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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 28-May-15

Funding
SI-Bone secured $21 million in growth capital in a round of funding led by new investor Redline Capital Management, with additional participation from all existing major investors. The new capital will be utilized to fund U.S. and European market expansion.

Regulatory
EOS imaging received CE Mark certification for its kneeEOS 3D stereo radiographic planning software intended for total knee arthroplasty procedures. The software utilizes EOS's bi-planer imaging technology and the 3D platform is based on EOS low dose 3D images and technology from OneFit Medica, a recent company acquisition. KneeEOS will launch as an online service that surgeons can utilize for simulations of patient leg alignment.

Spineart received regulatory approval from China's CFDA authority for multiple spinal fusion products including its cervical cages, plates, cage-plates, and lumbar cages. This approval allows Spineart to address 90% of the Chinese market.

VertiFlex received PMA approval from the FDA for its Superion Interspinous Spacer System. Superion is indicated for moderate lumbar spinal stenosis. The system is designed for minimally invasive, indirect decompression by expanding the distance of the spinous process on adjacent vertebra.

Product Introduction & Updates
Dymicron announced the first two human implantations of its flagship Triadyme-CTM Cervical Total Disc Replacement device. Tridyme-CTM is made of polycrystalline diamond compact (PDC), for high durability and a low coefficient of friction, and is designed with three spherical lobes seated within three non-congruent, spherical pockets to emulate natural spinal motion.

Clinical
TiGenix announced the results of its Phase I sepsis challenge trial of its Cx611, an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASCs). The study up to this point has resulted in no serious adverse events, confirming safety and tolerability of the product. The 32 enrolled patients received three doses of Cx611 in the randomized, placebo controlled, parallel group study.

Appointments
NuVasive appointed Greg Lucier as the company's Chief Executive Officer (CEO). Mr. Lucier has been serving as Interim CEO since the April 1, 2015 resignation of Alex Lukianov. Prior to NuVasive, Mr. Lucier served as Chairman & CEO of Life Technologies, which was acquired by Thermo Fisher Scientific for $16 billion in 2013.

SI-BONE appointed Laura Francis as company Chief Financial Officer (CFO) effective immediately. Prior to SI-BONE, Ms. Francis served as CFO for Auxogyn, a U.S. based life science start-up that develops diagnostic technologies for women's reproductive health.


Dental News Roundup May 2015

Earnings
DENTSPLY reported financial results for 1Q:15. Net sales were $656.3 million in 1Q:15, missing consensus estimates by 5% and representing a decrease of 10% from $730.1 million in 1Q:14, caused primarily by European market weakness and substantial currency exchange headwind. Revenue, excluding precious metals, grew 1% on a constant currency basis. Gross margin, excluding precious metals, increased to 59.1% in 1Q:15 from 57.2% in 1Q:14. All growth rates are on a reported basis except where noted.

Henry Schein reported financial results for 1Q:15. Net sales were $2.5 billion in 1Q:15, missing consensus estimates by 3% and representing an increase of 5% compared to $2.4 billion in 1Q:14. Gross margin increased to 29.0% in 1Q:15 from 28.7% in 1Q:14. The company's segments grew at: Dental +3%, Animal Health +5%, Medical +12%, Technology & Value-added Service +8% in 1Q:15 respectively. The company's International segment increased 3.2% and represented 34% of the company's total revenue in 1Q:15, declining from 38% in 1Q:14. All growth rates are on a constant currency basis and exclude affects of acquisitions.

Sirona reported financial results for its 2Q:15. Revenue was $257.3 million in 2Q:15, missing consensus estimates by 2% and representing an increase of 2% compared to $282.7 million in 2Q:14. Gross margin increased in 2Q:15 to 55.9% from 53.6% in 2Q:15. The company's segments grew at: CAD/CAM +3%, Imaging Systems (1%), Instruments +6% and Treatment Centers +2% in 2Q:15. Domestic and International revenue increased 9% and (0%) respectively for 2Q:15 compared to 2Q:14. All growth rates are on a constant currency basis.

M&A
Microbrush International acquired DentiSmart the manufacturer of the SmartView Sectional Matrix System, which is utilized in Class II dental restorations (cavities affecting proximal surfaces of molars). The transaction provides Microbrush complimentary technologies for its restorative accessories portfolio.

Regulatory
Sonendo received 510(k) clearance from the FDA for its third generation Multisonic Ultracleaning System http://sonendo.com/images-videos , utilized for root canal therapy. The device delivers broad spectrum sonic energy through a handpiece into a closed loop, fluid-based system that is designed to loosen and remove all the tissue, debris, and bacteria from the canal. The new clearance expands the system's use to include anterior and pre-molar cases in addition to posterior molars.

Product Introduction & Update
3M ESPE updated its Lava Plus High Translucency Zirconia products to offer in a disc format for open-source milling. The discs are offered in three thicknesses and are compatible with the shading system for monochrome dip or gradient shading.

