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Venarum Medical Receives FDA SBIR Grant Support for Development of Its Canine Urinary Incontinence Implantable Valve

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EATONTOWN, N.J.–(BUSINESS WIRE)– Venarum Medical today announced receipt of a Phase I SBIR Grant award for development of K9-ICT: A Novel Urethral Valve Treatment for Canine Urinary Incontinence.

Under this Phase I work, Venarum proposes to develop and evaluate the feasibility of the Canine INCONTrol Urethral Valve system (K9-ICT), a novel urethral implant solution for the treatment of urinary incontinence (UI). The transurethral, catheter-delivered K9-ICT is intended to work with the normal voiding initiation mechanism to help control the flow of urine in order to reduce urine leakage and other complications of UI. The K9-ICT consists of a Nitinol stent-like scaffold embedded in a biocompatible polymer with a polymeric inner valve comprised of a flexible leaflet-like membrane; with a user-friendly catheter, it is placed in the urethra. It is designed to significantly reduce urine leakage by restoring the ability to retain urine and void at appropriate urinary bladder pressures that are seen in continent dogs.

Canine urinary incontinence (UI) is a condition characterized by involuntary passage of urine. UI can have neurogenic or non-neurogenic causes; the most common non-neurogenic cause is urethral sphincter mechanism incompetence (USMI), which is thought to be hormone-related and affects over 20% of spayed female dogs, equating to roughly 5 million otherwise healthy pets in the U.S. Hundreds more dogs receive a urethral stent for benign or malignant causes of urethral obstruction, with many left incontinent following stenting.

Venarum’s CEO/CTO, Janet Burpee, said, “None of the current treatment options for UI—medical management, urethral bulking agents, and surgical correction—are reliably efficacious and all carry risks. We are hoping to bring forward a simple user-friendly solution.”

About FDA Grant Support of this Project

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $167,648 with 63 percentage funded by FDA/HHS and $100,000 amount and 37 percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

About Venarum Medical, LLC

Venarum is a privately held medical device company that develops medical devices using its patented integrated valve manufacturing process. The Company’s two leading devices are a prosthetic venous valve and a urinary incontinence device, both of which are catheter-delivered implants. Venarum’s integrated valve process may enable commercial catheter-delivered valves with idealized flow conditions that address large unmet clinical needs.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210317005791/en/

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Source: https://www.biospace.com/article/releases/venarum-medical-receives-fda-sbir-grant-support-for-development-of-its-canine-urinary-incontinence-implantable-valve/?s=93

Medical Devices

New York Bone & Joint Specialists: New Invention Stops or Delays the Progression of Osteoarthritis of the Knee

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Source: https://infomeddnews.com/new-york-bone-joint-specialists/

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Medical Devices

Ping An AskBob Doctor’s Smart Imaging Model for Diagnosis of Pelvic and Hip Injuries is a Breakthrough for Artificial Intelligence

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April 1, 2021

Ping An Insurance (Group) Company of China, Ltd. “Ping An” announced that Ping An AskBob Doctor’s smart imaging model for diagnosing pelvic and hip injuries is the first of its kind to accurately detect all kinds of trauma-related findings simultaneously in X-ray images.

In a research paper published in the international journal Nature Communications, the model is shown to overcome the limitation of other artificial intelligence (AI) systems, which can only detect individual fractures.

The model, a deep learning algorithm, can help physicians make faster, more accurate diagnoses and save lives. Hip fractures mainly occur in elderly people and patients with major trauma. Although they are not directly fatal, complications can lead to a high mortality rate. Reducing the rate of missed diagnoses, improving the comprehensiveness of the detection, and providing accurate diagnoses is critical.

Ping An Health Technology Research Institute, Ping An Smart City, Ping An Good Doctor and the Department of Trauma and Emergency Surgery of Chang Gung Memorial Hospital in Taiwan jointly released the research paper “A scalable physician-level deep learning algorithm detects universal trauma on pelvic radiographs”. The research team gathered the pelvic X-ray data of 1,888 emergency room patients to evaluate the model’s performance in obtain the fracture results and locations. It achieved an overall accuracy of 92.4%. Compared with general clinical diagnoses, the model substantially improves detection accuracy, speeds up the treatment progress, improves the treatment effectiveness on high-risk patients, and reduces the economic cost to patients through earlier detection and treatment.

This is the first AI algorithm to detect all fracture types captured on the X-ray images, including, but not limited to, hip fractures, pelvic fractures, femoral fractures, hip dislocation and artificial joint peripheral fractures.

As of March, 2021, the AskBob Doctor AI pelvic trauma detection technology has been used in the real-life clinical environment in Chang Gung Memorial Hospital in Taiwan for nearly eight months. The results have shown that the misdiagnosis rate has significantly reduced. Since adopting the AI system, the misdiagnosis rate has dropped from 9.7% to 0.7% among emergency physicians, 11.3% to 1.58% among resident physicians and 6% to 0.5% among specialist physicians. The model has performed comparably to radiologists and certain orthopedic specialists in terms of quantitative indicators such as sensitivity and specificity.

The smart imaging model for the diagnosis of pelvis and hip injuries is Ping An’s latest achievement in smart imaging technology. Ping An’s smart imaging technology covers nine major systems of human body — the motor, digestive, respiratory, urinary, reproductive, endocrine, immune, nervous and cardiovascular systems. It supports various equipment including computed tomography (CT,) X-ray, ultrasound and fundus optical coherence tomography (OCT).

