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MiMedx loses appeal in placental allograft tissue patent spat
A Federal Circuit Court this week affirmed a Patent Trial and Appeal Board ruling which found a MiMedx (NSDQ:MDXG) tissue graft patent invalid in a spat between the company and the Musculoskeletal Transplant Foundation. The ruling came from a 3-judge panel, delivered in a 1-line order without an opinion, affirming the PTAB’s decision from last month which found the patent as invalid as obvious, according to court documents. The spat is related to a dehydrated human amnion/chorion membrane placental tissue allograft patent, with Marietta, Ga.-based MiMedx claiming that the MTF infringed upon it with their own gra...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement MiMedx Group Inc. Source Type: news

MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles Tendonitis
MARIETTA, Ga., Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts ... Biopharmaceuticals, Regenerative Medicine, Orthopaedic, FDA MiMedx Group, AmnioFix, achilles tendonitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 7, 2017 Category: Pharmaceuticals Source Type: news

Never say never again: a bone graft infection due to a hornet sting, thirty-nine years after cranioplasty - Maugeri R, Giammalva RG, Graziano F, Basile L, Gul ì C, Giugno A, Iacopino DG.
BACKGROUND: Cranioplasty (CP) is a widespread surgical procedure aimed to restore skull integrity and physiological cerebral hemodynamics, to improve neurological functions and to protect the underlying brain after a life-saving decompressive craniectomy (... (Source: SafetyLit)
Source: SafetyLit - September 7, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 5, 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. How medical device risk management is connected with design controls Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear. Intended us...
Source: Mass Device - September 5, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic launches long-term PLF, TLIF Infuse bone protein study
Medtronic (NYSE:MDT) said today it launched a long-term clinical study of its Infuse bone graft for use during posterolateral fusion and transforaminal lumbar interbody fusion spine procedures. The 1st patient in the study was enrolled at Indiana’s Fort Wayne Orthopedics and underwent a procedure led by Dr. Kevin Rahn and Dr. Robert Shugart, Fridley, Minn.-based Medtronic said. “Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion. We believe there is significant data on the safety and efficacy profile of Infuse in approv...
Source: Mass Device - September 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Spinal Medtronic Source Type: news

Bone Binders for bone augmentation?
Do you know of any bone binders used in oral bone augmentation procedures that would not interfere with osteogenesis, resorb parallel with bone graft material and be biologically inert? (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 30, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Metro Atlanta's MiMedx to spin out subsidiary to focus on biopharma
Marietta-based MiMedx Group, Inc. (NASDAQ: MDXG) has signed an agreement to divest the company's subsidiary, Stability Biologics LLC, back to its original stockholders. MiMedx's said its transition into a biopharmaceutical company was an impetus for this divestiture initiative. MiMedx Group is developing and marketing regenerative and therapeutic biologics with human placental tissue allografts and patent-protected processes for multiple sectors of health care. In January of 2016, the company acquired… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 21, 2017 Category: American Health Authors: Eric Mandel Source Type: news

MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January. The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company. “The transaction is expected to be completed in the 3rd quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine MiMedx Group Inc. Stability Biologics Source Type: news

Camber spine wins FDA nod for Spira interbody fusion device
Camber Spine Technologies said today it won FDA 510(k) clearance from the FDA for its Spira open matrix anterior lumbar interbody fusion device. The Wayne, Penn.-based company said the Spira device consists of spiral support arches designed to increase fusion rates and stabilization. The company said the spiral support arches also decrease subsidence by load sharing over the entire endplate while also maximizing bone graft capacity. “Camber Spine is very excited to be launching our first in a series of spinal implants using 3D printed – additive manufacturing. This specialized manufacturing technology allows us...
Source: Mass Device - August 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Spinal camberspine Source Type: news

Prolonged Allograft Survival in Chronic Immunosuppression Prolonged Allograft Survival in Chronic Immunosuppression
This review explores the potential for the indefinite survival of a skin allograft among transplant patients on chronic immunosuppression.Wounds (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - August 15, 2017 Category: Intensive Care Tags: General Surgery Journal Article Source Type: news

