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Infectious Disease Biotech Raises $100M in Venture Funds

Syringe and three vials

(Arek Socha, Pixabay)

7 Apr. 2021. A biotechnology company designing vaccines for viral diseases including Covid-19 is raising $100 million in its second venture funding round. Icosavax Inc. in Seattle is a three year-old business spun-off from the Institute for Protein Design at University of Washington.

Icosavax creates vaccines to protect against infectious diseases from viruses, particularly diseases affecting respiratory functions. The company uses computational techniques to design synthetic antigen proteins from virus-like particles that to the immune system look like invading viruses, but do not cause infections on their own. Mathematical models of these viral particles are needed, says the company, to accurately capture the precise protein configuration in the vaccine’s final assembly. And Icosavax uses engineered genes to express individual protein components that assemble into the designed nanoscale viral particles.

The company’s lead product code-named IVX-121 is a vaccine against respiratory syncytial virus, or RSV, that infects lungs and breathing passages. For most people RSV causes symptoms like the common cold for one or two weeks, but for infants and older individuals, RSV can lead to more serious airway inflammation or pneumonia. Icosavax licenses the basic design for the vaccine from National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, that developed an early form of the drug. NIAID showed the precursor vaccine’s safety in an early-stage clinical trial, reported in the journal Science.

Icosavax, with colleagues from Institute for Protein Design, reformulated the early vaccine into nanoscale virus-like particles, with the new form described and tests with lab animals reported in the journal Cell. The company says its virus-like particles are the first use of this technique with RSV, where up to now were used for vaccines against less complex viruses like human papillomavirus and hepatitis B. Icosavax also designed IVX-121 to protect against human metapneumovirus, a severe respiratory disease affecting vulnerable populations including infants, older adults, and those with compromised immune systems.

SARS-CoV-2 vaccine trials expected

“Based on preclinical data,” says Icosavax CEO Adam Simpson in a company statement, “we believe our vaccine candidates could offer significant protection against leading viral causes of pneumonia in older adults where no licensed vaccines currently exist.”

In addition, the company is developing a vaccine against the SARS-CoV-2 virus code-named IVX-411 that targets the virus’s receptor binding domain, licensed from Institute for Protein Design. The vaccine adapts Icosavax’s virus-like particle technology to generate antibodies that bind to multiple sites on the virus, which may make the vaccine less susceptible to resistant mutations. The company reported preclinical results of IVX-411 with lab mice last year in the journal Cell and plans clinical trials of the vaccine later this year.

Icosavax is raising $100 million in its second venture funding round, led by life science venture investor RA Capital Management in Boston. Taking part in the round are current investors Qiming Venture Partners USA, Adams Street Partners, Sanofi Ventures, and ND Capital. Also participating are new investors Janus Henderson Investors, Perceptive Advisors, Viking Global Investors, Cormorant Asset Management, Omega Funds, and Surveyor Capital.

Included in the round is $6.5 million for development of IVX-411, from Open Philanthropy in October 2020. The Bill and Melinda Gates Foundation also awarded $10 million for the vaccine. According to CrunchBase, Icosavax raised $51 million in its first venture round in October 2019.

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Trial Shows Inhaled Covid-19 Therapy Safe

Nasal spray

(Wikimedia Commons)

6 Apr. 2021. Results of a clinical trial show an anti-microbial treatment for Covid-19 infections given as a nasal spray is safe and well-tolerated in healthy volunteers. The findings from a trial testing an inhaled version of the drug niclosamide, formulated as a nasal-spray therapy for Covid-19, appear in today’s issue of the journal The Lancet Regional Health – Europe.

Union Therapeutics A/S in Hellerup, Denmark develops treatments for inflammatory and infectious diseases, including Covid-19. Among the company’s therapy candidates is niclosamide, originally created as an anti-parasitic drug, which Union Therapeutics reformulates into an ointment for atopic dermatitis, also known as eczema, and is testing in a mid-stage clinical trial. The company points to data from a study in Korea published in June 2020, showing niclosamide as a particularly promising candidate, already approved by FDA, that acts against SARS-CoV-2 viruses responsible for Covid-19.

