Ibex Obtains CE-IVD Mark for Galen™ Prostate Solution

February 27, 2020

The company reports this is the first-ever AI-based solution for cancer detection used in routine clinical practice – is already deployed in pathology labs with demonstrated success in alerting on missed cancer cases. With this CE-IVD Mark of Galen Prostate, Ibex is now partnering with leading institutes across Europe to implement AI and support pathologists in their diagnostic workflow.

Pathology is the medical specialty of diagnosing disease in patients and plays a pivotal role in cancer diagnosis and treatment decisions. To this day, cancer diagnosis is performed by pathologists looking at biopsies through a microscope. In recent years, a global increase in cancer incidence and in the number of screening tests has coincided with a decline in the number of pathologists, causing a crisis that affects labs worldwide and results in longer turnaround times and rising concerns about diagnostic accuracy.

Ibex uses AI to develop clinical-grade solutions that help pathologists detect and grade cancer in biopsies, helping them ensure diagnostic accuracy, integrate comprehensive quality control and enable a more efficient workflow. Galen Prostate is a vendor-neutral AI solution, evaluated across multiple scanning systems, staining platforms and pathology labs. The solution uses an algorithm that was trained on slides from a dataset of over 60,000 prostate slides from multiple institutions and representing a variety of diagnoses and clinical findings.

The CE-IVD Mark follows the outstanding results from a blinded multi-site prospective clinical study measuring, for the first time, performance against consensus diagnosis between multiple pathologists. The study included digitized slides from prostate core-needle biopsies analyzed by Galen Prostate. Performance was evaluated against the consensus diagnosis of multiple pathologists. Ibex’s AI-powered algorithm demonstrated the highest AUC (area under the ROC curve) reported in the field, 0.997, as well as very high sensitivity and specificity (98.6% and 95.6%, respectively). These results validate the robustness of Galen Prostate and support its adoption by pathology institutes aiming to improve their diagnostic accuracy by enhancing quality control with AI.

“We are impressed with the results of the study, particularly with the performance of Galen Prostate, which was in near perfect concordance with the consensus diagnosis between multiple pathologists. This solution can become an important tool for pathologists that look for ways to improve diagnostic quality and workflow efficiency,” said Delphine Raoux, MD, Head of Innovation Technologies at Medipath – the largest network of private pathology labs in France, who participated in the study. “Medipath believes that AI-powered solutions are the future of pathology and we are happy to participate in trials that demonstrate their accuracy and utility, and to collaborate with Ibex to help the evolution of their AI solutions.”

“We hit an important milestone with the CE-IVD Mark, facilitating a wider adoption of Galen Prostate in the market. These clinical-grade results confirm our robust and meticulous approach to AI, that corresponds to the pathologist’s own workflow,” said Joseph Mossel, Ibex Medical Analytics CEO. “Cancer incidence and testing for cancer keep growing, with an impact on pathologists’ turnaround times and misdiagnosed cases. Ibex is committed to providing practical solutions that help pathologists meet these challenges.”

First Patient Enrolled in Pivotal Atherectomy Clinical Study

February 27, 2020

Athar Ansari, MD, FACC, Director of the California Heart & Vascular Clinic in El Centro, Calif. and the study chairman said, “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device.” He added, “We are thrilled to be the first center to begin enrollment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.”

“We are committed to the successful commercialization of DABRA and we believe that initiating patient enrollment in this study is a significant step forward in achieving this goal,” said Andrew Jackson, Ra Medical Systems CFO and Interim CEO. “Furthermore, we have built a team of experienced, motivated and enthusiastic physician partners and employees to execute on this goal and we look forward to providing updates on our progress.”

Ra Medical received investigational device exemption (IDE) approval for the study from the FDA in January 2020. This multicenter, open-label pivotal atherectomy clinical study will enroll up to 100 patients with symptoms of PAD (Rutherford Class 2-4). Outcome measures include safety, acute technical success and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularization (TLR) at six months will be the safety and clinical success endpoints.

Peri-Strips Dry With Secure Grip Technology for Reliable Staple Line Reinforcement in Surgical Procedures Launched

February 27, 2020

Wil Boren, president of Baxter’s Advanced Surgery business said, “We continue to advance innovation by providing surgeons tools that are faster and easier to use in the operating room.” He added, “As surgical procedures are becoming more complex, it is important that surgeons have the tools they need to optimize patient care.”

