DiFusion, Inc., an Austin, Texas-based leader in biomaterial technological innovation focused on introducing bioactive polymers in spinal and orthopedic surgery, today announced the results of the study "Can a bioactive interbody device reduce the time horizon for Spinal fusions?" that validates ZFUZE as the first homogenous new biomaterial introduced in more than 20 years.

Beyond titanium and PEEK, there has been little industry innovation in recent years, according to Derrick Johns, the CEO and Founder of DiFusion Technologies — a company dedicated to engineering and bringing to market a suite of patented immunomodulatory, tissue regenerating and antimicrobial polymers — who said, "ZFUZE overcomes the shortcomings of titanium and PEEK such as cage subsidence and fibrous tissue encapsulation.

"The industry has taken shortcuts with regard to new biomaterials. To date, they have merely applied surface coatings to PEEK and altered the surface topography of titanium. Large device companies are hesitant and may not be equipped to take on new biomaterial projects that take years to develop and test with no guarantee of success." Johns continued, "ZFUZE is a long-overdue innovation."

The ZFUZE retrospective study was conducted by Paul Kraemer, MD, at the Indiana Spine Group and consisted of 41 patients who underwent TLIF [define] single and double level lumbar interbody fusions. Radiographic CT analysis conducted by third-party Medical Metrics Inc on ZFUZE implants showed a 91.4% fusion rate at 8 months. "Maybe the most important thing about the study was there were no exclusion criteria," Dr. Kraemer said. "It included anyone who I felt had surgical pathology best amenable to a TLIF, which is my most common fusion technique. There were old people, patients with scoliosis and osteoporosis, lots of adjacent segment pathology and more. It's a realistic view of a modern surgical practice — and the material acquitted itself very well. It fused and fused quickly. Importantly, it fused like we thought it would, with real bone seen on CT directly adjacent to the implant, including through the cage. Even better, there was no cage subsidence and no fibrous encapsulation. It's a testament to the material acting in vivo exactly as we expected from our in vitro and animal studies."

Peter Whang, MD, associate professor at Yale University in New Haven, Conn., summarized: "ZFUZE is truly an example of differentiated homogenous new material technology that bridges the gap between conventional PEEK and titanium. Specifically, ZFUZE shares the same advantages of standard PEEK relative to titanium in that it facilitates visualization of bone formation across the disc space, exhibits the same modulus of elasticity which reduces the risk of subsidence and does not produce metal wear debris. However, it is not associated with the formation of a fibrous capsule and promotes osseointegration, like titanium. There is ample data from basic science investigations, animal studies and now extensive clinical experience showing that this novel biomaterial does not give rise to chronic inflammatory changes which may limit the utility of PEEK and titanium. I am extremely excited about the potential of ZFUZE to bring about earlier and more robust bone formation for my fusion cases."

The ZFUZE research and development process has involved laboratory, animal and human studies. These studies include:

Osteoimmunology testingi conducted by the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. This testing found a decrease in chronic inflammation compared to titanium and PEEK and a 700 percent increase in osteoblast proliferation versus titanium and PEEK. There was also pro-reparative immunomodulation, as ZFUZE increases Interleukin-10 and Interleukin-12. In addition, ZFUZE demonstrated higher levels of rhBMP upregulation versus titanium and PEEK. "We have tested over 300 materials here at McGowan and have never observed positive immunomodulation toward early healing like we see in ZFUZE," said Stephen Badylak, MD, DVM, PhD.

Animal studiesii by Boyle Cheng, PhD, at Meadville, Pa.-based Alleghany University, using sheep and rabbits, found statistically significant reductions in proinflammatory cytokines Interleukin-1 beta and Interleukin-6 at six months versus titanium and PEEK, along with successful fusion.

Human studies,iii led by Paul Kraemer, MD, of Indiana Spine Group, were conducted retrospectively with 41 patients. No patients were excluded, as is typically the case in other retrospective studies; in fact, smokers, osteopenic and diabetic patients were all included. The average patient age was 67. Medical Metrics LLC performed third-party radiographic fusion analysis via CT scan for 91.4% fusion rates at an early 8-month timepoint.

About DiFusion

By definition, biomaterials are foreign bodies. Historically, their design has largely been based upon mechanical and physical properties, and bio-inertness was a desirable characteristic. Today, as the adaptability of immune cells and the role that biomaterials play on immune-mediated tissue responses become better understood, there is a shift toward designing materials that can proactively modulate the immune system.

