Allergan closes $3B Acelity LifeCell buy
Acelity said today that it closed the sale of its regenerative medicine unit, LifeCell, to Allergan (NYSE:AGN) for $2.9 billion in cash. The deal brings LifeCell’s regenerative medicine and reconstructive portfolio to Allergan, joining a portfolio of medical aesthetics, breast implant and tissue expander product lines. Dublin-based Allergan said it expects to bring in $450 million in revenue this year, growing at a mid-single digit rate. “This milestone marks an important step in our continued evolution of Acelity,” Acelity president & CEO Joe Woody said in prepared remar...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Mergers & Acquisitions Regenerative Medicine Wall Street Beat Wound Care Acelity Allergan Inc. LifeCell Corp. Source Type: news

MiMedx touts data from study of AmnioFix, EpiFix allograft
MiMedx (NSDQ:MDXG) today announced the publication of a study of its AmnioFix and EpiFix allografts in treating myocardial infarction patients, touting enhanced vascularization and recruitment of autologous stem cells within infarcted cardiac tissue. Data from the study was published in the Journal of Cardiology & Cardiovascular Therapy, the Marietta, Ga.-based company said. “There is a critical need for novel and innovative therapies for effective treatments following myocardial infarction and to promote regeneration of cardiac tissues. At present, total heart transplants and left ventricular assist devices...
Source: Mass Device - January 25, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Regenerative Medicine MiMedx Group Inc. Source Type: news

Lateral window sinus lift: will bone grow over membrane?
I performed a  lateral window approach for a sinus lift and bone graft.  I cut a window in the lateral wall and I accidentally dropped the bone fragment that I had cut out, into the floor of the sinus. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - January 23, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

After ankle replacement surgery, pain-free walks on the beach
Treatment TermsAnkle replacement surgery CategoriesAdvanced treatments Additional SEO Keywords ankle replacement, ankle surgery, ankle injury, ankle pain, joint replacement SEO Meta Description Ankle pain kept David Deitz from enjoying retirement on the North Carolina shore. After ankle replacement surgery at Duke, he ’s walking on the beach once more. Author MaryAnn Fletcher Overview Ankle pain kept David Deitz from enjoying retirement on the North Carolina shore. Afterankle replacement surgery at Duke, he’s walking on the beach once more. Hero Imagemc2_1588_cropped.jpg Preview Image Content Bl...
Source: dukehealth.org: Duke Health News - January 23, 2017 Category: Consumer Health News Authors: mf205 at duke.edu Source Type: news

After ankle replacement surgery, pain-free walks on the beach
Treatment TermsAnkle replacement surgery CategoriesAdvanced treatments Additional SEO Keywords ankle replacement, ankle surgery, ankle injury, ankle pain, joint replacement SEO Meta Description Ankle pain kept David Deitz from enjoying retirement on the North Carolina shore. After ankle replacement surgery at Duke, he ’s walking on the beach once more. Author MaryAnn Fletcher Overview Ankle pain kept David Deitz from enjoying retirement on the North Carolina shore. Afterankle replacement surgery at Duke, he’s walking on the beach once more. Hero Imagemc2_1588_cropped.jpg Preview Image Content Bl...
Source: dukehealth.org: Duke Health News - January 23, 2017 Category: Consumer Health News Authors: mf205 at duke.edu Source Type: news

Xtant Medical floats shares, promissory notes for interest payments
Xtant Medical (NYSE:XTNT) this week announced new rounds of fund raising, closing a direct offering of shares and the offering of new promissory notes to pay interest due on existing indenture notes. The company said yesterday it floated 843,289 shares at 57¢ per share directly to holders of existing promissory notes. Belgrade, Mont.-based Xtant Medical said it owes $2 million in interest on the indentured notes, of which $480,000 were paid for by the offering. All expenses for the offering will be paid by the company from cash on hand, the company added. Today, the company announced a new offering of promissory ...
Source: Mass Device - January 19, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Xtant Medical Source Type: news

