 +9% +3% +39%
Total Sales 7,13 9,34 8,46 5,33 8,82 6,61 +34% +6% +28%

(unaudited)

  • Appointment of Eric Maulavé to the Position of Chief Operating Officer

As part of the continued execution of its global growth strategy, the Company is strengthening its senior leadership with the appointment of Eric Maulavé as Chief Operating Officer effective October 1, 2017. In this position Eric will have responsibility for production, maintenance, engineering, clinical, quality/regulatory activities as well as sales in the EMEA, Asia-Pacific and LATAM regions. Mr. Maulavé previously served as the Company’s Vice President of Global Sales and has been with the Company since 2012.

  • Journées Francophones de Radiologie

The company will present its new 3D image sharing application at the Journées Francophones de Radiologie (JFR) meeting in Paris from October 12-16, 2017, focused this year on the patient. The new software is dedicated to 2D/3D and clinical data sharing and aimed at facilitating the relationship between radiologist, patient and referring physician (orthopedic surgeon, rheumatologist or general practitioner).

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging service dedicated to osteo-articular pathologies and orthopaedics, as well as the associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan, and the European Union (EC). It posted revenues of €30.8 million in 2016 and employed 132 people at December 2016, including an R&D team of 43 engineers. The group is based in Paris and has five subsidiaries: in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

EOS imaging has been selected to integrate the EnterNext © PEA – SME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Pierre Schwich, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent, +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Exactech Comments on Impact of Hurricanes Irma and Harvey; Adjusts Q3 Earnings Guidance and Announces Q3 Earnings Call

October 12, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, said today it is adjusting guidance for the third quarter of 2017 as a result of the impact of Hurricanes Irma and Harvey.

CEO and President David Petty said the estimated US revenue impact of the two hurricanes was approximately $1.2M to sales in Q3 across Florida, Texas, Georgia and the Carolinas.

“We were fortunate that our facilities were undamaged during the hurricanes. However, the storms caused our surgeon customers in the affected states to postpone scheduled surgeries, directly affecting our Q3 revenue stream. In addition, due to hurricane preparation procedures at our Gainesville and Sarasota locations, our manufacturing and shipping operations lost two days of operating capacity. As a result, domestic revenues were near the bottom of our expectations. We now expect to report approximately $61.4MM in worldwide revenue for the third quarter. We also are adjusting our EPS guidance for the quarter to $0.19-$0.21 per share, a reduction of approximately $0.04 per share from our previously issued guidance of $0.23-$0.25 per share due to the net income impact of these lower revenues as well as the impact of the operations interruption,” Petty said.

The company will release its third quarter 2017 financial results on Monday, October 30, 2017. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will host a conference call with CEO David Petty and key members of the management team on Tuesday, October 31 at 10:00 a.m. Eastern Time. The call will cover Exactech’s third quarter 2017 results. Mr. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-800-334-0872 any time after 9:50 a.m. Eastern on October 31. International and local callers should dial 1-719-325-4845. A live webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=126701. This call will be archived for approximately 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com and http://www.hawkassociates.com.

An investment profile on Exactech may be found at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various 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, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech, Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance &
Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Media contact
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Oska Wellness Wins TechCo’s 2017 Startup of the Year Competition

October 11, 2017/Adam Rowe

Oska Wellness, a health-tech, wearable pain relief device startup based out of Carlsbad, CA, is the 2017 Startup of the Year winner.

The announcement, made at the Innovate Celebrate conference held by TechCo in partnership with CTA, came following a three-day event attended by 100 startup semifinalists, and eventually narrowed down to five finalist startups today. Of all contestants at the wide-sweeping startup competition, Oska Wellness has officially risen to the top.

As the first-place winner, Oska Wellness will receive a prize package worth potentially $150,000 and from a list of companies including Start Co., 500 Startups, Techstars, Dreamit Ventures, Business Blocks, American Airlines, and Moo.

Oska Wellness Is the 2017 Startup of the Year

Oska Wellness designs a technology that can help areas of the body prone to injury and degeneration. You can listen to their final competition pitch below, and can watch the other four startup of the year finalists pitch here.

 

READ THE REST HERE

NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology

SAN DIEGOOct. 12, 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 received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) with expanded indications that now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport.

The PRECICE system is an innovative, market-leading solution to treat patients with limb length discrepancy, limb deformities and chronic nonunions. The platform consists of an intramedullary device that once implanted utilizes an external remote controller to non-invasively compress and distract long bones. The key to the PRECICE platform is the magnetic interaction between the PRECICE intramedullary nail and external remote control. The proprietary technology includes a complex internal gear system remotely activated and controlled by permanent magnets. This advancement in limb reconstruction allows for a precision controlled distraction phase with the ability to non-invasively customize treatment.

Prior to the expanded FDA clearance, the PRECICE system was indicated for limb lengthening of the femur and tibia. The system is now indicated for bone transport of long bones in addition to limb lengthening. Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e. infected nonunions, segmental defect, and chronic bone infections. The expanded indications for use allows the Company to continue to build a platform for further growth in the limb reconstruction and trauma markets.

“This FDA 510(k) clearance of PRECICE for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets,” said Massimo Calafiore, president of NSO. “NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures.”

The Company has also created a patient and family online resource dedicated to providing information on limb length discrepancy with Reach Your Height. The digital resource center provides education on treatment options and shares patient success stories. To learn more, visit reachyourheight.com.

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 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

New System Designed to Enhance Implant Fixation for Hip Fracture Patients with Poor Bone Quality Launches in the U.S.