Union reconstitutes niclosamide as a treatment and vaccine against Covid-19 infections. The treatment candidate, code-named UNI91104, is formulated as a nasal spray, since an oral form of the drug dissipates in the blood stream before reaching the nasal passages and lungs where it can do the most good. The company says UNI91104 blocks replication of the SARS-CoV-2 virus, reduces inflammation, and helps open the airways, with results shown in preclinical tests with animals.

No more than mild adverse effects

The early-stage clinical trial, conducted by Union Therapeutics, enrolled healthy adult volunteers in Denmark. The study team tested various doses of UNI91104 nasal spray, looking primarily for any adverse effects from the drug, from one to seven days following the treatment. The paper reports on 44 participants, 34 receiving UNI91104 and 10 placebo recipients. The 34 recipients of UNI91104 were randomly assigned to receive one of four escalating doses in one day, or five doses of the drug in 2.5 days.

The results show only mild adverse effects from UNI91104 and no serious reactions to the drug. Of the volunteers, 26 reported mild and temporary upper-respiratory irritations. Tests of respiratory function given to participants show no evidence of difference between UNI91104 and placebo recipients. Blood tests of participants receiving UNI91104 show varying levels of the drug depending on dosage size, but no long-term accumulation.

Vibeke Backer, a pulmonologist at Rigshospitalet in Copenhagen, is the study’s principal investigator and first author of the paper. Backer notes in a Union Therapeutics statement that “the poor bioavailability of niclosamide is addressed, enabling a high drug concentration in the area from which the Covid-19 infection otherwise starts to spread. In this way, inhaled drugs have been crucial in the management of other respiratory conditions such as asthma.”

Union Therapeutics is also testing its formulation of niclosamide as a preventative vaccine code-named UNI91103, but for more vulnerable patients. A clinical trial of UNI91103 is testing the vaccine among patients in the U.K. with kidney disorders, considered a high-risk population that may not respond to conventional vaccinations.

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Microsoft, Biotech Partner on Metastatic Cancer

Lung cancer illustration

(NIH.gov)

6 Apr. 2021. A biotechnology start-up is collaborating with Microsoft Corp. on computational tools to find and predict factors that cause cancers to spread. Volastra Therapeutics in New York, spun-off from labs at Weill Cornell Medical Center studying molecular processes responsible for cancer, is also adding $32 million to its seed financing.

Volastra Therapeutics, which began operating last year, develops therapies seeking to block the spread of cancer from the initial tumor to other parts of the body, called metastasis. The company’s technology is based on research on unstable chromosomes that contribute to metastatic cancer. Chromosomal instability encourages errors in cell division, with fragments of chromosomes transported outside the nucleus of cells, where chromosomes usually reside. These fragments can easily break open in cells, exposing their genetic contents to cell fluids. The exposed genes then trigger a process that encourages the spread of cancer cells, while blocking the immune system from detecting the condition.

Volastra designs therapies to block this process first with informatics to identify cancers most likely to express high levels of unstable chromosomes leading to cancer spread. The company says it uses a range of computational processes, including artificial intelligence and imaging techniques, to discover therapeutic targets. Volastra says it also employs metastatic tumor organoids, lab-grown tissue from cancer cells, to test prospective therapies, which the company says returns results faster than tests with lab animals.

Develop machine-learning algorithms

The company’s technology is derived from research at Weill Cornell in New York by its scientific founders Lewis Cantley, Samuel Bakhoum, and Olivier Elemento. Bakhoum, now at Memorial Sloan Kettering Cancer Center, conducted the original studies on chromosomal instability, or CIN, while a researcher in Cantley’s cancer biology lab. Elemento’s lab studies big data analytics and mathematical models for therapies. The three researchers and colleagues outlined their techniques in a paper published in the journal Nature in Jan. 2018.

