Conformal Medical Announces Launch of CONFORM Pivotal Trial

On June 17, 2022, Conformal Medical Inc, is a medical device company manufacturing devices to avoid strokes in patients with non-valvular atrial fibrillation and developing next-generation LAAO technology. Its exclusive technology is intended to make left atrial appendage closure on the same day, by single operator procedure and the company was founded in 2016.

The company announced the launch of the CONFORM pivotal trial with the enrollment of first patients at two United States locations. To support U.S. Food and Drug Administration (FDA) pre-market approval, the investigational device exemption (IDE) research will assess the safety and efficacy of the company’s CLAAS® System in comparison to commercially marketed LAAO devices.

In order to lower the risk of stroke without the use of anticoagulants, the CLAAS System is intended to seal the LAA in patients with non-valvular Afib. With just two sizes, the implant accommodates a variety of LAA anatomies because of its unique foam-based construction. The technology intends to streamline delivery and eliminate the requirement for a procedural transesophageal echocardiography, allowing physicians to execute the surgery without the use of general anaesthesia, a significant step forward with the potential to shift clinical practice to a same day, single operator procedure.

“I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (Afib),” stated Dr. Gray. “In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal and incidence of device-related thrombus.”

We are pleased to enroll the first patients in the CONFORM trial, an important milestone for the company. Kicking off the study builds on the strong momentum from our EFS experience,” commented Andy Levine, President and CEO of Conformal Medical. “This IDE includes the rigor of both a randomized study comparing CLAAS to commercial devices, and a separate sub-study designed to support a conscious sedation, ICE-driven approach; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants.”

As per DelveInsight analysis, the development of such devices would help to lower the risk of stroke, this would massively transform care for patients with cardiovascular diseases. According to DelveInsight’s “Congestive Heart Failure Treatment Devices Market” report, the global Congestive Heart Failure (CHF) treatment devices market was valued at USD 17.41 billion in 2021, growing at a CAGR of 8.26% during the forecast period from 2022 to 2027 to reach USD 27.96 billion by 2027. The Congestive Heart Failure (CHF) Treatment Devices market is witnessing positive growth owing to the rising incidence of Cardiovascular Diseases (CVDs), a surge in the research and development activities in product development, increasing incidences of the aging population who are susceptible to these diseases. Moreover, the sedentary lifestyle and extreme benefits of these devices in heart failure cases during the COVID-19 pandemic and the growing popularity of minimally invasive interventions had further pushed for the demand of these devices, thereby contributing to the growth of Congestive Heart Failure (CHF) Treatment Devices market during the forecast period from 2022-2027.

Ibex Obtains CE Mark for Galen Gastric, the World’s First AI-powered Solution for Gastric Cancer Detection

On June 15, 2022, Ibex Medical Analytics, IBEX is the pioneer in pathology AI-powered cancer diagnoses. The company enables the doctors to diagnose every patient’s cancer in a precise, quick, and customized manner.

The company announced CE-Mark for the Galen™ Gastric solution which aids pathologists in the diagnosis of several kinds of gastric cancer. Ibex now has the largest portfolio of artificial intelligence (AI) solutions for pathology, making it possible to identify cancer and other diseases in stomach, breast, and prostate biopsies. This first-of-its-kind solution is now publicly available.

“Diagnosis of gastric biopsies remains a challenging task for pathologists. Gastric cancers are relatively scarce, often minute and sometimes easy to miss”, said Judith Sandbank, MD, Director of the Pathology Institute at Maccabi Healthcare Services2, and the principal investigator in the study. “We were impressed with the successful outcomes and the very high accuracy demonstrated by Galen Gastric in detection of different cancer types. It’s also encouraging to see an AI solution that goes beyond cancer detection to accurately identify H. pylori, and provide additional insights on dysplasia, lymphoma, gastritis and other pathologies. We have already started to use Galen Gastric in Maccabi and it helped us improve the quality of cancer diagnosis and patient care. I am looking forward to seeing this technology now becoming widely available at pathology departments around the world.”

As per DelveInsight analysis, the extensive research and development activities aids pathologists in the diagnosis of cancers. According to DelveInsight’s “Cancer Diagnostic Market” report, the global cancer diagnostic market was valued at USD 125.13 billion in 2021, growing at a CAGR of 9.43% during the forecast period from 2022 to 2027, to reach USD 214.88 billion by 2027. The increase in demand for cancer diagnostic products and services is predominantly attributed to the spike in the cancer cases reported worldwide. In addition, growing manufacturers focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among the patients, and others are anticipated to drive the global cancer diagnostic market during the forthcoming years.

