Collagen Matrix received FDA 510(k) approval for Fibrillar Collagen Wound Dressing

On June 29, 2022, Collagen Matrix, Inc., a leader in regenerative medicine, a global manufacturer of collagen and other biomaterial-based medical devices, and Linden Capital Partners portfolio company announced  FDA 510(k) Clearance for a Fibrillar Collagen Wound Dressing, product offerings into the advanced wound care market

The Collagen Matrix Fibrillar Collagen Wound Dressing is an absorbent microfibrillar matrix designed to handle moderately to severely exuding wounds and prevent mild bleeding. When a dressing is put immediately on a wound bed, it begins to absorb exudates and protects the wound bed and fragile new tissue. Pressure ulcers, diabetic ulcers, venous stasis ulcers, acute wounds (such as trauma and surgical wounds), and partial-thickness burns may all benefit from this treatment.

“This 40th 510(k) milestone is a testament to our team’s tireless commitment to developing meaningful innovation in regenerative medicine throughout our 25-year history. We’re excited to expand our portfolio into advanced wound care, a $9B global market with numerous opportunities for our technologies to make a difference for patients worldwide,” said Shawn McCarthy, CEO of Collagen Matrix. He also added, “Significant unmet needs in this area demand more effective and proficient treatment of wounds of all types, especially chronic wounds, and with the synergies, our technology platforms offer, Collagen Matrix is well-positioned to gain approvals and commercialize products quickly with our partners in markets around the world.”

McCarthy also added, “With the introduction of this unique wound dressing, Collagen Matrix is demonstrating its commitment to serving the advanced wound care market. We have the unique ability to utilize our diverse set of technology platforms, processes, and materials to custom design products for our partners based on their needs and the problems they aim to solve with regenerative solutions,” He also commented, “For wound, it may be the application of a coating for fluid management or the integration of novel material with collagen to provide anti-microbial properties. The point is: we have the development capabilities and expertise to deliver all of that and more.”

Additionally, according to DelveInsight’s “Wound Healing Devices Market” report, the global Wound Healing Devices market was valued at USD 19,724.65 million in 2021, growing at a CAGR of 5.32% during the forecast period from 2022 to 2027 to reach USD 26,761.38 million by 2027. The rise in demand for wound healing devices is predominantly attributed due to the rising shift from the traditional techniques of wound care management towards sophisticated wound care techniques and products across the globe. Moreover, the surging cases of various chronic and acute wounds across the globe will increase the demand for wound healing devices. As per the Delveinsight analysis, North America is expected to have a significant share of revenue in the overall wound healing devices market during the forecast period. This is due to the factors such as the increasing prevalence of chronic disorders, rising traumatic wounds due to increasing accidents, increase in expenditure on surgical and chronic wounds, and technological advancements in the product portfolio are expected to aid in the growth of North America in wound healing device market. 

Roche launched the ULTRA PLUS system for cancer diagnostics

On June 29, 2022, F. Hoffmann-La Roche Ltd, one of the first industrial manufacturers of branded medicines, launched the ULTRA PLUS system, an advanced tissue staining platform. 

A healthcare professional may detect these indicators by applying chemical solutions to tissue on glass slides using the BenchMark ULTRA PLUS to evaluate the presence or absence of critical drivers that feed the sick cells and, in many circumstances, the sort of therapy that might be employed to battle them. The BenchMark ULTRA PLUS system offers optimized workflow and adaptable solutions, allowing anatomic pathology labs to manage their operations more effectively and reliably while picking alternatives that are appropriate for their lab.

The new BenchMark ULTRA PLUS system continues the progression of the BenchMark series, which revolutionized cancer diagnostics by entirely automating activities that were previously conducted manually, one slide at a time.

Several improvements are included in the new system, including more intuitive software, remote monitoring functions, an integrated touchscreen for a more optimized user experience, and a more ecologically efficient waste system and product packaging.

The BenchMark ULTRA PLUS system will be available to European Union countries in July 2022 and to the United States and in the Asia-Pacific market in September 2022, followed by a worldwide rollout in 2023.

“With the BenchMark ULTRA PLUS, we are pleased to offer an advanced tissue staining platform, co-developed with lab professionals. Waiting for a diagnosis is often one of the most stressful times for patients. This system enables pathologists to provide quick and accurate results that help inform patient treatment options.” said Thomas Schinecker, CEO of Roche Diagnostics.

According to the DelveInsight analysis, the Cancer Therapy Devices Market is anticipated to grow at a significant rate during the forecast period (2022-2027). This is owing to an increase in the prevalence of cancer globally. For instance, the GLOBOCAN study conducted by the International Agency for Research on Cancer mentioned that in the year 2020 there were an estimated number of 19.3 million new cases of cancer, and approximately 10.0 million cancer deaths were reported globally. The increasing prevalence of cancer will increase the demand for cancer therapy in the market, thereby owing to an increase in the overall market growth of the cancer therapy device market during the forecast period of 2022 – 2027.