The company’s collaboration with Microsoft aims to develop artificial intelligence algorithms that identify biomarkers or molecular indicators associated with metastatic cancer. These algorithms would then be extended into predictive machine-learning tools that integrate insights from multiple data sets, pathology images, and results of tests on organoids. Financial aspects of the agreement are not disclosed.

Volastra Therapeutics is also raising another $32 million in seed funds, added to the company’s original $12 million raise in February 2020, according to CrunchBase. The company was formed by life science venture capital company Polaris Partners in Boston, with the other first seed funders Droia Ventures, ARCH Venture Partners, and Quark Venture. Vida Ventures, also in Boston, led the second stage of seed funding with new investor Catalio Capital, and Volastra’s current investors.

“In just over a year,” says Cantley in a Volastra statement, “the Volastra team has shepherded this science into the next stage of development, building technologies to identify CIN at scale and developing novel compounds to block metastasis. By leveraging these unique insights into CIN, we are one step closer to unlocking new therapeutic options for some of the toughest-to-treat solid tumors.”

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Important Factors in Building Your Online Presence

– Contributed content –

Business desk

(Pexels.com)

6 Apr. 2021. When you are trying to get your business and your brand out there, the online side of things is more important than ever. You need to make sure that you know how to actually spread the word about your business digitally, as without that you are much less likely to find the success that you have been looking for. When you are looking into this, one of the most important factors is your online presence, which just means how often, and in what way, people are seeing your business appear online.

As it happens, there are several important factors that go into a good online presence, and you need to be aware of these if you are going to have the best results. Let’s take a look at some of the most vital factors that you should be aware of, and how you can make them work for you.

Help your customers find you

An important point in all this is to make sure that you are doing everything in your power to make it easy for your customers to actually find you in the first place. Findability ensures greater visibility, so you need to think about what makes it easier to find your business. There are many things you need to think about here. You should make sure your website’s URL is simple and as close to your actual brand name as possible, for instance. It would also be worthwhile ensuring that the website is mobile-friendly, so that all kinds of web users can find it and navigate through it.

Beyond those things, you should also think about boosting the SEO of your website, so that your site is more likely to rise the ranks on the search engines’ results pages. These sorts of steps make it much more likely that people can find you easily, which will in turn do great things for your online visibility.

Look into content marketing

Of course, it’s not just about helping your existing customers find you, but also reaching out to new potential customers too. To do that, you have to extend your reach, and one of the most powerful ways to do that is to use content marketing. With good content marketing, you are going to be much more findable and visible, and people are going to be more likely to get in touch with you and find out more about your services.

Importantly, content marketing helps you to share your brand’s story in a way that people will get on board with, and that is what makes them so much more likely to want to engage with your business further. This is equally true for B2B situations, so no matter who your clients are, you should think about making use of content marketing as best as you can. You will find that it really helps to boost your online presence significantly.

Embrace the power of social

There are very few businesses these days which are not making use of social media in some way or another. There are a lot of different opinions about social media as a tool in building an online presence, but the fact is that it is something you have to be thinking about if you want to remain competitive. As long as you embrace the power of social media, your business is going to be much more likely to have the kind of digital presence you are looking for. So how do you actually make sure that you are making good use of these channels for the sake of your business?

One vital step is simply to approach social media marketing with the help of a professional marketing team. There are many teams out there who can help you to promote your business on Twitter, Facebook and the rest in very powerful ways, and you would do well to entrust the position to them. You should also think about your brand’s voice and how you are going to make that fit in with the social side of things. This, as it turns out, will drive a lot of engagement, which in turn means that you are going to have many more people on your website and converting into sales.

Update your website frequently

There are a lot of good reasons to make sure that you are updating your website on a regular basis. For one, it means that the search engines are going to re-crawl through your site more often, which makes it more likely that you will crop up on the first page of Google, and that obviously helps in a big way. You will also be providing genuinely useful information to your visitors, which means they are more likely to manually return to the site as well. The best way to do this is to have a blog that you update regularly, using a professional writer if necessary to ensure the best possible quality.

