Positive Results Report REVIAN RED System as a Possible Treatment for Central Centrifugal Cicatricical Alopeciain African American Women

On June 02, 2022, REVIAN Inc., an aesthetic medical technology company focused on stimulating the body’s natural processes in order to rejuvenate hair and skin with light released promising results from a study using the REVIAN RED System to treat patients with Central Centrifugal Cicatricial Alopecia (CCCA) at the Society for Investigative Dermatology Annual Meeting by researchers at the Wake Forest University School of Medicine. CCCA is a form of scarring hair loss that predominately affects women of African descent. 

The REVIAN RED System is an FDA-cleared, wireless wearable cap that can be controlled by a mobile “smart” app to provide a hair loss treatment for men and women using LED light. The device is equipped with the patented dual-band, LED technology that provides broader scalp coverage and better skin penetration than red lasers used in low-level laser therapy (LLLT). Dual wavelengths of LED light facilitate and accelerate scalp healing, allowing the body to renew cells associated with hair growth and retention.

For this prospective clinical study conducted by the Center for Dermatology Research, Department of Dermatology at the Wake Forest University School of Medicine, African American women with a biopsy-proven diagnosis of stage II-IV CCCA were enrolled. All patients were required to be on a stable treatment regimen for at least three months prior to enrollment, and regimens were kept constant throughout the study period. The mean age of patients was 53.4 years old (38-69), the average duration of disease was 12 years, and baseline stages of disease severity ranged from IIB-IVA.  Each patient was instructed to use the REVIAN RED all-LED treatment cap for standard treatment of 10 minutes per day.  Patients’ hair loss was assessed with follow-up visits at 2, 4, and 6-months using digital photography, patient self-assessments of symptoms, and clinician evaluations of severity.

The following study results were reported:

  • Decreased loss of follicular openings and breakage in 75% of patients
  • Follow-up imaging revealed short, regrowing vellus hairs and minimal inter and perifollicular scale
  • 75% of patients had improved Dermatology Life Quality Index (DLQI) at the end of the study
  • 80% of the patients completed the study
  • No side effects reported

Overall, patient satisfaction with treatment was high, with patients referring to the REVIAN RED treatment system as a convenient, safe, and effective option for their hair loss.

Dr. Amy McMichael M.D., Chair and Professor of Dermatology at Wake Forest University School of Medicine mentioned, “In my opinion, the Revian Red system is showing promising results for a complex disease for which we have no treatment options.”

As per DelveInsight analysis, the entry of such devices in the market would help offer treatment options for indications such as CCCA that currently do not have a cure. This, in turn, would drive the demand for energy-based aesthetic devices.  According to DelveInsight’s “Energy-based Aesthetic Devices Market” report, the global energy-based aesthetic devices market as valued at USD 3.36 billion in 2021, growing at a CAGR of 8.93% during the forecast period from 2022 to 2027 to reach USD 5.60 billion by 2027. The rise in demand for energy-based aesthetic devices is primarily attributed to the growing number of aesthetically conscious patients in the country, the increase in the prevalence of indications such as alopecia, obesity wherein energy-based aesthetic devices are employed as a treatment method, technological advancements in product development, enhanced accessibility to aesthetic procedures, among other factors.

Cardio Flow, Inc Receives US FDA Clearance for FreedomFlow Guidewire

On June 02, 2022, Cardio Flow, Inc., a medical device company involved in the development of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD) received regulatory approval from U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire.

The FreedomFlow guidewire has a stainless steel core-to-tip design with a fixed distal-spring coil. The device was developed to provide exceptional support for diagnostic and therapeutic devices employed in the treatment of plaque blockages in arteries both above and below the knee. 

The new guidewire features a silicone-coated spring coil along with a silicone coating on the distal 200cm that eases the crossing of difficult blockages. Furthermore, the 0.014-inch core-to-tip design provides interventionists superior torque transmission and precise control when delivering therapeutic devices.

Dr. Jihad Mustapha, MD, FACC, FSCAI, the Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, MI, completed the first commercial case with the new guidewire on a patient presenting with a complex multi-vessel disease with blockages below the knee, requiring a pedal loop. He mentioned, “This new product has the potential to save time and costs in the endovascular lab, given its versatility in crossing occlusions and ability to deliver multiple interventional devices on a single guidewire.”

Scott Kraus, Vice President of Sales & Market for Cardio Flow, said, “Cardio Flow is encouraged by the initial feedback from Dr. Mustapha, who is a recognized leader in the treatment of PAD and critical limb ischemia (CLI). We look forward to bringing this advancement in guidewire technology to our U.S. customers with a limited market release, followed by expanded commercial efforts in 2022.” 

