MCRA, an IQVIA business’ Post

What is the most innovative and game changing advancement in orthopedics? 🍿 U.S. Food & Drug Administration (FDA) granted Onkos Surgical a De Novo approval for its novel antibacterial coated implants. Bacterial contamination of a permanent implant may have devastating effects, particularly in orthopedic oncology and revision arthroplasty applications where the patient population is highly vulnerable. The data showed that the proprietary coating does not elute and has been proven to be bactericidal, with a 99.999% (5 log) kill rate in in-vitro testing of bacteria that are commonly found in the operating room environment. #additivemanufacturing #3dprinting #oncology #revision #tumor #patientspecific #infection #bacteria

Ophthopedia Update:Subgroup Analysis from a Phase 1/2 Randomized Clinical Trial of 2.6% EDTA Ophthalmic Solution in Patients with Age-Related Cataract: Effective non-invasive therapy to treat visual function decline due to pre-surgical cataract remains as a significant unmet medical need in the US and the rest of the world. It is estimated that over 80 million people worldwide have moderate and severe vision impairment caused by cataract.1 Currently, there are no Food and Drug Administration (FDA) approved pharmacological therapies for age-related cataract, and cataract surgery remains the only safe and effective treatment option available. Although cataract surgery has become common in many parts of the world, the number of individuals with vision loss associated with cataract has been increasing due to an aging population in many developed countries. #Ophthalmology #Ophthotwitter #Scicomm

My comprehensive look at PRP or platelet rich plasma. Why are so many orthropods even at academic centers using it? What do the data say? https://lnkd.in/gUhAsxpz #stemcells #orthopedics

🌟 Check out this insightful article from the Review of Ophthalmology, "What’s on the Horizon for Keratoconus?" featuring our very own EpiSmart! 🔬 Our innovative epithelium-on cross-linking system is highlighted for its groundbreaking approach in Phase III FDA trials. With a focus on minimally invasive treatment, EpiSmart is poised to change the landscape for keratoconus patients. 🚀 #Keratoconus #Ophthalmology #EpiSmart #EyeHealth #MedicalInnovation #EpionTherapeutics

📃Scientific paper: Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse Abstract: Introduction and hypothesis Fully absorbable implants may be an alternative to permanent meshes in the correction pf pelvic organ prolapse (POP) as they may reduce adverse events by promoting tissue regeneration and collagen metabolism. This study was aimed at evaluating the long-term host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with polypropylene (PP) mesh. Methods Poly-4-hydroxybutyrate scaffold ( n  = 16) and PP mesh ( n  = 16) were surgically implanted in the posterior vaginal wall of parous female Dohne Merino sheep. Vaginal explants were evaluated in terms of gross necropsy, host response (immune response, collagen deposition, tissue regeneration), biomechanics, and degradation of P4HB at 12 and 24 months post-implantation. Results Gross necropsy revealed no infection or fluid collection using P4HB or PP. At 12 months, exposures were observed with both P4HB (3 out of 8) and PP (4 out of 8), whereas at 24 months, exposures were observed only with PP (4 out of 8). The tensile stiffness of the P4HB explants was maintained over time despite complete absorption of P4HB. The collagen amount of the vaginal tissue after P4HB implantation increased over time and was significantly higher than PP at 24 months. P4HB scaffolds exhibited significantly lower myofibroblast differentiation than PP meshes at 24 months. Conclusions The P4HB scaffold allowed for gradual load transfer to the vaginal wall and resulted i... Continued on ES/IODE ➡️ https://etcse.fr/BMc ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

NEW RESEARCH ALERT! Crystal Research Associates released a 48-page EIO on NeXtGen Biologics, Inc. (Closely Held), a closely held medical device company that holds a suite of patents for extracellular matrix (ECM) platform technology derived from the axolotl, a rare paedomorphic salamander closely related to the tiger salamander. Leveraging the Company’s innovative biotechnology, NeXtGen Biologics, Inc. is seeking to unravel the mysteries of regeneration and scar-free healing using the ECM of the axolotl, as this species is capable of regenerating organs and complex tissues (including its nervous system). The Company is currently developing platform solutions to address and enhance the treatment of various intricate conditions found in wound care, general surgery, trauma, plastic surgery, cardiovascular diseases, neurosurgery, orthopedics, and ophthalmology. NeXtGen’s first FDA-cleared device, NeoMatriX® Wound Matrix, is indicated for partial and full thickness wounds, pressure venous diabetic and chronic vascular ulcers, surgical wounds, trauma wounds, Mohs surgery, and burns. NeoMatriX is provided as sheets in various sizes for placement on wound beds to help manage the wound environment. Check out our report to learn more about the Company. | https://bit.ly/3LreZjL #NeXtGenBiologics #NeoMatriXWoundMatrix #ExtracellularMatrix #Axolotl #ChronicVascularUlcers #SurgicalWounds #TraumaWounds #MohsSurgery #PartialAndFullThicknessWounds

