Orthofix Launched WaveForm A – 3D Printed Anterior Lumbar Interbody

On June 19, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched WaveForm® A, an interbody for Anterior Lumbar Interbody Fusion (ALIF) procedures. For the treatment of patients who require fusion due to degenerative disc disease, the company’s Meridian ALIF system smoothly connects with the WaveForm A interbody. 

With a wide implant graft aperture for bone graft material, the WaveForm A interbody’s exclusive wave-like design balances strength, porosity, and stability while assisting in the creation of an osteoinductive environment to optimize supplemental fixation techniques.

The Meridian ALIF system is a modular instrument and implant system that offers a variety of fixation choices for single and multilevel ALIFs in fewer trays, helping to simplify ALIF procedures. WaveForm implant is a 3D-printed WaveForm® technology with a continuous and recurring wave-like structure. 

With an endplate porosity that maximizes the chance of early stabilization, WaveForm is developed to tolerate large compressive loads. This strength-to-porosity ratio allows more room for bone packing, a lower stiffness profile, and improved imaging capabilities.

“Implant design and surface technology play a vital role in the bone growth process during fusion,” said Dr. Neil Arif Tayyab, orthopedic spine surgeon at Girard Orthopaedic Surgeons, in San Diego, CA. Dr. Neil further added, “Newer designs such as the WaveForm A interbody can help stimulate a better bone growth response and give me greater confidence that the patient will have a successful fusion.”

Kevin Kenny, President of Global Spine said, “Our Meridian ALIF system integrates the most advanced technologies into our surgical sets, minimizing the need for multiple instrument sets during the procedure.” Kevin also said, “The WaveForm A interbody is an exciting addition to our portfolio of solutions for ALIF procedures and enables us to provide a more streamlined option so surgeons can do more for their patients.”

As per DelveInsight’s Interbody Cages Market” report, the global interbody cages market is estimated to grow at a CAGR of 4.72% during the forecast period from 2023 to 2028. The rise in demand for interbody cages is predominantly attributed due to the increasing number of spinal disorders such as degenerative disc degeneration (DDD), spinal fusion, spinal injuries, and others. Further, the rising adoption of advanced and innovative technologies, the increasing demand for minimally invasive surgeries, and the rising cases of accidents are thereby contributing to the overall growth of the interbody cages market during the forecast period from 2023-2028. 

BD Entered into Agreement to Sell its Surgical Instrumentation Platform to STERIS 

On June 20, 2023, BD (Becton, Dickinson, and Company), a leading global medical technology company, signed a definitive agreement to sell its Surgical Instrumentation platform to STERIS, a leading global provider of products and services that support patient care for USD 540 million.

Products under the V. Mueller, Snowden-Pencer, and Genesis brands as well as three manufacturing facilities in St. Louis, Missouri, Cleveland, Ohio, and Tuttlingen, Germany will be sold as part of the divestiture. 

Upon conclusion of the deal, roughly 360 personnel who support this platform will transition to STERIS. The divestment is anticipated to close during BD’s fiscal year 2023, which ends on September 30, pending the fulfillment of customary closing requirements and regulatory approval from the US Federal Trade Commission (FTC). 

The BD Surgery business, which is a part of the BD Interventional segment, is reported to include the surgical instrumentation platform.

This strong value-creating transaction supports the achievement of BD’s 2025 financial goals, including revenue growth and margin expansion. Cash proceeds will be deployed consistent with BD’s capital allocation priorities to enable a continued durable growth profile.

BD’s surgical instrumentation platform is complementary to STERIS’s Healthcare segment and will allow them to better meet hospitals’ and surgery centers’ product and service needs.

An estimated USD 170 million in annualized revenue is represented by the assets that are being sold. The effect on adjusted profits per share (EPS), if the transaction is complete as anticipated during BD’s fiscal year 2023, would be negligible. The agreement’s other details weren’t made public.

“The Surgical Instrumentation platform has a 120-year legacy of providing reliable and trusted high-quality products, and STERIS is well positioned to maximize the value of this extensive portfolio and is fortunate to be adding such a dedicated and talented team to its organization,” said Rick Byrd, president of the Interventional segment at BD. Rick Byrd further commented, “This transaction further advances the BD Interventional segment’s focus on high-growth end markets. We look forward to continuing to address unmet needs in health care through a highly differentiated and innovative set of solutions and products.”

