According to DelveInsight’s ‘Laparoscopic Devices Market Insight Report,’ this will help Hologic expand its portfolio due to the addition of laparoscopic vessel sealing, dividing, and dissecting devices and developing their use of Bolder’s devices to OB/GYN specialists. Currently, there are five times more laparoscopic procedures in OB/GYN applications than in pediatrics, the focus of Bolder.
Robert Kline, Bolder Surgical’s President, and Chief Executive Officer said that becoming a part of Hologic and its highly revered and well-known Surgical business is an exhilarating and central junction for Bolder. Together, they will expedite realizing Bolder’s vision to grow the efficiency of both surgeons and hospitals.
HistoSonics secures Breakthrough Device Designation for Novel Sonic Beam Therapy
On October 18, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation for HistoSonics’s new non-invasive platform and novel sonic beam therapy called histotripsy. Histotripsy of the liver offers clinicians the first automated external beam therapy utilizing acoustic energy to damage and liquefy tissue in the liver without incisions, ionizing radiation, or heat.
Mike Blue, President, and CEO of HistoSonics, said that the Breakthrough Device Designation is a major milestone for their company and confirms their belief that their platform proffers major advantages over currently approved or cleared alternatives, as per FDA requirements. Early and ongoing clinical results are promising and cue that their ability to damage targeted liver tissue, entirely non-invasively precisely, and without the problems associated with ionizing radiation or other locoregional therapies offers advantages to patients and physicians that do not exist today. They look forward to working with the FDA to make the technology available as quickly as possible.
As per the analyst, this breakthrough status for new histotripsy targeted liver therapy will help provide timely access to non-invasive liver treatment. It is estimated that the company will benefit from the new mechanism of action of their proprietary technology as it will provide significant advantages to patients, including equivalent treatment effects throughout the complete treatment volume leading to precise and predictable treatment zones. The outcomes from the early clinical and preclinical studies have shown that histotripsy essentially conserves vital structures such as the liver capsule and larger vessels and ducts within or adjacent to the treated volume of tissue.
The HistoSonics System is investigational and is unavailable for sale in the United States or Europe.
FDA grants Breakthrough Device Designation for Biological Dynamics’ early-stage Pancreatic Cancer detection test
On October 20, 2021, Biological Dynamics, Inc., a multi-omics liquid biopsy company focused on detecting cancers at the earliest stages, received the Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its liquid biopsy assay, Exo-PDAC. This test will help in the early detection of pancreatic ductal adenocarcinoma (PDAC), one of the most aggressive and lethal forms of cancer globally.
Scott Lippman, MD, Director of Moores Cancer Center at UC San Diego Health, said that early identification of pancreatic cancer in elevated risk individuals might save several lives. The promise of Biological Dynamics’ cutting-edge exosomal isolation technology is meeting a critical, unmet medical requirement in their multidisciplinary and multi-dimensional fight against pancreatic cancer.
According to DelveInsight’s Pancreatic Ductal Carcinoma Market Insight Report, PDAC is estimated to be the second leading cause of cancer-related deaths by 2040 since the disease is asymptomatic in its early stages. The early detection with the help of PDAC biomarkers could benefit the identification of vulnerable patients before the disease progresses or metastasizes. Though, it needs a higher degree of sensitivity and specificity than conventional laboratory testing methods lack.
The Exo-PDAC diagnostic assay detects exosomal biomarkers associated with an increased risk of pancreatic cancer, such as individuals with new-onset diabetes, a family history of pancreatic cancer, specific germline mutations, and other pertinent factors which might be determined by the United States Preventive Services Task Force (USPSTF).
According to DelveInsight’s Liquid Biopsy in Cancer Diagnostics Market, Exo-PDAC is the first assay to utilize Biological Dynamics’ Verita™ platform, a novel alternating current electrokinetic-based technology applied for early disease identification, comprising cancer, Alzheimer’s disease, and infectious diseases. The test needs a small amount of blood from patients, then evaluated with minimal sample preparation or processing.
Phillips-Medisize expands Global Manufacturing capacity, capabilities, and collaborations to drive drug delivery, diagnostic, and MedTech innovations
On October 19, 2021, Phillips-Medisize, a Molex company and leader in the design and manufacture of drug delivery, diagnostic, and MedTech devices, expanded its worldwide manufacturing footprint, along with extended product design, development, and manufacturing abilities to modernize the delivery of products and solutions. The company has 36 world-class facilities with scalable, end-to-end capabilities custom-made to support customers bringing groundbreaking products to market swiftly and efficiently from anywhere in the world.