Senseonics Announces CE Mark Approval of the Eversense E3 Continuous Glucose Monitoring System

On June 16, 2022, Senseonics, is It is a medical technology company focused on the development and manufacturing of glucose monitoring gadgets made to alter lives in the worldwide diabetes community with differentiated, long-term implantable glucose management technology. The Eversense®, Eversense® XL, and Eversense® E3 CGM systems from Senseonics have a tiny sensor that is fully subcutaneously implanted and connects to a smart transmitter that is worn on top of the sensor. The user’s smartphone’s mobile app receives the glucose data automatically every 5 minutes.

The company announced that it has achieved CE Mark clearance for the next-generation Eversense® E3 CGM System, a long-lasting system available, with remarkable accuracy. The CE Mark clearance certifies that the Eversense E3 satisfies the standards of the European Medical Device Regulation (MDR), and authorizes the sale of Eversense E3 in European Union (EU) member nations. The enhanced system, which may be utilized for up to 6 months, will be made accessible beginning in the third quarter of 2022 by Senseonics’ business partner Ascensia Diabetes Care.

The Eversense E3 CGM System provides users with: 

  • It is a third-generation sensor that is fully implanted and has patented SBA technology to extend sensor life showed a mean absolute relative difference (MARD) of 8.5 percent in the PROMISE Study
  • Eversense, with its industry-leading 6-month sensor wear duration and essentially two sensor insertion and removal operations per year, is the longest-lasting CGM sensor currently on the market
  • Removable smart transmitter, is maintained in place with a gentle, silicone-based adhesive, delivering on-body vibratory alerts & data transmission to a mobile app where glucose values, trends, and alerts are displayed

“The CE Mark approval for E3 is another demonstration of our commitment to advancing implantable CGM to improve the lives of more diabetes patients worldwide. Not only does E3 strengthen our position in the market, but it enables increased operational efficiency as Senseonics will now commercialize the same product iteration globally for the first time,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We are excited for Ascensia to continue to build on the momentum of the E3 launch in the U.S. as they commercialize the improved system in European markets in the coming months.”

According to DelveInsight analysis, the entry of such glucose monitoring systems would massively transform care for patients with diabetes. 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, in order to reach USD 20.40 billion by 2027. The escalating demand for blood glucose monitoring systems is predominantly attributed to the increasing prevalence of diabetes amongst the population across the globe, the growing burden of the geriatric population who are susceptible to developing hyperglycemia. In addition, the spike in technologically advanced blood glucose monitoring devices product launch and government initiatives to raise awareness regarding proper diabetes management, among others are the factors likely to spur the global blood glucose monitoring systems market.

Sentinel Diagnostics Launches the New SENTiFIT®800, a New Completely Automated and High-Throughput Instrument for Fecal Tests

On June 15, 2022, SENTINEL, an Italian company which has spent more than 35 years in developing and manufacturing in-vitro diagnostics for the most cutting-edge platforms in clinical chemistry, immunochemistry, and molecular diagnostics. It meets the large requirement of clinical laboratories’ and organizations’ expanding need for colorectal cancer screening.

The company announced the launch of the SENTiFIT® 800 Analyzer, a fully automated and high throughput instrument for Fecal Immunochemical Test. The SENTiFIT® 800 Analyzer is a high-end fecal testing device that can perform up to 550 tests per hour, 1 million tests per year, and samples with complete traceability. It provides a meaningful reduction in hands-on time, improved resource management, and decreased manual mistakes. A specialized sample loader (Rack Handler RH-150) feeds the system by continuously feeding up to 250 samples to the analysis unit. It is compatible with the CALiaGold® line reagents for the measurement of fecal Calprotectin, the go-to test to determine the presence of intestinal inflammation, and the FOB Gold® line, the complete solution for the detection of occult blood in faeces.

“For almost 20 years, Sentinel Diagnostics has supported the fight against colorectal cancer with high quality FOB Gold® test and analyzers,” explains Marco Buonaguidi, Head of Sales and Marketing. “The SENTiFIT® 800 has been developed specifically for FIT screening centers and represents a step further in the direction to strengthen our commitment in the field of gastrointestinal diseases diagnosis“.

As per DelveInsight analysis, development of devices for gastrointestinal diseases diagnosis helps in the growth of bowel management systems overall market. 