Use email marketing

There are many marketing techniques that you might want to think about using, but email marketing is one that proves to be very powerful as a means of staying visible online. With email marketing, all you need to do is send out a newsletter once a fortnight or even just once a month, and yet this is going to mean that your brand remains at the forefront of people’s minds that much more easily. This is not something you want to overlook.

Pay attention to offline

As well as doing all those online things, you will want to pay attention to what you are doing offline too, as the actions you take in the offline world are also going to affect how visible you are on the web. So, make a point of advertising in all the traditional ways, as well as simply spreading the word through word of mouth. All of that will draw back to your online presence, and you’ll be amazed at what a difference it can really make to your digital marketing.

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Graphene Crispr Chip Detects Small Genetic Differences

DNA chip graphic

(Gerd Altmann, Pixabay)

5 Apr. 2021. An academic-industry team designed a computer chip with graphene circuits using the gene-editing technique Crispr to detect fine genetic differences in samples. Researchers from Keck Graduate Institute in Claremont, California and biotechnology company Cardea Bio in San Diego describe their device in today’s issue of the journal Nature Biomedical Engineering.

The researchers, with associates from Vilnius University in Lithuania and other institutions, are seeking a technology to simplify genomic analysis from today’s systems that often require large-scale and expensive optical lab equipment and amplified DNA to conduct high-throughput sequencing. While results from these analytical engines are considered accurate and reliable, their scale and expense limit their use to sophisticated labs, when the need for genetic analysis can be at the point of care or at remote field locations.

The lab led by Keck biomedical engineering professor Kiana Aran studies bio-microelectromechanical systems for research and clinical use, including graphene-based devices, to help solve this problem. Among the lab’s work is a transistor built on graphene that applies the gene-editing technique Crispr to detect genomic sequences of target materials.

Graphene is a material with many desirable qualities for a range of industries. The material is very light, strong, chemically stable, and only one atom in thickness, arrayed in a hexagonal pattern. Graphene can conduct both heat and electricity, with many applications in electronics, energy, and health care.

SNP-Chip detects healthy from disease sequences

Aran is also co-founder and chief scientist of Cardea Bio that builds graphene semiconductors designed to detect biological signals for applications that combine molecular biology with advanced electronics, software, and artificial intelligence. As reported in Science & Enterprise last month, Cardea Bio is developing a graphene sensor for Department of Defense to quickly detect SARS-CoV-2 viruses in indoor air.

In their paper, Aran and colleagues demonstrate a graphene chip with Crispr circuits using Cas9 enzymes designed to detect genomic sequences with a high degree of precision, down to single nucleotides, basic building blocks in the genome. These granular differences, called single nucleotide polymorphisms, or SNPs (pronounced snips), occur throughout the human genome, about once in every 1,000 nucleotides. And because of their precision, SNPs can serve as important biomarkers for detecting or treating genetic diseases.

The researchers demonstrated their Crispr-Cas9 chip, called SNP-Chip, with DNA samples from individuals with and without specific diseases: sickle cell disease and amyotrophic lateral sclerosis or ALS. Donors of the samples have similar genetic characteristics, except for the key SNP mutations associated with these diseases. The team reports the SNP-Chip accurately detects the disease-associated sequences in the donated samples, and without a need for amplifying the DNA, further simplifying the process.

“The ability to detect SNPs on a chip does not just get to the core of human health genetics,” says Aran in a Cardea Bio statement released through BusinessWire, “it also gives us valuable and actionable insight into areas like agriculture, industrial bioprocesses, and even evolutionary change, such as mutations conferring resistance to antibiotics or mutating viruses.” Aran adds, “By eliminating the need for amplification and large optical instruments, SNP-Chip will make SNP genotyping for these purposes readily accessible.”

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Hearing Tech Company Raises New Venture Funds

Smart Ear device and app

Smart Ear device and app (Olive Union)

5 Apr. 2021. A company creating devices that help people with hearing impairments, but without the stigma or cost of hearing aids, is raising $7 million in new venture funds. Olive Union, based in Tokyo, offers devices that amplify sounds for people with hearing loss, but are sold over-the-counter without a prescription, thus at a considerably lower cost than conventional hearing aids.

