Misonix Enters into $11 Million License, Royalty and Manufacturing Agreement

Posted On October 20, 2017 By OrthoSpineNews In Financial, Top Stories /

FARMINGDALE, N.Y., Oct. 20, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that it has entered into a license and exclusive manufacturing agreement with Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd., a Chinese corporation, under which Misonix has licensed certain manufacturing and distribution rights to its SonaStar product line in The People’s Republic of China (“PRC”), Hong Kong and Macau in exchange for payments totaling a minimum of $11 million.

The agreement calls for (i) upfront technology license fees and stocking orders of $5 million; (ii) minimum royalty payments from the sale of SonaStar products in the licensed territories of $2 million per calendar year in each of 2019, 2020, and 2021 and (iii) additional royalty payments based on product sales through August 2027. The Agreement also provides that Misonix will supply SonaStar products to Hunan Xing Hang Rui Kang Bio-Technologies Co., Ltd. at agreed prices during the transition period prior to their commencement of manufacturing, and provides for reimbursement of technology transfer costs to Misonix of up to $1 million.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “We look forward to working with the team at Hunan Xing Hang Rui Kang Bio-Technologies Co. to establish our SonaStar technology throughout The People’s Republic of China, Hong Kong and Macau. We will be focused on assisting them to effectively and efficiently manufacture the SonaStar product line once they complete the required manufacturing facilities. In the meantime, we will supply them the product they need to begin to establish the SonaStar product line in these important and fast-growing markets. This is an important technology that will result in better patient outcomes with cost-effective treatment modalities.”

Quan Li, Chairman of Hunan Xing Hang Rui Kang Bio-technologies Co., Ltd., said, “Working with Misonix represents a unique opportunity to add an important technology to our suite of products. SonaStar is an advanced technology engineered to provide powerful and precise ultrasonic aspiration with maximum control and ease-of-use. We are dedicated to bring these important benefits to our markets in The People’s Republic of China, Hong Kong and Macau.”

“We are extremely excited to be partnering with the team at Hunan Xing Hang Rui Kang Bio-Technologies Company to bring our SonaStar technology to The People Republic of China,” added Scott Ludecker, Senior Vice President of Sales and Marketing with Misonix. “Both organizations share a common commitment to improving the lives of patients with our therapeutic ultrasonic surgical technology.”

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Corporate Contact
Joe Dwyer
Misonix, Inc.
631-927-9113
jdwyer@misonix.com

Investor Contact
Joe Diaz
Lytham Partners
602-889-9700
mson@lythampartners.com

RTI Surgical® Introduces TETRAfuse® 3D Technology Becoming First to Offer 3D Printed Interbody Polymer Optimized to Participate in Fusion

Posted On October 20, 2017 By OrthoSpineNews In Biologics, Top Stories /

October 20, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced the introduction of TETRAfuse^® 3D Technology, providing surgeons a solution they have been seeking. From the beginning, surgeons have had to choose between bone in-growth, radiolucency or mechanical strength when selecting a spinal interbody implant. TETRAfuse 3D Technology is the first 3D printed polymer implant material that has demonstrated trabecular bone ingrowth while maintaining radiolucency and bone-like mechanical properties¹.

“The 3D printing process creates a nano-rough surface on every aspect of the implant, not just the endplates,” noted Robert Watkins IV, M.D. of Marina Spine Center in Marina Del Ray, Calif. “This nano-rough surface facilitates bony ingrowth throughout the disc space from endplate to endplate, allowing deeper implant osseointegration.”

TETRAfuse 3D Technology was developed to offer surgeons an interbody material that participates in the fusion process while maintaining bone-like mechanical properties and radiolucent imaging. Bringing these features together combines the osseointegrative advantages of titanium and allograft bone with the benefits surgeons experience with PEEK. RTI will soon announce the release of a family of products manufactured with TETRAfuse 3D Technology, providing a platform that will have many derivative products.

