Israeli medical device company SoniVie, announced on Sunday that it received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration for its REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) pilot study to treat resistant hypertension patients with renal artery denervation using its proprietary therapeutic intra-vascular ultra-sound system, or TIVUS.
Renal denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused ultra-sound energy to burn away nerves in the renal artery. The TIVUS catheter is inserted into the pulmonary artery and selectively damages nerves afflicted by the disease without touching vessel walls or damaging adjacent tissues. This causes a reduction in the nerve activity, which decreases blood pressure and is meant for patients who suffer from resistant hypertension.
Resistant hypertension is defined as blood pressure that remains higher than 140/90 mmHg despite the use of three hierarchical classes of antihypertensive medications at their most appropriate tolerated doses. The condition affects millions of people around the world, increasing the risk of heart attack, stroke, and kidney failure.
Founded in 2014, SoniVie has developed a first-of-its-kind ultra-sound denervation platform with active programs establishing nuanced therapeutic solutions for pulmonary hypertension denervation, renal artery denervation for resistant hypertension, and lung denervation for obstructive pulmonary disease with chronic bronchitis.
“We are very pleased that the FDA has approved the REDUCED1 study,” said Christian Spaulding, chief marketing officer of SoniVie. “Sites initiation has started, and many clinical teams have responded very favorably about participating in the study.
“There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS in the US,” he added. “There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment.”
“This is a significant US regulatory milestone for SoniVie, starting the feasibility study using the ultra-sound ablation platform in the US for the renal denervation indication,” said Tomaso Zambelli, CEO of SoniVie. “This is a major step and priority in the company’s history.”
On this World Blood Donor Day, let’s explore some Israeli tech that is making a difference to one of our most vital components: our blood
Hematological awareness is important as body vitality is exclusively dependent on blood flow. Blood is our natural producer of oxygen and carbon dioxide, and it is also a key mechanism for medical identification. For decades, doctors have prioritized blood analytics and testing as these results present in-depth information regarding diagnostics, treatment methods, and one’s overall physical state. Blood is as much the cure as it is the cause– blood donations are organized worldwide to act as a remedy for the shortage of blood and blood products that can single-handedly save hundreds of lives. Here in Israel, MedTech’s innovative efforts have always been advanced, yet amidst the effects of COVID-19 and how it continues to modify all spheres of society, Israeli MedTech innovations are at an all-time high. With the focus strictly on blood analytics, Israel’s start-up environment has pushed forth incentives and actions that have seemingly revolutionized how blood can be analyzed, detected, and measured. Here are some Israeli startups that play a role in hematology solutions.
Blood diagnostic information, in most cases, does not do enough to create an effective impact on immediate health solutions and products. The devices and technologies that have been used thus far do not provide doctors and patients with substantial information when it matters most. Moreover, real-time blood testing is not accessible to everyone which presents numerous implications when patients are in emergencies. These obstacles have disrupted medical efforts for decades as there is a pressing need for in-depth, easily accessible blood diagnostic tools. In an accidental discovery made by a team of researchers at the Technion (Israel Institute of Technology), Viscoelastic Focusing (VEF) has been recognized as the saving grace toward efficient cell analytics. The Israeli startup PixCell has created the HemoScreen that uses advanced technology making use of VEF potential. This product uses a disposable cartridge with specific reagents to elicit a Complete Blood Count test. HemoScreen does not require maintenance or calibration and is versatile to fit the precise needs of its user.
PixCell was founded in 2008 with a keen focus on simplifying and regularizing real-time blood testing worldwide. Their research and entrepreneurial staff have surpassed company expectations with the discovery of Viscoelastic Focusing (VEF), paving a way for pivotal advancements in hematological efforts. Their team consists of Avishay Bransky (CEO, Co-Founder), Prof. Max Herzberg (Co-Founder), Armin Schon (CCO), Hanan Ben-Asher (COO, BD Manager), Mark Erez (CFO), Yaara Ben-Yosef (Director of RA and Clinical Affairs), and Eitan Hod (Director of QA and RA). PixCell has raised over $7 million in grant funding from the European Commission, the International Health-Tech Pilot Program, and the Israel Innovation Authority. In 2021 PixCell was acquired by Soulbrain Holdings.
The global supply of red blood cells has seeped far under worldwide medical demands. This shortage has served as a detriment to medical interventions such as trauma, childbirth, operations, chronic illness, cancer, and the list goes on. Red blood cells are the oxygen-carrying capacity of the body which is why 120 million blood units are donated each year, yet there is still a concerning decrease in these donations. Blood drives and donation sites, although they function as a temporary solution, are still not enough to compensate for the urgency in transfusion methods, productions, and resources. The Israeli startup RedC Biotech has initiated a “one blood type fits all” method with RedC Universal Red Blood Cell Transfusions. This product is suitable for almost every patient and provides a uniform potency. It is pathogen-free and donor free and also eliminates undesirable blood components as well as additional hospital testing.
RedC was founded in Haifa in 2015 by Dr. Ari Gargir. Over the past couple of years, the company has received $1.4 million in pre-seed and seed funding from PipelBiz. Their revolutionary technology addresses issues associated with industrial red blood cell production, and cost reductions. From the lab to global production, Red C Biotech is eager to scale the count of red blood cells to save lives worldwide. RedC has a small employee base but is growing in accordance with its production timeline.