Despite the sophistication of modern stapling technology used in bariatric procedures, staple line complications that result in high morbidity and mortality persist. The most prevalent complications are staple line bleeding and leaks. While the incidence of these complications is low, the impact can be clinically debilitating for the patient and costly to address.²

Peri-Strips Dry With Secure Grip Technology (PSDV) is proven to effectively reduce intraoperative and postoperative staple line bleeds and leaks in routine bariatric procedures such as a sleeve gastrectomy or gastric bypass. A 2015 meta-analysis extracted data from 295 studies predominantly comprised of morbidly obese patients undergoing laparoscopic gastric bypass and laparoscopic sleeve gastrectomy to include nearly 42,000 patients concerning bleeds and over 56,000 patients concerning leaks. PSDV showed statistically significant greater relative efficacy in reducing bleeding and leaks when compared to no staple line reinforcement, oversewing, and another staple line reinforcement product.²

PSDV with Secure Grip is applied to the surgical stapler via a pressure-sensitive adhesive strip. The new generation of PSDV provides strong adherence to the stapler, allowing surgeons to easily manipulate tissue. In a recent Staple Line Reinforcement Comparison study,¹ 30 bariatric nurses and surgical technicians evaluated stapler preparation time, ease of use and learnability of the PSDV with Secure Grip versus other options. Participants unanimously chose PSDV with Secure Grip as the most preferred staple line reinforcement material in the operating room.

PSDV with Secure Grip is available now to Baxter customers.

Surgeons Find the Best Preoperative Definition of Cancer-Related Malnutrition Depends on Cancer Type

February 26, 2020

Cancer-related malnutrition is common—affecting between 20 and 70 percent of cancer patients¹—because of the disease or its treatment. Many studies show that malnutrition raises the risk of complications from a major cancer operation, but patients can improve their nutritional status through preoperative rehabilitation, or “prehabilitation,” programs involving nutrition counseling, nutritional supplementation, and exercise.

“Surgeons must know a patient’s nutritional status to predict outcomes and direct therapy,” said study co-author Robert Cima, MD, FACS, a general surgeon at Mayo Clinic, Rochester, Minn. “A malnutrition screening tool meant for the general population is not useful in patients with cancer. Their cancer diagnosis already places them at high risk of malnutrition.”

Yet, the common definitions of malnutrition that surgeons use for risk assessment vary widely, and the best definition is unclear, said lead study author Nicholas P. McKenna, MD, a third-year surgical resident at Mayo Clinic. The simplest malnutrition definitions, Dr. McKenna said, rely on unintentional weight loss and/or body mass index (BMI), a measure of body fat based on height and weight.

To determine the best simple definition of malnutrition in cancer patients for preoperative risk assessment, the investigators studied clinical registry data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP^®) database. ACS NSQIP is the leading nationally validated, risk-adjusted, outcomes-based program to measure and improve the quality of surgical care in hospitals. Using ACS NSQIP data, the researchers identified 205,840 major cancer resection (removal) operations performed from 2005 to 2017 for six types of cancer: colorectal, esophageal, gastric, liver, lung, and pancreatic. Using statistical analyses, the research team studied the effect of malnutrition on the risk of any major postoperative complication (a composite including infections, pulmonary problems, stroke, and heart attack) or death within 30 days of the operation.

Malnutrition definitions

The researchers evaluated patients’ nutritional status using several current classifications: the European Society for Clinical Nutrition and Metabolism (ESPEN) diagnostic criteria for malnutrition,² the ACS NSQIP risk factor of more than 10 percent weight loss over the prior six months, and the World Health Organization (WHO) BMI classification.³

ESPEN defines malnutrition in two ways, according to Dr. McKenna: (1) by age: for patients younger than 70 years, BMI below 20 kilograms per meter squared (kg/m²), or for patients 70 or older, BMI below 22 plus unintended weight loss either greater than 10 percent of body weight over any time or more than 5 percent in the past three months; or (2) a BMI below 18.5 alone, which the WHO considers severely thin. The study authors called these definitions ESPEN 1 and 2.

Using those definitions, the researchers added their own definitions of “severe malnutrition,” a combination of BMI under 18.5 kg/m²and more than 10 percent weight loss, and “mild malnutrition,” a BMI of 18.5 to 20 for patients younger than 70 or BMI under 22 if age was 70 or above. They called the final malnutrition definition “NSQIP”: more than 10 percent weight loss with a normal BMI (above 20 for ages less than 70 and above 22 for ages 70 and older).

Next, they looked at the risk of major postoperative complications associated with each nutrition category, including obesity and no malnutrition, for all patients and by cancer type.

Implications for surgeons and patients

“We found that using one-size-fits-all definitions of malnutrition across all cancer types when counseling a cancer patient preoperatively could result in overestimating or underestimating the patient’s risk of complications after a major cancer resection procedure,” Dr. McKenna said.