Pain and itch outcome trajectories differ among European American and African American survivors of major thermal burn injury
Over half of individuals experiencing major thermal burn injury (MThBI) receive an autologous skin graft (autograft), in which skin is removed from a healthy " donor " site and transplanted to the burn site. Persistent pain/itch at the graft site are major causes of suffering and disability in MThBI survivors. African Americans have a higher risk of MThBI, and in other clinical settings African Americans experience a greater burden of pain and itch relative to European Americans. However, to our knowledge, ethnic differences in skin graft site pain/itch outcomes after MThBI have not been assessed. We evaluated sk...
Source: Current Awareness Service for Health (CASH) - August 14, 2017 Category: Consumer Health News Source Type: news

7 medtech stories we missed this week: August 11, 2017
[Image from unsplash.com]From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally m...
Source: Mass Device - August 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Food & Drug Administration (FDA) Oncology Regulatory/Compliance Spinal Surgical Apifix Cardiac Science Hip Innovation Life Spine Inc. MedTech Pentax Medical Varian Medical Systems Xtant M Source Type: news

Immediate implant placement into posterior sockets with or without buccal bone dehiscence defects: A retrospective cohort study
ConclusionsWithin the limitations of this study, flapless implant placement into compromised sockets in combination with DBBM grafting may be a viable technique to reconstitute the defected buccal bone plates due to space maintenance and primary socket closure provided by healing abutments and bone grafts.Clinical significanceImmediate implants and DBBM grafting without using membranes may be indicated for sockets with buccal bone defects. (Source: Dental Technology Blog)
Source: Dental Technology Blog - August 4, 2017 Category: Dentistry Source Type: news

Wright Medical shares rise on Q2 beat
Shares in Wright Medical (NSDQ:WMGI) rose yesterday after the medical device maker beat expectations on Wall Street with its 2nd quarter earnings results. The Amsterdam-based company posted losses of $41.2 million, or 39¢ per share, on sales of $179.7 million for the 3 months ended June 25, seeing losses shrink 82.1% while sales grew 5.3% compared with the same period during the prior year. Adjusted to exclude 1-time items, losses per share were 7¢, just ahead of the 9¢ loss per share consensus on The Street, where analysts were looking for sales of $178.2 million for the quarter. “All of our most...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat wrightmedical Source Type: news

Exposure of threads after bone graft?
I recently uncovered an implant after about 3 months. About 1-2mm of the buccal threads were exposed. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - July 31, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Biopsies to Identify Patients at Risk for Allograft Loss Biopsies to Identify Patients at Risk for Allograft Loss
Serial allograft biopsies may help determine which patients with de novo donor-specific antibodies are most likely to experience allograft loss.American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 19, 2017 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

Radiolucent lesion and immature bone: Proceed with caution?
Tooth #19 had failed RCT with infection and fistula and large radiolucent lesion.  It was extracted and a bone graft done and implant placed 5 months later. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - July 13, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for July 3, 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. BD extends Bard note exchange offering again Becton Dickinson said today is once again extending its exchange offering for up to $1.1 billion in outstanding C. R. Bard notes from July 3 to August 1. The company is offering exch...
Source: Mass Device - July 3, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic nearing resolution on Infuse suits
Medtronic (NYSE:MDT) is closing in on a resolution to the long-running legal battles over its Infuse bone-growth protein designed for back surgeries, according to an SEC filing posted last week. The Fridley, Minn.-based company said that it is approaching agreements to settle approximately 6,000 cases against it which asserted personal injury claims due to the bone graft product in an SEC filing. “As of June 1, 2017, the company has reached agreements to settle substantially all of these claims, resolving this litigation,” Medtronic wrote in an SEC filing. While Medtronic did not release exact financial de...
Source: Mass Device - July 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Regenerative Medicine Spinal Medtronic Source Type: news

Socket Grafting and Ridge Preservation using Bond Apatite
The socket and the ridge were preserved by augmenting the area with Bond apatite bone graft cement. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 30, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 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. DeviceTalks: 3M’s Cindy Kent on leadership, growth and inclusion in medtech Cindy Kent is no stranger to medtech – she’s spent 20 years in healthcare, moving up the ranks and finding her way to president &...
Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Spineology wins FDA nod for Rampart One lumbar interbody fusion system
Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system. The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated fixation screws. “Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” Dr. Jeremy Shore said in a prepared stateme...
Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Spineology Source Type: news

