Science & Enterprise subscription

Please share Science & Enterprise

Follow by Email
Visit Us


How Going Green Could Help Your Business

– Contributed content –

4 January 2018. We’ve established that, yes, your business needs to care about the environment because the environment is in a state where it simply needs to be cared for. But, going green in this fashion within your business will not only help the environment but it will stand to help your business, too. To see just how going green could help your business, make sure to carry on reading.

Green business graphic

(Public Domain Pictures, Pixabay)

Cutting down on harmful emissions could equate to a cut down in expenditure

As a business owner, you will probably attest to the fact that it is expensive to run a business. To some extent, this will always be the case, no matter how many budget cuts you make. But, making budget cuts and cutting down on expenditure is the only way you are going to ease any money troubles you may have, even if only a little. And, going green, specifically cutting down on harmful emissions, is a great way to cut expenditure in this fashion. Yes, by opting for far greener forms of energy souring, such as having commercial solar panels fitted to your business’s work premises roof in order to source your office electricity, you will stand to save a whopping 50% on your next electricity bill and, whilst you do that, you will be cutting down on using harmful emissions and using up all the earth’s remaining fossil fuels. So, both the earth and your electricity bill will win.

An eco-friendly mantra will attract customers

Being socially conscious and eco-friendly is a big draw in today’s world, and this means that if you make it your mantra to be green you will attract a lot of customers. And, attracting a lot of customers is only ever a good thing, right?

When it comes to making your green venture your business mantra, you are going to have to be obvious about it without being too ‘in your face’ about it all. To achieve this, simply have the aforementioned commercial solar panels fitted to your premises roof, leave them there for passers by to see and watch them draw in the customers. Or, show your business to be working towards the abolition of pollution by opting for air pollution solutions that are clean and beneficial to the environment. Or, work alongside other businesses in your local area on green initiatives and go out of your way to, say, plant an abundance of trees in a local park; just make sure you document the tree planting event and plaster it on your business website and social media pages!

Going green will improve your sustainability

Going green is the single best way to go sustainable, and when your business is self-sustainable in this manner you will not have to worry that it will get left behind as the world progresses in the future. Yes, when you make your business sustainable you give it the best chance possible of survival in the future regardless of what state the earth is in and whether or not its natural resources do in fact run out, because you will have your own resources to keep your business ticking over.

Going green within your business is not just going to help the environment, it is going to help your business. So, go out there and go green!

*     *     *

Sangamo, Pfizer Partner on ALS Gene Therapy

Brain synapses illustration

(AllanAjifo, Wikimedia Commons)

3 January 2018. Drug maker Pfizer Inc. is licensing and collaborating on a gene therapy technology from Sangamo Therapeutics Inc. to treat amyotrophic lateral sclerosis, or ALS, and a related neurodegenerative disease.  The deal with Pfizer could bring the Richmond, California-based Sangamo Therapeutics as much as $162 million if all phases of the agreement are fulfilled.

ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disorder where neurons or nerve cells controlling muscles in the body begin to waste away, and can no longer send or receive signals from the brain or spinal cord. As the nerve cells stop functioning, the muscles in the limbs, and later speech and breathing muscles, begin weakening and eventually stop functioning. Most people with the disease die of respiratory failure. There are currently no cures for ALS, nor effective treatments for slowing progression of the disease.

The companies are also investigating applying Sangamo’s gene therapy to frontotemporal degeneration, or FTD, a progressive neurodegenerative disease affecting the frontal and temporal lobes of the brain. FTD is marked by a gradual decline in behavior or language, similar to dementia, but usually not affecting memory. People with FTD often find it difficult to plan or organize activities, engage in social interactions, behave appropriately in professional situations, or care for oneself. Like ALS, there are no effective treatments for this disorder.

