Safe Orthopaedics Reports Its Revenue for the First 9 Months of 2016 and Its Cash Position

Posted On October 13, 2016 By OrthoSpineNews In Financial /

October 13, 2016 – ERAGNY-SUR-OISE, France –(BUSINESS WIRE)

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, has today released its revenue for the first nine months of 2016 and its cash position at September 30, 2016.

in thousands of euros	9m 2016	9m 2015	Change
France	855	738	+16%
Rest of the world (excluding United States)	770	822	-6%
*Total adjusted revenue**	1,625	1,560	+4%
United States (discontinued operations)	100	375	-73%
Total revenue	1,726	1,935	-11%
Cash position (in millions of euros, at September 30)	4.3	7.6

*Adjusted for operations in the United States discontinued effective March1, 2016.

In the first nine months of 2016, revenue adjusted for operations in the United States grew 4% to €1,625 thousand, compared with €1,520 thousand in the same period of 2015. Growth in France continued, with revenue moving up 16% to €855 thousand in the first nine months of 2016, compared with €738 thousand in the same period of 2015.

in thousands of euros	Q3 2016	Q3 2015	Change
France	256	232	+10%
Rest of the world (excluding United States)	165	280	-41%
*Total adjusted revenue**	421	512	-18%
United States (discontinued operations)	0	116	-100%
Total revenue	421	628	-33%

*Adjusted for operations in the United States discontinued effective March1, 2016.

In the third quarter of 2016, Safe Orthopaedics’ adjusted revenue came to €421 thousand, down from €512 thousand in the same period of the previous year. Quarterly revenue in France totaled €256 thousand, up from €232 thousand in the year-earlier period. This 10% increase reflected the success of the Group’s strategy of focusing on a direct sales model.

The French market continued to grow, and sales are expected to reap the benefit of additions to its sales force. In the fourth quarter, Safe Orthopaedics plans to manage its sales directly in Switzerland. The revenue contraction in export markets reflected some major disparities. In particular, the third-quarter 2016 figure was depressed by a credit note issued in connection with the termination of a relationship with an underperforming distributor in Switzerland.

What’s more, following on from its expansion into South America, Safe Orthopaedics intends to continue establishing a presence in emerging markets with great commercial potential. For example, the regulatory approval process for Safe Orthopaedics’ products is nearing completion in Russia (commercial launch scheduled for the first half of 2017).

“Although our third-quarter 2016 performance in export markets was disappointing, our sales have really gained pace in areas where our marketing efforts are focused on our most highly differentiated technologies. Our products for treating trauma (SteriSpine^TMPS and Oak screw) and degenerative conditions by means of a minimally invasive technique (Cypress screw) are very popular with our customers, as five surgeons recently explained in their EuroSpine presentations”, said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics. “The refocusing of our business in March 2016, the new hires strengthening our sales and marketing teams, and the promotion of our unique technologies are set to pay off in the near future”.

Cash position

At September 30, 2016, Safe Orthopaedics had €4.3 million in cash, not including the €650 thousand raised from the issue of a new tranche of OCABSA notes on September 29, 2016.

For the record, Safe Orthopaedics held €4.3 million in cash at June 30, 2016 and €5.9 million at December 31, 2015.

Next Financial Release

Fourth-quarter 2016 revenue: Thursday January 19, 2017 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the SteriSpine™ Kits are CE-marked and FDA cleared. The company is based at Eragny-sur-Oise (France), and has 34 employees.

