Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test 

On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA).

The enzyme-linked immunosorbent in vitro diagnostic technique is used to detect antibodies (IgG) to the AAVrh74 capsid in human serum in a semi-quantitative manner. The test is intended to be used in conjunction with other clinical data as a tool to help identify patients who are qualified to receive treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy for some Duchenne muscular dystrophy patients, from Sarepta Therapeutics, Inc.

Additionally, Quest and Sarepta—the pioneer in precision genetic therapy for rare diseases announced an expanded partnership, as part of which Quest will create one or more supplemental diagnostics to go along with Sarepta’s line of approved and under-development gene therapies. The partnership may include screening procedures for antibodies to Sarepta’s gene therapies for muscular dystrophies, such as Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMD), based on AAV vectors. The first companion test will be for ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy developed by Sarepta and approved by the U.S. Food and Drug Administration in June 2023 to treat the genetic basis of DMD. Additionally, Quest will conduct clinical lab tests for Sarepta.

“Achieving breakthrough designation for our AAVrh74 ELISA, and collaboration with AAV-gene therapy pioneer Sarepta, positions Quest at the forefront of companion diagnostics innovation in the growing field of gene therapies,” said Bill Finger, General Manager, Pharma Services, Quest Diagnostics. Bill Finger also said, “Our AAV testing expertise has the potential to empower many life science collaborators to develop, and ultimately bring to market, companion diagnostics for their gene therapies.”

“Sarepta is pleased to expand its collaboration with Quest beyond our investigational therapies and to partner to develop essential diagnostic tools for our approved gene therapies that help streamline/match gene therapy treatment to eligible patients. Quest’s diagnostic R&D capabilities and laboratory capacity play a critical role in identifying the patients who may benefit from these treatments,” said Louise Rodino-Klapac, executive vice president, head of R&D and chief scientific officer, Sarepta Therapeutics.

As per DelveInsight’s “Viral Vector Manufacturing Market” report, the global viral vector manufacturing market was valued at USD 696.17 million in 2022, growing at a CAGR of 19.22% during the forecast period from 2023 to 2028 to reach USD 1,995.43 million by 2028. The demand for viral vector manufacturing is primarily being boosted by the rising cases of serious genetic disorders such as spinal muscular atrophy, hemophilia, retinitis pigmentosa, and others, the rising incidence for different cancer types, increasing popularity and research on gene and cell therapy, and growing concern over sudden occurrence of epidemics and pandemics are further contributing in the overall growth of the viral vector manufacturing market during the forecast period from 2023-2028.

Signia Introduces Hearing Aids That Tackle the Most Difficult Challenge for People with Hearing Loss

On September 05, 2023, Hearing aid innovator Signia, part of WS Audiology, launched Integrated Xperience, a breakthrough technology that enables hearing aid wearers to hear all speakers in noisy group conversations. Even when speakers move or the wearer turns their head, the hearing aids ensure improved speech understanding. 

Signia Integrated Xperience is the world’s first hearing aid that identifies and locks onto the voice of every person in a conversation, enhancing their speech and reducing background noise.

Signia Integrated Xperience significantly improved the hearing aid user’s ability to perceive speech in research looking at speech performance in a group discussion setting. In comparison to those who did not use Integrated Xperience RealTime Conversation Enhancement, 95% of the participants performed better.

Signia’s brand-new Pure Charge&Go IX is the first device to use the Integrated Xperience platform. The first in-canal rechargeable hearing aids in the world, Silk Charge&Go IX, are also part of Integrated Xperience.

“Integrated Xperience is about more than just hearing better. It is about giving hearing aid wearers the confidence to engage, interact, and contribute, especially in noisy group conversations. They don’t have to observe from the sidelines anymore. No other hearing aid can track and enhance multiple speakers in real-time. We are pleased to introduce this important innovation to the market from one of our flagship brands and to deliver on our purpose of making wonderful sound part of everyone’s life,” said Maarten Barmentlo, Chief Marketing Officer, WS Audiology.

According to DelveInsight’s “Hearing Aid Devices Market” report, the global hearing aid devices market was valued at USD 7.01 billion in 2022, growing at a CAGR of 5.47% during the forecast period from 2023 to 2028, to reach USD 9.61 billion by 2028. 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 raising awareness, and government initiatives about hearing aid devices are likely to propel the global hearing aid devices market.

Synchron Completed Patient Enrollment in Brain-Computer Interface Trial 

On September 05, 2023, Synchron announced that the company completed patient enrollment in the COMMAND clinical trial for its brain-computer interface (BCI). Six patients were included in the COMMAND trial. 

Through minimally invasive endovascular surgery, the Synchron Switch brain-computer interface is implanted in the blood artery on the surface of the motor cortex of the brain. Once implanted, it is intended to wirelessly detect and transmit motor intent from the brain, restoring the capacity for individuals with severe paralysis to point-and-click-operate personal electronics.

The Synchron Switch motor neuroprosthesis for patients with severe paralysis is being evaluated in an early feasibility trial that simultaneously evaluates the safety and quantifiable efficacy parameters.

