Orthox Obtains MHRA Approval to Commence FFLEX Study 

On July 14, 2022, Orthodox Ltd, a clinical-stage company created medical implants to treat orthopedic problems including damaged knee articular cartilage. It was founded in 2008 by life scientist, Dr. Nick Skaer, and knee surgeon, Professor Oliver Kessler.

The company states that the UK’s MHRA granted it a Letter of No Objection, allowing it to begin its “FFLEX Study” (derived from the “FibroFixTM cartiLage repair Experience”). The study received support from funding from the National Institute for Health & Care Research (NIHR), Wellcome Trust, and the European Innovation Council (EIC).

The study will test the safety and efficacy of Orthox’s FibroFix™ Cartilage P (FibroFix™) implant and accessory surgical instrumentation in the knee joints of patients suffering from cartilage injuries. Patient recruitment was scheduled to begin in July 2022 at the lead clinical site, Southmead Hospital, North Bristol NHS Trust, the United Kingdom before eventually being expanded across Europe.

Commenting on the approval, and patent grant, Nick Skaer, co-founder, and CEO of Orthox said: “This MHRA approval is another significant milestone for our award-winning FibroFix product platform. FibroFix is unique in emulating the functional properties of cartilage while also, in laboratory tests, facilitating rapid tissue regeneration. It could make a real difference to patients suffering the debilitating effects of serious knee cartilage injuries. With our approach, there is significant bone sparing and strong tissue integration of the implant, which will result in much faster patient recovery from surgery. The multiple grants of our patent in key global economic territories further validate the novelty of our technology and extend our intellectual property coverage across countries in which a significant number of patients could be treated with our FibroFix implants every year.”

As per DelveInsight analysis, the development of such devices would massively transform care for patients with orthopedic diseases. According to DelveInsight’s Orthopedic Devices Marketreport, the global orthopedic devices market was valued at USD 44.09 billion in 2021, growing at a CAGR of 4.78% during the forecast period from 2022 to 2027 to reach USD 57.79 billion by 2027. The orthopedic devices market is slated to witness increasing revenue owing to factors such as a growing population of people above the age of 65, a rise in the cases of bone disorders such as osteoarthritis and osteoporosis among others, increasing cases of occupational injuries and non-occupational injuries along with latest technological developments in healthcare technology are further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period (2022-2027).

Centinel Spine® Receives FDA Approval for 3 Additional prodisc® Cervical Total Disc Replacement Devices 

On July 13, 2022, Centinel Spine® LLC is a top global medical device manufacturer that uses anterior surgical access to treat cervical and lumbar spinal diseases. The firm provides the most powerful and clinically-proven technological platforms in the world for total disc replacement (prodisc®) and Integrated InterbodyTM fusion (STALIF®). These solutions are underpinned by over 30 years of clinical success.

The company announced that it had received U.S. Food and Drug Administration (FDA) Pre-Market Application (PMA) Approval for 1-level indications and three additional cervical total disc replacement (TDR) devices: prodisc C Vivo, prodisc C Nova, and prodisc C SK. Along with the already accessible prodisc C implant, which is still frequently utilized in the United States, Centinel Spine now provides the world’s largest selection of cervical TDR options to accommodate surgeon choice and unique patient anatomy.

The prodisc C Vivo product has keel-less endplates, including a convex, superior endplate to match more concave vertebral anatomy, while the prodisc C SK and prodisc C Nova implant designs have flat endplates with low-profile keels to better match flat vertebral anatomy.

Centinel Spine’s CEO, Steve Murray, stated, “Anatomic cervical total disc options provide surgeons the benefit of selecting implants to optimally fit the disc to each patient. This is unique and represents a major advancement in spinal reconstruction. PMA approval for these three additional devices is a significant accomplishment, and we look forward to bringing the new prodisc options to the market in Q4 2022.”

According to DelveInsight’s “Spinal Stenosis Devices Market” report, the global spinal stenosis devices market will grow at a CAGR of 5.20% during the forecast period from 2022 to 2027. The spinal stenosis devices market is witnessing positive growth owing to the factors such as rising cases of spinal stenosis among the growing geriatric population, rising incidence of spinal injury, technological advancements in product development, increase in the number of product offerings, thereby contributing to the growth of the spinal stenosis devices market during the forecast period from 2022 to 2027.

