Paxeon Reconstruction Adds the Genius Knee to its Disruptive Savings Model After Receiving FDA Clearance

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces that has received full clearance to introduce the Genius Knee to the marketplace.

In today’s orthopedic environment, it is important that companies not only provide quality products but also financially beneficial products. With that in mind, Paxeon Reconstruction has created a unique Value Solutions Program that has provided hospitals over $1.3m in savings through its first 12-months of clinical use. Physicians that have utilized Paxeon’s Total Hip Products have saved on average $1,315.00 per case.

Kyle Sineath, President of Paxeon Reconstruction said: “The addition of this total knee to our already proven hip implants is an exciting milestone for Paxeon. We look forward to adding the Genius Knee to our very successful Value Solutions Program to extend savings throughout the total joint continuum of care.”

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

 

Orthopaedic surgeons warn parents and young children about the dangers of trampolines

ROSEMONT, Ill., July 19, 2017 /PRNewswire-USNewswire/ — During the summer months, many children are drawn to indoor and outdoor trampolines for fun and physical activity. And yet, trampolines can be extremely dangerous, especially for children under age 6.

In 2015, there were more than 295,000 medically treated trampoline injuries in the U.S., according to the Consumer Product Safety Commission, including 102,943 emergency department visits.

“We want children to enjoy exercise and physical activity, especially during the summer months,” said AAOS spokesperson and Los Angeles pediatric orthopaedic surgeon Jennifer M. Weiss, MD, “but parents and caregivers should know about the dangers of trampolines and the risk for serious injury, especially in very young children. Children younger than age 6 are less likely to have the coordination, body awareness, and swift reaction time necessary to keep their bodies, bones and brains safe on trampolines.”

The dangers of trampoline use were recently highlighted when a 3-year-old Florida boy broke his femur (thigh bone) during routine jumping on a trampoline, requiring a full lower body cast, and causing him tremendous pain and discomfort.

The most common trampoline injuries are sprains and fractures resulting from falls on the trampoline mat, frame or springs; collisions with one or more jumpers; stunts gone wrong; and falls off the trampoline on the ground or other hard surface, according to CPSC.

As highlighted in the American Academy of Orthopaedic Surgeons’ position statement, “Trampolines and trampoline safety,” nearly one-third of trampoline injuries involved fractures; 60 percent of the fractures were located in the upper extremities and approximately 36 percent in the lower extremities. In addition:

Most trampoline injuries occur in the home environment, and more than 90 percent are sustained by children, usually those between the ages of 5 and 14 years. Although most injuries to children occur while they are unsupervised by parents or adults, many also occur when adults are present. More than half of injuries occur on the mat of the trampoline and three-fourths of injuries involve two or more children on the trampoline at the same time.

There is no data that shows a reduction in injury rates for trampolines outfitted with netting and/or other safety equipment.

The American Academy of Orthopaedic Surgeons recommends that parents and caregivers ensure the following to minimize and avoid trampoline injuries:

  • Do not allow children younger than 6 years of age to use trampolines.
  • Provide careful adult supervision, proper safety measures and instruction when trampolines are used for physical education, competitive gymnastics, diving training, and other similar activities.
  • Allow only one participant at a time to use a trampoline.
  • Ensure that spotters are present when participants are jumping. Somersaults or high-risk maneuvers should be avoided without proper supervision and instruction; these maneuvers should be attempted only with proper use of protective equipment, such as a harness.
  • Place the trampoline-jumping surface at ground level.
  • Ensure that supporting bars, strings, and surrounding landing surfaces have adequate protective padding that is in good condition and appropriately placed.
  • Regularly check equipment for safety conditions; discard worn or damaged equipment if replacement parts are unavailable
  • Do not rely on safety net enclosures for injury prevention; most injuries occur on the trampoline surface.
  • Remove trampoline ladders after use to prevent unsupervised access by young children.

More Information about the AAOS
With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world’s largest medical association of musculoskeletal specialists. The AAOS provides educational programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS, at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.org/AAOS1
Twitter.com/AAOS1

CONTACT: Kelly King Johnson, 847-384-4033, king@aaos.org; Sheryl Cash, 847-384-4032, scash@aaos.org

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

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

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

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

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

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

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

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

Implanet Announces H1 2017 Revenue

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

ApiFix Closes Spanish Distribution Deal with Acuna-Fombona

MISGAV, IsraelJuly 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 GermanyItalyGreeceThe 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

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

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.

 

EOS imaging Appoints Pierre Schwich as Chief Financial Officer

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