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Simplify Medical Closes $21 Million Series B Financing to Support Innovative Cervical Artificial Disc

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

July 19, 2017

SUNNYVALE, Calif.–(BUSINESS WIRE)–Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced the closing of a Series B financing of $21 million. LSP (Life Sciences Partners) led the round, with additional investment from Sectoral Asset Management and returning investor M.H. Carnegie. The new funds will be used to complete two ongoing U.S. pivotal clinical trials of the Simplify Disc studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease.

“We are gratified by the confidence investors are showing in our Simplify Disc, which is designed to be clearly viewed on MRI without the artifact that can result from metal used in typical spine implants. By avoiding the radiation that would otherwise accompany a computed tomography (CT) scan, we intend to minimize patient exposure to unnecessary radiation risk,” said Simplify Medical Chief Executive Officer David Hovda. “The new funds will enable us to develop the rigorous evidence that gets us one step closer to availability for U.S. patients in need.”

“We are very impressed with the intelligence of the Simplify Disc technology,” said LSP General Partner Dr. Fouad Azzam. “With hospitals being held to higher standards relative to complications and post-operative costs, it is important that innovations minimize patient risk. Not only does the Simplify Disc avoid substantial radiation exposure, it also avoids metal wear that has been problematic for other orthopedic devices. In addition, it offers the lowest-profile device available, opening up a broader patient population for the technology.”

While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 15 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group. For information about eligibility or enrollment in either pivotal trial, please visit http://www.simplifytrial.com/.

The Simplify Disc has received the CE Mark and has been used to treat more than 700 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

ABOUT SIMPLIFY MEDICAL

Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/.

Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications, Inc.
Michelle McAdam, 949-545-6654
michelle@chronic-comm.com

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EOS imaging Reports 16% Revenue Growth for the First Half 2017

Posted On July 18, 2017 By OrthoSpineNews In Financial /  

July 18, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), the pioneer of orthopaedic medical imaging, 2D/3D, today announced its (non-audited) consolidated revenue for the first semester ended June 30, 2017.

Marie Meynadier, Chief Executive Officer of EOS imaging, commented: “We continue to experience positive commercial dynamics in the EMEA and Asia-Pacific regions. This was a key driver of our performance during the first half of 2017, in line with our global market expansion strategy. We also benefitted from the strong growth of EOS system service contracts, which contributes to the recurring revenue component of our business. In North America, we have appointed Mike Lobinsky to the newly created position of President North America. In this role, he will lead our global North American operations, providing a stronger leadership presence with a focus on accelerating commercial activities, particularly in the U.S., which is one of the most important markets for the Company. Based on the strength of our business in the EMEA and Asia-Pacific, along with our recent initiatives to invigorate the activity in North America, we are confident that we will see an acceleration in global adoption of the EOS solutions.”

  • Revenue for the First Half 2017
€ millions H1 2017 H1 2016 % change
Equipment sales 13.15 11.45 +15%
As a % of total revenues 80% 81%
Sales of maintenance 2.83 2.22 +28%
As a % of total revenues 17% 16%
Sales of consumables and services 0.49 0.46 +4%
As a % of total revenues 3% 3%
Total revenues 16.46 14.14 +16%
Unaudited data

In the first half of 2017, the Company generated a revenue of €16.5 million, up 16% compared to the first half of 2016. The Company sold 34 EOS® systems during the first half of the year, compared to 28 systems in the same period last year. Sales of maintenance contracts increased by 28% to €2.84 million, reflecting the continued growth of the installed base of EOS systems under contract.

The increase in revenues over the first half of 2017 was driven by strong sales in the EMEA and Asia-Pacific regions, partially offset by lower sales in North America, related to an operational reorganization.

€ millions H1 2017 H1 2016 % change
EMEA 7.39 5.36 +38%
North America 5.74 7.66 -25%
Asia-Pacific 3.34 1.12 +197%
Total revenues 16.46 14.14 +16%
Unaudited data

Revenue grew by 38% in EMEA, primarily driven by results from the United Kingdom and France, where the Company recently installed its 50th EOS system, demonstrating its ability to achieve a significant adoption in its target market.

Revenues tripled in Asia-Pacific, reflecting rapid adoption of the EOS system, particularly in the Chinese and Australian markets.

In North America, revenues declined by 25%, as the Company continued to expand its installed base, predominantly in its existing network of client hospitals.

