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Editorial Posts Resume Tomorrow

Photographer

(Robert-Owen-Wahl, Pixabay)

16 Sept. 2019. Today was one of those rare occasions (I promise) where my alternate life as a news photographer crowded out time for stories on Science & Enterprise. We’ll resume our regular posting tomorrow. Thanks for your understanding.

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Infographic – Mobile Industry’s Economic Role

Chart: mobile global economy

Click on image for full-size view (Statista)

14 Sept. 2019. As mobile phones, smart watches, and tablets play an increasingly key role in our daily lives, a new report shows mobile technology makes a sizeable contribution to the world’s economy. The organization GSMA representing the global mobile industry issued its annual report on the mobile economy, with data our friends at Statista highlighted this week, offered as our weekend infographic.

In the report, GSMA estimates the mobile industry added $3.9 trillion to the world’s gross domestic product in 2018, making up 4.6 percent of the total. The mobile industry in the Asia-Pacific region contributes the most to this total, with $1.6 trillion, making up 5.3 percent of the region’s GDP. North America follows with an $840 billion contribution, 4.1 percent of that area’s GDP, and Europe contribution $620 billion, 3.5 percent of its total GDP.

Sub-Saharan Africa contributed the smallest amount to its GDP in 2018 at $144 billion, but that amount makes up 8.6 percent of the region’s GDP, the largest proportion in any geographic area. West Africa alone provides $52 billion to the region, with about the same overall percent age of GDP, 8.7 percent.

As we’ve noted in Science & Enterprise, mobile technology is being used increasingly in research and diagnostics. We reported just this week that Apple unveiled its upcoming research app for use with iPhones and Apple Watches in studies of women’s health, hearing, and heart health.

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Migraine Drug Developer Raises $82.5M in IPO

NASDAQ share price display

(Julien Gong Min, Flickr)

13 Sept. 2019. A developer of a drug for migraine formulated as a dry powder and given as a nasal spray is raising $82.5 million in its initial public offering of common stock. Satsuma Pharmaceuticals Inc. in South San Francisco, California, trading on the Nasdaq exchange as STSA, issued today 5.5 million shares priced at $15.00.

Satsuma’s lead product is a dry powder formulation of a compound now used to treat acute or episodic migraine called dihydroergotamine, or DHE. Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.

DHE is a compound in a class of medications called ergot alkaloids, derived from fungi. The drug works by tightening blood vessels in the brain, and preventing release of substances that cause swelling. DHE formulations are approved to treat migraine as injections given under skin and as a liquid nasal spray.

Satsuma formulates DHE as a dry powder nasal spray, packaged in a plastic squeeze bottle for self-administration, code-named STS101. The company says STS101’s formulation combines DHE with a carrier that quickly adheres to and is absorbed by mucous membranes, allowing for faster uptake.

In July, the company presented results of an early-stage clinical trial, which demonstrated absorption of DHE by participants within 10 minutes. The results also show STS101 is tolerated by users, with sustained levels of DHE in the blood stream and little variation in chemical effects among trial participants. The company is now recruiting 1,140 participants for a late-stage clinical trial testing STS101 against a placebo at 52 locations in the U.S.

Satsuma is a spin-off enterprise from Shin Nippon Biomedical Laboratories, a preclinical and contract research company in Tokyo, formed in January 2017. The company raised $12 million in venture capital at its founding.

After opening at $15.00, Satsuma’s shares rose briefly to nearly $19.00, then fell back near its starting price for most of the day. As of the Nasdaq’s closing bell at 4:00 pm ET, Satsuma shares rallied to $16.90, up 13 percent for the day. For comparison, the overall Nasdaq composite index declined 0.22 percent at its close.

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A.I.-Powered Network to Identify, Build Molecules

Networked earth

(geralt, Pixabay)

13 Sept. 2019. A chemical engineering team is creating an open network for chemists and data scientists to share data for speeding the development of new molecules. A pilot project for the network is funded by a nearly $1 million grant from National Science Foundation for researchers at Virginia Commonwealth University in Richmond and colleagues with other academic groups and private companies.

