Össur Launches World’s Actively Powered Lower Limb Bionic Prosthesis- New Power Knee for Amputees

On February 09, 2022, Össur announced the launch of the new POWER KNEE, the first actively powered microprocessor-based prosthetic knee in the world. This device is aimed at treating patients with above-knee amputation or limb differences. 

The POWER KNEE is essentially a motor-powered “smart” prosthesis which is based on advanced algorithms enabling the device to detect human movement patterns, learn and adjust as per the wearer’s speed and cadence in real-time. The device is equipped with features such as active powered assistance wherein it can distinguish the wearer’s motion on different surfaces and helps in emulating different motions in navigating different purposes such as ascending/descending of stairs. The bionic prosthesis further helps the user achieve more symmetrical motion and helps the users conserve their own energy. 

Jon Sigurdsson, President, and CEO of Össur, mentioned, “No other knee thinks, acts or behaves remotely like the new, next-generation POWER KNEE. While other microprocessor knees are “passive” in nature, we have always considered the restoration of power – which is fundamental to the biomechanical systems that move all human bodies – to be a critical function that was lacking in other prosthetic solutions for amputees. The POWER KNEE delivers on that promise and represents an extraordinary milestone in mobility for people with limb loss and limb difference.”

According to DelveInsight’s analysts, the entry of such a device into the market further indicates the growing popularity of electric-powered orthopedic prosthetic devices. This can be attributed to the advantages associated with the electric-powered prosthetic devices such as greater range of motion, increased comfort and control of the prosthetics, and less expenditure and effort for initiating and maintaining the motion from the user’s end. Therefore, such devices may become the norm in the coming future.

Helical Radiotherapy System by Accuray Presents Positive Results for Maintaining Long-Term Heart and Lung Functionality in Breast Cancer Patients

On February 10, 2022, Accuray Incorporated announced the data from a Phase III randomized, controlled clinical trial which presented the findings that post-surgery hypofractionated radiotherapy delivered via the TomoTherapy System turned out to be superior to conventional therapy in preserving long-term lung and heart functions in women diagnosed with early breast cancer. 

An analysis of patient-reported outcomes showed 10-year survival free of heart and lung deterioration was 84.5% with TomoTherapy delivered radiotherapy – a significant improvement above the 66.9% achieved with conventional radiotherapy. The single-center trial results were published online in BMC Cancer.

The TomoTherapy platform which also includes the next-generation Radixact® System is the first in the world capable of helical radiation delivery. Previous results from the TomoBreast trial presented that treatment with the TomoTherapy System provided uniform dose delivery to the tumor, decreased the dose to the heart and lung, which significantly reduced the side-effects related to the heart and lung, implying that the system’s unique architecture helps improve the accuracy of the treatment.

Mark De Ridder, head of the radiotherapy department of UZ Brussel, Vrije Universiteit Brussel, Belgium mentioned, “This most recent TomoBreast trial analysis reinforces the outcomes seen in previous clinical evaluations and demonstrates the potential of the TomoTherapy System to make a meaningful difference in breast cancer patients’ daily lives. The improvement in cardiorespiratory-related functioning experienced by patients treated with the system was remarkable considering a high proportion of them received concurrent medication and were current or ex-smokers receiving lymph node irradiation – both of which can increase the potential risk of side effects.”

Philippe Degreze, Ph.D., vice president, downstream marketing & communications channels at Accuray, said, “The TomoBreast data show we are on the right path. This analysis of patient-driven, Real-World Evidence (RWE) is important because it suggests that patients treated with the TomoTherapy System are less likely than those receiving conventional radiotherapy to experience the debilitating heart and lung side effects that make breathing difficult and interfere with a person’s ability to take part in even the most routine daily activities. Additionally, the overall course of treatment was significantly shorter for TomoTherapy treated patients enabling them to get back to living their lives, faster.”

According to DelveInsight’s analysts, such studies and the reporting of positive results help stimulate product development activities in cancer therapy. The positive result obtained from this study is further expected to help boost the development of such radiotherapy and cancer-treatment focused systems that help target tumors and cancer cells in a precise manner thereby decreasing the damage to the surrounding tissue microenvironment. For instance, besides breast cancer, tomotherapy is also used in different cancers such as brain cancer. 