Located in Austin, Texas, DiFusion was founded in 2009 and is dedicated to engineering and bringing to market a suite of patented Immunomodulatory, Tissue Regenerating and Antimicrobial
Polymers. DiFusion has assembled a team of leading clinical and research experts on their Scientific Advisory Board

i McGowan Institute for Regenerative Medicine - UPITT
ii Allegheny University - Center for Neuroscience: Un-plated Cervical Sheep Fusion Study Cage Study;

DaVinci Labs: Rabbit Femur Critical Defect Study
iii Indiana Spine Group and Medical Metrics LLC - Third Party Radiographic Fusion Analysis

Author and Book
Theo Bill and his new book, Coaching Leads Formula

With over two million coaches in America, most have only one-two clients and don't earn more than $500 per year. Combined, obesity and depression affect over 200 million Americans every year - and coaches can help eliminate many of those challenges. That is why marketing expert and entrepreneur Theo Bill, founder of CoachingMBA, wrote his latest book, Coaching Leads Formula.  

According to Mr. Bill, "Coaches love to help others, but don't know how to get consistent clients - and too many people are still suffering. Eventually, the coaches get discouraged and stop coaching." In the book, Mr. Bill explains that you "don't have to be on Instagram or TikTok every day" in order to attract clients. In fact, if you follow his formula, coaches get to do more of what they love. 

Using his 20+ years of experience in the marketing field, his aim is to get health and life coaches going from coaching part-time to full-time. This is especially important with all the physical and mental health issues currently facing millions across the America.  

Coaching Leads Formula is a quick and easy read with simple exercises to help any coach come up with a proven marketing system so they can focus on their clients rather than sales calls. In just six steps, Coaches of any kind will learn how to connect with their prospective clients easily.   

Peppered throughout the book are anecdotes from his personal life and experience. He uses his years of experience in marketing and entrepreneurship to show how a coach can go from one or two clients to as many as they want.  

His realistic and down-to-earth attitude is a breath of fresh air in an industry fueled by hype and images of fast cars and private jets. Mr. Bill avoids the jargon of "6 Figures" because he believes that's a random number - not a realistic one. "Your full-time number is entirely up to you and your needs," he says. "You could be happy and fulfilled with five clients or 50 - it depends on your coaching model and your financial goals."  

Theo Bill has a deep respect for coaches because they've helped him in his own life. Having worked through severe depression and helping him to drop over 40 pounds, various coaches helped him overcome some of his biggest struggles. "I learned to not only like but love the guy in the mirror - that's my real goal - helping as many people get the same outcome I got from my coaches."

Learn more:  getclf.com 

Coaching Leads Formula: How to go from coaching part-time to full-time using a proven 6-step formula.

Available on:
Amazon $8.99; Kindle $2.99.

Press contacts:  [email protected]

Pace\u00ae Life Sciences Logo
Pace\u00ae Life Sciences Logo

Pace^® Life Sciences, LLC, a full-service contract development and manufacturing organization (CDMO) and a subsidiary of Pace^®, a science and technology company, announced today that it has acquired Biopharma Global (Biopharma). Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs.

"Pace^® provides great value in our marketplace through our technical expertise and by meeting the strong commitments we make to our clients that rely on us to successfully advance their programs through development," said Eric Roman, CEO of Pace^®. "The acquisition of Biopharma Global extends our reach further into regulatory strategy, guidance, and support in key therapeutic areas and greatly extends the reach of Pace^® into our markets."

Expertise gained through the Biopharma acquisition allows Pace^® to extend the following capabilities to its clients:

• Regulatory strategy development
• Regulatory affairs submissions including FDA and EMA applications
• IND applications
• Orphan drug consulting
• Rare pediatric disease designations
• Fast track designations
• Biologics license applications

"The Biopharma Global team brings strong expertise in early drug development with sound regulatory strategy guidance and robust submission support," notes Greg Kupp, President of Pace^® Life Sciences. "These services greatly enhance the continuity of offerings we provide to our clients and helps them to efficiently drive new drug candidates through the development process."

In the coming months, Biopharma will transition to the Pace^® brand. The Biopharma operation is located in Vienna, Virginia, and joins Pace^® Life Sciences locations near Boston, MA, Salem, NH, Philadelphia, PA, Ann Arbor, MI, San Diego, CA, St. Paul, MN, and San Germán, PR.

Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.

