Category Archives: Industry: Healthcare

Healthcare is an ever evolving industry, and field. These Press Releases, will keep you up to date on the newest, greatest, best, solutions available.

Joseph Spine Institute Patient First to Receive Revolutionary 3D Printed Aries Titanium Spinal Implant


Lumbar Fusion Customized Spinal Implant

Aries-L Titanium Spinal Implant

“I can’t tell you what it is like to be without the pain! I am constantly saying, thank you God, thank you! Thank you Dr. Joseph, thank you,” Suzanne Shahan, first patient to receive Aries-L spinal implant.

For over three decades Suzanne Shahan suffered from debilitating back pain, multiple spine issues and had undergone multiple surgeries that ultimately left her living a life in unbearable pain.

“My life went away overnight I just kind of lived my life in limbo, I had no strength, it took years to gain the ability just to walk to my mailbox.”

Suzanne got her new chance for a normal life on January 8, 2019, when she became the first person in the world to receive Osseus Fusion Systems revolutionary 3D Printed Aries Titanium Spinal Implant. The procedure was performed by Dr. Samuel A. Joseph Jr. and was assisted by Dr. Andrew Moulton of Joseph Spine Institute in Tampa.

“Through 3D printing we are able to manufacture spinal implants that are customized to the patient,” stated Dr. Joseph, “this cutting edge technology offers our patients implants such as the Aries L Interbody Fusion Device which can be created at a certain height, a certain length, as well as a certain angle, which offers our patients better, customized care.”

After many years of unsuccessful surgeries and procedures to reduce the debilitating pain she had been suffering from, Suzanne was referred to Dr. Joseph. Suzanne was willing to try new procedures, Dr. Joseph discussed the new implant that he had been developing with Osseus Fusion Systems. Dr. Joseph asked Suzanne if she wanted to give this new type of implant a try.

“Absolutely,” stated Suzanne, “I want my life back. I can’t grocery shop, I can’t cook, I can’t clean. I need to function.”

Osseus’ innovative and proprietary 3D printed technology provides surgeon-inspired spinal implants that fit perfectly with the patient’s anatomy which can be produced faster and more economically than traditional methods and provides better patient outcomes. 

The procedure consisted of two surgeries in two days. The first surgery was to take out Suzanne’s old fusion hardware, which consisted of vertical pedicle screws, which secure the vertebra to each other. The following day Dr. Joseph replaced the old implant with the new titanium implant Aries-L that has lateral rather than vertical screws.

“It was remarkable…instantly,” stated Suzanne, “I had never had a surgery like that which I was so able to just get up out of bed and walk around. They want you up that first 24 hours anyway, and I’m very good about that, but this was…ok, I’m up and I don’t have that profound pain.”

The Aries-L interbody fusion device features a proprietary multi-axis mesh and optimized micro-surface topology, both of which are designed to facilitate fusion. The product’s lattice helps increase the implant’s porosity to 80%, which provides unparalleled in-situ radio-visibility compared with other titanium implants. The implant’s anatomic profile, anti-migrational teeth, and streamlined insertion promote reduced recovery time by helping increase procedural efficiencies. 

Proprietary multi-axis mesh is designed to facilitate bone fusion throughout the implant.

Before the surgery Suzanne’s not only had the pain from sciatica but she also developed incredibly painful spasms that went from her rib cage all the way down into her ankle. Her whole side would lock up.

“I called them lightning pains, I didn’t know they were spasms, I had never had spasms before,” stated Suzanne, “the spasms started to diminish right away. I had fewer episodes and they lasted less time, but towards the end of the summer of 2019, they went away and they did not return, which was incredible!”

“I can’t tell you what it is like to be without the pain! I am constantly saying, thank you God, thank you! Thank you Dr. Joseph, thank you! The first thing I think about when I get up in the morning is…I’m not in pain. I can stand up. I don’t have to grab on to my walker to get up. I can just stand up and walk downstairs, take care of feeding my animals and get them outside, get my coffee and move about normally without profound pain.”

About Joseph Spine Institute

Joseph Spine Institute is the advanced center for spine, scoliosis and minimally invasive spine surgery. Founded by Dr. Samuel A. Joseph, Jr., a fellowship-trained, board-certified orthopedic surgeon. From state-of-the-art technology to alternate therapies and interventional pain management treatments our industry-leading spine care practice offers patients a comprehensive, multidisciplinary approach to diagnosis, treatment, and rehabilitation of spinal conditions. Our highly-trained surgeons and physicians offer an integrated approach to patients that includes surgical and non-surgical options such as pain management and physical therapy.