Sangamo develops therapies targeting specific genes for editing, silencing, or regulation using a process known as zinc-finger nucleases, where synthetic enzymes modify DNA sequences, including corrections or insertions. These enzymes, with a hydrocarbon and zinc chemistry, branch out in finger-like protrusions that bind with DNA molecules. Sangamo says it engineers the proteins to predictably and consistently bind with longer DNA sequences.

In this case, the companies are investigating Sangamo’s zinc finger transcription factors, engineered proteins designed to suppress mutations in the C9ORF72 gene. The C9ORF72 gene produces proteins found in motor neurons, as well as the brain and spinal cord, associated with sending and receiving signals from other nerve cells. Mutations in this gene are linked to ALS, particularly accumulations of proteins that impair normal cell functions and promote the death of nerve cells.

Sangamo says its zinc finger transcription factors bind to precise sequences of DNA, in this case, mutations of the C9ORF72 gene. The engineered proteins then suppress expression of that mutation. The companies plan to address a particular challenge in this strategy, namely differentiating between healthy and mutated forms of the gene, so only the mutation is suppressed.

Under the agreement, Sangamo is responsible for development of zinc finger transcription factor treatment-candidates for ALS and FTD. Pfizer will then conduct further research, development, manufacturing, and commercialization to take the candidates to market. Sangamo is receiving an initial payment of $12 million from Pfizer, and will be eligible for up to $150 million in subsequent payments tied to development and commercialization milestones, as well as royalties on sales of products from the collaboration.

This is not the first partnership between Sangamo and Pfizer. In May 2017, the companies began a collaboration on gene therapies to treat hemophilia A.

More from Science & Enterprise:

Disclosure: The author owns shares in Pfizer.

*     *     *

RNA Therapies Start-Up Raises $55.3M in Early Funds

RNA molecule illustration

RNA molecule illustration (Nicolle Rager Fuller, National Science Foundation)

3 January 2018. A start-up company creating treatments for inherited diseases that target faulty RNA transcribed from genetic codes is raising $55.3 million in its first venture funding round. Expansion Therapeutics Inc. in San Diego is a spin-off enterprise from the lab of Scripps Research Institute chemistry professor Matthew Disney, scientific founder of the company.

Expansion Therapeutics discovers and develops small molecule, or low molecular weight, drugs to treat diseases caused by ribonucleic acid, or RNA molecules that either result from mutations, or incorrectly transcribe DNA genetic codes into protein instructions for cells. Recent research on RNA, says the company, shows the molecules form structures and patterns that provide targets for therapies, which the company plans to exploit. The first of these disease targets are expansion repeat disorders, where repeated short sequences known as microsatellites expand beyond a safe length, stopping genes from functioning or causing aberrant proteins to be produced.

The company says at least 30 disease conditions can be traced to  expansion repeat disorders. The first of these disorders addressed by Expansion Therapeutics is type 1 mytotonic dystrophy, caused by defects in the DMPK gene. Another, less severe form of the disease, known as type 2, results from defects in a different (CNBP) gene. Symptoms of type 1 mytotonic dystrophy include myotonia — inability of contracting muscles to relax — progressive muscle weakness, and malfunctioning central nervous, cardiac, and endocrine systems. Myotonic Dystrophy Foundation says the condition affects about 1 in 8,000 people worldwide, including some 40,000 individuals in the U.S.

Disney’s lab at the Scripps Research Institute facility in Jupiter, Florida studies RNA molecular structures and behavior, discovering targets and potential therapies. Expansion Therapeutics licenses technologies from Scripps for identifying and developing small molecule drugs that bind to these expansion repeat disorder targets, beginning with type 1 mytotonic dystrophy. The company says it is also identifying treatments for type 2 mytotonic dystrophy and two other undisclosed diseases.

“It is clear,” says Disney in a company statement, “that disease-related RNA is now an addressable target with small molecule medicines and we are now on the verge of developing treatments for patients with the most urgent medical needs. We will work tirelessly to fulfill this promise.”