“We are excited about the promise this cutting-edge technology holds for our surgeon customers and their patients,” said Camille Farhat, RTI chief executive officer. “Being the first to offer surgeons a 3D printed interbody polymer optimized to participate in fusion marks another significant milestone for RTI in our quest to continuously deliver relevant and innovative products without compromise.”

^® indicates U.S. trademark registration. All trademarks and/or images are the property of their respective owners or holders.

¹Data on file at RTI Surgical, Inc. Animal and in vitro data may not be representative of clinical experience.

Clinical cases are unique and results may vary.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical Inc.
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com

OrthoSpineNews Interview with Charanpreet Bagga, Prosidyan’s President and CEO and Renowned Surgeon Dr. Hyun Bae

Posted On October 20, 2017 By OrthoSpineNews In Biologics, Spine /

At OrthoSpineNews, we enjoy attending all the conferences and learning about new technology. There aren’t many areas in orthopedics and spine that has seen more growth, development and enthusiasm over the past few years but one of the shining stars is the Orthobiologics space. One of the most intriguing technologies that we have seen in this segment is the bioactive glass product called Fibergraft which is manufactured by Prosidyan.

We had the opportunity to sit down with Prosidyan’s President and CEO, Charanpreet Bagga (CB) as well as one of the leading surgeons in the country, Dr. Hyun Bae to learn more about the company and the product.

How about we start out with you both taking a minute to introduce yourself for our audience.

CB- I have been very fortunate to have worked on a variety of exciting projects and for a number of great companies over the years. Over the last 25 years, I have worked for Howmedica, Spinetech, Orthovita, Orthofix and Prosidyan as a full-time employee and I also helped build Titan Spine and Knee Creations as a consultant. Over the years, I am a named inventor in over 125 US Patent applications, with over 50 issued patents, spanning hardware and biomaterials associated with treatments for back and knee pain.

Bae- I graduated from Columbia in NY with a degree in Biomechanical Engineering. Looking back the biggest impact to my career choice was working in the Orthopaedic Research Lab as an undergrad with a world renown leader in cartilage and bone biology named Dr. Van C. Mow. His post docs are now the Directors of many leading academic institutions and are the preeminent thought leaders in the field of musculoskeletal science. From there I completed my medical training at Yale School of Medicine and continued research during my medical training by spending a year at the NIH as a Howard Hughes Fellow. I completed my orthopaedic training at the Hospital for Special Surgery and spine fellowship with the late Henry Bohlman in Cleveland.

What led you to create Prosidyan and more specifically, Fibergraft?

CB- Infuse was a Billion-dollar product in 2006. By late 2008, we had seen a rapid decline in the market share of Infuse, which created a void in the bone grafting market. Dr. Bae and I met around that time and felt that there was an unmet clinical need for a viable synthetic bone graft. We researched the field and narrowed in on bioactive glass as the most promising material. Bioactive glass at that time already had a strong body of research to support its amazing properties, but had the limitations of only being available as crushed glass or as solid microspheres, with no porosity. We had learnt over the years how important three-dimensional porosity providing direct cell connectivity is for allowing bone growth. I decided to visit MoSci, the global dominant manufacturer of bioactive glass. It led to a joint collaboration between Prosidyan and MoSci to develop FIBERGRAFT.

As a surgeon, what about Fibergraft do you most appreciate?

Bae- I love the fact that Fibergraft is truly a paradigm shift in grafting. Most synthetics look like cancellous bone. The problem is that they either resorb too quickly and you are not left with much or they are inert and do not resorb. I feel we have been disenchanted with synthetics that look good on x-ray but on reoperation are found to be present in a deteriorated state without any true bone formation. We have learned from BMP that bone induction is less about the providing a scaffold that looks like bone but more about enhancing the cellular healing process. Fibergraft consists of micro and nano-sized fibers that are thoughtfully engineered in a 3-D structure to specifically induce and optimize the cellular process of bone development.