According to DelveInsight’s Powered Surgical Instruments Market Assessment”, the global powered surgical instruments market was valued at USD 2.65 billion in 2022, growing at a CAGR of 4.26% during the forecast period from 2023 to 2028 to reach USD 4.56 billion by 2028. The demand for powered surgical instruments is primarily witnessing growth due to the rising aging population resulting in the increasing prevalence of degenerative bone disorders and ophthalmic conditions, a rising number of brain cancers, an increasing number of trauma cases, and growth in product innovation are stimulating the growth of the powered surgical instruments market positively.

Surmodics Received FDA Approval for the SurVeil™ Drug-Coated Balloon

On June 20, 2023, Surmodics, Inc., a leading provider of medical devices and in vitro diagnostic technologies to the healthcare industry, received the US Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB).

After proper vessel preparation, clinicians in the United States may now advertise and sell the SurVeil DCB for percutaneous transluminal angioplasty of de novo or restenotic lesions (less than 180 mm in length) in the femoral and popliteal arteries with reference vessel sizes of 4 mm to 7 mm. 

In June 2020, the SurVeil DCB was granted CE Mark Certification in the European Union.

The SurVeil DCB may only be sold by Abbott around the world. Surmodics will produce and supply the good, as well as earn money from product sales to Abbott and a cut of Abbott’s third-party sales revenue. Abbott will also provide Surmodics USD 27 million milestone payment. In the third quarter of its fiscal year 2023, the business anticipates recognizing revenues linked to the milestone payment of between USD 24.0 and USD 24.5 million.

“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, President and CEO of Surmodics. Maharaj added, “It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them. I would like to thank our internal SurVeil DCB team and our external advisors, investigators, and partners for their multi-year efforts to make this achievement possible.” 

Mr. Maharaj continued, “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB. We’ll discuss details on the developments and update our fiscal year 2023 financial guidance during our third quarter earnings call.”

“I am excited that the Surveil DCB will be available to treat patients in the US,” said Kenneth Rosenfield, M.D., co-principal investigator of the TRANSCEND clinical trial. Kenneth further added, “The Surveil DCB is the next generation DCB as established by results from the TRANSCEND trial which is the only head-to-head pivotal study that has been conducted vs the market-leading DCB. The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years post-treatment with a substantially lower drug dose.”

According to DelveInsight’s Balloon Catheters Market Assessment, the global balloon catheters market was valued at USD 4.60 billion in 2022, growing at a CAGR of 8.78% during the forecast period from 2023 to 2028 to reach USD 7.62 billion by 2028. The balloon catheters market is witnessing positive market growth owing to the factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology and technical innovation in product development such as manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.

Cardio Flow Design Inc. received FDA Approval for 4D Flow MRI Blood Flow Analysis Software

On June 19, 2023, Cardio Flow Design Inc., a company providing diagnostic procedures based on blood flow, announced that the US Food and Drug Administration approved the use of iTFlow® in blood flow analysis. 

Cardio Flow Design Inc.’s cutting-edge software programme, iTFlow®, offers blood flow analysis and evaluation in the domains of radiology and cardiovascular surgery. Users can conduct their analyses and blood flow visualizations using MRI data. Even without the use of contrast agents, it makes it possible to see the fluid dynamics in the heart and blood arteries in both 2D and 3D. 

Additionally, several quantitative evaluations can be performed using factors such as flow rate, velocity, pathline, streamline, and others. Combining cutting-edge algorithms and image analysis methods helps doctors and other healthcare professionals make diagnoses and arrange treatments.

Further, with the potential to improve diagnostic accuracy for patients with cardiovascular diseases and cardiac ailments, the FDA approval is noteworthy since it acknowledges the security and efficacy of iTFlow® in analyzing blood flow through 4D Flow MRI data. 

The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care.

Dr. Itatani, MD, Ph.D., a cardiovascular surgeon specializing in adult congenital heart disease and the inventor of iTFlow®, said, “We developed this software to enable all physicians, regardless of their level of experience, to propose the most appropriate treatment for patients even with complicated anatomy and cardiac function by quantitatively evaluating blood flow.”