For more information, visit: www.SafeOrtho.com

View source version on businesswire.com:http://www.businesswire.com/news/home/20161013006217/en/

Safe Orthopaedics
Thierry Lambert
CFO
Tél. : +33 (0)1 34 21 50 00
investors@safeorthopaedics.com
or
NewCap
Investor Relations
Julien Perez / Valentine Brouchot
or
Nicolas Merigeau
Media Relations
Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

This article was originally distributed via Business Wire. Business Wire, Frankly and this Site make no warranties or representations in connection therewith. If you are affiliated with this page and would like it removed please contact pressreleases@franklyinc.com

Vexim: +37% Sales Increase to €13.3 Million as of September 30, 2016 (9 Months)

Posted On October 13, 2016 By OrthoSpineNews In Financial /

October 13, 2016

TOULOUSE, France–(BUSINESS WIRE)–

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA‐PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its consolidated sales results for the third quarter 2016.

« Vexim continues to develop according to its plan. Our results confirm the objectives set as the SpineJack® is becoming a reference on the spine trauma market. We are aiming at a market share of 10% in Europe by the end of 2016 and continue to strengthen our presence namely in Germany. Outside of Europe, we are also extending our market coverage with new developments in Australia and South Africa, a trend that will be reinforced in 2017. As announced during our half-year result publication, we are still confident in achieving profitability in the second-half of 2016 while maintaining a solid cash position”, said Vincent Gardès, Vexim’s CEO.

Continued growth in the third quarter 2016


Revenues (in million of euros as of September, 30^th)
Quarterly sales			Cumulated sales (9 months)
Q3 2016	Q3 2015	Variation (%)	2016	2015	Variation (%)
4.700	3.561	+32%	13.265	9.657	+37%

Vexim’s sales reached €4.7 million over the third quarter 2016, up 32% compared with the same period in 2015. These results are in line with the objectives set for the full year 2016 and reflect Vexim’s strong performance on all its markets.

Vexim’s growth in Europe remains solid, up 37% in the first nine months of the year. Vexim continues to gain market shares in France and pursues its development in Germany.

There is also a growing interest in the SpineJack® technology outside of Europe, where Vexim’s cumulated sales increased by 51% as of September 30, 2016. The company recently announced the signature of a distribution agreement in South Africa¹ and the registration of its products SpineJack® and Masterflow™ in Australia².

As of September 30, 2016, the total number of implants sold since the launch of the SpineJack® in 2011 came over 38,150 units, representing approximately 18,175 patients treated.

Click on the following link to view the presentation of Vexim’s half-year 2016 results:
http://www.vexim.com/us/shareholder-area/investors-guide/

Financial reporting schedule:
2016 sales results: January 17^th, 2017³

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital⁴ and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 64 employees, including its own sales teams in Europe and a network of international distributors.

VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com

SpineJack® ⁵, a revolutionary implant for treating Vertebral Fractures

The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.

Masterflow^TM ², a high-performance orthopedic cement delivery system

The Masterflow^TM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the Masterflow^TM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The Masterflow^TM contributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.

Name : VEXIM
ISIN code : FR0011072602
Ticker : ALVXM

¹ Press release: http://www.vexim.com/us/vexim-signs-a-distribution-agreement-with-creatori-health-and-expands-its-market-to-south-africa/

² Press release: http://www.vexim.com/us/vexim-announces-the-registration-of-its-products-spinejack-and-masterflow-in-australia/

³ Indicative date, subject to changes.

⁴ Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.

⁵ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
investisseur@vexim.com
+33 5 61 48 48 38
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
vexim@alizerp.com
+33 1 44 54 36 66
+33 6 48 82 18 94

AAEAAQAAAAAAAAK-AAAAJGU5YmZlNWM4LTEwNWItNDQyMC1iMmEwLTkyOWVjOTQwZDU1Mg.png

Exactech Breaks Ground in Foot and Ankle Market with Successful First Surgery

Posted On October 13, 2016 By OrthoSpineNews In Extremities /

October 13, 2016

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for extremities, hip, knee, and spine, announced today a successful first surgery using its new Vantage® Total Ankle System, the newest addition to the Exactech extremities product line and its first product in the foot and ankle market.

