SpinalCyte, LLC Receives Institutional Review Board Approval for Phase I Clinical Trial

Posted On December 14, 2016 By OrthoSpineNews In Biologics, Spine /

December 13, 2016

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today it has received Institutional Review Board approval to begin clinical trials with its dermal fibroblast cell product, CybroCell, in the treatment of degenerative disc disease. SpinalCyte is now approved to begin randomized, placebo-controlled, double-blind Phase I clinical trials.

The clinical trials will enroll 18 patients between the ages of 18 and 85 who will either be administered CybroCell alone, in combination with platelet-rich plasma (PRP) or saline only. The primary endpoint of the study will measure outcome at 12 months. Multiple preclinical trials involving rabbits demonstrated the ability of CybroCell to regenerate the nucleus of the spinal disc in an animal model of degenerative disc disease.

“Initiating this clinical trial is an important step toward commercializing our first cell therapy product,” said Pete O’Heeron, CEO of SpinalCyte. “The opportunity to relieve the pain associated with degenerative disc disease presents an enormous benefit to the effected patient population and an equally large business opportunity for SpinalCyte.”

“Lower back pain due to degenerative disc disease can be a chronic and debilitating problem for our patients,” said Carlos Manuel Ruiz Macias, M.D., principle investigator of the SpinalCyte clinical trials. “SpinalCyte’s new cell therapy is a promising option for patients who could benefit from disc regeneration.”

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 12 U.S. and international issued patents, and has filed for an additional 39 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

Investor Contact:
SpinalCyte, LLC
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com
or
Media Contact:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

RTI Surgical® Names Robert P. Jordheim Interim CEO

Posted On December 14, 2016 By OrthoSpineNews In Biologics, Spine /

December 14, 2016

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that Robert P. Jordheim, executive vice president and chief financial officer of RTI, has been named interim CEO. He succeeds Brian K. Hutchison, who informed the RTI board of directors last August of his decision to retire from his position as president and chief executive officer and step down from the company’s board of directors. The transition will be completed December 17, 2016.

Jordheim’s CFO responsibilities will be assumed on an interim basis by Wy Louw, vice president and controller of RTI. The RTI board of directors continues to actively review candidates for the permanent chief executive officer position.

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. 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
Wendy Crites Wacker, APR, 386-418-8888
Vice President, Global Communications
wwacker@rtix.com

Bioventus Enters Into New Agreement for DUROLANE®

Posted On December 14, 2016 By OrthoSpineNews In Biologics /

December 14, 2016

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has a new agreement with Galderma for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis. Financial terms of the transaction were not disclosed.

Bioventus plans to file a premarket approval application with the FDA in early 2017 to bring DUROLANE to the US market in the near future. It owns the international rights to the product and has commercialized it outside of the United States for nearly 15 years. Bioventus currently markets and sells it in more than 25 countries including Canada, Mexico, Australia and much of Europe. Galderma manufactures DUROLANE and other HA products.

“Bringing DUROLANE to the US is the next step in our strategy to offer osteoarthritis patients more choices for pain relief,” said Tony Bihl, CEO of Bioventus. “As a single-injection HA, it has improved the lives of more than one million people worldwide and we are pleased to work with Galderma to complete the process of introducing this solution to US patients.”

The addition of DUROLANE to the US portfolio for Bioventus will complement its newly launched three-injection HA GELSYN-3 and its popular five-injection HA SUPARTZ FX, giving the company an unmatched offering of options for patients, physicians and payers.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, EXOGEN and DUROLANE are registered trademarks and GELSYN-3, is a trademark of Bioventus LLC. SUPARTZ FX is a trademark of Seikagaku Corporation.

