Minimum 5-year clinical outcomes, survivorship, and return to sports after hamstring tendon autograft reconstruction for sternoclavicular joint instability - Lacheta L, Dekker TJ, Goldenberg BT, Horan MP, Rosenberg SI, Pogorzelski J, Millett PJ.
BACKGROUND: Instability of the sternoclavicular (SC) joint is a rare but potentially devastating pathologic condition, particularly when it occurs in young or active patients, where it can lead to persistent pain and impairment of shoulder function. SC joi... (Source: SafetyLit)
Source: SafetyLit - February 13, 2020 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Rescue stem cell allograft in intensive care unit patients during septic shock with multi-organ failure
We describe what we believe to be the first two cases of patients who received an allograft in intensive care unit (ICU) despite severe septic shock with multi-organ failure (MOF). Allograft should be considered as a rescue therapy in ICU for patients with aplasia, during septic shock with multi-organ failure, however close multidisciplinary discussion is required between intensivists and onco-hematologists. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 23, 2020 Category: Consumer Health News Source Type: news

20 Private Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

20 Private Medtech Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

A mouse model of prostate cancer bone metastasis in a syngeneic immunocompetent host
(Impact Journals LLC) The research team reports the establishment of B6Ca P, an allograft tumor line from a Hi-Myc transgenic mouse that had been backcrossed onto C57BL/6J background. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 4, 2019 Category: Cancer & Oncology Source Type: news

New Score Accurately Predicts Risk of Kidney Allograft Loss New Score Accurately Predicts Risk of Kidney Allograft Loss
A new eight-factor scoring system, iBox, accurately predicts the risk of allograft loss in patients receiving kidney transplants, according to an international study.Reuters Health Information (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - October 30, 2019 Category: Pathology Tags: Transplantation News Source Type: news

Autogenous bone graft after tenting?
I posted a tenting case question a couple months ago and it did fine. I gained 3mm height and I want to gain another 5mm.   I have used 5mm block bovine grafts in the past but I am on board with an autogenous block graft.The postAutogenous bone graft after tenting? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - October 24, 2019 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Protecting the Heart Allograft With a Statin Protecting the Heart Allograft With a Statin
An intriguing study investigates whether a single dose of a statin administered to a brain-dead heart donor might improve outcomes for the transplant recipient.Circulation (Source: Medscape Transplantation Headlines)
Source: Medscape Transplantation Headlines - October 4, 2019 Category: Transplant Surgery Tags: Cardiology Journal Article Source Type: news

Medtronic Announces New Infuse Trial on Heels of NASS Panel
This study has the potential to add to the broader clinical and scientific evidence regarding use of Infuse and may allow surgeons to better understand its safe and effective use in TLIF procedures.” (Source: MDDI)
Source: MDDI - September 28, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news

NASS Panel Revisits Medtronic Infuse Bone Graft Controversy
A panel at the North American Spine Society (NASS) meeting in Chicago, IL, revisited a controversy that dates back nearly 15 years surrounding Medtronic’s Infuse bone graft, which contains a recombinant version of bone morphogenetic protein-2 (rhBMP-2). The timing of Wednesday’s panel session, “The Biologic Hasn’t Changed but the Evidence Has,” was interesting given Medtronic was already gearing up to announce on Thursday that FDA has signed off on a new Infuse trial that could lead to the product being cleared for a new indication. &...
Source: MDDI - September 25, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news

Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance
Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine. Robert Gewirtz, a neurosurgeon based in Columbus, OH, collaborated on the development of the Boxcar VBR product. “I see many patients that require a cervical corpectomy, and it's excitin...
Source: MDDI - September 24, 2019 Category: Medical Devices Tags: Plastics Today Source Type: news

Mallinckrodt Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of StrataGraft(R) Regenerative Tissue in Patients with Deep Partial-thickness Thermal Burns
Study met both co-primary endpoints with high statistical significance, demonstrating autograft sparing and durable wound closure at three months with StrataGraft Company plans to submit Biologics License Application to the U.S. Food and Drug Administra... Regenerative Medicine Mallinckrodt, StrataGraft, regenerative tissue, burn wounds (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 23, 2019 Category: Pharmaceuticals Source Type: news

