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

News - Device: SeaSpine® Announces Full Commercial Launch of Vu a∙POD™ Prime NanoMetalene® System

CARLSBAD, Calif., Jan. 31, 2017 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of its Vu a•POD Prime NanoMetalene System.

The Vu a•POD Prime NanoMetalene System features a zero-profile, standalone anterior lumbar interbody device that can be configured in a variety of footprint and lordosis combinations to accommodate an individual patient’s pathology. The Vu a•POD Prime NanoMetalene System offers multiple fixation options for maximum versatility and adds to SeaSpine’s growing portfolio of offerings featuring proprietary NanoMetalene technology.
“The new lordosis options enable me to better recreate the patient’s natural alignment.  These features, particularly when combined with the NanoMetalene technology, should speed the healing process and improve long-term outcomes,” stated Dr. Nilesh Patel, an orthopedic surgeon practicing at Beaumont Hospital in Dearborn, MI.

NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.

Additionally, Vu a•POD Prime NanoMetalene implants are delivered individually sterile-packaged and ready-to-use.  This packaging solution is designed to facilitate configurations tailored to address individual surgeon preferences, while simplifying hospital processing requirements and inventory management. 

NanoMetalene, SeaSpine and the SeaSpine logo are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and other countries.  Vu a•POD Prime is a trademark of SeaSpine Orthopedics Corporation or its subsidiaries. PEEK-OPTIMA is a registered trademark of Invibio and is used by SeaSpine under license.

About SeaSpine

SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal fusion hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes and cellular grafts that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal fusion hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development allows SeaSpine to offer our surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.


Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the versatility of the Vu a•POD Prime NanoMetalene System; its ability to better recreate patient anatomy; the benefits of NanoMetalene technology and products; the benefits of sterile-packaged products; and whether new lordosis options, alone or when combined with NanoMetalene, will speed the healing process and improve long-term outcomes.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products, including the Vu a•POD Prime NanoMetalene System, to perform as designed and to meet clinical needs when implanted in patients; the lack of clinical validation of newly launched products, including the Vu a•POD Prime NanoMetalene System; the Company’s ability to invest adequately in the commercialization of its products, including new products such as the Vu a•POD Prime NanoMetalene System, and the risk of excess inventory in the event demand for new products is less than the Company’s expectations; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; other difficulties and delays in launching new products; the inability to apply NanoMetalene technology consistently and reproducibly; the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 513-1281
Published at Nasdaq GlobeNewswire

Friday, February 10, 2017

News - Biologics: Vericel Announces First MACI Implant in the United States for the Treatment of Symptomatic Cartilage Defects of the Knee

Vericel CorporationCAMBRIDGE, Mass., Feb. 01, 2017 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced the first implant of MACI®(autologous cultured chondrocytes on porcine collagen membrane) in the United States for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.

“While surgeons have long understood that autologous chondrocyte implantation can repair cartilage tissue, the previous surgical procedure was more invasive, technically demanding, time consuming and could result in an uneven distribution of cells,” said Dr. David Recker, chief medical officer of Vericel.  "With the introduction of MACI, surgeons now have an FDA-approved product in which the patient’s own cells can be reproducibly delivered using less invasive techniques.  The MACI implant not only ensures more uniform distribution of the cells in the cartilage defect, but also greatly simplifies the implantation procedure.”

“Treating the first patient with MACI this soon following FDA approval is incredibly rewarding for everyone at Vericel,” said Nick Colangelo, president and CEO of Vericel.  "We believe that the simplified MACI surgical technique, together with the MACI Phase 3 clinical data demonstrating statistically significantly greater improvement in pain and function scores compared to microfracture, will drive significant growth for our cartilage repair franchise.  We are now focused on realizing this growth potential by providing training to expand the number of implanting surgeons and working with payers to ensure reimbursement for MACI."

About MACI 

MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane.  Autologous cultured chondrocytes are human-derived cells which are obtained from the patient's own cartilage for the manufacture of MACI.


The FDA approval of MACI was supported by the results of SUMMIT trial1, a Phase 3 two‑year, prospective, multicenter, randomized, open-label, parallel-group study that enrolled a total of 144 patients, ages 18 to 54 years, with at least one symptomatic Outerbridge Grade III or IV focal cartilage defect on the medial femoral condyle, lateral femoral condyle, and/or the trochlea.  The co-primary efficacy endpoint was change from baseline to Week 104 for the subject’s Knee injury and Osteoarthritis Outcome Score (KOOS) in 2 subscales:  Pain and Function (Sports and Recreational Activities [SRA]).2  At Week 104, KOOS pain and function (SRA) had improved from baseline in both treatment groups, but the improvement was statistically significantly (p<0.001) greater in the MACI group compared with the microfracture group.  In a responder analysis, the proportion of subjects with at least a 10‑point improvement in both KOOS pain and function (SRA) was greater in the MACI group (63/72 = 87.5%; 95% CI [77.6%, 94.6%]) compared with the microfracture group (49/72 = 68.1%; 95% CI [56.0%, 78.6%]).  

The most frequently occurring adverse reactions (≥5%) reported for MACI in the 2‑year randomized, controlled clinical trial were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.  Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis. 