In its first round of venture finance, Expansion Therapeutics is raising $55.3 million led by investment companies 5AM Ventures and Kleiner Perkins, as well as the venture capital arms of pharmaceutical companies Novartis and Sanofi.  RA Capital Management and Alexandria Venture Investments are also taking part.

5AM Ventures, an investor in early-stage life science enterprises in Boston and San Francisco, is a founder of Expansion Therapeutics, which also incubated the company at its 4:59 Initiative. Both 5AM Ventures and Sanofi Ventures provided seed funding for the company.

More from Science & Enterprise:

*     *     *

NIH Grant Funds Synthetic Peptide for Severe Asthma

Girl with inhaler

(Longevity Biotech)

2 January 2018. A synthetic peptide, a short chain of amino acids, is being developed as a treatment for severe cases of asthma that do not respond to conventional drugs. The $225,000 funding for the peptide to Longevity Biotech in Philadelphia is provided by a Small Business Innovation Research grant from National Heart, Lung, and Blood Institute, part of National Institutes of Health.

Longevity Biotech is a developer of synthetic peptides it calls Hybritides that provide a framework for its therapies. These peptides are based on research by Samuel Gellman, an organic and biological chemist at University of Wisconsin in Madison and company co-founder. Longevity’s technology platform enables the design of synthetic peptides with enough stability and absorption for formulation into oral drugs, for which the company is developing into treatments for neuroinflammation and diabetes.

For an asthma treatment, the company is extending its technology into an inhaled form. Asthma is chronic condition, where the airways become inflamed and narrow, causing wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Among asthma’s underlying causes are infections, pollutants in the air, and allergies to pollen, molds, or dust mites that trigger airway inflammation. Centers for Disease Control and Prevention estimates that in 2010 some 18.7 million adults had asthma, along with 7 million children.

In this case, the Longevity peptide is addressing severe cases of asthma that result from a special type of immune reaction encouraging inflammation in the airways that does not respond to conventional anti-inflammatory drugs, such as steroids. The new peptide will be designed to act like the natural peptide 5A apolipoprotein A-I, or 5A apo A-I, that encourages release of a high-density form of lipoprotein similar to cholesterol that controls immune reactions, like inflammation. Tests with lab mice induced with asthma show synthetic 5A apo A-I peptides reduce inflammation in the airways, and can also protect against airway inflammation.

The project calls for Longevity to develop an inhaled form of 5A apo A-I peptide and test the peptide in lab mice, with the goal of submitting the therapy for FDA review to conduct clinical trials. Those trials are expected to be conducted by NIH staff and Longevity Biotech. The project also requires Longevity to create a manufacturing process for the peptide.

Pavan Puligujja, the lead scientist for Longevity Biotech on the project says in a company statement the peptide “represents a new strategy to target fundamental pathways involved in the allergic response associated with the development of asthma. Specifically, by modulating the recruitment of specific inflammatory cells to the pulmonary system, the 5A peptide could provide dramatic improvement in clinical outcomes for severe asthmatics.”

The Small Business Innovation Research and Small Business Technology Transfer programs set aside research funds for smaller U.S. companies to stimulate technological innovations and encourage their commercialization. In the 2017 fiscal year, NIH distributed some $980 million to health care and life science enterprises through these programs.

More from Science & Enterprise:

*     *     *

Techniques Devised to Speed-Up Plant Breeding

Speed breeding

LEDs illuminate speed breeding greenhouse (University of Queensland)

2 January 2018. Plant scientists in Australia and the U.K. developed a process that sharply cuts the amount of time needed to produce new breeds of plant crops including commercial varieties of wheat. A team from University of Queensland in Brisbane, Australia and John Innes Centre in Norwich, U.K. describes its techniques in yesterday’s issue of the journal Nature Plants (paid subscription required).

The researchers led by plant geneticists Lee Hickey at Queensland and Brande Wulff at the John Innes Centre are seeking ways to speed up the development of new crop varieties to meet critical needs imposed by a rapidly growing population and a changing climate. Current breeding techniques can return 2 or 3 generations of crops like wheat and chickpeas in per year greenhouses, or 1 generation in the field. Demands of population and climate change on food security, say the authors, require a faster turnover of plant generations.