About Our Founder Dr. Samuel A. Joseph Jr.

Dr. Joseph has been practicing in the Tampa Bay area for over 10 years and is the founder of Joseph Spine Institute. He is dedicated to pioneering minimally invasive, outpatient spine surgical techniques along with complex scoliosis and revision surgery. He is also the team spine surgeon for the Tampa Bay Buccaneers. Dr. Joseph has assembled a comprehensive team of highly skilled spine specialists that are devoted to offering the highest level of spine care available. He has also strategically partnered with some of the most innovative leaders in the spine care industry in order to bring our patients the latest in technology, products, and resources.

About Osseus Fusion Systems 

Osseus was founded in 2012, and is based in Dallas, Texas. Osseus is an innovative medical device firm focused on developing advanced technology products for minimally invasive surgery. Its team of visionary product developers and forward-thinking surgeons push the boundaries of device development, creating unique products that make surgeries more successful, help patients recover faster, and improve healthcare outcomes. The Osseus product line includes Black Diamond Pedicle Screw System, White Pearl Anterior Cervical Plate, Red Ruby Anchored Cervical Interbody, Gemini-C Cervical Interbody and now Aries-TS, Aries-TC, Aries-A, and Aries-L. For more information about Osseus, please visit our website.

Advancing Genomics for Pediatric Orthopaedic Diseases


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“We are excited to collaborate with the world-renowned Jackson Laboratory to advance precision medicine and specialized pediatric care for the more than 100,000 patients we treat every year,” said Marc Lalande, Ph.D., vice president of research programs, Shriners Hospitals for Children.

With the goal of identifying advanced treatment approaches for children with genetic orthopaedic conditions, Shriners Hospitals for Children® and The Jackson Laboratory (JAX) have entered into a research affiliation agreement.

The agreement is part of Shriners Hospitals for Children’s new Genomics Institute. Based at its headquarters in Tampa, Florida, the Genomics Institute is focused on finding the genetic causes of orthopaedic conditions and disabilities such as clubfoot, scoliosis, and osteogenesis imperfecta, and easing – and, in some cases, perhaps even ending – the potential for a lifetime of medical care and personal struggle.

“We are excited to collaborate with the world-renowned Jackson Laboratory to advance precision medicine and specialized pediatric care for the more than 100,000 patients we treat every year,” said Marc Lalande, Ph.D., vice president of research programs, Shriners Hospitals for Children.

The availability of individual genetic data can lead to the identification of disease-related variations, or gene alterations, which can further lead to better ways to diagnose and treat pediatric orthopaedic diseases and other conditions.

As part of this agreement, Shriners Hospitals will perform next-generation sequencing on DNA samples obtained from families at its 22 hospitals and outpatient locations in North America and from its international network of outreach clinics.

Investigators at JAX will provide expertise on genomic data analysis, specialized knowledge bases and algorithms, as well as the microbiome. JAX will also aim to develop mouse models carrying the same genetic variations as patients with these rare pediatric diseases, providing impactful research platforms for discovering new treatments and important clinical information.

“Harnessing the power of genomics to understand the basis for orthopaedic and other pediatric diseases is of the utmost importance,” said Charles Lee, Ph.D., FACMG, scientific director and professor, The Jackson Laboratory for Genomic Medicine. “This research can bring hope to countless families, and we’re looking forward to working with Shriners Hospitals to help children around the world.”

About The Jackson Laboratory

The Jackson Laboratory is an independent, nonprofit biomedical research institution with more than 2,200 employees. Headquartered in Bar Harbor, Maine, it has a National Cancer Institute-designated Cancer Center, a genomic medicine institute in Farmington, Conn., and facilities in Ellsworth, Maine, Sacramento, Calif., and Shanghai, China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health. For more information, please visit http://www.jax.org.

About Shriners Hospitals for Children

Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our health care system provides care for children with orthopaedic conditions, burns, spinal cord injuries, and cleft lip and palate. All care and services are provided regardless of the families’ ability to pay. Since opening its first location in 1922, the health care system has treated more than 1.4 million children. For more information, please visit shrinershospitalsforchildren.org.

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FDAnews Announces — Early Bird Pricing Ends on Feb. 18, EU-Medical Device Regulation Compliance Workshops March 17-20, 2020


WCG FDAnews

WCG FDAnews

EU-Medical Device Regulation Compliance Workshops

Interactive Workshop Training from FDAnews and Ombu Enterprises

March 17-20, 2020 • Philadelphia, PA

https://www.fdanews.com/eumdrworkshops

Early bird pricing for EU-Medical Device Regulation Compliance Workshops ends on Feb. 18.