Important Safety Information
  • MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.  MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.  MACI is also not indicated for use in patients who have undergone prior knee surgery in the past six months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant. 
  • MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program.
  • The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown.  Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible.  
  • Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases.  A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue.  Universal precautions should be employed when handling the biopsy samples and the MACI product.
  • Final sterility test results are not available at the time of shipping.  In the case of positive sterility results, health care provider(s) will be contacted.
  • To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI. 
  • Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed.  Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.
  • The MACI implant is not recommended during pregnancy.  For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.
  • Use of MACI in pediatric patients or patients over 55 years of age has not been assessed.
  • The most frequently occurring adverse reactions reported for MACI (≥5%) were arthralgia, tendonitis, back pain, joint swelling, and joint effusion.
  • Serious adverse reactions reported for MACI were arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.

About Articular Cartilage Defects of the Knee

Articular cartilage is a highly organized avascular tissue composed of chondrocytes embedded within an extracellular matrix of collagens, proteoglycans and noncollagenous proteins.  Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile and shearing forces.  Articular cartilage damage is caused by both acute and repetitive trauma resulting in knee pain, effusion or mechanical symptoms such as catching and locking, and swelling.  Since articular cartilage is avascular it has little capacity to repair itself or regenerate.  Articular cartilage lesions that are left untreated may progress to debilitating joint pain, dysfunction, and osteoarthritis.3  The prevalence rate for cartilage lesions in the knee has been reported to be 63% in patients undergoing investigational arthroscopies.4


About Vericel Corporation

Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions.  The company currently markets two cell therapy products in the United States.  Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  Vericel is marketing MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults, which has just been approved by the FDA.  Vericel is also developing ixmyelocel‑T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM).  For more information, please visit the company's website at www.vcel.com.


Epicel®, Carticel®, and MACI® are registered trademarks of Vericel Corporation. © 2017 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of MACI® and our other products, and timing, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "can continue," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial potential of our products and product candidates, market demand for our products, product performance and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel's Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission ("SEC") on March 14, 2016, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management's current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

References
1Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, et al. Matrix-applied characterized autologous cultured chondrocytes versus microfracture: two-year follow-up of a prospective randomized trial. Am J Sports Med. 2014 Jun;42(6):1384-94.
2Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.
3Bedi A, Feeley BT, Williams RJ. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(4):994‑1009.
4Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13(4):456-60.

CONTACT:
Chad Rubin | The Trout Group | crubin@troutgroup.com | (646) 378-2947
or
Lee Stern | The Trout Group | lstern@troutgroup.com | (646) 378-2922
Published at Nasdaq GlobeNewswire

Thursday, February 9, 2017

News - Device: CHOICESPINE ACQUIRES THE ASSETS OF EXACTECH SPINE

KNOXVILLE, TENN. – February 1, 2017 – ChoiceSpine, a privately held spinal fusion device manufacturer based in Knoxville, Tenn., announced today it has acquired the spinal assets of Exactech (Nasdaq:EXAC). Exactech is a developer and producer of bone and joint restoration products for extremities, hip, knee and spine, with corporate headquarters in Gainesville, Fla.

Logo“This is a great addition to our emerging product line,” said Rick Henson, co-owner of ChoiceSpine. “We look forward to building relationships with Exactech distributors and end users, as well as extending our product offering to potential new customers.”

The acquisition will also have beneficial international implications with Exactech having distribution channels in Spain, Portugal and Germany. “We currently have distribution partners in Italy and Mexico, so these new assets will immediately boost our international footprint,” added Marty Altshuler, co-owner of ChoiceSpine.

“This investment will continue to build the momentum behind our pursuit of becoming a prominent, full-line spinal implant provider.”

In addition to today’s acquisition announcement, ChoiceSpine also announced it would be rolling out several new products this year, along with a complete biologics line, set to complement its expanding implant portfolio.

Founded in 2006, ChoiceSpine now has more than 45 employees and is majority-owned by Henson and Altshuler. For more information on the company, visit choicespine.com.

About ChoiceSpine
ChoiceSpine is a privately held spinal implant company located in Knoxville, Tenn., and prides itself on providing excellent products and exceptional service to meet the needs of their customers.  ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to the market.

Contact: Carson Barnes
Phone: 865.862.4467


Published at ChoiceSpine

Monday, January 30, 2017

News - Device: DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems


VIPER® and EXPEDIUM® Fenestrated Screw Systems Designed for Enhanced Fixation in Patients with Advanced Stage Spinal Tumors



VIPER®
VIPER 2 System rod intro | DePuy Synthes Companies
VIPER®


RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ -- DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM® Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery. 
EXPEDIUM 5.5 System implant | DePuy Synthes Companies
EXPEDIUM®

EXPEDIUM 5.5 System instrument | DePuy Synthes Companies
EXPEDIUM®
Metastatic spine disease accounts for 10 percent to 30 percent of new cancer diagnoses annually.1 Surgical fixation with pedicle screws may be used as palliative care to stabilize the spine, help reduce pain and help keep the patient mobile.1 The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with holes called fenestrations above the screw tip enable controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation.  

"Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely," said William C. Horton, M.D., Vice President of Research & Development, DePuy Synthes Spine. "We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease."

The VIPER Fenestrated Screws are compatible with the VIPER and EXPEDIUM 5.5 Spine Systems and the EXPEDIUM Fenestrated Screws are compatible with the EXPEDIUM VERSE Spinal System. Both fenestrated screw systems are anticipated to be available in the United States in mid-2017.

Indications for Use

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

About DePuy Synthes Companies

DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.


*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International, SARL is the legal manufacturer of the VIPER and EXPEDIUM Fenestrated Screw Systems. DSUS/SPN/0117/1510 01/17

1 Dunning, E.C, et al. Complications in the management of metastatic spinal disease. World J Orthop. 2012 Aug 18; 3(8): 114–121. SOURCE DePuy Synthes

Published at PRNewsWire