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Real-world evidence (RWE) is valuable not only for regulatory compliance, clinical decision-making and tracking adverse events. It can also drive patient engagement, profitability and professional advancement.The highest quality RWE reflects scientific rigor, long-term outcomes capture and statistical significance. For many, these parameters suggest expense and clinical burden. This need not be the case, especially in the context of Circles. An interesting use case for the efficient development of RWE, and subsequent value creation, is the recent work done by BioXcellerator (Biox) in Colombia.Biox treats patients from throughout North America, often coordinating with physicians in the U.S. and other countries. In 2022, Biox developed an observational study protocol comprising key pre-, peri- and post clinical datapoints. Outcomes are measured utilizing the Impairment Scale for traumatic spinal cord injury developed by the American Spinal Injury Association. Patients are also assessed using the Barthel Index For Activities of Daily Living.Biox has now collected real-world data against their protocol for more than 380 cases. Its preliminary reports and analysis are summarized in the charts below. These are already providing value to treating physicians, referring physicians, existing patients as well as those considering therapeutic alternatives for spinal indications.Moreover, such real-world observational studies are now standard for BIOX physicians and their patients. This will result in transparent evidence-based standards of care specific to a variety of indications and patient-cohorts.Although this use case involves biologics for degenerative spine disease, systematic collection and analysis of real-world evidence are valuable in the context of any indication or clinical setting. The generation by practitioners in any specialty of scientifically valid real-world evidence need not be burdensome or expensive. Moreover, it adds substantial benefits not only in clinical decision support, but practice growth, professional advancement, collaboration, product improvement and influence among peers.Contact us to find out more.

Evidence-based solutions for professional and financial advancement.You have the Cases, and RegenMed has time, tools and expertise toextract their true value. If you’ll share your objectives, we will present a turnkey, burden-free solution comprising one or more of: Study Design Patient-Reported Outcomes Patient Engagement Electronic Data Capture Peer-to-Peer Collaboration Social Media Management Ethical Industry Intermediation Compliance IRB’s and Ethics Committees Contact us to learn more.

Benchmarc™ provides instant access to patients' own health data, allowing them to see and understand the progress they have made. With this information, patients are able to have deeper conversations with their physician, such as discussing key milestones or manage a personalized recovery plan.To learn more, please see check out our downloadable Benchmarc™ Brochure.

RegenMed’s January 2023 Newsletter. Here, we summarize client activities of interest, events and upcoming activities. Find out more on our Latest and Circle Academies pages. SELECT CLIENT ACTIVITIES Healthcare providers and medical device manufacturers around the World are using Circles to advance their clinical, scientific and commercial objectives. Following are some recent examples. More information on each Circle can be found by clicking on the Circle Academy link provided after each entry. This will allow interested clinicians to get in touch with Circle Founders for permission to follow, or join, their Circles. Get Started With Your Own Circle Singapore General Hospital Together with his colleagues, Professor Tay Boon Keng, head of orthopedics at the prestigious Singapore General Hospital, is completing a twelve month study comparing the safety and efficacy of hyaluronic acid alone with HA plus PRP for knee osteoarthritis patients. Outcomes data using the WOMAC scoring system have been collected for 118 patients. Those data suggest improved scores for the HA+PRP group, compared with that of HA alone and this group is finishing the long-term follow-up for this project. Visit Dr. Tay Boon Keng's Knee OA and PRP Circle Academy Space Pagdin Health In 2020 Health Canada issued a Policy Position Paper regarding autologous cell therapy products. The paper emphasized the importance of practitioners working with Health Canada in helping to develop evidence-based standards of care for such interventions in the context of specific indications. Dr. Grant Pagdin in British Columbia is among the leading clinicians closely following Health Canada’s policy goals. Working with RegenMed, Dr. Pagdin has designed and implemented multiple Circles covering the use of PRP for various urological and musculoskeletal indications. He has established a dedicated Outcomes Page on his website, allowing patients to follow their progress over time against standardized benchmarks. Visit Dr. Pagdin's Circles Academies Space Apex Biologix Apex Biologix has funded 4 initial Circles to support its key opinion leaders, including Dr. George Chang Chien, in the establishment and growth of quality improvement registries around the use of PRP, BMC, A2M and more. Circle design and clinical/scientific hypotheses undergirding the Circle will be discussed on the EVOLVE Conference hosted by the Advanced Regenerative Medicine Institute February 3 – 5, 2023 in Salt Lake City. Visit Dr. George Chang Chien's Circle Academy Space Gulf Coast Biologics Under the