Accept our invitation for one, two, three or four productive days of hands-on training.

The EU-MDR compliance clock is ticking. Legacy products marketed in the EU are at serious risk unless one acts now. Many devicemakers still aren’t ready for May 2020 set date. The transition is one complicated set of rules!

Training kicks off with an introductory 2-day workshop Understanding and Implementing the EU-Medical Device Regulation/In Vitro Diagnostics Regulation on March 17-18. Master the conversion and implement the new MDR including:

  • The new MDR classification system (how to apply the system)
  • Conformity assessment paths (how paths apply to specific devices)
  • Annex I requirements (how to document compliance)
  • Technical documentation requirements
  • Unique Device Identification (EU approach)
  • Notified Body (its role)

Stay an extra day, March 19, to continue training with Post-Market Activities in the EU-MDR — A Detailed Analysis. Untangle one of the most complicated aspects of the new EU-MDR:

  • Which devices (by class and other attributes) require any specific activity
  • How to develop a plan and report for each activity
  • Understanding frequency and distribution of each report
  • Adverse events classification and reporting

Need help with EU-MDR auditing? Extend to March 20 with Implementing Effective EU-MDR/IVDR Internal Audit Programs. Get the information needed to integrate a Notified Body (NB) EU-MDR/IVDR type audit into internal quality programs:

  • Conformity assessment paths in the EU-MDR/IVDR based on device class
  • Initial NB auditing requirements in each conformity assessment annex
  • Surveillance NB auditing requirements
  • NB QMS requirements for Annex VII
  • Specific Annex VII areas in the initial audit
  • NB auditor qualifications from Annex VII
  • Mapping the NB audit approach to the medical device auditing program

Space is limited. First come – first served. There’s no time to waste between now and May 2020.

Early bird pricing ends on Wednesday, Feb. 18.

Conference Details:

EU-Medical Device Regulation Compliance Workshops

Interactive Workshop Training from FDAnews and Ombu Enterprises

March 17-20, 2020 • Philadelphia, PA

https://www.fdanews.com/eumdrworkshops

Tuition:

Course #1 Early Bird Pricing: $1,527 (available until Feb. 7, 2020)

Course #1 Regular Pricing: $1,797 (after Feb. 18, 2020)

Course #2 Early Bird Pricing: $767 (available until Feb. 7, 2020)

Course #2 Regular Pricing: $897 (after Feb. 18, 2020)

Course #3 Early Bird Pricing: $767 (available until Feb. 7, 2020)

Course #3 Regular Pricing: $897 (after Feb. 18, 2020)

Significant team discounts are available.

Easy Ways to Register:

Online: https://www.fdanews.com/eumdrworkshops

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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Shriners Hospitals Wants Children and Families to “Be Burn Aware”


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“The most important point to remember is that burns are preventable,” said David Greenhalgh, M.D., chief of burns at Shriners Hospitals for Children — Northern California.

Feb. 2–8, 2020, is Burn Awareness Week. During this time, Shriners Hospitals for Children® launches its annual burn awareness and prevention campaign. Since the 1960s, Shriners Hospitals for Children has been a leader in burn care, research and education — and burn injury prevention is a key component in these efforts.

Burn Awareness Week is Shriners Hospitals for Children’s kickoff of a yearlong educational campaign aimed at burn awareness and prevention. Free educational materials, available via the website beburnaware.org, are designed to be a resource for firefighters, teachers, parents and others concerned with the safety and well-being of children.

Building on the theme “Be Burn Aware,” our focus is on preventing burn injuries in the home, because most preventable burn injuries occur in residences. Homes are the sites of thousands of burn injuries to children every year, including scalds, fire-related injuries, and even electrical burns. Many of these types of incidents may be prevented by implementing some simple safety precautions.

“The most important point to remember is that burns are preventable,” said David Greenhalgh, M.D., chief of burns at Shriners Hospitals for Children — Northern California.

Consequently, educating parents and families about burn injuries is an important part of the mission of Shriners Hospitals for Children.

The burn awareness campaign features two child-friendly characters, Boots and Brewster – a caped, cuddly bear and a googly-eyed teapot – who are featured in activity books for children ages 3-7 and 8-12. The duo leads children through the various rooms of a house, pointing out dangers, and how to easily correct or avoid them. The coloring pages, word searches, cartoons and other activities are designed to grab children’s attention and present the information in a memorable, age-appropriate manner. The campaign also features various tip sheets and fact cards, all available online. Most of the materials are available in French and Spanish.