BioActive Glass products have been around since VITOSS, what makes this different?

CB- We are the first company to commercialize nano and micro sized fibers of bioactive glass for bone grafting. Everyone else had solid particles, with no porosity. Fibers allow the ultimate flexibility in engineering. Our 3-D fiber array allows not only engineered porosity but direct cell connectivity. This makes all the difference in ability to create rapid and sustained bone formation.

We have heard many different responses from surgeons regarding the quality of a fusion. Some say it’s the implants and biologics while others will say it’s the carpentry skills of the surgeon. What have you experienced and why do you think Fibergraft is displaying such great results?

Bae- Obviously its all of the above. But having trained fellows for the past 15 years, I am proud to say that the level and skill of spinal surgeons have advanced tremendously. BMP taught us that we do not need iliac crest autograft in every fusion. By advancements in implant technology and importantly knowledge and skill of the surgeon we have been able to achieve great results and outcomes for our patients without iliac crest autograft. Fibergraft is just a well-deserved and needed evolution in synthetic bone grafting. The results are a simple derivative of applying sound science and innovative engineering to the field of synthetic bone biology.

All publically traded orthopedic and spine companies have noted negative pricing pressure on their quarterly calls over the past few years, how has it been to create a new and innovative company while facing the same challenges?

CB- This is a new world. Gone are the days when you could spend unlimited amount of money in the development cycle with the promise of huge payback someday. We ran Prosidyan very lean right from the beginning. I worked from my home office for the first five years until we were close to our first FDA clearance. We spent most of our funds directly on R&D and we stayed away from any expenses which were not absolutely needed. I am proud to share that we have been operationally profitable, right from our first full year of commercial operations.

BMP’s like Infuse took the market by storm in the early 200’s but it appears that the product has been losing market share to products like Fibergraft, why do you think that is (clinical results? Finances?)

Bae- First I think that BMP revolutionized the grafting market. For all intensive purposes it put an end to the use of iliac crest autograft. I do feel like this was a great thing for our patients. It allowed the exploration of alternatives to iliac crest to be put to use. The two main alternatives are allograft and synthetics. I truly feel that we just fell behind in the synthetic category. There is no reason with the advancement of technology and science today that a synthetic bone graft cannot be engineered to equal autograft. It just took us a long time to understand and apply technological innovations to synthetics. Fibergraft is an incredible and thoughtful application of todays technology in synthetic bone grafting. Its clinical results speak for themselves and it is the best synthetic bone graft available today.

Thank you both for taking the time to sit down with us and share the exciting story of Prosidyan and Fibergraft. You will be at NASS and I’m sure if anyone reading this has questions, it would be highly recommended for them to stop by your booth (#1730) while they are in Orlando. We wish you both the best of luck and thank you again for sharing this exciting story.

Orthofix International Schedules Third Quarter 2017 Earnings Release and Conference Call for October 30, 2017

Posted On October 20, 2017 By OrthoSpineNews In Financial /

October 19, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that it plans to release financial results for the third quarter 2017 after market close on Monday, October 30, 2017. Brad Mason, Chief Executive Officer, and Doug Rice, Chief Financial Officer, will host a conference call and webcast to review the Company’s results at 4:30 p.m. ET the same day.

Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 2078866. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 2078866. A webcast of the conference call may be accessed by going to the Company’s website www.orthofix.com by clicking on the Investors link and then the Events and Presentations page.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Investor Contact:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Contact:
Denise Landry, 214-937-2529
deniselandry@orthofix.com

Spineology Initiates Post-Market Lateral Interbody Fusion Study Using Novel Implant Design

Posted On October 20, 2017 By OrthoSpineNews In Spine /

October 20, 2017

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., the innovator in anatomy-conserving spine surgery, has announced the initiation of a prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes using its FDA-cleared Duo^™ Lumbar Interbody Fusion System.