Dr. Loke, Associate Professor of Pediatrics at Children’s National Hospital, who has been conducting retrospective blood flow analysis research with iTFlow® before FDA approval, commented, “Cardiac magnetic imaging research has demonstrated the emerging potential of advanced intracardiac flow analysis in heart disease beyond traditional measurements. To that end, iTFlow® provides a front-line software interface to measure kinetic energies, vortexes, and shear stresses inside the heart without the need for complex in-house engineering software. I am excited by the potential of software such as iTFlow® in bringing intracardiac flow analysis to clinical cardiology.”

Company CEO, Teruyasu Nishino, MD, expressed his joy with FDA approval, “We are delighted this software has obtained FDA approval. We have been pursuing the concept of blood flow analysis with 4D flow MRI for many years, and iTFlow® encapsulates the essence of this concept. With this approval, we believe that healthcare professionals will be able to provide more accurate diagnoses and treatment plans for cardiovascular diseases, especially for children with congenital heart disease, and will save many lives. This innovation will change the way of diagnosis and catalyze to spread the adoption of blood flow analysis worldwide.”

According to DelveInsight’s Blood Pressure Monitoring Devices Market Assessment”, the global blood pressure monitoring devices market was valued at USD 1.04 billion in 2022, growing at a CAGR of 10.68% during the forecast period from 2023 to 2028 to reach USD 2.10 billion by 2028. The blood pressure monitoring devices market is witnessing positive growth owing to various factors such as the increasing prevalence of hypertension, the surge in the geriatric population, the increasing prevalence of cardiovascular disease, and technological advancements in product offerings. Therefore, the market for blood pressure monitoring devices is estimated to grow during the forecast period from 2023 to 2028.

Galvanize Therapeutics Completed Enrollment in Pivotal Trial of RheOx® System for Chronic Bronchitis

On June 19, 2023, Galvanize Therapeutics, Inc., a leader in developing pulsed electric field (PEF) therapies for COPD, soft tissue, and cardiac arrhythmias, completed enrollment in the RheSolve pivotal trial evaluating the RheOx® Bronchial Rhinoplasty System as a treatment for chronic bronchitis symptoms.

The non-thermal pulsed electric field (PEF) energy is delivered via the minimally invasive RheOx System to kill aberrant, mucus-producing cells on the surface of the lung airways. 

In patients with chronic bronchitis, the RheOx bronchoscopic device is used to lower the number of cells that produce mucus. An electrosurgical generator and a single-use catheter are part of the ground-breaking device, which together provide non-thermal energy to the airways to decrease the amount of aberrant mucus-producing cells in the lungs and allow for the development of new, normal cells.

RheSolve is a double-blind, randomized, sham-controlled research that looked at how RheOx affected the signs and symptoms of moderate to severe chronic bronchitis in 270 COPD patients in the United States and Europe. The validated COPD Assessment Test, a patient-reported outcome, is the main effectiveness endpoint and is examined after six months.

“Closing our RheSolve study enrollment is a major step towards transforming the lives of patients with chronic bronchitis using an entirely new therapeutic approach,” said Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics. Jonathan further added, “We look forward to reporting RheSolve trial results and submitting them to the FDA in a Premarket Approval (PMA) application, while simultaneously advancing our other unique PEF energy platform applications across disease categories.”

Frank Sciurba, M.D., Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Pittsburgh, and RheSolve Co-Principal Investigator, said, “Chronic bronchitis significantly impacts the quality of life, as patients suffer from a persistent cough and overproduction of mucus.” Frank commented, “Currently there are no FDA-approved chronic bronchitis treatments targeting the airway cells that over-secrete mucus. I eagerly await the results of RheSolve and the possibility to offer RheOx as new therapy for affected patients.”

Co-principal investigator Arschang Valipour, M.D., FCCP, Associate Professor, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Wien, Austria, also commented, “We see a lot of patients with severe chronic bronchitis symptoms, which can develop after exposure to pollutants and irritants such as cigarette smoke, vaping, airborne chemicals and more. I am pleased to help lead this international study for RheOx, a novel therapy that we have seen deliver important quality-of-life improvements for patients in Europe in the early commercial launch of the product. I am hopeful that the RheSolve study will show similar benefits.”