Contacts

Bioventus LLC
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Orthopaedic Institute for Children Installs EOS Imaging System for the Safe and Accurate Diagnosis of Musculoskeletal Conditions

Posted On December 14, 2016 By OrthoSpineNews In Extremities, Spine /

December 13, 2016

LOS ANGELES–(BUSINESS WIRE)–Orthopaedic Institute for Children (OIC) announced today that it now provides healthcare’s most precise and safest way to diagnose musculoskeletal conditions in children through the installation of the highly renowned EOS Imaging System (Euronext, FR0011191766 – EOSI). As the region’s first and only standalone ambulatory care provider with this technology, OIC will use the EOS Imaging System to more accurately diagnose and treat kids while limiting their exposure to radiation. The imaging system delivers extremely precise images of a child’s limbs and spine.

“With this technology now on site, patients and their families will have peace of mind knowing they have access to an imaging system that offers safe, low-dose and highly accurate exams,” said Anthony A. Scaduto, M.D., president and chief executive officer of OIC. “As many of these children suffer from complex conditions that often require frequent imaging exams, we are glad they won’t need to add the fear of radiation exposure to their already complex concerns.”

Born from a technology awarded the Nobel Prize for Physics to Georges Charpak, the EOS^® system is the first imaging solution able to simultaneously create a 2D and 3D image of the skeleton in a natural standing position with a very low radiation dose. Specifically adapted to the needs of orthopaedic surgeons and radiologists, the EOS 2D/3D^® exam allows a better accuracy of diagnosis, surgical planning, and monitoring of bone and joint diseases.

Medical imaging plays an extremely important role in the diagnosis and treatment of numerous medical conditions in children and has led to significant medical advances. There are many types (or modalities) of medical imaging procedures that are used on children – from conventional X-rays to fluoroscopy to computed tomography (CT) – and the prudent use of any is critical as children are relatively more vulnerable to radiation risks than adults. This is partly due to the fact that there is a longer life expectancy (in which to manifest potential radiation-induced health concerns) and partly because the care of children can be more complicated. EOS imaging is the pioneer in 2D/3D orthopaedic medical imaging and is the safest and most accurate technology available.

“Our entire organization is committed to delivering the best orthopaedic care to children so they can go on to lead healthy, active lives,” said OIC Medical Director Mauricio Silva, M.D. “The addition of the EOS Imaging System to our already existing technologies further provides our physicians and staff the tools they need to help make this possible.”

About Orthopaedic Institute for Children
Orthopaedic Institute for Children (OIC) was founded in 1911 as Los Angeles Orthopaedic Hospital. Focused solely on musculoskeletal conditions in children, Orthopaedic Institute for Children receives 60,000 patient visits each year. In alliance with UCLA Health and with the support of the OIC Foundation, we advance pediatric orthopaedics worldwide through outstanding patient care, medical education and research. Our locations in Downtown Los Angeles, Santa Monica, Westwood and Calexico treat the full spectrum of pediatric orthopaedic disorders and injuries. For more information, visit us at ortho-institute.org.

Contacts

Orthopaedic Institute for Children
Camille Strickland, 213-742-1501
CStrickland@mednet.ucla.edu

Courtroom-in-US-District-Court-in-Wichita-KS-brite-adjust-940x270.jpg

Arthrex Victorious in Patent Infringement Lawsuit Against Smith & Nephew

Posted On December 14, 2016 By OrthoSpineNews In Financial, Regulatory /

NAPLES, FL – December 12, 2016 – On Friday, December 9, 2016, a jury in the United States Eastern District of Texas upheld the importance of Arthrex Inc.’s innovation, issuing a verdict that Smith & Nephew, Inc. and Arthrocare, Corp. have been willfully infringing two of Arthrex’s patents on their knotless and cross-support technology. Today, a judgment was entered confirming this verdict and granting Arthrex Inc. more than $17 million in damages.

The jury found every variation and size of Smith & Nephew and Arthrocare’s HEALICOIL™ Suture Anchors, TWINFIX™ Ultra Suture Anchors, TWINFIX™ PK FT and SPYROMITE Suture Anchors, Titan Ti Suture Implants, SpeedFix Suture Implants, SPEEDSCREW™ Suture Implants, SPEEDLOCK™ Knotless Implants, SPEEDLOCK™ Hip Knotless Implants, Spartan Suture Anchors, BIORAPTOR Knotless Suture Anchors, FOOTPRINT PK Suture Anchors, FOOTPRINT Ultra, LabraLock™ P Knotless and MULTIFIX™ Knotless, all infringe an Arthrex Patent.