Derma Sciences pays $13m for Medihoney ahead of Integra buyout
Derma Sciences (NSDQ:DSCI) said last week that it paid $13.3 million for Medihoney, on the same day that Integra LifeSciences (NSDQ:IART) agreed to pay nearly $200 million for the tissue regeneration company. Prior to the acquisition, Derma Sciences held the exclusive global license for the Comvita-owned Medihoney brand and patents. Medihoney is eligible to receive an additional $5 million upon achievement of annual sales milestones, according to a regulatory filing. “Under Derma’s leadership, the Medihoney brand has grown to be the largest line of medical-grade honey products for advanced wound care ...
Source: Mass Device - January 18, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Mergers & Acquisitions Regenerative Medicine Wall Street Beat Wound Care Derma Sciences Inc. Integra LifeSciences Corp. Medihoney Source Type: news

UK based medical device company announces two new patents granted by the US Patent and Trademark Office
SIRAKOSS Ltd., a UK-based medical device company developing innovative bone grafting solutions for the $3 billion global orthopaedic market, has announced that the United States Patent and Trademark Office (USPTO) has granted two  patents for its bone graft technologies.  SIRAKOSS‘ patent portfolio encompasses advanced synthetic bone graft technologies which  form the company’s product pipeline designed to address the significant clinical need for a fully-synthetic, standalone bone void filler.  SIRAKOSS’ technologies provide consistently effective bone regeneration without the establi...
Source: Orthogate - Latest News - January 18, 2017 Category: Orthopaedics Tags: Featured Industry News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for January 11, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Califf on the way out at FDA, Ostroff to take over as interim commish Dr. Robert Califf’s tenure as commissioner of the FDA, which formally began only last February, will reportedly end less than a year after it began. Ca...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Integra LifeSciences to acquire Derma Sciences for $200m
Integra LifeSciences (NSDQ:IART) said yesterday that it agreed to pay nearly $200 million for Derma Sciences (NSDQ:DSCI) and its line of wound care products. The $7-per-share deal includes a line of regenerative allograft products derived from human placental tissue that Derma Sciences acquired when it paid nearly $80 million for BioD last year. Integra also agreed to pay $32 per share Series A preferred stock and $48 per share for Series B preferred stock in Derma Sciences, according to a regulatory filing. The deal, slated to close by the end of the 1st quarter, is due to be funding using Integra’s e...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: MassDevice Earnings Roundup Mergers & Acquisitions Wall Street Beat Wound Care Derma Sciences Inc. Integra LifeSciences Corp. Source Type: news

J & J ’ s DePuy Synthes picks up Interventional Spine assets
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes said today it inked a purchase and development deal with Interventional Spine to pick up its expandable cages designed for minimally invasive spinal fusion surgeries. The newly acquired implants are designed for optimal tactile feedback and feature a continuously adjustable design to allow for height to be customized to the patient’s anatomy, the company said. The expandable cages are designed to maximize bone graft contact and containment to promote bone growth and fusion, the companies said. “DePuy Synthes and Interventional Spine h...
Source: Mass Device - January 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Spinal Surgical DePuy Synthes Interventional Spine Inc Johnson & Johnson Source Type: news

MiMedx touts Aetna reimbursement win for EpiFix implant
MiMedx (NSDQ:MDXG) said today that it won coverage from Aetna Inc. for its EpiFix allograft effective December 23rd. The insurance company classified EpiFix as “medically necessary” for the treatment of partial and full-thickness neuropathic diabetic foot ulcers when used in combination with standard diabetic ulcer care. The non-viable cellular amniotic membrane allograft helps to regenerate soft tissue by delivering extracellular matris proteins, growth factors and other proteins found in amniotic tissue, according to MiMedx. “We are very pleased to have received coverage from Aetna and with the sig...
Source: Mass Device - December 28, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Legal News Regulatory/Clearance Wall Street Beat Wound Care MiMedx Group Inc. Source Type: news