leadership of Peter Everts, Ph.D., FRSM, Gulf Coast Biologics is organizing a clinically-sophisticated Circle for knee treatments utilizing PRP. Long-term outcomes utilizing the IKDC and WOMAC scoring measures will generate correlations against key pathoanatomic real-world datapoints, including PRP preparation, dosing and specific injection locations. Respected interventional practitioners from around the country are participating, including Doctors Luga Podesta, Glenn Flanagan, Donald Buford, Timothy Mazzola, Ariana Demers, Imran Siddiqui, Alberto Panero, Gayan Poovendran and more. In addition, Christine Mahoney, Ph.D. is providing statistical analysis support. Gulf Coast Biologics expects at least 50 patients to be enrolled each month for a minimum of six months. In addition, GCB will host monthly “Circle Hours” – LiveStream discussions on Circle Academies among Circle Members and registered participants reviewing early observations. Dr. Everts and RegenMed’s Scientific Director, Seve dos Anjos, Ph.D., will moderate the LiveStream event, as well as subsequent on-line Circle Academy discussions. Visit Dr. Peter Evert's Circle Academy Space JoinTechLabs Working with Doctors Mitchell Sheinkop, John Ferrell, III, Imran Siddiqui, Ariana DeMers and Janet Pearl, RegenMed has designed and implemented Circles to facilitate two studies for the delivery of micronized adipose for knee and shoulder pathologies. Endpoints will be measured using both patient-reported and clinically-assessed outcomes measures. The Circles are funded by JoinTechLabs, and will enroll over 30 patients. They will be overseen by the IRCM IRB. Visit Dr. Mitchell Sheinkop's Circle Academy Space Dr. Guillermo Álvarez Rey Guillermo Álvarez Rey, M.D. (sports medicine specialist) and Carlos Ferrer Señorans M.D. (orthopedic surgeon) from AMS Sonosurgery center - located in Málaga, Spain, have created several real-world studies using Circles out of their own clinical practice. As one relevant example for Knee Osteoarthritis, they are capturing patient outcomes up to a year using KOOS, and correlating those outcomes to various clinical factors, such as biological treatments used, and the Kellgren-Lawrence (KL) grade of each of their patients. They are capturing Real World Clinical Data for many other musculoskeletal indications such as Achilles tendinopathy, epicondylitis or shoulder pathologies. They have reached the landmark of 180 cases in all their Circles, many of which have already achieved the 12-months follow-up. Visit Dr. Guillermo Álvarez Rey's Circle Academy Space Dr. José Miguel Catalán Dr. José Miguel Catalán, orthopedic surgeon expert in the use of biological therapies for different indications, but particularly on PRP and BMC, is one of the pioneers in the use of Circles and the inCytes platform for Real World Data Collection since 2019. Dr Catalán has already collected PRP characterization data from near 300 clinical cases, including platelet dose and other variables, that he is now correlating against the longterm patient-reported outcomes using WOMAC scale. He is presenting these updated Real World Data at OrtoBioMSK specialized course in Seville on February this year, and also at the next TOBI Conference. Visit Dr. Catalan's Knee PRP Circle Academy Space Visit Dr. Catalan's Bone Marrow Aspirate, Knee and Hip Circle Academy Space THE WORLD OF REAL-WORLD EVIDENCE AAOS Real-World Evidence Registry The AAOS registries cover several traditional orthopedic interventions. The Academy is now discussing how to collect real-world evidence to deliver efficacious, safe orthobiologic therapies, as well as the elements for biologics registries and bio-repository systems. RegenMed attended a small conference held in November of 2022 in Washington D.C. by AAOS. Other invitees included representatives from the FDA, HHS, the Biologic Association and clinicians from around the country. For more information on approaches to and benefits of biologics registries, this RegenMed Article may be useful. Sunsetting Of Arthrex’s Surgical Outcomes Center About ten years ago, Arthrex introduced its Surgical Outcomes System (“SOS”) to help customers collect outcomes data against particular orthopedic interventions. Arthrex has announced the discontinuation of SOS effective August 1, 2023. RegenMed is working with former SOS users to transition their existing data and outcomes capture programs to Circles. Mandates, Best Practices, References The concepts of “real-world” data and evidence have existed in the literature for many years. They are now playing important roles for providers, payers, manufacturers and other healthcare stakeholders due to legal/regulatory mandates, value-based medicine, and patient expectations. A good summary of references, as well as clinically efficient approaches to generating value from real-world data and evidence, can be found in this publication by the Agency For Healthcare Research and Quality, part of the U.S. Department of Health and Human Services. COMPANY NEWS New Website RegenMed’s website has been thoroughly reorganized. We hope it will help healthcare stakeholders more easily find information on PROMs, Studies, Registries, Publication and other solutions to developing and generating value from real-world clinical data. The site makes it easy to get started in generating value from Circles in a number of ways. These include free Demo Circles, as well as Open Outcomes Circles and Open Registry Circles. These allow providers to be up and running with value-added Circles in a matter of minutes, and at minimum cost. Circle Academies RegenMed has now launched Circle