The techniques Hickey, Wulff, and colleagues call speed breeding are designed for greenhouses, where the growing environment is completely enclosed, and conditions can be monitored and controlled. The researchers adapted methods tested in space by NASA to find food sources for deep-space travelers, including the use of light-emitting diodes or LEDs to provide a constant source of light. Most current techniques for constant illumination use sodium vapor lamps, like those in street lights, which the authors say give off lower-quality light and generate too much heat.

The team combined constant LED lighting with the introduction of new genes to produce sets of desired traits for not only growing the plants faster, but also decreasing the turnaround time for new plant generations, from seed planting to seed harvest. The results, say the authors, are up to 6 generations per year of spring wheat, durum wheat, barley, peas, and chickpeas, as well as 4 generations of canola plants, instead of 2-3 generations per year. The paper also documents cost savings from the use of LEDs.

In addition to growing test plants faster than under normal methods, speed breeding also produces higher-quality crops, contrary to warnings that speed breeding would return plants lower in quality. “People said you may be able to cycle plants fast,” says Wulff in a John Innes Centre statement, “but they will look tiny and insignificant, and only set a few seed. In fact, the new technology creates plants that look better and are healthier than those using standard conditions.”

While the team initially designed speed breeding for research labs, commercial seed companies are taking notice. Working with colleagues from Dow AgroSciences in Australia, the Queensland team applied speed breeding to develop the DS Faraday variety of wheat, which the company plans to release later this year. “DS Faraday is a high protein, milling wheat with tolerance to pre-harvest sprouting,” says Hickey in a Queensland statement. “We introduced genes for grain dormancy so it can better handle wet weather at harvest time, which has been a problem wheat scientists in Australia have been trying to solve for 40 years.”

John Innes Centre says the company RAGT Seeds Ltd in the U.K. is also working with Wulff’s lab to develop speed breeding in a commercial setting. In the following video, Hickey tells more about the technique.

From The University of Queensland on Vimeo.

More from Science & Enterprise:

*     *     *

Happy 2018 — Here Are Our Most Read Articles in 2017


(Andrew Martin, Pixabay)

1 January 2018. Happy new year to our visitors. We want to thank the nearly 20,000 individuals who read Science & Enterprise since we started tracking the numbers through Google Analytics in April. Here are the most visited of our 539 posts in 2017, excluding the nearly 5,000 people who looked at the site’s home page. We look forward to continue reporting on more exciting stories about science for business people and enterprise for scientists in the year ahead.

11 April 2017. A joint venture between Food and Drug Administration and a developer of chip devices simulating human organs, is evaluating the chips as a way to test new drugs for toxic effects. FDA and Emulate Inc. in Boston, Massachusetts, a spin-off enterprise from the Wyss Institute for Biologically Inspired Engineering at Harvard University, will assess the ability of organs-on-chips to fulfill regulatory needs for testing drugs, as well as food, dietary supplements, and cosmetics.

10 August 2017. Researchers in the U.S., Denmark, and China devised a process with genome editing to remove viruses that prevent organs from pigs from being used for human transplants. The process is described by a team from the start-up company eGenesis Inc. in Cambridge, Massachusetts, with colleagues from Harvard University, Aarhus University in Denmark, and several institutions in China, in today’s issue of the journal Science (paid subscription required).

29 August 2017. A team of undergraduate students won first prize in a National Institutes of Health biomedical engineering contest for a headset device to diagnose early-stage Alzheimer’s disease. The engineering students at University of Maryland in College Park, who received notice of the award on Friday, are also starting a company to take their invention to market.

20 September 2017. A company developing treatments for disease by restoring the natural balance of bacteria on the skin received a patent for its acne therapy using spray-on live bacteria. The U.S. Patent and Trademark Office awarded patent number 9,738,870 on 22 August to AOBiome LLC in Cambridge, Massachusetts. The three inventors on the patent include the two company founders, David Whitlock and Spiros Jamas, and chief medical officer Larry Weiss.

