Sunday, February 24, 2019

News: Globus Medical Reports Third Quarter 2018 Results


AUDUBON, Pa.Nov. 08, 2018 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the third quarter ended September 30, 2018.
  • Worldwide sales were $169.2 million, an increase of 11.5% as reported -
  1. Third quarter net income was $35.2 million, an increase of 37.6%
  2. Diluted earnings per share (EPS) was $0.35 and non-GAAP diluted EPS was $0.39
  3. Non-GAAP diluted EPS increased 29.2% compared to third quarter of 2017
  4. Non-GAAP adjusted EBITDA was 34.1% of sales
“The third quarter marks the fourth consecutive quarter of double-digit organic growth for Globus Medical, as our U.S. Spine business continues to take market share, growing by 7.5%; our international revenue increased by 16.8%; and Emerging Technologies contributed $6.3 million," said Dave Demski, CEO.  "During the third quarter, we completed the acquisition of Surgimap®, the leading surgical planning software for spine.  The addition of Surgimap® will further strengthen Globus Medical’s ExcelsiusGPS® platform by streamlining workflow and enabling superior data analytics.  The level of adoption we are seeing by surgeons in accounts with our ExcelsiusGPS® robotic system continues to show positive momentum and the pipeline for potential robotic sales is robust."
Worldwide sales for the third quarter were $169.2 million, an increase of 11.5% over the third quarter of 2017.  Revenue from Emerging Technologies was primarily due to continued demand for our ExcelsiusGPS® robotics and navigation system.
Third quarter sales in the U.S., including robotics, increased by 10.5% compared to the third quarter of 2017.  International sales increased by 16.8% over the third quarter of 2017 on an as-reported basis and 18.5% on a constant currency basis.
Third quarter GAAP net income was $35.2 million, an increase of 37.6% over the same period last year.  Diluted EPS for the third quarter was $0.35, as compared to $0.26 for the third quarter 2017.  Non-GAAP diluted EPS for the third quarter was $0.39, compared to $0.30 in the third quarter of 2017, an increase of 29.2%.
The company generated net cash provided by operating activities of $51.8 million and non-GAAP free cash flow of $36.4 million in the third quarter, and ended the quarter with cash, cash equivalents and marketable securities of $541.6 million.  The company remains debt free.
2018 Annual Guidance
The company today issued new guidance for full year 2018 sales of $705 million and non-GAAP diluted earnings per share of $1.62.  2018 guidance was previously sales of $700 million and non-GAAP diluted earnings per share of $1.55.
About Globus Medical, Inc.
Based in Audubon, PennsylvaniaGlobus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.
Source - 
http://www.investors.globusmedical.com/news-releases/news-release-details/globus-medical-reports-third-quarter-2018-results

Sunday, February 10, 2019

News - Zavation Launches Facet Screw and Sacroiliac (SI) Screw Systems

LOWOOD, Miss.Aug. 14, 2018 /PRNewswire/ -- Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today the launch of a fenestrated Facet Screw system and a Sacroiliac (SI) Screw system.
For more information on Zavation's complete product portfolio, visit http://zavation.com/.

Monday, July 16, 2018

News: Biologics - Artoss Announces FDA Clearance to Market of NanoBone® SBX Putty



Artoss, Inc. is pleased to announce that, on October 26, 2016, Artoss GmbH received notice from the U.S. Food & Drug Administration that NanoBone® SBX Putty has been cleared to market as 510(k) K161351.

Walter Gerike, Managing Director of Artoss GmbH said, “Nanotechnology is the key technology for the 21st century and Artoss is harnessing this potential for orthopaedic surgery. In NanoBone SBX Putty, we have a product that combines Applied NanoBiology™ for bone repair with perfect handling for the surgeon.” NanoBone synthetic bone graft products have been used in Europe for ten years in approaching 400,000 clinical cases across all indications.

 James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, stated, “NanoBone technology has been in great demand by U.S. surgeons since we launched NanoBone Granules in 2015. NanoBone SBX Putty offers the same clinical performance in an easier to use presentation. We look forward to introducing this product in a variety of sizes to the U.S. market in the coming weeks.”

