“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target,” said Komal Jhaveri, M.D., section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study. “The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated.”
As per DelveInsight’s “Hormone Replacement Therapy Market Report,” the hormone replacement therapy market is estimated to grow at a CAGR of 6.48% during the forecast period from 2024 to 2030. The hormone replacement therapy (HRT) market is experiencing significant growth, driven by the increasing prevalence of hormonal and targeted diseases like menopause and osteoporosis, along with an expanding geriatric population, which is driving the demand for hormone replacement therapy. Rising awareness about menopause management and interest in regenerative medicines, including anti-aging and reproductive cycle therapies, the surge in drug approvals, product launches, and the presence of key market players highlight the dynamic nature of the HRT market, which is projected to grow substantially from 2024 to 2030.
Bausch + Lomb Secured FDA Approval for The Envista® Envy™ Full Range of Vision Intraocular Lens
On October 14, 2024, Bausch + Lomb Corporation, a leading global eye health company committed to helping people improve their vision for a better quality of life, announced that the U.S. Food and Drug Administration approved the enVista® Envy™ full range of vision intraocular lens (IOL). This IOL provided a continuous range of vision with excellent dysphotopsia tolerance on the widely adopted enVista IOL platform.
Envy delivered outstanding performance in all lighting conditions, with ActivSync Optic’s intelligent energy distribution, which optimized vision across various lighting environments. It also enabled surgeons to treat a broader range of astigmatic patients with greater accuracy and precision, offering 0.5D steps (or less) throughout the cylinder range.
“We’re confident that U.S. surgeons will agree with what their Canadian colleagues have already told us: enVista Envy delivers exceptional outcomes and meets cataract patients’ high expectations, as well as their own,” said Anthony Wallace, Vice President and General Manager, U.S. Surgical, Bausch + Lomb.
“I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients,” said Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial. “I expect that having a lens on the same platform that offers a full range of vision with minimal visual disturbances, as well as a toric option for precision astigmatism correction, will significantly enhance my ability to achieve that goal.”
As per DelveInsight’s “Intraocular Lens Market Report”, the global intraocular lens market was valued at USD 3.85 billion in 2023, growing at a CAGR of 4.89% during the forecast period from 2024 to 2030 to reach USD 5.13 billion by 2030. The demand for intraocular lenses is witnessing a surge primarily due to the rising prevalence of eye diseases, increasing initiatives by various governments across the globe in controlling and treating blindness, technological advancements in IOLs, and the increasing geriatric population who are more susceptible to ocular ailments which are expected to contribute in the growing product demand thereby boosting the growth of the intraocular lens market during the forecast period from 2024 to 2030.
Microbot Medical Announced the Successful Completion of its Pivotal Human Clinical Trial and Accelerated its go-to-market Strategy in Preparation for the Commercial Launch of LIBERTY®
On October 15, 2024, Microbot Medical Inc., developer of the innovative LIBERTY® Endovascular Robotic Surgical System, announced that they successfully completed enrollment and follow-up for all patients in its ACCESS-PVI human clinical trial. The company remained on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024.
The company also announced that it accelerated its go-to-market strategy. This has planned to begin building out the commercial infrastructure, including hiring a seasoned healthcare executive to lead its sales efforts, upon receiving FDA clearance, which was expected in 2nd quarter of 2025.
ACCESS-PVI was a prospective, multicentered, single-arm trial that evaluated the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions. The trial supported the 510(k) submission to the FDA and the subsequent commercialization of the device. The company expressed its gratitude to the patients, physicians, and clinical sites for their participation in the trial.
“We are very pleased with the performance of LIBERTY® throughout the study,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer. “We want to thank all our investigators for their enthusiastic commitment to the trial. We expect to share the results of the clinical trial with the medical community and the public at a conference in early 2025.
“This is a monumental moment and a significant achievement for Microbot Medical,” commented Harel Gadot, Chairman, CEO and President. The conclusion of the trial and physician feedback is an encouraging development, and our immediate task is to prepare and finalize the FDA 510(k) submission package so we can file it by the end of the year. Concurrently, we will deploy our go-to-market strategy and begin to build out a commercial infrastructure to ensure we are fully prepared to launch LIBERTY® upon the FDA’s clearance, which we expect during 2Q 2025.”
According to DelveInsight’s “Surgical Robotic System Market Report”, the surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
Positive Guidance Received From the U.S. FDA Regarding The Phase III Trial Of 64Cu-SAR-Bispsma in Patients With Recurrent Prostate Cancer
On October 14, 2024, Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on developing next-generation products to improve treatment outcomes for children and adults with cancer, announced that it commenced a pivotal Phase III trial of its 64Cu-SAR-bisPSMA diagnostic in patients with biochemical recurrence (BCR) of prostate cancer. This followed a successful end-of-phase meeting with the U.S. FDA. The trial, named AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer), was set to begin patient recruitment in early 2025.
