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HistoSonics Announces First Patient Treated in European Clinical Trial

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HistoSonics, developer of a non-invasive platform and novel sonic beam therapy, announced today that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year.

The study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of therapeutic focused ultrasound, to destroy unwanted tissue, including targeted primary and metastatic liver tumors, without the need for incisions or invasiveness.  The #HOPE4LIVER Europe Study is a multi-center, open label, single arm trial planned to enroll up-to 45 patients throughout sites in Spain, Italy, UK, and Germany, and is being run in parallel with a similar US trial.

HistoSonics’ non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels.  The company believes that the novel mechanism of action of their proprietary technology, intended to avoid thermal necrosis and ionizing radiation, may provide significant advantages to patients, including the ability of the treatment site to recover and resolve quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

The procedure was performed at the Otto von Guericke University Clinic Magdeburg by Professor Dr. med. Maciej Pech, Interventional Radiologist, Director of University Clinic for Radiology and Nuclear Medicine and Principal Investigator of the #HOPE4LIVER site in Magdeburg, Germany. Professor Pech commented, “The first treatment in the #HOPE4LIVER was successful in destroying the targeted tumor and the patient performed well both during and after the procedure. We will follow up with the patient per the trial protocol and look forward to enrolling more patients that may be good candidates for histotripsy therapy. The ability to use histotripsy to destroy tumors completely and non-invasively could represent a tremendous advantage for many patients.”

Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery.  Primary liver tumors were the third leading cause of tumor related death worldwide in 2020, with approximately 906,000 new cases and 830,000 deaths globally, and 5-year survival rates less than 18%.  Additionally, the liver is second only to lymph nodes as the most common site of metastatic tumors, those that spread from other organs, and estimated to be present in up-to 70% of patients with advanced disease from another site.  Histotripsy may provide benefits to these patients due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.

HistoSonics‘ Vice President of Medical Affairs, Joe Amaral, M.D., added, “It is extremely exciting to be working with Professor Pech and the team at Otto con Guericke University Clinic in Magdeburg to build upon the company’s initial success of the THERESA Study conducted in Spain.  We believe our non-invasive platform and novel therapy has the potential to change the experience for patients with solid liver tumors, and our aim is to continue to build this evidence with the #HOPE4LIVER Trials.  We are very thankful to Professor Pech and the entire team in Magdeburg for their continued commitment to clinical research and providing leadership in this important trial.”

The HistoSonics device is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.

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Source: https://infomeddnews.com/histosonics-first-patient-european-clinical-trial/

Medical Devices

What Kind of Equipment is Used to Analyze DNA?

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Below are some of a few basic processes followed throughout DNA testing. The general procedure entails: 

Isolating DNA from a sample containing the needed DNA of unknown origin, as well as isolating DNA from the test sample (e.g., blood, semen, skin tissue, or saliva) from a known individual.

Processing the DNA to obtain test results,

 Determining the variations in the DNA test results (or types) from specific regions of the DNA, 

Comparing and interpreting the test findings from the unknown and known samples to have a conclusion.

How is DNA Analyzed?

The DNA sample is taken to a forensic laboratory. These labs differ significantly in terms of how they have been organized and the kind of analyses they provide. Many laboratories can test nuclear DNA, which is the copy of DNA found in every cell’s nucleus. However, specialized procedures such as mtDNAanalysis and Y-chromosome among others are only available in a few sophisticated labs. Let us take a closer look at a few of these strategies.

Restriction Fragment Length Polymorphism (RFLP)

One of the first forensic approaches for analyzing DNA is restriction fragment length polymorphism (RFLP). It measures the length of DNA strands with repeating base pairs. Variable number tandem repeats (VNTRs) is a type of repetition that can occur anywhere between one and thirty times.

Process: To do RFLP analysis, researchers must dissolve DNA in an enzyme that breaks down the strand at specific locations. The length of each strand of DNA is affected by the number of repeats. The investigators compare the sizes of the strands in the samples. RFLP analysis requires a piece of uncontaminated DNA for the best and accurate results. 

Short and Tandem Repeat Analysis (STR)

RFLP analysis is slowly being phased out in favor of short tandem repeat (STR) analysis in many laboratories. One of the most significant benefits of this technology is that it can begin with a considerably smaller quantity of DNA. 

STR analysis evaluates the frequency of repeat of base pairs in specific segments on a DNA strand after DNA amplification. Repeats of two, three, four, or five base pairs are known as dinucleotide, trinucleotide, tetranucleotide, or pentaLetnucleotide repeats. Investigators frequently look for tetranucleotide or pentanucleotide repetitions in PCR-amplification samples because they offer high accuracy.

