May 26, 2017

3D Bioprinter Produces Skin for Tranplants

3D Bioprinter Prints Functional Human Skin Adequate for Transplant

3dprintedskin-frankmagliochetti-healthcareinnovationA team of researchers in Spain reports the development of a new three-dimensional (3D) printer capable of printing human skin suitable for transplant into patients. The printed skin is also suitable for testing drugs and cosmetics.

The team included several groups of researchers, including a group from the Universidad Carlos III de Madrid (UC3M) in Spain. The researchers describe their breakthrough in the scientific journal, Biofabrication.

3D Printing and Skin Production

3D printing has been around since the 1980s, when Charles (Chuck) Hull introduced the first stereolithography apparatus (SLA), but the 3D printing industry is now experience rapid growth with applications in many fields. In medicine, 3D printing holds great promise in someday giving clinicians the ability to produce personalized, complex human tissues and organs on demand. One woman has already received a 3D printed ear from one company, for example, while another frankmagliochettireport-3d-bioprintercompany provides 3D printed implants that the recipient’s body converts to bone.

Three-dimensional printing of human body parts is challenging in a number of ways. Replicating the complexity of anatomical structures is difficult. Ensuring the printed tissue survive transplantation in a living body is another problem.

The scientists in Spain have already engineered plasma-based, two-layered skin used successfully in the treatment of burns and other wounds in a large number of patients. The primary drawback to this method is that it takes 3 weeks to produce enough skin to cover an extensive burn or large wound. Another disadvantage is that the scientists must perform much of the process manually.

3D printing is similar to a desktop computer printer except that the nozzle on the 3D printer exudes biological components rather than ink. These biological components, or bio-inks, are essential to successful 3D printing of human organs and tissues.

To aid in the process, a computer controls the nozzles and flow of biological components so that the nozzles deposit the bio-inks on precise locations on the print bed.

Prints large area of skin in 35 minutes

The authors of the study describe how their 3D printing method generated a 100 x 100 centimeter area of skin in just under 35 minutes.

Like the scientists’ existing plasma-based manual method of producing skin, the 3D printing technology generates two layers of skin – the epidermis and the dermis. The printer starts by producing the epidermis, including the protective outermost layer of keratinized cells, known as the stratum corneum. Next, it prints the thicker, deeper dermis, complete with collagen-producing frank-magliochetti_bioprinter-skinfibroblasts.

The new 3D printing method is faster, but still complex. One of the authors of the report, Juan Francisco del Cañizo of the Hospital General Universitario Gregorio Marañón and Universidad Complutense de Madrid, notes:

“Knowing how to mix the biological components, in what conditions to work with them so that the cells don’t deteriorate, and how to correctly deposit the product is critical to the system.”

The research team tested the printed skin in test tubes and in immunodeficient mice. Transplantation of the printed skin into the mice helped the scientists test the long-term effects in a living animal. In both tests, the 3D printed skin was very similar to human skin and indistinguishable from the manually produced bi-layered skin from plasma.

There are two main potential uses for this 3D skin – to produce skin for research and laboratory testing of drugs and cosmetics, and to produce person-specific skin from the patient’s own cells to treat burns and other wounds. The research team is also investigating ways to use the technology to print other human tissues.

Source

http://iopscience.iop.org/article/10.1088/1758-5090/9/1/015006/meta

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Smart Tech: Wearable Medical Devices

Smart Tech:  Wearable Medical Devices 2017 – 2020

Smart technologies will continue to drive the ever-growing medical wearable device market in 2017 and well into the future.
The global medical wearable devices market topped $3.2 billion in revenue in 2015, according to Mordor Intelligence, which expects the market to surpass $7.9 billion in 2020 as the industry continues to grow at a healthy CAGR of 19.8 percent during that period.
wearablemedicaldevices_frank-magliochetti-reportWearable medical devices, known simply as “wearables,” are small pieces of equipment featuring sensors that attach to the body. These sensors detect and monitor changes in specific body signatures produced by various body systems and organs. Early wearable technology allowed consumers to monitor vital signs. Today’s wearables allow users to monitor food intake, activity, and sleep levels. Tomorrow’s devices may provide continuous monitoring of glucose levels, smart clothing for infants, and smart EKG necklaces for those with heart problems.
Wearables have the potential to fill a number of applications in remote patient monitoring, sports and fitness monitoring, and home healthcare. Simplified usage of these devices, coupled with the ability to synchronize with smartphones and tables, assisted growth in this segment.
Global Wearable Devices Market- Market Dynamics