CareDx Enrolls First Patient in OKRA Registry
CareDx has enrolled the first patient in the Outcomes of KidneyCare in Renal Allografts (OKRA) registry. There will be about 4,000 patients in the Brisbane, CA-based company’s registry, which is statistically powered to determine the use of KidneyCare and provide real-world data on the use of KidneyCare and AlloSure. OKRA targets more than 50 transplant centers and will enroll 1,500 newly transplanted patients, complementing the Kidney Outcomes Allograft Registry (KOAR) with 1,500 patients, matching both arms with 1,000 control patients. “Data on 4,000 patients provides the ultimate regi...
Source: MDDI - September 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

New hydrogels show promise in treating bone defects
Bioengineers and dentists from the UCLA School of Dentistry have developed a new hydrogel that is more porous and effective in promoting tissue repair and regeneration compared to hydrogels that are currently available. Once injected in a mouse model, the new hydrogel is shown to induce migration of naturally occurring stem cells to better promote bone healing. Current experimental applications using hydrogels and stem cells introduced into the body or expensive biological agents can come with negative side effects.The findings, published online in the journal Nature Communications, suggest that in the near future the...
Source: Dental Technology Blog - August 28, 2019 Category: Dentistry Source Type: news

New hydrogels show promise in treating bone defects
Bioengineers and dentists from the UCLA School of Dentistry have developed a new hydrogel that is more porous and effective in promoting tissue repair and regeneration compared to hydrogels that are currently available. Once injected in a mouse model, the new hydrogel is shown to induce migration of naturally occurring stem cells to better promote bone healing. Current experimental applications using hydrogels and stem cells introduced into the body or expensive biological agents can come with negative side effects.The  findings, published online in the journal Nature Communications, suggest that in the near future th...
Source: UCLA Newsroom: Health Sciences - August 19, 2019 Category: Universities & Medical Training Source Type: news

Islet-Allograft Tolerance Possible in Monkeys Without Long-Term Immunosuppression Islet-Allograft Tolerance Possible in Monkeys Without Long-Term Immunosuppression
Long-term tolerance of islet allografts may be possible without prolonged immunosuppression, according to studies in monkeys.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - August 17, 2019 Category: Allergy & Immunology Tags: Transplantation News Source Type: news

Camber Spine Announces Addition of Biologics to Its Portfolio
KING OF PRUSSIA, Pa., Aug. 7, 2019 -- (Healthcare Sales & Marketing Network) -- Camber Spine, a leading innovator in spine and medical technologies, today announced that it is expanding its portfolio by offering biologics through a signed private label ag... Devices, Orthopaedic, Product Launch, Distribution Camber Spine, Scylla, cellular bone graft, allograft, bone matrix (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 7, 2019 Category: Pharmaceuticals Source Type: news

Research in Regenerative Medicine proposes a quality control framework for umbilical cord blood-sourced allografts
(Future Science Group) The recent study from Burst Biologics challenges existing standards and outlines future safety and potency benchmarks. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 22, 2019 Category: International Medicine & Public Health Source Type: news

Does autograft choice in ACL reconstruction affect recurrent ACL revision rates?
(American Orthopaedic Society for Sports Medicine) Young athletes who have anterior cruciate ligament surgery are more likely to need an additional surgery if they received a hamstring graft compared to a bone-patellar tendon-bone graft, according to research presented today at the American Orthopedic Society for Sports Medicine Annual Meeting. The research was conducted by group of clinicians led by Dr. Christopher C. Kaeding of Ohio State University in Columbus, Ohio. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 12, 2019 Category: International Medicine & Public Health Source Type: news

Lateral extra-articular tenodesis reduces hamstring autograft
(American Orthopaedic Society for Sports Medicine) The addition of lateral extra-articular tenodesis to a hamstring autograft in knee surgery in young active patients significantly reduces graft failure and persistent anterolateral rotatory laxity at two years post operatively. The research, presented at the Annual Meeting of the American Orthopedic Sports Medicine Society, received the O'Donoghue Sports Injury Award. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 12, 2019 Category: International Medicine & Public Health Source Type: news

Cerapedics Appoints Patrick O'Connor as Vice President of Clinical and Market Development
WESTMINSTER, Colo., June 24, 2019 -- (Healthcare Sales & Marketing Network) -- Cerapedics, a privately-held orthobiologics company, today announced the appointment of Patrick O'Connor as Vice President of Clinical and Market Development. "We are p... Devices, Orthopaedic, Neurosurgery, Personnel Cerapedics, i-FACTOR Peptide, Bone Graft, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 24, 2019 Category: Pharmaceuticals Source Type: news