WEST CHESTER, Pa.Oct. 12, 2017 /PRNewswire/ — Today DePuy Synthes* announced the U.S. launch of the new TFNA Augmentation System, the first and only polymethylmethacrylate (PMMA) cement with specific trauma device indications, offered exclusively for use with the TFNA System. The TFNA Augmentation System is used to address the needs of patients with hip fractures and who have poor bone quality.

The TFNA Augmentation System can be used to provide enhanced implant fixation in cases where the potential risk of cut-out is significant. Cut-out is a loss of implant anchorage or stability in the bone, frequently occurring in those with poor bone quality. It causes the femoral neck-shaft angle to collapse, and is a leading clinical complication during hip fracture surgery. Cut-out can also lead to reoperation, which increases risks to the patient and increases costs to the healthcare system. Each year, more than 300,000 hip fractures occur in the U.S.1 These fractures are common in the elderly, especially those with osteoporotic bone. Fractures are expected to increase as the population ages.2 When used together with the TFNA System, the TFNA Augmentation System is designed to help reduce the risk of cut-out and provide enhanced implant fixation.3,4

“The TFNA Augmentation System addresses an important clinical need for patients who undergo hip fracture surgery, especially those who suffer from poor bone quality,” said Charisse Y. Sparks, MD, Franchise Medical Leader Trauma, DePuy Synthes Trauma. “This new system complements the TFNA System and has the potential to improve patient outcomes, reduce costs, and increase patient satisfaction.”

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

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the TFNA Augmentation System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.

**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.

DSUS/TRM/0817/1555

1 Agency for Healthcare Research and Quality. National and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample (NIS). 2013.http://www.ahrq.gov/research/index.html. Accessed 12 October 2015.

Cummings SR. Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs and potential effect of postmenopausal estrogen. Clin Orthop Relat Res. 1990;252:163-166

3 DePuy Synthes test data on file, Windchill 0000268245. 

4 Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement augmentation on the fixation strength of TFNA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

In Start to Unwinding the Health Law, Trump to Ease Insurance Rules

October 12, 2017/APhA

President Trump is expected to sign on Thursday an executive order that would initiate the unwinding of the Affordable Care Act (ACA). With the order, the president will direct federal agencies to take actions aimed at providing less expensive options and fostering competition in the individual insurance markets. According to two senior White House officials, the specific steps in the order will represent just the first moves in his White House’s effort to strike parts of the ACA. By increasing alternative insurance arrangements that would be exempt from some key ACA rules, the change would provide more choices for consumers. Health insurance experts note, however, that it could increase costs for sicker individuals by drawing together healthier, younger consumers to the alternative plans, which could be cheaper and provider fewer benefits. The executive order will seek to increase access to plans that allow small businesses and possibly individuals band together to purchase insurance. In addition, it will life limits on the sale of short-term insurance and will expand the ways in which workers use employer-funded accounts to purchase their own insurance policies. White House officials also noted Wednesday that the order would call on agencies to study and issue a report on federal and state policies that could contribute to increasing health costs, including, potentially, the effect of health care provider consolidation.

Wall Street Journal (10/11/17) By: Radnofsky, Louise; Armour, Stephanie; Mathews, Anna Wilde

Alphatec Denounces “Baseless” NuVasive Complaint

CARLSBAD, Calif., Oct. 11, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, released a statement in response to a recent complaint filed by NuVasive, Inc. (Nasdaq:NUVA) against Patrick S. Miles, Alphatec’s recently appointed Executive Chairman.

On October 10, NuVasive, without prior inquiry or notice, filed a baseless lawsuit against Mr. Miles. NuVasive then issued a press release to broadcast the complaint, not to “protect corporate assets” as stated, but in an attempt to inflict maximum damage to the public reputations of both Mr. Miles and Alphatec. The complaint is fictional, and includes disclosures by NuVasive that breach its contractual confidentiality obligations owed to Alphatec.  It was filed by a law firm in violation of its own ethical obligations, as the firm is currently actively representing Alphatec in related matters.

“I was fortunate to be a part of NuVasive’s growth from zero dollars in sales to close to a billion dollars in revenue,” said Mr. Miles.  “I am exceptionally proud of my contribution, and I have lifelong friends who remain affiliated with the organization.  I did not leave NuVasive to damage the company; in fact, I remain a significant shareholder.  I chose to pursue a new opportunity at Alphatec because I want to align my talents and influence with a Company that is focused on serving spine surgeons and their patients.  The allegations made by NuVasive against me are clearly false, and typical of a management team reacting to mass departures of key, spine-experienced executives.  I intend, ultimately, to clear my name. In the meantime, I will not be distracted by baseless claims, and will drive Alphatec’s pursuit of improved surgical outcomes.”

Terry Rich, Alphatec’s Chief Executive Officer, continued, “I have known Pat since I joined him in building NuVasive twelve years ago. He is well known to the spine industry worldwide and is highly respected for his integrity.  The complaint against him is full of false claims, and is nothing more than a PR stunt by NuVasive.  It has been orchestrated to detract from a decaying, toxic culture that has contributed to the resignations of three C-Suite officers since July 2017, and caused dozens of NuVasive employees and countless surgeon customers to reach out to Alphatec, seeking more attractive opportunities. The current issues at NuVasive have nothing to do with Pat. We look forward to continuing to move our business forward under his leadership.”

Mr. Miles plans to file a timely response to the complaint. Alphatec will vigorously support him in this matter.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com