There are immense potential socio-economics of wearable medical devices for multiple sectors. Fitness devices that encourage the users to exercise can significantly reduce healthcare costs, for example.

Investors are focusing on a wide variety of projects, ranging from downloadable apps to improving the size, cost and sensitivity of sensors.wearablemedicaldevices_frankmagliochettireport

Several factors propel the growth of the global wearable market. Technological innovation is perhaps the most important factor, as these advancements lead to the introduction of new products.
Diabetes and other chronic diseases are rising at a seemingly uncontrollable rate. Wearable devices will play an increasingly important role in helping doctors and patients manage chronic diseases.

Developers make wearable devices easier to use and simplify interpretation of the data collected. Simplicity encourages use.
Market penetration of smartphones, smart watches and other wearable devices will promote the use of wearable medical technology. These devices have already penetrated the market deeply, with the worldwide smart watch shipments reaching about 25 million in 2015.

Some factors, such as reimbursement issues and high device cost, will restrain the medical wearables market somewhat but the effect should be minimal, as demand should remain high.
Several companies are already exploiting the growing interest in medical wearable technology by creating affordable products that offer high value to users and their healthcare partners.

Some of the key players already operating in the medical wearable device market include:
• Dräger
• Fitbit Inc.
• Intelesens Ltd.
• Lifewatch AG
• Omron Corporation
• Polar Electro
• Philips Electronics
• Withings SAS
These wearable manufacturers will likely improve hardware in existing products and create sturdier devices within the next few years. Hardware and device ifrankmagliochettireport_wearable-medical-devicesnnovations may include larger and easier to read displays, extended battery life, waterproof hardware, and compatibility with GPS and other sensors included in a standard smart phone. Software innovations may include advanced monitoring systems and improved patient care software, such as breathing exercises and on-demand nutrition counseling.
The wearable market is expanding because the devices are autonomous, which makes them easy to use, and non-invasive. It is also growing because of its ability to help prevent and manage chronic diseases.

Source
https://www.mordorintelligence.com/industry-reports/global-wearable-medical-device-market-industry

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Innovative Developments in Medical History

Preventative Vaccines:  Bexsero & Trumenba

Frank Magliochetti Report

One of the biggest public health epidemics occurred back in 2014; Ebola and Meningococcal B were responsible. These two diseases took 10,000 people in Sierra Leone, Guinea and Liberia. These three countries have weak health systems, which is the reason why they were unable to treat their people.

In order to fight this disease, which made its first appearance in 1976,  WHO (World Health Organization) had been trying to find a cure for many years. On August 8, 2015, WHO declared that Ebola and Meningococcal B is a disease of international concern and thus began the search for its vaccine. By late October, 2015 WHO had finally come up with two vaccines that were guaranteed to prevent Meningococcal B. Sadly; the cure for Ebola has not yet been found however, its vaccines trials are currently being conducted in Sierra Leone.who_frankmagliochettireport

Meningococcal B is caused by bacteria called “Neisseria Meningitidis”. Neisseria Meningitidis has five serogroups: B, C, Y, W and A. The most common serogroups that affect people in the US is B, C and Y.

Meningococcal B disease is not caught through the air. In fact, it is a diseasewhich is transmitted from one person to another in close physical contact. The disease commonly spreads faster in the family due to the exchange of fluids from daily contact. The disease is found at the back of the throat and later causes sepsis. Sepsis is transferred to the blood that infects the blood stream, which causes damage to the brain and spinal column. Meningococcal B often results in liver failure, vision loss, amputation of limbs and death.

bexsero-frankmagliochettireportThe two vaccines Bexsero and Trumenba specifically treat Meningococcal B and were approved by the FDA in October 2015. The trials for Bexsero were conducted in UK, Chile, Australia and Canada amongst 2,600 young adults and adolescents. The results were that the three infectious strains that cause Meningococcal were destroyed.