OrthoAccel Technologies, Inc is seeing its own growth accelerating in response to continued demand from orthodontists and patients for safe, gentle, accelerated orthodontic treatment. Now available in 2,500 practice locations in the U.S. and Canada and growing daily, OrthoAccel's AcceleDent is the only FDA-cleared Class II medical device that has been proven to speed up orthodontic treatment by as much as 50 percent. A recent Journal of Clinical Orthodontics survey illustrates the company's dynamic growth story, stating that AcceleDent is the most common accelerated treatment technique used by orthodontists, with 62% of practices who use accelerated treatment reporting that they occasionally or routinely used AcceleDent.

Operations
DENTSPLY reached an agreement with the applicable works councils in Germany to begin their lab business restructuring that was announced in September 2014. The realigned business will increase emphasis on prosthetic materials and exit portions of the lab equipment and fabrication businesses. The company plans to implement the restructuring during the remainder of 2015 and in 2016. It will affect two sites in Germany, one which will be closed and one which will be downsized. The company expects to incur total costs in the range of $33 to $38 million.

Collaborations
3M announced its Margin Marking Software is now fully integrated with 3Shape Dental System, exocad Dental Cad and Dental Wings CAD/CAM design platforms, in addition to 3M's True Definition Scanner. With this improved compatibility, 3M aims to broaden design options.

Appointments
MicroDental Laboratories' Kim Bradshaw Passes the Reigns to Bill Johnson as Next Chief Executive Officer. MicroDental Laboratories announced the promotion of Bill Johnson to CEO and Len Liptak to President. Earlier this year Kimberly Bradshaw identified that an organizational and leadership change was prudent based on the new needs of the organization and emerging industry trends. After carefully considering her recommendations along with other alternatives, the Board of Directors agreed with Bradshaw's suggestions and fully supports her passing the reigns to Bill Johnson as Chief Executive and to Len Liptak as President. Both gentlemen served as members of her Executive Team and have been integral to the success of the Company.

OrthoAccel Technologies, Inc. announced that Len Hedge, a retired Align Technology senior executive, has joined OrthoAccel's Board of Directors. Hedge currently serves on the boards of directors for two additional dental companies, Convergent Dental, Inc. and MicroDental Laboratories. His in depth experience in the orthodontic industry includes a 14-year career at Align Technology where he served in various roles including senior vice president of business operations, vice president of operations and vice president of manufacturing.


OrthoAccel Technologies Continues Trajectory of Accelerated Growth with Over 2,500 Practice Locations

OrthoAccel Technologies, Inc., the leader in non-invasive, accelerated orthodontic treatment, is seeing its own growth accelerating in response to continued demand from orthodontists and patients for safe, gentle, accelerated orthodontic treatment. Now available in 2,500 practice locations in the U.S. and Canada and growing daily, OrthoAccel's AcceleDent is the only FDA-cleared Class II medical device that has been proven to speed up orthodontic treatment by as much as 50 percent.

A recent Journal of Clinical Orthodontics survey illustrates the company's dynamic growth story, stating that AcceleDent is the most common accelerated treatment technique used by orthodontists, with 62% of practices who use accelerated treatment reporting that they occasionally or routinely used AcceleDent.

Contributing to AcceleDent's steady increases in market share are the technology's simplicity, ease of use and patient satisfaction. Orthodontic patients simply bite down on the hands-free AcceleDent device for 20 minutes daily and the gentle vibrations of the patented SoftPulse Technology® stimulate tooth movement at the cellular level. In a recent independent study, 100 percent of patients surveyed reported that they were satisfied with their experience using AcceleDent.

"The market research clearly shows that both orthodontists and patients want accelerated orthodontic treatment and that AcceleDent is the premier choice for accelerating treatment," said Michael K. Lowe, president and CEO of OrthoAccel. "As this market continues to expand, integration of AcceleDent into orthodontic practices is primed for continued rapid growth."

Lowe said that the conversation about AcceleDent is spreading and points to the company's 30,000 Facebook fans as another indication of growing interest among patients and doctors. "Brand awareness just keeps growing as pleased patients share their AcceleDent testimonials with friends and family through social media and traditional channels," he said. To capitalize on market opportunities, OrthoAccel has doubled its sales team in the past year and expanded its operations support team, he added.

The orthodontic industry is also taking note of AcceleDent's rapid ascension, said Lowe. He notes that OrthoAccel's senior management team is comprised of executives with in-depth experience from other major dental or orthodontics companies. Lowe added that the recent addition of former Align Technology senior executive Len Hedge to the OrthoAccel board of directors is a strategic complement to an already strong group that includes Todd Cooper, president and CEO of Presbia PLC; John C. McCormick, managing director and senior member of HealthpointCapital's research and investment team; and Brian R. Smith, managing director of S3 Ventures.

Noting that there are approximately 2.8 million orthodontic case starts in the U.S. annually according to a 2013 study by Fletcher Spaght, Inc., Lowe is optimistic about AcceleDent's continued growth, particularly as orthodontic treatment among the adolescent and adult patient segments continue to grow. The American Association of Orthodontists reported a 22 percent increase in adolescent patients from 2010 to 2012, which is the most recent data available. Among adult patients during the same timeframe, there was a 29 percent increase.

