Serac Life Sciences’ Post

We are excited to report major news this week for the development of ⁹⁹ᵐTc-maraciclatide as an imaging agent for endometriosis: the US Food & Drug Administration (FDA) has granted fast track designation to maraciclatide "for the visualisation and diagnosis of superficial peritoneal endometriosis in women 16 years of age or older". Fast track is a process designed to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need so that patients can benefit sooner. Superficial peritoneal endometriosis (SPE) is the earliest and most common form of endometriosis, comprising approximately 80% of all diagnoses. SPE is not well visualised with current non-invasive imaging tools (ultrasound and MRI) and definitive diagnosis requires laparoscopy. In data previously reported from the DETECT study being run by our colleagues at the Nuffield Dept of Women's & Reproductive Health, University of Oxford, maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy. Please see full details here: https://lnkd.in/eQM3nCKm Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. #FDAFastTrack #endometriosis #womenshealth #molecularimaging #diagnosticimaging #medicalimaging #precisionmedicine #nuclearmedicine EndoCaRe Oxford 🎗️ Spectrum Dynamics Medical Hermes Medical Solutions Krina Zondervan Tatjana Gibbons

🧑⚕️ Artificial Kidney: A Breakthrough in Medical Innovation 🧑⚕️ The Kidney Project has made a significant leap forward with its implantable bioartificial kidney. This innovative device, which combines a hemofilter and bioreactor, has successfully completed its first functional prototype demonstration. KidneyX, a partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology, supports advancements in kidney disease treatment. This artificial kidney could transform the lives of millions by offering a high quality of life without the need for dialysis or immunosuppressant drugs. At Viltis, we understand the importance of breakthroughs like this in advancing healthcare. Our team supports the clinical research and regulatory processes that bring life-changing medical innovations to patients safely and efficiently. Source: https://lnkd.in/gspy3hiV #MedicalInnovation #KidneyHealth #Viltis #ClinicalResearch #Healthcare

Literature Review and International Consensus Validation of FORTA Labels of Oral Anticoagulants for Long-Term Treatment of Atrial Fibrillation in Older Patients #atrialfibrillation #cardiovascular #anticoagulants #consensus #patientcentricity

A must read editorial for someone who is interested in clinical trial design, outcomes and regulation of innovative therapies for Inherited Retinal Dystrophies (IRDs). In this piece that is co-authored by clinical scientists, patient experts and IRD specialists, the authors discuss the current challenges and propose potential solutions to foster innovation in the IRDs therapeutic space. 👉 Current challenge include: - several clinical trials not meeting primary endpoints or being withdrawn by investors - issues with clinical trial designs due to small patient populations, appropriate controls and long trial duration - stringent and expensive vector manufacturing regulations - irrelevant endpoint (Best Corrected Visual Acuity) requirements by regulatory agencies 🌟 Proposed solutions: - optimization of trial designs for small populations possibly using adaptive designs - Identification and stratification of appropriate control groups - development of relevant outcome measures specific to the IRD patient population that captures patient experience, daily living activities and ability to adapt to and navigate environments - conduction of natural history studies to identify suitable endpoints for specific IRD types - harmonization of regulatory procedures globally for faster approval process - consideration of conditional approval with close monitoring of post approval data #clinical #research #genetherapy #celltherapy #inherited #retinal #dystrophies #degenerations #retina #innovation #retinainternational #regulation #therapies #drug #discovery #development #erneye #euretina Full text of the article is behind a paywall but can be accessed here: https://lnkd.in/exQn_-km

✅ Serac Healthcare’s 99mTc-Maraciclatide Granted FDA Fast Track Designation for Diagnosing Superficial Peritoneal Endometriosis 💬 "Granting Fast Track designation to maraciclatide highlights the FDA’s recognition of the critical need for improved diagnosis of endometriosis. The average delay for diagnosis of this condition, which affects 190 million women worldwide, is seven and a half years and is often only possible with laparoscopy. We are committed to working closely with the FDA and clinicians to complete the development of 99mTc-maraciclatide. A non-invasive test which could be used for earlier diagnosis of endometriosis would represent a major advance in women’s healthcare." David Hail, Serac Healthcare CEO #femtech #womenshealth #womenshealthinnovation #health #healthcare #healthtech #endometriosis #periodpain #biotech #diagnostics #fda #regulatory

Exploring the Role of NSAIDs in Fracture Healing I'm excited to share my recent project: "Foe or Ally: Unraveling the Role of NSAIDs in Fracture Healing." This project delves into the complex effects of nonsteroidal anti-inflammatory drugs (NSAIDs) on bone repair. 🔍 Key Insights: - Reviewed current research on the benefits and adverse effects of NSAIDs in fracture healing. - Investigated the mechanisms by which NSAIDs influence inflammation and bone regeneration. - Examined the variability of effects based on dosage and duration. 📊 Findings: - Provided clinical recommendations for optimizing fracture recovery while managing pain. - Offered actionable insights for healthcare professionals to improve patient outcomes. I'm thrilled about the potential impact of this work on clinical practices and patient care. A big thank you to everyone who supported and contributed to this project! #ClinicalResearch #PharmD #Clinicaltrails #Adversedrugreactions #ADR #FractureHealing #NSAIDs #Healthcare