Another 5,000 participants in the trials conducted in the USA experienced headache, muscle and joint pain, chills, fatigue and diarrhea after receiving the vaccine. Whereas, 15,000 participants experienced less side effects. All in all, the FDA approved the vaccines because the side effects were not viewed aslong term or fatal.

An accelerated approval was used by the FDA to make this vaccine go public claiming that Meningococcal B is a life-threatening disease. The effectiveness of Bexsero was approved two months prior to the trials being conducted.

FDA recommends that the vaccine should be given to infants, children from the ages of ten till twenty three and people who have a weak immune system. It is recommended that more than one dosage should be given to people having serogroup B Meningococcal.

Anna Jaques, a non-profit Hospital in Newburyport, Massachusetts has taken extra measures and brought more doctors and experts on anna_jaques_hospitaltheir team to prepare themselves if a patient with Ebola or Meningococcal B comes to their door.

https://www.ajh.org/

Anna Jaques is a remarkable medical facility housed with some of the top health care professionals North of Boston.

Frank Magliochetti

With 2016 being the year of medical innovations, the vaccine for Meningococcal B has come as a godsend that will save millions of lives in rural areas where this disease is commonly found. The vaccines are set to be released worldwide by the end of the year.

Other News and information on Trumenba and Bexsero

Trumenba Offical Website:

http://www.trumenba.com/

Important Safety Information

  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Individuals with weakened immune systems may have a reduced immune response
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills
  • Data is not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your healthcare provider prior to the vaccination if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Trumenba. Only a healthcare provider can decide if Trumenba is right for you or your child

 

trumenba-frankmagliochettireportIndication

  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidisgroup B
  • Trumenba is approved based upon demonstrated immune response against four group B strains representative of prevalent strains in the US. The effectiveness of Trumenba against diverse group B strains has not been confirmed

Bexsero

Official Site

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html?cc=3282D9F3E686&pid=

Important Safety Information

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.Bexsero_logo_4C_temp_norDNA_bigger

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

AAP issues meningococcal B vaccine ( Trumenba & Bexsero)  guidelines for adolescents
Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Please Click the link below to read the entire post:

http://www.healio.com/internal-medicine/vaccination/news/online/%7B9d42e15b-0c08-477d-8b1e-f28a59c545ea%7D/aap-issues-meningococcal-b-vaccine-guidelines-for-adolescents

Pfizer heads back to school with Trumenba vaccination campaign

Please click the link below to read the entire post:

http://www.fiercepharma.com/marketing/pfizer-menb-vaccination-campaign-for-trumenba-gears-up-for-back-to-school

Teaching kids to share is usually a parental goal, but a new ad from Pfizer may have some parents rethinking the parameters.

The first campaign for meningococcal group B vaccine Trumenba highlights the dangers of MenB, which can be spread through habits common among teens–including kissing and sharing drinks and food.

The TV ad shows a mother in the hospital with her stricken son, asking “how did we get here?” The ad then goes back through events earlier in evening showing the son sharing food and drinks with several different friends at a party and kissing a girl.

“The campaign was designed to reach parents of teens and young adults during the summer and back-to-school season, when many parents are thinking about steps they can take to help protect their child’s health, including vaccination,” she said.

Trumenba is one of two vaccinations to protect against MenB, along with GlaxoSmithKline’s Bexsero. But last year, the CDC’s Advisory Committee for Immunization Practices (ACIP) stopped short of granting the pair universal recommendation. The vaccines are recommended for young adults ages 16 to 23, with a preferred age of 16 to 18, which means that doctors decide on an individual basis whether to vaccinate their patients against MenB.

watch the ad on iSpot.tv

https://www.ispot.tv/ad/ARCj/trumenba-meningitis-b

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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