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 statement.
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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 the...
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)
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 pivotal tria...
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.
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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 post BoneSu...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Orthopedics Surgical Bonesupport Source Type: news