Arthrex will seek an injunction prohibiting Smith & Nephew and ArthroCare from further manufacturing or selling the infringing devices in the United States and will also seek enhanced damages and attorney fees as allowed by statute.

“Since its foundation, Arthrex has been committed to the mission of helping surgeons treat their patients better, and we are very appreciative for the extraordinary efforts of our trial team and the sound judgment of the jurors of East Texas which have helped Arthrex continue this mission and protect its innovative technology,” said John Schmieding, Senior Vice President, General Counsel at Arthrex.

The Arthrex patents involved are U.S. Patent No. 9,179,907, invented by Dr. Stephen S. Burkhart, Peter J. Dreyfuss and Dr. Neal S. ElAttrache and U.S. Patent No. 8,821,541, invented by Peter J. Dreyfuss and William C. Benavitz.

Arthrex, headquartered in Naples, FL, is a global leader in orthopaedic product development and medical education for orthopaedic surgeons. More than 10,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.arthrex.com.

###

Category: Corporate Press Releases

Zimmer Biomet Announces Closing of €1 Billion Senior Notes Offering and Early Settlement of Its Cash Tender Offers for Certain Outstanding Debt Securities

Posted On December 14, 2016 By OrthoSpineNews In Financial /

WARSAW, Ind., Dec. 13, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) (the “Company”) today announced that it has completed an offering of €500 million aggregate principal amount of 1.414% Notes due 2022 (the “2022 Notes”) and €500 million aggregate principal amount of 2.425% Notes due 2026 (together with the 2022 Notes, the “Euro Notes”) in an SEC registered offering. The Company used the net proceeds from the sale of the Euro Notes to pay for the debt securities identified in the table below (collectively, the “Tender Offer Notes”) purchased in its previously-announced cash tender offers (the “Offers”). The completion of the offering of the Euro Notes satisfies the financing condition to the Offers as set forth in the Offer to Purchase dated November 21, 2016 (the “Offer to Purchase”) and the related Letter of Transmittal (the “Letter of Transmittal”), each as amended by the Company’s press releases dated December 5, 2016and December 6, 2016.

The Company today also announced that it has accepted for purchase the aggregate principal amount of each series of Tender Offer Notes validly tendered and not validly withdrawn on or before 5:00 p.m., New York City time, on December 5, 2016 (the “Early Tender Deadline”), as shown in the following table. Because the aggregate purchase price for certain series of validly tendered Tender Offer Notes exceeded the aggregate purchase price (excluding accrued and unpaid interest to, but not including, the settlement date and excluding fees related to the Offers) of $1.25 billion (the “Maximum Tender Amount”), the Tender Offer Notes were accepted for purchase subject to the Acceptance Priority Levels (as defined in the Offer to Purchase) and proration, each as described in the Offer to Purchase and Letter of Transmittal. Settlement of such Tender Offer Notes accepted for purchase occurred today.

Title of Security	CUSIP Number	Acceptance Priority Level	Aggregate Principal Amount Tendered	Aggregate Principal Amount Accepted
5.750% Senior Notes due 2039	98956PAB8	1	$ 182,227,000	$ 182,227,000
4.450% Senior Notes due 2045	98956PAH5	2	$ 854,576,000	$ 854,576,000
4.250% Senior Notes due 2035	98956PAG7	3	$ 319,295,000	$ 246,583,000
3.550% Senior Notes due 2025	98956PAF9	4	$ 1,060,858,000	—
4.625% Senior Notes due 2019	98956PAA0	5	$ 171,447,000	—

Holders of Tender Offer Notes validly tendered and not validly withdrawn on or prior to the Early Tender Deadline received the Total Consideration (as defined in the Offer to Purchase), which included an early tender premium of $30 per $1,000 principal amount of Tender Offer Notes validly tendered by such holders and accepted for purchase by the Company. Accrued interest up to, but not including, today, December 13, 2016, was paid in cash on all validly tendered Tender Offer Notes accepted for purchase by the Company in the Offers. Tender Offer Notes purchased in the Offers were retired and cancelled. Validly tendered Tender Offer Notes that were not accepted for purchase pursuant to the Offers will be returned to holders.