Shriners Hospitals has also created an animated video, Boots and Brewster: The Burn Awareness Pair, which kids are sure to enjoy. In the video, available on YouTube.com/ShrinersHospitals, Boots and Brewster take viewers on a fun and educational adventure to help them become more burn aware.

“Burn prevention strategies by Shriners Hospitals for Children and other organizations have resulted in a significant reduction in burn injuries in children and adolescents,” said George H. Thompson, M.D., interim chief medical officer of Shriners Hospitals for Children.

Shriners Hospitals for Children encourages everyone concerned with keeping children safe to visit beburnaware.org for helpful burn prevention tips and information on how to order the free materials.

About Shriners Hospitals for Children

Shriners Hospitals for Children is changing lives every day through innovative pediatric specialty care, world-class research and outstanding medical education. Our health care system provides care for children with orthopaedic conditions, burns, spinal cord injuries, and cleft lip and palate, regardless of the families’ ability to pay. Shriners Hospitals for Children is a 501(c)(3) nonprofit organization and relies on the generosity of donors. All donations are tax deductible to the fullest extent permitted by law. For more information, please visit shrinershospitalsforchildren.org.

Contact:

Ashley Ozols

Shriners Hospitals for Children

813-499-4273

aozols@shrinenet.org

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Litiscape Protects Physicians by Vetting Patients for Litigation Risk


The founder and CEO of Litiscape, Michael Kamalu.

“My goal is for physicians to be able to perform their job to the best of their ability without fear of vulnerability and exploitation,” Kamalu said. “Litiscape will provide physicians with peace of mind again, while also enabling them to provide the best-informed care for their patients.”

Litiscape, a new software company created to protect physicians from frivolous malpractice litigation and financial exploitation, launched this month. By screening for over 1,200 different liability factors in real time, Litiscape provides physicians with information that allows them to both protect themselves and give better care to their patients.

The program’s creator, Michael Kamalu, thought of the concept after his father, a private practice family physician, was hit with his fourth malpractice suit. After months of stress and damage to his practice, he discovered the patient had a long history of filing baseless lawsuits in pursuit of monetary payouts. Utilizing his business and medical school background, Kamalu created Litiscape so that physicians wouldn’t have to be blind to high risk situations and even exploitation. He’s also partnered with malpractice insurance carriers to provide physicians who use their software with a significantly discounted insurance policy, saving them a considerable amount of money.

“Unfortunately, the malpractice system incentivizes frivolous litigation,” Kamalu said. “Less than 15% of claims ever show any evidence of medical error, yet 97% of patient plaintiffs receive monetary payouts. Some people justify it by saying malpractice insurance pays the claims so it doesn’t have any significant effect on physicians, but that couldn’t be further from the truth. Premiums go up, countless hours are wasted, carefully groomed reputation is damaged, and in some cases, careers have been ruined. With Litiscape, we are putting some control back in the hands of physicians so that they can have the peace of mind to focus on what they became a doctor for – to help and to heal.”

Litiscape has a proprietary algorithm that calculates a risk profile based on numerous factors including past litigation history, fraud and criminal records. The software also notifies physicians of potential healthcare-influencing factors such as DUIs, prescription fraud, or drug arrests, even detailing what type of drug was involved such as narcotics, barbiturates, or amphetamines. With this knowledge, a physician can be on the lookout for drug-related symptoms and also be aware of which prescriptions may not be appropriate to prescribe.

“My goal is for physicians to be able to perform their job to the best of their ability without fear of vulnerability and exploitation,” Kamalu said. “Litiscape will provide physicians with peace of mind again, while also enabling them to provide the best-informed care for their patients. We believe it will soon become a new standard in the healthcare industry.”

About Litiscape

Litiscape’s core product is a software that allows physicians to vet prospective patients for potential liabilities – analyzing and weighing over 1,200 distinct background factors in real-time, and categorizing them by litigation risk, financial risk, criminal risk, and healthcare-influencing factors. By pulling from every public record and court database across the country, physicians have access to invaluable insights into everyone they treat. Litiscape is redefining the standard in provider protection and informed care. To learn more, visit http://www.litiscape.com.

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Immunitor publishes interim results from Phase III trial of oral immunotherapy for liver cancer


What makes this investigation standing apart from immunotherapeutic approaches in oncology is that it attacks the problem from a new angle not attempted before

Liver cancer, called hepatocellular carcinoma (HCC), occurs each year in more than 800,000 people around the world and about 700,000 die from the disease. HCC is the 5th most common cancer and the 2nd leading cause of cancer deaths. Mongolia firmly occupies the first place among all countries when it comes to incidence of HCC, while China has half of all patients suffering from liver cancer. The incidence of HCC is expected to rise in the United States and across the world, given the increasing prevalence of hepatitis C and B infections, alcohol consumption, NASH, diabetes, toxin exposure and obesity. By the time diagnosis of HCC is made, various surgical interventions or liver transplantation are often not feasible. Conventional systemic chemotherapy such as sorafenib, regorafenib, lenvatinib, and cabozantinib are seldom effective and quite toxic. The FDA has recently approved three antibody-based drugs for HCC indication: nivolumab, pembrolizumab, and ramucirumab. Additional immune interventions from the checkpoint inhibitor family, i.e., durvalumab, atezolizumab, and bevacizumab, as well as tremelimumab, which belongs to the anti-CTLA4 class, are being investigated. Experience has shown that none of the currently approved or experimental HCC drugs are free from adverse side effects and have limited effect in shrinking tumors. While we have witnessed a surge of systemic therapies in recent years, the need for safer and truly effective treatment remains.

The Immunitor study is published in January issue of Hepatoma Research(ClinicalTrials.gov Identifier: NCT02232490). Easy-to-use, once-per-day oral tableted therapeutic vaccine called hepcortespenlisimut-L (V5 or Hepko-V5) was developed by Vancouver-based Immunitor Inc in collaboration with medical team at the National Cancer Center in Mongolia and investigators in the USA, China and Thailand. This trial is continuation of successful 75-patient Phase II trial published in 2017 in the Journal of Hepatocellular Carcinoma. Anti-HCC property of V5 was discovered accidentally ten years ago during clinical use for original primary indications, which are chronic viral hepatitis and liver cirrhosis. V5 has been used by over 30,000 individuals since 2002 and has never been reported of causing any serious adverse reactions. The US FDA granted Hepko-V5 orphan drug designation status in 2014. V5 inherently incorporates all circulating antigens from pooled blood of HCC patients, including tumor unrelated immunogens such as viral hepatitis antigens, microbial antigens such as Mycobacterium TB, and alloantigens, which are not necessarily pathogenic. A version of V5 also known as Tubimod is approved by US FDA for immunotherapy of tuberculosis – most prevalent infectious disease in the world.

“What makes this investigation standing apart from current immunotherapeutic approaches in oncology is that it attacks the problem from a new angle that has not been attempted before. Our goal is to demonstrate that oral allogeneic vaccine delivery induces both the immune activation and at the same time the tolerance, which is the counterintuitive approach against paradigm dominating the field of immuno-oncology,” said Dr Aldar Bourinbaiar – the CEO of Immunitor. “We firmly believe that our approach makes sense since we see drastically higher response rate and unprecedented safety unlike anything published in in the past. Our investigation of hepcortespenlisimut-L is in its early stage and we are sure we will make more surprising discoveries down the road. Besides the profound influence on the immune response, which is expected from cancer vaccines, we see very clear clinical benefits in terms of improved liver function and decrease in tumor marker alphafetoprotein (AFP), which we have shown to be correlated with tumor regression. Indeed, when AFP levels in a patient are back to normal levels the tumor disappears.”

About Immunitor

Canada-based Immunitor is a private biopharmaceutical company with affiliations in USA, Russia, China, Hong Kong, Ukraine, Mongolia and South Africa. Immunitor has developed unique oral delivery platform and is among the top ten leading oral vaccine companies globally. Company has an extensive pipeline of 22 oral immunotherapy products at various stages of development, including many already commercialized. Immunitor’s therapeutic vaccines are made as ordinary appearing tablets or pills stable at room temperature for years. They are broadly split into three clinical categories: infectious diseases, metabolic/ inflammatory/autoimmune disorders and oncology indications (cancers affecting lungs, breast, liver, pancreas, gallbladder ducts, GI tract, kidneys, ovaries, cervix, brain, sarcoma, multiple myeloma, etc. For more information, please write at info@immunitor.com.