Academies in two versions. The Open Academy is available to anyone in the healthcare field. The Members Only Academy is accessible only to clinicians who register. It provides a secure, moderated forum to clinicians to teach, learn and observe in the context of real-world data pertaining to specific clinical conditions and procedures. Circle Academies provide all of the functionality of modern social media platforms, without the multiple disadvantages. Events Circle Members and RegenMed regularly present their study designs and observations at medical and scientific conferences around the world. Recent and upcoming events include: CASEM, Quebec City September 2022 EVOLVE, Salt Lake City, February 3- 5, 2023 IOF Max Experience, Scottsdale, February 16 – 19, 2023 TOBI 2022, June 2022, Hollywood Fl. OrthoBioMSK, February 9 – 11, Seville, Spain Sport AMS Ultrasound, April 20-22 2023, Malaga Spain Fidia Academy, October 28 – 29, 2022, Praglia Abbey, Italy Gulf Coast Biologics

Introduction"My name is Dr. Grant Pagdin. I live in Kelowna British Columbia and my practice focuses on anti-aging and regenerative medicine. I have a specific interest in using PRP and stem cells for regenerative procedures. Principally the focus is on orthopedic issues, so tendons, ligaments, and joints. But also we address areas of cosmetic concern, like facial rejuvenation and scalp treatments for the stimulation of hair growth. I also do regenerative injections for sexual enhancement for both men and women. I started doing regenerative procedures back in 2013. Initially we were interested in getting some feedback from our patients as to how they were doing. And typically we would just ask them questions, what do you estimate has been your improvement? And they would give us sort of a percentage, oh, I feel 60% better.More recently, we've taken an interest in tracking outcomes a bit more specifically than just asking patients subjectively how much better they feel.How do you capture patient outcomes?One of the issues that we faced initially when we made a decision to engage in some formal follow-up with symptom scores was actually get the patients to kind of buy in and participate. So the platform that we're using for gathering this data is very user friendly. We encourage the patients at the time that they enroll for a treatment of PRP to download an app that they can interact with. And the great thing is that my staff doesn't have to constantly be sending out reminders for our patients to complete these sorts of questions. The system is completely automated so that the reminders come to the patient automatically they fill in the data for us and the data comes to us directly for our analysis. So that we have been able to establish a really good percentage of participation amongst our PRP clients.How will you use these data in your practice?In terms of the reasons behind why we would be collecting this data and what we might be using it for? There's really three main areas that are important to me. Number one is I want to be able to have some actual objective numbers that I can share with prospective clients. And that way they can have a little bit better handle on exactly what I'm doing and what what kinds of outcomes I'm experiencing. The second area that I think is important for me is to be able to share some of my outcomes with my colleagues. Now we want to make sure that we're comparing apples with apples. So I make sure that my PRP for instance is concentrated at five times baseline. And so we're able to indicate the sorts of parameters around the intervention that we're doing and also share some of our outcomes data with like-minded colleagues. So in this way we could actually pull together some data that is much more powerful than just the data I'm collecting my own clinic. If there were other providers doing similar procedures, then we could say, well you know over the 200 or 300 cases that we have done together, these are the sorts of outcomes we're getting. Then the numbers start to become really very significant. And then the third important reason why I want to try to collect this data is that we are in a field that is increasingly facing regulatory oversight. And we know that you know Health Canada is particularly interested in regulating cells and biologic materials. So any use of stem cells, whether fat or bone marrow or any other sources are being classified as drugs. And the individual colleges of physicians and surgeons in each province are keeping a close eye on this field as well. So that I think that it behooves us to be acknowledging that these types of interventions are experimental in nature. We tell our patients that there's no guarantee as to the outcome, but we want to make sure that we are tracking outcomes to ensure that these procedures are being done safely and effectively.How can interested colleagues learn more?At this point in my practice, I have collected data on over 60 subjects for a variety of different indications and I am willing to share that data with my regenerative medicine colleagues. I would also encourage my colleagues to be collecting data of their own and sharing that as well because I think that's a very important way that we can really move this field forward. I think if we pool our efforts and and work together cooperatively then I think this field of regenerative medicine in Canada can really advance that by leaps and bounds. So I'd invite my colleagues to reach out and I'd be happy to give you some more information on just exactly what we're doing and share with you some of the data that I've accumulated to date."