Mallinckrodt launches pivotal trial for StrataGraft regenerative skin graft
Mallinckrodt (NYSE:MNK) said today that it enrolled the 1st patient in the pivotal Phase III trial of its StrataGraft skin tissue graft. The study is slated to include patients with 3% to 49% total body surface area of severe thermal burns. Researchers intend to evaluate outcomes including the area of StrataGraft treatment site that requires a subsequent autograft compared to the control site and the proportion of participants that achieve durable wound closure of the treatment site without autograft placement. Get the full story at our sister site, Drug Delivery Business News. The post Mallinckrodt launches pivo...
Source: Mass Device - June 7, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Regenerative Medicine Wall Street Beat Mallinckrodt Source Type: news

NovaBone launches bioactive bone graft substitutes
NovaBone Products added NovaBone IRM and IRM MacroPOR to its portfolio of biologically active bone graft substitutes today. The Jacksonville, Fla.-based company touted its devices as the industry’s most advanced bioactive synthetic bone graft substitutes available for orthopedic applications. The 2 new formulations are highly irrigation resistant and promote osteogenesis and osteoblastic activity, according to NovaBone. Get the full story at our sister site, Drug Delivery Business News. The post NovaBone launches bioactive bone graft substitutes appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Orthopedics Regenerative Medicine Surgical Wall Street Beat NovaBone Source Type: news

Custom 3D-Printed Resorbable Bone Grafts for Ridge Augmentation
The image is then printed by a 3D printer, producing a resorbable bone graft that fits your patient precisely. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - May 25, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 22, 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. BoneSupport launches trial of antibiotic-eluting bone graft BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft su...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

BONESUPPORT Announces First Patient Enrolled in FORTIFY Trial With CERAMENT G, a Novel Injectable, Antibiotic-eluting Bone Graft Substitute
FORTIFY trial to assess CERAMENT G as part of the surgical repair of severe tibial fractures LUND, Sweden, May 22, 2017 -- (Healthcare Sales & Marketing Network) -- BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute ... Devices, Orthopaedic BONESUPPORT, bioceramic bone substitute, CERAMENT G (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 22, 2017 Category: Pharmaceuticals Source Type: news

BoneSupport launches trial of antibiotic-eluting bone graft
BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute. The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up to 230 patients and the primary endpoints are the absence of deep infection at the fracture site and the lack of secondary procedures designed to encourage fracture union. Get the full story at our sister site, Drug Delivery Business News. The pos...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Orthopedics Surgical Bonesupport Source Type: news

FDA panel recommends approval for TransMedics lung transplant device
An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told MassDevice.com via email. TransMedics did not respond to a request for comment. A previously scheduled advisory panel hearing for another TransMedics device, the OCS Heart system, was cancelled by the...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Gastroenterology & Urology Devices panel Organ Transplant Transmedics Inc. Source Type: news

Tiny bubbles help heal broken bones, in pigs
Researchers have developed a much needed alternative to bone grafts that could help alleviate the long-term hospitalization, disability, and considerable costs to the health system associated with non-healing fractures. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 18, 2017 Category: Science Source Type: news

Gene Therapy Might Mend Badly Broken Bones
Animal experiments suggest this may be a potential alternative to bone grafts, researchers say (Source: WebMD Health)
Source: WebMD Health - May 17, 2017 Category: Consumer Health News Source Type: news

Gene Therapy Might Someday Mend Badly Broken Bones
Animal experiments suggest this may be a potential alternative to bone grafts, researchers say Source: HealthDay Related MedlinePlus Pages: Bone Grafts, Genes and Gene Therapy, Stem Cells (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 17, 2017 Category: Consumer Health News Source Type: news

7 medtech stories we missed this week: April 21, 2017
[Image from unsplash.com]From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses Life Spine’s titanium surface technology, Osseo-Loc, that helps with potential bone growth. Plateau-C Ti also has additional graft windows to help with visibility in-situ and bone graft containment. It entered full-market release on Apri...
Source: Mass Device - April 21, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) News Well Pre-Market Approval (PMA) Regulatory/Compliance Clearflow Condor Getinge Life Spine Lifetrack Medical Mayo Clinic Monitored Therapeutics Owlstone Medical Physio- Source Type: news

NuVasive launches Reline Trauma posterior fixation portfolio
NuVasive Inc. (NSDQ:NUVA) said yesterday it launched its Reline Trauma spinal posterior fixation portfolio designed to aid in the preservation and restoration of patient alignment. The San Diego, Calif.-based company said the portfolio will support multiple approaches to spinal fixation procedures, including open, maximum access surgery or hybrid approaches. NuVasive claims that its portfolio of products will allow surgeons to transition from open to MAS spinal procedures, and to customize implant types and support a number of different techniques. “The versatility of the new Reline Trauma system allows me to ad...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Spinal Surgical Nuvasive Source Type: news