Allergan picks up Acelity ’ s LifeCell biz for $2.9B
Acelity said today that it inked a definitive agreement with Allergan (NYSE:AGN) to sell its LifeCell business for $2.9 billion in cash. The deal will put LifeCell’s regenerative medicine and reconstructive portfolio under Allergan’s roof, joining its medical aesthetics, breast implant and tissue expander product lines. Dublin-based Allergan said it expects will generate approximately $450 million in revenue this year, growing at a mid-single digit rate. “The acquisition of LifeCell is both strategically and financially compelling to Allergan and serves as our entry point into regenera...
Source: Mass Device - December 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine Acelity Allergan Inc. LifeCell Corp. Source Type: news

Amedica re-files with FDA seeking approval for ceramic spinal implant
Amedica (NSDQ:AMDA) said today that it is refiling an application with the FDA seeking approval for its cancellous-structure ceramic cervical implant. The decision comes on the heels of “encouraging results” from a study which showed rapid bone growth into porous silicon nitride, according to the Salt Lake City, Utah-based company. “We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future. The porous silicon nitride sample used in this study is the cancellous-structured ceramic used in the center of our composite cervical implants that were the subj...
Source: Mass Device - December 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Amedica Source Type: news

Zimmer-Biomet launches PrimaGen advanced bone allograft
Zimmer Biomet (NYSE:ZBH) said today it launched the PrimaGen advanced bone allograft designed as an allogeneic bone graft substitute for use in the repair, replacement, reconstruction or supplementation of tissue in muscuoloskeletal defects. The Warsaw, Ind.-based company said the PrimaGen advanced allograft contains the same bone healing elements as autografts while eliminating the risks associated with donor site morbidity or harvest site complications. “PrimaGen Advanced Allograft was developed to overcome the limitations of other bone graft substitutes and designed to offer a real alternative to autogra...
Source: Mass Device - December 14, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Orthopedics Zimmer Biomet Source Type: news

Zimmer Biomet Strengthens Spine Offering with PrimaGen Advanced(TM) Allograft
WARSAW, Ind., Dec. 13, 2016 -- (Healthcare Sales & Marketing Network) -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of PrimaGen Advanced Allograft, an autograft substitute co... Devices, Orthopaedic, Product Launch Zimmer Biomet, PrimaGen, Advanced Allograft, Allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 14, 2016 Category: Pharmaceuticals Source Type: news

Lab-grown bone shows 100% success rate in small, early study
Israel’s Bonus Biogroup (TLV:BONS) said today that it successfully injected its lab-grown, semi-liquid bone graft into the jaws of 11 people in an early stage clinical trial evaluating bone loss repair. The company is presenting its results at the International Conference on Oral & Maxillofacial Surgery in Spain today. The material is grown in a lab from a patient’s  own fat cells and then injected into the voids of problematic bones in the jaw. Over the course of a few months, the material hardens and merges with existing bones to fill out the jaw. The transplant “was 100% successful i...
Source: Mass Device - December 5, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Materials Testing Orthopedics Research & Development Stem Cells Bonus Biogroup Source Type: news

Xtant Medical wins FDA nod for Xsert lumbar implant
Xtant Medical (NYSE:XTNT) said today that it won 510(k) clearance from the FDA for its Xsert lumbar expandable interbody spine implant. The device is designed for lumbar fusion at 1 or 2 levels and is also cleared for use with autograft or autologous bone grafts including Belgrade, Mont.-based Xtant’s 3Demin and patented OsteoSponge allografts. “We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” director Dr. David Kirschman said in prepared re...
Source: Mass Device - November 23, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Xtant Medical Source Type: news