30 June 2017. The U.S. Food and Drug Administration approved use of vagus nerve stimulation to treat epilepsy in children who do not respond to drug therapy as young as 4 years old. The company LivaNova PLC in London, U.K. that makes the VNS Therapy system says FDA previously set the minimum age for its vagus nerve treatments for epilepsy at 12 years.

14 August 2017. The European Patent Office announced its intent to award a patent on treatments for nerve cell damage based on the peptide thymosin beta 4. The patent will be awarded to Michael Chopp, a neuroscience researcher at Henry Ford Health System in Detroit, which licensed his discoveries to the company RegeneRx Biopharmaceuticals Inc. in Rockville, Maryland.

*     *     *

Trial Testing Biomarkers as Brain Injury Diagnostics

Brain map illustration

(Arthur Toga, UCLA/

29 December 2017. A clinical trial is underway in Finland testing the ability to detect traumatic brain injuries with simple blood, urine, and saliva tests. The company Medicortex Finland Oy in Turku said yesterday the intermediate-stage trial enrolled its first patient.

Medicortex Finland is developing a technology to diagnose concussions and other mild traumatic brain injuries, where in many cases people with these injuries do not exhibit symptoms. Quick detection of concussions can prevent those injured, such as athletes in contact sports or victims in auto accidents, from aggravating their injuries, leading to debilitating neurological disorders, such as Parkinson’s disease, epilepsy, or chronic traumatic encephalopathy.

In a paper in the journal eNeuro published late in 2016, Medicortex’s founder and CEO Adrian Harel and colleagues outlined the case for for chemical detection of traumatic brain injuries, instead of evaluation of symptoms or imaging, which can produce ambiguous results. The authors identified 12 biomarkers of traumatic brain injury, most of which are elevated for a short time following the injury’s occurrence.

The clinical trial is recruiting 160 participants at a hospital in Turku. In the first part of the study, up to 60 individuals will be recruited with a suspected head injury, a bone fracture other than the skull, and healthy volunteers with no history of head trauma. People with suspected head injuries will be asked to give up to 5 blood, urine, and saliva samples over a 1-year period, while people with bone fractures and healthy participants, will be asked for  a single round of blood, urine, and saliva samples for comparison.

In the study’s second phase, up to 100 more people with concussions or traumatic brain injuries will be enrolled, also taking blood, urine, and saliva samples and tracked for a year. All samples will be analyzed with the Medicortex test kit and high-performance liquid chromatography to identify the characteristic biomarkers of traumatic brain injury.

Medicortex completed in May 2017 an earlier clinical trial to prove the concept of traumatic brain injury biomarker detection. That study recruited 12 participants with suspected head injuries, who provided fluid samples that showed the presence of characteristic biomarkers, while volunteers without head injuries did not. Based on those results, Medicortex developed its ProbTBI test kit, which is being evaluated in the new trial.

Mårten Kvist, Medicortex’s medical director, says in a company statement, “Medicortex plans to quickly advance its second clinical trial to confirm the promising findings of its previous proof-of-concept study. Such a diagnostic tool is truly awaited and it will considerably improve the possibilities to detect a traumatic brain injury in patients who are suffering from symptoms caused by a hit to the head.”

More from Science & Enterprise:

*     *     *

Microneedle Patch Delivers Anti-Obesity Drugs

Cheng Peng and Xu Chenjie

Chen Peng, left, and Xu Chenjie with a set of microneedle patches (Nanyang Technological University, Singapore)

29 December 2017. A skin patch containing hundreds of tiny porous needles is shown in lab mice to deliver drugs that turn ordinary body fat into calorie-burning brown fat to reduce body mass. Researchers at Nanyang Technological University in Singapore describe the patch in a recent issue of the journal Small Methods (paid subscription required).