Current diagnostic tests cannot distinguish between acute and chronic inflammation, as well as monitoring immune functions that are pivotal for personalized treatment methods. With Improdia’s array of Unique BioMarkers, the innovative diagnostic company has developed a simple way to supervise inflammation levels for patients suffering from autoimmune and cancer diseases. ImproDdia’s technology department has made substantial discoveries enabling pharma companies a kickstart in their drug development processes as well as suggesting personalized treatment methods. Improdia’s Diagnostic Kit includes three easy-to-use, unique biomarkers with three distinct functions: the IMPC (for chronic inflammation), IMPI (for immunotherapy), and IMPD (for diabetes complications. IMPC evaluates the immune status and inflammatory pain levels of those with niche medical implications. It aids physicians in selecting the type and timing of specific treatments as well as monitoring the efficacy of such treatments. IMPI is a prognostic test for the efficiency of immunotherapy. It monitors the immune status of cancer patients before immunotherapy or chemotherapy. IMPD is a prognostic test for diabetes complications as it predicts the occurrence of these complications before they are medically obvious.
Improdia’s team consists of Miriam Lerner (Founder, Co-CEO, CTO), Gil Pogozelich (Chairman), Dr. Roy Eldor (Medical Director), Prof. Michal Baniyash (Inventor), and Prof. Ido Wolf (Member of the Scientific Advisory Board). The company has been based in Herzliya since 2012 and continues to aid doctors and patients in the diagnostic and management endeavours of those with chronic immune-mediated diseases.
Sight’s technology represents breakthrough innovations in diagnostic methodology. Their latest blood analyzer, Sight OLO, performs a Complete Blood Count, the most ordered blood test, in minutes. It’s compact and designed to be used in a variety of settings. OLO creates a digital version of a blood sample by capturing more than 1,000 highly detailed images from just two drops of blood obtained from a finger prick or venous sample. These images are then interpreted by proprietary and fully automated AI algorithms, and the results are available within minutes.
Sight OLO provides 5-part differential complete blood count (CBC) results with 19 parameters and sophisticated flagging capabilities, for on-site testing. It is the first CBC analyzer that is FDA 510(k) cleared for blood taken directly from either a finger prick or a venous sample. Sight OLO has been validated for use in patients 3 months and above, in a variety of CLIA-certified (Clinical Laboratory Improvement Amendments) moderately complex clinical settings such as hospitals, emergency departments, oncology clinics, pediatric practices, and urgent care locations. The sample preparation process can be completed in under one minute, with the full results ready in minutes on a touchscreen interface, printout, email, or via LIS (Latent Semantic Indexing)/middleware. Sight OLO comes factory calibrated for a quick setup with internal Failsafe systems and requires no maintenance. Its minimal training and step-by-step on-screen guidance are designed to be used by operators with any level of experience. OLO also has an Operator Management feature that allows for complete control over who can access the device, including traceability of operator activities.
Sight OLO was founded in 2011 by Yossi Pollack (CEO) and Daniel Levner (Chairman of the Scientific Advisory Board). The company is based in Tel Aviv, London, and Brooklyn with 300 employees. With investments from Koch Disruptive Technologies, OurCrowd, and Longliv, Sight Diagnostics has raised over $120 million to date. Sight has gained worldwide traction with partners eager to use and expand the company’s advanced technology. Among them are Boston Children’s Hospital, Oxford University Hospitals NHS Foundation Trust, and Nicklaus Children’s Hospital in Miami.
Handheld blood test diagnostic tools are not affordable for the average patient and consumer. Most of these tools require laboratory conditions and specific preparations which fail to account for real-time informed decisions an individual may have to make. Israeli startup EFA developed RevDx™, a revolutionary, European Commission-approved, mobile, and fully automated diagnostic system to be used for different care, including primary care physicians, home care, emergency care, and remote care. RevDx™ is easy-to-use; from a finger prick, you get results within minutes. The application provides a Complete Blood Count test, the most requested hematology test worldwide which provides indications for broad clinical conditions such as infections, disease, fever, immune system, and anemia.
Founded in 2016 by Yoel Ezra (CEO), an engineer and a physicist who served in a technological-operation unit in the IDF for over 23 years, EFA is acting to develop the RevDx solution as a platform that will enable the creation of more diagnostic applications over time. Among the company’s investors are Maccabi Healthcare Services, eHealth Ventures, Merchavia, and Medison. The company currently employs 12 people.
Diverse clinical settings have not found easy nor accurate methods to measure blood parameters as current testing devices and tools are not appropriately equipped for such conditions. The key to medical testing is to establish a comfortable environment for any and all patients; with invasive monitoring, though, this element is rather ignored. Israeli startup OrSense works to transform patient health through non-invasive monitoring as they develop and commercialize innovative monitoring technologies focused primarily on donor and patient comfort. Using their revolutionary SpectOLight ™ Occlusion Spectroscopy Technology, OrSense has developed the NBM 200 Device that detects blood hemoglobin (Hb), oxygen saturation levels and pulse rate (PR) values. Patients place their fingers on a ring-sensor probe where the portable desktop attached to the monitor device calculates and displays the figured measurements. To make matters even easier and more efficient, OrSense has developed a software application attached to the device that allows for Tablet or Smartphone use.
Since 1996 OrSense has been working worldwide to overcome key obstacles that do not account for comfortable, accessible, and efficient blood parameter testing. For over 20 years, OrSense has made substantial adjustments toward non-invasive monitoring technologies: the intellectual property portfolio at OrSense consists of 51 granted patents and over 20 additional applications. So far, OrSense has raised over $44.4 million in seed and grant funding from Israel HealthCare Ventures, Star Ventures, Saints Capital, The Lewis Trust Group, and Shimon Eckhouse. Their team consists of Yoav Resiman (Founder and CEO), Aharon Weinstein (VP of Research). Asher Zysman (CFO), and Chip Neff (President). OrSense is located both in Tel Aviv, and Raleigh, North Carolina, USA.
Patients who suffer from renal failure are required to be connected to a hemodialysis machine for a few hours, 2-3 times a week, via a fistula on the patient’s arm. The fistula is the point of connection between the hemodialysis machine and the patient for the treatment. One of the most dreaded complications for hemodialysis patients is fistula loss due to stenosis (blood clogging of the fistula) resulting in an inability to perform routine dialysis – a major risk to patient life. PatenSee is a medical device company (currently in the clinical stage) that has developed a contactless, machine vision-based, surveillance system for the early detection of vascular stenosis and/or a clogged fistula. The technology is designed to provide a very simple way to improve the quality of patient care and to support the nursing staff in the hemodialysis center without adding any burden on the patient or the clinic. The system can also be adapted to home use adding a critical diagnostic feature to home dialysis.
PatenSee was founded in 2019 as a portfolio company of MEDX Xelerator, a MedTech incubator working under a license from the Israel Innovation Authority. Hagay Drori and Oz Seadia founded PatenSee based on an unmet need presented to the MEDX Xelerator by a major strategic player in the dialysis field. Dr. Gal Goshen, PatenSee’s CEO, led it from its early concept through its first-in-human 60-patient clinical study, conducted less than two years after the company’s founding. PatenSee is currently raising a Series A round and is preparing for a multi-center, international, clinical trial of its second-generation imaging system.
The Technion-Israel Institute of Technology and Rambam Health Care Campus together with philanthropists Andi and Larry Wolfe, announced the establishment of the Wolfe Center for Translational Medicine and Engineering
The Technion is one of the few academic institutions in the world in which the Faculty of Medicine operates alongside engineering and scientific faculties. The university conducts extensive teaching and research activities in the fields of medicine as well as biomedical engineering, computing, design, and architecture.
The Rambam Health Care Campus is heavily active in the research and innovation fields through its partnerships with its Division of Research, technology transfer company Rambam MedTech, and the MindUp incubator in cooperation with IBM, Medtronic, and Pitango VC.
The Wolfe Center will elevate the partnership between Rambam and the Technion and will serve as a platform for comprehensive clinical applied research to advance human health technologies that address unmet clinical needs. Interdisciplinary teams will collaborate to solve human health issues, translate research insights into innovative therapeutic tools, and train the next generation of doctors and engineers.
The Center will be located within the Rambam campus inside the Helmsley Health Discovery Tower and serves as the first joint project of its kind between Rambam, academia, and the biomedical high-tech industry. The Tower will also host centers of excellence, clinical institutes, innovation centers, and several start-up companies, alongside an exhibition and visitor center.
“Research and innovation are critical components in the success of the healthcare system in the 21st century. The tremendous contribution of the Wolfe family will enable us to increase our capabilities. Research is now a necessity for keeping Israeli doctors relevant in a competitive and constantly evolving field. The new center will allow us to convince doctors who are engaged in the difficult, demanding clinical field to continue to work in a large medical center, by providing opportunities for advanced research,” said MikI Halberthal, professor and general director of Rambam Health Care Campus.
“Human health is one of the greatest challenges facing humanity in the 21st century and coping with this challenge requires a combination of capabilities from different worlds of content, from the patient’s bed and the doctors around it, to scientists and engineers from a variety of disciplines,” said Technion President Professor Uri Sivan. “Today, the Technion is creating a revolution aimed at connecting all those disciplines to deal with major challenges in human health, and the Wolfe Center will express the combination of the capabilities of one of Israel’s leading hospitals with a world-renowned scientific-technological university.”
The Israel Institute of Technology (TECHNION) has announced the establishment of the country’s first Artificial Intelligence (AI) research institute for medical technology solutions.
The Technion’s Zimin Institute for AI Solutions in Healthcare, which was jointly launched and operated with the Russian charity Zimin Foundation on Sunday, will focus on multidisciplinary research and technological development in human health and medicine using big data and computational learning, according to a statement from Technion.
Zimin Institute for AI Solutions intends to improve human healthcare on all levels, including hospitals, clinics, drug development, home therapy, and medical wearables. “This new centre is a crucial component of Technion President Uri Sivan’s goal of collaboration and connectivity between research, engineering, and medicine,” said Technion President Uri Sivan.
“It will support applied research that will speed the creation of new and important technologies with real-world applications,” he added.
The Israeli Institute of Technology continues to be at the forefront of groundbreaking solutions to help protect our planet.
This development coincides with Better Speech and Hearing Month
Israeli scientists at the Technion – Israel Institute of Science have engineered a working ear, alongside Sheba Medical Centre.
Led by Professor Shulamit Levenberg of the Faculty of Biomedical Engineering, the team combined techniques of organ printing, tissue engineering and the extraction of human cells to create a custom implant that can be used to replace ears that don’t develop properly in utero.
The scaffold, which allows for the formation of the new ear, is designed from a CT scan of the patient’s ear.
It is hoped the breakthrough will significantly help children with microtia – a condition in which the underdeveloped ear is small, malformed and sometimes unable to hear.
Previously, it was treated using cartilage tissue from the ribs, which is both painful and comes with the risk of added complications. The new surgery can also be performed at the age of six instead of after 10, which may also help reduce the psychological effects for children who, up until now, have had to start school with a malformed ear.
It could also be tailored to “other applications, such as nasal reconstruction and fabrication of various orthopedic implants”, Professor Levenberg hopes.
Microtia affects 0.1% to 0.3% of births.
Each May, Better Hearing and Speech Month helps raise awareness about communication disorders and hearing health.
The Israeli Institute of Technology continues to be at the forefront of groundbreaking solutions to help protect our planet
Using a disposable cartridge that includes all necessary reagents and requires no maintenance or calibration, HemoScreen delivers lab-accurate data from a single finger-prick of blood within five minutes.
“Even before we get approval for home use, we can improve the life of cancer patients dramatically,” says Armin Schon, PixCell’s chief commercial officer.
“They get blood drawn before chemotherapy and if their white blood cell count has recovered sufficiently since the last treatment, they can get the next dose. If not, they are sent home. They have to sit and wait till the central lab returns results, which takes half an hour to several hours,” he explains.