"AcceleDent is ideally positioned as the perfect practice companion for treating teens and adults because one of their key objections to orthodontic treatment is length of treatment time," said Lowe. "Our goal is to become the standard of care that supports every patient in achieving the healthy, beautiful smile they have always wanted...even faster."


Musculoskeletal News Roundup 22-May-15

Earnings
Orthofix International reported financial results for 1Q:15. Net sales were $89.8 million in 1Q:15, slightly beating consensus estimates and representing a decrease of 7% compared to $100.0 million in 1Q:14. Gross margin for 1Q:15 increased to 78.5%, from 73.2% in 1Q:14. Adjusted EBITDA in 1Q:15 was $8.4 million compared to $14.9 million in 1Q:14. Adjusted EBITDA margin in 1Q:15 was 9.4% compared 14.9% in 1Q:14. The company's segments grew by: Biostim +2%, Biologics +7%, Extremity Fixation (9%) and Spine Fixation (28%) in 1Q:15 respectively. All growth rates are on a constant currency basis.

Victrex reported financial results for its first half 2015. The company's Invibio revenues were £25.9 million ($39.7 million) in 1H:15, representing no change on a constant currency basis compared to £26.9 million ($44.0 million) in 1H:14. Gross margin for 1H:15 was 88.4% compared to 87.7% in 1H:14 Victrex reported spine sales in 1H:15 were £19.2 million ($31.1 million), a decrease of 5% on a reported basis compared to 1H:14.

Funding
OrthoSpace Ltd. announced the completion of a financing transaction led by HealthpointCapital, LLC, which also includes existing investors Smith & Nephew and TriVentures. The proceeds from the transaction will facilitate the Company's continued market adoption, clinical study programs and entry into the emerging markets. The Company's flagship product, InSpace, is a disruptive technology for the treatment of severe rotator cuff tears. The terms of the transaction were not disclosed.

ConforMIS, Inc. filed an S-1 to raise up to $172.5 million through an initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined. The company intends to use the proceeds to expand the company's manufacturing capacity, sales, research and development, clinical activities, and to fund working capital and general corporate purposes.

Regulatory
IMPLANET received FDA 510(k) clearance and CE mark certification for its 3.5mm, 4.0mm and 6mm Jazz rods, which are utilized in the treatment of adolescent scoliosis and degenerative spinal disorders in adults.

Product Introduction & Update
Emerging Implant Technologies announced the first implantation of a 3D printed, individualized cervical titanium implant. The devices is laser printed from titanium alloy powder in an open diamond pattern. It features a pore size that mimics bone structure and an osteoinductive surface texture.

Collaborations
Weigao Orthopaedic and Victrex are collaborating for Victrex to supply semi-rigid spinal rod formed from PEEK-OPTIMA for Weigao's Tulip spinal stabilization system. The polymer based rods restore lumbar stability and because of the nature of dynamic stabilization may decelerate degeneration of spinal discs at adjacent levels.


ConforMIS Proposes $173M IPO

ConforMIS, Inc. filed an S-1 to raise up to $172.5 million through an initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined.

The company intends to use the proceeds to expand the company's manufacturing capacity, sales, research and development, clinical activities, and to fund working capital and general corporate purposes.

ConforMIS develops customized (individually sized and shaped) joint replacement implants through its proprietary iFit Image-to-Implant technology platform. The company's iFit platform aims to contour each implant to the patient's unique anatomy and consists of three elements: 1) proprietary algorithms and computer software to design the implants and associated patient-specific instrumentation (iJigs), 2) 3-D printing technology to manufacture the iJigs (currently in process of extending capability to manufacture certain components of customized knee implants) and 3) delivery. Presently ConforMIS offers a line of customized knee implants, however, management expects to submit an application for clearance of its iTotal Hip, the company's first customized hip replacement implant, to the FDA in 2015. The company is based in Bedford, MA, and as of April 30, 2015, had 344 full-time employees.

For the 2014 fiscal year, ConforMIS reported total revenue of $48.2 million, representing an increase of 39% on a reported basis compared to $34.6 in 2013. Gross margin increased to 36.4% in 2014 from 21.1% in 2013. As of March 31, 2015, ConforMIS' LTM revenues were $52.1 million. To date, the company has sold more than 30,000 knee implants in the United States and Europe.

Since 2004, ConforMIS has raised an aggregate of $330 million from the sale of preferred stock and the exercise of preferred stock warrants and common stock warrants and options. The company's largest shareholders include: Procific, Veron International, SGR Sagittarius, Aeris Capital, Tasik Temenggor Investments and Stanhope Investments.

The company plans to list on the NASDAQ Global Market (NasdaqGM) under the ticker symbol "CFMS". JP Morgan and Deutsche Bank are acting as Joint Lead Bookrunners on the deal, while Wells Fargo and Canaccord will serve as a Co-managers.



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