The Duo System offers a unique implant design that is the first to combine PEEK, titanium, and graft containment mesh elements. The design dramatically reduces the access required to implant a device compared to traditional lateral systems. By minimizing the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System can reduce the post-operative thigh pain and other complications commonly associated with the lateral approach. In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.

“We think minimizing the amount of retraction by having the ability to efficiently place a narrow implant and then expanding the implant up to 30mm in width once deployed, offers significant clinical benefits to the patient as well as procedural benefits to the surgeon,” said John Booth, CEO, Spineology Inc. “The Duo System represents next-generation fusion technology and we’re extremely excited to see the clinical results of patients treated in the post-market study,” added Booth.

Post-market study sites for the Duo System are in the process of being finalized.

The Duo Lumbar Interbody Fusion System will be highlighted at the Spineology booth, #913, at the North American Spine Society (NASS) annual meeting next week in Orlando, Florida.

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

Contacts

Spineology Inc.
John Booth, 651-256-8511
jbooth@spineology.com
or
Risdall
Dave Folkens, 651-286-6713
dave@risdall.com

Corin Group acquire Belgium & Luxemburg large joint business unit of MBA NV

Posted On October 19, 2017 By OrthoSpineNews In Extremities, Recon, Spine, Top Stories /

18 October 2017

Corin Group, after the successful acquisition of the Tornier Hip and Knee business is announcing a further European expansion by acquiring the large joint business unit of MBA Belgium & Luxemburg NV.

Over the last 7 years MBA has successfully distributed the Corin portfolio. The team have gone from strength to strength, expanding and developing solid collaborative relationships with key surgeons throughout the countries. The combination of Corin technologies and the MBA team’s passion for orthopaedics will deliver greater value to the Belgium and Luxemburg Orthopaedic community.

Stefano Alfonsi, Chief Executive Officer of Corin commented “With MBA’s, responsive service and solid working relationships they are well placed to engage their attentive audience with Corin’s world leading innovative technologies. We are delighted to welcome the team who are transitioning to Corin from MBA and look forward to building an even stronger surgeon focused organisation.”

Paul Griffin, International Business Director, MBA, commented, “Building on MBA’s success in Belgium & Luxemburg in the recent past, Corin’s involvement will streamline the representation from MBA and Tornier to a single Corin entity, simplifying the customer experience, and enabling more surgeons to engage with Corin’s Ecosystem of ground breaking technologies’.”

About Corin

Since its inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics.

We offer a unique combination of clinically-proven hip, knee, ankle and shoulder solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever.

The deep insight we gain, understand and share at every stage of the connected orthopaedic experience leads to advanced, patient-specific solutions that exceed expectations, maximise value in healthcare and positively impact lives.

About MBA

MBA is a leading company in the European medical and surgical technology field. Our objective is to create value for the specialist through technology, service and sharing knowledge.

MBA currently has two divisions:

MBA

The Company began by specialising in providing complete solutions for Orthopaedic and Neurosurgeons via a full range of product lines for the following specialities:

Knee
Hip
Shoulder
Other joints: Elbow, Hand, Wrist, Foot and Ankle.
Tumour and Extremity Reconstruction
Biomaterials
Spine
Trauma

BIOSER

This Division provides solutions for nine surgical specialties: Anaesthesiology, General Surgery, Cardiovascular Surgery, Thoracic surgery, Urology, Gynaecology, Obstetrics, ENT, Plastic Surgery and Emergency Medicine.

Nexxt Spine to Showcase NEXXT MATRIXX™ at the 2017 North American Spine Society Annual Meeting

Posted On October 19, 2017 By OrthoSpineNews In Spine /

October 18, 2017

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, announced that it will introduce the NEXXT MATRIXX™ System, the company’s new 3D printed porous titanium interbodies and vertebral body replacement (VBR) devices, during the 2017 North American Spine Society (NASS) Annual Meeting in Orlando at Booth #1550.