NEW RESEARCH ALERT! Crystal Research Associates released a 48-page EIO on NeXtGen Biologics, Inc. (Closely Held), a closely held medical device company that holds a suite of patents for extracellular matrix (ECM) platform technology derived from the axolotl, a rare paedomorphic salamander closely related to the tiger salamander. Leveraging the Company’s innovative biotechnology, NeXtGen Biologics, Inc. is seeking to unravel the mysteries of regeneration and scar-free healing using the ECM of the axolotl, as this species is capable of regenerating organs and complex tissues (including its nervous system). The Company is currently developing platform solutions to address and enhance the treatment of various intricate conditions found in wound care, general surgery, trauma, plastic surgery, cardiovascular diseases, neurosurgery, orthopedics, and ophthalmology. NeXtGen’s first FDA-cleared device, NeoMatriX® Wound Matrix, is indicated for partial and full thickness wounds, pressure venous diabetic and chronic vascular ulcers, surgical wounds, trauma wounds, Mohs surgery, and burns. NeoMatriX is provided as sheets in various sizes for placement on wound beds to help manage the wound environment. Check out our report to learn more about the Company. | https://bit.ly/3LreZjL #NeXtGenBiologics #NeoMatriXWoundMatrix #ExtracellularMatrix #Axolotl #ChronicVascularUlcers #SurgicalWounds #TraumaWounds #MohsSurgery #PartialAndFullThicknessWounds

OssDsign AB today announces that the previously communicated outstanding 12-month results from the clinical study TOP FUSION have been published in the peer-reviewed journal Biomedical Journal of Scientific & Technical Research. The results show a 93 % spinal fusion rate as well as improvements in quality of life and pain following surgery with the novel nanosynthetic bone graft OssDsign Catalyst. "The publication of the outstanding clinical results in TOP FUSION is a crucial step in our process of establishing OssDsign Catalyst as a clinically proven synthetic bone graft. The favorable outcome of this first material clinical study paves the way for a strong position of OssDsign Catalyst in the U.S. market," said Morten Henneveld, CEO of OssDsign. The use of synthetic bone graft substitutes has become more common to avoid the need to source allograft or iliac crest autograft. A new nanosynthetic, silicate-enriched calcium phosphate bone graft substitute, OssDsign Catalyst, has been designed to deliver consistent and rapid bone healing and remodeling. The high level of substituted silicate (5.8%) in the porous granules combined with the nanoscale architecture is thought to promote early bone formation. Find publication here: https://lnkd.in/dGJMBK94 Go to full press release here: https://lnkd.in/dDgKiKNy

Exciting Advancement: Theradaptive’s Groundbreaking Pivotal Preclinical Study featured in Spine!   We are thrilled to announce the publication of Theradaptive’s landmark study in Spine, the leading journal for the treatment of spinal disorders. This pivotal study showcases progression of fusion and healing time using an osteobiologic for interbody fusion in comparison to the standard of care in a large animal model.   Our lead product for spinal fusion, OsteoAdapt SP, has been shown to enhance fusion and stimulate more robust bone formation at earlier time points in comparison to traditional iliac crest bone graft (ICBG). The study not only highlights OsteoAdapt’s performance but also demonstrates its effectiveness and safety in a clinically relevant animal model.   Explore the full article below.   Thanks to our amazing team for making this breakthrough possible! #SpinalFusion #BoneBiologics #MedicalResearch #Innovation #OrthopedicSurgery #BoneGraft #PreclinicalResearch

Triple-Row Staple Technology May Reduce Anastomotic Leak in Colorectal Surgery A systematic review compared the efficiency of double-row staple technology with triple-row staple technology in reducing anastomotic leaks in colorectal surgeries. The review included six retrospective cohort studies, finding that triple-row staple technology significantly lowers the risk of anastomotic leaks compared to double-row staples. However, there were no significant differences in anastomotic hemorrhage, 30-day mortality, or reoperation rates between the two technologies. The review suggests that triple-row staple technology may reduce the risk of anastomotic leaks but does not significantly affect other surgical complications. For more details please click the link! https://lnkd.in/dc5WHMs3 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical