November 17, 2020
Gun Violence: The rising toll of gun violence across cities and communities of color has increased tensions in areas that have already been disproportionately impacted by the coronavirus disease 2019 (COVID-19), social unrest and an economic recession.
In response, Northwell Health will host the second annual Gun Violence Prevention Forum, which will join leaders across health care and other fields to actively discuss how to address the bloodshed in these communities and gun violence as a public health issue. The conference will highlight the critical issues facing gun violence in the US, including public policy, advocacy and the role of government; corporate America and finding a middle ground; and health care partnerships that make a difference.
“Gun violence is a public health emergency and it’s on us to keep the conversation going and work together to find solutions,” said Michael Dowling, Northwell’s president and CEO. “We have a great opportunity here to find common ground, speak about what is truly happening in our inner cities and other communities, and fix it. Our communities deserve better.”
Among the headline speakers are:
- Michael Bloomberg, founder of Bloomberg LP and Bloomberg Philanthropies, co-founder of Everytown for Gun Safety and Mayor of New York City (2002-2013) who cut crime by a third while reducing incarceration by nearly 40 percent.
- Former US Congresswoman Gabrielle Giffords, the youngest woman ever elected to Arizona State Senate who was the victim of gun violence when she was shot in the head during a mass shooting that killed six people and injured 12 others.
- Connecticut Sen. Chris Murphy, who has fought for solutions to gun violence after 20 children and six educators were killed in a mass shooting at Elementary School.
- John Feinblatt, president of Everytown for Gun Safety, the largest gun violence prevention organization in the US.
In addition, the event will spotlight rising gun violence in cities across the US. New York City, for example, had endured more than 500 shootings in the first six months of 2020 and more than double the amount it had from June 2019 to this June. In July, nearly every person shot (about 100 total) had been a person of color.
Minority communities have also struggled in Chicago, where gun violence increased 76 percent the first half of 2020, as compared to the same timeframe in 2019. Nearly all of the shootings happened in Chicago’s predominantly Black and brown communities on the South and West Sides.
Erica Ford, CEO of Life Camp, Inc., one of the leading violence prevention and intervention organizations in the US, will provide insight on the issues facing communities of color, and Thomas Jackiewicz, president of the University of Chicago Medical Center, and Peter Slavin, MD, president of Massachusetts General Hospital, who established the hospital’s Center for Gun Violence Prevention, will discuss health care collaboration.
“We have an outstanding roster of experts who can not only speak to the issues of gun violence, but who are living it every day,” said Chethan Sathya, MD, director of Northwell’s Center for Gun Violence Prevention and a pediatric trauma surgeon. “As a pediatric surgeon, I too have experienced this firsthand, having pulled bullets out of babies. It’s a growing issue and we need to continue to have these important discussions to provide the attention it needs.”
Gun violence is a public health issue
Northwell’s inaugural Gun Violence Prevention Forum in 2019 leveraged the power of a $3.5 trillion health care industry to find ways of stopping the unnecessary violence and increase awareness of gun violence as a public health issue. Mr. Dowling closed the event by pledging $1 million toward Northwell’s effort, which helped create the health system’s Center for Gun Violence Prevention.
During the summer, Northwell established the Gun Violence Prevention Learning Collaborative — a national, first-of-its-kind, multiyear, multiphase platform that joins gun violence prevention experts from health care and community-based organizations to collectively share knowledge and expertise while developing best practices.
In September, Northwell secured $1.4 million from the National Institutes of Health to study gun violence prevention and establish the “We Ask Everyone. Firearm Safety is a Health Issue” research study, which instituted universally screenings those at risk of firearm injury at three hospitals within the health system. Emergency department clinicians are now asking patients specific questions about having firearms in their homes and determine their risk of injury.
“As we’ve learned this year with the pandemic, social injustices and excessive gun violence, it will take us all working together to make significant change,” Mr. Dowling said. “The Gun Violence Prevention Forum will continue our momentum. But rest assured, we won’t stop until we finally have viable solutions for gun violence.”
Elcam Medical Joins Serenno Medical as Strategic Investor and Manufacturer of its Automatic Monitoring of Kidney Function Device
January 20, 2021
Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, announced today that Elcam Medical, a leading producer of medical devices, has invested $1.5 million in the Company and will also manufacture SentinelTM, Serenno’s urine output and intra-abdominal pressure digital monitoring device for the detection of acute kidney injury (AKI). Elcam Medical join existing investors Alon Medtech and serial medical device inventor, entrepreneur and investor, Dr. Shimon Eckhouse.
The partnership announced today combines Serenno’s unique solution with Elcam’s superior manufacturing experience to deliver high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments.
Continuous kidney function assessment allows the early detection of AKI, a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization. Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring changes in kidney function. However, UO is currently monitored intermittently and manually by ICU staff, therefore acute changes in urine flow are difficult to detect. Thus, kidney injury is often detected relatively late, sometimes after it is impossible to prevent further progression.