“This is very unpleasant for the patient and inefficient for the clinic’s workflow. Our CBC analyzer can shorten that wait time to a few minutes. A staff member can roll it around from patient to patient and within five minutes say, ‘You are good to go’ or ‘Sorry, come back next week.’”
A clinical trial in Denmark led by Changing Cancer Care successfully trained 12 breast-cancer patients to use PixCell’s HemoScreen to perform their CBC test at home. Their results were compatible to standard hospital lab results.
“With HemoScreen, we can potentially save patients significant time and energy exertion when undergoing these serious treatments, and also save time and costs for hospitals,” said Dr. Niels Henrik Holländer, head of Changing Cancer Care and an oncologist at Zealand University Hospital in Næstved.
Into the community
“From day one, the HemoScreen was developed with the goal to be usable by basically everyone with just half an hour or so of training,” says Schon.
“For maximum deployment we want to be independent of expert users, laboratory technicians and other highly skilled people who usually operate this type of equipment, and really go into the community,” he says.
“However, regulatory authorities are very hesitant to allow non-medical personnel to operate this type of equipment, so we have an uphill battle to convince them that this is a safe use and will bring value in the treatment of home-based patients. There’s only one way to do that, and that’s clinical trials.”
To that end, the Danish Ministry of Health has approved a second bigger trial to be done in Denmark and Germany that will include patients with various types of cancer at more advanced stages.
It is these patients who stand to benefit most from spending less time in a clinic, Schon points out.
“We believe that will provide the evidence we need to get approval in Europe for home-based CBC measurements,” he says, and FDA approval for home use could take several more years.
Meanwhile, PixCell won a grant from the International Health-Tech Pilot Program — an alliance between the Israel Innovation Authority and leading US and Europe hospitals — to develop and validate additional applications for HemoScreen.
In addition, the product was named a gold winner in the Testing and Diagnostic Products and Systems category in the 2022 Medical Design Excellence Awards and received Best-in-Show honors.
Devices in 18 countries
Headed by microfluidics expert Avishay Bransky, PixCell Medical was founded in 2009 and launched HemoScreen in the market two years ago.
Although the pandemic prevented the company from traveling internationally to demonstrate HemoScreen, several hundred devices were sold through distributors in 18 countries.
Now, says Schon, “production is fully loaded with orders. We have just opened a US subsidiary, so commercialization is going at full speed.”
Many hospitals have ordered HemoScreen to improve workflow, Schon reports. “Emergency departments in particular benefit from getting results in five minutes.”
However, the device originally was designed for “extreme point of care” uses, such as rural clinics.
It was for just such a purpose that PixCell donated a HemoScreen device, along with hundreds of cartridges, to Ukraine via the Ukrainian Embassy in Tel Aviv.
Schon says the HemoScreen could be used for quick testing and triaging of refugees on the border or in hospitals.
“The reason we dare to donate this system to Ukraine is that a nurse can unbox it and start testing – you just need electricity and reasonable temperatures. The box comes with a leaflet explaining how to do it, and there are short training videos. Within 15 minutes of unboxing you can be using the device.”
Another use of the HemoScreen is for assessing the effects of certain psychiatric drugs that require regular lab visits and venous blood draws because they have potentially lethal effects on the immune system that must be monitored, Schon explains. “We can revolutionize this area by reducing the inconvenience and taking the needle anxiety away.”
Three-day annual conference, marking 20th year, brings together thousands of participants for newest innovations in medical and heath tech
Some of the innovative scientific developments behind leading food technologies, as well as new cancer treatments, will take center stage at the upcoming Biomed Israel summit next week, an annual conference on life sciences and health tech that brings together scientists, healthcare professionals, entrepreneurs, and investors from dozens of countries across the world.
This year, the three-day conference is marking its 20th anniversary with 10 different tracks — infectious diseases, robotics in the medical field, and AI and machine learning, among others, in addition to precision cancer diagnostics and therapies, and “bio food” and its impact on human health. Each track will be chaired by a professional leader in their relevant field and the conference, which organizers say expects about 6,000 people, will also host an exhibition where hundreds of Israeli companies can present their products and technologies.
Dr. Tammy Meiron, CTO at Israel’s Fresh Start Food Tech Incubator and the chair of the food tech track, told The Times of Israel that the sessions will focus on “bio-food technologies and how we adapt biotech into the food tech arena to produce more sustainable food.”
“There’s a growing consensus that, due to the climate crisis, we have to find better ways to feed the growing [world] population. There are increasing demands for food and there are ethical aspects of growing our food from animals,” said Meiron.
“This younger generation is more aware of this [issue], and it’s also the first generation to come to realize the dangers of the climate crisis,” she added. These dangers have been described as a “code red for humanity” that requires urgent action by the United Nations Intergovernmental Panel on Climate Change (IPCC).
“We have a window of about 10 years. It is critical that we deliver solutions in food tech,” she said.
Meiron is an experienced food tech professional, having headed the protein department at US biochemical company Sigma Aldrich (later acquired by Merck) where she led production on more than 450 different proteins and enzymes, before joining Fresh Start in 2019.
The food tech incubator, based in the northern Israel city of Kiryat Shmona, is a project led by the Israel Innovation Authority together with Israeli company Tnuva, beverage firm Tempo, Israeli investment company OurCrowd, and Finistere Ventures, a global investor in food tech and agritech.
“We incubate companies for 2-3 years and bring them to the next level of investment. So far we have supported eight companies and intend to support at least 40 by 2028,” she explained.
Fresh Start is currently working with seven companies including one that is developing cell-cultured fish and two that are working on sugar reduction technologies.
During the conference next week, a number of known companies will be presenting, including Future Meat and Aleph Farms, leading developers of cultivated meat, and Wilk, a developer of animal-free cultured milk and cell-based human milk.
Meiron believes food tech such as cultivated meat and fish, alternative protein, animal-free milk and dairy, and others, can help ensure food security in the decades to come. “The weather and the agriculture won’t be the same. We will have to adapt,” she said.
Her track at the Biomed conference will cover new biotech technologies that are now applied to food production to help solve these issues and release the reliance on traditional agriculture for more sustainable methods.
Challenges the industry faces will also be addressed including pricing, scalability, resources, and infrastructure. “It costs thousands of dollars to make food in a lab, it’s a huge issue. We need people to choose these options as their food,” said Meiron.
At the same time, investors are flocking to the industry. “We saw a dramatic acceleration in the last 2 years, VCs now all want a piece of food tech. We’re seeing a lot of money [being invested] because of the understanding that this is a critical issue,” she said.
In Israel, the alternative protein sector, a segment of its vibrant food tech industry, grew by about 450% in 2021 from the previous year, with Israeli startups in the field raising some $623 million in investments, according to a report released in March. The Good Food Institute (GFI) Israel, a nonprofit organization that seeks to promote research and innovation in food tech, found that the $623 million in investments accounted for about 12% of the global capital raised for the sector worldwide last year (about $5 billion) and was “second only to the US.”
The next stage in food tech, Meiron said, was the “enabling tech that facilitates the tech of companies that already raised money, to reduce pricing and so on.”
In oncology, the next stage is “precision oncology” where cancer treatments are adapted based on individual biology, said Dr. Ofer Sharon, CEO of OncoHost, the developer of a blood test to predict how well cancer patients will react to treatment. Sharon will chair the Biomed track that looks at advancements in cancer therapies and precision-based therapeutics, driven by biomarkers and artificial intelligence tools.
Today, most cancer care treatment plans are “based on protocol, and given to everyone, whether they are a 74-year-old woman or a 35-year-old man; they’ll get the same treatment,” Sharon said.
“Chemotherapy is like carpet bombing and it doesn’t differentiate between healthy cells and cancer cells,” he explained. “The field is now changing to focus on specific targets and adapt treatment to the level of the mutation” while providing customized care based on biology.
The track will hear from two types of companies — those developing targeted drugs that tackle specific mutations and those, like Oncohost, that look for individual biomarkers.
“We look for the biological indications that affect treatment… to identify whether a patient is going to respond to treatment” or help point to another one, said Sharon.
Another company in this field is Nucleai, which uses computer vision and machine learning to study the characteristics of tumors to help drug companies predict who will react to medication.
This rising field is also facing key issues, such as regulatory hurdles, and a need for a medical “paradigm shift,” said Sharon.
“Fighting cancer is a war, and there is understanding that there is a price. There’s a need to ‘kill the entity’ and doctors want to act as quickly as possible,” Sharon explained. Precision medicine takes a different approach that may take more time but can be much more effective.
The industry also needs closer collaboration with pharmaceutical giants. “There are excellent drugs out there but they work for a minority of patients. To treat cancer, we need a better understanding of this complex disease. It requires education and more awareness,” said Sharon.
On the regulatory side, he said, “there is no regulatory body that can approve [the technologies] in an efficient way.” There is also no regulatory body that specifically examines technologies based on AI and machine learning.
“There is a lot of work to be done for market adoption,” said Sharon.
The Biomed conference will run from May 10 to 12 in Tel Aviv. It is co-chaired by Ruti Alon, founder and CEO of Medstrada, a food tech VC fund, Dr. Ora Dar, a consultant and expert in medical sciences and health innovation and the former head of health and life sciences sector at the Israel Innovation Authority, and Dr. Nissim Darvish, a managing general partner at MeOHR Ventures, a private equity firm that focuses on world-changing cures for serious diseases.
Israel is celebrating its 74th anniversary after a record-breaking year for its high-tech sector, with $5.6 billion raised in the first quarter of 2022 and over $25 billion raised through 2021.
Indeed, the record fundraising should be praised, but it’s the incredible innovation and technological achievements that have kept Israeli companies at the top of their game this year in sectors like cybersecurity, digital health, and climate tech.
The Israeli tech sector “reached new heights” in the last year, Rotem Shacham, a principal at venture capital firm Viola Ventures, tells NoCamels. “We shattered all kinds of ceilings.”
“Security and Fintech are always at the top of innovation sectors in Israel,” Shacham says, noting that the country is also strong in data infrastructure and both vertical and horizontal applications.
This year, Israelis made medical breakthroughs, resolved problems, dealt with cyber threats, reduced carbon emissions, developed cancer treatments, disrupted industries, and in general, made a significant impact on the world at large.
“I think what is unique about innovation here in Israel is our culture,” Shacham says, “Entrepreneurs are willing to take risks, experiment, and fail. We address problems head-on in a very direct fashion and are not sentimental in admitting failure, learning from it, and venturing out to try again. This grit and perseverance is very unique.”
As Israeli turns 74, NoCamels highlights the companies that have stood out in the past year:
Matricelf, the Israeli regenerative medicine firm established by founder and Chief Scientific Officer Professor Tal Dvir in 2019, announced it was closer than ever to curing paralysis with the development of 3D printed neural implants for paralyzed patients with spinal cord injuries. The company reported it had produced its own in-house induced pluripotent stem cells (iPSCs) from human peripheral blood cells, which could be combined with a unique hydrogel from 3D printed implants to potentially cure the condition.
Matricelf VP R&D Dr. Tamar Harel Adar called the achievement a revolutionary and promising technology in the world of cellular therapy and regenerative medicine,” according to Globes.
In February, Israeli scientists reported they had engineered 3D human spinal cord tissues from tissue engineering technology developed by Dvir of Tel Aviv University (TAU) and licensed by Matricelf. The tissues made an implant that could replace the affected tissue of patients suffering from Spinal Cord Injury (SPI,) scientists said, according to “highly encouraging results” when implanted into an animal lab model with long-term chronic paralysis. The implant was said to have an 80 percent success rate in restoring walking abilities in patients.