As per DelveInsight analysis, the development of such devices would help smoothen the workflow in interventional cardiology and enable a more precise approach for cardiovascular interventions. According to DelveInsight’s “Interventional Cardiology Devices Market” report, the global interventional cardiology devices market was valued at USD 13.21 billion in 2021, growing at a CAGR of 6.53% during the forecast period from 2022 to 2027, to reach USD 19.31 billion by 2027. The growing demand for interventional cardiology devices is predominantly attributed to the rising prevalence of cardiovascular diseases, the rising geriatric population, and the growing popularity of minimally invasive interventions. Moreover, the growing focus on creating awareness about cardiovascular diseases as well as continuous research and development activities in terms of product development are also some of the factors responsible for driving the interventional cardiology devices market in the upcoming years.

LumiraDx Expands its Cardiovascular Testing Portfolio

On June 02, 2022, LumiraDx, a next-generation point of care diagnostics company, announced the expansion of its cardiovascular offering with a CE Mark for its new NT-proBNP test to aid in the diagnosis of congestive heart failure (CHF) and an updated CE Mark for its D-Dimer test to now rule out venous thromboembolism (VTE) in symptomatic patients. With these two additions, the LumiraDx Platform can further support clinicians in quickly and accurately assessing patient symptoms for both VTE and heart failure at the point of care.

The LumiraDx NT-proBNP (natriuretic peptides) direct fingerstick assay monitors levels of peptides elevated in the majority forms of heart failure and provide results in twelve minutes from sample application. It is designed for use in community-based healthcare settings to quickly and accurately aid in the diagnosis of individuals suspected of having congestive heart failure.

D-Dimer testing is widely accepted as the first step in the management of patients suspected of VTE. The LumiraDx D-Dimer test may now be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in symptomatic patients. 1A prospective clinical study (EMBOL) conducted in Germany and the UK with 618 symptomatic patients presenting in the Ambulatory clinic settings and emergency departments, demonstrated that the LumiraDx D-Dimer test has a strong correlation with the laboratory reference method with a 99.5% negative predictive value at the 500 ug/L cut off when used in combination with a pretest probability score. EMBOL is the first study to prospectively demonstrate the use of a quantitative fingerstick D-Dimer test at POC to rule out VTE in symptomatic patients, which has the opportunity to significantly improve primary care assessment by physicians and also potentially reduce the time of the patient’s hospital visit, as well as follow up testing.

Ron Zwanziger, LumiraDx’s Chief Executive Officer, said, “The new and updated CE Marks for our NT-proBNP and D-Dimer tests represent an important advancement in cardiovascular testing in the point of care space. Healthcare systems in Europe and globally are looking to shift care from centralized hospital settings to community settings. Our new tests deliver results in minutes from an easy-to-collect fingerstick sample, allowing fast and accurate management of cardiovascular conditions by first responders, primary care, urgent care, and the emergency department. Being able to do this at the point of care can improve patient pathways, reduce strains on health systems, specifically emergency departments and lead to improved patient outcomes.”

The LumiraDx D-Dimer test is commercially available across Europe. The LumiraDx NT-proBNP test is expected to begin commercialization later this year.

According to DelveInsight analysis, the entry of such molecular tests would massively transform care for patients with cardiovascular diseases. According to DelveInsight’s “Cardiac Biomarker Testing Market” report, the global molecular diagnostics market was valued at USD 3.50  billion in 2021, growing at a CAGR of 7.77% during the forecast period from 2022 to 2027, to reach USD 5.48 billion by 2027. Factors such as the increasing prevalence of cardiovascular disorders, the growing need for early disease diagnosis, the rising aging population, and the advancements in research in identifying novel clinically-relevant cardiac biomarkers are expected to drive the cardiac biomarker testing market during the forecast period (2022-2027).

GRAIL Enters into a Strategic Partnership with AstraZeneca to Develop Companion Diagnostic Tests for Early-Stage Cancer Treatment

On June 02, 2022, GRAIL, LLC announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage diseases, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable the recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies. 

Across the projects within this collaboration, GRAIL will deploy its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for liquid biopsy companion diagnostics. 

GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for adjuvant or neoadjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable the detection of early-stage disease and minimal residual disease (MRD).

Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL stated, “GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration.” He further mentioned, “Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers.”

Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca, said, “Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure.”

As per DelveInsight analysis, the extensive research and development activities in the liquid biopsy domain for the development of multi cancer detection assay, and companion diagnostic tests among others are expected to transform the field of cancer diagnosis and treatment. According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market” report, global liquid biopsy in the cancer diagnostics market was valued at USD 7.64 billion in 2021, growing at a CAGR of 16.64% during the forecast period from 2022 to 2027 to reach USD 19.24 billion by 2027. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand of precision medicine, and technical innovation in product development among other factors are expected to drive the liquid biopsy in the cancer diagnostics market. 

Omnipod by Insulet Provides Significant Improvement in Children with Type 1 Diabetes

On June 03, 2022, Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, presented a new Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) study results for very young children with type 1 diabetes. 