Amniox Medical lands DoD contract for Neox, Clarix products
Amniox Medical said yesterday it landed a Federal Supply Schedule contract for its Neox and Clarix regenerative product lines with the US Military Health System. The Neox wound allograft is designed for use as a wound covering for dermal ulcers and defects, while its Clarix regenerative matrix is indicated for use as a surgical covering, wrap or barrier during orthopedic surgery and soft tissue repair, Atlanta-based Amniox said. Amniox said that the contract will serve all US Department of Defense institutions, and the company will partner exclusively with veteran-owned small business Alliant Healthcare to provide the...
Source: Mass Device - April 18, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Amniox Medical Source Type: news

Silicon Valley Bank puts up $25m credit line for Organogenesis
Organogenesis said today that it entered into a revolving line of credit agreement with Silicon Valley Bank to provide $25 million in new capital to the regenerative medicine company. “The people of Silicon Valley Bank are not only excellent bankers, but what sets them apart is they also understand business,” Organogenesis chief financial officer Tim Cunningham said in prepared remarks. “We at Organogenesis are looking forward to building a strong, long-term relationship.” “Organogenesis is a pioneer in the field of regenerative medicine,” Kevin Longo, director & northeast head of me...
Source: Mass Device - April 10, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Funding Roundup Regenerative Medicine Wall Street Beat Organogenesis Inc. Source Type: news

7 medtech stories we missed this week: April 7, 2017
[Image from unsplash.com]New studies for umbilical cord allografts and tumor targeting were published this week while another company received European CE Marking. Here are some medtech stories we missed this week but thought were still worth mentioning. 1. AMNIOX touts new umbilical cord study AMNIOX Medical announced that it has published the results of 3 studies that demonstrate the effectiveness of umbilical cord tissue for treating chronic wounds, according to an April 7 press release. The company’s cryopreserved human umbilical cord tissue, NEOX Cord 1K was tested on 29 patients who needed a wound all...
Source: Mass Device - April 7, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Clinical Trials Radiosurgery Regulatory/Compliance Research & Development Spinal Wound Care Aesculap Implant Systems Amniox AngioDynamics Cianna Medical InVivo Therapeutics MedTech Nu-Med Occlutech Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 29, 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. Pulmatrix jumps 8% on rumors of potential Mylan takeover bid Shares in Pulmatrix jumped more than 8% today on rumors that the company’s collaboration partner Mylan may be interested in a takeover bid. In 2015, the 2 compa...
Source: Mass Device - March 29, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

NuVasive wins 1st FDA nod for CoRoent multi-level cervical implant
NuVasive Inc. (NSDQ:NUVA) said today that the FDA granted 510(k) clearance for its CoRoent small interbody implant for fusion procedures in the cervical spine, claiming it as the 1st U.S. nod for a cervical cage used at up to 4 levels. The CoRoent device is an interbody cage made of PEEK-Optima polymer, designed to stabilize the cervical spinal during fusion. It’s hollow to allow autogenous and/or allogeneic bone grafts to be inserted. The FDA clearance covers the CoRoent small, small lordotic, small lordotic plus, small hyperlordotic and small contoured implants, San Dieg...
Source: Mass Device - March 29, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news

Burst Biologics to launch spinal fusion trial
Burst Biologics said today that it won regulatory approval to begin a clinical trial evaluating its BioBurst Fluid cellular allograft in spinal fusion patients. The company’s cellular allograft is derived from umbilical cord blood and has yielded promising results in spinal fusion procedures, according to the Boise, Idaho-based company. The prospective trial is slated to enroll 450 patients across 15 sites in the U.S. “As we continue to try to understand the mechanisms that lead toward successful fusion, it is critical that we consider the cellular content and activity that may contribute to positive outcomes,&...
Source: Mass Device - March 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Stem Cells Wall Street Beat Burst Biologics Source Type: news

Can it be neuropathy of anterior mandibular incisive canal?
I placed an implant with a bone graft 10 days ago.  The patient returned 2 days later complaining of pain at the site and pain radiating to the mandibular posterior. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - March 27, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Surgical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 13, 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. Spineology wins expanded FDA clearance for Elite interbody fusion system Spinal tech developer Spineology said today it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion proc...
Source: Mass Device - March 13, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Root resorption after bone graft: cause?
I have treatment planned this 56 year old male with a noncontributory medical history to replace his missing maxillary teeth with implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - March 5, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 2, 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. Analyst bearish on intermediate-risk TAVR uptake, but still sees market as positive While transcatheter aortic valve replacement technologies are on target to becoming a $5 billion market by 2021, analysts believe the path to i...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s NanoFuse BA is a composite of bioactive glass and a human demineralized bone matrix that Amend Surgical touts as providing optimal surgical handling performance and graft stability. Bioactive glass rapidly bonds bones and encourages cellular osteogenesis, or bone formation, helping to contain the operative site graft, according to the company. It also creates a favorable environment for bone fusion while it assimilates in...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Orthopedics Surgical Wall Street Beat Amend Surgical Source Type: news