This has been said to be the first time in the world that implanted engineered tissues have generated recovery in an animal model for long-term chronic paralysis.
In April 2019, TAU researchers, including Dvir, used the same tech to create a “major medical breakthrough” — a live heart — using the revolutionary 3D printing process that includes the human tissue taken from a patient based on the patient’s own biomaterials and cells.
The team hopes to start clinical trials in humans within the next few years, Dvir said. Alongside Spinal Cord Injury, Matricelf’s regenerative tissue engineering technology aims to cure patients suffering from Age-related Macular Degeneration (AMD), Parkinson’s Disease, and Myocardial Infarction.
Between higher consumption rates, rising living standards, and linear life cycles of products, the world now generates just over 2 billion metric tons of municipal solid waste on a yearly basis and at least 33 percent of that waste is environmentally mismanaged. By 2050, global waste is estimated to grow to 3.4 billion metric tons.
Founded in 2012, Israeli cleantech company UBQ Materials offered a solution to the global waste problem through its patented advanced conversion process which turns landfill-destined waste, including organic material, into a climate-positive, cost-competitive, and fully recyclable material called UBQ™. The resulting bio-based thermoplastic can be used as a drop-in material for existing manufacturing processes as a substitute for virgin petroleum plastic, wood, and even concrete to reduce the overexploitation of finite natural, raw resources, and decrease methane volume and carbon, that would otherwise be emitted from landfills.
“By unlocking the value of waste and converting it into thermoplastic UBQ we have the potential to shift the manufacturing industry from a linear process to a fully circular model. By implementing UBQ, manufacturers are diverting waste, reducing methane emissions and preserving finite natural resources for future generations,” UBQ CEO Tato Bigio tells NoCamels.
This year, UBQ has partnered with giants like PepsiCo, to retrofit its petroleum plastic-based delivery pallets, saving the equivalent of 6,500kg of GHG emission, while Israel’s largest food manufacturer, Nestlé subsidiary Osem-Nestlé, has tapped UBQ Materials to create sustainable shipping pallets of their own, initiating a 24 percent decrease in CO2-equivalent emissions over a 20-year period. Other partnerships include beer brewer Anheuser-Busch and Rhode Island-based thermoplastic designer Teknor Apex Company.
This past March, the company was selected as a winner in the Speculative Design category at the 24th annual SXSW Innovation Awards held in Austin, Texas for its signature waste-based 3D filament.
Israeli startup Empathy has been on a mission to change the way the world deals with loss by helping users deal with problems that no one wants to face after the death of a loved one.
Both of Empathy’s co-founders, CEO Ron Gura and CTO Yonatan Bergman, have extensive experience as entrepreneurs, but after the early death of his brother and watching a co-worker in the US deal with the aftermath of his wife’s death, Gura realized he wanted to help others deal with the difficult bureaucracy.
Empathy launched its app last year to help families navigate both the emotional and practical aspects of death, including tasks like planning funerals, dealing with legal and financial issues, and other assistance. The company has already raised $43 million in total just a year after it was founded in 2020.
The app provides step-by-step instructions to complete necessary financial, familial, and bureaucratic tasks, customized to the user’s specific location and situation. They can also enter updates on how they’re feeling. As a side note, Empathy runs a 24/7 call center manned by specially trained “care specialists.”
“The demand in the market for Cider Security is massive,” said John Curtius, partner at Tiger Global Management, in March when Cider Security raised $38 million for its platform that provides a unified view of the entire engineering ecosystem for security teams.
Founded towards the end of 2020, Cider Security’s mission is to solve the most common challenges encountered by chief information security officers and security engineers. The company provides security teams with a tailored set of controls and optimized security strategies tackling anything from code protection to deployment. Cider Security enables AppSec programs to be implemented in minutes by a range of industry verticals, sizes, and maturity levels.
According to the team, founders Guy Fletcher (CEO) and Daniel Krivelevich (CTO) decided to create Cider Security because they felt a lot of frustration while they were trying to implement security as part of the engineering ecosystem and that pain was industry-wide. They felt that the industry’s situation was problematic and that the solutions were very particular and pointed to specific issues without an understanding of the broader challenge. So they established Cider to help the security and engineering teams bridge the gaps that they had when they were trying to implement security as part of the engineering ecosystem.
The company says Cider’s AppSec Operating System is the first of its kind and is presently being used by dozens of global companies such as Databricks, Rapid7, Built Technologies, Lemonade, Rapyd, and more.
Using AI to leverage data in order to develop new treatments for cancer and other diseases is the future of drug development and treatment and Nucleai is at the forefront. The Tel Aviv-based company has developed an AI-powered precision oncology platform that leverages unique tissue datasets to produce insights into cancer biology, increasing the efficacy of clinical trials and improving patient care.
Last March, the company partnered with Sheba Medical Center’s ARC (Accelerate, Redesign, Collaborate) innovation complex so that the Nucleai team would be able to access Sheba’s extensive repository of pathology, clinical, and other multi-omics data. The partnership expanded on Nucleai and Sheba’s existing collaboration to identify histological biomarkers that predict response to immunotherapy in non-small-cell lung cancer patients.
Nucleai has raised $50 million to date.
“RiseUp provides families with the opportunity to change their story about money – something that is very difficult to do alone due to the cumbersome and impenetrable financial system,” said Yuval Samet, CEO and founder of RiseUp, when the company announced it had completed a $30 million Series B funding round last month, bringing its total funding to more than $50 million.