Beyond the high death toll associated with kidney failure routinely in the ICU, the recent spread of COVID19 had greatly increased prevalence of, and death from AKI, while vastly increasing the demand and exposure risk on medical professionals and ICUs worldwide.
Sentinel offers a simple and cost-effective solution for the precise, continuous measurement of urine volume and flow rate in real time. The system promotes early detection of kidney injury, while there is still time to intervene and prevent further damage. It aims to automatically and accurately detect small changes in kidney function, allowing remote detection by the medical staff, thus reducing both patient and caregiver risk.
“The investment by Elcam Medical is a strong endorsement, and will allow us to swiftly move toward commercialization of our device,” said Tomer Lark, Serenno’s co-founder and CEO. “Elcam’s world class production capabilities and experience, will enable mass production and increased market access of Sentinel. Our plan is to begin deployment of the devices in several US hospitals towards the end of 2021, in the hope to eventually reduce kidney failure risk for every patient at ICUs.”
Dr. Shimon Eckhouse, Serenno’s Chairman, added, “We are pleased with Elcam’s investment, which marks the first commitment in Serenno’s larger planned current financial round. This partnership with Elcam is an excellent indication of the high degree of innovation and the significance of Serenno’s solution for the advancement of monitoring technologies. We are confident that Elcam’s leadership position in the global point-of-care market will play a critical role in bringing Serenno’s exciting technology to ICUs and patients around the world.”
“Our investment in Serenno and the establishment of a production line for its device is aligned with Elcam’s strategy to cooperate with promising Israeli startups to deliver products with added value for the patient,” said Igal Kohn, Elcam Medical’s CEO. “Elcam Medical has joined Serenno as a board member and we look forward to taking part in the Company’s continued successes.”
Best Coronary Stents from the Top Brands
The total coronary stent market comprises bare-metal stents, drug-eluting stents, covered stents, and bifurcated stents. Stents can be defined as small mesh tubes inserted into an artery to prevent it from collapsing and keep it open after an angioplasty surgery (percutaneous coronary intervention, or PCI). Following multiple clinical studies that presented evidence of over-stenting in the U.S market, the value of the overall market has decreased through 2019 and is expected to trend downwards over the coming years, outside of COVID-19-related fluctuations. We have identified the different types of stents and analyzed their benefits and draw-backs:
Top Companies for Coronary Stents by Market Share
1. Boston Scientific – The leading competitor in the coronary stent market was Boston Scientific. Most of the company’s success can be attributed to its strong position in the drug-eluting stents (DES) market, where it held the leading share.
The company currently offers the SYNERGY™ and REBEL™ BMS product line. SYNERGY™ is the first and only FDA-approved DES with abluminal bioabsorbable polymer coating available in the U.S. coronary stent market. REBEL™ is made of a platinum chromium alloy, which is designed to reduce device usage, procedure times, and radiation exposure.
2. Medtronic – Medtronic is the second-leading competitor and maintained a notable position in both the bare-metal stents (BMS) and drug-eluting stents (DES) markets. Through strategic acquisitions and aggressive bundling, Medtronic has increased its share across the interventional cardiology market in recent years.
The company currently offers the Resolute Onyx™ and Resolute Integrity™ DES product lines, as well as the Integrity™ BMS product line. Unlike Boston Scientific and Abbott’s DES devices, which use the everolimus drug, Medtronic’s DES devices use zotarolimus.
3. Abbott – Abbott is the third-leading competitor in the coronary stent market. Competition between Abbott and Medtronic has increased within the DES market, resulting in Abbott losing share in recent years.
The company currently offers the XIENCE™ and Multi-Link Vision™ product lines. Multi-Link Vision™ has been the leading BMS in the U.S. since its introduction. It is constructed of a cobalt-chromium alloy that is more radiopaque than stainless steel stents. This alloy is also stronger than stainless steel, which allows stent construction to be much thinner while still retaining its strength.
Coronary Stent Market Trends – By Type
1. Drug-eluting stents (DES) – All stents have a risk that scar tissue will form and narrow the artery again. This scar tissue can block blood flow. However, drug-eluting stents are coated with drugs that prevent scar tissue from growing into the artery. DES are used for an overwhelming majority of stenting procedures, due to the continued publication of clinical studies supporting their safety and efficacy as the gold standard for stenting procedures. With this clinical backing, the DES market sits at over $1 billion.
However, due to increased bundling and competitive pricing, significant ASP depreciation resulted in negative market value growth in 2019. Negative to flat growth is expected to continue for most of the next few years.
2. Bare-metal stents (BMS) – “Bare-metal stents are mesh-like tubes of thin wire without a coating or covering. Ideally, bare-metal stents will be covered by a new layer of endothelial cells, sealing it into the vessel wall, within a few weeks after implant.” – DAIC.
Bare-metal stents were once the gold-standard choice for stenting procedures but have lost substantial share to drug-eluting stents. It is expected that the segment will continue to contract in market value in the upcoming years with decline rates in the double-digits.