  • Revenue for the Second Quarter 2017
€ millions 2017 2016
Q1 Q2 Q1 Q2
Equipment sales 5.47 7.67 4.09 7.36

As a % of total revenues

 77% 82% 76% 83%
Sales of maintenance contracts 1.40 1.43 0.99 1.23

As a % of total revenues

 19% 15% 19% 14%
Sales of consumables and services 0.26 0.23 0.24 0.22

As a % of total revenues

 4% 3% 5% 3%
Total revenues 7.13 9.34 5.33 8.82
Unaudited data

In the second quarter of 2017, EOS imaging achieved revenue of €9.34 million, up 6% compared to the second quarter of 2016. The Company sold 20 EOS systems in the quarter and continued to increase in the installed base of EOS systems under maintenance contracts.

About EOS imaging

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

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

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

Next press release: 2017 Half-Year Results, September 8, 2017 (after market close)

Contacts

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

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Materialise NV to Report Second Quarter 2017 Earnings on Tuesday, August 8, 2017

Posted On July 18, 2017 By OrthoSpineNews In Financial /  

July 18, 2017

LEUVEN, Belgium–(BUSINESS WIRE)–Materialise NV (NASDAQ:MTLS), a leading provider of additive manufacturing software and of sophisticated 3D printing services, today announced that it will release financial results for the quarter ended June 30, 2017 on Tuesday, August 8, 2017 at 6:30 a.m. ET/12:30 a.m. CET.

Senior management will hold a conference call to discuss the second quarter 2017 financial results on the same day, Tuesday, August 8, 2017, at 8:30 a.m. ET/2:30 p.m. CET. To access the call, please dial in at least 10 minutes prior to the start time. Dial-in numbers for the conference call are as follows:

  • U.S. Dial In: 844-469-2530
  • International Dial In: 765-507-2679
  • Passcode: 45016167

A live audio webcast will be accessible through http://investors.materialise.com. The webcast of the conference call will be archived on the company’s website for one year.

About Materialise

Materialise incorporates more than 25 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise’s open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines one of the largest groups of software developers in the industry with one of the largest 3D printing facilities in the world. For additional information, please visit: www.materialise.com.

Contacts

Investor Relations
LHA
Harriet Fried, 212.838.3777
hfried@lhai.com

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Anika Announces $5 Million Milestone Payment from U.S. Commercial Sales of MONOVISC

Posted On July 18, 2017 By OrthoSpineNews In Financial, Top Stories /  

July 17, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that it will receive a $5 million milestone payment under the terms of the Company’s license agreement with its U.S. commercial partner. The milestone payment was triggered by MONOVISC® achieving $100 million in U.S. end-user sales within a consecutive 12-month period at the end of June 2017. The Company will recognize this milestone payment as revenue in the second quarter of 2017.

“This significant commercial milestone reflects a strong 12 months of growth in U.S. end-user demand for MONOVISC, especially in the second quarter of 2017,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “We are proud of MONOVISC’s growth and success in the U.S., and we remain focused on the global expansion of MONOVISC to drive future growth.”

The Company also announced preliminary revenue for the second quarter of 2017. Anika expects total revenue growth for the second quarter of 2017 to be in the range of 23% to 26% year-over-year, including licensing, milestone and contract revenue of approximately $5 million as a result of the milestone payment announced today. The company will provide a complete update on its second quarter 2017 financial results on July 26, 2017.

About MONOVISC

MONOVISC is Anika’s second-generation hyaluronic acid-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expectations regarding its financial results for the second quarter of 2017, which preliminary results were announced herein. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer
781-457-9000
or
For Media Inquiries:
Pure Communications, Inc.
Sonal Vasudev
917-523-1418
sonal@purecommunicationsinc.com

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Implanet Announces H1 2017 Revenue

Posted On July 18, 2017 By OrthoSpineNews In Financial /  

July 18, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its revenue for the second quarter and first half to June 30, 2017.

In € thousands – IFRS* 2017 2016 Change
Total 1st quarter revenue 2,048 1,988 +3%

2nd quarter
Spine (JAZZ) 1,337 1,175 +14%
Knee + Arthroscopy 734 932 -21%
Total 2nd quarter revenue 2,071 2,107 -2%

1st half
Spine (JAZZ) 2,404 2,012 +19%
Knee + Arthroscopy 1,716 2,082 -18%
Total 1st half revenue 4,119 4,094 +1%

*Unaudited data

In H1 2017, Implanet recorded stable revenue (+1% growth) of €4,119 thousand.

JAZZ® sales were up 19% to €2,404 thousand, and now account for 58% of total revenue (vs. 49% in 2016), offsetting the 18% decrease in sales of the Knee/arthroscopy range to €1,716 thousand.

JAZZ® sales increased by +24% to €790 thousand in France and +101% to €553 thousand in the rest of the world over the first six months of the year.