Although the Offers are scheduled to expire at 11:59 p.m., New York City time, on December 19, 2016, because holders of Tender Offer Notes subject to the Offers validly tendered and did not validly withdraw Tender Offer Notes on or prior to the Early Tender Deadline for which the aggregate purchase price exceeded the Maximum Tender Amount, the Company has not accepted, and will not accept, for purchase any tenders of Tender Offer Notes after the Early Tender Deadline.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 regarding the cash tender offers for certain outstanding senior notes of the Company and the offering of Euro Notes of the Company. Forward‑looking statements may be identified by the use of forward-looking terms such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” and “seeks” or the negatives of such terms or other variations on such terms or comparable terminology. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see the Company’s filings with the Securities and Exchange Commission (the “SEC”). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in the Company’s filings with the SEC. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in its periodic reports. Accordingly, such forward‑looking statements speak only as of the date made. Readers of this communication are cautioned not to place undue reliance on these forward‑looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this communication.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/zimmer-biomet-announces-closing-of-1-billion-senior-notes-offering-and-early-settlement-of-its-cash-tender-offers-for-certain-outstanding-debt-securities-300377513.html

SOURCE Zimmer Biomet Holdings, Inc.

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Regenexx® Releases Patient Outcomes Application for Orthopedic Stem Cell Treatments

Posted On December 14, 2016 By OrthoSpineNews In Biologics /

BROOMFIELD, Colo., Dec. 13, 2016 /PRNewswire/ — Regenexx, a Colorado-based stem-cell-treatment network and pioneer in the invention of orthopedic stem cell injections, launched a new patient outcomes application to its website today. One of the many Regenexx differences is that it is transparent about its stem-cell-treatment results. With this new app, which is only available on the Regenexx website, you can easily see the results of what all participating Regenexx patients, not just a selected few, report regarding their outcomes following treatment.

The patient outcomes app allows you to search outcomes by body part, including ankle/foot, hand/wrist/elbow, hip, knee, shoulder, and spine. From there, you can select from a variety of outcome averages (“metrics”). For example, if you are looking at the knee arthritis, you can select specific outcomes to review, including percent improvement, average pain, average function scores (LEFS), and an additional function and pain score called the IKDC. For each body part, the app provides the number of patients who have reported outcomes, age ranges and average, BMI ranges and average, and numbers and percentages of male and female patients reporting. Each metric reviewed also includes a line graph showing reporting time points in months. Additionally, an explanation of the outcome data is provided below each graph.

Regenexx tracks almost ten thousand stem cell treated patients and actively collects outcome data via the Interventional Orthopedics Foundation Registry, the world’s largest and oldest stem-cell-treatment registry. Chris Centeno, MD, an International Expert in regenerative medicine and interventional orthopedics and founder of Regenexx, said, “No other clinic system on earth has the ability to show its patients their real time outcome data.” Dr. Centeno goes on to say, “While registry data always suffers from patients who fail to respond, the large numbers of patients being tracked allows for segmenting data in ways that smaller randomized controlled trials can’t.” This registry data is the tool Regenexx uses to provide actual patient outcomes on performance, pain, and function to anyone who wishes to read the data results.

While Regenexx has always provided outcomes reports on its website, this new app is another step forward in providing transparency on its stem cell treatments and procedures and in giving patients and potential patients a user-friendly avenue to research those outcomes.

The patient outcomes app can be accessed at http://www.regenexx.com/outcomes/.