They found that the malnutrition (undernutrition) definition that best predicted postoperative risk differed for six cancer types as follows:

Colorectal: severe malnutrition
Esophageal: ESPEN 2
Gastric: ESPEN 1
Liver: NSQIP
Lung: ESPEN 1
Pancreatic: ESPEN 1

The best malnutrition definition also varied by cancer type for predicting the risk of dying within a month after a cancer operation, the researchers reported.

“Because it is uncommon for surgeons to look at cancer type when estimating malnutrition-related preoperative risk, these results could potentially change surgeons’ view of how to evaluate cancer patients,” Dr. Cima said.

He recommended that surgeons consider, “What is the best marker of nutritional status for this cancer type?”

“Cancer patients should understand that good nutrition before having an operation is very important,” Dr. Cima concluded.

Other study co-authors are Katherine A. Bews, John H. Pemberton, MD, FACS, and Elizabeth B. Habermann, Ph.D., all from Mayo Clinic, Rochester, Minn.; Waddah B. Al-Refaie, MD, FACS, from MedStar Georgetown University Hospital, Washington, D.C.; and Dorin T. Colibaseanu, MD, FACS, from Mayo Clinic, Jacksonville, Fla.

The authors had no disclosures related to this study.

“FACS” designates that a surgeon is a Fellow of the American College of Surgeons.

This study was presented at the Southern Surgical Association 131st Annual Meeting, Hot Springs, VA, December 9, 2019.

Citation: Assessing malnutrition before major oncologic surgery: one size does not fit all. Journal of the American College of Surgeons. DOI: https://doi.org/10.1016/j.jamcollsurg.2019.12.034 (.)

¹Arends J, Baracos V, Bertz H, et al. ESPEN expert group recommendations for action against cancer-related malnutrition. Clin Nutr. 2017;36(5):1187-1196. DOI:10.1016/j.clnu.2017.06.017 (.)

² Cederholm T, Bosaeus I, Barazzoni R, et al. Diagnostic criteria for malnutrition–an ESPEN consensus statement. Clin Nutr. 2015;34(3):335-340. DOI:10.1016/j.clnu.2015.03.001 (.)

³ World Health Organization. BMI classification. Available at: https://apps.who.int/bmi/index.jsp?introPage=intro_3.html (.) Accessed February 3, 2020.

Adaptas Solutions to Acquire Applied Kilovolts and Analytical Instrumentation Business from L3Harris Technologies

February 26, 2020

Today, February 26, 2020 Jay Ray, President and CEO of Adaptas Solutions notes, “These strategic acquisitions expand our mass spectrometer component product offering and allow us to continue to build our market-leading position in mass spectrometry components, subassemblies and contract manufacturing.” Ray added, “Adding the CeraMAX^™ product line allows us to cultivate future innovation for our market-leading mass spectrometry OEM customers. The Applied Kilovolts business deepens our product offering while expanding our global manufacturing to now include Europe.”

This latest acquisition further enhances Adaptas’ manufacturing and engineering resources, allowing Adaptas to accelerate OEM client development projects while offering the industry’s broadest range of next generation mass spectrometer detection solutions.

Adaptas Solutions is a portfolio company of Ampersand Capital Partners. Financial terms of the acquisition were not disclosed. The transaction is expected to close in mid-2020.

Gore Innovation Center Announces Collaboration With Robotics Startup Moray Medical

February 26, 2020

Founded by materials science company W. L. Gore & Associates (Gore), the Gore Innovation Center leverages the company’s 60 years of engineering expertise to help startups pursue new concepts and ideas, build prototypes, test material sets and explore a world of possibilities. Proven to withstand the harshest environments and exacting requirements of aerospace, sustainability, medical and energy applications (to name a few), Gore delivers both pioneering solutions and trusted mission-critical materials that have been relied on for decades — including its revolutionary GORE-TEX Fabric.

Lab use case – robotics in healthcare

In July 2019, Moray Medical was named a Rosenman Innovator for its innovative technology and patient impact. An esteemed panel of subject matter experts, clinicians, and investors selected Moray Medical for digitizing the user interface of cardiac catheter systems to enable precise delivery of therapies within the beating hearts of millions of patients. Additionally, Moray Medical was awarded time in the Gore Innovation Center prototyping lab to test, build, and enhance its robotic catheter system in the Gore Innovation Center prototyping lab.

Today, Moray Medical is leveraging the prototyping lab to deliver transformative breakthroughs at scale. The lab offers broad ideation, testing, and manufacturing capabilities — including additive and subtractive manufacturing, wet chemistry, analytical tools, and more.

