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LumiThera Announced the Result of US LIGHTSITE III Trial of Non-neovascular Age-Related Macular Degeneration (AMD) Subjects Treated with Photobiomodulation (PBM) using the Valeda® Light Delivery System
On June 22, 2022, LumiThera Inc., a commercial-stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, released the results of its US LIGHTSITE III multi-center clinical trial of non-neovascular (dry) age-related macular degeneration (AMD) patients treated with photobiomodulation (PBM) using the valeda® light delivery system.
The company conducted the trial at ten leading US retinal centers. LIGHTSITE III is a prospective, double-masked, randomized, multi-center clinical trial conducted with the aim to treat non-neovascular (dry) AMD subjects with PBM every four months for a duration of 24 months. In the trial, 100 patients were enrolled in a 2:1 ratio of PBM to sham in the treatment groups.
The average age of patients in the trial was 75 years, and the average duration of dry AMD from diagnosis was 4.9 years prior to trial enrolment. The sham and PBM treatment groups had baseline best-corrected visual acuity (BCVA) letter values of 69.4 + 0.8 and 70.1 + 0.7, respectively. The vast majority of individuals were diagnosed with moderate dry AMD. The study included 91 eyes in the PBM treatment group and 54 eyes in the sham treatment group.
The study results showed that the PBM treatment group outperformed the sham-treatment group in the prespecified primary outcome of BCVA at 13 months (p = 0.02). At the 13-month time point, PBM-treated participants had a sustained, mean rise in ETDRS letter score of 5.5 letters from baseline (p 0.0001) was observed. In the PBM therapy group, 55% of individuals improved by more than 5 letters on the standard EDTRS eye chart, with a mean of 9.7 letters, and 26% improved by more than 10 letters, with a mean of 12.8 letters.
In naive individuals, the progression to later-stage disease pathology, such as the neovascular (wet) form or the development of Geographic Atrophy (GA), i.e., loss of retinal tissue, was examined. At month 13, the percentage conversion of dry AMD to wet AMD was 1.8 percent for sham, 5.4 percent for PBM, and 8.3 percent for non-study eye groups. At baseline, a few individuals exhibited GA (9 eyes at screening), and they were evenly split across 5 PBM and 4 sham eyes. At month 13, 6 more eyes had progressed, with new GA detected. At month 13, five of the 55 sham eyes (9.1%) proceeded to new GA, whereas just one of the 93 PBM eyes (1.1%) moved to new GA.
Diana Do, MD, and Quan Dong Nguyen, MD, MSc, FARVO, Professors of Ophthalmology and members of the Retina Division at the Byers Eye Institute at Stanford University, a clinical site for the LIGHTSITE III trial said, “The subjects had good starting vision with approximately 70% having between 20/32 to 20/40 visions. Study subjects were only enrolled in the study if their vision was 20/32 to 20/100 and no evidence of GA in the central macula.” They also added, “Intermediate dry AMD patients have pathology and visual impairment consistent with earlier stages in the disease and have not lost retinal tissue by progressing to GA. Thus there is an opportunity to improve their vision while retinal tissue is still viable. Therapy with PBM using the Valeda Light Delivery System may serve a significant unmet need for many of our patients with dry AMD who now have the potential to improve their visual acuity with treatment.”
“Overall, the clinical results show improvements in vision; what is further interesting is the lack of drusen deposit in the PBM treated group, and potentially less patient conversions to wet form of disease,” remarked Glenn Jaffe, MD, Robert Machemer Professor of Ophthalmology; Chief, Vitreoretinal Division and Director, Duke Reading Center, the central imaging center for the LIGHTSITE III study. He also commented that “Patient progression to new GA was also evaluated and was less in the PBM group, and while the new GA progression numbers are small in this study group, all outcomes point in favour for PBM as a novel approach to treat dry AMD patients earlier in disease.”
Clark Tedford, PhD, President and CEO, LumiThera, said, “The study continues to strongly support that Valeda PBM treatments can improve visual acuity.” He also added that, “Our commercial and clinical trial experience has demonstrated an excellent safety and clinical benefit profile and we plan on submitting a PMA to the FDA for U.S. approval.”
Additionally, According to DelveInsight’s “Ophthalmic Devices Market” report, the global ophthalmic device market was valued at USD 55.91 billion in 2021, growing at a CAGR of 4.12% during the forecast period from 2022 to 2027 to reach USD 71.23 billion by 2027. The rise in demand for ophthalmic devices is predominantly attributed due to the increasing prevalence of various eye-ailments such as myopia, glaucoma, age-related macular degeneration, and others, the increasing burden of the geriatric patients, the increasing number of ophthalmic surgeries, and technological advancements in the product, that will increase the demand of the ophthalmic devices.