Helping the body's ability to grow bone
(University of Portsmouth) For the first time, scientists have been able to study how well synthetic bone grafts stand up to the rigors and 'strains' of life, and how quickly they help bone re-grow and repair. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - June 24, 2019 Category: Biology Source Type: news

Biologics in acute burn injury - Kogan S, Halsey J, Agag RL.
There have been significant advances in the care of burns over the past decade. As a result of the improved survival of burn patients, attention has shifted to the optimized management of their wounds. Traditionally, autografts have been described as the g... (Source: SafetyLit)
Source: SafetyLit - June 19, 2019 Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news

Implant with lingual cortex perforation: Explant or wait for osseointegration ?
While placing the implant there was an incorrect angulation and the implant gave away apically at the lingual cortex.   Buccal bone graft and membrane were placed.  Should one explant, graft and place implant later or should one wait for it to osseointegrate?The postImplant with lingual cortex perforation: Explant or wait for osseointegration ? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - June 3, 2019 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

Immediate Implant Placed too Labial gets saved by Soft Tissue: No Graft Needed
The implant was placed, by me, too labial in my opinion. Because the patient had adequate quantity/quality of attached tissue the case was saved. In this case no bone graft material was used.The postImmediate Implant Placed too Labial gets saved by Soft Tissue: No Graft Needed appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - May 29, 2019 Category: Dentistry Authors: Timothy C Carter Tags: Clinical Cases Surgical Source Type: news

Need buccal bone augmentation for implant – Indication for Bond Apatite?
The patient is a 67 year old physician who underwent surgical removal of #30 with socket preservation allograft 6 months ago. Would you graft at the time of implant placement?The postNeed buccal bone augmentation for implant– Indication for Bond Apatite? appeared first onOsseoNews Dental Implants. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - May 28, 2019 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

MiMedx Appoints Timothy R. Wright as Chief Executive Officer
Healthcare Industry Veteran to Lead Next Phase of MiMedx MARIETTA, Ga., May 9, 2019 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (OTC PINK: MDXG) ("MiMedx" or "the Company"), an industry leader in advanced wound c... Devices, Wound Care, Personnel MiMedx Group, PURION, placental tissue, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 9, 2019 Category: Pharmaceuticals Source Type: news

New AlphaGRAFT DBM Fiber Technology Improves Regenerative Capacity
Optimized handling enables combination with allograft or autograft for use in spinal fusion procedures Provides moldable allograft with cohesive handling characteristics and osteoconductive scaffold for delivery of autologous stem cells Regenerative capacity exhibits all five elements of new bone formation in validated animal modelsThis story is related to the following:Surgical Implants (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - May 7, 2019 Category: Medical Devices Source Type: news

How CareDx Is Bringing AI to Transplant Care
Brisbane, CA-based CareDx has partnered with Cibiltech, a French company that develops artificial intelligence-based products for predictive medicine, to commercialize Predigraft.  Predigraft is a data analysis tool designed to provide an early prediction of a patient's risk of allograft rejection and transplant loss. It was developed from Cibiltech’s software algorithm called iBox, which is built off the outcomes data from tens of thousands of transplant patients. The deal is yet another example of how AI is disrupting the status quo in medtech. MD+DI recently publishe...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Software Source Type: news

FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix
Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures. The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites. The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said. “We continue to expand our product portfo...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal collagenmatrix Source Type: news

Miach Orthopaedics touts results of two-year study on ACL repair
Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure. The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft ACL reconstruction and was conducted under an FDA Investigational Device Exemption. The BEAR implant was designed to be surgically placed between the torn ACL ends at the time of re...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Featured Implants News Well Orthopedics Research & Development Surgical Miach Orthopaedics Source Type: news

Wright Medical closes rights agreement for BioMimetics buyout
Wright Medical (NSDQ:WMGI) said yesterday that it closed a contingent value rights agreement connected to its acquisition of BioMimetic Therapeutics. Wright agreed to pay $380 million in cash, stock and milestone payments to pick up BioMimetic and its Augment bone graft back in 2013. The FDA cleared the bone graft with indications as an alternative autograft for ankle and hindfoot fusion procedures in September 2015. The Amsterdam-based company said that the agreement, dated March 1, 2013 between it and American Stock Transfer & Trust, is terminated effective March 1, according to a press release. The Augment bone...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat wrightmedical Source Type: news