The NEXXT MATIRXX™ implants which are now available nationwide have been successfully implanted as indicated for use as cervical intervertebral fusion devices and lumbar intervertebral fusion devices. To date, all surgeon feedback has been overwhelmingly positive.

The NEXXT MATRIXX™ System leverages Nexxt generation technology to create interbody and VBR devices with optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

“We are extremely excited to introduce the Nexxt generation technology with our 3D printed porous titanium devices along with our comprehensive product portfolio during the largest spine meeting and exhibition in the world,” said Andy Elsbury, Nexxt Spine’s President.

For more information about NEXXT MATRIXX™, visit www.nexxtspine.com.

Contacts

Nexxt Spine
Sarah Koch
Info@NexxtSpine.com

Amplitude Surgical – 2016/17 Annual Results

Posted On October 19, 2017 By OrthoSpineNews In Financial /

October 18, 2017

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its annual results for the 2016-17 financial year to June 30, 2017.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “20 years after Amplitude Surgical was founded, 2016-17 was another year with many key events and strong growth, with sales exceeding €90 million and an EBITDA margin of almost 17%. These results reflect the successful implementation of our development strategy, which is based on state-of-the-art R&D, major investments and staff eager to open up new markets and introduce new equipment to support medical practitioners and their patients. Beyond these solid foundations, the potential of the United States – the world’s largest market on which we are developing fast – and an innovative product portfolio that is continuously being enhanced will drive our growth, with our target of doubling the Group’s sales in 5 years to June 2021 reiterated.”

Key 2016/17 events

At product level, Amplitude Surgical achieved the following:

in early March 2017, it obtained the CE Mark for the use in consultation of Kneemap®, a device for measuring knee kinematics to help surgeons assess all knee movements and refine their diagnosis and therapeutic strategy;
in early 2017, it received 510(k) regulatory clearance from the FDA (American Food and Drug Administration) for its Anatomic® posterior-stabilized knee prosthesis. After Europe in February 2013, Australia in August 2015 and South Africa in early 2016, this clearance provides access to the world’s largest lower-limb prosthetic reconstruction market. In the United States, this approval follows that obtained in late 2014 – early 2015 by the Novastep range for lower-limb (foot and ankle) surgery;
at the end of 2016, it obtained the CE Mark for its new ACLip® product, a fixation implant for anterior cruciate knee ligament transplants that provides surgeons with simplicity and replicability and rigid fixation that favors transplants in patients. After hips, knees and lower limbs, Amplitude Surgical’s offering thus now covers one of the most frequent knee pathologies and opens up this major market to the Group. The first transplants, over 600, undertaken in France during the final quarter of 2016-17 financial year bode well for the launch at the next SFA – French Society of Arthroscopy congress early December 2017.

At Group level, Amplitude Surgical carried out the following:

in February 2017, it settled the case pertaining to the acquisition of the remaining minority interests in Australia via a transactional agreement with Austofix, a minority shareholder in its Amplitude Australia Pty subsidiary. This agreement enabled the acquisition of the remaining 25% stake in this subsidiary and the payment of €8.8 million settlement compensation;
at the end of 2016, it finalized a €65 million bond issue, providing the Group with €30 million to continue its international development and €35 million towards the early repayment of its previous debt;
in mid-December 2016, it announced the acquisition of a 50% stake in SOFAB Orthopédie, a longstanding strategic industrial subcontractor. This transaction will provide a net positive contribution from 2017-18;
in July 2016, it finalized the acquisition of the remaining minority interests (40%) in its Brazilian subsidiary, Amplitude Latam, for €4.1 million.

Moreover, in France, Amplitude Surgical has recently signed Memoranda of Understanding with a view to acquiring two companies responsible for the direct management of key French regions, in the east of the country and the Paris region, thus intensifying its commercial presence on the domestic market.