Olive Union is a five year-old enterprise seeking to address the growing global occurrence of hearing loss. Much of the spread in hearing loss is due an aging population, but the problem is exacerbated by long-term or repeated exposure to loud noises, in some cases self-inflicted. World Health Organization estimates 430 million people worldwide require assistance with disabling hearing loss, with that number expected to grow to 700 million by 2050.

In addition, says the organization, 1 billion young adults are at risk of permanent hearing loss, an avoidable condition, due to unsafe listening practices. “Collective exposure to prolonged and nearby loud noises has put us in the middle of an unprecedented decline in global hearing health,” says Owen Song, Olive Union’s founder and CEO in a company statement released through BusinessWire.

Song says he started Olive Union to fill the need for a simpler, yet more advanced technology to address varying degrees of hearing loss. Conventional hearing aids, says the company, are made for advanced-stage hearing loss and require a prescription, thus are often expensive for either the person needing the device or health insurance payer. As a result, many people with hearing loss are deterred from wearing a hearing aid because of the cost, but also the stigma of old age or disability.

Amplifier for mild to moderate hearing loss

As CrunchBase News notes as well, Olive Union benefits from a 2017 law in the U.S. allowing for over-the-counter products to address early-stage hearing loss. So far, however, the Food and Drug Administration has not written regulations for authorizing marketing of over-the-counter hearing aids in the U.S.

The company’s lead product is a personal sound amplifier called Smart Ear for people with mild to moderate hearing loss. Smart Ear is worn and looks like an ear bud. The rechargeable device is controlled by a smartphone app that connects to the device via Bluetooth and can be set up in about five minutes. That same Bluetooth connection is used to channel voice telephone calls or music from the phone to the Smart Ear.

Olive Union is also developing a combination hearing aid and Bluetooth smartphone ear bud called Olive Pro that the company expects to ship in July. In two IndieGoGo campaigns this year, Olive Union raised some $2.7 million for the Olive Pro. In addition, the company plans to develop digital therapeutic devices for tinnitus and hearing health in general.

Olive Union is raising $7 million in its second venture funding round led by Beyond Next Ventures, Bonds Investment Groups, and Japan Policy Finance Corporation. According to CrunchBase, the company raised $10 million in its first venture round in Mar. 2019, and some $141,000 in seed funding in Jan. 2018.

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Infographic – Biotech Index Dips in Q1

Chart: NBI, Q1 2021

Click on image for full size view (Nasdaq)

3 Apr. 2021. We follow the Nasdaq Biotechnology Index at Science & Enterprise as an indicator of investor sentiment in companies based on life science research. For the first three months of 2021, the NBI continued its climb from last year through the first week of February, but then headed south and ended up about where it began for the year.

The NBI is an index of 277 companies in biotechnology, life sciences, and pharmaceuticals listed on the Nasdaq exchange. Throughout 2020, the index climbed steadily, despite or maybe because of the pandemic. In 2021, NBI opened on 4 Jan. at 4,759.14 and continued climbing to 8 Feb., when it closed at 5,427.13. At that point, the index declined over the next month until 4 Mar. when it closed at 4,624.27.

The NBI rallied somewhat after 8 Mar., rising to barely over 5,000 that day, then declining again and fluctuating to a close of 4,764.34 on 2 Apr. For 2021 to date, NBI managed to return to about where it started, with a gain of only 0.11 points. For comparison, the Nasdaq Composite Index, reflecting the broader technology industry, experienced similar fluctuations, but rose by 6.2 percent so far this year.

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Robot Designed to Find, Retrieve Hidden Objects

Warehouse

(Rob Pongsajapan, Flickr, https://www.flickr.com/photos/pong/2390885810/)

2 Apr. 2021. An engineering lab studying wireless technologies developed a robotic arm using radio waves to find and grab objects blocked from direct view. A team from the Signal Kinetics research group at Massachusetts Institute of Technology describe the system in a paper to be delivered next month at the IEEE International Conference on Robotics and Automation.