Xtant Medical raises $4m, wins FDA nod for Irix-C cervical cage
Xtant Medical (NYSE:XTNT) said today it raised $3.8 million from a recent offering, and won FDA clearance for its Irix-C cervical cage. Subscriptions to the offering, offered at 75¢ per unit, ended yesterday. The Belgrade, Mont.-based company expects the offering to close completely on November 17, according to a press release. Xtant priced the offering earlier this month, looking to raise $11 million in the round. The company said it planned to float 15 million units at 75¢ per unit. Each unit in the round consists of 1 share of common stock and 1 warrant to purchase another share of stock. Xtant ...
Source: Mass Device - November 15, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Spinal Xtant Medical Source Type: news

Sinus Elevation: Are Bone Grafts Needed?
Would an implant placed after sinus elevation without a bone graft provide a satisfactory long-term outcome? (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - November 15, 2016 Category: Dentistry Authors: osseonews Tags: Implant News Regenerative Source Type: news

Efficacy of Epidermal Skin Grafts Over Complex Wounds Efficacy of Epidermal Skin Grafts Over Complex Wounds
Is epidermal skin grafting a safe and effective alternative to traditional autografts?Wounds (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - November 15, 2016 Category: Surgery Tags: General Surgery Journal Article Source Type: news

MassDevice.com +5 | The top 5 medtech stories for November 14, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Final FDA rules clarify adverse event reporting for contract manufacturers The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LeMaitre Vascular pays $14m for Restore Flow Allografts
LeMaitre Vascular (NSDQ:LMAT) said last week that it agreed to put up $14 million for tissue preservation service provider Restore Flow Allografts. The deal calls for Burlington, Mass.-based LeMaitre to pay $12 million up front and another $2 million in May 2018, plus earn-puts pegged to sales performance over the next 2 years. Fox River Grove, Ill.-based Restore Flow, which offers human tissue preservation services for the processing and cryopreservation of peripheral vascular veins and arteries, posted break-even operating profits on sales of $3.7 million for the last 12 months, LeMaitre Vascular said...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Vascular Wall Street Beat LeMaitre Vascular Inc. Peripheral Artery Disease Restore Flow Allografts Source Type: news

Olympian D ’Agostino shares 3 lessons after ACL injury
“The crux of Olympic competition is to do everything you can to be the first one to cross the finish line,” says Abbey D’Agostino. But that’s not what Abbey did during the 5,000-meter qualifying heats in the 2016 summer games. Abbey had trained for her Olympic moment for years, adhering to the rigid 24/7 lifestyle of an elite athlete since graduating from Dartmouth College and signing to run professionally with New Balance. Abbey’s Olympic moment came unexpectedly when she and New Zealand runner Nikki Hamblin collided and tumbled to the ground. What happened at the Olympics is an example we sh...
Source: Thrive, Children's Hospital Boston - November 14, 2016 Category: Pediatrics Authors: Lisa Fratt Tags: Our Patients’ Stories ACL injury ACL tear Dr. Mininder Kocher Orthopedic Center Sports Medicine Source Type: news

BONESUPPORT(TM) Announces Key Corporate Appointment To Drive Growth In North America
LUND, Sweden, November 7, 2016 -- (Healthcare Sales & Marketing Network) -- BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone graft substitutes to treat bone voids caused by trauma, infection, disease or related surgery, is pleas... Devices, Orthopaedic, Personnel BONESUPPORT, CERAMENT, BONE VOID FILLER (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 7, 2016 Category: Pharmaceuticals Source Type: news

Wright Medical jumps on $240m hip settlement, Q3 results
Wright Medical (NSDQ:WMGI) shares are up nearly 4% today after the orthopedics company yesterday said it inked a $240 million settlement this month for nearly 1,300 product liability lawsuits brought over its metal-on-metal hip implants and released 3rd-quarter earnings that beat expectations on Wall Street. Wright, which lost an $11 million verdict in the 1st Conserve bellwether suit last year (the company is still litigating that decision), said it will pay $180 million in cash and cover the remaining $60 million with insurance. The deal covers about 85% of the claims lodged over Wright’s Conser...
Source: Mass Device - November 3, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: MassDevice Earnings Roundup Orthopedics Wall Street Beat Wright Medical N.V. Source Type: news

