BioGX Announced Ex-US Commercial Launch of ‘pixl™’ Portable qPCR Platform

On December 8, 2022, BioGX, a global provider of easy molecular diagnostic solutions, announced the Ex-US commercial release of BioGX’s portable pixl™ qPCR real-time PCR platform for use with BioGX CE-IVD approved assays. 

This opens up access to the world and complements the recent US FDA EUA expanded usage of Xfree™ COVID-19 Direct RT-PCR on pixl.

A tabletop 4-channel, 16-well RT-PCR apparatus with integrated results interpretation on a touchpad-sized screen, the pixl instrument offers quick turnaround times for batches of up to 16 samples. 

Shazi Iqbal, Ph.D., CEO of BioGX said, “pixl, combined with our unique Xfree chemistry, offers a low-cost direct-sample-to-answer PCR solution on a portable, compact device. pixl will provide broader access to clinical laboratories for decentralized PCR testing, enabling faster, better, low-cost near-patient molecular diagnostics.”

As per DelveInsight’s Polymerase Chain Reaction Market” report, the global polymerase chain reaction market was valued at USD 4.90 billion in 2021 and is expected to grow at a CAGR of 8.66% to reach USD 8.04 billion by 2027. The factors driving the market for polymerase chain reaction include the increasing prevalence of infectious diseases caused by viruses, bacteria, fungi, and other pathogens, including tuberculosis, HIV AIDS, and others, increasing application of PCR in clinical diagnostics, and the latest technological advancements to enhance the accuracy of PCR among others. 

Stryker launched Citrefix™ Suture Anchor System 

On December 13, 2022, Stryker, launched a disposable suture anchor system named Citrefix™, which is made up of award-winning bioresorbable material Citregen™ capable of mimicking the chemistry and structure of native bone. 

When used in orthopedic surgical procedures, Citregen™ allows the healing of grafted tissue and helps in the growth of healthy bone. 

The complete sterile-packed set comes with a cartridge with a preloaded implant and eyelet, a drill bit, a drill guide, and a pre-assembled inserter.

Michael Rankin, Vice President of marketing and medical education for Stryker’s Foot & Ankle business, said, “Our customers will now benefit from the expanded use of one of the most innovative bioresorbable materials available for use in foot and ankle procedures.” He further added, “Citrefix’s unique suture anchor system is the next step in our expanding Citregen portfolio.”

“By leveraging Citregen’s unique material properties, Citrefix introduces design features that greatly increase its pull-out strength compared to other suture anchors,” said Wayne Berberian, M.D., an orthopedic surgeon at the Ankle & Foot Institute in Maywood, N. J. He further said, “At the same time, the Citregen material benefits patients’ recovery since it is more easily accepted by the body, so they heal without suffering from the chronic inflammation that may occur with other bioresorbable suture anchors.”

According to DelveInsight’s “Foot and Ankle Devices Market” report, the global foot and ankle devices market was valued at USD 5.94 billion in 2021, growing at a CAGR of 7.69% during the forecast period from 2022 to 2027, to reach USD 9.26 billion by 2027. The foot and ankle devices market is estimated to register positive revenue growth primarily due to the increasing prevalence of bone-related disorders, rising diabetes-related complications, increasing cases of accidents, trauma, sports, and other injuries, along with the rising geriatric population. Moreover, the increasing focus of companies on developing technologically advanced foot and ankle devices is likely to propel the market for foot and ankle devices in the upcoming years. 

FDA Approved the Next-Generation Dexcom G7 Continuous Glucose Monitoring (CGM) System 

On December 8, 2022, DexCom, Inc., the global leader in real-time continuous glucose monitoring for people with diabetes, received the US Food and Drug Administration (FDA) approval for the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all types of diabetes aged two years and older. 

