J&J intends to split into two companies, separating consumer products and pharmaceutical businesses 

On November 12, 2021, Johnson & Johnson announced its plans to split the Company’s Consumer Health business, forming a new publicly traded company. This will help the company create two global leaders that are well-positioned to provide enhanced health outcomes for patients and consumers through innovation, continue more targeted business strategies and expedite growth. 

This will result in the separation of its domestic products unit, maker of Band-Aid bandages, Aveeno and Neutrogena skincare products, and Listerine, from its riskier but faster-growing division, which makes and sells prescription drugs and medical devices, comprising its COVID-19 vaccine

According to DelveInsight’s analyst, this separation will play a significant role in strengthening the position of J&J in the pharmaceutical and medical device market. The company includes advanced technologies like robotics and artificial intelligence, which would hold the name Johnson & Johnson in the market. The Pharmaceutical and Medical Devices segments will generate approximately USD 77 billion in Full-Year 2021. It plans to complete the transaction in 18 to 24 months.

The company’s New Consumer Health Company would be a global leader with a robust portfolio of iconic brands, including four USD 1 billion megabrands and 20 brands over USD 150 million, and leading positions in Self Care (OTC), Skin Health and Essential Health that comprises baby care, feminine care, wound care and oral health.

This statement comes just days after General Electric said it intends to split into three separate publicly traded companies, spinning out its medical and energy units from its aviation unit.

Abbott’s new leadless Pacemaker System meets primary endpoints in a pivotal trial

On November 12, 2021, Abbott announced new, late-breaking data from the global Leadless II IDE study evaluating Abbott’s investigational Aveir leadless pacemaker in patients with specific abnormal heart rhythms. The data demonstrated that the Aveir device met its pre-specified primary endpoints and recommended that the Aveir system, once approved, could provide new advantages for patients who require a pacemaker to treat slow heart rhythms.

These findings were presented in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS) and, at the same time, published in the Journal of the American College of Cardiology: Clinical Electrophysiology. The data from the study has also been submitted to the US Food & Drug Administration as the Aveir leadless pacemaker is assessed for US approval.

Dr Vivek Y. Reddy, Helmsley Trust professor of medicine, director of cardiac arrhythmia services, Mount Sinai Hospital, said that the new Aveir pacing system holds the potential to advance treatment for patients who require a pacemaker but where physicians are worried about more invasive surgery or where they contemplate a patient’s therapy needs may change in the future and where retrievability will be a critical device feature.

Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott, said that as they developed the Aveir leadless pacemaker platform, their fundamental guiding principle was to design a device with an extended battery life, which could be retrievable, expandable to incorporate future innovation and deliver enhanced patient outcomes with a minimally-invasive implant procedure. The outcomes of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can benefit physicians and manage the care of patients with particular abnormal heart rhythms.

According to DelveInsight’s “Pacemakers Market Insights & Competitive Landscape”, the market was valued at USD 4.63 billion in 2020, growing at a CAGR of 5.81% during the forecast period from 2021 to 2026, to reach USD 5.78 billion by 2026. The demand for Pacemakers is increased owing to the increase in cardiovascular diseases (CVDs), superior treatment results of sudden cardiac arrests, and rising technological advancements.

OrthAlign announces the Lantern® launch, the latest handheld smart tool for Knee Replacement Surgery 

On November 12, 2021, OrthAlign, Inc., a privately-held US-based medical device and technology company providing orthopaedic surgeons with advanced precision technologies, announced the full market launch of Lantern: the latest in intelligent surgical technology for total and partial knee replacement surgery.

Dr Michael Ast, an orthopaedic surgeon based out of New York, became the first surgeon to perform a total knee replacement using Lantern navigation; they said it is one of the most efficient and straightforward systems one can bring into a hospital or hospital ASC. The data is highly accurate. 

Eric Timko, Chairman and CEO of OrthAlign Inc. added, this is a crucial moment for OrthAlign. Lantern is their next-generation flagship product. It is the culmination of years of effort devoted to creating a technology delivering the accuracy, simplicity, and efficiency required in today’s transitioning market. Surgical technologies must deliver clinically valuable solutions through high-quality, cost-effective care. With Lantern, they are perfectly positioned to meet the operational needs of the hospital and ASC while continuing to provide the solid clinical outcomes that surgeons expect. They are excited to expand the commercial release of Lantern and continue to fuel an already strong close to 2021.