A team led by biomedical engineering professors Chen Peng and Xu Chenjie is seeking simple, safe, and effective methods to help reduce the epidemic of obesity. Overweight and obesity are worldwide problems, with World Health Organization estimating in 2016 that 1.9 billion people are overweight, with 650 million of those considered obese. And while obesity is preventable, the number of people with the condition tripled since 1975, according to WHO.

Chen and Xu focus on methods for delivering drugs that increase the amount of brown fat in the body. Babies are born with brown fat cells that keep their bodies warm by burning energy. Brown fat cells are rich in mitochondria, the energy producers in cells, that help burn calories to release heat. But brown fat cells disappear over time, replaced by white fat cells that store calories, which in excess lead to overweight and obesity.

The NTU team identified two drug types known to oxidize fat or help control metabolic and digestive functions. One drug type is beta3 adrenergic receptor agonists that in tests with lab mice, and in some cases humans, increase fat oxidation and energy expenditure, showing promise to help control weight. Another drug is the hormone T3 triiodothyronine, produced by the thyroid gland to help control a number of functions, including metabolism and digestion.

Both drugs are approved by FDA respectively for overactive bladder and underactive thyroid, but are also shown to convert white fat into brown fat. For these drugs, however, control of dosing, adverse side effects, and extending effectiveness over time are challenges.

To meet these issues, Chen, Xu, and colleagues devised a skin patch made with biocompatible polymers, containing hundreds of tiny porous needles, each thinner than a human hair, and loaded with one of the two drugs. The needles penetrate the outer layers of skin, enough to release the drug-laden needles, but not causing discomfort to the recipient. The patch is applied for 2 minutes, causing the needles to detach, degrade, and release their payloads.

A key feature of the patch is the ability to deliver drugs to precise locations in the body, thus reducing the amount of the compounds administered. “The amount of drugs we used in the patch,” says Xu in a university statement, “is much less than those used in oral medication or an injected dose. This lowers the drug ingredient costs while our slow-release design minimizes its side effects.”

The researchers tested the patch in lab mice induced with obesity by a high-fat diet. The team reports the mice began converting white fat into brown in about 5 days. After 4 weeks, mice receiving the drug patches lost about 30 percent of their body fat, as well as showing lower levels of blood cholesterol and fatty acids than untreated mice.

“What we aim to develop,” notes Chen “is a painless patch that everyone could use easily, is unobtrusive and yet affordable.” The researchers estimate the cost to produce the patches is equivalent to $US 3.50. The university also reports the authors recently received expressions of interest from biotechnology companies, and are seeking to partner with clinical scientists to test the patch with humans.

More from Science & Enterprise:

*     *     *

Audio-Brain Stimulation Shown to Reduce PTSD Symptoms

U.S. Army in Iraq

U.S. Army artillery supporting Iraqi advance on Islamic State positions, September 2016 (

28 December 2017. A clinical trial shows a non-invasive technique that translates and feeds back brain waves as audio tones reduces PTSD symptoms in current and former military personnel for 6 months. Researchers from Wake Forest Baptist Medical Center in Winston-Salem, North Carolina reported results of the trial in the 22 December issue of the journal Military Medical Research.

A team led by neurology professor Charles Tegeler at Wake Forest School of Medicine, affiliated with the medical center, is testing a technique called high-resolution, relational, resonance-based, electroencephalic mirroring, or Hirrem, as a treatment for PTSD, short for post-traumatic stress disorder. The condition results in behavioral disturbances following a traumatic experience, with symptoms including anxiety, depression, insomnia, and heightened arousal, leading in some cases to substance abuse and suicides.

The Department of Veterans Affairs cites data showing 30 percent of veterans returning from Vietnam, 12 percent from the first Gulf War, and up to 20 percent from Iraq and Afghanistan suffer from PTSD. Some current psychotherapies ask people with PTSD to directly confront their traumatic experiences, which the authors say have mixed results, including high dropout rates and little impact on disturbed sleep. And while psychiatry officially recognizes PTSD as a clinical disorder, concerns have been raised about “medicalizing” the problem, which can stigmatize people with combat-related PTSD.