The study’s main objective is to determine whether neuro-interventional techniques can be used to safely implant the device into the brain’s blood arteries. The study is also intended to assess how the BCI may allow patients who are no longer able to use their hands to manage digital devices for daily activities like texting, emailing, online shopping, and telehealth services.

Three clinical locations are participating in the COMMAND study: UPMC, in association with the Carnegie Mellon University College of Engineering, University at Buffalo Neurosurgery, and Mount Sinai Health System in New York City. The NIH BRAIN Initiative is providing funding for the project.

“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially patients and caregivers as well as the physicians and research staff at our clinical sites in the United States,” said Tom Oxley, MD, PhD, CEO & Founder, Synchron. Tom Oxley also added, “We look forward to announcing the results from our COMMAND study and will continue to advance the development of Synchron Switch towards a pivotal clinical trial in the US.”

“Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI. We look forward to analyzing the results of the study and potentially bringing this technology to those in need in the future,” said Raul Nogueira, MD, FAHA, FSIN, Endowed Professor & Division Chief of Cerebrovascular Medicine, Director, UPMC Stroke Institute, Professor of Neurology & Neurosurgery at the University of Pittsburgh.

According to DelveInsight’s “Brain/Cranial Implants Market” report, the global brain/cranial implants market was valued at USD 1.09 billion in 2022, growing at a CAGR of 6.07% during the forecast period from 2023 to 2028 to reach USD 1.55 billion by 2028. The demand for brain/cranial implants is primarily being boosted by the rising number of trauma cases, increasing prevalence of brain cancers, technological advancement in product development, and growing prevalence of brain aneurysms, among other factors.

Boston Scientific Received FDA Approval for the Latest-Generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device

On September 06, 2023, Boston Scientific Corporation received the US Food and Drug Administration approval for the latest-generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device. 

The WATCHMAN technology is indicated to lower stroke risk in patients with non-valvular atrial fibrillation (NVAF) in patients who require an alternative to oral anticoagulation therapy. The device includes a polymer coating, visualization markers, and a wider-size matrix to treat a wider range of patients.

The latest WATCHMAN FLX Pro device is enhanced with a coating designed to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface. In addition, newly added visualization markers are intended to enhance device placement for optimal sealing around the LAA. This device is also available in a new 40mm size option, which will enable physicians to treat a broader range of anatomies with the WATCHMAN technology.

Positive outcomes for quicker, more regulated healing around the device surface have been seen in preclinical trials for the novel technology. Data from a number of these preclinical trials showed that the polymer coating significantly reduced thrombus 14 days after the treatment, 86% reduced inflammation three days later, and 50% increased endothelial tissue coverage 45 days afterward.

The fully rounded design that enables medical professionals to securely enter and move around the left atrial appendage is one of the primary features of the WATCHMAN FLX Pro device that has been carried over from the original WATCHMAN FLX. The frame design enables excellent device engagement with the tissue for long-term stability and a quicker, more thorough seal, and it can also be fully recovered, repositioned, and redeployed for accurate placement. 

The WATCHMAN FLX Pro CT study, a single-center premarket study using several imaging modalities to evaluate post-procedural device tissue coverage and the relationship, if any, to clinical outcomes, is now researching the WATCHMAN FLX Pro device. It will also be further evaluated in the post-market HEAL-LAA study, which will commence over the coming weeks and follow outcomes from approximately 1,000 patients with NVAF implanted with the technology at 60 sites in the U.S.

“We are pleased to introduce US clinicians to our newest LAAC technology, which is designed to enhance post-procedural healing, improve the precision of WATCHMAN FLX Pro implants, and expand the size range of treatable appendages,” said Joe Fitzgerald, group president of cardiology, Boston Scientific. Joe Fitzgerald also said, “These enhancements to our WATCHMAN FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients.” 

“There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilize this thromboresistant polymer coating, and we have adapted that model to provide a more streamlined healing process that begins immediately following LAAC,” said Dr. Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. Dr. Kenneth added, “We believe this evolution of the WATCHMAN device also gives promise for a future with less thrombosis risk, which may eventually enable a simpler post-implant drug regimen for patients.”

According to DelveInsight’s “Left Atrial Appendage Closure Device Market” report, the global left atrial appendage closure devices market is estimated to grow at a CAGR of 15.1% during the forecast period from 2023 to 2028. The escalating demand for left atrial appendage closure devices is primarily attributed to the rising prevalence of atrial fibrillation, one of the most difficult conditions where appendage treatment is required, increasing high-calorie diet, smoking, and physical inactivity, technological advancements in interventional treatments and improvements in the diagnosis pathway among others are also some of the factors responsible for potentially increasing the global left atrial appendage closure devices market during the forecast period (2023-2028).

Laborie Medical Technologies Announced an Agreement to Acquire Urotronic for up to USD 600 Million 

On September 06, 2023, Laborie Medical Technologies, Inc., a leading diagnostic and therapeutic medical technology company, signed a definitive agreement to acquire Urotronic, Inc., a Minnesota-based medical device company pioneering the application of its Optilume® drug-coated balloon technology for use in interventional urology including treating urethral strictures and benign prostatic hyperplasia (BPH).