Bonesupport closes $57m IPO
BoneSupport said last week it closed its initial public offering, raising a total of approximately $57.1 million (SEK 500 million), not including an over-allotment option. The Swedish company, which is developing the Cerament G injectable antibiotic-eluting bone graft substitute, said it floated approximately 17.2 million new shares at $3.40 per share (SEK 29) in the round, raising approximately $57.1 million before issue costs and $54 million (SEK 461 million) after issue costs. Read the whole story at our sister site, Drug Delivery Business The post Bonesupport closes $57m IPO appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Orthopedics Bonesupport Source Type: news

7 medtech stories we missed this week: June 23, 2017
[Image from unsplash.com]From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for false advertising and unfair competition. Guardant Health is claiming that Foundation Medicine’s advertising causes harm to Guardant Health and its patients because it misleads oncologists about the sensitivity and accuracy of...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Food & Drug Administration (FDA) Implants Neurological Regulatory/Compliance Ultrasound EndoStim Foundation Medicine Inc. Guardant Health Interson Lee's Pharmaceutical Meditech Med Source Type: news

Swiss Kuros Biosciences wins CE Mark for NeuroSeal dural sealant
Swiss tissue repair and regenerative med focused Kuros Biosciences said today it won CE Mark approval in the European for its Neuroseal novel dural sealant. The Neuroseal sealant is designed as an adjunct to suturing and is used to seal the dura after cranial surgery and reduce the risk of cerebrospinal fluid leakage, the company said. Kuros added that the sealant was designed to be easy to prepare, use and handle to reduce adverse effect risks. Kuros Biosciences said that the approval is the 2nd for the company following the approval of its MagnetOs Granules, a novel synthetic bone graft substitute designed to regenerate ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Surgical kurosbiosciences Source Type: news

BoneSupport readies $62m IPO
BoneSupport said this week that it’s planning to float an initial public offering that would fetch roughly $62 million at the midpoint, not including an over-allotment option. The Swedish company, which is developing the Cerament G injectable antibiotic-eluting bone graft substitute, said it plans to offer more than 18.5 million shares at $3.13 to $3.59 apiece (SEK 27 to SEK 31), for total proceeds of $57.9 million to $66.4 million (SEK 500 million to SEK 574 million). Get the full story at our sister site, Drug Delivery Business News.  The post BoneSupport readies $62m IPO appeared first on MassDevice...
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Orthopedics Wall Street Beat Bonesupport Source Type: news

Silver Spring tissue regeneration company raises $12 million
Silver Spring regenerative medicine company Aziyo Biologics Inc. raised $12 million in a recent funding round, a Securities and Exchange Commission filing shows. HighCape Partners, a New York equity fund and majority owner of Aziyo, led the funding round for the local company, which creates customized human tissue products for use in orthopedic, spinal, sports medicine and dermal surgeries. Several of its products are allografts — or tissue grafts from d onors — for bone repair, ligament replacement… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 14, 2017 Category: Pharmaceuticals Authors: Tina Reed Source Type: news

How to rehabilitate the maxillary arch?
 I am considering as my primary treatment plan doing bilateral sinus lifts with bone grafts and installing 3 implants on each side or All on 4. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 12, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

Bioventus expands market access for surgical products with new contract
When Durham-based Bioventus acquired OSTEOAMP – a bone fusion solution – from Advanced Biologics back in 2014, the product was already on contract with Premier, Inc. (Nasdaq: PINC), which has an alliance of 3,750 hospitals and upward of 130,000 other organizations across the U.S. Three years later, Bioventus has secured a new contract with Premier for its full, nine-product surgical portfolio, which includes bone grafts and marrow extraction devices, among other products. The new contract “improves… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 8, 2017 Category: American Health Authors: Jennifer Henderson Source Type: news

Infection of Grafted Site: recommendations?
This patient had peri-implantitis. I grafted the area with Bio-Oss, allograft and autogenous mixed with PRF serum and held in place with titanium-reinforced membrane. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 7, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

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 17, 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