Orthopaedic surgeons Mark Easley, MD, and James Nunley, MD, of Duke University, performed the first case with the ankle implant in Durham, N.C. “The surgical team and I were pleased that the Vantage Total Ankle replacement went exactly according to plan,” Easley said. “After several years of thoughtful development and design, the anatomic implants, practical instrumentation and relatively simple technique performed as they were designed. Based on proprietary anatomic data, the Exactech Vantage Total Ankle team of surgeons and engineers developed an innovative total ankle design that features both anatomic talar and tibial components.”

Easley also added, “The technique, with its favorable tibial and talar bone preparation which was clearly designed with minimal bone resection in mind, affords optimal support for the anatomically shaped implants. The Vantage Total Ankle has a reproducible and surgeon-friendly technique.”

Exactech Vice President of Extremities Marketing Darin Johnson said, “We had the privilege to design this product with some of the best thought leaders in the world who have dedicated their careers to the treatment of the ankle. Our team is proud to be a part of successfully improving the surgical outcome for one patient and laying the foundation for many, many more in the years to come. This marks a strategic expansion into the foot and ankle market where we will leverage Exactech’s founding principle of solving clinical challenges in collaboration with surgeons in order to improve the lives of patients. It is an exciting time.”

This ankle system represents years of collaboration among Exactech and a design team of esteemed surgeons including: James Nunley, MD; James DeOrio, MD; and Mark Easley, MD, of Duke University in Durham, N.C.; and Victor Valderrabano, MD, PhD, of Swiss Ortho Center of Schmerzklinik Basel in Basel, Switzerland.

Full market availability of the Vantage Total Ankle System in the United States is planned for 2017.

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 can be found at http://www.exac.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

Titan Spine Initiates Full U.S. Launch of New nanoLOCK® Surface Technology

Posted On October 13, 2016 By OrthoSpineNews In Spine /

October 13, 2016

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has expanded the distribution of its line of Endoskeleton^® titanium implants featuring the company’s new proprietary nanoLOCK^® surface technology nationwide. The full U.S. launch follows the successful alpha introduction of the nanoLOCK^® technology initiated recently in a limited number of sites. The Company has achieved sales of nanoLOCK^® implants in 14 hospitals in 8 states since its introduction and is in the process of signing contracts with several large hospital systems.

The nanoLOCK^® surface technology, which is manufactured through a proprietary subtractive process, has received two differentiated government agency designations that highlight its uniqueness within the interbody fusion device market. In late 2014, Titan Spine added an additional U.S. Food and Drug Administration (FDA) clearance for “nano-textured surface” to the product line’s initial 510(k). In October 2016, nanoLOCK® was granted its own new technology category and code, formally known as an “ICD-10pcs New Technology Section X Code,” by the U.S. Centers for Medicare & Medicaid Services (CMS).

Steve Cichy, Vice President of Sales for Titan Spine, said, “The full launch of nanoLOCK^® will add to Titan Spine’s continued sales growth, highlighted by our 51% sales increase in 2015 compared to prior year. The interest in nanoLOCK^® has been incredibly strong and has challenged us to keep up with demand. We have generated a strong start and anticipate rapid surgeon adoption of nanoLOCK^®as we ramp up the full U.S. launch and showcase the technology at the upcoming North American Spine Society (NASS) Annual Meeting in Boston.”

Kevin Gemas, President of Titan Spine, commented, “The full U.S. launch of our nanoLOCK^® surface technology comes at an optimal time as the interbody market is rapidly shifting toward titanium surface-enhanced implants. It represents a major milestone for Titan Spine and is the culmination of years of preparation through scientific study, manufacturing validation, IP protection, and unique regulatory clearances through collaboration with the FDA and CMS. This effort resulted in nanoLOCK^® being the only nano-cleared interbody device on the market and is the only interbody device that has access to the recently-created new technology ICD-10 code for a nanotextured surface on an interbody fusion device. Through our extensive research, which has been published in several peer-reviewed journals, the industry is now beginning to understand the importance of our very specific titanium nano-architecture in its ability to promote the generation of osteogenic and angiogenic growth factors necessary for bone growth and fusion compared to other surfaces.¹ And finally, we appointed a general counsel to protect our legal interests and ensure that our extensive IP portfolio and proprietary scientific data are fully defended. We have taken all of these vital steps to ensure that our nanoLOCK^® surface is truly differentiated in a market that is quickly becoming crowded with imitators. We are very pleased with its launch thus far and look forward to it benefiting more surgeons and patients moving forward.”