The Hirrem process reads and translates a person’s brain waves into audio tones and feeds the tones back to the individual through earphones. Brain waves are captured with sensors like those used with electroencephalograms or EEG tests, then translated into audio tones with algorithms and software. Hirrem’s developers say when hearing this audio stimulation, the person’s brain adjusts and optimizes its electrical activity toward balance and quieting. The number of audio feedback exposures, and number and length of Hirrem sessions varies, depending on the individual’s brain wave patterns.

The paper reports on first results from an ongoing clinical trial of Hirrem at Wake Forest Baptist with 18 participants, 15 active-duty military and 3 veterans. Most of the participants served in special operations, with an average age of 41 years and 1 female, and all receiving Hirrem sessions over 12 days. The group answered a battery of standard checklists and scales on PTSD, insomnia, depression, and anxiety immediately before and after the Hirrem sessions, then at 1, 3, and 6 months following their sessions. Researchers also measured participants’ heart rate, blood pressure, reactions and grip strength, and biomarkers for stress and inflammation.

The results show statistically reliable reductions in all of the behavioral symptoms, including insomnia, depression, and anxiety after the Hirrem sessions, which continued for 6 months. Similar results were found on the physiological tests. No dropouts or adverse effects were reported. The authors note that the small sample and lack of control group are limitations of the study, which can be rectified in further research.

Hirrem was developed and offered commercially by Brain State Technologies Inc. in Scottsdale, Arizona. Lee Gerdes, founder of Brain State and developer of the technology, is a co-author of the paper. Wake Forest Baptist licenses Hirrem from the company for research and evaluation.

More from Science & Enterprise:

*     *     *

FDA Clears Targeted Breast Cancer Radiation Treatment

MRI of breast

MRI of breast (National Cancer Institute)

27 December 2017. The U.S. Food and Drug Administration approved a device that sends high doses of radiation to cancerous breast tissue while sparing healthy tissue nearby. FDA approved the device known as GammaPod, made by Xcision Medical Systems LLC in Columbia, Maryland, and invented by researchers at University of Maryland medical school in Baltimore.

The GammaPod system is designed to take advantage of advances in breast cancer diagnostics that spot the disease in its early stages, while the cancer is still confined to breast tissue or nearby lymph nodes, but before it spreads to other parts of the body. In this early stage, radiation treatment can kill tumor cells in the breast and damage their DNA, but the radioactive emissions can also harm healthy tissue near the tumor. FDA estimates 60 percent of cancer patients are treated with some form of radiation therapy.

The GammaPod is an invention of radiation cancer specialists Cedric Yu and William Regine at University of Maryland. The device encases and immobilizes the breast while 36 rotating cobalt-60 sources send thousands of radioactive beams into the diseased tissue. “With this breast-specific treatment system,” says Regine in a university statement, “we will be able to deliver high-dose radiation to a tumor while minimizing damage to normal breast tissue and even more importantly, to major organs such as the heart and lungs.”

FDA based its clearance of GammaPod, announced on 22 December, in part on a clinical trial testing the feasibility and safety of a prototype device at University of Maryland Medical Center. The results of the trial from its 17 participants show the device delivers the prescribed dose of radiation to the tumor, while minimizing common side effects from radiation, such as skin redness. FDA points out, however, that GammaPod is not shown to be more effective than whole breast radiation therapy and not intended to replace this treatment.

The agency reviewed GammaPod using its 510(k) prenotification pathway. In this process, a medical device developer demonstrates to FDA that the new system is substantially equivalent to an earlier legally marketed device.

Yu founded Xcision Medical Systems in 2006 to commercialize GammaPod, and serves as the company’s CEO. “We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel,” notes Yu. “This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”

More from Science & Enterprise:

*     *     *