ABOUT BIOPHARMA GLOBAL

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. BIOPHARMAGLOBAL.com 

ABOUT PACE® LIFE SCIENCES

Pace^® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Part of the Pace® Science and Technology Company, Pace^® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the United States. Learn more at PACELABS.com

ABOUT PACE®

Pace® makes the world a safer, healthier place. For decades, Pace® people have been committed to advancing the science of the pharmaceutical and biotechnology industries in our Life Sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more through our Analytical Services laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science, and the data they need to make critical decisions that benefit us all. Learn how Pace® people are working to advance science through sustainable practices and continuous innovation. More at PACELABS.com

###

Media Contact: Pam Bednar | [email protected]

Former OptimizeRx CEO and founder David Harrell today announced the launch of his newest endeavor, TranspareRx.  The company aims to bring full transparency to prescription pricing and coverage, and is expected to soon introduce Cuverd™, the next-generation prescription savings platform and mobile app. 

"Nobody should leave a medical office without knowing the best price for their prescribed medications, or be surprised by a high cost once they get to the pharmacy counter," said Harrell. "One thing most Americans can agree on is that the cost of prescription drugs is way too high, which is why we are setting out to disrupt the industry and bring greater savings to patients."

With Cuverd's proprietary technology, TranspareRx will take the cost mystery out of prescribing for both patients and healthcare professionals. Powered by a simple, user-friendly interface, the platform automatically navigates all the complexities for each unique user to deliver the lowest "out of pocket" price per medication by factoring a multitude of variables in real-time, including medication coverage across 7,000 employers and health plans; estimated copays; eligibility for additional copay savings and other programs; and comparisons to "cash" prices from leading discount card partners. Cuverd also provides less expensive medication alternatives for patients to discuss with their healthcare provider(s). 

Unlike stand-alone drug discount card companies who only provide best "cash" prices, Cuverd goes further to also provide savings to the 85% of Americans with prescription insurance who also want to save on their rising copay costs. As one example, a cancer medication that costs thousands of dollars per month can become as low as $0.00 for a patient using Cuverd.

Harrell is a recognized healthcare industry leader who pioneered the development and integration of prescriptions savings and clinical support technology directly into hundreds of Electronic Health Records (EHR) systems during his 10 years leading OptimizeRx. To build TranspareRx, he again teamed up with Karthik Sundaram as Chief Technology Officer, who previously led all aspects of technology at OptimizeRx. 

"I am proud we brought prescription savings and support directly into the prescribers' electronic workflow. However, many patients did not always have the savings applied," commented Harrell. "With Cuverd, we now want to bring those savings directly to the key financial stakeholder: the patient."

Through its pharmacy dispensing system integration, patient and provider-facing apps and websites, TranspareRx will be launching customized solutions in partnership with some of the largest retailers, PBMs, employers and healthcare platforms in the country to help their customers, members and employees better understand their medication coverage and available savings.

About TranspareRx

TranspareRx Corporation encompasses a team of proven industry leaders who all share a passion to deliver better price transparency and savings right into the hands of millions of Americans needing help in understanding their prescription costs and available savings on their rising out-of-pocket prescription costs and benefits. 

TranspareRx Contact 
Julia Bidigare

[email protected]

Media Relations Contacts 
Dean Mastrojohn, Group Senior Vice President, Media

Goodfuse  
[email protected] 

Emily Kelley, Senior Account Executive

Goodfuse

[email protected]

Tampa General Hospital and Recora

Recora today announced that it is partnering with the Tampa General Hospital Heart & Vascular Institute for its Cardiac Recovery Program. This program will be the first of its kind in Florida's Tampa Bay region, expanding Tampa General Hospital's (TGH) outpatient cardiac rehabilitation program to more eligible patients in the academic medical center's 23-county service area. 

"Cardiac rehabilitation with supervised, escalating doses of exercise is crucial for complete recovery from a major cardiovascular surgery or procedure. Similarly, patients with heart failure can receive enormous benefit from cardiac rehabilitation. The main barrier for patients to fully benefit from this therapy has always been convenience and access," said Dr. Guilherme Oliveira, professor and chief, Division of Cardiovascular Sciences, USF Health Morsani College of Medicine, and executive director, Tampa General Heart & Vascular Institute. "Recora removes the access barrier and provides the convenience that patients need to successfully complete cardiac recovery and rehabilitation by allowing this to happen right at home. It's a game changer for patients that require cardiac rehabilitation."

Through virtual tools provided to patients and on-demand access to care teams and other resources, the program empowers patients to manage their heart health from home while enabling providers and plans to provide comprehensive cardiac care and strengthen patient relationships. Recora currently serves more than 30,000 cardiac patients in the U.S. across health systems, health plans and medical groups in urban, suburban and rural communities. 

Recora's Cardiac Recovery Program moves beyond 12 weeks of rehabilitation to deliver comprehensive care management that focuses on a patient's overall health and wellness.