S & amp;N Expands Reach into Regenerative Medicine with M & amp;A
Smith & Nephew is taking a deeper dive into the regenerative medicine market through its $660 million acquisition of Osiris Therapeutics. The London-based company said it hopes to close the deal in 2Q19 and made the announcement of the pending merger at the American Academy of Orthopedics Annual Meeting held this week in Las Vegas. Columbia MD-based Osiris Therapeutics delivered revenue of $102 million for the nine-months ended 30 September 2018, an 18.7% increase over the comparable period in 2017. Revenue was $36.5 million for the three-month period ended 30 September 2018, a 22.4% increase year on year. Osiris is ex...
Source: MDDI - March 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Orthopedics Source Type: news

Smith and Nephew expands in high growth regenerative medicine market through acquisition of Osiris Therapeutics, Inc.
LONDON, March 12, 2019 -- (Healthcare Sales & Marketing Network) -- Smith & Nephew plc (LSE: SN,NYSE: SNN), the global medical technology business, announces that it has agreed to acquire Osiris Therapeutics, Inc. (NASDAQ: OSIR), a fast growing company de... Devices, Orthopaedic, Mergers & Acquisitions Smith & Nephew, Osiris Therapeutics, dermal graft, bone graft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 12, 2019 Category: Pharmaceuticals Source Type: news

Timing of Medicare Loss Linked to Kidney Transplant Outcomes
MONDAY, March 11, 2019 -- Kidney transplant recipients receiving Medicare who lose coverage before or after the current three-year policy time point have an increased risk for allograft loss, according to a study published online March 5 in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 11, 2019 Category: Pharmaceuticals Source Type: news

Medtronic launches Grafton DBM in Japan
Medtronic (NYSE:MDT) said today that it launched its Grafton demineralized bone matrix bone grafting product in Japan. The Fridley, Minn.-based company touted the Grafton DBM as the first and only demineralized bone matrix product available in Japan, having won clearance from the country’s PMDA last August. The newly launched Grafton DBM is a bone graft extender, bone graft substitute and bone void filler intended for use in bony voids or gaps in the skeletal system. The company added that the Grafton DBM has consistently high osteoconductivity scores and that it is the “most utilized and scientifically-st...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Orthopedics Spinal Medtronic Source Type: news

Orthofix wins FDA PMA nod for M6-C artificial cervical disc
Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration. The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April. The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said. Pre-market approval of the de...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Spinal Orthofix Source Type: news

Sirakoss wins CE Mark for Osteo3 bone graft substitute
Sirakoss said yesterday that it won CE Mark clearance in the European Union for its Osteo3 novel nanosynthetic bone graft substitute. The Aberdeen, Scotland-based company said that its Osteo3 consists of an inorganic matrix intended to be completely reabsorbed into the bone. Sirakoss added that the newly cleared bone graft substitute features a unique surface chemistry designed to catalyze rapid and complete bone regeneration following a fracture or for support after corrective surgeries. “Osteo3 is the first of our new generation of bone substitute products to receive CE Mark, a major milestone for Sirakoss. We...
Source: Mass Device - February 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Orthopedics Regulatory/Compliance sirakoss Source Type: news

Plasma Marker Predicts Allograft Failure in Lung Transplant
THURSDAY, Jan. 24, 2019 -- Donor-derived cell-free DNA (ddcfDNA) is a potential biomarker that can predict allograft failure after lung transplantation, according to a study published online Jan. 23 in EBioMedicine. Sean Agbor-Enoh, M.D., Ph.D.,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 24, 2019 Category: Pharmaceuticals Source Type: news

Bioventus launches Osteomatrix+ bone graft
Bioventus announced today that it has started selling Osteomatrix+ – a moldable bone graft substitute intended for a variety of orthopedic and spine bone remodeling applications. Bioventus officials boast that Osteomatrix+ has improved moldability, flexibility and versatility versus its predecessor. “Osteomatrix+ represents the first of several next-generation products that will be added to the Bioventus portfolio in the next five years,” Bioventus CEO Tony Bihl said in a news release. Get the full story on our sister site Medical Design & Outsourcing.  The post Bioventus launches Osteomatri...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well Orthopedics Bioventus LLC Source Type: news

New RBI for Kidney Allografts: Can It Replace Routine Tests? New RBI for Kidney Allografts: Can It Replace Routine Tests?
Dr Desai reviews a study examining the usefulness of a new renal biopsy index (1-RBI). Could it be used in place of invasive routine biopsies in deceased-donor kidney transplant recipients?Medscape Nephrology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 14, 2019 Category: Consumer Health News Tags: Nephrology Viewpoint Source Type: news