Insightec Announced the Receival of IDE Approval from FDA for Comparative Study of Prostate Cancer Using High Intensity Focused Ultrasound Technology

On June 30, 2022, Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that the company has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue.

The purpose of this research is to compare the safety and efficacy of localized therapy with high-intensity focused ultrasound versus active surveillance in males with prostate cancer

Sound waves are used by the Insightec Exablate Prostate device to ablate or kill, specific tissue in the prostate. The therapy is carried out under the direction of Magnetic Resonance Imaging (MRI) enabling high-resolution imaging of the patient’s anatomy for accurate targeting and real-time temperature monitoring. The single-session therapy eliminates the need for incisions and allows patients to resume regular activities with few consequences. 

In November 2021, the Insightec Exablate Prostate system got 510(k) FDA clearance, paving the path for the system to be delivered to patients in a commercial setting and for additional clinical trials. The technology was utilized to treat prostate illness in its first commercial patient in the United States in January 2022. 

A prior Insightec-sponsored clinical trial for the Exablate Prostate system, performed by Memorial Sloan Kettering Cancer Center, found minimal harm to neighboring structures and low rates of impact on potency and continence, supporting function, and quality of life for patients. The current comparison analysis expands on the findings from the previous clinical trial to improve prostate treatment choices and clinical results. Moreover, the new study’s findings will clarify the importance of focused treatment in delaying and avoiding radical therapy for men with prostate cancer, as well as encourage greater clinical acceptance of the technology and enhanced patient access through insurance coverage.

“We are excited to continue this important research that can impact the standard of care for prostate cancer treatment,” said Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and principal investigator for the study. He also added, “Exablate Focused Ultrasound has been shown to provide an accurate, safe, and effective option to engage the prostate gland directly in select patients based on 2-year biopsy outcomes. The new trial will build on this success and help further enhance treatment options.”

Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board said “At Insightec, we are committed to the next generation of prostate cancer research and patient care,” Maurice R. Ferré, also said, “Through technological innovation and medical advancements, there has been significant progress made in treating the prostate over the last decade, but we’re not done yet. Our goal for this study is to demonstrate the clinical benefits of Exablate Prostate and provide patients with the opportunity for improved quality of life outcomes.”

According to DelveInsight’s “Cancer Diagnostics Market” report, the global cancer diagnostics devices market was valued at USD 125.13 billion in 2021, growing at a CAGR of 9.43% during the forecast period from 2022 to 2027 to reach USD 214.88 billion by 2027. The cancer diagnostics devices market is slated to witness prosperity owing to factors such as the growing burgeoning old-age population and the rising prevalence of various cancer diagnostic labs, rising government initiatives to raise awareness regarding early detection, and management of cancer among the patients, and others. Furthermore, as per the Delveinsight analysis, among all regions, North America is estimated to hold the highest share in the global cancer diagnostics market owing to the rising prevalence of cancer cases and the presence of key- manufacturers in the region along with an increase in the healthcare spending in the region. 

JustLight plc. Initiated Clinical Trials for Sunflower Rx™, a Breakthrough Medical Device Treatment for Alzheimer’s disease

On June 30, 2022, JustLight, a public benefit corporation, initiated clinical trials for its medical device, Sunflower Rx™, which provides smart photobiomodulation (PBM) treatment for Alzheimer’s disease.

Photobiomodulation is the medical application of red or near-infrared light to heal, restore, and revitalize cells in our bodies – all while causing no harm. Sunflower RxTM bypasses the skull and is absorbed directly by the brain by using precise wavelengths of near-infrared light.

This revolutionary technology designed by JustLight, in partnership with Light Tree Ventures and Kaiyan Medical, aims to be the world’s first FDA-cleared safe, and effective Alzheimer’s medical device.

“Our patent-pending technology automatically adjusts the LED Light output to replicate clinical parameters, delivering precise and effective photobiomodulation treatment in the comfort of one’s home,” said JustLight founder Peter Forhan. Peter also added, “We aim to solve the $321 billion Alzheimer’s crisis and revolutionize our health care system through universal access to photobiomodulation.”

According to Dr. Janet Price, JustLight’s Chief Scientific Officer, the pilot program with Nexcare assisted JustLight in identifying possible improvements to the device and routines to better fit customer needs. Price said, “After six weeks of continuous Sunflower use, Nexcare participants reported positive experiences and showed improved or stable cognition scores based on standard clinical measures,”. He also added, “The majority of mild-moderate individuals experienced an improvement in standardized cognitive test scores in one month of daily use. Participants had improved mood, better communication with staff, and one individual stopped being a fall risk.”

Forhan said, “We have begun recruitment and subsequent clinical evaluation of Violet at the University of Michigan Hospital,” Forhan added, “We expect the completion of this clinical study to be a major step towards earning FDA clearance for UV-C hand sanitation.”