Titan Spine offers a full line of Endoskeleton^® devices that feature Titan Spine’s proprietary nanoLOCK^® surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^1,2 All Endoskeleton^® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton^® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

²Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Contacts

Company
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com

SpineGuard reports €1.7M revenue for 3Q 2016, and 9 months growth of 15%

Posted On October 12, 2016 By OrthoSpineNews In Financial /

October 12, 2016

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today that its third quarter revenue grew to €1.7 million, a 2% increase compared with 3Q 2015.

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “After six consecutive quarters of more than 20% growth in the US, sales growth slowed in the third quarter of 2016. Since the US FDA clearance of the PediGuard Threaded in June, the US team has been actively preparing the commercial launch of this breakthrough product scheduled for the NASS (North American Spine Society) congress at the end of October in Boston. Our sales managers and product specialists are already promoting this very promising new extension of SpineGuard’s DSG™ technology with agents, surgeons and hospital purchasing committees. We experienced similar situations in the past when launching the PediGuard Curved, the PediGuard Cannulated and the PediGuard XS. In the rest of world, the quarter growth was solid, mainly driven by Europe and the Middle East.”

€ thousands – IFRS

2016

2015

Variance

First Quarter

1 760

1 517

+16%

Second Quarter

1 873

1 452

+29%

Half-Year

3 633

2 970

+22%

Third Quarter

1 678

1 646

+2%

Year to Date 9 Months

5 311

4 616

+15%

Unaudited

Global revenue in the third quarter of 2016 increased 2% to €1,678k, compared with €1,646k in the third quarter of 2015. In the USA, the decrease was 3% both as reported and at constant exchange rate (cc), while the rest of the world increased 29%.

For the 9 months, global revenue increased 15% to €5,311k, compared with € 4,616k in the first nine months of 2015. The growth in the United States was 15% at both actual exchange rate and cc.

6,324 PediGuard units were sold in the first nine months of 2015 compared with 5,580 in the first nine months of 2015, including 3,581 in the United States, representing 57% of total units sold.

Next financial press release: 2016 full year revenue, January 5, 2017
SpineGuard will participate at Actionaria retail investor show on November 18 and 19 in Paris.

About SpineGuard®
Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Close to 50,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris.

For further information, visit www.spineguard.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

MiMedx Third Quarter 2016 Revenue Exceeds Upper End of Guidance

Posted On October 11, 2016 By OrthoSpineNews In Financial /

MARIETTA, Ga., Oct. 10, 2016 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today its revenue for the third quarter of 2016.

Third Quarter 2016 Revenue Highlights:

Q3 2016 revenue of $64.4 Million is a 31% increase over Q3 2015 revenue
Q3 2016 revenue exceeds $64.0 Million upper end of guidance
Q3 2016 revenue beats analyst’s estimates of $63.1 Million
Revenue for the nine months ended 9/30/16 is a 29% increase over same 2015 period

The Company recorded record revenue for the 2016 third quarter of $64.4 million, a $15.4 million or 31% increase over 2015 third quarter revenue of $49.0 million. For the nine months ended September 30, 2016, the Company recorded record revenue of $175.1 million, a $39.7 million or 29% increase over revenue of $135.4 million recorded in the same period of 2015.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are very pleased that we were able to exceed our third quarter revenue guidance. This makes 20 consecutive quarters of sequential revenue growth and 19 of 20 quarters of meeting or exceeding our revenue guidance. Our core advanced wound care revenues were led by our commercial accounts. With the launch of our two new product lines in the third quarter, AmnioFill™ and OrthoFlo Lyophilized, we are looking forward to very robust growth in the fourth quarter and beyond. Third quarter revenue is typically impacted by vacations, and we are pleased with our third quarter results in light of that fact. With many year-end deductibles being met during the fourth quarter, we anticipate that typical additive impact on our fourth quarter revenue.”