"Today, one in four people in the U.S. die of heart disease, according to the Centers for Disease Control and Prevention (CDC). Although cardiac rehabilitation is considered the standard of care, just 16% of eligible patients start the program and 26% finish all sessions. Tampa General has made the decision to change that," said Recora CEO Abhishek Chandra. "We are excited to extend Tampa General's care delivery to patients within their own home through a personalized and convenient cardiac rehabilitation curriculum that can engage patients in continuing a healthier lifestyle that can improve their health." 

Recora's Cardiac Recovery Program has already garnered industry-leading results that include:

• 15% hospital readmission rate for Recora patients, versus the national average of 43% across Medicare patients with heart failure at six months.
• 87% Recora cardiac recovery program completion rate, versus the national average of 26%. 
• 95% of Recora patients with hypertension improved into normal blood pressure ranges.
• 94% of Recora patients adhere to their cardiac medication.
• 80% improvement of distance and strength gains among Recora patients.

In addition to its strategic collaboration with Recora, Tampa General participated in Recora's most recent Series A round of financing, which was led by San Francisco-based venture capital firm SignalFire. The Series A funding will help accelerate Recora's product and technology development, as well as grow its sales and marketing efforts, according to the company. 

Tampa General's participation was coordinated through TGH Innoventures, which, among other things, provides Tampa General with a platform to invest resources and funds into emerging companies. "We are very excited to expand our partnership with Recora by making this strategic investment," said Rachel Feinman, vice president of Innovation at TGH and managing director of TGH Innoventures. "This investment emphasizes our commitment to driving growth and providing value to companies we believe have the potential to transform the future of healthcare." 

ABOUT RECORA

Recora's mission is to redefine the future of heart health. Recora's Cardiac Recovery Program for health systems, medical groups and health plans makes it easier to recover from a cardiac event through immersive programs delivered online. With Recora, health care providers are able to establish a longitudinal relationship with patients and help them live longer, fuller lives. To learn more, visit recora.com. 

ABOUT TAMPA GENERAL HOSPITAL 

Tampa General Hospital, a 1,040-bed, not-for-profit, academic medical center, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2022-23 Best Hospitals, and is tied as the third highest-ranked hospital in Florida, with seven specialties ranking among the best programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic medical center's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings — first nationally in the 2022 America's Best Employers for Women and third out of 100 Florida companies in the 2021 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2020, provided a net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health, and 21 TGH Imaging powered by Tower outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.

Media Contacts: 

Adam Hritzak
Director of Marketing, Recora
(614) 946-7916 | [email protected]

Karen Barrera                                                                      
Assistant Director Communications & Partnerships                                  
(813) 928-1603 | [email protected]                                                             

MDR Logo

A new health records app, MyDigiRecords, has announced that it has received an undisclosed, sizable pre-seed investment from Terry Dunn. The funds will be used to help commercialize the app, which will enable consumers to directly manage their health records, like immunizations and prescription drugs. The app will leverage artificial intelligence (AI) to send notifications and reminders based on guidelines, enabling individuals make better decisions about their health, and ultimately reduce cost to the overall healthcare system.

The current healthcare system is based on fragmented systems that leave individuals with major blind spots in their healthcare, resulting in billions of dollars in medical waste each year due to inefficiency, over-treatment or poor care coordination.

"Patients need easier access to their medical records," says MyDigiRecords founder and CEO, Dr. Saroj Gupta. "They could face life-threatening issues if they miss important vaccinations or erroneously obtain multiple doses because of poor or hard-to-find documentation. We're excited that Terry decided to invest in MyDigiRecords - which will play a big role in driving our mission."

The launch of MyDigiRecords will focus on immunizations with future updates that will allow individuals to also track their medications. The app will provide notifications about proper use, including alerts for when to stop taking the medication to curb overuse. It will leverage AI to identify potential drug interactions as well as schedule appointments with one-click.

"By empowering healthcare consumers with better access to their records, we see a huge opportunity and are excited to be a part of MyDigiRecords growth," says Terry Dunn.

MyDigiRecords plans to reach individuals by partnering with large organizations, like commercial insurance companies, state-based health insurance, and employers along with non-profit organizations to empower individuals to take control of their healthcare and ultimately drive down the cost of healthcare.

ABOUT MYDIGIRECORDS
Founded in 2022, MyDigiRecords is focused on empowering people to take control of their healthcare by ensuring health information is always within reach. Families can stay up to date with immunizations based on CDC guidelines, manage their medications, get notified of potential medication reactions, and work with their healthcare providers to make informed choices about their health. For more information, visit MyDigiRecords.com.

MEDIA CONTACT
For press inquiries, please contact Chris Humphreys at [email protected]