In a world where individuals are always worrying about their budgets, RiseUp’s platform makes it clear and easy to understand. Founded in 2017, RiseUp analyzes a user’s spending data to predict future transactions, generates a snapshot of their financial situation, and sends it to the customer via WhatsApp’s messaging service. This enables users to better manage their expenses and save money on a more consistent basis. RiseUp was the first startup to initiate open banking partnerships in Israel, and it currently collaborates with Bank Discount and Bank Leumi
Eco Wave Power
With the constant and natural motion of waves, our oceans and seas present a massive potential for generating renewable energy. According to the U.S. Energy Information Administration (EIA), “the theoretical annual energy potential of waves off the coasts of the United States [alone] is estimated to be as much as 2.64 trillion kilowatt-hours or the equivalent of about 66% of U.S. electricity generation in 2020.”
Founded in 2011, Israeli energy-tech company Eco Wave Power developed an innovative technology to produce clean electricity from waves. The award-winning tech is made up of specially designed floaters attached to coastal structures like piers and jetties. The up-and-down motion of the waves lifts and lowers the floaters, which compresses and decompresses hydraulic pistons that pressurize hydraulic fluid. With enough pressure, the fluid is discharged to mechanically rotate a hydraulic motor, which a generator then converts into electricity before being transmitted to the electrical grid. The fluid is then looped back to the pistons creating a closed circular system.
This past April, Eco Wave Power signed a deal with Port Adriano in Spain to construct a power station that would generate up to 2 megawatts of clean electricity, helping Spain, a country with over 8,000 km of coastline, achieve its 74 percent renewable energy target for 2030.
The company pioneered the wave-energy field in 2016 starting with a small pilot project located in Gibraltar to test its energy-generating capabilities as well as its built-in storm-protection mechanism over the course of several years. After successfully supplying as much as 15 percent of local electricity needs, the company announced this past March that it will relocate the energy conversion unit to the AltaSea premises at the Port of Los Angeles to upgrade its floaters ahead of its US market entry. Meanwhile, Eco Wave Power is in talks with the government of Gibraltar to augment its prior operations.
Big data and machine learning are taking the health world by storm, but who would have thought that one day, instead of complex and time-consuming clinical trials conducted in state-of-the-art labs with expensive toolkits for pharmaceutical drug development, we would see a technology that can predict the effectiveness of drugs on patients, without exposing them to unnecessary risk?
Key to this breakthrough achieved by the 2016 established company CytoReason is the throve of clinical data amassed over the years. . “Every year, hundreds of thousands of clinical trials are conducted,” CytoReason CEO David Harel tells NoCamels in an email, “That’s a lot of data. And yet, it still takes over 10 years to bring a new drug to market, and 90 percent of drugs in development ultimately fail.”
The company’s unique machine learning platform can quantify a person’s immune system at the cellular level, run simulations, and in so doing establish how a patient will respond to certain treatments which in turn should facilitate the development of more effective drugs.
And big pharmaceutical and biotech companies, like Pfizer, are starting to notice. In February, Pfizer announced it would extend its current collaboration agreement with the Israeli biotech firm. CytoReason first announced its cooperation with Pfizer in early 2019 to leverage the Israeli company’s cell-centered models of the immune system and diseases in order to develop innovative drugs. Since the start of the collaboration, CytoREason said it has provided Pfizer with “multiple insights in a number of R&D programs across over 20 diseases.”
Researchers develop a machine learning technology that rectifies the effects of underrepresentation of women in clinical trials.
It is an open secret that women are underrepresented in clinical trials of new pharmaceuticals and other medical treatments. This has a significant impact on the female half of the population.
A new article in the Journal of the American Medical Informatics Association by computer scientists at the Technion-Israel Institute of Technology, in collaboration with Plia Gillis of Tel Aviv University and Eric Horvitz of Microsoft Research, describes the problems caused by this bias and presents a machine-learning remedy.
“Nowadays, we know that different population groups react differently to a given treatment – in particular, women can have a different reaction than men to a treatment,” said Shunit Agmon, the PhD candidate who conducted the research with Technion alumna and visiting professor Kira Radinsky.
“For example, Zolpidem, a drug used to treat sleeping problems, clears more slowly in women and therefore it is important to prescribe a smaller dose for women than for men – which was discovered only after the drug was released to the market,” said Agmon.
“The underrepresentation of women in clinical trials creates a problematic bias that harms the quality of women’s healthcare, including misdiagnosed diseases and adverse drug reactions.”
The gender gap in clinical trials can be traced to traumatic events including the Thalidomide affair – a drug that caused numerous birth defects when prescribed to pregnant women to alleviate morning sickness in the early 1960s. This tragedy led to a drastic decline in female participants in clinical trials.
In 1993, laws were passed in the United States that mandated the inclusion of women in clinical trials and the analysis of results with regard to gender. Yet, female underrepresentation remained a prevalent phenomenon. Agmon said other population groups are also underrepresented, including certain age groups, ethnic groups, and other demographics.
In some cases, there is also an underrepresentation of men in trials seeking treatments for conditions considered “women’s diseases,” such as fibromyalgia.
Algorithm corrects gender bias
In recent years, machine learning models have been introduced to improve medical diagnosis, treatment, and prevention. However, Agmon claims that “many of these models are based on biased trials and therefore they ‘inherit’ their biases, and in some cases even amplify them.”
The researchers experimented with machine learning methods including natural language processing (NLP) and word embedding, which enable computers to “understand” texts. They used these tools to analyze 16,772 articles from the PubMed database. Each was allotted a “weight” based on the percentage of women in the clinical trials described in the article.
Their work led to the development of an algorithm that enables gender-sensitive use of clinical literature. This algorithm corrects the gender bias and improves the treatments’ suitability for female patients.
The algorithm succeeded in substantially improving predictions for women in various situations, including length of hospitalization, re-hospitalization within a month, and correlation between various diseases.
Although the model focused on improving predictions for women, it also significantly improved overall clinical predictions for men as well.