According to DelveInsight’s “Bowel Management Systems-Market” report, the global bowel management systems market was valued at USD 1.48 billion in 2021, growing at a CAGR of 3.98% during the forecast period from 2022 to 2027, in order to reach USD 1.87 billion by 2027. The increase in demand for bowel management products is primarily attributed to the increasing geriatric population across the globe who are more susceptible to developing bowel-associated disorders. In addition, the rising neurological disorders such as Parkinson’s disease, stroke, among others, and growing cases of nerve injuries due to spinal cord injuries, trauma injuries, and others would also increase the demand for bowel management systems as these factors most often lead to bowel incontinences. Also, rising government initiatives to raise awareness regarding prevention and management of bowel control issues, approval and launch of various bowel management products, among others are anticipated to bolster the market for bowel management systems during the forecasted period.

NEUSPERA MEDICAL® Announces Second Phase of SANS-UUI IDE Clinical Trial With The Nuvella™ System

On June 14, 2022, Neuspera Medical, a medical device company, dedicated for creating medical implants that enhance the lives of people with chronic conditions. The Neuspera platform, which includes the Nuvella system, provides patients and doctors new, and early, treatment options that are less invasive and more adaptable.

The company said that it will start recruitment in its major clinical trial (SANS-UUI), a one-arm study that will enroll 145 patients at 25 locations worldwide. The trial will assess the effectiveness and safety of Neuspera’s Nuvella system, which is intended to treat overactive bladder (OAB) in people who have symptoms of urinary urgency incontinence (UUI). The system is the first sacral neuromodulation (SNM) device to provide a minimally invasive approach, potentially improving patient comfort and increasing procedural flexibility.

“We are very pleased the SANS-UUI trial has reached this important enrollment milestone, as we are now one step closer to bringing the life-changing benefits of this technology to patients,” said Alexander Yeh, Founder and Chief Technology Officer at Neuspera Medical. “The Nuvella system is the smallest available SNM device designed to minimize post-procedural discomfort and have no visible external appearance of the implant.”

According to DelveInsight analysis, the research and development of such systems uplift the urinary incontinence devices overall market. According to DelveInsight’s “Urinary Incontinence Devices Market” report, the global urinary incontinence devices market was valued at USD 2.97 billion in 2021, growing at a CAGR of 6.36% during the forecast period from 2022 to 2027, to reach USD 4.30 billion by 2027. The Urinary Incontinence Devices market is expected to witness growth due to the rising prevalence of urinary incontinence cases, development of innovative devices, aging population prone to urological conditions like urinary tract infections, weakening of pelvic floor, and conditions including pregnancy, diabetes, menopause, and Parkinson’s disease.

Meridian Launches New qPCR Master Mixes for Stool Samples to Accelerate Development of Molecular Assays

On June 20, 2022, Meridian Bioscience Inc, a leading global provider of diagnostic testing solutions & life science raw materials. It develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. Through diagnosis, the company provides diagnostic solutions for gastrointestinal, upper respiratory infections and blood lead level testing. In more than 70 nations throughout the world, it creates connections and offers solutions in hospitals, reference labs, research facilities, veterinary testing facilities, doctor’s offices, diagnostics manufacturers, and biotech firms.

The company announced two new sample-specific master mixes, Lyo-Ready™ Direct DNA qPCR Stool Mix, and Lyo-Ready™ Direct RNA/DNA qPCR stool Mix. These novel master mixtures enable room temperature stability of diagnostic tests while enhancing the molecular detection of DNA and RNA from unprocessed fecal material. With the use of these stool mixes, component optimization and time-consuming nucleic acid extraction are no longer necessary. Because of this, assays for analyzing faeces samples may be created more rapidly and with greater sensitivity. When assay stabilisation at room temperature is required, the mixes can also be utilised in liquid or lyophilized form, negating the necessity for cold storage.

Florent Chang-Pi-Hin, Ph.D., Vice President of Research & Development – Life Science, commented, “The use of Lyo-Ready™ Direct qPCR Stool mixes for DNA and RNA is ideal for cancer biomarker detection, early cancer detection, and cancer treatment monitoring where assay sensitivity can be lifesaving. The specific adaptation of our chemistries to stool specimens makes our master mixes the perfect tool for any developer seeking faster new product introduction, shorter time to results, or the ability to transform a wet assay to an ambient temperature-stable assay with minimum developmental time.”According to DelveInsight’s “Point of Care Diagnostics Market” report, the global point of care diagnostics market was valued at USD 1.85 billion in 2021, growing at a CAGR of 7.99% during the forecast period from 2022 to 2027 to reach USD 2.93 billion by 2027. The demand for point of care diagnostics is primarily being boosted by the rising number of patients suffering from various infectious diseases, rising prevalence of diabetes, increasing frequency of both chronic and acute diseases, increasing demand of point of care kits in the diseases management of COVID-19 infection, and the increasing technological advancements associated with the Point of Care Diagnostic devices will help in driving the overall market growth of point of care diagnostics during the forecast period from 2022-2027.