According to DelveInsight’s “Knee Reconstruction Devices Market & Competitive Landscape”, the market has players such as Integra LifeSciences Corp., Zimmer Biomet, Artherex Inc, Johnson & Johnson, Wright Medical Group, Smith & Nephew Plc., Conmed Corp., DJO Global, Exactech Inc, Evolutis, among others. 

In Q4 2020, Lantern received 510(k) clearance and has been available in limited settings since. It supports total knee and unicompartmental knee arthroplasty with emerging applications for total hip arthroplasty, intraoperative evaluation tools such as soft tissue balancing, data collection capabilities, and network connectivity. 

Medtronic declares 510(k) clearance for PillCam™ Small Bowel 3 @HOME endoscopy procedure 

On November 15, 2021, the US Food and Drug Administration (FDA) granted 510(k) clearance for Medtronic’s PillCam™ Small Bowel 3 system for remote endoscopy procedures. The PillCam™ SB3 @HOME program combines Medtronic’s PillCam technology with Amazon logistics, a combination planned to ensure both timely and accurate results for patients from the comfort of their homes.

Giovanni Di Napoli, president of the Gastrointestinal business, part of the Medical-Surgical Portfolio at Medtronic, said they have an excellent opportunity to deliver diagnostic testing and other minimally invasive procedures from patients’ homes. The pandemic necessitated more remote innovation. Their capabilities have exceeded expectations in providing better quality care to patients without the risk of COVID infection and without adding to the burden on the medical staff. PillCam SB3 @HOME proffers a convenient option for a contactless procedure and helps ensure that patients can access care promptly.

Dr Michael Bass of GI Specialist of Delaware, added that early diagnosis and treatment are crucial to achieving the best outcome for GI patients. Fortunately, patients can receive their GI diagnosis conveniently from home with telehealth options. The COVID-19 pandemic has underscored the importance of early detection and not delaying care following the onset of symptoms. This system allows for patients to remain in the comfort and safety of their own homes while giving providers access to the high-quality images required to make a diagnosis. 

According to DelveInsight’s Endoscopy Cameras Market & Competitive Landscape”, the approval of such products will drive the market growth as it offers a telehealth option for direct visualisation and monitoring of the small bowel, to aid in better detect lesions not detected by upper and lower endoscopy, which may indicate Crohn’s disease, locate obscure bleeding, or identify sources of iron deficiency anaemia (IDA).

Hydrus Microstent decreases visual field loss by 47% as per new 5-Year pivotal trial data 

On November 15, 2021, Ivantis Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device planned to lower eye pressure for open-angle glaucoma patients, declared new data from its five-year HORIZON pivotal trial showing that the Hydrus Microstent decreases the rate of visual field loss by 47% versus cataract surgery alone. The breakthrough findings position the Hydrus Microstent as the first glaucoma procedure to reduce vision loss compared to standard medical treatment in a large randomised clinical trial since trabeculectomy, the gold standard surgical intervention for glaucoma, first did so in the Collaborative Initial Glaucoma Treatment Study over 20 years ago.

Dr Iqbal “Ike” Ahmed, research director at the Kensington Eye Institute and director of the Glaucoma and Advanced Anterior Segment Surgery (GAASS) Fellowship Program at the University of Toronto, stated that this is a game-changer. Since the inception of MIGS, the impact narrative has been limited mainly to surrogate endpoints – IOP lowering and medication reduction. At three years, they saw that Hydrus influenced the rate of invasive secondary surgery. At five years, they have data indicating that the Hydrus affects the underlying disease itself, which changes forever how they think of MIGS. 

According to DelveInsight’s Glaucoma Drainage Devices Market & Competitive Landscape”, the market is anticipated to increase at a CAGR of 5.39% during the forecast period from 2021 to 2026. The need for glaucoma drainage devices is primarily being increased by rising geriatric population base, increasing prevalence of lifestyle disorders such as hypertension and diabetes, growing prevalence of glaucoma, and technical innovation in product development that are anticipated to drive the product need, hence contributing to the glaucoma drainage devices market growth in the forecast period. 

FDA grants the Hemolung® De Novo Clearance 

On November 15, 2021, the Food and Drug Administration (FDA) has granted ALung Technologies, Inc., the leading low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies, De Novo clearance for the Hemolung Respiratory Assist System for treating patients with acute respiratory failure. It is the first and only ECCO2R device cleared by the FDA and is indicated for respiratory support that offers extracorporeal carbon dioxide (CO2) removal from the patient’s blood for up to 5 days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is anticipated.