Bill Taylor, President and COO, related, “We had particularly strong growth in the commercial side of our wound care business, and our nationwide footprint in this market sector continues to rapidly expand. Our EpiFix® product line continues to have a significant impact on the broadening of the usage of advanced wound care products. We believe the market-moving effect of this flagship EpiFix product is due to its clinical and cost effectiveness. We have continued to make investments in our international activities over the last two years, and the results are beginning to develop with noteworthy activity arising in certain foreign markets. Our EpiFix and AmnioFix® dehydrated Human Amnion/Chorion Membrane (dHACM) products were highlighted at the recently completed World Union Wound Healing Societies (“WUWHS”) symposium. Overwhelming interest was expressed by leading international physicians regarding the clinical effectiveness of our EpiFix and AmnioFix allografts. We also showcased EpiCord™, our dehydrated human umbilical cord allograft, at the WUWHS, and it likewise received a tremendous amount of interest. The WUWHS is the most widely attended international symposium dedicated to wound healing.”

Petit added, “We have high expectations for our new OrthoFlo Lyophilized and AmnioFill product lines. Each new product line fills different needs in the wound care and surgical markets, and collectively, they bring much more diversity to our product lines. AmnioFill is being offered in multiple sizes to address physicians’ needs for a product to treat larger acute and chronic wounds encountered in the surgical setting. OrthoFlo is adding to our portfolio of regenerative medicine solutions that serve the Orthopedics and Sports Medicine sectors of healthcare.”

The Company announced today that it plans to release its results for the third quarter ended September 30, 2016, before the opening of the market on Thursday, October 27, 2016. The Company also announced that it will provide guidance for the fourth quarter of 2016 in that quarterly earnings release.

MiMedx will host a live broadcast of its third quarter conference call on Thursday, October 27, 2016 at 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.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone. “Innovations in Regenerative Biomaterials” is the framework behind our mission to give physicians products and tissues to help the body heal itself. The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ and AmnioFill™ brands; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft; EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.

We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to the Company’s financial projections for the remainder of the year, Company looking forward to very robust growth in the fourth quarter and beyond, the Company’s belief that EpiFix’s impact on broadening usage of advanced wound care products is due to its clinical and cost effectiveness, the Company’s international efforts are beginning to show results in certain foreign markets, and the Company’s high expectations for OrthoFlo Lyophilized and AmnioFill. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company’s revenue and earnings may not grow or may decline; the Company’s new products may not gain acceptance in the medical community as anticipated; the Company’s new products may not have the expected market impact; usage of advanced wound care products such as EpiFix may be impacted by changes in reimbursement or other issues that could decrease usage, regardless of clinical or cost effectiveness, or that may change the cost effectiveness of the products; international efforts to date may not translate into revenue in the future, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015 and its most recent 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

TEPHA, Inc. Announces Buy-Out of its Royalty Obligation to Metabolix, Inc.

Posted On October 11, 2016 By OrthoSpineNews In Financial /

LEXINGTON, Mass., Oct. 11, 2016 /PRNewswire/ — TEPHA Inc, the pioneer developer of implantable medical devices based on a resorbable polymer known as poly4hydroxybutyrate (P4HB), announced today that the Company has completed a buy-out of its royalty obligation to its former licensor and parent company, Metabolix, Inc. Beginning in 2008, Tepha and its partners have commercialized implantable medical devices manufactured from P4HB in both the US and Europe. Tepha’s commercial partners include, C.R. Bard Inc., B Braun, Wright Medical Group NV, and Galatea Surgical, a wholly owned subsidiary of Tepha focused on the Aesthetic Plastic Surgery market.

