The Latest

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.

Recalling the deeds of Jonas Salk, David Pritchard, August Bier; it is admirable, but not so uncommon, that an enterprising scientist and/or clinician would use their own bodies in a study. Such is the case with Dr. Sameh Elguizaoui of New York Orthopedics in NYC, who when frustrated by the disparity of standards and outcomes from PRP processing methodologies, cast an eye to his own blood.Dr. Elguizaoui would ultimately compare 5 samples of his own blood, each with different centrifugation times and durations, against a single vial of his whole blood. Using a PRP characterization service offered at the Fortier Comparative Orthopedic and Regenerative Laboratory, he was able to characterize all 6 samples to contrast platelet concentrations. The results are part of a larger effort to help Dr. Elguizaoui achieve more predictable outcomes for his orthobiologic patients, while offering distinctive, transparent and evidence-based care to his patients.‍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.

Like many clinicians around the world treating musculoskeletal conditions, Dr. Lora Brown of St. Petersburg, Florida is aware of orthobiologic approaches utilizing PRP, BMAC, adipose, exosomes and more. However, relevant data which are independent, statistically significant and verifiable are difficult to find.Dr. Brown is the founder of TruWell Health, is board certified in anesthesiology and regenerative medicine, and is committed to being evidence-based in the eyes of her patients, regulators and the greater clinical community. To help develop standards of care based on real-world evidence, Dr. Brown has established a Circle which efficiently captures and reports on human/cell tissue characterization, post-clinical outcomes, and other relevant data points.Dr. Brown will be presenting her real world evidence via quarterly webinars, and inviting interested clinicians to attend, participate in her or related Circles, and contribute in establishing evidence-based standards of care in this promising field.To learn more about Dr. Brown, her Circle or her first webinar, please contact us.

Leading Physical Medicine and Rehabilitation (“PMR”) doctors affiliated with a large New York City hospital system are exploring the use of activated PRP in the context of lower back pain. Working with internationally-recognized Ph.D.’s in their academic institution, as well as the broader Regen Med network, they have designed a “Circle”. This Circle includes platelet and protein characterization at a respected off-site laboratory, to determine best practices for safe, efficacious PRP preparation for epidural delivery. Upon institutional IRB approval, collection of real-world evidence against that protocol will commence, including long term patient outcomes capture, as well as the production and distribution of a webinar series covering the study design, collection of real-world data and interpretation of discovered correlations.