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

Tuesday, March 7, 2017

News - Biologics : Synergy Biomedical Receives CE Mark for BIOSPHERE PUTTY

COLLEGEVILLE, Pa.--()--Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced today that it has received CE Mark clearance in the European Union for its next generation bone graft, BIOSPHERE PUTTY.
“Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling”
Originally launched in the U.S. in 2013, BIOSPHERE PUTTY is a synthetic bone graft product that utilizes a unique form of bioactive glass in combination with a moldable phospholipid carrier. Based on the Company’s patented BioSphere Technology, BIOSPHERE PUTTY has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range.
“Since its introduction, BIOSPHERE PUTTY has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
Picture
BioSphere® Technology : A New Form of Bioactive Glass with Improved Bone Healing
Under its cleared European indication, BIOSPHERE PUTTY is intended to be used as a bone graft material for filling bony voids or gaps of the skeletal system. This includes the use of the product for interbody and posterolateral fusion, and general bone defect filling in the extremities and pelvis. The product may be used alone or in combination with autograft or allograft.
Picture“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. BIOSPHERE PUTTY is an elegant bone graft solution that is based on scientifically valid principles,” said Erik Westerlund MD, FACS, Director of the Ortho-Neuro Integrated Spine Surgery Program at St. Francis Hospital in the U.S. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with BIOSPHERE PUTTY over the past two years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”
BIOSPHERE PUTTY is the first of several bone graft products being developed by Synergy Biomedical that utilize patented bioactive glass spheres that have been shown to improve the bone healing potential of bioactive glass. BIOSPHERE PUTTY provides surgeons with a moldable bone graft material that is easy to use and compatible with a variety of bone grafting techniques.
About Synergy Biomedical, LLC
Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial based products to the orthopaedic and spinal markets. The Company’s BioSphere Technology represents a unique approach to advancing bone graft technology, and improving bone healing and patient outcomes.

Contacts

Synergy Biomedical, LLC
Mark Borden, Ph.D.
President/CEO
484-902-8141

Published at BusinessWire

Sunday, March 5, 2017

News - Finance : Globus Medical Reports Full Year and Fourth Quarter 2016 Results

AUDUBON, PA, February 27, 2017: Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the fourth quarter and year ended December 31, 2016.
Fourth Quarter
  • Worldwide sales increased 6.3% as reported to $151.6 million, or an increase of 6.5% on a constant currency basis
  • Fourth quarter net income was $24.3 million, or 16.0% of sales
  • Diluted earnings per share (EPS) were $0.25
  • Non-GAAP diluted EPS were $0.31
  • Non-GAAP adjusted EBITDA was 37.7% of sales
Full Year 2016
  • Worldwide sales increased 3.5% as reported to $564.0 million, or an increase of 3.8% on a constant currency basis
  • Net income for the year was $104.3 million, or 18.5% of sales
  • Diluted EPS were $1.08
  • Non-GAAP diluted EPS were $1.19
  • Non-GAAP adjusted EBITDA was 37.4% of sales
 
David Paul, Chairman and CEO said, “Fourth quarter sales were $151.6 million, a year-over-year increase of 6.3%. Despite our increased spending in support of our pending robotics and trauma launches, our adjusted EBITDA margins was an outstanding 37.7%. We also delivered EPS of $0.25 and non GAAP EPS of $0.31.

“During the fourth quarter, we continued to make progress with product development, sales force development and integration of Alphatec’s international business. We also further expanded our in-house manufacturing capacity. We are proud of our innovation and product development efforts, which resulted in a total of 17 new product launches in 2016. We have addressed our sales force expansion challenges and are optimistic that we will return to more robust growth rates in the second half of 2017. We also remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”
Fourth quarter sales in the U.S. decreased by 2.7% compared to the fourth quarter of 2015, primarily due to one less selling day in the fourth quarter of 2016. International sales increased by 109.0% over the fourth quarter of 2015 on an as reported basis and 111.8% on a constant currency basis.
Fourth quarter GAAP net income was $24.3 million, a decrease of 35.4% over the same period last year resulting from the one-time positive net income impact of $7.6 million in 2015 due to the settlement of outstanding litigation. Diluted EPS for the fourth quarter was $0.25, as compared to $0.39 for the fourth quarter 2015. Non-GAAP diluted EPS, which removes the impact of this litigation and acquisition related expenses, for the fourth quarter was $0.31, compared to $0.32 in the fourth quarter of 2015.
The company generated net cash provided by operating activities of $51.9 million and non-GAAP free cash flow of $37.7 million in the fourth quarter. Cash, cash equivalents and marketable securities ended the quarter at $350.8 million. The company remains debt free.
The company plans to request an extension to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 by filing Form 12b-25, Notification of Late Filing with the Securities and Exchange Commission. The company concluded it is not able to compile all information necessary to complete its Form 10-K by March 1, 2017 without unreasonable effort or expense. The company anticipates filing its Form 10-K for the fiscal year ended December 31, 2016 within the extension period.
2017 Annual Guidance
The company projects 2017 full year sales of $625 million and and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2016 fourth quarter and full year results with the investment community at 5:30 p.m. Eastern Time today. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.
The call will be archived until Monday, March 6, 2017. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940-2658.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company 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.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, Adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, changes in the fair value of contingent consideration in connection with business acquisitions and other acquisition related costs, and provisions for litigation, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Our management also uses Adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections. In addition, for the periods ended March 31, 2016 and for other comparative periods, we also define the non-GAAP measure of Free Cash Flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Furthermore, we define the non- GAAP measure of sales on a constant currency basis as the current and prior period sales translated at the same predetermined exchange rate. We believe that sales on a constant currency basis provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Adjusted EBITDA, Free Cash Flow and sales on a constant currency basis are not calculated in conformity with U.S. GAAP. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of Adjusted EBITDA, Free Cash Flow, and sales on a constant currency basis may differ from that of other companies and therefore may not be comparable.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forwardlooking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidlydevelop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800