In the rest of the world, sales were strong – buoyed by the impact of continued strength in Italy, the UK and in Spain, by the Q1 launch of JAZZ® in Australia, as well as initial sales in Germany, the largest European spine market.

In the USA, sales were stable at €1,059 thousand. Continued recruitment and training of larger and more experienced sales agents and distributors (longer than initially planned) will help us resume growth in the upcoming quarters.

In markets where the Company operates directly, the adult degenerative bone disorder segment – now a priority segment – saw sales increase by +34% to €695 thousand, thus accounting for 38% of usage (vs. 31% in H1 2016).

Altogether over the first half of the year Implanet sold 4,641 JAZZ® implants (vs. 3,118), a volume growth of 49% representing 66% of total number of JAZZ® implants sold in 2016.

As anticipated, arthroscopy sales continued to decrease, as a result of the decision to gradually cease the distribution of these products, along with persistent difficulties with the Brazilian distributor. However, the Madison sales (total knee prosthesis developed by Implanet) were stable.

Ludovic Lastennet, CEO of Implanet, says: “We are continuing to refocus on our core business, as shown by the growth in JAZZ® sales in spine surgery. We accelerated our penetration of the degenerative bone disorder market in France and in the United States, larger and less seasonal, which should gradually enable us to better smooth out our sales quarter by quarter. Overall, during the first six months of this year we have already sold more than 66% of the total number of JAZZ® implants sold in 2016. Regarding our Knee activity, as mentioned in our first-quarter revenue release, we expect activity to stabilize during the second half of 2017, the gradual end of the distribution of Arthroscopy implants having been finalized. Confident in our ability to continue expanding our JAZZ® technological platform on all our markets over the coming quarters and costs savings, we should observe an improvement in our operating profit from the next financial publication.”

As a reminder, IMPLANET will host a Conference Call in French at 12 :30pm EST. To access the Conference Call, you need to dial-in the following number: + 33 (1) 70 77 09 30 and follow instructions thereafter.

Next financial press release: results for the 1st half of 2017, on September 19, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Euronext™ Growth market in Paris.

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

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ApiFix Closes Spanish Distribution Deal with Acuna-Fombona

Posted On July 18, 2017 By OrthoSpineNews In Spine /  

MISGAV, Israel, July 18, 2017  /PRNewswire/ — Medical device company ApiFix, a portfolio company of The Trendlines Group (SGX: 42T; OTCQX: TRNLY), announced it inked an exclusive distribution deal in Spain with Acuna-Fombona, a distributor of Spain and Portugal. The first scoliosis correction surgery was performed in Hospital Universitari Sagrat Cor, Barcelona (Spain)Hospital, Spain by Dr. Juan Carlos Olaverri.

ApiFix has developed a minimally invasive, non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). ApiFix improves the quality of life of patients who undergo scoliosis surgery, saves hospitalization and OR time, and costs substantially less than standard scoliosis surgery.

“When Acuna Fombona learned about the ApiFix system, we immediately recognized that the technology is a game-changer for AIS patients. We are thrilled to exclusively represent ApiFix with their non-fusion solution to surgeons and patients alike,” stated Acuna-Fombona CEO, Sergio Fombona

Current scoliosis surgical correction is a highly invasive, lengthy surgical procedure involving fusion, and resulting in a rigid spine with long recovery period. The ApiFix system is a market disruptor with its minimally invasive, non-fusion spinal implant system, inserted in a short procedure, followed by a brief recovery period, and maintains spine flexibility.

ApiFix CEO Eran Feldhay, M.D. remarked: “We are excited to continue our expansion in Europe and to add Spain to the growing list of European countries where we distribute and perform surgeries with the ApiFix system. The Spanish market is important to us and we are proud to offer our products to Spanish AIS patients.”

About ApiFix

ApiFix is an innovation-driven medical device company focused on providing less invasive solutions for scoliosis patients. ApiFix’s leading product for non-fusion treatment of adolescent idiopathic scoliosis (AIS) is used today in Europe. ApiFix is led by a team of highly-regarded spine surgeons and veteran spine specialists. The company has CE clearance and is marketed in Germany, Italy, Greece, The Netherlands and Israel.

ApiFix principals will attend the annual meeting of the Scoliosis Research Society, (SRS) in Philadelphia, USA on September 5-8 to present the ApiFix system, clinical cases and their follow-up to potential users from all over the world.

Contact:  Saar Wollach, ApiFix Sales & Marketing Manager, +972-54-4511512, Philadelphia saar@apifix.com

 

SOURCE ApiFix & Acuna Fombona

Related Links

http://www.apifix.com

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EIT Emerging Implant Technologies Announces 510(k) Approval from the FDA for Full 3D Printed Cage Portfolio and Begins Commercialization in the U.S.