Furthermore, according to DelveInsight’s “Surgery and Radiation Therapy in Brain Cancer Market” report, the rising incidence of brain cancer, technological advancement in the field of radiation oncology, rising use of proton therapies for the purpose of cancer treatment, adoption of radiation therapy procedures and increasing awareness program are certain factors that are driving the demand for surgery and radiation therapy in brain cancer treatment. 

DePuy Synthes Acquires CrossRoads Extremity Systems

On February 10, 2022, DePuy Synthes, a Johnson & Johnson Medical Devices Companies announced the acquisition of CrossRoads® Extremity Systems, a company with an extensive foot and ankle portfolio. 

With this acquisition, CrossRoads® brings several differentiated products to the DePuy Synthes portfolio, including miniBunion® 3D, dynaBunion® 4D, and DynaForce® Staple Compression Plates. The miniBunion® system is a minimally invasive solution for metatarsal bone osteotomy (a procedure to manage mild to moderate hallux valgus) that reduces the incision size as compared to traditional techniques and aims for less pain and a faster recovery. The dynaBunion® lapidus system is an option for lapidus bunionectomy (a procedure to manage moderate to severe hallux valgus) and provides instrumentation and implants to correct bunions in four dimensions through smaller incisions. DynaForce® staple compression plates combine stability with dynamic continuous compression at the fusion site. 

Oray Boston, DePuy Synthes Trauma, Extremities, Craniomaxillofacial and Animal Health, stated “Healthy feet are a foundational element of overall good health, and we are thrilled about the acquisition of CrossRoads® and the opportunity to accelerate meaningful innovation by strengthening our offering for elective foot and ankle procedures, enabling us to provide more comprehensive and leading-edge options to surgeons and patients.”

According to DelveInsight’s “Foot and Ankle Devices Market” report, the global foot and ankle devices market was valued at USD 5.52 billion in 2020, growing at a CAGR of 7.66% during the forecast period from 2021 to 2026 to reach USD 8.58 billion by 2026. Factors such as the rising demand for the prevalence of bone-related disorders, rising number of diabetes-related complications, increasing geriatric population, rising number of accident and trauma cases, and the rising number of sports-related injuries, and the increasing focus on developing technologically advanced devices are expected to drive the foot and ankle devices market.

Senseonics Receives USFDA Approval for Eversense® E3 Continuous Glucose Monitoring System

On February 11, 2022, Senseonics Holdings, Inc received regulatory approval from the US Food and Drug Administration (FDA) for their next-generation Eversense® E3 CGM System. The Eversense E3, including proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, is expected to be available to patients in the U.S. from the beginning in the second quarter of 2022 through Ascensia Diabetes Care which is Senseonics’ global commercial partner.

The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for the continuous measurement of glucose levels in diabetic patients aged 18 and older for up to 6 months, the system is indicated to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions.

The Eversense E3 CGM System offers patients:

  • Fully implantable third-generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.
  • Industry-leading 6 month sensor wear duration, making Eversense the longest-lasting CGM system available, with essentially two sensor insertion and removal procedures per year.
  • Removable smart transmitter, held in place with a mild silicone-based adhesive, provides discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed. 

Satish Garg, M.D., Professor of Medicine and Director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the Principal Investigator of the PROMISE study, stated, “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”

Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics stated, “Further extending the duration of the longest-lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community.”

According to DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 12.12 billion in 2020, growing at a CAGR of 7.72% during the forecast period from 2021 to 2026, in order to reach USD 18.89 billion by 2026. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes among the population across the globe, the growing burden of the geriatric population who are susceptible to developing hyperglycemia. In addition, the spike in technologically advanced blood glucose monitoring devices product launch and government initiatives to raise awareness regarding proper diabetes management, among others are the factors likely to spur the global blood glucose monitoring systems market.