Andrew Joiner, President and CEO of Tepha, commented: “The buy-out of our royalty obligation in conjunction with Metabolix was financially advantageous for both companies. Specifically for Tepha, the cash flow from our savings will help finance the continued development of our core technology as well as pre-clinical and clinical testing of new applications.”

P4HB is a biologic polymer produced through a controlled fermentation process. Compared to medical devices based on other commercially available resorbable polymers, P4HB constructed devices have been shown to be less inflammatory, less acidic, more flexible, less brittle, and stronger with implanted strength retention that is compatible with the body’s natural healing process. Tepha currently offers a range of P4HB-based fibers, mesh and other constructs. Tepha is continuing to expand its P4HB technology platform to include collagen and antibiotic coatings, high strength multi-filament fiber, and non-woven materials, all targeting new market and partnering opportunities.

About Tepha: Tepha Inc, founded in 1998 and headquartered in Lexington, MA, is a supplier of medical devices focused on the BioMaterials market. Tepha’s products are designed and developed to elevate, support and reinforce areas of soft tissue weakness as well as to promote improved healing responses. To date Tepha and its partners have received 23 510(k) clearances for devices marketed in the US as well as five CE Marks for products sold in Europe. Commercial products based on Tepha’s resorbable P4HB polymer technology include: high tensile strength sutures for orthopedic soft tissue repair; mesh constructs for ventral and inguinal hernia repair; monofilament sutures for abdominal wall closure and plastic surgery; patches for tendon and ligament repairs; and mesh constructs for face and breast lifts. To date, products made from P4HB have been successfully used in more than 1,000,000 surgical procedures worldwide, and have been the subject of over 30 published clinical and scientific papers.

Contact:	John Hartnett
	Executive Vice President and Chief Operating Officer, Tepha Inc.
	781-357- 1772

	Andy Joiner
	President and Chief Executive Officer, Tepha Inc.
	781-357-1770

SOURCE TEPHA, Inc.

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http://www.tepha.com

State’s high court hears arguments in legal challenge to Medtronic-Covidien deal

Posted On October 11, 2016 By OrthoSpineNews In Financial, Regulatory /

By Joe Carlson Star Tribune – October 5, 2016

Medical device maker Medtronic moved its legal headquarters to Ireland last year in a controversial $50 billion deal that forced about 20 percent of the people who owned its stock to shell out thousands of dollars each to cover capital gains taxes.

Now some shareholders want the company to cover those costs. First they will have to convince the Minnesota Supreme Court to agree with them that state law does not — or should not — prevent them from being able to bring their lawsuit at all. If they win at the high court, the plaintiffs would still have to prevail in a future trial or get a settlement to see any money.

In oral arguments Wednesday morning at the Supreme Court, the attorney representing Medtronic said the two-year-old class-action lawsuit should never have gotten to the state’s highest court. That is because long-standing Minnesota business law gives boards of directors legal protections so they can run a company without being second-guessed by litigious shareholders.

“The question before you this morning is whether you will abandon the rule of law that has been effectively applied for decades, and embrace a rule of law … that is inconsistent with your most recent statements of public policy,” said Medtronic’s attorney, Eric Magnuson, who was chief justice from 2008 to 2010.

The aggrieved shareholders, however, argue that long-standing rule of law doesn’t address unique situations that can arise during corporate inversions like Medtronic’s.

An inversion happens when a U.S.-based company relocates its headquarters to a lower-tax jurisdiction through a corporate acquisition. In January 2015, Medtronic acquired health care supplier Covidien for $49.9 billion in cash and stock in a deal that put the combined company in Covidien’s old headquarters building in Dublin, Ireland. CEO Omar Ishrak continues to run the company from offices in Minnesota.