3. Covered stents – Covered stents are composed of fabric or graft material, such as polytetrafluoroethylene (PTFE), covering a metal stent. These devices are seldom used and are indicated for the treatment of free perforations of native coronary arteries or saphenous vein grafts, which would have been treated with a coronary artery bypass graft (CABG) procedure in the past.
The incidence rate of coronary perforation has historically been low. It is estimated to occur in less than 1% of percutaneous coronary intervention (PCI) procedures performed in the United States.
4. Bifurcated stents – Bifurcated stents represent a small fraction of the total market value. Tryton Medical’s TRYTON® Side Branch was the first dedicated bifurcated stent to be approved in the U.S. market, in March 2017.
The segment was once expected to experience very rapid growth, due to the strategic alliance between Tryton and Cardinal Health. However, after the first year on the market, unit sales declined sharply, due to a lack of clinical studies for and efficacy of the stents.
Coronary Stent Market Analysis and Forecast
Overall, the U.S. Coronary Stent market size was valued at over $1 billion in 2020. This is not expected to increase by much over the next few years, as the market observed a loss of 22% resulting from the impacts of COVID19. This is expected to bounce back with growth over the next 2 years but then drop off again as stents become less used in surgeries.
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Occlutech Announces Atrial Flow Regulator Has Received U.S. FDA Breakthrough Device Designation for Heart Failure
January 19, 2021
Occlutech, a Swiss-based privately-held company reported that the FDA has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.
Heart failure (HF) is a serious condition characterized by the heart’s inability to pump an adequate blood supply to the body. Worldwide, HF affects over 30 million people, and the lifetime risk of HF increases with age, with over 50% of hospitalizations of persons aged 65 or older attributable to HF. Heart Failure Symptoms include fatigue, palpitations, and exertional dyspnea. HF may result from disorders of the pericardium, myocardium, endocardium, heart valves, great vessels, or specific metabolic abnormalities. These disorders affect the heart’s structure or function, which results in reduced cardiac output and/or elevated intracardiac pressures at rest or during exercise. When HF is left untreated, symptoms gradually worsen, resulting in increased morbidity, clinically driven hospitalizations, and higher mortality.
The AFR is for use in patients with Heart Failure with Preserved Ejection Fraction (HFpEF) or Reduced Ejection Fraction (HFrEF) and who, despite optimal medical therapy, experience worsening symptoms. The AFR maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. Reduced left atrial pressure has been shown to reduce heart failure symptoms and improve exercise tolerance.
Breakthrough Device Designations aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market approval.
“It is an important milestone for us to have received this second breakthrough designation for our AFR device.” says Sabine Bois, CEO Occlutech Group. “After receiving the first Breakthrough Device designation for pulmonary arterial hypertension (PAH) in December 2020, the heart failure (HF) indication addresses a substantial market with rapid growth and only limited options for the treatment for critically ill patients. We are looking forward to developing an important new therapy and working closely with the FDA on both indications.”
Occlutech is one of the leading companies in its field, with several major products including state-of-the-art PFO occluders, ASD occluders among others. Occlutech has sales of congenital and structural heart products in over 80 countries and maintains manufacturing and R&D facilities in Jena, Germany and Istanbul, Turkey. Occlutech has developed many novel products and technologies to improve treatment of patients in these and related areas.
The AFR is not approved in the United States. Product availability is subject to local regulatory clearance. The AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws.
StemVacs Cellular Immunotherapy: Positive Animal Data Reported in the 4T1 Breast Cancer Model
January 19, 2021
StemVacs cellular immunotherapy update: Therapeutics Solutions has reported positive animal data in the 4T1 breast cancer model using StemVacs cellular immunotherapy.
In a series of experiments, it was demonstrated that StemVacs™ administration resulted in a) regression of established breast cancer in mice; b) that regression was dependent on natural killer cells, and c) that immunity to breast cancer could be transferred by CD4 T cells to naïve mice.
Previously the Company announced positive safety data in 10 patients treated with StemVacs™1. Additionally, the Company has filed an Investigational New Drug Application (IND) which is currently pending based on the Company responding to questions posed by the FDA.
“The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND,” said Dr. James Veltmeyer, Chief Medical Officer of the Company and voted Top Doctor of San Diego. “Given the fact that we have human safety data from outside of the United States, combined with these new mechanistic findings, we are confident in a smooth interaction with the FDA as we get closer to clearing of our IND application.”
“It is known that numerous immunotherapies such as Herceptin® are dependent on the ability of natural killer cells to function properly,” said Famela Ramos, Vice President of Business Development. “The current data provides a scientific basis for us to collaborate with other immuno-oncology companies to identify and leverage possible synergies with other drugs that work via the natural killer pathway of the innate immune system.”
“Therapeutic Solutions International is a ‘science-driven’ organization,” said Timothy Dixon, President and CEO. “Having key opinion leaders such as Drs. Santosh Kesari and Francesco Marincola as advisors allows us to design and execute experiments with the highest level of academic rigor. We believe that the FDA and our scientific and medical peers will appreciate our philosophy.”
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