A team led by Tyler McQuade, professor of life science and chemical engineering at VCU is building an exchange for researchers in chemistry and engineering to contribute their data for analysis by machine learning to identify and build new molecules. The exchange, called MPrint-OKN, aims to collect quantum mechanical data on molecular performance for configuring into molecular imprints, or MPrints. The proposed open knowledge network, or OKN, offers incentives to participants to share data and benefit from more advanced mechanisms for building new molecules.

Currently, say the researchers, there are no shared repositories or portals with tools to build models of molecules or predict their performance. MPrint-OKN is expected to collect contributions from chemistry, molecular modeling, and data science to develop machine learning algorithms and data visualization tools. With more participation in the network, the tools are expected to become more refined and valuable to participants, thus encouraging wider use and more contributions.

Carol Parish, a chemistry professor at University of Richmond and a collaborator on the project, says in a joint statement, “The ability to compute molecular properties using computational techniques, and to dovetail that data with experimental measurements, will generate databases that will produce the most comprehensive results in the molecular sciences.” Parish adds, “There are many laboratories around the world working in this space, but there are few organizational structures available that encourage open sharing of this data for the benefit of the common good.”

The award for MPrint-OKN is made through NSF’s Convergence Accelerator program that aims to identify areas where research across disciplines can solve big problems with practical, near-future payoffs. Convergence Accelerator grantees are also expected to put together teams from the academic world, industry, and other sectors. The MPrint-OKN team includes co-investigators from University of Florida, as well as VCU and Richmond, and the data science companies Two Six Labs in Arlington, Virginia and Fathom Information Design in Boston. The team says several large and small companies, national labs, and National Institute of Standards and Technology are interested in taking part in MPrint-OKN.

The NSF award of $994,433 covers development through May 2020 of a pilot MPrint-OKN network that reduces the time and cost of discovering new molecules, and predicting their performance. At that point, the project team can make a pitch for funds to further develop MPrint-OKN for five years and up to $5 million.

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NIH Funds Augmented-Reality Endovascular System

Heart, circulation system

(Bryan Brandenburg, Wikimedia Commons)

12 Sept. 2019. A grant from National Institutes of Health is funding a system using augmented reality and holography to improve minimally-invasive repair of blood vessels. National Heart, Lung, and Blood Institute is providing $1.5 million over two years to Centerline Biomedical Inc. in Cleveland, Ohio for its technology to boost the speed and accuracy of placing stent grafts to repair aneurysms with minimally-invasive surgery.

Aneurysms are bulges in blood vessels that occur when the blood vessel wall weakens and can rupture. In the chest cavity, aneurysms can develop from a disorder in the aorta, the main artery from the heart that pumps blood to the rest of the body. Endovascular surgery is a newer approach to repairing aortic aneurysms that uses a catheter, rather than open surgery, to reach the repair site with a stent for grafting into the blood vessel wall to provide more support.

Centerline Biomedical develops endovascular systems to repair aneurysms, with its main product called the Intra-Operative Positioning System or IOPS. The company is spun-off from the Cleveland Clinic that conducted the initial work on IOPS, with Vikash Goel, an inventor of the system, co-founding the company. The other IOPS inventor, Karl West, is director of medical device solutions at the Cleveland Clinic, and a scientific advisor to the company.

IOPS, says Centerline, offers a clearer and more detailed view of the patient’s chest cavity than the current X-ray fluoroscopy used for endovascular surgery. The company says X-ray fluoroscopy provides two-dimensional grayscale images of the patient’s blood vessels, while IOPS gives vascular surgeons a color and three-dimensional image. As a result, says Centerline, IOPS can make placement of stent-grafts in blood vessels more precise, and reduce the need for continuous X-ray fluoroscopy and contrast dyes. In July, the company received clearance from FDA to market IOPS in the U.S.

The NIH award funds enhancements to IOPS with three-dimensional guidance, navigation, and control for endovascular blood vessel repair. The enhancements use holograph images projected on a surgeon’s headset, and data projected in the surgeon’s field of view with augmented reality. An initial NIH grant funded a prototype device for IOPS that in tests with lab models reduces procedure time by more than half, improves orientation accuracy by 42 percent, and eliminates the need for X-rays and contrast dyes.