Ankle fusion or ankle replacement?
Treatment TermsAnkle pain and ankle injuryAnkle replacement surgeryOrthopaedics SEO Meta Description Ankle fusion and ankle replacement can relieve ankle pain and restore motion when nonsurgical treatments aren ’t effective. Author Karen Doss Bowman Sub-Title Choosing the right ankle surgery OverviewWhen persistent ankle arthritis from a chronic ankle injury or ankle fracture makes walking, exercise or climbing stairs unbearable, it’s time to consider your treatment options. Ankle fusion and ankle replacement can relieve ankle pain and restore motion when nonsurgical treatments aren’t effec...
Source: dukehealth.org: Duke Health News - November 1, 2016 Category: Consumer Health News Authors: dg62 at duke.edu Source Type: news

Amedica reduces workforce by 38%
Amedica (NSDQ:AMDA) said today it laid off approximately 38% of its workforce to lower operating expenses. The Salt Lake City, Utah-based company said the layoffs were part of a plan implemented on October 3 and completed the next day, which resulted in savings of approximately $2 million in annual cash operating expenses. The company said the action also incurred approximately $465,000 in one-time severance and related costs, which will be recorded in its 4th quarter of the 2016 fiscal year. “We acknowledge the hard work of those affected by this decision, towards bringing silicon nitride technology to patient ...
Source: Mass Device - October 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Amedica Source Type: news

Stryker launches Lite Bio bone graft delivery system
Stryker (NYSE:SYK) said today it is launching the Lite Bio bone graft material delivery system device designed for spinal surgeries. The company said the device allows for the use of preferred graft materials while allowing direct visualization of graft placement. The device can be operated signle-handed and used with any type of autograft, allograft or synthetic bone graft. “Our new Lite Bio delivery system is innovative in the marketplace, simplifying graft delivery for spine surgeons. Its sleek, versatile design can accommodate any bone graft material and provides surgeons with direct visualization to ai...
Source: Mass Device - October 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Spinal Stryker Source Type: news

For patients who need bone grafts, a 3D-printer could come to the rescue
Scientists have 3-D-printed splints for babies ’ airways, faux brains to study cortical folding — and now they’ve done it with bone. A team of researchers at Northwestern University has created a highly flexible artificial bone that helps speed up recovery and that can be easily manipulated by surgeons... (Source: Los Angeles Times - Science)
Source: Los Angeles Times - Science - September 28, 2016 Category: Science Authors: Amina Khan Source Type: news

Scientists fix fractures with 3D-printed synthetic bone
(Reuters) – Scientists in the United States have successfully treated broken spines and skulls in animals using 3D-printed synthetic bone, opening the possibility of future personalized bone implants for humans to fix dental, spinal other bone injuries. Unlike real bone grafts, the synthetic material – called hyper-elastic bone – is able to regenerate bone without the need for added growth factors, is flexible and strong, and can be easily and rapidly deployed in the operating room. Giving details in a teleconference, the scientists said the results of their animal trials – published on Wednesday i...
Source: Mass Device - September 28, 2016 Category: Medical Equipment Authors: MassDevice Tags: Orthopedics Research & Development Spinal Source Type: news

Are demineralized bone allografts (cortical or cancellous) fully bio-resorbable?
Have there been any conclusive studies to show whether or not allografts, particularly demineralized allografts, are fully bio-resorbable? (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - September 27, 2016 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

NovaBone wins CE Mark for collagen-based dental wound dressings
Bio-active synthetic bone graft company NovaBone said today it won CE Mark approval in the European Union for its NovaTape and NovaPlug dental wound dressings. The Jacksonville, Fla.-based company said both devices are collagen-based and designed for the management of soft tissue oral wounds and sores, including dental sores, oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites and surgical and traumatic wounds. “The CE mark approval is a major milestone for our company and a benefit to physicians and dentists in the European Union. NovaTape and NovaPlug are exceptionally user-friendly and ...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Dental Regulatory/Compliance Wound Care NovaBone Source Type: news