Omnipod 5 is the first tubeless, wearable automated insulin delivery (AID) system in the United States., significantly improved time in range and reduced HbA1c in children aged 2 through 5.9 years with type 1 diabetes over 12 months of use. This pivotal trial extension data was presented at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans, Louisiana.

In the original three-month pivotal trial, Omnipod 5 was shown to be safe and effective, showing appreciable improvement time in range and reducing HbA1c in 80 very young children (ages 2 to 5.9 years) with type 1 diabetes. Insulet previously presented these results at the ADA Virtual 81st Scientific Sessions in 2021.

The pivotal trial participants were invited to continue using the Omnipod 5 System in an ongoing 12+ month extension phase, with 100% electing to participate. Results were analyzed after all participants had completed a total of 12 months of Omnipod 5 use (three months in the pivotal trial and nine months in the extension phase). The extension phase results demonstrated that participants continued to experience significantly improved outcomes compared with baseline throughout 12 months of system use, including lower HbA1c and greater time in range, and there were no episodes of diabetic ketoacidosis or severe hypoglycemia.

After 12 months of Omnipod 5 use, the average HbA1c was 6.9%, compared with 7.4% at baseline and 6.9% at the end of the three-month pivotal trial. Similarly, the percent time in range during months 10 – 12 of use was 67.6%, compared with 57.2% during standard therapy and 68.1% during the three-month pivotal trial. Percent time in hypoglycemia (<70 mg/dL) was reduced compared with standard therapy: the median was 1.9% during months 10 – 12 of use compared with 2.2% during standard therapy and 1.9% during the three-month pivotal trial.

Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet Senior Vice President, and Medical Director, said, “ One of our biggest goals in the development of Omnipod 5 was to ease the burden that type 1 diabetes places on families and caregivers of this vulnerable age group.” 

Dr. Daniel DeSalvo, MD of Baylor College of Medicine, said, “It is particularly challenging for caregivers to manage diabetes in children under six, given their unpredictable eating habits and activity levels. These results, along with the system’s tubeless form factor and ease of use, make Omnipod 5 an excellent choice for automated insulin delivery in this age group, not only for optimizing glycemic outcomes but for alleviating the burden of diabetes for the entire family.” 

According to DelveInsight’s “Insulin Delivery Devices Market” report, the global insulin delivery devices market as valued at USD 15.51 billion in 2021, growing at a CAGR of 9.28% during the forecast period from 2022 to 2027, in order to reach USD 26.35 billion by 2027. The insulin delivery devices market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of diabetes in both geriatric as well as pediatric populations, favorable reimbursement scenarios, rising awareness about diabetes management as well as various types of insulin delivery devices, among other factors.

ETHICON Launches Next Generation ECHELON 3000 Stapler

On June 06, 2022, Ethicon, a part of the Johnson & Johnson MedTech announced the launch of the ECHELON 3000 Stapler in the United States. It is a digitally enabled device that provides surgeons with simple, one-handed powered articulation to help address the unique needs of their patients. The device is designed with a 39% greater jaw aperture and a 27% greater articulation span. ECHELON 3000 gives surgeons better access and control over each transection, even in tight spaces and on challenging tissue. These features combined with software that provides real-time haptic and audible device feedback enable surgeons to make critical adjustments during procedures.

ECHELON 3000 builds upon the ECHELON™+ Stapler with GST Reloads, bringing forward the same capabilities in advancing staple line security and delivering fewer leakage pathways at the staple line, even in challenging conditions compared to the Medtronic Signia™ Stapling System. While it can be used in a wide range of surgical procedures, it was essentially designed to be employed in thoracic, colorectal, and bariatric/gastric laparoscopic procedures where improvements in device access and control can make a meaningful difference. 

Zane Hammoud, MD, FACS***, Chief of General Thoracic Surgery at Ascension Providence Hospital System, said, “The ECHELON 3000 has the flexibility that we as surgeons have long craved in a surgical stapler – with greater articulation for better access to tissue in tight spaces, such as the thoracic cavity.”

Tom O’Brien, Worldwide President, Endomechanical, Ethicon, Inc, added, “Our goal, with ECHELON 3000, is to arm surgeons with a device that helps address the root causes of surgical complications, enabling them to successfully navigate the differing needs of each patient’s anatomy, deliver on their preoperative plans and ultimately make a meaningful difference in patient outcomes.”According to DelveInsight’s “Surgical Stapling Devices Market” report, the global surgical stapling devices market was valued at USD 4.12 billion in 2021, growing at a CAGR of 8.36% during the forecast period from 2022 to 2027, to reach USD 6.67 billion by 2027. The demand for surgical stapling devices is primarily being boosted by the rising number of surgical procedures across the globe, the growing popularity of minimally invasive procedures, technological advancements in product development as well as various advantages associated with surgical staplers, which in turn is expected to propel the growth of the surgical staplers market in coming years.