Financial summary – (actual currency):

€ thousands – IFRS	2016-17	2015-16	Δ
Sales	93,356	80,788	+15.6%
Gross margin	70,519	62,213	+13.3%
as a % of sales	75.6%	77.0%
Sales & Marketing costs	38,626	32,115	+20.3%
General & Administrative costs	9,321	9,297	–
R&D costs	7,072	7,327	‐3.5%
EBITDA	15,500	13,473	+15.0%
as a % of sales	16.6%	16.7%
Core Operating Profit	17	3,477
Non-core operating expenses	1,064	11,736
Operating Profit/Loss	-1,046	-8,259
Financial profit/Loss	-8,510	5,352
Attributable Net Profit/Loss	-12,314	-174
Net financial debt	80,043	49,540
Net cash position	41,610	32,071

Improvement in the operating expenses / sales ratio; EBITDA margin of 17.6% excluding costs associated with the launch of the Japanese subsidiary

On the basis of annual sales of €93.3 million, up 15.6% in actual terms and 13.8% at constant currency, Amplitude Surgical recorded a gross margin of 75.6%, a decrease compared with 2015-16 mainly due to the distributor margin affected by the putting in place of substantial volumes of instruments.

The Group’s operating costs totaled €55.0 million, up 12.9%, with an improvement in the operating expenses / sales ratio of more than 150 bp, while EBITDA came to €15.5 million, up 15% compared with 2015-16. The EBITDA margin remained stable at a high level of close to 17%. Excluding the costs associated with the launch of the new Japanese subsidiary, i.e. €906 thousand, Amplitude Surgical recorded EBITDA of €16.4 million, up 21.5%, and a margin of 17.6%.

These changes reflect the human and commercial investments maintained by the Group in order to develop new territories and continue to increase its market share. At June 30, 2017, Amplitude Surgical had a workforce of 368 staff, of which 64 for SOFAB Orthopédie, vs. 297 at the end of June 2016. Moreover, the Group stabilized its R&D investments at more than €7 million, or 7.6% of sales.

The Core Operating Loss includes an increase in non-recurring provisions on inventory depreciations and legal disputes of €2.5 million. The Operating Loss was €1.0 million, compared with a loss of €8.3 million in 2015-16, as a result of:

the writing down, at June 30, 2017, of an additional provision of €2.6 million relating to the dispute with URSSAF (social security contribution collection authority) regarding tax on medical devices inherent to 2016-17 activity;
the settlement of the dispute with the Australian subsidiary’s minority shareholders, which resulted in a non-recurring profit of €1.5 million.

There was a financial loss of €8.5 million, which reflects the strengthening of the financial debt, but includes a €1.2 million non-recurring expense associated with the early repayment of a portion of the Group’s debt and a -€0.4 million currency impact essentially associated with the strengthening of the euro. The income tax level is a result of the tax rate on loss carryforwards being adjusted to 28%, contributing to a one-off expense of €2.3 million. The net loss was €12.3 million, including €7.2 million in non-recurring expenses and income, giving a core net loss of €5.1 million.

Substantial investments, notably in industrial and logistical integration

Over the 2016-17 financial year, Amplitude Surgical continued to implement an investment policy aimed at consolidating the foundations of its future growth, notably with:

a new logistic building for €4.0 million and a cutting-edge clean room for €2.5 million;
a 50% stake in SOFAB Orthopédie, an historical subcontractor, for €3.4 million;
the acquisition of the remaining minority interests in its Australian and Brazilian subsidiaries;
the installation, among new clients, of a large quantity of ancillary equipment, booked as tangible capital assets, for €6.3 million in France and €3.9 million abroad.

Reduction in WCR (substantial decrease in the WCR / sales ratio) and net cash of €42 million at end-June 2017

Amplitude Surgical has a solid financial structure, with Cash & Cash Equivalents of €41.6 million at end-June 2017.