Spineology makes Musculoskeletal Transplant Foundation its sole allograft supplier
Spinal tech developer Spineology said today it expanded its relationship with the Muscoloskeletal Transplant Foundation, making it the sole tissue provider for its allograft product lines. The expanded deal will position MTF as the sole provider of tissue for Minneapolis-based Spineology’s new Incite cortigal fibers bone grafting solution. “MTF has a long track record of delivering safe, high quality tissue products using the most stringent standards in the industry. Our expanded relationship allows us to pass along that safety and quality to our customers,” CEO John Booth said in a prepared release. The ...
Source: Mass Device - September 23, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Spinal Spineology Source Type: news

FDA clears Life Spine ’ s Pro-Link Ti cervical spacer
Life Spine said today that it won 510(k) clearance from the FDA for its Pro-Link Ti cervical spacer. The Huntley, Ill.-based company said the product is slated for full release by the end of 2016, joining a portfolio of devices that Life Spine launched this year. The spacers allow for the fusion of adjacent segments of spine without removing an existing anterior cervical plate. The locking plate provides security against screw backout, without disturbing the surrounding tissue, according to Life Spine. “Pro-Link Ti offers a low-profile, stand-alone cervical interbody with our groundbreaking Osseo-Loc technology. Osse...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Spinal Life Spine Source Type: news

Sunstar ’s GUIDOR® easy-graft® Alloplastic Bone Grafting System Now Available through Dental Dealers
Bone graft delivers easy handling and can eliminate the need for dental membrane SCHAUMBURG, ILLINOIS, June 10, 2016 — Sunstar Americas announced that it has expanded the purchasing options for its GUIDOR®easy-graft® Alloplastic Bone Grafting System by making it available through a network of 28 authorized U.S. dental dealers.Launched in late 2014 and capable of being syringed directly into a bone defect, GUIDOReasy-graftis the patented1bone grafting material that hardens into a stable, porous scaffold in minutes. Additionally, its ability to harden into a stable, porous scaffold allows clinicians to cho...
Source: Dental Technology Blog - September 20, 2016 Category: Dentistry Source Type: news

Bonesupport touts high infection eradication rate in prospective trial
Bonesupport today released data from the prospective trial of its Cerament G injectable antibiotic-eluting bone substitute, touting a 96% infection eradication rate in patients treated with the substitute. Data from the study was published in The Bone and Joint Journal, the company said. Cerament G is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis. The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months, while preventing colonization of microorganisms by eluting the antibiotic gentamicin. “The results th...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Orthopedics Bonesupport Source Type: news

FDA releases July 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016 TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16 DEVICE: Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional) ATTN: Stephen Deardorff PHONE NO : 1 317 8494210 10377 HAGUE RD. SE DECISION MADE: 21-JUL-16 INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheath Introducer BIOTEQUE CORP. 510(k) NO: K150932(Traditional) ATTN: Simon Lin PHONE NO : 886 2 25710269 5 F-6, NO. 2...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Return to play following meniscus surgery - Brelin AM, Rue JP.
Meniscus tears are commonly encountered in the athletic population and can result in significant loss of playing time. Current treatment methods for acute tears consist of meniscectomy and meniscal repair, whereas meniscal allograft transplant is reserved ... (Source: SafetyLit)
Source: SafetyLit - August 27, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Amedica wins expanded FDA indication for Valeo II spinal fusion devices
Amedica (NSDQ:AMDA) said yesterday it won expanded FDA clearance for additional sizes of its Valeo II lateral lumbar interbody fusion device. The Valeo II lateral lumbar fusion device is made out of proprietary medical grade silicon nitride ceramic and includes 2nd-generation instrumentation for improved patient safety, the Salt Lake City, Utah-based company said. The device is indicated for intervertebral body fusion of the spine in skeletally mature patients with the use of an autograft to facilitate fusion, the company said. “I’m delighted to announce the recent FDA clearance of our expanded silicon nitride ...
Source: Mass Device - August 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Amedica Source Type: news