Orthofix Medical and LimaCorporate Announce Partnership to Provide Solution for Patients with High Hip Dislocation for the United States Market

On July 13, 2022, Orthofix Medical Inc, is a top producer of spinal, orthopedic, bone development, and mobility preservation products, and has been in business since 1980 and LimaCorporate S.p.A., a medical device company focused on digital innovation and patient-tailored hardware, announced a licensing partnership for the United States market to provide a novel solution for patients with the challenging condition of chronic high dislocation of the hip.

The agreement combines the exclusive, patient-specific, 3D-printed pelvic fixation device from LimaCorporate with the novel limb-lengthening technology of Orthofix’s patented FitboneTM intramedullary nail system. After being surgically implanted, the devices cooperate to enable surgeons to divert the femur to an anatomically proper position, correcting the leg-length disparity, relieving pressure on the spine, and enabling a total hip replacement to follow.

“We are excited to partner with LimaCorporate to bring together our complementary technologies to satisfy the previously unmet needs of patients requiring a personalized and unique complex hip replacement solution,” said Kimberley Elting, President of Orthofix Orthopedics.  He also added, “This solution will be the only offering in the U.S. for certain patients with hip dysplasia or abnormalities of the hip leading to the leg-length discrepancy, and reflects the strength and versatility of the Fitbone platform.”

Emmanuel Bonhomme, LimaCorporate CEO, stated, “This partnership is an important opportunity for us to explore new segments and support even more U.S. surgeons and their patients. Additionally, the collaboration with the ProMade Point of Care Center (PoC Center), which opened last year, will bring added value in terms of experience and knowledge combined with our market-leading technologies in the custom prosthesis.”

According to DelveInsight’s “Hip Reconstruction/Replacement Devices Marketreport, the global hip reconstruction/replacement devices market was valued at USD 9.26 billion in 2021, growing at a CAGR of 5.06% during the forecast period from 2022 to 2027 to reach USD 12.44 billion by 2027. The rise in demand for hip reconstruction/replacement devices is primarily due to the rising geriatric population across the globe, the increase in obesity owing to a sedentary lifestyle, the introduction of custom-made implants, and technological advancement in the product portfolio, among others.

Cordis Started Enrolment of Patients in Europe for RADIANCY Clinical Study

On July 14, 2022, Cordis, a global leader in cardiovascular technologies, started the RADIANCY pre-market clinical study in Europe. It is a prospective, multi-center, single-arm study to assess the safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System intended for the treatment of lesions in the iliac, superficial femoral, or proximal popliteal arteries via radial artery access through 30-day follow up. 

The RADIANCY trial will recruit 159 patients at around 15 locations across seven European nations, coordinated by Principal Investigator Raphael Coscas MD, Ph.D., and Professor of Vascular Surgery at Ambroise Paré Hospital in France. 

The FDA approved the S.M.A.R.T. RADIANZTM Vascular Stent System for use in the United States earlier this year. 

“The radiancy study initiation marks a new course for the future management of patients with the peripheral arterial disease (pad) by expanding their treatment options from current conventional femoral to radial access,” Professor Coscas said.

Professor Coscas also added, “As the gold-standard approach in coronary interventions, radial is in its exciting inception phase for pad and offers unequivocal patient-centric advantages in terms of early mobility and comfort, critical in both in-patient and out-patient practice settings.”

The first procedure was performed by Dr. Mercedes Guerra, Chief of Angiology, Vascular and Endovascular Surgery at the University Hospital of Guadalajara in Spain, using the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter to facilitate delivery of the S.M.A.R.T RADIANZ™ self-expanding stent in an iliac lesion.

After completion of the first procedure, Dr. Guerra said, “My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study. We applaud Cordis for pursuing technological innovation to meet the need for radial access solutions in lower extremity interventions. We look forward to contributing our findings to the global endovascular community as part of the RADIANCY clinical study.”

According to DelveInsight’s Vascular Stents Marketreport, the global vascular stents market is expected to grow at a CAGR of 7.90% during the forecast period (2022-2027). The increase in the vascular stents market is predominantly owing to the increasing prevalence of vascular disorders such as atherosclerosis, carotid artery diseases, and peripheral artery diseases, among others. Additionally, as per DelveInsight analysis, North America is expected to hold a considerable market share in the year 2021. This is due to rising obesity levels, rising hypertension, coronary heart disorders, and peripheral vascular disorder, among others.  

With the help of Amazon Web Services, Medtronic is expanding its Health Equity Assistance Program for colon cancer screening 

On July 15, 2022, Medtronic plc., a global leader in healthcare technology, and the American Society for Gastrointestinal Endoscopy (ASGE), announced both companies are expanding the Medtronic Health Equity Assistance Program for colon cancer screening in medically underserved communities across the United States, with support from Amazon Web Services (AWS) Health Equity Initiative. The GI Genius units provided as part of the program by the company have increased from 50 to 133 systems being placed at 62 facilities. 

