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Regenerative medicine and precision cancer care may be the future of healthcare for humans, but it is yesterday’s news for forward-thinking company Ardent Animal Health, LLC. Ardent and its affiliated veterinary clinics have treated more than 20,000 horses, dogs and cats with their innovative regenerative and oncology armamentarium. These therapies have shown promising results with degenerative joint and oncological indications — even in instances where traditional therapies have failed — creating a growing list of “petsimonials”.Working with RegenMed, Ardent plans on launching a leading clinical data registry in early 2022 to aggregate and assess those animal outcomes. Bolstered by participation from more than 1,000 affiliated clinics, Ardent anticipates that their data will play a pivotal role in helping to standardize regenerative treatments and precision cancer care for animals, and perhaps one day, their owners, too.Thomas Masterson, President of Ardent Animal Health, states, “Aggregating data and sharing patient outcomes is integral to the sustainability of innovative technology. Our veterinarian customers are outstanding clinicians and scientists. RegenMed will unlock collaboration and allow for a registry that is aimed to raise the standard of care for veterinary patients.”Ardent Animal Health will launch its first two Circles for Osteoarthritis and Oncology in early 2022.To learn more about Ardent Animal Health or its Circle, contact us today.

Lower back pain is among the top 10 reasons for occupational absenteeism, placing a strong economic incentive for preventing and treating this prolific symptom. Opiate use has been a traditional standard of care, but its failure to address the underlying cause of disease coupled with a global rise of addiction, has caused payers to look for alternative solutions.First State Spine offers patients orthobiologic spine treatments, including platelet rich plasma “PRP” and bone marrow derived stem cells. These novel procedures are currently out of pocket, but First State Spine is using their Circle to monitor patients’ post-operative outcomes over time, including reduction in pain, opiate usage, and return to work. Bonnie O’Connor, PA-C, who oversees the evidence-based initiative, has tried other patient follow-up systems, but says this about Circles:"Circles has allowed our facility to customize surveys in addition to incorporating the standard outcome measures for Orthobiologic patients. The process is streamlined for staff, patients and reporting. Customer service has been responsive and helpful from start to finish.”First State Spine intends to use their Circle data to generate real-world evidence demonstrating long-term treatment and cost-efficacy, helping future patients to receive reimbursement.To learn more about First State Spine or its Circle, contact us today.

This recently published position statement by the AMSSM summarily articulates the opportunities, risks and considerations for inclusion of orthobiologics into a modern sports medicine practice.What leaps out at us, having been privy to the slow, at times chaotic, but seemingly inevitable global adoption of these therapies for more than seven years, is the growing inequity between hundreds of thousands of patients treated and the continued debates upon, or outright absence of, strong, definitive clinical data. This isn’t to say that these therapies don’t work, but rather, that the world is much more advanced at delivering this sort of care than understanding it.This no longer needs to be the case. The rising role and acceptance of real-world evidence, the increased availability of clinically efficient data capture technologies and the growing interconnectivity and collaboration of globally disparate, but singularly minded, “good actor” practitioners, hold the combined weight to convert growing patient volumes into evidence-based standards of care. Such evidence-based practitioners will help advance the field, but on a more practical, personal level, they will find collecting and contributing such evidence useful for a good number of AMSSM’s expert recommendations, including:Patient Education Patient Selection Regulatory Documentation and Submissions Clinical Decision-MakingProduct Quality Control Informed Patient Consent Professional Collaboration and Training Publications and Presentations RegenMed hopes that this continued leadership among good clinical actors, paired with growing volumes of integrated, longitudinal and statistically-significant real-world data, help answer those persistent questions leading to better options and outcomes for patients around the world.

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.‍