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Ever-more powerful algorithms are “crawling” through the petabytes of insurance claims, PROM’s, pharmacy, genome and other healthcare databases in an attempt to drive more efficient therapies and medications and to help control spiraling medical costs. However, the results have lagged the promise. See here and here for two examples (from the American Medical Association, and Harvard Medical School).A major reason for disappointment with “big data” is the absence of data which are reliable (collected real-time), longitudinal (integrated across the patient’s entire treatment path) and clinically-relevant (represents the scientific and clinical criteria associated in the respected medical literature with better outcomes).Such useful data are notoriously difficult to obtain. By definition, they should be collected before, at and after the point of care by treating physicians or their assistants. However, those healthcare professionals are already overburdened by their clinical responsibilities, as well as other data-entry requirements increasingly demanded by government and insurers. Practicing physicians are often uncertain as to which clinical/scientific data should be collected. Pre-treatment and post-discharge outcomes data are, at best, episodic and poorly correlated with clinical data. Moreover, they are often not standardized and are difficult to obtain.inCytes™ was developed by leading product-independent clinicians and medical scientists. It is now being used to address the foregoing obstacles. It is an important tool, efficient and low-cost for any group – hospitals, ACO’s, payors, regulators, clinicians and researchers — seeking to develop evidence-based, superior, predictable and lower-cost outcomes over the long term for broad patient groups.

Professional medical societies are committed to providing value to their members, and advancing science and clinical excellence. They do so through education, fostering collaboration and often engagement with regulators. However, the plethora of conferences, the dynamic nature of medicine, members’ busy clinical schedules, funding limitations and lack of engagement between meetings all challenge societies’ desire to maintain their relevance and impact. While most societies have third parties to assist with conference logistics, few have the outside support needed to achieve even a fraction of the potential of their mission.inCytes™ — developed by clinicians for clinicians – allows societies to add real value to members’ everyday practices at nominal cost. A society-designed study enhances education, evidence-based clinical procedures and continuous, real-time collaboration in a manner highly attractive to physicians. The society will justify membership dues, attract more members, establish new revenue opportunities and increase its scientific and clinical relevance.Illustrative uses of inCytes™ by a medical society include:Development of society-branded and product-agnostic Observational Protocols and Reports specific to the society and its clinical/scientific focus.Invitation to existing and prospective members to participate in a corresponding study, based on members’ current clinical practices and utilizing inCytes™.Collection of real-world data through the society, which then converts it into real-world evidence as increasingly demanded by regulators, providers, payers and patients.Reports on results throughout year, or at next annual meeting. Society-specific registry.

Abstract The concepts of Real World Data (“RWD”) and Real World Evidence (“RWE”) are now recognized by regulatory agencies, providers, payers and patients as essential to determining the safety and efficacy of medical products, devices and procedures. By definition, RWD and RWE are not derived from “traditional clinical trials”, the limitations of which are increasingly recognized. DOWNLOAD WHITE PAPER

SummaryGovernment regulators, providers, payers and patients increasingly recognize the potential benefits of human cell and tissue products (“HCT/P”). At the same time, they are differentiating between “good actors” and “bad actors” in the clinical delivery of those HCT/P’s. The recent U.S. federal court injunction against US Stem Cell Centers confirms the FDA’s commitment to enforcing its HCT/P regulations against clinicians it places in the latter category. That case makes clear, for example, that enzymatic digestion of adipose – commonly used to produce stromal vascular fraction – is considered more than minimal manipulation and thus subject to regulation as a drug.The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use. To help clinicians understand and document compliance with them, inCytes™ now includes a short survey/report addressing key elements surrounding harvest, processing and delivery of a large number of applicable cell/tissue types. The survey and report – easily modifiable for specific practice considerations – will inform regulatorily-compliant clinical protocols, support patient engagement, establish correlations with outcomes, and document protocol and regulatory compliance.Surveys and reports, all easily customized, are available on inCytes™ for many indications, procedures and patient cohorts. New ones are created regularly, often for the specific needs of Users. Sign up for a free, custom trial today of the platform designed by clinicians for clinicians to capture and exploit true clinical evidence.

SummaryPositive results for PRP treatments in Hip OA when compared to hyaluronic acid.Multiple studies presented this year have revealed positive results for PRP treatments in Hip OA when compared to hyaluronic acid and other conventional treatments. Most notably, one trial showed only 11% of patients who got PRP shots in their hips went on to get a hip replacement compared to 50% in the hyaluronic acid group over the course of 6 months. Other important results for PRP include:Better HOOS scores and other PROMsIncreased ROM in patientsHigher patient satisfactionThese sorts of studies are easy to recreate and validate, as long as you have the tools to e-monitor patient HOOS scores, reward PROM completion with engaging progress reports, and correlate those outcomes to pre-clinical factors, such as the characterization of your PRP product.The inCytes™ app offers all of these features and more, allowing you to design the surveys, reports, and evidence for any pathology or product.Interested in more information or getting more involved? Please state your interest through our Contact page, and a RegenMed representative will be in touch shortly.‍