In the next phase of the project funded by the new grant, Centerline and the Cleveland Clinic will develop a working 3-D IOPS guidance, navigation, and control module for usability testing by three medical centers. The company also plans to test the enhanced IOPS on lab models with stent grafts from at least two manufacturers. If those usability and lab tests prove successful, Centerline and the Cleveland Clinic will then seek approval for a clinical trial to assess the system’s safety and verify its operational improvements over current methods.

“Adding this piece to our technology will have a multiplicative effect on the value to the clinician,” says Goel in a company statement. “We believe it will improve patient outcomes right away, and the strategic opportunities it opens for Centerline will make the IOPS technology much more impactful.”

The award was made under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related Small Business Technology Transfer awards.

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Hydrogel Shown Safe to Repair Heart Damage

Karen Christman

Karen Christman (University of California in San Diego)

12 Sept. 2019. Results of a small-scale clinical trial show an experimental treatment using an injectable gel to repair damage from a heart attack is safe for patients. The findings, which also suggest improvements in heart functioning, appear in yesterday’s issue of the journal Basic to Translational Science published by American College of Cardiology.

The trial is testing a treatment for repairing damage to heart tissue that results from heart attack, developed in the lab of bioengineering professor Karen Christman at University of California in San Diego. A heart attack occurs when blood flow in one or more of the coronary arteries is blocked, reducing the amount of oxygen needed by heart muscles to function. Blockages often occur when cholesterol plaques building up in an artery break off and form a clot. Heart muscle tissue, in this circumstance, becomes damaged, with the amount of damage depending on the size of the area affected by the blockage. Scar tissue forms in the damaged area, and while the heart continues to pump blood, it becomes weakened as a result.

Christman’s lab studies bio-materials for repair and regeneration of heart tissue, including materials that can be injected into the heart. One of those materials is a hydrogel, a water-based biocompatible polymer, with extracellular matrix, the material making up the framework in cells, from heart muscles of pigs. The extracellular matrix is freeze-dried and milled into a powder, then mixed with water when needed. When injected into the heart, the liquid forms into a gel, with the extracellular matrix providing a scaffold for new heart muscle cells to build into healthy tissue, replacing the scar tissue from a heart attack.

The technology behind this treatment is licensed to Ventrix Inc., a company in San Diego co-founded by Christman. Ventrix conducted the early-stage clinical trial, recruiting 15 individuals age 45 to 69 who suffered a heart attack in the past three years, and experience moderate dysfunction of the left ventricle, the section of the heart that pumps blood to the rest of the body. Participants were injected with VentriGel, the product developed by Ventrix, using a catheter, with each injection taking about 45 seconds. Patients were then monitored and tracked for six months, looking primarily for signs of adverse effects.

The researchers say VentriGel was well-tolerated by patients, with none of the group discontinuing their participation in the trial. The first participant in the trial experienced the most adverse effects, cardiogenic shock — failure to pump blood — and a complete heart block that may have been caused by the treatment, but also from the patient’s previous heart blocks. No other adverse effects, say the researchers, were directly linked to the treatments.

“Although the study was designed to evaluate safety and feasibility and not designed to show whether VentriGel effectively helps improve heart function, we observed some improvements in patients,” says Christman in a university statement. After three and six months, participants could walk longer distances in six minutes, than before the treatments. Participants overall also improved on the New York Heart Association heart failure classification scale that measures limits on physical activity, and a quality-of-life index for people living with heart failure.

The company now plans a mid-stage study, with a larger randomized sample that tests the hydrogel treatment against a placebo, and measures more indicators of efficacy as well as safety.

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Network to Promote Real-World Dementia Trials

Older couple

(Mabel Amber, Pixabay)

11 Sept. 2019. University and senior care center researchers are building a nationwide network to collect real-world evidence on caring for people with dementia. The project, led by a team from Brown University in Providence, Rhode Island and Hebrew SeniorLife in Boston, is funded by a five-year, $53.4 million grant from National Institute on Aging, part of National Institutes of Health.