As per the Delveinsight analysis, North America is expected to have a significant share in revenue in the overall ophthalmic market during the forecast period. This is due to the factors such as the increasing prevalence of ocular disorders, rising geriatric population, increasing prevalence of lifestyle disorders such as diabetes, hypertension, and surging government programs to create awareness of eye-related disorders are expected to aid in the growth of North America in the ophthalmic device market.
3Spine, Inc. Announced IDE Approval for MOTUS device, the implant used in the BalancedBack Total Joint Replacement Procedure
On June 22, 2022, 3Spine, Inc., a medical device company developing a total joint replacement for the lumbar spine, announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial.
The MOTUS device from 3Spine, which is utilized in the BalancedBack Total Joint Replacement operation, is a “first of its kind” technology that replaces the function of the disc and facet joints via a posterior route. Through the restoration of the functional spinal unit, the surgery treats leg pain, back pain, and spinal instability while improving posture and restoring range of movement.
In 2020, the Food and Drug Administration (FDA) classified MOTUS as a Breakthrough Device. The BalancedBack Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment after decompression at one lumbar level from L1/L2 to L5/S1 in skeletally mature patients with symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level. Prior to receiving the BalancedBack Total Joint Replacement, patients must have exhausted conservative (non-operative) treatment for at least 3 months (opioid use, physical therapy, invasive cortisone anti-inflammatory medications) or be determined to have a neurologic emergency or intractable pain.
“This is important, breakthrough technology for an underserved patient population,” said Justin Eggleton, Vice President of Spine Regulatory Affairs at MCRA. He also added, “The considerations for such a novel treatment required significant resources at FDA, and we appreciate the agency’s dedication to the review. The FDA review team carefully and thoughtfully challenged over 10,000 pages of biomechanical data, clinical history, and an exhaustive battery of non-clinical testing. FDA’s review establishes an important foundation for our project. MCRA is excited to partner with 3Spine as CRO for the IDE to strengthen the safety and effectiveness profile for our future pre-market approval application.”
Ron Yarbrough, Chief Operating Officer at 3Spine said, “Breakthrough Device Designation was critical to our success in the IDE approval process,” He also added that, “This project is the culmination of decades of technical and clinical research in the lumbar spine, and while the courage of pioneering patients and surgeons brought us to this point, today it is all about the tenacity and expertise of the FDA review team. Our interactive review with FDA over the past two years has resulted in comprehensive coverage of an unparalleled number of technical disciplines, reflecting the potentially transformational nature of this spine technology. We are very excited to begin IDE enrollment.”
According to DelveInsight’s “Knee Reconstruction/ Replacement Devices Market” report, the global knee reconstruction of replacement devices market was valued at USD 7.87 billion in 2021, growing at a CAGR of 4.52% during the forecast period from 2022 to 2027 to reach USD 10.27 billion by 2027. The knee reconstruction devices market is slated to witness prosperity owing to factors such as the growing burgeoning old-age population and the rising prevalence of various knee-associated musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis, and others.
Furthermore, as per the Delveinsight analysis, among all regions, North America is estimated to hold the highest share in the global knee replacement market owing to the presence of advanced healthcare systems in the region along with an increase in healthcare spending in the region.
First Patient enrolled in vascular closure device study of Teleflex
On May 22, 2022, Teleflex Incorporated, a leading global provider of medical technologies, announced the first patient enrolment in a clinical study that is intended to demonstrate the safety of MANTA® Vascular Closure Device ultrasound (U/S) guided closure, without dependence on the pre-procedural depth locator measurements.
The MANTA Ultra Study will enroll up to 150 patients in up to 15 investigational sites across the United States and Canada. The trial is a multi-center, single-arm trial employing the primary safety endpoint of any large bore access-site related Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complication within 30 days (adapted from VARC-2 Criteria). The prevalence of access site problems has been linked to greater rates of morbidity and death, as well as higher expenses associated with extended lengths of stay. Ultrasound-guided access has been linked to a lower risk of major and small vascular problems, as well as a lower risk of life-threatening, major, and minor access site bleed issues.
The goal of the study is to show that ultrasound enables precise deploy and placement of the MANTA® Device anchor within the vessel. If successful, this strategy will allow the MANTA® Device to be employed in clinical circumstances where the baseline arterial depth is not determined or has altered intra- or post-operatively. The MANTA® Device ultrasound-guided closure is designed to provide an alternate solution to the traditional pre-procedural depth locator measuring procedure, giving operators more procedural freedom.