Medtronic’s board members knew the inversion would impose taxes on the minority of shareholders whose stock was not protected in a tax-deferred account like an IRA. The board members also knew Medtronic’s management strongly favored of the deal — so much so that the company agreed to cover $69 million in special excise taxes on company officers imposed by Congress to discourage inversions.

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Winning 3D printing startup rings the NASDAQ bell

Posted On October 11, 2016 By OrthoSpineNews In Extremities, Financial /

October 10, 2016 – by Michael Petch

TriFusion Devices, winners of the Rice Business Plan Competition (RBPC) and manufacturers of custom 3D printed prosthetic devices, rang the NASDAQ opening bell earlier today.

This morning in New York, Blake Teipel, TriFusion Devices’ CEO, joined Brad Burke from the Rice Alliance for Technology and Entrepreneurship to announce the opening of the tech focused stock exchange for the first day of the week. Commenting on the event the CEO said, “We are grateful for the support, guidance, and encouragement that we’ve received from the Texas A&M University and Rice University programs. The experience and coaching we have received as we’ve launched our venture have proven immensely valuable to our success.”

Texas based TriFusion Devices beat 41 rival companies to take the RBPC prize earlier this year in April. The young company aims to revolutionize “the health care and sports-equipment industries in powerful and profitable ways” by using 3D printing to create tailored solutions for “amputees and prosthetists”.

The Super Bowl of Business Plan Competitions

In the U.S. alone, approximately two million people manage with the loss of a limb: a group currently growing at a rate of 185,000 each year.

TriFusion Devices emerged as the 2016 RBPC winner after review by 275 judges and was awarded prizes and cash valued at approximately $400,000. The total prize pool for this year’s competition was reported at over $1.7 million.

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Novastep Enhances its Nexis® Headless Screws Portfolio

Posted On October 11, 2016 By OrthoSpineNews In Extremities /

Orangeburg, New York, Oct. 07, 2016 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, has further expanded its coverage of midfoot and rearfoot indications with the addition of a full range of Nexis^®5.0 and 7.0mm headless, cannulated compression screws.

The implants feature all of the hallmark design attributes inherent to the Company’s Nexis^® brand, including helical thread flutes that are self-drilling, self-tapping and reverse-cutting; Torx drive recess interfaces for optimal force distribution and tapered, self-penetrating compression cones. Loïc Girod, Novastep’s Vice President of Research and Development, noted that “The Nexis^® system provides surgeons with a complete and versatile selection of sterile packaged, low-profile, cannulated screws that are designed to address a broad spectrum of midfoot and hindfoot pathologies.”

The system is likewise supported with a robust instrumentation platform that is neatly stored in a versatile, light-weight, space-saving tray to combine the Nexis^® 5.0 and 7.0mm instruments with interchangeable Nexis^®4.0mm headless screw or Arcad 18/20/25mm nitinol compression clip instrument modules that serve to further enhance its versatility. “Operating room efficiency and cost reduction are prime areas of focus for Novastep” said Joseph Larsen, DPM of ProHealthCare Foot & Ankle in New York; adding that “Novastep’s implant and cleanSTART^® deployment technologies provide a systematized logistics platform that is easily customizable to fit virtually anyone’s needs and substantially reduces inventory requirements and sterile field volumes.”

All Novastep implants are packaged sterile in quickSTACK™ containers or quickTUBE™ nested cylinders, depending on the size and configuration of the product. The STACKS and TUBES are housed and organized in the cleanSTART^® Implant Dispenser console, which may be uniquely tailored to address individual surgeon preferences.

Nexis^® and other key elements of Novastep’s portfolio will be featured at the Desert Foot 2016 meeting on October 19–22 in Phoenix, AZ and the upcoming 2016 Global Foot and Ankle Symposium in New York City on December 2–3.

About Novastep

Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to info@novasteportho.com or call 877.287.0795.

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For general information visit: novastep-us.com

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