A team from Brown University’s school of public health and Hebrew SeniorLife, a senior care center and research institute affiliated with Harvard Medical School, aim to establish ways for assisted-living and senior care facilities to readily test new techniques for caring for people with Alzheimer’s disease or related dementia. The researchers say innovations in care for people with Alzheimer’s disease is hampered by the lack of data from research on new methods of care conducted under real-world conditions.

The team, led by Brown University public health professor Vincent Mor and Hebrew SeniorLife’s Susan Mitchell, director of the center’s palliative care research, seeks to establish embedded pragmatic clinical trials in senior care facilities to collect high quality data. Pragmatic clinical trials take place at the point of care and are designed to collect evidence on treatment benefits and risks under real-world settings, as well as disseminate the results. NIH already established a Health Care Systems Research Collaboratory in 2012 to encourage embedded pragmatic clinical trials, which the Brown/Hebrew SeniorLife team is using as a model.

The researchers are setting up their Alzheimer’s disease and dementia research collaboratory, beginning with the basic infrastructure for the network and guidelines for conducting pragmatic clinical trials among people with Alzheimer’s disease or related dementia and their caregivers. The team then plans to enhance the network’s research and investigator capacity to conduct these trials, and disseminate findings and best practices for conducting the studies throughout the network.

The team aims to establish early on 40 pilot projects that assess non-drug, care-based interventions for people living with dementia. The researchers then expect to glean best practices on evaluating interventions for Alzheimer’s and dementia care from this experience to share with the research community at large. “The key is figuring out how to take an idea that worked in an ideal situation,” says Mor in a Brown University statement, “and adapt it so it can be piloted in the messy real-world system of care providers that exists across the U.S.”

The collaboratory expects to provide assistance to participating institutions on research design, statistics, collecting data on patient- and caregiver-reported outcomes, technical issues, and ethical concerns, such as gaining informed consent from people with dementia. The collaboratory also plans to address management issues such as project administration, partnering with other health care institutions, gaining participation from people with diverse backgrounds, and training junior staff.

The researchers expect their project to have a catalytic effect that benefits people with Alzheimer’s disease. Mitchell notes that the collaboratory “will transform the delivery, quality, and outcomes of care provided to Americans with dementia and their caregivers by accelerating the testing and adoption of evidence-based interventions within health care systems.” In this video, Mor and Mitchell tell more about the project.

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New App for Medical Research, Studies Revealed

Apple vice-president Sumbul Desai describes medical research studies planned for Apple’s new research app, 10 Sept. 2019. (Apple Inc.)

11 Sept. 2019. Apple Inc. plans to release a new medical research app and announced a series of studies for its use in women’s health, hearing, and heart health. The company unveiled the app and studies as part of its product announcements yesterday in Cupertino, California.

The new research app, made for the iPhone and Apple Watch, will allow users to join in studies designed for the app. The company plans to release the software later this year for download in the U.S., and through its Apple stores.

Apple also announced three research projects that take advantage of the app. The company is collaborating with Harvard University’s school of public health and National Institute of Environmental Health Sciences, part of National Institutes of Health, on a long-term study of menstrual cycles and gynecological conditions. Researchers expect to collect data with the app on issues including pregnancy, infertility, polycystic ovary syndrome, menopausal transition, and osteoporosis.

The team plans to focus on the relationship between menstruation – treating it as a vital sign similar to blood pressure and pulse rate —  and women’s overall health outcomes. “Women make up half of the world’s population, yet even today there has been limited investment in studying their unique health needs,” says Michelle Williams, a reproductive epidemiologist at Harvard’s school of public health in a joint statement, adding that the study, “will greatly advance our understanding of the biological and social determinants of women’s health, and lead to better health outcomes.”

A University of Michigan team in Ann Arbor is using the research app to collect data on noise exposure and hearing problems. Participants in the study will collect data over time on their exposure to environmental sounds and its impact on hearing. Up to now, researchers lacked the technology to routinely measure exposure to everyday sounds.

