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AbstractHealthcare is about telling stories. Patients telling stories to doctors, doctors sharing stories with colleagues, and organizations building stories around their brands. The most effective stories are grounded in facts, and in today’s modern world, such evidence has never been easier to discover.inCytes™ is a clinical evidence application, yet it so much more. Through its engaging interfaces, user-specific experiences, and social collaboration, inCytes™ is a tool for building and sharing stories.DOWNLOAD WHITE PAPER

SummaryRegen Med was in attendance at the recent ICRS meeting in Vancouver, Canada, to connect with global scientists, clinicians and industry in the pursuit of improved cartilage repair, replacement and regeneration.Key takeaways included:Regen Med sat down with Profs. Lisa Fortier, Daniel Grande, and Dr. John Kennedy to form a Clinical/Scientific Advisory Board for its Regenerative Medicine Services of New York “RMSNY”. RMSNY will act as a managed services company, providing funding, support and guidance to affiliated Regenerative Medicine centers and its clinicians in the NY area. Immediate Board activities will include determining the high standards of excellence required amongst clinics and clinicians to participate in its clinical network. The first approved center, Tribeca Center for Regenerative Medicine, opens in Q1 2020.The ICRS patient registry distributed its first annual report since its inception and announcement in Sorrento, 2016. Despite the inherent and unavoidable challenges in typical registries, its membership seems to be growing in number and contributions. inCytes was introduced and is being currently vetted as a suitable platform for ICRS’ plans of expansion.Registries were a common topic of interest among the exhibiting sponsors. Most companies had prior experience with having run a registry in the past, and the more sizable companies had several concurrent registries ongoing. Challenges in compliance, motivation, incentives and validity of aggregated data seemed to be shared by all. We presented our COR product, powered through inCytes, as a solution to those typical problems. We are responding to several RFPs and hope to launch these CORS in early 2020.We are in discussions with several other key attendees for the formation of RMCE networks in Poland, Israel, Germany, Amsterdam, France and Italy, and were able to reconnect with many to further those discussions.Regen Med will next attend and speak at the Sports Medicine International Congress in Moscow on November 22-24th.

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