Pirfenidone in RAS After Lung Transplantation Pirfenidone in RAS After Lung Transplantation
How might pirfenidone benefit lung transplant recipients with restrictive allograft syndrome?American Journal of Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 10, 2019 Category: Consumer Health News Tags: Transplantation Journal Article Source Type: news

New Data Boosts Value Proposition of AlloSure
When our kidneys fail to function as they should, our treatment options generally begin with dialysis and end with a kidney transplant. Unfortunately, transplanted kidneys last, on average, between 12 years and 15 years (depending on if the donor is living or deceased, and if they are a relative or not). Some recipients are lucky if they even get five good years out of their transplanted kidney. CareDx has already established the clinical value of AlloSure, a donor-derived cell-free DNA test designed to assess allograft health in kidney transplant patients, and new data demonstrates the test's clinical utility in patients ...
Source: MDDI - January 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: IVD Source Type: news

Kuros raises $16m for bone-growth protein
Kuros Biosciences (SIX:KURN) said this week that it raised more than $16 million for clinical trial of its bone-growth protein as it expands the commercial footprint for its MagnetOs bone graft substitute. Proceeds from the CHF 16.1 million round are earmarked for a Phase II trial of the Fibrin-PTH protein in spinal fusion procedures and for the commercialization of MagnetOs, which won 510(k) clearance from the FDA in August 2017 and CE Mark approval in the European Union in May. Kuros won CE Mark approval in the European for its Neuroseal dural sealant in June 2017. The Zurich-based company said it plans to laun...
Source: Mass Device - December 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Orthopedics Regenerative Medicine kurosbiosciences Source Type: news

Hamstring injuries in Major League Baseball pitchers: implications in graft selection for ulnar collateral ligament reconstruction - Howard DR, Banffy MB, Elattrache NS.
BACKGROUND:: Hamstring tendons are commonly harvested as autograft for ulnar collateral ligament reconstruction. There is no consensus in the literature whether the hamstring tendon should be harvested from the ipsilateral (drive) leg or contralateral (lan... (Source: SafetyLit)
Source: SafetyLit - December 19, 2018 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

MiMedx accounting firm quits
The troubles at MiMedx (NSDQ:MDXG) continued last week with the resignation of the accounting firm tapped to audit its books in the wake of a financial scandal. Marietta, Ga.-based MiMedx last July ousted ex-CEO Parker Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June. At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into ...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Regenerative Medicine Wall Street Beat MiMedx Group Inc. Source Type: news

Globus Medical launches ExcelsiusGPS in EU
Globus Medical (NYSE:GMED) said yesterday that it launched its ExcelsiusGPS robotic guidance and navigation system in the global market, having completed installations of the system in several European countries. The ExcelsiusGPS system won CE Mark clearance in the EU in early 2017 with indications for use in both minimally invasive and open procedures for orthopedics and neurosurgery, including procedures for the spine, long bones and cranium. The system is designed to integrate with Globus Medical implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging, the co...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Globus Medical Source Type: news

FDA warns Globus subsidiary HBT over ViaCell production facility issues
The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues. In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away ...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Globus Medical Source Type: news

Pushing 3D Printing Forward
Researchers and students have demonstrated that inks can be used instead of thermoplastic filaments to 3D print functional biomedical devices. Michael McAlpine, Benjamin Mayhugh Associate Professor of Mechanical Engineering at the University of Minnesota, described such advances in the ESC Minneapolis keynote, “3D Printing Functional Materials & Devices.” A lot of the inks McAlpine’s group uses are nanometer-scale particle inks printed at a line-width scale of 10 microns and above for printing devices at the macro level. They have developed software as well as a hig...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M Minneapolis 3-D Printing Source Type: news

RTI Surgical wins coverage nod for Simmetry implant
RTI Surgical (NSDQ:RTIX) said today that non-profit healthcare organization HealthPartners issued a positive coverage decision covering the company’s minimally invasive sacroiliac joint fusion surgery using the Simmetry system, effective November 1. The Simmetry system is a minimally invasive surgical solution using decotrication technology, bone graft and threaded fixation to facilitate bone fusion and provide long-term pain relief, Alachua, Fla.-based company said. “As a surgeon in the HealthPartners network who has experience using the Simmetry System, this positive coverage decision is a win for patien...
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal RTI Surgical Source Type: news