Peter M. DeComo, Chairman and CEO, said that the FDA De Novo review process is designed to evaluate that the clinical benefits exceed the clinical risks associated with a medical device when there is not a tremendous equivalent predicate device. As a result, the De Novo process is quite rigorous. To show benefit over risk, ALung submitted data to FDA from over 1,000 Hemolung patient treatments on clinical safety and over 230 Hemolung patient treatments on clinical performance results. This clinical data, along with all of their preclinical data, showed to the FDA that the clinical benefits of the Hemolung for ECCO2R therapy had been substantiated. 

Steven Conrad, MD, PhD, MCCM, Medical Director at ALung and Professor of Medicine at Louisiana State University Health Sciences Center, said that Hemolung would be a vital new treatment modality for acute respiratory failure to avoid or mitigate harm from invasive mechanical ventilation. The FDA clearance of the Hemolung is a game-changer for treating these critically ill patients and will usher in a new era of extracorporeal lung support.

According to DelveInsight’s CO2 Removal Devices (Extracorporeal) Market & Competitive Landscape”, the leading companies that are working in the CO2 Removal Devices (Extracorporeal) Devices Market are Medica S.P.A, ESTOR SPA, ALung Technologies, Inc., X-COR Therapeutics, and Aferetica Srl. and others.

FDA authorises AppliedVR’s EaseVRx for chronic back pain reduction 

On November 16, 2021, the Food and Drug Administration (FDA) approved the marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioural therapy and other behavioural methods to benefit them with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.

Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said that many adults live with chronic lower back pain in the United States. Pain reduction is a vital component of living for these affected people. Today’s authorisation delivers a treatment option for pain reduction, which does not comprise opioid pain medications when utilised alongside other treatment methods for chronic lower back pain.

The FDA stated that the EaseVRx treatment includes 56 VR sessions, ranging from two to 16 minutes. The sessions are intended to be used over a daily eight-week treatment program.

The regulator authorised the device after assessing data of a double-blinded, randomised clinical trial that included 179 chronic lower back pain patients. About 66% of participants treated with EaseVRx reported a more than 30% pain reduction at the end of treatment.

According to DelveInsight’s Chronic Lower Back Pain Market”, the total prevalent population of CLBP in the 7MM was observed to be 73,802,461 in 2017. Furthermore, the total diagnosed overall population of CLBP in the 7MM was assessed to be 44,281,476 in 2017.

LumiThera, Inc. announces the creation of a Light-based Theranostic approach to treat Ocular Disease with Diopsys, Inc. acquisition    

On November 11, 2021, LumiThera Inc., a commercial-stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, entered into a definitive merger agreement with Diopsys, Inc., a leader in modern visual electrophysiology medical devices, which aid eye care professionals analyse the entire visual pathway for visual and neuro-visual disorders.  As per the agreement, the stocks of LumiThera will be held by Diopsys, and it will become a wholly-owned subsidiary of LumiThera. It is anticipated to finish in the next few months.

This acquisition is anticipated to offer a complimentary diagnosis and monitoring platform to LumiThera’s leading treatment platform using Photobiomodulation (PBM) for ocular disease and damage. Electroretinography (ERG) is a recognised diagnostic test, which measures the electrical activity of the retina of the eye in response to a light stimulus. Diopsys adds an established commercial US sales force, together with LumiThera, which constructs a larger global footprint with a significant ophthalmology/optometry customer base. Formerly, LumiThera stated the completion of enrolment of 100 subjects in 1Q of 2021 in the US LIGHTSITE III dry Age-related Macular Degeneration (AMD) trial.  The LIGHTSITE III trial continues with the 13-month efficacy time point for all patients expected in 1Q of 2022.

Joe Fontanetta, CEO, Diopsys, said that Diopsys ERG testing is a powerful and quantitative diagnostic, which can be coupled with LumiThera’s PBM treatments to characterise early patient benefits on visual function. The theranostic company will be able to offer the tools physicians need to diagnose, treat and monitor patients and provide physicians with a solution for multiple ocular diseases with limited treatment options.”As per Clark E. Tedford, PhD, President, and CEO, LumiThera, Inc, they strongly believe in treating the degenerative disease early to slow the progression of the vision-threatening disease. The synergy of these technologies makes sense on many levels and could optimise Valeda’s treatments. Early diagnosis, treatment, and monitoring are the key to chronic ocular disease. They believe using light-based devices can create a unified approach to diagnose, treat and follow patients.  This may further pave the way to a more preventative approach to vision loss and a path to optimise and create a machine learning approach to individualise ocular therapy.