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Together with his clinical colleagues in the Department of Orthopedic Surgery at the Singapore General Hospital, Professor Tay Boon Keng will be collecting and analyzing real-world evidence comparing the safety and efficacy of two treatment paths for knee osteoarthritis – hyaluronic acid alone and HA together with autologous platelet-rich plasma. Dr. Severiano Dos Anjos Vilaboa of RegenMed worked closely with Professor Tay to design a Circle supporting a product-agnostic, scientifically legitimate, and clinically efficient randomized trial that will involve at least one hundred patients, allocated to two separate interventional groups.To date, PRP is not broadly utilized for musculoskeletal indications in Singapore. The verifiable and statistically significant insights to be derived from Professor Tay’s Circle may lead to additional evidence-based treatment options for knee OA, as well as related MSK conditions.As the study progresses, RegenMed and Professor Tay will produce a complimentary webinar series intended for healthcare professionals. The series will cover approaches to (i) designing and implementing real-world studies in the context of a busy clinical practice, (ii) supporting patient education and engagement, and a (iii) review of the potential correlations deriving from the study being undertaken by Professor Tay and his team.To learn more about Prof. Keng’s Circle or to attend his upcoming webinar series, please contact us.

RegenMed closed an agreement with StemMedical A/S to construct and manage a private real-world evidence registry for regenerative aesthetic procedures for their Stemform® brand.StemMedical, located in Søborg, Denmark, provides clinicians with autologous culture expanded adipose tissue-derived stem cells (ASCs) that can be mixed with patient’s adipose (≥ 20 million ASCs/ml fat) to form a natural and highly effective fill material to augment volume in patient’s face, buttocks and/or breasts.The registry will capture critical data points along the customer journey, including demographics and consent, clinical observations around the liposuction and ASC-enriched Lipofilling procedures, characterization and toxin screens of the SVF product, and various methods of objective outcomes capture, including volume assessment, fat retention calculation, and various 3D image analyses. Patients and clinicians use the Stemform® registry to report upon their outcomes up to ten years, compare their objective results in real-time against themselves and others, and access their own library of high-quality, clinical, and 3D rendered before/after images.StemMedical is targeting a late-May / early-June launch and will standardize registry access for all plastic surgeons within the growing network of clinical affiliates offering the Stemform® brand.Contact us to learn more about StemMedical® and its Regenerative Aesthetic Registry; Stemform®.

RegenMed is honored that Kenneth R. Zaslav, M.D. has agreed to join the RegenMed C/SAB. Ken is well-known internationally for his leadership of major medical/scientific societies such as the ICRS and the Biologic Association. Ken’s multi-decade background in clinical orthopedic and sports medicine will be of great value as we partner with hospitals and independent practices world wide to establish Regenerative Managed Services Organizations.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.‍

The FDA has recently confirmed definitive enforcement of its regulations regarding regenerative medicine products. Effective May 31, “discretionary” compliance by manufacturers, distributors, and their clinical customers will no longer be allowed. As a result, they can expect increased scrutiny and heightened risk of public enforcement letters and penalties. Moreover, these risks are amplified by the increased focus of state authorities, and indeed concerns expressed by patients themselves, in this area.All this underscores the importance of independent and verifiable real-world evidence, relevant documentation, and transparent, accurate communications to HCP’s and patients. This is precisely the purpose of Circles. They create and maintain -- in a cost-efficient and minimally burdensome manner – evidence-based engagement with HCP and patient communities. Those communities in turn generate critical real-world data and transparency.Contact us to find out more.

Despite remarkable growth in value and international interest, the field of orthobiologics and regenerative medicine continues to rely upon “standards” derived from case studies, clinical opinions, and/or inadequate clinical evidence. Dr. Catalán, certified orthopedic surgeon and founder of Catalán Trauma Sports Medicine Center wants to change that.Dr. Catalan’s activity, situated in sunny Palma Mallorca, Spain, is mainly focused on intra-osseous PRP and BMAC injections for treating severe Knee OA. With the support of a leading manufacturer, he has developed several Circles which correlate PRP and BMAC characterization results, from his own hematology analyzer, against the long-term, remotely monitored outcomes of his patients. The result is the generation of real-world evidence which substantiates his approach, informs standards leading to predictable outcomes, and has attracted the participation of other doctors in Spain.Dr. Catalán is presenting his real-world evidence results and protocols at ESSKA Virtual Congress (11-15 May, 2021) and at the SEROD (Knee Spanish Society) meeting next September in Spain. If you’d like to learn more about Dr. Catalán, his upcoming presentations, or his Circles please contact us.