According to DelveInsight’s Chronic Obstructive Pulmonary Disease Treatment Devices Market Assessment”, the global chronic obstructive pulmonary disease treatment devices market is estimated to grow at a CAGR of 6.37% during the forecast period from 2023 to 2028. The increase in demand for chronic obstructive pulmonary disease treatment devices is primarily attributed to the rising exposure to air pollution, airborne particles, chemicals & fumes, second-hand smoke, industrial chemicals, and dust owing to which the prevalence of COPD is increasing globally. Further, a rise in the consumption of tobacco among the youth population will increase the risk of respiratory disorders like COPD, and asthma ultimately leading to propel the demand for COPD treatment devices.

Additionally, the burgeoning demand for short-term and effective treatment in case of attacks, technological advancements in the devices such as the production of ideal aerosol particle size & property of providing a higher amount of dose, and others, and increasing awareness about the symptoms and treatment of disorders like COPD and asthma across the world are anticipated to bolster the market, thereby contributing to the growth of the chronic obstructive pulmonary disease treatment devices market during the forecast period from 2023-2028.

AWAK and SGH Initiated Clinical Trial for Wearable Peritoneal Dialysis Device Trial

On June 20, 2023, AWAK Technologies (AWAK), a company developing wearable and ultra-portable peritoneal dialysis (PD) systems, and Singapore General Hospital (SGH) initiated a pre-pivotal clinical trial with the enrolment of the first subject to study the safety and efficacy of an improved Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.

The single-site, prospective, single-arm study is a follow-up of its first-in-human study which reported no serious adverse events. The team of SGH researchers is now recruiting subjects to participate in this pre-pivotal clinical trial in Singapore. 

The trial will evaluate the feasibility of automated wearable artificial kidney peritoneal dialysis (AWAK PD) in subjects with end-stage kidney disease. 

The AWAK PD system uses AWAK’s unique sorbent technology to revolutionize the way peritoneal dialysis is currently carried out. It is the first wearable and ultra-portable PD system in the world. Patients who require dialysis today confront the issue of long hours of stationary therapy and connection to large-size dialysis machines in hospitals and clinics. The AWAK PD is a portable device that weighs around 3 kg and allows dialysis to be performed on the go.

Suresha Venkataraya, Chief Executive Officer, of AWAK Technologies, said, “Entering the pre-pivotal trial with the enhanced version of our device signifies a significant step in our mission to revolutionize the dialysis industry. The invaluable insights and feedback from the initial first-in-human trial have been vital in refining and enhancing our product. We remain committed to redefining kidney care by bringing disruptive products to improve the quality of life of people with kidney disease. We thank our board of directors, investors, and clinical partner, Singapore General Hospital, for their unwavering support throughout our innovation journey.”

Associate Professor Marjorie Foo, Principal Investigator of both AWAK PD trials and Senior Consultant, Department of Renal Medicine, SGH, added, “Although most patients with end-stage kidney disease are on hemodialysis, peritoneal dialysis offers similar efficiency and cost-effectiveness with the added flexibility of treatment schedule to accommodate ones’ lifestyle and offers patient another option to choose from. We have collaborated with AWAK Technologies on this project since its early years of development. Despite COVID-19 slowing us down, we have continued to improve on the device and are now ready to embark on a pre-pivotal trial, one step closer to what our patients are hoping and looking forward to, a life on dialysis that will minimally affect their lifestyle and yet provide good quality dialysis.”

According to DelveInsight’s Peritoneal Dialysis Equipment Market Assessment”, the global peritoneal dialysis equipment market was valued at USD 4.36 billion in 2022, growing at a CAGR of 5.90 % during the forecast period from 2023 to 2028, to reach USD 6.14 billion by 2028. The increase in demand for peritoneal dialysis equipment is primarily attributed to the increasing prevalence of kidney disorders such as end-stage kidney disorder, kidney failure, and others. In addition, the constantly increasing old population, high blood pressure, and high diabetes prevalence is also driving factor for peritoneal dialysis equipment as old age and diabetic people are more likely to develop kidney disorders. Moreover, technological advancement in the peritoneal dialysis product pipeline and an increase in product approvals are among the other factors responsible for the global peritoneal dialysis equipment market.