Posted On July 18, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.

EIT Cellular Titanium® is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize bone ingrowth. Due to the availability of metal 3D printing Selective Laser Melting (SLM) technology and proprietary post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration. This EIT Cellular Titanium® structure has been applied in the complete ALIF, TLIF, PLIF and Cervical implant line, and clinical case studies and retrieval analysis demonstrate extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short time frame.

EIT Cellular Titanium® Interbody cages target for Smart Spinal Fusion™ in combining an osteo influential scaffold with designs to address spinal alignment. The implants have been used in over 10,000 cases in over 15 countries including Germany, France, Australia, Korea and the Netherlands. With the milestone of this 510(k) approval, EIT is moving towards full commercialization effective immediately.

Guntmar Eisen, Co-Founder and CEO for EIT says “This is a major milestone for EIT. We look forward to bringing our unique technologies to the United States and partnering with top tier surgeons and institutions to bring the best results to patients that are in need of these devices.”

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 10.000 EIT cases have been performed in over 15 markets globally.

 

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EOS imaging Appoints Pierre Schwich as Chief Financial Officer

Posted On July 17, 2017 By OrthoSpineNews In Financial, Top Stories /  

July 17, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, today announced the appointment of Pierre Schwich as Chief Financial Officer (CFO), effective immediately.

Marie Meynadier, CEO of EOS imaging, says: “We are pleased to welcome Pierre to our team. His extensive experience with healthcare and technology growth companies, listed in France and in the U.S., will contribute to the ongoing expansion of our business. He joins us at a key stage of our development and his skills will be extremely valuable as we execute on our growth strategy.”

Pierre Schwich brings over 20 years of experience in Financial Management at high growth, public and private companies in the healthcare and technology sectors. Before joining EOS imaging, he was CFO of Pharnext, where he successfully led the company’s initial public offering. He was previously Financial and Legal Director of Oceasoft, a company specialized in connected sensors, and CFO of Cellectis where he contributed to a private placement with U.S. investors. Pierre was also Deputy CEO, in charge of finances, of Genesys Conferencing, a public company listed in Paris and on the NASDAQ, with a strong activity in the U.S.

After graduating from the MinesParisTech Engineering School, Pierre began his career in the industrial sector (Corning, Danone, Hewlett-Packard) before turning to Private Equity, as Investment Director at 3i, then General Secretary of Siparex. He has developed an extensive experience in mergers and acquisitions, fund raising, LBO and business transfer operations, along with financial and administrative team management.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Euronext GROWTH markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

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

Contacts

EOS imaging
Pierre Schwich
CFO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent
Ph: +33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
Press Relations
Annie-Florence Loyer
Ph: +33 (0)1 44 71 00 12 / + 33 (0)6 88 20 35 59
afloyer@newcap.fr
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
Ph: 646-536-7006
jzimmerman@theruthgroup.com

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North America Will Remain Dominant in the Global Spinal Cord Stimulators Market: Future Market Insights

Posted On July 17, 2017 By OrthoSpineNews In Financial, Neuro /  

VALLEY COTTAGE, New York, July 17, 2017 /PRNewswire/ —

Introduction of affordable devices would pave huge opportunities for the global spinal cord stimulators market across developing economies. Customized spinal cord stimulators as per the requirements of an individual is expected to offer higher growth potential for leading market players. Specialists in healthcare settings are more likely to prescribe devices that are smaller in size, owing to their easy implantation and less painful surgical procedure.

     (Logo: http://photos.prnewswire.com/prnh/20161020/430874LOGO )

In terms of value, an impressive 6.4% CAGR is estimated for the global spinal cord stimulators market by a report of Future Market Insights (FMI). In 2017, the market will account for nearly US$ 2,000 Mn in revenues; by 2027 this number is estimated to reach US$ 3,568.2 Mn. Growth of the market is primarily attributed to under penetration of potential market.

Request a Sample Report with Table of Contents and Figures: http://www.futuremarketinsights.com/reports/sample/rep-gb-2030

Spinal Cord Stimulators‘ Ability of Reducing Opioid Analgesics Addiction to Drive the Market Growth

Majority of patients with chronic pain are increasingly depending upon opioid analgesics; however spinal cord stimulators is capable of reducing this addiction to a great extent. Entry of additional competitors in the market is expected to increase awareness about effectiveness of spinal cord stimulators. Spinal cord stimulators are comparatively more cost-effective than conventional medical management (CMM). Leading companies in the market are taking initiatives in improving technology for spinal cord stimulators. The aforementioned factors are estimated to drive growth of the global spinal cord stimulators market.