The Group has reduced its working capital requirements, recording a working capital surplus of €6.3 million over the year. The WCR / sales ratio has seen a substantial 24-day improvement. Nevertheless, the high level of growth investments (€19.7 million during the year vs. €13.2 million in 2015-16) and the acquisition of the Australian minority interests increased Amplitude Surgical’s net financial debt to €80.0 million at the end of June 2017, vs. €49.5 million at June 30, 2016. The Group’s gearing (Net Financial Debt over Shareholders’ Equity) was thus 0.77, compared with 0.42 at the end of June 2016.

The Annual Financial Report can be found on Amplitude Surgical’s website: www.amplitude-surgical.com/fr/documentationold/documents-de-reference

Next financial press release: Q1 2017-18 sales, on Wednesday November 8, 2017, after market.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
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Tenex Health Announces Executive Team Changes

Posted On October 19, 2017 By OrthoSpineNews In Sports Medicine /

October 18, 2017

LAKE FOREST, Calif.–(BUSINESS WIRE)–Tenex Health, Inc., a privately held provider of minimally invasive solutions for chronic tendon pain, announced today that its Board of Directors has appointed William “Bill” Maya as the Company’s President and Chief Executive Officer, effective October 9, 2017. Mr. Maya will replace Bernard Morrey, M.D., who will step down as interim Chief Executive Officer and resume his previously held role as Chief Medical Officer. The Company also announced today that Leslie “Les” Cross has been appointed to its Board of Directors.

Bill Maya Appointed CEO

Mr. Maya has spent more than three decades successfully leading, innovating and growing medical device and healthcare organizations. He has unique, demonstrated experience identifying and capitalizing on business opportunities, including guiding a number of companies through critical transformation periods. He has built long-term customer, physician and distributor relationships in the domestic and international markets and has a demonstrated track record of re-focusing organizations for growth and profitability. Throughout his career, Mr. Maya has built top performing leadership teams and instilled a winning culture focused on building long-term value for stakeholders.

Most recently Mr. Maya served as Chief Executive Officer at OrthAlign, Inc. During his six-year tenure, he productively first fixed and then successfully grew the organization globally, secured multiple millions of venture capital financing and led the commercialization efforts to support the launch of its next generation product. Prior to OrthAlign Inc., Mr. Maya spent over twenty years serving as Chief Executive Officer at such innovative companies as Vestara, LLC, DataLabs, Inc., Advanced Spine Fixation Systems, Inc., and Birtcher Medical Systems. Mr. Maya received a B.S. in Biology from Saint Joseph’s College. Mr. Maya currently also serves on the Board of Directors of three other companies.

Chuck Grant, Chairman of the Tenex Health Board of Directors, said, “Bill brings more than 35 years of strong operational and market growth experience, as well as sales and distribution expansion expertise to Tenex. His extensive leadership experience in the medical device industry, coupled with his strong track record of turn-arounds and delivering results, will be invaluable to Tenex. Bill is an excellent addition to Tenex and I look forward to working with him as we execute on our strategy for future growth.”

Mr. Grant added, “The Board would also like to thank Dr. Bernard Morrey for his leadership over the past year as interim CEO while we engaged in our executive search. We appreciate his guidance and dedication.”

Mr. Maya said, “I am honored with the appointment to lead Tenex as CEO. I have spent most of my career helping medical device companies transform their operations and realize their true potential. Tenex has pioneered a safe, minimally invasive solution for chronic tendon pain that is designed to provide relief to patients and ultimately, improve their lifestyles. With over 70,000 cases performed to date and proven clinical evidence, I believe there is significant opportunity ahead for Tenex. I am excited to work with the management team, Les and the Board of Directors, and our employees to capitalize on the opportunity and unlock stakeholder value.”

Les Cross Appointed to the Board of Directors

“We are extremely pleased to welcome Les to Tenex Health’s Board of Directors,” said Mr. Grant. “Les is an accomplished business leader and experienced board member in the medical device industry. We are confident that he will add great value to our Board of Directors and that Tenex will benefit from his insights and contributions as we execute on our strategy for long-term success.”