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Source: https://infomeddnews.com/ping-an-askbob-doctors-smart-imaging-model/

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Medical Devices

Sander de Vos Is Appointed Chief Business Officer of IME Medical

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April 1, 2021

Sander de Vos will be responsible for the worldwide roll-out of the company’s medical electrospinning strategy, based on IME’s ground-breaking MediSpin™XL industrial production platform.

Judith Heikoop, CEO of IME Medical Electrospinning said, “We at IME are thrilled to welcome Sander to our fast-growing team of professionals. Sander clearly brings a wealth of well-needed life science experience into the company, that will certainly be of key-value to the further development of our electrospun medical device franchises. Our aim is to become the first partner of choice worldwide for the development of a novel, groundbreaking class of medical devices and pharma products based on nanofibers. Our ever-growing portfolio of customers and partners includes the Medtech and Pharma industry, universities, hospitals, and medical institutes.”

Sander de Vos (46) is an accomplished executive with more than 15 years of leadership experience across healthcare and biotech commercial and business development positions. Prior to joining IME, Sander worked at Mimetas, an innovative Dutch start-up company providing novel human cell biology models for improved therapies, where he played a key role in expanding the collaborations with its pharma and biotech partners.

In previous roles, Sander led the commercial team of Isogen Life Science and acquired experience as an entrepreneur growing a private business. His commercial career started at Westburg Life Sciences and for more than 10 years he shaped and directed the sales strategy and commercial development of part of their life science business.

Sander has a background in molecular biology, co-developed a molecular diagnostic test for simultaneous detection of tick-borne pathogens, and contributed to the development of a vaccine against ticks at the Faculty of Veterinary Medicine of the Utrecht University.

Sander de Vos, Chief Business Officer of IME Medical Electrospinning, said: “With the potential of becoming the global leader in large-scale production of best-in-class nanofiber based medical devices and drug delivery solutions, I’m proud, gratified and delighted to become a member of the IME management team. The company’s technology enables faster and better recovery of tissues and body structures, and therefore IME is uniquely positioned to make a meaningful difference in the lives of patients.”

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Source: https://infomeddnews.com/sander-de-vos-ime-medical/

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Medical Devices

Dipti Itchhaporia, MD, FACC: New American College of Cardiology President

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April 1, 2021

Dipti Itchhaporia, MD, FACC, today begins her term as president of the American College of Cardiology.

During her one-year presidency, she will lead the over 54,000-member global organization in its mission to transform cardiovascular care and improve heart health.

“From the moment I became a Fellow of the ACC, I’ve been excited about being a part of this community and contributing to advancing the field of cardiology and the patients we serve,” Itchhaporia said. “I’m looking forward to connecting the cardiovascular community over the next year, as we emerge from a mostly virtual world, to make strides in our strategic priorities and improve the lives of heart disease patients. We must be prepared as a profession to embrace and move to center stage our solutions and vision of digital transformation and health equity.”

Itchhaporia is an interventional cardiologist who is the Eric and Sheila Samson Endowed Chair in Cardiovascular Health, director of disease management for Hoag’s Jeffrey M. Carlton Heart and Vascular Institute in Newport Beach, California, and associate professor of medicine at the University of California, Irvine. She has been a leader in the College for over 20 years, previously holding positions both nationally and in the ACC California Chapter.

Most recently, Itchhaporia held the position of ACC vice president. She previously served as a member of the ACC’s Board of Trustees and the Board of Governors, secretary of the ACC as chair of the Board of Governors, and president of the ACC California Chapter. She has also served on multiple ACC committees and helped to advance the College’s education, science and innovation efforts, including as a member of the ACC Lifelong Learning Oversight Committee, Science and Quality Committee, Governance Committee, Practice Administrator Workgroup and as an advisor for the ACC’s Innovation Program.

Itchhaporia’s professional interests include quality measurement and improvement in cardiovascular disease, focusing on emerging risk factors and medical and lifestyle interventions to prevent coronary heart disease. She is also extensively involved in advancing technology and innovations that will advance the digital transformation of cardiovascular medicine to ultimately improve the lives of patients and clinicians, while helping to achieve health equity.

Itchhaporia’s professional passions have led to leadership roles in advancing the ACC’s strategic priorities, including serving as chair of the ACC Board of Trustees Health Equity Task Force, which addresses issues of health disparities, the social determinants of health and improving access to care for underserved patients. Further work toward health equity will be at the forefront of her presidential year.

“Health equity has been a priority for the College for a long time and for the first time we are feeling like this could be actualized,” Itchhaporia said. “In cardiology we need to have the mindset to prioritize health equity issues, and I’m excited that this is in our reach.”

She received her medical degree from St. Louis University School of Medicine and completed her residency in internal medicine at Stanford University Medical Center. She then joined the general medicine faculty at the University of California, San Francisco (UCSF), ultimately pursuing a cardiology fellowship at Georgetown University and an interventional cardiology fellowship at Stanford University.

Other ACC officers for 2021-2022 are Vice President Edward T. A. Fry, MD, FACC; Board of Governors Chair Joseph Marine, MD, FACC; and Treasurer Christopher M. Kramer, MD, FACC.

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Source: https://infomeddnews.com/dipti-itchhaporia-president-acc/

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