Independent Research with Myomo’s MyoPro Presents Positive Results in Individuals with Chronic Moderate-to-Severe Arm Weakness

On February 14, 2022, Myomo Inc reported that new research aimed at analyzing the benefits of MyoPro myoelectric orthoses reported “statistically significant improvements” in numerous motion function measurements. 

The research study, titled “Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits after Stroke and Traumatic Brain Injury,” was funded by the U.S. Army Medical Research Acquisition Activity, and supported by the Office of Secretary of Defense for Health Affairs, through the Orthotics and Prosthetics Outcomes Research Program. It was published in the peer-reviewed journal Frontiers in Neurology.

The study followed thirteen individuals with chronic moderate-to-severe arm weakness from stroke or traumatic brain injury (TBI). Outcomes were collected from in-therapy sessions and home use. The study was conducted by lead investigator and grant recipient Svetlana Pundik, M.D., and colleagues at the Louis Stokes Cleveland Veterans Administration Medical Center.

The authors noted that “Statistically significant and clinically meaningful improvements were observed on Fugl-Meyer (+7.5 points). Gains were seen at week 3, increased further through the in-clinic phase and were maintained during the home phase. Statistically significant changes in Modified Ashworth Scale, Range of Motion, and Chedoke Arm and Hand Activity Inventory were seen early during the in-clinic phase. The Orthotic and Prosthetic User’s Survey demonstrated satisfaction with the device throughout study participation. Both stroke and TBI participants responded to the intervention.” The authors concluded, “Use of MyoPro in motor learning-based therapy resulted in clinically significant gains with a relatively short duration of in-person treatment.”

Harry Kovelman, M.D., Chief Medical Officer of Myomo said, “We are encouraged by the continually increasing body of evidence that demonstrates that the use of MyoPro results in clinically significant gains in a relatively short duration of in-person treatment. We look forward to expanding on these results which may lead to innovations in treatment for patients who suffer from chronic upper extremity weakness.” He further added, “This data supports why the payer community both in the U.S. and Germany continue to expand its reimbursement coverage for patients.”

According to DelveInsight’s analysts, such studies and the reporting of positive results help stimulate product development activities in niche areas such as medical robotics and medical exoskeletons which are crucial fields in the healthcare domain. The obtaining of positive clinical results further paves the way for such products to reach the market and fulfilling the unmet needs in neurological and neuromuscular disorders and injuries, thereby presenting a positive future outlook for the medical exoskeletons/medical robotics market in the near future. 

US FDA Grants Breakthrough Device Designation to a Spinal Fusion Implant by Theradaptive

On February 15, 2022, Theradaptive received the breakthrough device designation for their Osteo-Adapt SP Spinal Fusion implant by the US Food and Drug Administration.  The implant is intended for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, retrolisthesis, or spondylolisthesis.

Theradaptive’s regenerative implants are best-in-class and are designed to allow for precise tissue regeneration for different types of tissues and clinical indications. The new technology helps in achieving superior outcomes and safety, and offers improvements in terms of product usability. 

Dr. George Muschler of the Cleveland Clinic mentioned, “Theradaptive has developed a technology that may provide several significant advantages over the current state-of-the-art in spinal fusion and musculoskeletal repair, including greater safety and more consistent outcomes.” He further stated, “This is an exciting development in the field and having a Breakthrough Designation from the FDA is strong validation of the approach. The potential for patients is enormous.”

John Greenbaum, Senior Vice President of Clinical & Regulatory Operations, Theradaptive., said, “This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible. This opens the door to entirely new treatments for conditions that currently have very few options.”

According to DelveInsight’s “Spinal Implants Market” report, the global spinal implants market was valued at USD 12.35 billion in 2020, growing at a CAGR of 5.37% during the forecast period from 2021 to 2026 to reach USD 16.88 billion by 2026. The rise in demand for spinal implants is predominantly attributed due to the increasing prevalence of various spinal disorders which include spinal stenosis, disc herniation, and degenerative disc diseases, among others in the older population across the globe. Moreover, shifting focus towards technological advancement in bone graft products, rising awareness among the patient population regarding the spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implants market.