Medtronic to pay $12m to settle Infuse false marketing claims
Medtronic‘s (NYSE:MDT) spinal devices division has agreed to pay $12 million to settle allegations that the medtech giant made false claims to doctors and patients about its Infuse bone-growth protein, according to a Star Tribune report.
States joining in the settlement include California, Massachusetts, Illinois, Washington and Oregon, according to the report.
In Oregon, Attorney General Ellen Rosenblum said that Medtronic Sofamor Danek agreed to settle claims that it manipulated journal articles to make its controversial Infuse protein appear safer than it was to sell more products, breaking Oregon law, the Star Tr...
Source: Mass Device - December 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Spinal Medtronic Source Type: news
Medtronic settles states' probe into Infuse marketing for $12 million
BOSTON (Reuters) - Medtronic Plc has agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
C-reactive protein promotes bone destruction in human myeloma through the CD32-p38 MAPK-Twist axis
Bone destruction is a hallmark of myeloma and affects 80% of patients. Myeloma cells promote bone destruction by activating osteoclasts. In investigating the underlying mechanism, we found that C-reactive protein (CRP), a protein secreted in increased amounts by hepatocytes in response to myeloma-derived cytokines, activated myeloma cells to promote osteoclastogenesis and bone destruction in vivo. In mice bearing human bone grafts and injected with multiple myeloma cells, CRP bound to surface CD32 (also known as FcRII) on myeloma cells, which activated a pathway mediated by the kinase p38 MAPK and the transcription factor ...
Source: Signal Transduction Knowledge Environment - December 12, 2017 Category: Science Authors: Yang, J., Liu, Z., Liu, H., He, J., Yang, J., Lin, P., Wang, Q., Du, J., Ma, W., Yin, Z., Davis, E., Orlowski, R. Z., Hou, J., Yi, Q. Tags: STKE Research Articles Source Type: news
State of the U.S. Market for Dental Bone Graft Substitutes and Other Biomaterials
The dental bone graft substitute and other biomaterials market includes dental bone graft substitutes (DBGS), dental growth factors, and dental barrier membranes. The DBGS market is relatively stable with an increasing shift towards allografts. Already representing the largest segment of total DBGS materials, the allograft market is expected to grow at a 5.8% compound annual growth rate (CAGR) by 2023.
The most innovative market in dental biomaterials is dental growth factor technology. However, these products have been slow to make strides on the market due to their relatively high price point. As such, growth within the ...
Source: MDDI - December 9, 2017 Category: Medical Devices Authors: Salma Mashkoor and Celine Mashkoor Tags: Materials Source Type: news
Bone Resorption During Submerged Healing After Guided Bone Regeneration: A Prospective Case Series
Conclusion: Loss in graft quantity was observed after ridge augmentation using an allograft and nonresorbable membrane during submerged healing before implant placement. Further studies with larger sample sizes are recommended to confirm its findings. (Source: Dental Technology Blog)
Source: Dental Technology Blog - December 4, 2017 Category: Dentistry Source Type: news
Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017
Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately.
Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing Chris Fair, who will stay on as a board member with the company.
“I am excited by the opportunity to lead our talented team of employees and partners and create an even more vibrant and dynamic Spinal Elements in the years to come. I t...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Abbott Alphatec Apica Cardiovascular Bovie Medical Corp. Cardiovascular Systems Inc. Dentsply Sirona Guidant Corp. Lima Corporate Medical Device Innovation Consortium MedLumics MedTech Europe Medtronic Nuv Source Type: news
MiMedx Provides Update On Its Reimbursement Coverage
MARIETTA, Ga., Nov. 21, 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 ... Regenerative Medicine, Reimbursement MiMedx, EpiFix, Venous Leg Ulcer, Diabetic Foot Ulcer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 21, 2017 Category: Pharmaceuticals Source Type: news
RTI Surgical reveals FDA warning letter over Map3 allograft classification
RTI Surgical (NSDQ:RTIX) today revealed a warning letter it received from the FDA related to processes used to manufacture its Map3 cellular allogeneic bone graft over issues with the regulatory classification of the product.
The Alachua, Fla.-based company said it received the letter on November 9 based on an inspection of its facilities from April and that it is preparing an appropriate response to the letter.
In the letter, the FDA asserted that the Map3 allograft could not be regulated solely as a human cell, tissue and cellular and tissue-based product, but that the product was also subject to regulations applicable ...
Source: Mass Device - November 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine RTI Surgical Source Type: news
Hologic to retain CEO MacMillan | Personnel Moves – November 3, 2017
Hologic (NSDQ:HOLX) said this week its current prez and CEO Stephen MacMillan will stay on with the company, resolving rumors that he may depart it to take up the corner office at Zimmer Biomet (NYSE:ZBH).