The researchers’ goal is to increase awareness of the problems of underrepresentation in research in general and in clinical trials in particular, and to inspire additional solutions to improve the quality of personalized medicine.
Agmon, who earned her bachelor’s degree in the Technion’s Henry and Marilyn Taub Faculty of Computer Science, worked for Google for two years and then returned to pursue a master’s degree under the supervision of Prof. Assaf Schuster. Now she is earning her doctorate under the supervision of Radinsky and Prof. Benny Kimelfeld.
Algorithms help doctors create better treatment plans for aspiring parents
More than 8 million people have been born worldwide with the help of in vitro fertilization since 1978. In IVF, an egg is fertilized by sperm in the lab; the resulting clump of cells is transferred into a patient’s uterus.
Although IVF techniques have advanced significantly in recent decades, the average success rate is still fairly low: around 45 percent. The percentage steadily declines as women age; a 40-year-old woman has a likely success rate of about 12 percent, according to Pregnancy & IVF Clinics Worldwide.
Embryonics, a startup in Haifa, Israel, aims to raise the IVF success rate with its suite of AI algorithms. The company’s system uses machine learning to help doctors create personalized treatment plans.
“Technology can help fertility doctors make data-driven decisions and answer complex questions in a smarter way,” says Dr. Yael Gold-Zamir, CEO and cofounder. She launched the company in 2018 with David Silver and IEEE Fellow Alex Bronstein.
Gold-Zamir has a medical degree from the Hebrew University of Jerusalem. Silver is a machine learning engineer who previously worked for Apple and Intel. Bronstein is a computer science professor at the Technion.
“Embryonics is tackling very unique problems—the quality of human analysis and how to analyze big data so that it is clinically relevant,” Bronstein says.
In IVF, several mature eggs are retrieved from the patient’s ovaries. The eggs are then mixed with sperm in a clinic. The developing embryos grow in the lab for several days until an embryologist chooses one or two to be implanted. (The term embryo technically refers to the developmental stage, when the amniotic sac forms inside the uterus, around two weeks after fertilization. But fertility clinics typically refer to the clusters of cells that they evaluate and implant as embryos.)
Doctors typically choose which embryos to implant based on chromosomal testing and appearance, Silver says. Each is graded based on the number and size of its cells and its rate of development.
But there are several problems with that approach, Silver points out.
“One is that the embryologists’ ability to collect data is limited,” he says. “The amount of data about embryos, past patients, and successful live births available to any single doctor is very small, so it’s hard for them to generalize [about] what indicates that a fertilized egg is viable.”
Another problem is that not all clinics have the same grading system, so two facilities might rate the same embryo differently.
“Technology can help doctors in fertility make data-driven decisions and answer complex questions in a smarter way.”
One of the startup’s algorithms uses deep learning to classify images of the embryos and predict which ones will result in a successful pregnancy. It compares the patient’s medical information, such as age and underlying health conditions, along with images of her embryos to the same data from past patients who had successful or unsuccessful implantations.
Silver and Bronstein used thousands of medical images from around the world to train the AI system. But while developing the algorithm, the engineers found that clinics don’t have the same equipment or use the same settings on microscopes and other tools. The variation affected how the platform classified the embryos.
To overcome that problem, Bronstein and Silver developed their own data-augmentation system for the images. It cancels out environmental factors such as lighting and removes irrelevant parts of the images.
“The system only extracts information that is biologically meaningful, such as cellular structures,” Silver says.
The algorithm is currently being tested in clinics in several countries including Lithuania, Malaysia, and Spain. Doctors were hesitant to use the platform at first, Gold-Zamir says, but since testing it with patients, they have given the company positive feedback. The system has increased the success rate by more than 15 percent, Silver says.
The company has submitted its embryo-classification system to the U.S. Food and Drug Administration for approval. It already has been approved in Europe.
Embryonics is developing an algorithm to help doctors prescribe the best hormone-replacement treatment for patients who require it to increase their chances of successful implantations. There are currently no definitive guidelines to help doctors decide which medication is best for patients, Silver says.
“We found that sometimes the same patient goes to several clinics and is prescribed completely different hormone treatment plans,” he says.
To improve decision-making for the treatment plan, the Embryonics team is developing an algorithm that uses machine learning to provide customized recommendations. The algorithm is learning from information about patients as well as a collection of past treatment plans and their outcomes.
“Based on similarities among patients we can do simulations,” Silver says, “and estimate what would have happened if another treatment protocol was chosen.”
“IVF is complicated,” Gold-Zamir says. “It’s not just one decision doctors have to make; it’s a process of sequential decisions. And we need to maximize the potential for the success of all of those decisions.”
The startup emerged from Gold-Zamir’s belief that technology can help doctors make better decisions and therefore increase IVF success. She says most fertility specialists make decisions about a patient’s treatment options the same way experts did 40 years ago.
“Many complicated decisions are made based on the doctor’s gut feeling, which is based on all the cases they have seen in their career,” she says. The decisions include which embryos are viable, how many should be implanted, and what kind of hormone treatment is most appropriate.
Gold-Zamir was introduced to Bronstein and Silver through a colleague. Although their original goal was simply to publish a research paper, the trio wanted to improve fertility outcomes and decided to commercialize their first algorithm.
Initially, funding for the company came from friends and family, but the team later received a grant from the Israel Innovation Authority, a government agency that helps fund technology startups. Gold-Zamir says the grant enabled them to launch the company.
The founders also participated in the Google for Startups program, which provides companies with funding, mentoring, and networking.
Embryonics now has 17 employees including doctors, bioinformaticians and computer scientists.
Its next goal is to develop algorithms to help doctors choose which embryos to freeze for future IVF cycles as well as noninvasive genetic screening and analysis.
“I love being able to apply the latest and greatest technologies to something that impacts human life in one of the greatest ways possible: starting a family,” Silver says.