In addition to the primary safety endpoint, the study will employ a secondary endpoint of any large bore access-site related VARC-2 minor vascular complication within 30 days (adapted from VARC-2 Criteria) and secondary effectiveness endpoints that include time to hemostasis, technical success, ambulation success, time to ambulation, treatment success and procedure time – all with 30-day and 12-month follow-up time points.
Chris Buller, MD, Teleflex Medical Director, said “The resourcing of the MANTA Ultra Study by Teleflex reflects our commitment to providing interventional cardiologists and surgeons with category-defining tools that enable difficult procedures and minimize complications – in this case, the complications attributable to large bore access that are inherent to TAVI procedures,”
Illumina Announced the Launch of Research Test Co-developed with Merck used to Detect Tumor Genome in the Patient
On May 22, 2022, Illumina, Inc., a global leader in DNA sequencing and array-based technologies, announced the launch of a research test. The research test is co-developed with Merck. The research test builds upon a commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
The TruSightTM Oncology 500 assay, which is widely available, now includes an evaluation of a novel genetic signature. It will be available worldwide, with the exception of the United States and Japan, and will allow researchers to get deeper insights into the tumor genome by detecting genetic alterations employed in the assessment of homologous recombination insufficiency (HRD).
The TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)-based assay that combines the power of Illumina NGS technology with validated HRD technology from Myriad Genetics, allowing labs to detect genomic instability and analyze more than 500 genes at the same time, including those relevant to HRD status. HRD is a genetic signature that describes when cells are unable to repair double-stranded DNA breaks properly. Cells rely on alternate, error-prone DNA repair processes when this happens, which can lead to genomic instability and, eventually, tumor development.
“HRD status has emerged as an important biomarker in tumors that harbor high levels of DNA damage, such as ovarian, breast, prostate, and pancreatic cancers,” said Phil Febbo, MD, chief medical officer at Illumina. He also added, “With one sample and one test, TruSight Oncology 500 HRD assay provides labs with comprehensive, accurate, sensitive results that can greatly enhance our understanding of the genomic nature of a tumor.”
Large-cohort studies show that comprehensive genomic profiling (CGP) has the potential to identify relevant genetic alterations in up to 90% of samples. A single, comprehensive assay to assess a wide range of biomarkers uses less sample and returns results more quickly compared to multiple, iterative tests. As a kitted, distributable solution, this test helps to remove barriers to the internalization of CGP and HRD testing, so that labs of all sizes can offer this powerful test.
“We are pleased to reach this first milestone with Illumina to commercialize an assay for HRD assessment that will aid in advancing clinical research and broaden access to clinical trials,” said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.
According to DelveInsight’s ‘Cancer Diagnostic Market” report, the global cancer diagnostic market is expected to grow at a 9.43% CAGR during the forecast period (2022-2027). The increase in cancer diagnosis is predominantly owing to the increasing number of cases of cancer worldwide.
Additionally, as per DelveInsight analysis, in the product type segment, the reagents and kits are expected to hold a considerable market share in the year 2021. This is due to the wide availability of reagents and kits in the detection of cancer, cell signaling, cell proliferation and viability, tumor suppressor gene, bioactive proteins, and other cancer cells.
Investigational Device Exemption (IDE) Received by Varian for Flash Technology Clinical Trial, FAST-02
On May 27, 2022, Varian, a Siemens Healthineers company, announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to advance Varian’s Flash clinical research program with the FAST-02 (FeAsibility Study of Flash therapy for the Treatment of Symptomatic Bone Metastases) clinical trial.
Data from FAST-01, Flash’s first human clinical trial, was used to support the approval of the FAST-02 study, which will be published later this year.
The FAST-02 clinical study will cover bone metastases in the chest, expanding on the clinical data from FAST-01 and offering vital insights into the therapeutic usage of Flash therapy for cancer metastases. FAST-02 is scheduled to enroll 10 patients with painful thoracic bone metastases and will analyze treatment-related side effects and effectiveness using study participants’ reported pain alleviation.
Similar to FAST-01, FAST-02 was designed with input from leading scientific experts from the FlashForward™ Consortium.