Synergy Biomedical wins CE Mark for Biosphere putty
Synergy Biomedical said today that it won CE Mark clearance in the European Union for its Biosphere putty bone graft. The company’s Biosphere putty is a synthetic bone graft that uses a type of bioactive glass in combination with a moldable phospholipid carrier. Previous in vitro studies have shown that the bone graft product can significantly improve the healing potential of bioactive glass thanks to its spherical particle shape, Synergy Biomedical reported. “Since its introduction, Biosphere putty has been very well received by surgeons due to its successful clinical use and excellent intraoperative hand...
Source: Mass Device - February 28, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Orthopedics Regulatory/Clearance Wall Street Beat Synergy Biomedical Source Type: news

Integra LifeSciences closes $200m Derma Sciences buy
Integra LifeSciences (NSDQ:IART) said today that it closed its $205 million buy of Derma Sciences (NSDQ:DSCI) and its line of wound care products. The $7-per-share deal included 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, according to a regulatory filing. The deal was funded using cash on hand, Integra said. The same day that its own acquisition was announced, Der...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Wound Care Derma Sciences Inc. Integra LifeSciences Corp. Source Type: news

Paragon 28(R) announces the launch of first aseptically processed hammertoe allograft-PRESERVE(TM) HammerGraft(TM) System
ENGLEWOOD, Colo., Feb. 23, 2017 -- (Healthcare Sales & Marketing Network) -- Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has la... Devices, Orthopaedic, Product Launch Paragon 28, HammerGraft, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 24, 2017 Category: Pharmaceuticals Source Type: news

Crestal Sinus Lift with Osteotomes: Minimum Height?
Initially I used the drills to prepare the osteotomy to the depth of 5mm followed by osteotomes to perform a crestal sinus lift without using any bone graft. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - February 22, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

Developing new ways to monitor the progress of bone grafts
VIVOIMAG aims to develop a new contrast agent to improve visibility and enable the real-time evaluation of bone grafts using existing scanning and imaging techniques. Such innovation could, in the future, have a substantial impact on the medical field of tissue regeneration. (Source: EUROPA - Research Information Centre)
Source: EUROPA - Research Information Centre - February 14, 2017 Category: Research Source Type: news

DePuy Synthes Launches ViviGen Formable(TM) Cellular Bone Matrix, Providing a New Cellular Allograft with Alternative Consistency for Spinal Fusion Surgery
RAYNHAM, Mass., Feb. 13, 2017 -- (Healthcare Sales & Marketing Network) -- Today, DePuy Synthes*, in collaboration with LifeNet Health®, launches ViviGen Formable™ Cellular Bone Matrix**, a second generation cellular allograft used to assist in the fo... Devices, Orthopaedic, Neurosurgery, Product Launch DePuy Synthes, Johnson & Johnson, LifeNet Health, ViviGen Formable (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 13, 2017 Category: Pharmaceuticals Source Type: news

Missouri University researchers use autograft harvesting to treat chronic wounds
Dr. Jeffery Litt is a burn and wound care physician at University Hospital. The Acelity graft harvesting device eliminates the need for doctors to handle skin grafts with their hands. [Photo courtesy Missouri University]Chronic wound sufferers were able to get skin grafts in an outpatient clinic—all through a Missouri University research team’s work. The researchers used the Acelity Cellutome Epidermal Harvesting System. It is an automated, precise and reproducible process that offers minimal pain and less donor-site trauma. It features suction microsomes that harvest epidermal micrografts automatically, e...
Source: Mass Device - February 10, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Cosmetic/Aesthetic Diabetes Missouri University skin graft Source Type: news

Nonunion Fractures
In a fracture nonunion, the healing process of the fracture stops. Failure of fixation of a fracture usually indicates a nonunion (Figure 1). Nonunion may be caused by excessive motion of the bony ends and incomplete healing of the fracture (Figure 2). The fractures need stability to heal. Without a good blood supply and the growth of new blood vessels, it is difficult for the new bone to form and for the fracture to heal. Fracture needs an adequate blood supply to heal! Fractures at risk for nonunion includes the scaphoid, proximal femur (femoral neck fracture), fifth metatarsal (Jones Fracture), and open frac...
Source: Healthy Living - The Huffington Post - February 1, 2017 Category: Consumer Health News Source Type: news

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