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Plasmaconcept AG, headquartered in Köln, Germany, has chosen Circles to conduct a multi-center, post-market surveillance study on its IM.P.A.C.T. platform for autologous cell therapies.Working with multiple independent European customer sites, and under ethics committee approval, Plasmaconcept AG will aggregate longitudinal outcomes data from real-world patients suffering from tendinopathy and osteoarthritis of various joints. Patient compliance in this real-world study will be a key factor, so Plasmaconcept AG will be taking steps to ensure:Patients are regularly assigned patient reported outcomes measures (PROMs) to be completed electronically from their home and/or mobile devices for up to two years post-treatment.Engagement and compliance are increased through automated communications in their native German language, live feedback on their reported scores and long-term tracking of their progress over time.A Clinical Research Organization (CRO) handles telephonic follow-ups for patients who are of an advanced age, have issues with technology, or are simply unresponsive to multiple follow-ups.Complementing this strong patient follow-up regimen are key clinical criteria, such as the specific dosages of erythrocytes, leukocytes and platelets chosen for each patient/indication. Such data will require less than a minute of work per site per patient but will support meaningful correlations which advance working knowledge on autologous cell therapy dosages.Plasmaconcept AG anticipates ethics committee approval before close of 2021 and will be launching its Circle in early 2022.If you would like more information about Plasmaconcept AG, its IM.P.A.C.T. device, or its post-market surveillance Circles, contact us here.

The FDA states “Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD”. Medical affairs and clinical research teams are already fast at work exploring ways real-world evidence (RWE) can complement, or even one day replace, costlier, more traditional regulatory approaches. Less commonly explored, however, with potentially greater commercial value, are the channels by which RWE can augment product sales.‍Distribution Challenges Susceptible to RWEMedical product sales can be reduced to two foundational pillars: (1) having a good product and (2) properly communicating the benefits of that product to customers. Most managers across numerous industries agree that the second is generally the more important of these two. Therefore, companies who are struggling in their post-market sales and marketing strategies most likely have a communication problem, not a product problem. These issues can manifest in many ways, including:Speaking the wrong “language” to busy healthcare providers.Speaking through the wrong people, such as detail reps or inexperienced sales staff.Not sharing anything sufficiently new, nor interesting, from competitors.Communicating episodically, or infrequently through unimpactful mediums.Inability to use language which legally, you cannot say.These language issues generally cause poor ROI, and can drastically increase the time, cost and complexities in reaching your desired market growth. To fix your sales, you must first fix your language.‍RWE as Your Ideal Customer LanguageYour customers are your best spokespeople. Their routine language is cases, protocols and outcomes, communicated simply and quantitatively. They prefer their information to come from trusted peers, with whom they interact regularly of their own volition, and whose motivations for improved predictable outcomes mirror their own. Finally, although clinical trials remain amongst the strongest sources of clinical evidence, those real-world data which derive from the pragmatic health care practice and their heterogenous patient populations, can be more familiar, realistic and therefore actionable.Manufacturers and their distributors, confident in the quality of their product(s), should rethink their language, spokespeople and mediums of conversations. By supporting existing customers and KOLs in the generation of RWD and extricating oneself from the focus or delivery of such data, companies can significantly expand the number of conversations around the use, outcomes and manifold benefits of their products. Such conversations will be better received if delivered peer-to-peer, and if using a language which conforms to their quantitative, busy and pragmatic clinical realities.‍

According to the FDA, real-world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, including:Electronic health records (EHRs) Claims and billing activities Product and disease registries Patient-generated data including in home-use settings Data gathered from other sources that can inform health status, such as mobile devicesAlone, RWD have limited applications, but when properly organized, integrated, and correlated against longitudinal outcomes, may become real-world evidence (RWE). The FDA defines RWE as “evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.”RWE generation, therefore, requires a methodical application of robust analytics against proper sources of RWD deriving from routine clinical care.Why is Real-World Evidence Valuable?In healthcare, there’s a gap between traditional clinical research, such as double-blinded, placebo trials, and everyday clinical procedures, interventions, and office visits. This gap creates a growing discrepancy between studied outcomes against curated patient populations, and actual outcomes across a heterogenous population.RWE addresses those gaps by correlating RWD stemming from a larger, more genetically diverse, and therefore more broad-patient relevant population. As just one example, a medical manufacturer could more cost-effectively generate RWE to satisfy the following post-market obligations:Detecting adverse events for a new device.Comparing new products or treatments with existing options and the standard of care for different patient cohorts.Updating clinical guidelines.Complying with regulatory requirements.RWE has the potential to drive cost-efficiencies, address evidence-based gaps throughout the healthcare system, and ultimately drive more predictable, personalized patient outcomes.If you’re interested in learning more about how real-world data and real-world evidence could support your healthcare goals, talk to one of our experts.

In February 2020, RegenMed and StemMedical® signed a deal to create a Circle for their proprietary stem cell-enriched lipofilling method for breast, facial, buttock augmentation and artificial implant replacement where a mix of autologous fat and autologous laboratory-expanded stem cells ASC (adipose tissue-derived stem cells) is injected with approximately 100% fat graft survival.The Circle has two principal objectives:To provide StemMedical® with large registry of valuable patient data, helping to demonstrate the natural effectiveness of their expanded stem cell-enriched adipose material in achieving and maintaining volume over time.To provide StemMedical® patients with an engaging, automated follow up experience which presents their results, before/after images and obtains answers to efficient satisfaction surveys for a period of up to 10 years post-operatively.‍Demonstrational OnlyThis GDPR-compliant Circle is in currently in use by three StemMedical® licensed plastic surgeons and has already enrolled many of their patients. First patient follow-up results are a few months away.StemMedical® is first in the world to commercially offer stem cell-based products for the cosmetic industry and is setting its sights on expanding through select countries in Europe over the next few years, where the Circle will play a pivotal role in attracting practitioners and their patients to these novel, evidence-based procedures.To learn more information about StemMedical®, visit www.stemmedical.com.

Christian Jorgensen, M.D., Ph.D, and Rosanna Feirrera Lopez, M.D., of CHU Montpellier, Loïc Le Coz, M.D., of CosmaGap, and Marion Bertrand-Marchand M.D., of OC Santé, are forming a series of Circles aimed at standardizing orthobiologic treatments through real-world evidence. Unlike a traditional study, all clinicians will be free to use their professional judgment in the use of device, clinical protocol, and patient selection, but by aggregating and benchmarking their long-term patient outcomes, will begin answering key clinical questions surrounding various regenerative medicine produces.Their first Circle focused on Arthrose de Genou et traitement par PRP (or PRP for Knee OA) aims to answer key clinical questions surrounding the obtainment, processing, and delivery of PRP, including: PRP and Biological Products (Tubes + Centrifuge) Used Platelet and Leukocyte Quantification Factors Determine Indications/Contraindications for Use and Predictive Markers Injection Locations and Frequency Comparisons to Standard and Alternative Biological Approaches The collaborative is then deploying an engaging and standardized patient follow-up regimen to collect and correlate their aggregated patient outcomes to clinical data. Patients will be active participants, equally eager to see their results compared against others when opting for such elective and novel procedures.This collaborative, currently titled “Regenerative Medicine Services of France” is planning to enroll its first patient in mid-September and provide a three-month update by end of year. Though three months are still early in terms of long-term follow-up, the members intend to share their methods, opinions, early evidence and an open invitation to colleagues from within and outside France to join their mission.To learn more about RMSF or Circles, click here.