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Immunitor unveils breakthrough immunotherapy to treat tuberculosis in as short as one month


This is first-ever TB vaccine available as a low-cost pill

Immunitor Inc., commercial-stage biotech company, is pleased to announce the publication of positive results from the randomized, placebo-controlled Phase III clinical trial for Tubivac (V7), the first-in-class, orally-available therapeutic vaccine used as an immune adjunct for the chemotherapy of tuberculosis (TB). Tubivac consists of inactivated non-pathogenic strain of Mycobacterium vaccae, which is related to Mycobacterium tuberculosis – the pathogen that causes tuberculosis – most prevalent infectious disease affecting 10 million people every year. In addition, approximately 2 billion people, equivalent to roughly one quarter of the global population, are estimated to harbor a latent TB infection and therefore at risk of progressing to overt tuberculosis. The global spread of multi-drug-resistant (MDR) strains and co-infection with HIV also contributes to the challenges of treating TB – top infection in the world that killed 1.5 million people in 2018. The daily pill of Tubivac taken along with standard TB drugs has cleared TB bacteria within one month – the shortest treatment course available today. Currently, 6 months is required to treat drug-sensitive TB and at least 12 months for MDR-TB, which benefits 85% and 50% of patients respectively – the rates Tubivac can achieve after just one month.

The published trial confirmed safety and efficacy of two earlier Phase II studies of V7 at same 10 microgram per dosage strength. “This is first-ever TB vaccine available as a low-cost pill”, said Dr. Aldar Bourinbaiar, CEO of Immunitor. “Tubivac is a result of our earnest effort to address the unmet need for faster-acting regimens to treat all forms of tuberculosis including drug-resistant TB and TB with HIV. The anti-TB property of Mycobacterium vaccae strain used in this trial was first discovered in 1972 by Cynthia and John Stanford during Buruli ulcer outbreak in Uganda. The positive data from our trial, published in Elsevier’s Journal of Clinical Tuberculosis and Other Mycobacterial Diseases is a culmination of 10 years of altruistic endeavor aimed at developing oral immunotherapy with a novel mechanism of action that can alleviate suffering of people with TB. Our study has shown that Tubivac helps gain weight, reduce inflammation, and can counteract hepatotoxicity commonly caused by TB drugs. In addition, our clinical experience shows that Tubivac has a potential to treat asthma, emphysema, COPD, lung cancer and fibrosis – other serious medical conditions affecting lungs. Nothing principally new, since introduction of BCG vaccine in 1921 and deployment of TB antibiotics from 1940’s, has been developed to eradicate TB, which remains the number one killer disease today. Tubivac is faster, safer and cheaper of any TB interventions introduced so far and poised to be the paradigm shifter.”

About Immunitor

Canada-based Immunitor is a private biopharmaceutical company with affiliations in USA, Russia, China, Hong Kong, Ukraine, Mongolia and South Africa. Immunitor has developed unique oral delivery platform and is among top ten oral vaccine companies globally. Company has an extensive pipeline of twenty two oral immunotherapy products at various stages of development, including several already commercialized. Immunitor’s therapeutic vaccines are made as ordinary appearing pills stable at room temperature for years. They are broadly split into three clinical categories: infectious diseases; viral, bacterial, fungal and protozoan, metabolic/autoimmune/inflammatory disorders; atherosclerosis, diabetes, obesity, hypertension, psoriasis, endometriosis, etc. and oncology indications, e.g., cancers affecting lungs, breast, liver, pancreas, gallbladder ducts, GI tract, kidneys, ovaries, cervix, brain, multiple myeloma, etc. The development of three products was supported by Global Grand Challenges initiative from Bill and Melinda Gates Foundation, financed by the government of Canada. Immunitor currently offers for sale Ukrainian-made Immunoxel (Dzherelo) – immunomodulating phytoconcentrate and in-house developed Tubimod (V5), both of which were shown in Phase III trials to reduce the duration of TB treatment down to one month. Tubivac (V7) is yet another proprietary, orally formulated anti-TB orphan drug with shorter treatment duration. The injectable form of M. vaccae has been through over hundred clinical trials in more than 20 countries since 1980’s – however this inconvenient-to-use formula is twice-less effective and sold in China under VACCAE trademark by Anhui Zhifei Longcom – a company that has been inspired by John Stanford’s pioneering work. For more information, please write at info@immunitor.com.

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Cieplak Dental Excellence Attends ActDental Course to Improve Quality of Dental Care in La Plata, MD


La Plata, MD Dentist, Dr. Patrick Cieplak, and His Team at Cieplak Dental Excellence

Cieplak Dental Excellence Attends “The Successful Dental Practice” from ActDental

I couldn’t be happier with my nice smile. My teeth feel great!

Dr. Patrick Cieplak and his team recently attended a continuing education course from ActDental to better serve their patients. The course, titled “The Successful Dental Practice,” will help Cieplak Dental Excellence provide more innovative and personalized services like smile makeovers, dental crowns, and full mouth dental implants in La Plata, MD.