Robotic technology is advancing rapidly in manufacturing and distribution, particularly for picking and packing items stored in warehouses. Up to now, however, robots designed for selecting items in warehouses relied on components with a direct view of an object or bar code. In real-world settings, objects are jumbled, obscured, or stored in packaging materials that block some or all of the visual target.

Researchers led by Tara Boroushaki, a researcher in the Signal Kinetics group, designed a system called RF-Grasp, that uses radio frequency, or RF waves, along with computer vision to overcome these limits. RF-Grasp relies on RF tags, simple and inexpensive circuits that emit RF signals, used for years to deter shoplifting in retail stores but also to track items in warehouses. RF-Grasp has an RF signal reader that captures and relays the signals to the system controller.

RF-eye-hand coordination

Mounted next to the grasper hand in the robotic arm is a camera that captures video images of the arm’s surroundings. Those images are combined with the RF signals, which together are processed by a deep-learning algorithm that provides policies and directions to the system for locating the target object. But those directions go a step further: they also tell RF-Grasp how to uncover or declutter the item’s storage location to safely grab the object and put it in a selection box. As RF-Grasp gets more experience, the machine-learning algorithm gains more sophistication and nuance to navigate future tasks.

The algorithm decides which sensing mode to use — RF signals or camera — and directs the robotic arm to the object, switching back and forth between the two modes as needed. “The robot has to decide, at each point in time, which of these streams is more important to think about,” says Boroushaki in an MIT statement. “It’s not just eye-hand coordination, it’s RF-eye-hand coordination. So, the problem gets very complicated.”

In their paper, Boroushaki and colleagues report on a demonstration of RF-Grasp. A video of the demonstration shows the robotic arm sifting through open boxes cluttered with packing paper initially obscuring the target objects, removing the packing paper, then dropping the selected items in a separate box. The paper also reports on finding items hidden behind barriers. The researchers report RF-Grasp improved completion rates and efficiency by 40 to 50 percent over baseline measurements.

Fadel Adib, director of the Signal Kinetics group believes RF-Grasp could have applications in the home as well as in business. “Or you could imagine the robot finding lost items,” notes Adib. “It’s like a super-Roomba that goes and retrieves my keys, wherever the heck I put them.”

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Mobile App to Track Fat, Sugar Consumption

Sugar cubes

(Mae Mu, Unsplash. https://unsplash.com/photos/VoQ4kqDSFxg)

1 Apr. 2021. A mobile app is being created that allows users to record their eating of saturated fat and added sugar in near real time to better gauge health effects. A team at University of Arizona in Tucson is developing the app, funded by a five-year $3.3 million grant from National Cancer Institute, part of National Institutes of Health.

Researchers from University of Arizona’s medical school are seeking better research tools to more accurately measure individuals’ intake of food, particularly food associated with unhealthy outcomes. The team led by Arizona family and community health professor Susan Schembre includes researchers from other universities and the nutrition assessment technology company Viocare Inc. in Kingston, New Jersey that designs nutrition measurement systems for research.

Better assessments are needed, says the study team, since excessive intake of added sugar and saturated fat is a leading cause of premature mortality among adults in the U.S., contributing to some 700,000 deaths per year. In addition, the 2020 Dietary Guidelines for Americans, published by the U.S. Departments of Agriculture and Health and Human Services, recommend limiting these foods to less than 10 percent of total energy intake to prevent disease.

The use of mobile apps for tracking food intake is not new, but according to the researchers, they do not provide precise, reliable, or timely measurements needed by researchers. Most of today’s food surveys, says the project team, use food frequency questionnaires or require respondents to remember exactly what they ate in the previous 24 hours.

Mobile technology makes possible real time assessments

“The problem is these methods are time-intensive and cognitively taxing for study participants and costly for researchers,” says Schembre in a university statement. “They are also highly prone to recall bias and misreporting related, in part, to the reliance on a person’s memory over long recall intervals and errors in portion-size estimation.”