“This unique data set will allow us to create something the United States has never had, national-level estimates of exposures to music and environmental sound,” says Rick Neitzel, professor of environmental health sciences and global public health at Michigan in a university statement. ” And Neitzel notes, “We’ve never had a good tool to measure these exposures. It’s largely been guesswork, so to take that guesswork out of the equation is a huge step forward.”

A third research project uses the app to gauge the relationship between mobility and overall heart health. Brigham and Women’s Hospital in Boston is joining American Heart Association and Apple to measure indicators of physical activity such as walking pace and stair climbing, and discover associations with heart health, hospitalizations, and general quality of life.

Apple is no stranger to health care and medical research. The company offers software development kits for apps to capture data on health-related conditions. Those kits are now used for data collection in studies of Parkinson’s disease, autism, and epilepsy. In addition, Apple is sponsoring the Apple Heart Study, a collaboration with Stanford University to use the Apple Watch to detect atrial fibrillation. As reported by Science & Enterprise in November 2018, the study is recruiting 400,000 participants to screen for signs of irregular heart rhythms.

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If You’re a Specialist, You Need Specialist Support

– Contributed content –

10 Sept. 2019. Specialist businesses provide services and products that are in the upper-most echelons of the industry they’re in. All their focus goes on making the best product they can but unlike other businesses, they are focusing on a niche. They are not trying to serve the needs of the many just yet, they’re making products and services that will be extremely high-quality.

Many family-owned businesses are like this because they have a long history and knowledge of just one craft. Some of the best Scottish whiskey companies are family-run because their specialist product has been so successful that they would rather keep the employee count down so as to not give away secrets. If you’re a specialist business, you must find and use specialist companies for you need. This is to keep your products and services from being diluted into something more broad and lackluster in uniqueness.

Your best sell

For a specialist company, marketing has to be done in a selective manner. It’s not as if you’re providing services for the majority of people, you’re going after a niche demographic because you’re a niche company. For example, if you are a managed service provider (MSP) then you will want a marketing company that spreads your brand to the right kinds of businesses.

Take a look at this msp digital marketing guide and you’ll see there are around 10 key points. First you need to build you MSP website, making everything as clear as possible i.e. what it is you do, your experience, techniques and case studies. Write blog posts so your content marketing aspect is respectable and also gives any inquirers plenty of information as to what kind of business you are.

Building up reviews, learning about the insights your potential clients and leads, creating a Google Ad campaign, setting up the framework for proper analytics and make a viable marketing strategy. When you’re closing the deal as a specialist company, you will want to set out the plan of action to be unique to the client. This shows you can bend a little and give them a service that will fit their business model and needs while still maintaining your uniqueness.

Target your B2B clients

Specialist businesses are the types of entities that make fantastic products that other businesses want to use. For example, Ferrari are known to make some of the best supercars in the world. However, recently they have entered the turbocharged class and since they had a lot of knowledge making naturally aspirated cars but not a lot for turbocharged, they reached out to Garrett. Garrett is a specialist turbocharger manufacturer, they make products that any brand would be thankful to have. They made a special turbo for the Ferrari 488 GTB, increasing the black horse’s chances of competing with the already turbocharged McLaren P1. To this effect, you should target B2B clients with the service of making a unique product for them.

If you’re a large industrial vehicle manufacturer, you should reach out to mining and drilling companies to see what their needs are. If they could give you a brief such as the type of vehicle they would like to have but cannot find a niche product like it on the market, then you can take their plans and build such a vehicle for them. Service a need where they cannot fill it with anything they can find on the current market. Target B2B clients with such proposals to give them a unique product that might replace 1 or more of their current machines and or tools.

In the right section

Distributors are only too happy to take on niche products because they would like a full range of products on their shelves. It gives them a price spectrum so they can attract all manner of consumers to their brick and mortar and online stores. However it’s in your best interest to have your products be placed in the right section. For example, if you make a heated hair brush, this is a product that isn’t really a comb, hairbrush or hair straightener. This might seem like a battle of semantics but the more accurate you are in providing your product to people that want the exact kind of thing you’re selling, the more you will increase sales.