Cieplak Dental Excellence has been serving the La Plata, MD community for over 30 years, providing comprehensive dental services using the latest dental technology. Dr. Cieplak and his team regularly attend continuing education seminars to remain up-to-date in dentistry and to provide the most advanced treatments for their patients. Cieplak Dental Excellence has had many satisfied patients over the years.

“I had very bad teeth as a kid,” says Peter, a patient of Dr. Cieplak. “I got dental implants and dental crowns. Now, I couldn’t be happier with my nice smile. My teeth feel great!”

During the seminar, the team gained insight on how to grow their practice by differentiating themselves from organized dentistry. They also learned how to attract more patients to their practice and reduce cancellations. Improving how effectively the team can offer dental services will ultimately improve the overall experience of existing and new patients.

Cieplak Dental Excellence is proud to offer such services as dental crowns, smile makeovers, and full mouth dental implants. A smile makeover is a personalized treatment involving one or more procedures to restore the health, function, and cosmetic look of teeth. Treatment can include dental crowns or porcelain veneers to improve the shape, size, and color of teeth. Smile makeovers can also include the restoration of a full set of hopeless or missing teeth using full mouth dental implants. Dr. Cieplak and his team routinely provide custom smile makeover treatments to return their patients to a state of health, function, and confidence.

Dr. Cieplak welcomes patients to experience innovative and personalized dental care at Cieplak Dental Excellence. Those interested in dental crowns, full mouth dental implants, and other advanced dentistry treatments in La Plata, MD can contact the practice by calling 301-609-9999 or visiting http://www.patcieplakdds.com.

About the Practice         

Cieplak Dental Excellence has been offering trusted dental care to patients in the La Plata, MD area for over 30 years. Founder, Dr. Patrick Cieplak, is dedicated to learning the latest dental techniques and has completed thousands of hours of continuing education courses. Dr. Cieplak is one of only 3,000 dentists worldwide to achieve Mastership with the Academy of General Dentistry. He is a Fellow in the International Congress of Oral Implantology as well as Associate Fellow in the American Academy of Implant Dentistry. His associate, Dr. Charniece Whitaker, is a general dentist who received her Doctor of Dental Surgery degree from the University of Maryland School of Dentistry. She strives to always develop her skills and serve her community with minimally invasive and effective techniques. To learn more about Dr. Cieplak, Dr. Whitaker, their team or the services they offer, please visit http://www.patcieplakdds.com or call 301-609-9999 to schedule an appointment.

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FocalPoint Holdings Builds Patient Experience Expertise with Addition of Shareef Mahdavi and SM2 Strategic


“FocalPoint’s skill sets complement the work we’ve been doing with clients. They are bringing together best-of-class experts and I’m proud to be part of the group.” – Shareef Mahdavi

FocalPoint Holdings, one of the leading ophthalmic investment, management and technology firms, is pleased to welcome Shareef Mahdavi to their team, bringing deep expertise in helping clients improve the customer experience in medical environments. This addition to the FocalPoint portfolio gives clients access to one of the foremost thought leaders in this area. “I’ve had the privilege over the years of working with many practices and device manufacturers. The technology available to doctors for their patients is incredible,” noted Mahdavi. “What’s been missing is an experience that makes patients want to spend more time and money at the practice. This is especially critical in self-pay elective services, a large growth opportunity for modern medical practices.”

Earlier in his career, Mahdavi led the U.S. marketing launch for laser manufacturer VISX, helping LASIK become the top-performed elective surgical procedure in the US and Worldwide. Adding to his marketing and sales background, he became a Certified Expert in “The Experience Economy,” teaching clients how to create more value by differentiating their practices with a superior customer experience. His new book, “Beyond Bedside Manner: Insights on Perfecting the Patient Experience” will be launched in April by Story Seven Publishing.

“Shareef has always been a thought leader in the ophthalmic industry, and having him on our team seemed like a natural fit. The patient experience is so important for our practices and partners, and having someone of his caliber in our firm is something we are extremely excited about. We want FocalPoint to have the best and brightest innovators in our firm, and his addition continues that tradition,” said Dr. Anish Kapur, President of FocalPoint Holdings.

“FocalPoint’s skill sets complement the work we’ve been doing with clients,” added Mahdavi. “They are bringing together best-of-class experts and I’m proud to be part of the group.”

For more information on how FocalPoint Holdings can help improve your ophthalmology or optometry practice’s efficiency and revenue, please contact us at info@focalpointholdings.com today.

About FocalPoint Holdings

FocalPoint Holdings is a privately held investment and management firm specializing in healthcare and technology companies. As an experienced partner to outstanding management teams, FocalPoint helps build durable companies with sustainable value, especially within the ophthalmic industry. With their team’s depth of knowledge in multiple industries, FocalPoint is the perfect partner for entrepreneurs and business executives looking to grow their business.