According to DelveInsight’s Brain Monitoring Devices Marketreport, the global brain monitoring devices market is expected to grow at a 7.27% CAGR during the forecast period (2022-2027). The increase in brain monitoring devices is predominantly owing to the increasing number of cases of neurological diseases worldwide. Additionally, as per DelveInsight analysis, in the product type segment, EEG devices are expected to hold a considerable market share in the year 2021. This is owing to the wide application circle in the detection of neurological disorders such as epilepsy, seizure, Alzheimer’s, and other disorders. 

First Commercial Implantation of the Thoraflex Hybrid Device of Terumo Aortic in the United States

On July 04, 2022, Terumo, a global leader in medical technology, announced the first commercial implant of the device Thoraflex Hybrid, in the United States.

Thoraflex Hybrid is a single-use medical device that combines a Gelweave polyester graft with a self-expanding Nitinol stent graft. In the situations of an aneurysm and/or dissection, it is advised for open surgical repair or replacement of damaged or diseased arteries of the aortic arch, as well as repair of the descending thoracic aorta with or without the involvement of the ascending aorta.

Thoraflex Hybrid got CE Mark clearance in 2012 and FDA approval in 2022, with over 13,000 devices sold commercially worldwide in the previous ten years. Terumo Aortic’s market-leading array of surgical, endovascular, and hybrid devices for treating every section of the aorta includes this device.

The implant was performed by the Principal Investigator of the Thoraflex Hybrid Study, Joseph Coselli, MD, Professor, and Executive Vice-Chair, Division of Cardiothoracic Surgery, Baylor College of Medicine, and Houston, Texas, US.

Joseph Coselli said, “The procedure was very successful, the device performed well, and the patient is making a good recovery. Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States and it will allow US physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single-stage procedure for those with suitably limited disease, instead of two procedures which has been the conventional pathway in the United States for this group of patients”.

Paul Kuznik, President of Terumo Aortic North America, said, “This commercial implant represents a significant milestone for the company and a tremendous opportunity for Terumo Aortic in the United States. This innovative hybrid device complements our open surgical graft and endovascular portfolio making us one of the strongest medical device companies within the aortic space, helping to deliver our commitment to provide solutions for every aorta.”

According to DelveInsight’s Stents Marketreport, the global stents market is expected to grow at a 5.61% CAGR during the forecast period (2022-2027). The increase in stents is predominantly owing to the increasing number of cases of chronic diseases worldwide. Additionally, as per DelveInsight analysis, in the region segment, North America is expected to hold a considerable market share in the year 2021. This is owing to the rising prevalence of sedentary lifestyle and rising technological advancements associated with stents, thereby anticipated to increase the stents market in North America in the forecast period of 2022 – 2027. 

FDA 510(k) Clearance for the DABRA 2.0 Catheter Received by Ra Medical Systems

On July 5, 2022, Ra Medical Systems, Inc., a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the U.S. Food and Drug Administration 510(k) clearance for the DABRA 2.0 catheter, as part of the DABRA Excimer Laser System.

The catheter contains a braided over jacket design that is intended to improve deliverability and kink resistance when navigating tortuous anatomy. The catheter is also offering a six-month shelf life.

The FDA has approved DABRA for crossing chronic complete occlusions in patients with symptomatic infrainguinal lower extremity vascular disease, and it is also designed for ablating a channel in patients with occlusive peripheral vascular disease. DABRA has also received CE mark approval for the endovascular treatment of infrainguinal arteries by atherectomy and for crossing complete occlusions.

“While we are pleased to receive this regulatory clearance, it comes as our Board continues its evaluation of strategic alternatives to optimize our Company’s path forward in the current challenging economic environment,” said Will McGuire, Ra Medical Systems CEO. CEO also added, “As we have previously announced, the DABRA 2.0 catheter represents an interim step in our work to develop a guidewire-compatible version of the DABRA catheter, and at this time we have no plans to commercialize the DABRA 2.0.”According to DelveInsight’s Peripherally Inserted Central Catheter (PICC) Devices Market” report, the global Peripherally Inserted Central Catheter (PICC) Devices Market was valued at USD 924.09 million in 2021, growing at a CAGR of 5.26% during the forecast period from 2022 to 2027, to reach USD 1,256.94 million by 2027. The demand for peripherally inserted central catheter (PICC) devices is primarily motivated by the increasing prevalence of cancer, and infectious diseases, the growing demand for PICC due to an increase in prolonged treatment with antibiotics, transfusions, and technological advancements in the product. As per the Delveinsight analysis, in the product type segment of the PICC devices market, the power injected peripherally inserted central catheters account for the highest contributor to the peripherally inserted central catheter (PICC) devices market, due to the advantages associated with the power PICC. For instance, most of the power PICC is made of polyurethane, a stronger material that can withstand the pressure with only a small decrease in flexibility. Moreover, it can be used as multipurpose central lines for any type of infusion including hemodynamic monitoring, high-flow infusion, and high-pressure injection of contrast media during radiological procedures. These advantages account for the rising demand for the power PICC, thereby propelling the overall market growth of peripherally inserted central catheter (PICC) devices in the forecast period (2022 – 2027).