Process: The sample is amplified using a polymerase chain reaction technique. PCR copies DNA similarly to how DNA duplicates itself in a cell, yielding nearly unlimited amounts of genetic material by using agarose gel media.

Importance of DNA Analysis:

DNA analysis’s primary goal is to create a visual representation of DNA. A DNA “image” resembles a fingerprint taken from a flat surface with columns of dark-colored parallel bands, and it is unique to every individual. The DNA “fingerprint,” or profile, of a DNA sample, must be compared, either to DNA from a suspect or to a DNA profile kept in a database, to identify the sample’s owner.

Equipment Used to Analyze the DNA:

DNA testing investigates several loci in human DNA when investigating possible a match. Human DNA differs by around one-tenth of one percent, or roughly three million base pairs (a person has three billion in total); therefore, you must identify highly variable regions. Sterile cotton swabs are the most commonly used tools to collect samples because they limit the possibility of contamination. However, you can study any fluid or tissue from any item or object. Some of the lab equipment used in DNA analysis include: 

Thermostatic Cycler:

There are different equipment used for each procedure. A thermal cycler holds a block of tubes carrying PCR mixture. It raises or lowers the block’s temperature in pre-programmed steps, as used in PCR (polymerase chain reaction), a common technique in DNA analysis. This splits and amplifies the DNA, resulting in multiple copies of the same strand. The approach is used to evaluate even little or deteriorated materials. The DNA, on the other hand, must still be tested.

DNA Analyzer:

To detect particular nucleotide sequences, a DNA probe labeled with a radioactive molecular marker may bind to a complementary DNA sequence in the sample resulting in a unique pattern for each person, which can then match a different sample. 

It is more likely that scientists will find a match if there are more loci present. The recommended number is approximately four to six probes. After that, the amount of time and money spent on testing skyrockets.

Dyes and Electric Fields:

After amplification, another approach referred to as short tandem repeat (STR) is implemented. This process involves the use of either gel electrophoresis or capillary electrophoresis. Both methods use an electric field to see any repetitive DNA sequences across 13 distinct loci. Researchers can use silver staining, intercalating dyes like ethidium bromide, or fluorescent dyes to make the sequences more visible. The chances of two people having an exact match are roughly one in a billion, which means only approximately six or seven people on the planet will have a match.

DNA Isolation Kits:

Most molecular biology procedures, such as cloning, library preparation, and sequencing, need plasmid DNA purification as a starting material. There are ready-to-use plasmid purification kits and reagents to extract high-quality plasmids from bacterial and fungal cell types, such as those offered by Modern Biology. Select the purification scale (from miniprep to gigaprep), format (spin, vacuum, or magnetic), and compatibility with automated systems using the specified filters. 

Polymerase Chain Reaction Machines (PCR)

When you’re able to make several copies of a DNA segment, you can conduct various tests at the same time. You may, for example, run one test after another without causing the original sequence to be damaged. You may create a control segment and then compare it to other segments. A single tissue sample may be submitted, and numerous test results can be obtained. This is made possible by the polymerase chain reaction machine, which is why it is standard equipment in DNA analysis laboratories. 

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Source: https://infomeddnews.com/what-kind-of-equipment-is-used-to-analyze-dna/

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Medical Devices

mJOULE Launches in the United Kingdom Reports Sciton

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 “At Sciton, we work hand in hand with our clinician partners to drive visionary innovation that is founded on science and uncompromised quality,” shares Aaron Burton, Sciton CEO. “We are proud to be leading the industry with new product innovation and enhancements that benefit practices and patients alike.”

mJOULE is a dual wavelength platform that features BBL HERO and MOXI technologies, created in response to a changing market which desires less time consuming treatments, yet equally strong outcomes. Recently honored by NewBeauty as a 2020 ‘Innovation Award Winner,’ BBL HERO (High Energy Rapid Output) is the fastest, most powerful IPL in the industry, and empowers practitioners to treat the entire body with four times the speed, three times the peak intensity, allowing for a highly customizable protocol. The treatment results in smoother, clearer, younger and healthier looking skin in just one to two sessions.

“Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide.” says Lacee J. Naik, Vice President of Marketing and Public Relations.

The second technology available on the mJOULE platform is Sciton’s newest fractional laser, MOXI. MOXI is one of the most inclusive laser treatments available, and is safely suitable for those higher on the Fitzpatrick scale. This non-ablative laser addresses sun damage and aging, takes under 20 minutes and boasts little to no downtime, allowing it to fit comfortably into even the busiest of schedules and can be performed any time of the year.