The best thing to do is to first examine the consumer search trends on Google AdWords and see if consumers are using keywords or key phrases when looking for a heated hairbrush. Look at what reasons are and then accurately choose the kind of section you want your product to be displayed in. You might want your product to be featured alongside hairdryers if consumers are more likely to be a product that dries hair first.

Have your own launch

Arriving at business exhibitions with a bang is what all the top brands do. They do this by starting a rumor of some sort just as they leave for the event and by the representatives from the company land, everyone is already talking about them. It’s good to be part of industry events but if you’re a niche product, you might not fit in. Of course you won’t be the only niche brand but wouldn’t you rather have your own launch?

Live streaming your own product launches and creating multiple scenarios for demonstration purposes would show consumers why your product, albeit niche, should be a part of their daily lives. Using your examples, they can visualize your products and see how they would make a difference. As a bonus your brand is also given more exposure and consumers are given the opportunity to understand why you create niche products. When you launch a product on your own platform, you have time to story-tell as well.

Specialist companies are one of the best things about the modern world. They are crucial to not having a mundane society where every product does the same thing but to varying degrees of quality. As a niche business you might want to attract B2B investment and partnerships.

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Gene-Editing Biotech Gains $34M in Early Funds

Sickle cell illustration

Sickle cell illustration (National Heart, Lung, and Blood Institute)

10 Sept. 2019. A two year-old enterprise spun-off from Yale University is developing gene-editing treatments for genetic disorders with synthetic peptides and DNA delivered in nanoscale particles. Trucode Gene Repair Inc. in South San Francisco, California, is emerging from stealth mode and raising $34 million in venture funds.

Trucode Gene Repair designs treatments for genetic diseases such as sickle cell disease and cystic fibrosis. The company says its technology invokes natural DNA repair mechanisms with a combination of synthetic nucleic acids formed into peptides, short chains of amino acids, and DNA sequences for correcting genetic errors. These peptides and DNA sequences are packaged in nanoscale particles made from biodegradable polymers.

Trucode licenses its technology from the labs of genetics professor Peter Glazer, biomedical engineering professor Mark Saltzman, and pediatrics professor Marie Egan, all at Yale University. Egan is also director of Yale’s Cystic Fibrosis Center. In recent work, the researchers devised techniques for combining peptide nucleic acids with DNA to form triple-helix structures that induce DNA repair. The team also developed a non-toxic delivery method with biodegradable nanoparticles that the company says is safer than Crispr gene editing, which often relies on viruses for delivery.

This team demonstrated the technology in lab mice induced with human beta-thalassemia, an inherited blood disorder similar to sickle cell disease, in a paper published in June 2018. People with beta-thalassemia have blood with lower and unsafe levels of hemoglobin. In the paper, the researchers corrected a mutation causing the disorder in fetal mouse tissue, delivering the nanoparticles with infusions. The mice born with the gene-editing nanoparticles showed normal levels of blood hemoglobin, and no signs of off-target genetic edits.

Trucode is refining the technology into treatments for genetic disorders starting with sickle cell disease and cystic fibrosis. Like beta-thalassemia, sickle cell disease involves hemoglobin, but in this case people with sickle cell disease have hemoglobin molecules that cause blood cells to form into an atypical crescent or sickle shape. That abnormal shape causes the blood cells to break down, lose flexibility, and accumulate in tiny capillaries, leading to anemia and periodic painful episodes.

Cystic fibrosis is an inherited disease of the glands that make mucus, a substance keeping the lungs and airways moist, as well as helping prevent infection.  With cystic fibrosis, the mucus becomes thick and sticky, and builds up in the lungs and airways. The build-up of mucus can also affect the pancreas, liver, intestines, and other organs.

“The medical promise of gene editing to cure patients with genetic disease has arrived but has not realized its full transformative potential,” says Trucode founder and CEO Marshall Fordyce in a company statement. “Our technology could address key challenges faced by the industry, including editing fidelity, immune reactions, delivery, scaled manufacturing, and intellectual property.”

In Trucode’s first venture funding, the company raised $34 million, led by technology venture investors Kleiner Perkins and GV, a division of Alphabet formerly known as Google Ventures. No other investors were disclosed.

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