The AMPLIFY trial was a non-randomized, single-arm, open-label, multi-center, Phase III diagnostic clinical trial of 64Cu-SAR-bisPSMA Positron Emission Tomography (PET) involving approximately 220 participants with rising or detectable PSA following initial definitive treatment. As a pivotal trial, the final study results were intended to provide sufficient evidence to support an application to the FDA for the approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.
The Phase III trial aimed to investigate the ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect the recurrence of prostate cancer. Evaluation occurred across two imaging time points: Day 1 (the day of administration, with same-day imaging) and Day 2 (approximately 24 hours post-administration, with next-day imaging).
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to progress our second Phase III trial with Clarity’s lead product and appreciate the valuable guidance the FDA has provided in relation to our 64Cu-SAR-bisPSMA program to date. The data we have seen so far for this product has been incredibly favourable and we believe 64Cu-SAR-bisPSMA to be best-in-class.”
According to DelveInsight’s “Prostate Cancer Diagnostics Market Report”, the prostate cancer diagnostics market is estimated to grow at a CAGR of 12.45% during the forecast period from 2024 to 2030. The demand for prostate cancer diagnostics is primarily being boosted by the increasing incidence of prostate cancer, increasing awareness and screening programs, and growing advancement in diagnostic technologies, during the forecast period from 2024 to 2030.
ELEHEAR Launched Groundbreaking AI-Powered Hearing Aids Priced at Just $399
On October 15, 2024, the award-winning innovator, ELEHEAR, was thrilled to announce the launch of its latest innovation, ELEHEAR beyond Hearing Aids, which set out to revolutionize the hearing aid market. Designed with cutting-edge AI technology, beyond enhanced sound clarity, offered customizable tinnitus relief, provided seamless Bluetooth streaming, and featured advanced noise reduction—all at an incredibly affordable price point. ELEHEAR Beyond made premium hearing aid technology accessible to the masses without compromising quality.
ELEHEAR Beyond positioned itself as “cutting-edge hearing technology within your reach.” It set new standards in the over-the-counter (OTC) hearing aid market, offering features typically found in significantly more expensive devices.
“Our mission with ELEHEAR Beyond is simple,” says Eric Miao, CEO of ELEHEAR, “to deliver cutting-edge hearing technology at a price everyone can afford. With advanced AI-driven features like VOCCLEAR® and noise cancellation, we’re giving users the premium hearing experience they deserve at a fraction of the traditional cost.”
According to DelveInsight’s “Hearing Aid Devices Market Report”, the global hearing aid devices market was valued at USD 7.01 billion in 2023, growing at a CAGR of 5.47% during the forecast period from 2024 to 2030, to reach USD 9.61 billion by 2030. The rise in demand for hearing aid devices is predominantly attributed to the growing prevalence of hearing loss across the globe coupled with the rising geriatric population. Moreover, an increase in exposure to high-frequency sounds leading to noise-induced hearing loss could also augment the hearing aid market. In addition, technological advancement and raising awareness, and government initiatives about hearing aid devices are likely to propel the global hearing aid devices market.
Abbott Advanced its Pulsed Field Ablation Clinical Studies and Launched new Technology to Support Advanced Cardiac Mapping
On October 10, 2024, Abbott announced that it achieved new major milestones to support the company’s expanding suite of pulsed-field ablation (PFA) solutions in electrophysiology. These included the early completion of enrollment in the VOLT-AF IDE Study, which supports the Volt™ PFA System, and the launch of the FOCALFLEX trial aimed at assessing the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (SE), for the treatment of patients with paroxysmal atrial fibrillation. Together, these two studies marked significant advancements for the future of Abbott’s PFA catheters, which were being developed as crucial tools for physicians treating people with abnormal heart rhythms, such as atrial fibrillation (AFib).
Additionally, Abbott announced the U.S. Food and Drug Administration (FDA) clearance of the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, which would further support mapping in both PFA and radiofrequency (RF) ablation cases, where precise visualization of cardiac anatomy is critical to achieving the best outcomes for individuals undergoing ablation procedures.
PFA represented a promising opportunity to treat people with abnormal heart rhythms using new technology that offered potential safety advantages, reducing known risks associated with traditional ablation therapies. However, early-generation PFA systems had limitations, including the absence of three-dimensional visualization and integration with a 3D cardiac mapping system. Other issues that Abbott’s PFA systems aimed to address included the lack of catheter-tissue contact indication and the need for repeat ablations to ensure favorable patient outcomes. Growing interest in Abbott’s PFA system led to the U.S. VOLT-AF IDE Study being completed four months ahead of schedule, with nearly 400 patients enrolled in just three months.
“It was exciting to participate in the VOLT-AF IDE Study to help assess a next-generation PFA catheter that incorporates new design concepts we believe will advance PFA technology and improve patient outcomes,” said Monica Lo, M.D., an electrophysiologist with Arkansas Heart Hospital who specializes in complex arrhythmias. “Only through studies like VOLT-AF and Abbott’s new FOCALFLEX trial, can we fully understand and safely deploy the next generation of AFib treatments to help people enjoy life free from complex heart rhythm conditions.”
According to DelveInsight’s “Cardiac Ablation Devices Market Report”, the cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.