“The U.K. is an important market for Sciton’s global growth strategy,” says David Percival, Vice-President and General Manager for Sciton International. “We see a tremendous opportunity to introduce both these novel technologies into the growing aesthetic market in the U.K.  We have a strong reputation for delivering an outstanding customer experience and look forward to expanding our Sciton family of customers.”

Sciton will celebrate this monumental international launch with a premier event in London on June 24th, 2021, where staff, partners, and leadership will gather to recognize this milestone and officially welcome their ground-breaking technologies to the dynamic UK market.

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Source: https://infomeddnews.com/mjoule-launches-united-kingdom/

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Medical Devices

Sciton Celebrates the Newest Innovation in United Kingdom: Sciton’s mJOULE

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Exceptional Outcomes Now Available Overseas

LONDON, June 18, 2021 /PRNewswire/ — Sciton® Inc., a leading manufacturer of medical and aesthetic lasers and light source technologies based in Palo Alto, California, announces the launch of its latest platform, mJOULE, in the United Kingdom. This revolutionary system features some of the biggest updates in the history of pulsed light based technology, including its newest fractional treatment, MOXI, and the award-winning BBL HERO treatment.

Sciton® Inc., announces the launch of its latest platform, mJOULE, which includes MOXI and BBL HERO in the UK.

“At Sciton, we work hand in hand with our clinician partners to drive visionary innovation that is founded on science and uncompromised quality,” shares Aaron Burton, Sciton CEO. “We are proud to be leading the industry with new product innovation and enhancements that benefit practices and patients alike.”

mJOULE is a dual wavelength platform that features BBL HERO and MOXI technologies, created in response to a changing market which desires less time consuming treatments, yet equally strong outcomes. Recently honored by NewBeauty as a 2020 ‘Innovation Award Winner,’ BBL HERO (High Energy Rapid Output) is the fastest, most powerful IPL in the industry, and empowers practitioners to treat the entire body with four times the speed, three times the peak intensity, allowing for a highly customizable protocol. The treatment results in smoother, clearer, younger and healthier looking skin in just one to two sessions.

“Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide.” says Lacee J. Naik, Vice President of Marketing and Public Relations.

The second technology available on the mJOULE platform is Sciton’s newest fractional laser, MOXI. MOXI is one of the most inclusive laser treatments available, and is safely suitable for those higher on the Fitzpatrick scale. This non-ablative laser addresses sun damage and aging, takes under 20 minutes and boasts little to no downtime, allowing it to fit comfortably into even the busiest of schedules and can be performed any time of the year.

“The U.K. is an important market for Sciton’s global growth strategy,” says David Percival, Vice-President and General Manager for Sciton International. “We see a tremendous opportunity to introduce both these novel technologies into the growing aesthetic market in the U.K. We have a strong reputation for delivering an outstanding customer experience and look forward to expanding our Sciton family of customers.”

Sciton will celebrate this monumental international launch with a premier event in London on June 24th, 2021, where staff, partners, and leadership will gather to recognize this milestone and officially welcome their ground-breaking technologies to the dynamic UK market.

ABOUT SCITON
Sciton, Inc., located in Palo Alto, California, is an employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance and value. Sciton offers aesthetic and medical devices for women’s health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates on a worldwide basis with direct sales teams in the United States, Canada, Australia, United Kingdom, Ireland, Japan and distributor partners in more than 45 countries. For more information, and a complete listing of Sciton systems, visit www.sciton.com.

Facebook: @ScitonInc
Instagram: @Sciton_Inc
LinkedIn: @ScitonInc

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/sciton-celebrates-the-newest-innovation-in-united-kingdom-scitons-mjoule-301315294.html

SOURCE Sciton, Inc.

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Source: https://www.biospace.com/article/releases/sciton-celebrates-the-newest-innovation-in-united-kingdom-sciton-s-mjoule/?s=93

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Medical Devices

Avanos Medical, Inc. to Present at the 2021 Raymond James Human Health Innovation Conference

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ALPHARETTA, Ga., June 18, 2021 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) today announced that Joe Woody, chief executive officer, will present and participate in an analyst-led fireside chat at the Virtual 2021 Raymond James Human Health Innovation Conference Tues., June 22 at approximately 10:40 a.m., ET.

A live webcast of conference presentation will be available on the Investors section of the Avanos Medical website and will be archived on that site.

About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients’ quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/avanos-medical-inc-to-present-at-the-2021-raymond-james-human-health-innovation-conference-301315265.html

SOURCE Avanos Medical

Company Codes: NYSE:AVNS

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