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Medical Devices

MIMEDX Receives Regulatory Approval to Commercialize EPIFIX® in Japan

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MIMEDX Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced successful regulatory approval by the Japanese Ministry of Health, Labour and Welfare (JMHLW) to market EPIFIX® in Japan.

EPIFIX – a bioabsorbable, human amniotic membrane allograft, is applied to affected areas for wound healing. The product uses proprietary methods, including the PURION® process, to provide a semi-permeable, protective barrier that supports the healing cascade. EPIFIX protects the wound bed to aid in the development of granulation tissue and delivers a human biocompatible extracellular matrix that retains 300+ regulatory proteins.

MIMEDX submitted a Shonin (pre-market approval) to the JMHLW, Japan’s primary regulatory body for creating and implementing safety standards for drugs and medical devices, and the Pharmaceutical and Medical Device Agency (PMDA), an independent administrative agency that works with JMHLW to ensure the safety and quality of drugs and medical devices, in mid-2020. EPIFIX was approved for hard-to-heal chronic wounds, such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), which do not respond to conventional therapy. EPIFIX will be classified as a Class IV Medical Device and “Specified Biological Product” under JMHLW guidelines.

Dr. Hiroto Terashi, Chief Professor in Department of Plastic Surgery at Kobe University, Chairman of the Japanese Society for Foot Care and Podiatric Medicine (JFCPM), and Chairman of the Japan Society for Surgical Wound Care (JSSWC) said, “As a plastic surgeon and wound care physician for my entire career, I am delighted with EPIFIX’s approval in Japan. EPIFIX will greatly expand treatment options for chronic wounds caused by lower extremity venous and diabetic ulcers in patients in Japan, providing opportunities for increased limb salvage.”

“Diabetic foot ulcers and venous leg ulcers that are unable to heal on their own pose a serious long-term health risk to people around the world. Our vision is to provide access to EPIFIX technology that can change people’s lives, no matter where they live,” said Stan Micek, MIMEDX Senior Vice President, Business Development and International. “We are extremely pleased with JMHLW’s decision to grant Shonin approval for EPIFIX, and we are glad to be one step closer to bringing EPIFIX to market in Japan. Our focus will now shift toward obtaining appropriate reimbursement and establishing logistical and distribution networks for commercialization, which we hope will result in full availability of EPIFIX in the Japanese market in early 2022.”

The Company is currently working with JMHLW to establish reimbursement pricing, a process expected to take up to six months. Once a reimbursement pricing policy is approved and the reimbursement rate is listed, the Company can begin offering EPIFIX to patients and providers in Japan.

Timothy R. Wright, MIMEDX Chief Executive Officer, commented, “EPIFIX can only benefit patients with hard-to-heal wounds if they can access its life-improving properties, and regulatory approval is a significant milestone in addressing unmet need for people in Japan. With today’s announcement, EPIFIX now has the potential to reach as many as 100,000 additional patients each year. This critical step helps us fulfil our mission of bringing advanced regenerative medicine to suffering patient populations and is important in the Company’s global expansion.”

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Source: https://infomeddnews.com/mimedx-commercialize-epifix-japan/

Medical Devices

Intelivation Technologies Launches TruTrack™ Memory Staple System

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SAINT SIMONS ISLAND, Ga., June 21, 2021 /PRNewswire/ — Intelivation Technologies, a medical device company with a cutting edge lower extremity portfolio announced today that they are launching the TruTrackTM Memory Staple System. The TruTrackTM system will be on display at the firm’s technology suite during the Footprints In The Sand Podiatry Institute Conference being held in Hilton Head Island, SC June 24-27 2021. “The TruTrackTM represents a breakthrough in memory staple fixation instrumentation and furthers our mission to bring products to market that result in positive change for patients’ lives,” said Amit Sinha, President of Intelivation Technologies. Mr. Sinha also added, “I am thrilled with how fast our talented team brought this unique offering to market. We are looking forward to rapidly adding to our product portfolio through the remainder of 2021 and beyond.”

The TruTrackTM features novel instrumentation designed for more reliable and consistent insertion techniques during a wide variety of intraoperative conditions. Dr. David Murphy commented on the TruTrackTM Staple, “The TruTackTM Staple System provides a highly dependable and more efficient approach for surgeons. Compared to traditional methods that can be plagued with drill hole obscuration, the TruTrackTM System lends itself towards less soft tissue disruption, resulting in improved surgical outcomes for patients. The implant itself is very low profile and can be applicable to a wide variety of degenerative conditions and deformities of the foot.”