Contact:
Artoss, Inc.
15900 155th St.
NE Foley, MN 56329
320‐355‐4321
info@artossinc.com

Published at Orthoworld

Friday, March 16, 2018

News - Biologics:KICVentures Acquires Unique Portfolio of Synthetic Bioactive Glass for Its Newest Portfolio Company NanoFuse Biologics LLC

KICVentures acquires NanoFuse biologic platform, broadening its portfolio to serve new growth markets.
Mar 12, 2018, 12:35pm EDT
BOSTONMarch 12, 2018 /PRNewswire-PRWeb/ -- KICVentures, a Boston-based private investment firm leading in healthcare technology, announced today that it has acquired all assets of Amend Surgical Inc., offering several unique synthetic bioactive glass products and an FDA-cleared combination of demineralized bone matrix (DBM) and bioactive glass. The acquisition allows KICVentures to broaden its portfolio of biologics, positioning NanoFuse Biologics LLC to serve new markets and drive revenue growth worldwide. Amend Surgical Inc. will continue to manufacture the NanoFuse® Bioactive Matrix during the transition and focus exclusively on dental applications for the NanoFuse technology platform.

NanoFuse Bioactive Matrix is a unique and proprietary blend of DBM that combines the osteoinductive capabilities of demineralized bone with the osteostimulative properties of bioactive glass.

Results of animal studies conducted internally and by independent laboratories demonstrate that NanoFuse Bioactive Matrix performs better than other commercially available bone void filler implant preparations that include only DBM. Additionally, the calcium-based bioactive glass used in NanoFuse Bioactive Matrix allows production of an exceedingly strong interfacial bond between the graft and adjacent bony tissue within minutes.

"The NanoFuse matrix technology is the next generation of biologics, which, unlike any biologic on the market, offers surgeons the synergistic combination of bioactive glass and demineralized allograft bone in a single product," said KICVentures Founder and CEO, Orthopedic Surgeon Dr. Kingsley R. Chin. "The NanoFUSE matrix will come in a variety of configurations, offered as either a combination synthetic plus DBM or fully synthetic product - both of which KICVentures has the exclusive global rights to."

About KICVentures 
kicventures.com [KICVentures] is a private investment company founded in 2005 by Harvard-trained Orthopedic Surgeon & Professor Dr. Kingsley R. Chin, who brings unique experience at the intersection of medicine, business and information technology. KICVentures is equipped with a strong advantage in identifying niche healthcare opportunities, headquartered in Boston, Mass.


SOURCE KIC Ventures

Tuesday, May 16, 2017

News - Biologics: curasan launches CERASORB(R) Ortho Foam in US Orthopedics Market

- Successful first implantation case with advanced bone graft material
- Entry into biggest orthopedics market worldwide

Kleinostheim, Germany/Research Triangle Park, USA, 11 May 2017 - curasan Inc., the US-subsidiary of curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, today announced the first implantation of their CERASORB(R) Ortho Foam advanced bone graft product signaling curasan's entrance in the US orthopedics market. The United States orthopedics market, specifically for bone grafting products, is the largest market globally with annual market potential of over $800 million USD.

Foam Header.png
CERASORB(R) Ortho Foam was used in a challenging knee arthrodesis case performed by Dr. Divakar Krishnareddy at Los Angeles Community Hospital in Los Angeles, California. Dr. Krishnareddy commented on the product: "It's exciting to see a product that has both excellent handling and strong clinical evidence become available in the USA. CERASORB(R) Ortho Foam's handling is very easy to adapt to underlying anatomy while preventing leaving large gaps allowing graft placement where you need it."

"curasan has a strong 20 plus year history of delivering novel and highly effective materials for the bone regeneration market. With numerous patents, peer-reviewed clinical studies, and robust on-going research and development and clinical programs, we provide cost-effective and clinically proven orthobiologic solutions that integrate seamlessly in the operating room," said M. Shane Ray, President of curasan, Inc. "We are excited at entering the orthopedic market here in the United States and look forward to working with our sales partners to provide advanced biomaterials to our surgeon customers throughout the USA".
 

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan's innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.