Additional information about Focal Point Holdings is available at https://linkedin.com/company/focalpointholdings and http://www.focalpointholdings.com.

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Dr. Paul Amato Provides Dental Implants to Seattle, WA Holocaust Survivors Pro Bono


Dr. Paul Amato, Dentist in Seattle, WA

Dr. Paul Amato Offers Dental Implants in Seattle, WA as Part of the Holocaust Survivors Program

The fact that he survived such an awful thing, he is stricken by poverty, and he couldn’t afford dental care, made me want to do the best for him.

Respected Seattle, WA cosmetic dentist, Dr. Paul Amato, celebrates five years volunteering for the Henry Schein Cares Holocaust Survivors Oral Health Program, relieving tooth pain and treating the oral concerns of Holocaust survivors with pro bono care. By increasing their access to oral care, this compassionate program seeks to significantly enhance the overall quality of life of Holocaust survivors. Dr. Amato’s passion for oral health and compassion for his community is reflected, not only in his work with the Henry Schein Program, but in the quality of cosmetic and restorative dentistry he provides at LeCuyer & Amato Dentistry as well.

The Henry Schein Cares Holocaust Survivors Oral Health Program is a partnership between Henry Schein, Inc. and the Alpha Omega International Dental Fraternity, the world’s oldest dental fraternity. The program was created to answer the White House’s call to action to help vulnerable survivors age with dignity and support. When a survivor needs dental care, Jewish Family Services screens the patient then reaches out to dentists in that patient’s area that can serve the survivor pro bono. The care provided can range from simple tooth pain care with general dentistry to restorative dentistry including dental implant placement.

Dr. Amato has served many survivors during his five years volunteering with this program. In that time, he was able to work with Greg, a survivor from Moldova. As Dr. Amato explains, “Greg’s story is sad but poignant.” Greg was young when he was separated from his family. Now living in the United States, Greg has limited income and cannot afford the dental care he needs. Along with two other specialists, Dr. Amato was able to provide Greg with a full mouth reconstruction. They treated Greg with dental implants, root canals, crowns, and fillings. Not only did this care relieve Greg’s tooth pain, but the aesthetics and function of Greg’s mouth were fully restored.

Greg still visits Dr. Amato for regular hygiene visits. “I treat him like I would treat my own grandfather if he were still alive,” says Dr. Amato. “The fact that he survived such an awful thing, he is stricken by poverty, and he couldn’t afford dental care, made me want to do the best for him.” Every time Greg sees Dr. Amato, he calls out, “My son!” and wraps Dr. Amato in a hug.

Dr. Amato provides cosmetic and restorative dentistry in Seattle, WA at LeCuyer & Amato Dentistry along with Drs. Chris LeCuyer and Lauren Kopp. This dynamic team offers industry-leading treatments including dental implant placement, Bioclear Matrix, Invisalign®, and BOTOX®. They offer advanced technology in their state-of-the are facility and provide sedation dentistry to ease pain and anxiety for any treatment.

Those looking to relieve tooth pain or enhance their smile through restorative dentistry such as dental implants in Seattle, WA can connect with Drs. Amato, LeCuyer, and Kopp for a consultation. To schedule an appointment, call 206-626-5400 or visit http://www.lecuyeramato.com.

About the Dentists

LeCuyer & Amato Dentistry has brought industry leading cosmetic dentistry treatments to Seattle, WA for over 30 years. Dr. Paul Amato is passionate about his community and offers pro bono dental care through organizations like Jewish Family Services and the King County Dental Society. He actively attends continuing education courses to remain on the leading edge of his field, and has advanced training certifications from prestigious institutions including the American Academy of Cosmetic Dentistry and the Kois Center. Dr. Chris LeCuyer has over 30 years of experience in cosmetic dentistry and has lent his expertise to the Academy of General Dentistry and the American Dental Association. Dr. Lauren Kopp received her Doctorate of Dental Surgery from the University of Washington and regularly participates in continuing education courses to gain skills that will improve her patients’ health. These esteemed cosmetic dentists offer the most advanced treatments including the Bioclear Matrix, Invisalign®, and full arch dental implants. The team at LeCuyer & Amato Dentistry is committed to maintaining a standard of excellence in everything they do, providing the highest quality of care and precise results. To learn more about LeCuyer & Amato Dentistry and the industry leading cosmetic dentistry services they offer, visit their website at http://www.lecuyeramato.com, or call the office at 206-626-5400.

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