Dexcom G7 delivers a more potent and user-friendly system with a compact, all-in-one wearable, a redesigned mobile app, and no fingersticks or scanning necessary. It is the most popular CGM brand among patients and healthcare professionals. Additionally, the Dexcom G7 provides a range of programmable alerts that can assist users to stay in range by warning them of high or low glucose readings. A predictive low alert is a feature of the system that gives users a 20-minute head start on potentially dangerous low glucose levels so they can take immediate action to prevent a hypoglycemic crisis. Dexcom G7 generates less waste than the previous Dexcom G6 CGM System because of smaller plastic components and packaging.  The launch of Dexcom G7 in the United States is expected in early 2023. 

“There’s a reason Dexcom has the best-selling real-time CGM on the market,” commented Kevin Sayer, chairman, president, and CEO of Dexcom. He remarked, “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently delivers improved accuracy, reliability, and a simpler user experience, giving people greater control of their diabetes. When we set out to design G7, our goal was simple: to make the most powerful, easy-to-use CGM available for people with diabetes, whether they have Type 1 or Type 2. G7 delivers squarely on that promise. And now that it has been cleared by the FDA, we look forward to making G7 commercially available in the coming months.” 

According to DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2021, growing at a CAGR of 7.72% during the forecast period from 2022 to 2027, to reach USD 20.40 billion by 2027. The blood glucose monitoring systems market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of diabetes globally coupled with the rising geriatric population. Moreover, rising government initiatives for diabetes, and the increasing focus of manufacturers to develop technologically advanced blood glucose monitoring systems, are likely to propel the market for blood glucose monitoring systems in the upcoming years.

First Patient Enrolled in Glioblastoma Trial Using ClearPoint Prism™ Neuro Laser Therapy

On December 12, 2022, ClearPoint Neuro, announced the enrolment of the first subject in a single-center, single-arm, prospective glioblastoma clinical trial for the evaluation of the ClearPoint Prism™ Neuro Laser Therapy System. 

With the application of interstitial irradiation or thermal therapy under the guidance of magnetic resonance imaging (MRI), ClearPoint Prism Neuro Laser Therapy System necrotise or coagulate soft tissues. 

Sponsored by Clinical Laserthermia Systems AB, the Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions Study aims to assess the feasibility and safety of using the minimally invasive MR-guided system for ablating tumors in up to five patients with glioblastoma.

“We are proud to support SUS Lund and CLS on this pilot study using the innovative laser therapy system to treat glioblastoma lesions,” said Joe Burnett, Ph.D., president and CEO of ClearPoint Neuro. He further added, “The ClearPoint Neuro Navigation System offers an efficient one-room solution that helps neurosurgeons in the United States to accurately place laser fibres and help treat brain tumors, radiation necrosis, and epileptic foci in thousands of patients. Expanding brain and spine laser therapy treatment options for patients and neurosurgeons in the EU, and beyond, is a key priority in the years ahead.”

Dr. Peter Siesjö, Neurosurgeon and Principal Investigator of the study at Skåne University Hospital in Lund, Sweden, commented, “The clinical trial with minimally invasive laser thermal treatment of patients with recurrent malignant brain tumors, glioblastoma, has now started at Skåne University Hospital and the treatment of the first patient could be carried out as planned. The treatment was performed, for the first time in Sweden, in a magnetic resonance imaging (MRI) suite to avoid transporting the patient between surgery and the MRI suite. ”

According to DelveInsight’s Neurology Devices Market” report, the global neurology devices market is expected to grow at a CAGR of 7.46% during the forecast period from 2022 to 2027. The neurology devices market is observing optimistic market growth due to the factors such as a rise in the regulatory approvals for neurology devices across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of neurological diseases, thereby increasing the demand for various neurological devices across the globe. Additionally, the growing focus on improving the safety, affordability, and usability of neurology devices for end users is further expected to result in appreciable revenue growth in the neurology devices market during the forecast period (2022-2027).

Boston Scientific Announced Strategic Investment to Acquire Majority Stake of Acotec Scientific Holdings Limited 

On December 11, 2022, Boston Scientific Corporation and Acotec Scientific Holdings Limited announced that Boston Scientific will make a partial offer to acquire a majority stake, up to a maximum of 65%, of shares of Acotec. 