Contact: 
Ingo Middelmenne 
Head of Investor Relations 
Tel. +49 6027 40900-45 
Fax +49 6027 40900-39 
Andrea Weidner 
Head of Corporate Communications 
Tel. +49 6027 40900-51 
Fax +49 6027 40900-39 

Published at Yahoo Finance News

Sunday, March 26, 2017

News - Device: FIRST SURGERY AT CHESAPEAKE REGIONAL MEDICAL CENTER

Z-Medical is pleased to announce the first surgery at Chesapeake Regional Medical Center using the MIS Z-Pedicle Screw System.


This month Grant A. Skidmore, MD, a neurosurgeon from Tidewater Virginia performed his first implantation of the Z-Medical, MIS Z-Pedicle Screw System, at Chesapeake Regional Medical Center. “The system offers unique advantages that facilitated more accurate placement of the screws and easier assembly of the device,” said Dr. Skidmore.


First Surgery


While Dr. Skidmore utilized the system in an open lumbar 4-5 procedure, he sees the tremendous value of using the system in MIS fracture cases”.

Jim Talbert, US Distributor at Z-Medical GmbH + Co. KG, remarked on the advantages and benefits of the MIS Z-Pedicle Screw System: “The MIS Z-Pedicle Screw System was designed for a straight forward approach and to reduce surgical steps in a minimally-invasive or open trauma or spondylolisthesis procedure. The preloaded set-screw makes it faster and easier with fewer problems (no cross-threading or tulip splay). The multifunctional system and innovative implant design reduces the OR time, minimizes potential risks, and offers a wide range of treatment options.



About the MIS Z-Pedicle Screw System

The MIS Z-Pedicle Screw System and the pre-sterilized implants offer surgeons an ideal solution for their indication specific needs. The innovative screw design with only one instrument tray enable them to efficiently and cost effectively address the most common pathologies. It was specifically designed for a minimally-invasive approach for less tissue disruption, blood loss and trauma but finds its application due its advantages also in open procedures. It is approved for Degenerative, Trauma, Tumor and Deformity application.

Alignment after surgical correction of spondylolisthesis, reduction in fracture- and the derotation in scoliosis treatments are achieved directly with the lengthening shaft, pre-assembled set-screw, the long reduction thread and the especially designed uniplanar fracture- and deformity screws.



About Z-Medical

Based and founded in Tuttlingen in 2010, Z-Medical® GmbH + Co. KG is a privately financed and held medical device company that designs, develops, manufactures and markets innovative implants and surgical instruments in the section of Spine, Hand & Foot and Arthroscopy. The company's U.S. subsidiary was established in Atlanta, Georgia, in August 2015. Z-Medical implants stand for precision, are single sterile packaged and ready for surgery.


For further information about Z-Medical GmbH + Co. KG, the MIS Z-Pedicle Screw System or distributor opportunities please contact:

Mr. Jim Talbert
US Distributor

Mr. René Rothacker
Director International Business Development / US Operations

News - Biologics: Additive Orthopaedics Announces the Launch of a Multi-Centered Clinical Study Measuring Bone In-Growth into their 3D Printed Bone Segments

ITTLE SILVER, N.J., March 23, 2017 /PRNewswire/ -- Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that it has kicked off a multi-centered clinical study to measure bone in-growth into their 3D printed bone segments.


According to Brian McLaughlin, VP of Engineering, "Our unique variable honeycomb lattice structures have already shown tremendous post-operative success and potential bone in-growth as compared to current allograft wedges from which we have seen evidence of resorption and subsequent loss of correction.  For our lattice designs, we have aimed to optimize the shape, structure and porosity to closely mimic bone and take full advantage of the well-studied bone healing benefits of additively manufactured lattice structures and surfaces."

AddBone™

Bone Growth With 3D Printed Technology


The Company has implanted over 200 individual devices since it's first full commercial product launch at the end of 2016 and has recently closed a Series A Round of $1M.  

About Additive Orthopaedics, LLC. 
Additive Orthopaedics is an early stage orthopaedic company focused on the integration of advanced manufacturing and biologics for the benefit of a better patient outcome. 




Contact:  
Greg Kowalczyk 
732.882.6633  


Published at PRNewsWire