“The Gore Innovation Center offers deep engineering expertise and foundational capabilities that have helped us drive our idea forward,” said Phillip Laby, co-founder, Moray Medical. “We have made significant advancements on bringing robotic dexterity, precision and ease-of-use to a range of therapies.”

Gore Innovation Center startup application

Silicon Valley startups working on breakthroughs in sustainable technologies and advanced materials are encouraged to apply for workspace now through March 31, 2020. Technology focus areas for 2020 include, but aren’t limited to:

Advanced materials
Clean technology
Neurostimulation and bioelectronics
Sustainable fabrics

Who qualifies?

The Gore Innovation Center seeks nimble, forward-looking startups to collaborate on the development of industry-leading products. Applications from hard tech science startups, from seed to series A, that embody novel technologies and will benefit from Gore expertise are encouraged.

“Combining deep materials science expertise with market insights, the Gore Innovation Center helps startups accelerate their technology development,” said Linda Elkins, leader, Gore Innovation Center. “Gore materials are a core component for many everyday products. Our scientists can independently alter specific material attributes such as microstructure, thickness, modulus, and form factor to achieve desired performance in a variety of applications.”

To apply to work in the Gore Innovation Center prototyping lab, visit: https://www.research.net/r/GoreSVICapplication

Launch of VITROS XT 3400 Chemistry System from Ortho Clinical Diagnostics

February 26, 2020

Chris Smith, chief executive officer, Ortho Clinical Diagnostics. said, “Because Every Test is a Life, we make patient care our passion at Ortho Clinical Diagnostics. Driven by this, we work diligently to ensure the world’s labs are best equipped to partner with clinicians and medical teams to provide consistently fast, accurate results that help them confidently diagnose, monitor and treat their patients.”

“Like many industries, the diagnostic space is under constant pressure to do more with less, and often, that starts in the lab—the hub of the health care journey,” said Piper Antimarino, Ortho’s head of clinical labs product portfolio. “Our team has spent countless hours speaking with lab directors and decision-makers across hospitals, health care systems, and emergency departments to truly understand their realities and challenges. We are proud to introduce industry-changing products like our VITROS XT Solutions designed to help them succeed by driving efficiencies, reducing costs and improving patient outcomes.”

Results Processed Without Operator Interventions: VITROS XT Solutions ensure the right result the first time with an industry-leading 96.5 percent first-pass yield.ⁱ Further, they reduce the need for manual interventions such as those caused by reviews, reruns or redraws by 75 percent compared to competitive systems.ⁱⁱ For labs doing one million tests per year, this provides up to 300 more tests per day without delay. Ortho further reduces delays through its systems’ uptime, in some markets guaranteeing 98 percent uptime to e-Connected VITROS customers.ⁱⁱⁱ

Fastest Turnaround Time for Panel of Common Assays: The new VITROS XT 3400 Chemistry System, like the VITROS XT 7600 Integrated System, simultaneously performs two tests frequently ordered together on one VITROS^® XT MicroSlide, a multi-layered, postage-stamp-sized slide which filters out lipids and proteins that can impact the quality of results, and offers an up-to-40 percent higher throughput than current slides.^iv Double assay processing offers a 25 percent faster turnaround time on a common panel of assays^v, with an average processing time of 7.5 minutes compared to about 10 minutes for other industry options.^vi Further, the XT MicroSlide allows for the lowest sample volume at 2.7μl.^vii

Reduction in External Interferences: Reduction in external factors that may impact results further ensures the accuracy of VITROS XT Solutions results. Ortho’s proprietary “dry” chemistry technology does not require water to run, eliminating the risk that poor water quality could impact results. In addition, single-use tips and cuvettes eliminate the risk for both sample and reagent carryover.

The newly launched Ortho VITROS XT 3400 Chemistry System has obtained CE Mark, and is available for purchase in numerous countries, including Armenia, Australia, Austria, Bangladesh, Belgium, Canada, Caribbean Islands, Chile, France, Germany, Hong Kong, Iceland, Italy, India, Ireland, Japan, Liechtenstein, Luxembourg, Maldives, Malta, Nepal, New Zealand, Norway, Oman, Peru, Philippines, Portugal, Saudi Arabia, Spain, Switzerland, the U.K., U.S., and countries in the Middle East and Africa.