However, spinal cord stimulators have little access to evidence-based data in order to confirm effectiveness of these devices for management of chronic pain. Clinical validation of spinal cord stimulation is based on observational data, instead of verified data. This had led several private insurance companies to refuse reimbursement of costs, which in turn is impeding the market growth. In addition, complications associated with spinal cord stimulators, such as paresthesia- characterised by burning sensation, is further expected to restrain growth of the global spinal cord stimulators market.

Preview Analysis on Global Spinal Cord Stimulators Market Segmentation End User – Hospitals, Ambulatory Surgical Units, Clinics; Application – Failed Back Surgery Syndrome, Complex Regional Pain Syndrome, Ischemic Limb Pain, Others; Product Type – Rechargeable, Non-Rechargeable: http://www.futuremarketinsights.com/reports/spinal-cord-stimulator-market

Rechargeable Spinal Cord Stimulators will Remain Sought-After Product in the Market

In terms of value, rechargeable spinal cord stimulators are expected to remain sought-after product in the market. Revenues amassed from sales of rechargeable spinal cord stimulators are expected to reach US$ 2,530.4 Mn by 2027-end. In addition, sales of non-rechargeable spinal cord stimulators are anticipated to expand at 4.6% CAGR through 2027. Factors such as low battery life, and requirement of surgery for replacement of battery are restricting adoption of non-rechargeable spinal cord stimulators across the globe.

Application of spinal cord stimulators will remain highest in failed back surgery syndrome (FBSS), with sales estimated to surpass US$ 1,000 Mn in 2017. In addition, complex regional pain syndrome (CRPS) is projected to be the second-fastest growing application of spinal cord stimulators in the market. In terms of value, sales of spinal cord stimulators in CRPS are estimated to register 5.8% CAGR through 2027.

Adoption of Spinal Cord Stimulators to Witness Fastest Growth in Ambulatory Surgical Centres

Although hospitals will continue to be largest end-users of spinal cord stimulators, adoption will witness fastest growth in ambulatory surgical centres. Sales of spinal cord stimulators in hospitals are estimated to account for revenues worth US$ 627.9 Mn in 2017. Demand for spinal cord stimulators in ambulatory surgical centres is projected to exhibit 6.8% CAGR through 2027. In contrast, demand for spinal cord stimulators in clinics will remain sluggish in the market.

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North America will continue to remain dominant in the global spinal cord stimulators market, with sales estimated to reach nearly US$ 3,000 Mn in revenues by 2027-end. Western Europe will remain the second-largest market for spinal cord stimulators, expanding at 6.1% CAGR through 2027. In addition, markets in Eastern Europe and Japan are estimated to exhibit parallel expansion at 6% CAGR through 2027.

Key market players identified in FMI’s report include Boston Scientific Corp., Medtronic Private Limited Company, St Jude Medical LLC, Nevro Corp, Nuvectra Corporation, Stimwave, Saluda Medical PTY Limited.

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Bioventus Expands EXOGEN® Performance Program in Canada to Include All Fracture Types

Posted On July 17, 2017 By OrthoSpineNews In Biologics /  

July 17, 2017

MISSISSAUGA, Ontario–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologics, today announced it has expanded the Performance Program* for its EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1

Since 2014, the Performance Program has been in place to refund patients their out-of-pocket payment for EXOGEN if progression of fracture healing for nonunion was not shown. The company is now expanding this program in Canada to include delayed union and acute (fresh) fractures, excluding the skull and vertebrae.

“Physicians and patients have enjoyed positive outcomes from EXOGEN and the expansion of the Performance Program to include all fracture types underscores our belief in the device,” said Tony Bihl, CEO, Bioventus. “If progression of healing is not shown, we will take the device back and refund the patient associated out-of-pocket costs for it.”

Absence of healing (progression to bony union) is determined by the prescribing physician by comparing the patient’s X-rays taken prior to using EXOGEN to one taken at 120 days or later. Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve maximum adherence of 90%. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.

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. The company 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 uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

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 and EXOGEN are registered trademarks of Bioventus LLC.

*Certain restrictions apply, visit our website for full details.

1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001; 16(4):671-680.

Summary of Indications for Use: In Canada, the EU, Australia and New Zealand

EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

• Treatment of delayed union and non-unions†

• Accelerating the time to heal of fresh fractures

• Treatment of stress fractures

• Accelerating repair following osteotomy

• Accelerating repair in bone transport procedures

• Accelerating repair in distraction osteogenesis procedures

• Treatment of joint fusion

† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at www.exogen.com.

Contacts

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

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