The researchers are adapting a behavior assessment method called ecological momentary assessment or EMA, that aims to record behaviors and experiences in real time, or close to it. “Leveraging EMA to develop a new method of dietary assessment,” notes Schembre, “is of great significance to the field of human nutrition and will advance our understanding of eating behaviors as they naturally occur.”

Mobile technology makes EMA for tracking food intake more feasible. The researchers are designing the app to prompt users multiple times a day to report their eating of various foods by choosing items from lists. Those lists will include foods and beverages high in saturated fats and added sugar that contribute 70 percent or more of these substances to the American diet. The app will also provide images to help determine portion sizes.

Moreover, the team is designing the app as a tool for measuring dietary behavior in general, not just fats and sugar. The researchers expect the technology can be extended to provide real-time dietary guidance to users, and capture the context of an individual’s food consumption, such as social or environmental factors, to help guide appropriate advice.

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Univ. Lab Develops, Licenses Sports Injury Implant

Pitcher Matt Grace

Former Washington Nationals pitcher Matt Grace in a July 2019 game (A. Kotok)

1 Apr. 2021. A medical device company now offers a synthetic tissue implant for torn rotator cuff, a common sports injury, designed at a Purdue University engineering lab. Sparta Biopharma Inc. in Madison, New Jersey, licenses the technology behind the implant, based on research in Purdue’s Human Injury Research and Regenerative Technologies or HIRTT lab led by mechanical engineering professor Eric Nauman.

The rotator cuff is a set of muscles and tendons surrounding the shoulder joint that keeps the upper arm bone firmly in the shoulder joint socket. Injuries to the rotator cuff are common, particularly among older individuals and athletes in sports that put stress on arms and shoulders. A study by Nauman and colleagues published in 2013 cites data showing some 17 million Americans live with some kind of rotator cuff tendon tear, leading to more than 1 million surgical procedures per year to repair those injuries.

For high-performance athletes, a rotator cuff tear often means surgery, followed by a lengthy recovery and rehab period with no guarantee the joint will perform as well as before. A review of studies in 2016 investigating rotator cuff tears and the ability of athletes to return to their sports after surgery shows only half (50%) of professional and competitive athletes say they play as well after surgery as before. Baseball players are the athletes most treated for rotator cuff tears.

Nauman’s HIRTT lab studies new treatment methods for orthopedic injuries, such as sports injuries and gunshot wounds, as well as spinal cord and brain trauma, among others. Research by Nauman and then doctoral candidate Darryl Dickerson designed an implant to assist the enthesis, a key piece of connective tissue that joins rotator cuff tendons to the shoulder socket bone.

Heals and integrates with original tissue

“The enthesis is an important part of the skeleton,” says Nauman in a university statement, “because it makes it possible to transmit the enormous forces generated by the muscles during daily activities. Every muscle in a person’s body attaches from tendon to bone through an enthesis.”

The synthetic enthesis, about the size of a strip of gum, is made of mainly soft porous bone tissue with a thin layer of mineralized bone that attaches to the socket. The porous tissue in the enthesis implant acts as a matrix that encourages regeneration of torn tendons, with the mineralized bone layer simulating the natural bone-tendon connection. In their 2013 proof-of-concept study, Dickerson and Nauman successfully implanted the device in sheep that healed rotator cuff tears and integrated with the animals’ natural tissue. Purdue University filed patents on the technology, with Nauman and Dickerson listed as inventors.

Sparta Biopharma began collaborating with Purdue in 2018 to further develop the enthesis implant, which led to its first surgical use earlier this year. The device known as BioEnthesis encourages healing of tendons and bone, says Sparta, and integrates regenerated with original tissue, particularly where hard and soft tissue meet, which before had not been fully implemented. Rush University Medical Center in Chicago performed the first surgeries with the BioEnthesis in February 2021, and the company announced its commercial availability last month.

The inventors believe the technology can be used elsewhere in the body. Dickerson, now an engineering professor at Florida International University notes, “The success of BioEnthesis for this very challenging orthopedic repair offers insight that will enable future clinical breakthroughs.”

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