Clinical trials are not the only way to get phages to patients. An alternative is an approach that goes by a range of names: named patient use, expanded access, compassionate use… what they all cover is, to quote the European Medicines Agency, “a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies”. The extraction of useful data from such studies is heavily outweighed by the need to treat the patient, and in some cases even recording such data can be unacceptable. But it does get therapeutic phages to patients, and there are quite a few cases where there have been positive results. One excellent example was a case series pubished on treating diabetic toe ulcers, where some extremely nasty conditions were resolved through the use of phages, which was work explicitly intended to progress matters towards clinical trials. Fish R, Kutter E, Wheat G, Blasdel B, Kutateladze M, Kuhl S. Compassionate Use of Bacteriophage Therapy for Foot Ulcer Treatment as an Effective Step for Moving Toward Clinical Trials. Methods Mol Biol. 2018;1693:159-170. doi: 10.1007/978-1-4939-7395-8_14. PMID: 29119440. Sacher J and Zheng J, Phage Therapy Collaboration and Compassionate Use. ” in D.R.Harper, S.T.Abedon, B.H. Burrowes, M.L.McConville eds. (2021). Bacteriophages: Biology, Technology, Therapy (2 volumes). Springer Nature, Vienna. ISBN 978-3319419855 #bacteriophage #phage #compassionate_use #expanded­_access #named_patient #phagetherapy #thephageadviser drh@thephageadviser.com

Acute pain is a sharp pain that comes on suddenly and is brought about by something specific. This type of pain may be short, no longer than six months, but can impact quality of life long-term. The pain tends to be related to a temporary illness or a soft-tissue injury, so it typically goes away after the illness or injury subsides. When it is not effectively relieved and treated, acute pain has a detrimental effect on all aspects of the quality of life. Studies have shown that it can produce anxiety and emotional distress in the lives of individuals, affect their general well-being negatively, and also inhibit their ability to perform daily family activities. Patients with acute pain need effective pain relief.  SofPulse will provide pain relief without narcotics. Additionally, using SofPulse will reduce inflammation and edema, with most patients experiencing a better wound-healing outcome. SofPulse is the only FDA-approved, technology-based, and patented pain relief product with a demonstrable ability to get patients back to their lives faster, with an improved quality-of-life benefit. SofPulse PEMF therapy treatment has been used in more than 20 thousand cases to manage acute pain and edema in both outpatient and home settings, offering patients a safe and effective pain management alternative. Contact us for more information. #painrelief #sofpulse #surgery #plasticsurgery #endonovo #endonovotherapeutics #healing #effectivepainrelief #nomoreopiods #painmanagement #managepain #fdacleared #noninvasive #edema #electroceuticals #pain #reducepain #veterans #veteranshealth #militarymedicine www.sofpulse.com

PUB MED IncobotulinumtoxinA use in aesthetic indications in daily practice: a European multicenter, noninterventional, retrospective study > Purpose: To characterize utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics. > Patients and methods: Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638) treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice. > Results: Most patients (76.0%) received incobotulinumtoxinA for glabellar frown lines (GFL) and were given doses of ≤20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6%) and/or crow's feet (CF; 31.7%); for CF, >95% of injected doses were ≤24 U.... https://lnkd.in/eAVxAyDj

Clinical trials are not the only way to get phages to patients. An alternative is an approach that goes by a range of names: named patient use, expanded access, compassionate use… what they all cover is, to quote the European Medicines Agency, “a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies”. The extraction of useful data from such studies is heavily outweighed by the need to treat the patient, and in some cases even recording such data can be unacceptable. But it does get therapeutic phages to patients, and there are quite a few cases where there have been positive results. One excellent example was a case series pubished on treating diabetic toe ulcers, where some extremely nasty conditions were resolved through the use of phages, which was work explicitly intended to progress matters towards clinical trials. Fish R, Kutter E, Wheat G, Blasdel B, Kutateladze M, Kuhl S. Compassionate Use of Bacteriophage Therapy for Foot Ulcer Treatment as an Effective Step for Moving Toward Clinical Trials. Methods Mol Biol. 2018;1693:159-170. doi: 10.1007/978-1-4939-7395-8_14. PMID: 29119440. Sacher J and Zheng J, Phage Therapy Collaboration and Compassionate Use. ” in D.R.Harper, S.T.Abedon, B.H. Burrowes, M.L.McConville eds. (2021). Bacteriophages: Biology, Technology, Therapy (2 volumes). Springer Nature, Vienna. ISBN 978-3319419855 #bacteriophage #phage #compassionate_use #expanded­_access #named_patient #phagetherapy #thephageadviser drh@thephageadviser.com