Mr. Cross said, “I am delighted to join the Tenex Board of Directors. With over 20 million Americans suffering from tendon pain, I believe that Tenex is well-positioned to become a compelling solution for physicians and make a real difference in patient’s lives. I look forward to working with Bill and the rest of the Board as he leads Tenex through this exciting new phase of growth for the Company.”

Mr. Cross brings more than 30 years of medical device and executive experience throughout his distinguished career to the Tenex Board. Previously, Mr. Cross served as the Chairman of the Board of Directors of Alphatec Spine from 2011 to 2017. From 2012 to 2014 he also served as Alphatec Spine’s Chief Executive of Officer. Prior to 2011, Mr. Cross served as President and Chief Executive Officer of DJO Global, Inc., where he held several principal executive roles since 1995. From 1990 and 1994, Mr. Cross held the position of Senior Vice-President of Marketing and Business Development of the Bracing and Support Systems division of Smith & Nephew. He was Managing Director of two different divisions of Smith & Nephew from 1982 to 1990. Mr. Cross earned a diploma in medical technology from Sydney Technical College in Sydney, Australia and studied business at the University of Cape Town in Cape Town, South Africa. Mr. Cross currently also serves on the Board of Directors of two other companies.

About Tenex Health, Inc.

Tenex Health, Inc. develops innovative surgical instruments for the treatment of tendon pain due to repetitive motion injuries. The Company’s proprietary technology is designed to cut and remove diseased soft tissue in a minimally invasive outpatient setting. Since the surrounding healthy tendon tissue is not disturbed, patients feel less discomfort and enjoy faster recovery times versus traditional open surgical procedures.

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

Contacts

Tenex Health, Inc.
Bill Maya
949.454.7500 / 855.2 TENDON
info@tenexhealth.com
www.tenexhealth.com

Relievant Medsystems Names Ray M. Baker, M.D. as Chief Medical Officer

Posted On October 19, 2017 By OrthoSpineNews In Spine, Top Stories /

SUNNYVALE, Calif, Oct. 18, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, today announced the appointment of Ray M. Baker, M.D., as Chief Medical Officer. Dr. Baker will report to Relievant’s Chief Executive Officer, Kevin Hykes.

“Ray is an internationally recognized, highly respected clinician bringing over 30 years of pain management expertise and industry leadership to Relievant,” said Kevin Hykes, President and Chief Executive Officer of Relievant Medsystems. “His deep experience as an interventional pain management specialist, and as past president of both the North American Spine Society and the Spine Intervention Society will be instrumental in shaping the commercial introduction of the Intracept® Procedure. We look forward to his contributions as the company enters its next phase of growth.”

As Chief Medical Officer, Dr. Baker will be an integral part of the executive team at Relievant, guiding technology development, clinical research strategy, and commercial initiatives. Prior to joining Relievant, Dr. Baker served as VP & Executive Medical Director at Evergreen Health in Kirkland, WA. He brings both academic and private practice experience to the position, having previously served as a Clinical Professor and Director of Interventional Pain Services at the University of Washington. In addition to presiding over the North American Spine Society and Spine Intervention Society, he has held a number of prominent board and leadership positions within the industry, including serving as the Founding Chairman of the CMS Multi-Society Pain Workgroup, and Chairman of the UnitedHealthcare National Spine Advisory Board.

“I have consulted for Relievant since the company’s inception – the depth, experience and talent of the executive leadership team are extraordinary, and I am thrilled to be on board,” said Dr. Baker. “Throughout my time as a practicing interventionalist, I have had the opportunity to be involved with the development of a number of novel technologies. The FDA-cleared Intracept Procedure has been built on a foundation of level one evidence and clinical strength. I am acutely aware of how few options are open to these patients and am excited to be part of the team bringing this important new therapy to market.”

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN). This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain. As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com

Month: October 2017

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