According to the terms of the contract, the deal will include a USD 255 million upfront cash payment and up to USD 345 million in possible commercial and reimbursement milestone payments. The net upfront cash payment will be USD 232 million, with net possible milestone payments of up to USD 314 million, net of Laborie’s current minority ownership in Urotronic.

In conjunction with the purchase of Urotronic, Laborie will also invest USD 5 million in GIE Medical, a clinical-stage spinoff of Urotronic that is developing drug-coated balloon technology to treat gastrointestinal strictures, which, like Optilume urethral strictures, could provide a highly distinctive and cutting-edge treatment option for these conditions.

“There has never been a minimally invasive, combination drug-device therapy like Optilume before, leading to a highly disruptive, paradigm change for physicians treating urethral strictures and BPH,” said Mike Frazzette, President, and CEO of Laborie. Mike added, “With this acquisition, we will continue to advance innovative technologies by meeting multiple unmet medical needs and in doing so provide solutions that preserve and restore human dignity.”

“We are excited to announce this agreement with Laborie, and this acquisition will benefit men suffering from urethral strictures and BPH globally,” said David Perry, President and CEO of Urotronic. David Perry also commented, “Backed by positive clinical data, the Optilume BPH therapy is truly groundbreaking as the only MIST option that doesn’t require cutting, burning, steaming or a permanent implant. As global leaders in urology, Laborie will help drive the Optilume BPH technology forward.”

“Patricia Industries is committed to supporting the Laborie and Urotronic teams in their mission to bring Optilume BPH to urologists worldwide and help them improve their patient’s clinical outcomes. This transaction further enhances Laborie’s long-term growth by adding an innovative product with strong growth potential into its product portfolio, and aligns with our organization’s purpose of creating value for people and society by building strong and sustainable businesses,” said Yuriy Prilutskiy, Head of Patricia Industries North America, a part of investor AB and owner of Laborie Medical Technologies.

According to DelveInsight’s “Urinary Stents/Ureteral Stents Market” report, the global urinary stents/ureteral stents market was valued at USD 433.08 million in 2022, growing at a CAGR of 6.01% during the forecast period from 2023 to 2028 to reach USD 612.87 million by 2028. The urinary stents/ureteral stents market is witnessing positive growth owing to various factors such as the increasing prevalence of kidney diseases, the increasing prevalence of bladder cancer, the rise in the regulatory approvals for urinary stents/ureteral stents, and the rising prevalence of geriatric population across the globe. Therefore, the market for urinary stents/ureteral stents is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028.

Vitestro Started Clinical Trial for its Autonomous Blood Drawing Device, with Enrolment of First Patients in A.D.O.P.T.

On September 06, 2023, Vitestro, an expert in medical robotics, launched the A.D.O.P.T. Trial for its autonomous blood drawing device (image) with the enrollment of the first patients in the trial. The study is anticipated to have a sample size of over 10,000 patients. 

At the research site Result Laboratorium in the Albert Schweitzer Hospital, the first 350 patients have been enrolled in the A.D.O.P.T. (Autonomous Optimisation and Performance Tests for Blood Testing) Trial. 

St. Antonius, OLVG Lab, and Amsterdam UMC are research partners in addition to Result Laboratorium – Albert Schweitzer Hospital.

The venipuncture method used by Vitesro’s technology is precise and reliable because it combines robotic needle insertion with AI-based, ultrasound-guided 3D reconstruction. A prototype has already undergone testing on 1,500 people.

Toon Overbeeke, Founder and CEO at Vitestro, said, “The A.D.O.P.T. Trial is a two-year study. Our objective is to test and continue developing Vitestro’s autonomous venipuncture device and achieve performance and safety results required for regulatory approval.”

Michael Fouraux, Principal Investigator at Result Laboratorium said, “Both patients and phlebotomists are very excited about this particular innovation. The A.D.O.P.T. trial heralds a new phase in which we prepare for implementation in routine clinical practice.” Fouraux continued, “The degree of professionalism and energy that the Vitestro team brings along makes a difference and ensures we find our team and patients more than willing to collaborate. Our organizations just click very well together. In recent years, hundreds of patients at this location have already participated in various tests with the blood collection device.”

According to DelveInsight’s “Blood Collection Devices Market” report, the global blood collection devices market was valued at USD 6.23 billion in 2022, growing at a CAGR of 6.85% during the forecast period from 2023 to 2028 to reach USD 9.25 billion by 2028. The blood collection devices market is slated to witness prosperity owing to factors such as increase in diagnostic tests owing to the growing prevalence of infectious diseases such as COVID-19, malaria, and others, increasing awareness over health, rise in blood transfusion procedures, and the growing focus on improving the safety and usability of blood collection devices for end users are further expected to result in the appreciable revenue growth in the blood collection devices market during the forecast period (2023-2028).