Intelivation Technologies, headquartered in Saint Simons Island, GA and dedicated to research and development, is focused on bringing game-changing products to market that make patients’ lives better. For further inquiries, interested parties may email contact@intelivationtech.com.

Intelivation Technologies

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/intelivation-technologies-launches-trutrack-memory-staple-system-301315065.html

SOURCE Intelivation Technologies

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Source: https://www.biospace.com/article/releases/intelivation-technologies-launches-trutrack-memory-staple-system/?s=93

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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

What Will You Do First When COVID is Under Control?

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When COVID is Under Control

Summer is (almost) officially here. Vaccinations are up and lock downs are loosening as regions reach herd immunity levels. We’ve been working remotely for over a year, so it seemed like a good time to test StarFish culture. Yes, there is a consensus. Read on and see if you agree with our employee choices for their first activities when COVID is under control and COVID restrictions are lifted.

Hugs

First thing I will do? “I will hug tight my family and friends!” – Lorenzo G

I’m with you, Lorenzo! The first thing I will do is hug my loved ones! There is so much I want to do but that easily tops my list! – Sarah W

Go to the movies.  – Vanessa F

I’m not much of a hugger, but I can’t wait to start playing tabletop games with my friends again! 😉  – Andrei

Travel

When COVID is under control? Travel – to familiar places so I can hug people! 🙂 Travel to new places to make new friends. – Jess H

I want to go to Maui. I missed the trip by a week when COVID shut the border. I still have my flight voucher, so I’ve got to use it soon. I am going to eat fresh fish, walk the beach, and leave my kids behind, so I can enjoy it. – Sandy

After my family comes to visit for Thanksgiving, I will be jetting off to Hawaii for a long break. As long as everything goes well, I should be able to do both. I’ve got my flight booked and my fingers crossed! – Kathy Y

I’m looking forward to the US border opening up and eventually being able to travel in the States as well. – Christian

I’d like to see the US-Canadian border seamlessly open and get rid of the quarantining so I can come back and forth at ease. – Lynne

I am particularly looking forward to going to Toronto, California and Seattle to go do some relationship building and deal making. Just get out there and make it happen.  – Scott P

Hockey

When all restrictions are lifted I cannot wait to travel and attend a sporting event with lots of people I’ve never met before. – Mike R

Finally play ice hockey again! – Nick O

It’s nice to see some of the Toronto folks come out here and vice versa. Some folks have started and never got a chance to visit us. It will be fun to see colleagues. And I’m looking forward to getting back into playing hockey. I also miss the Canucks games, but I do that pretty rarely. I’m more excited about actually playing. I don’t think the Canucks will let me play, but we’ll see. Depends on how Covid impacts their team. – Nigel

Music

When COVID is under control? I want to go see a live band, I want some live music. Any kind of music. – Glen  

I’m looking forward to playing and recording music with people in person. We tried doing some recording remotely. It’s hard to keep people on track to actually submit their tracks. I play various instruments, mostly bass and drums. The group I play with most often right now does covers of rock songs mostly. – Ryan F

Ryan beat me to the punch there, but yes, we are frantically trying to get some stuff together so that we can get out and play just as soon as they let us. – Kenneth

We can have the Starfish House Band. Yeah, that’s pretty cool. We’ll have two house bands, one in Toronto and one in Victoria. And there’s a section on each side. That’s what I heard, too. – Scott

In-person school / work

I am excited for in-person lectures. I’m excited to go back to campus. – Chantaille

Lots of things

When COVID is under control? I’m really looking forward to some quiet time at home with a book or maybe a movie marathon. NOT! Professionally: see the office and meet a co-worker (any co-worker) for the first time : )  Personally: hopefully, travelling to the US to Umpire the Youth World Match Racing Championship sailboat race. – David P

I want to meet with friends that I have not seen for a long time. I want to catch up with every live concert in town and in Vancouver. I want to go back to the dance temple. I want to go out regularly. I want to see people on the streets. I want to see people in the office. Should I stop now? – Vesna

I don’t think this thing is getting to Vesna at all. – Nigel

No, not at all. – Vesna

When COVID is Under Control?

We hope you enjoyed this slice of StarFish culture. We’d love to hear about your plans. Send us a comment. If you felt a bit of bonding and are interested in a career in medical device development, then check out our career openings. You’ll have plenty of company for Music, Hockey, Music, Travel, and in-person Hugging.

Astero StarFish is the attributed author of StarFish Medical team blogs.  We value teamwork and collaborate on all of our medical device development projects.

Photo 111788666 © Tatiana Ronzhina | Dreamstime.com

 


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Source: https://starfishmedical.com/blog/when-covid-is-under-control/

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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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