In an SEC filing, the Marlborough, Mass.-based company’s board said it approved a special “performance-based retention equity grant” to MacMillan after he had begun to receive interest from other medical device firms.
“Mr. MacMillan has led a dramatic turnaround of Hologic since joining in December 2013. The company’s performance has increased significantly under his leadership and he perso...
Source: Mass Device - November 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News ConMed Corp. Hologic Invacare kentimaging Meritech Capital Partners Pulmatrix Inc. Sanofi-Aventis Smith & Nephew Tissue Regenix zimmerbiomet Source Type: news
Wright Medical shares tumble on Q3 sales miss, growing losses
Shares in Wright Medical (NSDQ:WMGI) fell today after the medical device maker missed sales expectations on Wall Street with its 3rd quarter earnings results.
The Netherlands-based company posted losses of $131.9 million, or $1.26 per share, on sales of $170.5 million for the 3 months ended September 30, seeing losses grow 19.7% while sales grew a smaller 8.4% compared with the same period last year.
Adjusted to exclude 1-time items, losses per share were 16¢, just ahead of the 17¢ consensus on Wall Street, where analysts expected to see revenue of $173.6 million.
“Our U.S. upper extremities business had an except...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup wrightmedical Source Type: news
MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions
MARIETTA, Ga., Nov. 1, 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 a... Devices, Regenerative Medicine, Wound Care, Litigation MiMedx, Halo Wound Solutions (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 1, 2017 Category: Pharmaceuticals Source Type: news
Arthrosurface acquires allograft tech from Wasas
Arthrosurface said today that it paid an unspecified amount to acquire an acellular dermal stabilization device technology from Wasas LLC.
Derived from human tissue, acellular dermis is made using a process that removes cells but retains portions of the extracellular matrix to create dermal allografts.
The deal includes the patent rights for the technology, which Franklin, Mass.-based Arthrosurface plans to develop and market “a platform of novel methods to be used to correct orthopedic challenges” for several indications. Wasas is based in Ft. Lauderdale.
“The availability of this allograft to Arthros...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Orthopedics Wall Street Beat Arthrosurface wasas Source Type: news
NASS 2017 Roundup: Zimmer Biomet launches Vitality+, Vital spinal fixation systems
Zimmer Biomet (NYSE:ZBH) today announced the launch of its Vitality+ and Vital spine fixation systems in the US following recent 510(k) clearance for pedicle preparation and screw insertion under power.
The Vitality+ spinal fixation system is composed of a Vitality+ Power designed for controlled pedicle preparation and pedicle screw insertion, Vitality+ PSO designed for optimal pedicle subtraction osteotomy and vertebral column resection and Vitality+ Hooks for additional fixation options, the Warsaw, Ind.-based company said.
The recent clearance allows the inclusion of the market’s first flexible drill and blunted ...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Spinal depuysynthes gssolutions johnsonandjohnson LifeNet Health Misonix Mizuho OSI Nuvasive RTI Surgical Xtant Medical zimmerbiomet Source Type: news
LifeNet Health Provides Uncompromised Fusion Solution with Launch of PliaFX(R) Strip
Presentations at NASS Annual Meeting (Booth 1113) will highlight the technology behind PliaFX Strip
ORLANDO, Fla., Oct. 25, 2017 -- (Healthcare Sales & Marketing Network) -- LifeNet Health has introduced its latest allograft bone-healing solution, the ... Devices, Orthopaedic, Product Launch LifeNet Health, PliaFX, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 25, 2017 Category: Pharmaceuticals Source Type: news
TGF-{beta} receptor I/II trafficking and signaling at primary cilia are inhibited by ceramide to attenuate cell migration and tumor metastasis
Signaling by the transforming growth factor–β (TGF-β) receptors I and II (TβRI/II) and the primary cilia-localized sonic hedgehog (Shh) pathway promote cell migration and, consequently, tumor metastasis. In contrast, the sphingolipid ceramide inhibits cell proliferation and tumor metastasis. We investigated whether ceramide metabolism inhibited TβRI/II trafficking to primary cilia to attenuate cross-talk between TβRI/II and the Shh pathway. We found that ceramide synthase 4 (CerS4)–generated ceramide stabilized the association between TβRI and the inhibitory factor Smad7, which lim...
Source: Signal Transduction Knowledge Environment - October 24, 2017 Category: Science Authors: Gencer, S., Oleinik, N., Kim, J., Panneer Selvam, S., De Palma, R., Dany, M., Nganga, R., Thomas, R. J., Senkal, C. E., Howe, P. H., Ogretmen, B. Tags: STKE Research Articles Source Type: news