The GI Genius intelligent endoscopy module is the first-to-market computer-aided polyp detection system powered by artificial intelligence (AI) to detect colorectal polyps of varying shapes and sizes automatically in real-time, assisting in the diagnosis and prevention of colorectal cancer. The findings of the first GI Genius study in the United States released this spring, indicated a 50% reduction in missed colorectal polyps with AI technology versus traditional colonoscopy.

“Equity in healthcare begins with ensuring access for all to life-transforming therapies,” said Geoff Martha, Medtronic chairman, and chief executive officer. He added, “It’s exciting to see how our new collaboration with AWS can help clinicians detect colon cancer early among some of the highest risk individuals in our country.”

“This initiative is so important because we know that almost half of all cases of post-colonoscopy colon cancer may be attributed to not catching polyps during the index colonoscopy,”, said Dr. Austin Chiang, M.D., M.P.H., chief medical officer of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. 

Dr. also highlighted, “We have seen the impact that AI-assisted colonoscopies can have, and this study unequivocally demonstrates that this technology helps physicians better detect polyps during colonoscopies. The impact of missed polyps could ultimately be the difference between life and death when we consider that 90% of patients with colon cancer can beat it when it’s caught early.”

According to DelveInsight’s “Cancer Diagnostic Marketreport, the global cancer diagnostic market is expected to grow at a 9.43% CAGR during the forecast period (2022-2027). The increase in the cancer diagnostic market is predominantly owing to the increasing number of various cancers worldwide. Additionally, as per DelveInsight analysis, in the product type segment, the reagent and kits are expected to hold a considerable market share in the year 2021. This is due to the wide availability of reagents & kits for detecting cell signaling, cell proliferation and viability, tumor, suppressor gene, bioactive proteins, and others in cancer cells.  

DyAnsys Neurostimulation Device Used to Treat Diabetic Neuropathic Pain Cleared by FDA

On July 14, 2022, Dyansys Inc., one of the leading providers of advanced medical diagnostic and monitoring systems to clinicians in individual practices and hospitals, announced the FDA clearance of the PENS (percutaneous electrical neurostimulation) device, called First Relief. The device is used for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy through multiple treatments for up to 56 days. 

The wearable device is placed behind the ear, which provides continuous pulses of low-level electrical current for several days.

“We are excited to have the FDA clearance of First Relief so that this device, which has been proven effective, can now be used to treat patients who have been experiencing pain related to diabetic neuropathy,” said DyAnsys CEO Srini Nageshwar. He also highlighted, “First Relief offers a significant treatment option without drugs or narcotics.”

The regulatory approval was based on data obtained from a randomized, double-blind, single-center, controlled prospective study, which was conducted with 63 participants aged between 30 and 74 years. In the trial, the device was evaluated against a placebo, as well as another device that had previously been approved by the US FDA. The devices were applied for 16 weeks on a bi-weekly basis. Pain intensity was measured through the Visual Analog Scale (VAS) score as the study’s primary efficacy endpoint.

During the observation, the insomnia severity index (ISI), vibration perception threshold (VPT) value, total neuropathy limitations scale (ONLS), and Hamilton rating scale for anxiety were measured as some of the study’s secondary endpoints. Based on the findings from the study, subjects treated with First Relief experienced a significant reduction in VAS pain score from the start of treatment to the end, with the improvements continuing throughout 90 days of follow-up. This suggests that the device can provide long-term improvement in neuropathic pain.

DyAnsys also noted that similar improvements were also observed for all secondary endpoints, demonstrating significant improvement in sleep and mood alongside a decrease in neuropathic pain.According to DelveInsight’s “Neurostimulation Devices Marketreport, the global neurostimulation devices market is expected to grow at an 11.77% CAGR during the forecast period (2022-2027). The increase in neurostimulation devices is predominantly owing to the increasing number of cases of chronic diseases such as migraine and epilepsy worldwide. Additionally, as per DelveInsight analysis, in the product type segment, the spinal cord stimulators are expected to hold a considerable market share in the year 2021. This is due to the increasing prevalence of neuropathic pain and spinal injuries globally. Moreover, this therapy is less invasive, thereby anticipated to increase the demand for spinal cord stimulators in the market, in turn, increases the overall market growth of neurostimulator devices during the forecast period.