References

ⁱ An internal Ortho study validated by a third party established that the VITROS^® 5600 Integrated System had an industry-leading 96.5 percent first-pass yield. Subsequent Ortho comparison studies established that the VITROS XT 7600 Integrated System met or exceeded that standard.
ⁱⁱ ORTHO VALUATOR℠ data from on‐site studies commissioned by Ortho‐Clinical Diagnostics are on file and available upon request.
ⁱⁱⁱ This is a contractual promise Ortho makes in the United States and Canada.
^iv Based upon head-to-head comparison data of the new VITROS XT 7600 Integrated System against current integrated system.
^v CAP Today, Chemistry and immunoassay analyzers for mid- and high-volume laboratories, July 2018. Turnaround time to complete the panel of these tests: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, CO2, Chloride, BUN, Creatinine, ALP, ALT, AST, Bilirubin.
^vi CAP Today, Chemistry and immunoassay analyzers for mid- and high-volume laboratories, July 2018.
^vii VITROS XT 3400 Chemistry System technical specifications sheet.

Daniel Florin Joins Pulmonix Board of Directors

February 26, 2020

In addition, Daniel Florin served as Interim Chief Executive Officer of Zimmer Biomet from July 2017 to December 2017. Prior to working at Zimmer Biomet, Mr. Florin was Senior Vice President and Chief Financial Officer of Biomet, Inc. until Biomet, Inc. merged with Zimmer, Inc. and became Zimmer Biomet Holdings Inc. Prior to working at Biomet, he held various roles at Boston Scientific Corporation, C.R. Bard Inc. and Deloitte & Touche, LLP.

“I am truly excited to join the Pulmonx board and be part of this experienced team,” said Mr. Florin. “I look forward to helping Pulmonx continue the important work of bringing minimally invasive solutions to patients suffering from severe emphysema, a form of COPD.”

“I am very pleased Dan has agreed to join the Pulmonx Board of Directors,” said Glen French, President, and Chief Executive Officer. “His financial and operating experience will be incredibly beneficial to Pulmonx as we continue our growth in the coming years. I look forward to working with and learning from him.”

Foldax Tria LifePolymer Heart Valve Technology Honored with The Best Innovation Award at CRT 2020

February 26, 2020

The presentation, titled “Foldax Tria First in Human Implant of a Totally Synthetic Polymeric Aortic Heart Valve,” was given by Dr. Steven Yakubov, Chair of Advanced Structural Heart Disease at OhioHealth Riverside Methodist during the Best Innovation Competition session. The Tria heart valve with its LifePolymer technology was competing as one of the Top Ten Innovations at the 2020 CRT meeting.

“I am honored that the judges selected the Tria synthetic polymer heart valve presentation as the Best Innovation Award winner since all of the technologies presented were excellent examples of the extraordinary research being done in cardiovascular medicine today. The Foldax technology holds the promise of the next major advancement in heart valves after transcatheter delivery,” stated Dr. Yakubov.

Tria LifePolymer heart valves are made with LifePolymer, a novel, patented biopolymer developed specifically for heart valve application. By utilizing computer engineering and robotic manufacturing, Tria heart valves are designed to provide optimal durability and hemodynamics with exceptional value compared to current valves.

“This award provides continued validation of our goal to transform heart valve therapy. Our thanks go to Dr. Yakubov and all our clinical investigators for their significant contributions to the Tria LifePolymer heart valve technology development,” stated Ken Charhut, Foldax Executive Chairman.

FDA Approves to Continue the PROMISE Sensor Clinical Study in an Extended Cohort to 365 Days to Gather Feasibility Data

February 26, 2020

“We are very pleased that we received a prompt approval to extend the study to gather valuable data,” said Tim Goodnow, Ph.D., President, and CEO of Senseonics. “The scientific, clinical and technical data we will obtain will be critical to further extend sensor longevity. We’re very grateful to the FDA for the green light, for the tireless clinical investigators, and particularly, to the devoted study participants for giving us this opportunity.”

The goal of the PROMISE Sensor Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S. Food and Drug Administration. One hundred and eighty-one (181) study participants at 8 sites across the United States had the Eversense CGM System inserted subcutaneously as part of the study, which is completing the 180-day duration in March. Now, a sub-set of more than 35 participants who all had a sensor with the modified chemistry will be left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days.

“Extending this study is really a critical step in developing a 365-day product. Information gathered from this cohort will allow us to characterize the improved sensor design and optimize our glucose algorithm for the extended, 365-day use period,” explained Mukul Jain, Ph.D., Chief Operating Officer at Senseonics. “This addition is an exciting extension phase of the PROMISE study and we look forward to evaluating the first multi-clinic investigation of a one-year implantable glucose sensor.”

The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-attached to the skin without discarding the sensor. Eversense users now have the freedom to make treatment decisions based on their Eversense readings. The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure.

Other FDA news items of interest.

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