Derma Sciences touts Medicare reimbursement win
Derma Sciences (NSDQ:DSCI) said yesterday that Medicare Administrative Contractor National Government Services will now consider the company’s Amnioexcel amniotic allograft membrane for coverage. The change comes as NGS, which serves states in the Northeast and Midwest, sets to retire its local coverage determination for cellular or tissue based products as of September 1st. The change will allow Derma Sciences’ Amnioexcel to be considered with appropriate documentation of medical necessity as a second-line therapy, following standard wound care treatment. “We are very pleased wit...
Source: Mass Device - August 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Medicare Regenerative Medicine Derma Sciences Inc. Source Type: news

Derma Sciences, Organogenesis tout Medicare reimbursement win
Updated to include more information, commentary from Organogenesis. Medicare administrative contractor National Government Services has retired previous coverage policies on cellular and tissue-based products, effective September 1st. The change will allow new coverages and reimbursement through Medicare for such products based on FDA labeling and packaging. Derma Sciences (NSDQ:DSCI and Organogenesis have said the changes will allow for their products to receive coverage and reimbursement for individuals covered under NGS. Approximately 24 million Medicare Part B beneficiaries are covered by NGS, ...
Source: Mass Device - August 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Medicare Regenerative Medicine Derma Sciences Inc. Source Type: news

Pregnancy After Kidney Transplant and Allograft Failure Risk Pregnancy After Kidney Transplant and Allograft Failure Risk
Delaying pregnancy after kidney transplantation may decrease the risk of allograft failure. What is the optimal timing?American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 24, 2016 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

Osteovation Bone Graft Cement in Sinus Lift Procedure?
 I was thinking of using Osteovation a calcium phosphate bone cement for the graft.   (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 23, 2016 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Return to play of rugby players after anterior cruciate ligament reconstruction using hamstring autograft: return to sports and graft failure according to age - Takazawa Y, Ikeda H, Saita Y, Kawasaki T, Ishijima M, Nagayama M, Kaneko H, Kaneko K.
PURPOSE: To assess return to play and the frequencies of graft failure in rugby players after anterior cruciate ligament (ACL) reconstruction using a hamstring autograft augmented with an artificial ligament and to compare outcomes between rugby players ag... (Source: SafetyLit)
Source: SafetyLit - August 20, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Bone graft quality?
I would like input on the bone graft quality. I see a kind of a void above the new bone below the sinus. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 17, 2016 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 12, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Bonesupport wins FDA nod for Cerament G trial Bonesupport said it won an investigational device exemption for the Fortify clinical trial of its next-generation Cerament G injectable antibiotic-eluting bone substitute. Cerament ...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Bonesupport wins FDA nod for Cerament G trial
Bonesupport said it won an investigational device exemption for the Fortify clinical trial of its next-generation Cerament G injectable antibiotic-eluting bone substitute. Cerament G product is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis. The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months, while preventing colonization of microorganisms by eluting the antibiotic gentamicin. Bonesupport said Cerament G, which won CE Mark approval in the European Union back in February 2013, is on the mark...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Source Type: news

Derma Sciences closes $80m deal for BioD
Derma Sciences (NSDQ:DSCI) said yesterday that it closed its acquisition of regenerative allograft maker BioD in a deal worth up to $78 million, including milestones and earn-outs. Princeton, N.J.-based Derma Sciences said it paid $21.3 million up front in a mix of cash and stock; meeting regulatory milestones could mean another $30 million, and the transaction included $26.5 million in earn-outs pegged to net sales growth. The deal, announced July 28, closed August 5, the company said in a regulatory filing. BioD makes a line of allograft products derived from human placental tissue, includin...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Regenerative Medicine Wound Care BioD Derma Sciences Inc. Source Type: news