Media Contact
Mark A. Testa
137545@email4pr.com
(303) 885-9630

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regenexx-releases-patient-outcomes-application-for-orthopedic-stem-cell-treatments-300377089.html

Orthofix Announces Appointment of Alex Lukianov to Board of Directors

Posted On December 14, 2016 By OrthoSpineNews In Spine /

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that Alexis V. Lukianov has been named to its Board of Directors. Mr. Lukianov’s appointment expands the Board to 10 directors, 9 of whom are independent directors.

With more than 30 years’ experience, and an extensive background in orthopedics, Mr. Lukianov has held senior executive positions with companies such as Medtronic SofamorDanek and Smith and Nephew Orthopaedics, where he was the director of a business unit that brought limb lengthening technology to the United States from Russia. He was the founder of and served as the Chairman of the Board and CEO of BackCare Group, Inc., a spine physician practice management company, and from 1999-2015, Mr. Lukianov served as the Chairman and CEO at NuVasive, Inc.

“We are pleased that Alex Lukianov will join our Board of Directors. As a senior experienced executive in the med-tech industry, Alex will be a valued strategic participant as we continue to focus on developing our growth opportunities,” said Ron Matricaria, Chairman of the Board.

An entrepreneur, Mr. Lukianov has served on a variety of public, private and not-for-profit boards including the Volcano Corporation, the California Health Institute, BIOCOM, and the Medical Device Manufacturers Association (MDMA).

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, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161213006261/en/

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

Source: Orthofix International N.V.

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Five ways Tom Price could change U.S. healthcare policy in a hurry

Posted On December 13, 2016 By OrthoSpineNews In Financial, Regulatory /

Dec 9, 2016 – By JULIE ROVNER

Prospective Health and Human Services Secretary Tom Price, currently the chairman of the House Budget Committee, brings a distinctive to-do list to the agency. And, if confirmed by the Senate, he will have tremendous independent power to get things done.

While he will report to the president, heads of major agencies like HHS — with a budget of more than $1 trillion for the current fiscal year — can interpret laws in different ways than their predecessors, and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” said Robert Moffit, a senior fellow at the conservative Heritage Foundation, in a statement.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said: “I don’t know if I want to brainstorm bad ideas for him to do.”

READ THE REST HERE

Amplitude Surgical: Acquisition of a 50% Stake in SOFAB Orthopédie, a Strategic Industrial Subcontractor

Posted On December 13, 2016 By OrthoSpineNews In Financial /

December 12, 2016

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

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading player on the global surgical technology market for lower-limb orthopedics, announces having acquired a 50% stake in SOFAB Orthopédie, a longstanding strategic industrial subcontractor.

Commenting on this newly-acquired stake, Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Following the construction of a logistics site and the launch of work to create our own ‘clean room’, the acquisition of a stake in SOFAB Orthopédie – an industrial subcontractor – is another strategic investment aimed at consolidating our industrial base and our supply chain within a context of the pursuance of our buoyant business growth.”

Yann Quinkal, CEO of the SOFAB Orthopédie group, adds: “This deal with Amplitude Surgical will enable us to continue our development alongside a longstanding partner that shares our vision of total quality.”

Founded in July 2007 and based near Valence in the Rhone valley, the SOFAB Orthopédie group incorporates FIRM Industrie, POLI ALPES and POLI-TECH’, three ISO 9001 and ISO 13485 certified companies specializing in the end-to-end manufacturing of implants and ancillaries, from machining to polishing and engraving. The Group employs close to 80 staff and generates annual revenue of almost €5 million, 80% of which comes from Amplitude Surgical. Yann Quinkal will continue to head this activity in close collaboration with the Amplitude Surgical teams.

Amplitude Surgical will consolidate in full SOFAB Orthopédie from the second half of 2016-17 and expects this transaction to provide a net positive contribution from 2017-18.

Next financial press release: H1 2016-17 sales, Wednesday February 15, 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. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
philippe.garcia@amplitude-ortho.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

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