The Varian ProBeam® system’s proton particle accelerator has been adapted to provide Flash therapy in association with the FAST-02 clinical study, and Varian’s EclipseTM treatment planning system has also been changed to produce plans for the Flash treatments. Varian is the industry’s sole partner advancing the development of Flash therapy as an integrated, end-to-end solution that incorporates advancements in treatment planning, quality assurance, and therapy delivery technologies. Flash therapy, an experimental treatment modality delivering radiation therapy at ultra-high dose rates in typically less than one second, maybe over 100 times faster compared to conventional radiation therapy.
“For the last decade, radiation oncologists have been exploring Flash therapy as an important opportunity to create a paradigm shift in the way we treat patients,” said Breneman, Medical Director of the Cincinnati Children’s/UC Health Proton Therapy Center, University of Cincinnati Cancer Center member. He also added, “The FAST-01 trial laid the groundwork for the approval of FAST-02, and we are excited to continue the clinical research and evaluate Flash therapy in a new patient cohort.”
Agam Sharda, Vice President of Flash Solutions at Varian, said, “Receiving IDE approval for FAST-02 reaffirms our confidence in the potential of Flash therapy and represents an important step toward delivering this groundbreaking therapy in a clinical setting,” He also added that, “Together with our FlashForward Consortium, we have expanded Flash therapy research using our systems as we work to improve the patient experience. We look forward to continuing to collaborate with experts around the world to push the boundaries of innovation in cancer care.”
“Preclinical research of Flash therapy indicates using ultra-high dose rates may be less toxic to patients overall and enhances sparing of adjacent healthy tissue,” said Deepak “Dee” Khuntia, M.D., Senior Vice President and Chief Medical Officer of Varian. “The FAST-02 study will advance our work toward an important proof of concept, particularly in deep-seated tumors. We are eager to build on our clinical understanding of Flash therapy as we continue our work to transform cancer care.”
According to the DelveInsight analysis, the market for Cancer Therapy Devices 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 in the market in the forecast period of 2022 – 2027.
AcQCross Qx System Launched by Acutus Medical
On June27, 2022, Acutus Medical, Inc., an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, launched AcQCross™ Qx system for use with the TruSeal (TM) and FXD(TM) delivery system for the Watchman™ LAAC Device.
Gaining access to the left atrium requires physicians to cross the septum, a multi-step process that often involves the exchange of wires and needles while trying to achieve the proper angle and location on the septum. To decrease these exchanges, AcQCross is the first and only transseptal device designed with an integrated needle and dilator. Acutus may now provide sheath-compatible transseptal access devices for 409,000 electrophysiological and structural cardiac treatments in the United States.
AcQCross catheters are length-, diameter-, and tip-matched and engineered to lock onto the hub of market-leading sheaths used in the great majority of left-heart surgeries, including Watchman delivery. AcQCross may now be used with any sheath for practically every left-heart access operation, thanks to the increased product portfolio.
“Crossing the septum at the proper location is important when doing any left-sided heart procedure, but it can be especially critical to the success of delivering Watchman to the left atrial appendage,” said Dr. Tom Waggoner, DO, FACC, FSCAI, FSVM, RPVI, Director, Structural Heart Program and Cardiovascular Research, Tucson Medical Center, Tucson, Arizona. He added, “With AcQCross, I can easily reposition without withdrawing or exchanging needles or wires, so its new compatibility with Watchman has made my procedures much safer for my patients and far more efficient for me and my team.”
David Roman, interim Chief Executive Officer, and Chief Financial Officer, Acutus Medical, said, “The AcQCross system provides interventional cardiologists and electrophysiologists with unique benefits of broad compatibility with market-leading access sheaths while also enhancing procedure versatility and workflow,.” David Roman also said that “The expanded AcQCross product line allows us to bring this innovative technology to a wider range of procedure categories that should drive sustained growth in this portfolio.”
According to DelveInsight’s “Cardiac Assist Devices Market” report, the global cardiac assist devices market was valued at USD 2.89 billion in 2021, growing at a CAGR of 13.70% during the forecast period from 2022 to 2027, to reach USD 6.23 billion by 2027. The demand for cardiac assist devices is primarily motivated by the increasing prevalence of cardiovascular disorders, the number of geriatric patients, growth in new devices, increasing acceptance and penetration of assisting devices, and technological advancement in the product.
As per the Delveinsight analysis, in the product type segment of the cardiac assist devices market, the ventricular assisting device accounts for the highest contributor to the cardiac assist devices market, due to the higher prevalence of ventricular failure. The rising number of geriatric patients, increasing unhealthy lifestyle, and the rising prevalence of obesity account for the rising demand for ventricular assisting devices, thereby propelling the overall market growth of cardiac assist devices in the forecast period (2022 – 2027).