Paul Chaffin, president, Medical and Pharmaceutical Solutions, Molex, said that as the preferred partner for leading global customers, they continually invest in new talent and technologies, which increase the capacity and capabilities of Phillips-Medisize across the entire value chain. Their expanded worldwide reach and resources will enable them to solve complex development and manufacturing challenges while meeting escalating customer demands for more localized production, supply chain management, and accelerated go-to-market strategies.
According to the analyst, this expansion is expected to address the growing demand as the company is building a state-of-the-art medical manufacturing facility in Katowice, Poland. This site will be functional in 2022 and complement production sites and innovation centers in Asia, Europe, India, Mexico, and North America. It is also expanding its reach by increasing production capacity in Suzhou, China, to assist global and regional pharmaceutical and MedTech customers.
PolyNovo to launch its NovoSorb BTM tech in the European market at MEDICA
On October 20, 2021, PolyNovo, a UK-based medical devices company operating to develop surgical solutions using the patented polymer technology NovoSorb, will join the ABHI UK Pavilion at MEDICA 2021 to launch its NovoSorb BTM (Biodegradable Temporising Matrix) technology into the European market.
NovoSorb BTM is PolyNovo’s first product to be commercialized and is available for use in many countries. It was granted CE mark approval for sale throughout UK/Ireland and the European Union at the end of 2019 and is now planning to expand its footprint across Europe by showcasing on the ABHI UK Pavilion at MEDICA 2021, where it will be launching a new tiny size of the device that is indicated for diabetic foot ulcers and venous leg ulcers.
PolyNovo’s managing director, Paul Brennan, said they were excited to declare their expansion into Europe in 2020. Following the travel limitations this past year, this is the first chance they will have to reveal the unique BTM dermal template to a broader audience. They are delighted for the opportunity to show their innovation within the worldwide trusted ABHI brand at MEDICA 2021. They look forward to associating with new distributors to extend its benefits to more patients across Europe and globally. Their vision is always to support enhanced patient care using the power of their disruptive NovoSorb technology to treat complex wounds.
According to DelveInsight’s ‘Burn Market Insight & Competitive Landscape Report,’ this launch will extend PolyNovo’s reach in Europe and will benefit it in capturing the market share.
Paul Benton, managing director, International at the ABHI, said they are happy that PolyNovo has chosen to launch their pioneering technology on the ABHI Pavilion. As a company, they embody the power of innovation and its importance within healthcare. They look forward to supporting them in their goals to expand and bring the benefits of their revolutionary device to more patients globally.
Luminopia declares FDA approval of Digital Therapeutic that utilizes TV shows to improve vision in children with Lazy Eye
On October 20, 2021, Luminopia, a digital therapeutics company, received de novo premarket approval from the US Food and Drug Administration (FDA) for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the prominent cause of vision loss in children.
Luminopia One is designated for improvement in visual acuity in children with amblyopia, aged 4-7, related with anisometropia and/or with mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional. It allows patients to watch therapeutically modified TV shows and movies to recover their vision within a virtual reality (VR) headset. It is the first FDA-approved digital therapeutic for children with amblyopia, and more widely, the first for a neuro-visual disorder.
David G. Hunter, MD, Ph.D., Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston Children’s Hospital, and advisor to Luminopia, said that the FDA approved a new digital therapy with robust clinical results proof for children affected by amblyopia is a significant development. The idea of prescribing TV shows and movies for amblyopia treatment in children instead of eye patches or eye drops is a thrilling prospect.
As per DelveInsight’s “Amblyopia Market Insight Report,” the company is expected to launch Luminopia One in the second quarter of 2022, and the therapeutic will be prescribed by eye care professionals for 1 hour per day, six days per week, for 12-week periods, and used at home by patients. This will bring changes in the Amblyopia market treatment scenario.
Scott Xiao, chief executive officer of Luminopia, said that they are proud to be part of the FDA’s groundbreaking decision to approve a first-of-its-kind digital therapeutic that lets patients watch their favorite TV shows and movies to enhance their vision. They are excited to bring Luminopia One to children with amblyopia across the country. This vital milestone also opens the door for them to adapt their technology to engage digital therapeutics for neuro-visual disorders.