Acotech is a Chinese medical technology company that offers innovative medical solutions for a variety of interventional procedures including drug-coated balloons. Along with thrombus aspiration catheters and radiofrequency ablation technologies, the Acotec portfolio also comprises more than 20 other devices in various stages of development across a variety of specializations. Actotec earned sales of RMB 339 million, or roughly US$53 million, for the 12 months that ended June 30, 2022.

Due to amortisation expense and acquisition-related net charges, Boston Scientific anticipates that the impact on adjusted profits per share will be insignificant in 2023 and the impact on GAAP earnings per share will be less accretive, or dilutive, as the case may be. The transaction’s conclusion, which is planned for the first half of 2023, is contingent on shareholder acceptance and approval as well as further requirements detailed in associated papers.

“Acotec is a profitable, fast-growing company with a strong portfolio and innovative pipeline of medical technologies, and we believe this investment will generate growth opportunities for both companies,” said Art Butcher, executive vice president and group president, MedSurg and Asia Pacific, Boston Scientific. He further commented, “We expect completion of the partial offer to further strengthen our presence in China and create the potential for commercialization of Acotec products globally, providing an increased number of physicians and patients access to our robust and complementary product portfolios.”

According to DelveInsight’s “Interventional Radiology Devices Market” report, the global interventional radiology devices market is estimated to grow at a CAGR of 5.23% during the forecast period from 2022 to 2027. The interventional radiology devices market is observing remarkable market growth due to the increasing patient pool suffering from chronic diseases such as cancer and the rising burden of the geriatric population across the globe. Additionally, the growing demand for minimally invasive surgeries, increasing technological advancements along with increasing product launches and approvals, the presence of key players in the market, and other factors will create a requisite for interventional radiology devices in the market. 

Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer

On December 12, 2022, Agilent Technologies Inc., received the US Food and Drug Administration (FDA) clearance for Agilent Resolution ctDx FIRST. The advanced non-small cell lung cancer patients (NSCLC) with KRAS G12C mutations who may benefit from treatment with KRAZATI™ (adagrasib) can be identified with the help of ctDx FIRST. 

This first liquid biopsy NGS assay was created in partnership with Mirati Therapeutics and was authorized by the FDA as a CDx for the recently approved KRAZATI in advanced NSCLC.

The comprehensive genomic profile on 109 genes across four categories of alterations—single nucleotide variations (SNVs), insertions and deletions, copy number amplifications (CNAs), and fusions are included in the ctDX FIRST test result. 

Utilizing cutting-edge proprietary technology, the ctDx FIRST assay may identify genomic changes in plasma-derived circulating tumor DNA (ctDNA). About 90% of cancer patients prefer this minimally invasive method over more invasive tissue biopsy examinations. Additionally, it has a quicker turnaround time to potentially speed up therapy choices.

“Commercializing the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC,” commented Sam Raha, Agilent’s President of the Diagnostics and Genomics Group. He further added, “Agilent values opportunities to partner with Mirati and other pharmaceutical companies in developing clinically relevant NGS-based diagnostics that enhance confidence in targeted cancer therapy.”

Kenna Anderes, Mirati’s Vice President of Translational Medicine and Companion Diagnostics, said, “Expanding access to accurate and fast genomic profiling is an essential step to unlocking important medicines for patients in desperate need.” He remarked, “We appreciate the opportunity to partner with companies like Agilent which are committed to creating more opportunities for ‘decision medicine’ for people living with cancer.”According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market”  report, the liquid biopsy in cancer diagnostics market was valued at USD 7.64 billion in 2021, growing at a CAGR of 16.64% during the forecast period from 2022 to 2027 to reach USD 19.24 billion by 2027. The demand for liquid biopsy in cancer diagnostics is primarily attributed to the increasing prevalence of different cancer types such as lung, breast, stomach, and others. In addition, the increasing demand for precision medicine and technical innovation in product development, among other factors, are anticipated to drive the market of liquid biopsy in cancer diagnostics during the forecast period from 2022 to 2027.