Serac Healthcare’s Post

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 👉 Current challenge include: - several clinical trials not meeting primary endpoints or being withdrawn by investors - issues with clinical trial designs due to small patient populations, appropriate controls and long trial duration - stringent and expensive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

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

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

FDA Approval Journey: The Pivotal CoreTherm® Study 📈 I am thrilled to share a milestone from my research odyssey – a pivotal study essential for the FDA approval of the CoreTherm® (PLFT®) method. 🌟 The third installment from my thesis details an FDA-regulated, prospective, randomized, multicenter comparison of CoreTherm® to TURP conducted over 3, 6, and 12 months across Sweden, Denmark, and the USA. This stringent study fulfilled the FDA's exacting standards for US approval. My role was hands-on; visiting and working alongside my esteemed colleagues Dr. Emmet Boyle in Toledo, Ohio, and Dr. Thyne Larson at the Mayo Clinic in Scottsdale, Arizona, ensuring our treatment was applied meticulously according to our guidelines. 💼 In Denmark, CoreTherm® was already a benchmark treatment. We meticulously analyzed the "Responder Rate," assessing IPSS, QOL, Q-max, and PVR against the globally recognized criteria by deWildt. Our research revealed equally high efficacy for both treatments, with no statistical difference up to one year, and an impressive responder rate exceeding 80%. 📊 An exceptional aspect of this study was the incorporation of pressure/flow studies for all participants pre and post one year of treatment, affirming the study's efficacy and robustness. Significantly, the rate of serious adverse events within one year post-treatment was seven times higher with TURP than with CoreTherm®. 🛡️ The synthesis of thorough technical documentation and this high-quality scientific study led to FDA approval in December 2002. This landmark not only signifies a profound accomplishment for our team but also validates the safety and efficacy of CoreTherm®. 🎉 Should you have any questions or wish for an in-depth discussion about this revolutionary study, I am more than happy to assist. Let’s engage in a conversation that broadens our horizon on a treatment that has transformed urological healthcare. 💬 https://lnkd.in/dAyY_cE7 For crafting LinkedIn hashtags based on the provided text, it's important to focus on keywords and concepts that are most relevant to the content and audience on the platform. Here are several hashtag suggestions: #CoreTherm #UrologyInnovation #MedicalResearch #TreatmentEfficacy #HealthcareTransformation #MedicalMilestone

As seniors live longer, they have more years to develop chronic health conditions that often lead to surgery and other disorders needing effective pain management. SofPulse would represent a game-changing pain treatment for seniors where there is a need to find effective non-pharmacologic pain management methods. The US population is aging and the number of older adults undergoing surgery is increasing. In addition to worse traditional surgical outcomes (i.e., mortality, morbidity), older adults are prone to geriatric-specific complications such as postoperative delirium and functional decline. Aging affects every organ system, and these physiologic changes need to be recognized and incorporated into geriatric-specific post-operative care. Pain control in older adults requires adequate treatment of pain while simultaneously avoiding over-treatment with drugs. Uncontrolled pain is more common in older adults and is also a precipitating factor for postoperative delirium. A PEMF approach towards pain management – specifically SofPulse – would be a game changer in this market segment. Effective pain management, less edema and swelling, reduced inflammation, and getting back to your life all with no adverse event risks – there is nothing like this in the market. SofPulse will provide pain relief without narcotics or any drugs. Additionally, using SofPulse will address the underlying cause of pain - inflammation and edema. SofPulse is the only FDA-approved, technology-based, and patented pain relief product with a demonstrable ability to get you back to your life 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 in-patient, outpatient, and home settings, offering patients a safe and effective pain management alternative. Contact us for more information. www.sofpulse.com #painrelief #sofpulse #surgery #plasticsurgery #effectivepainrelief #painmanagement #edema #reducepain #veterans #veteranshealth #militarymedicine #seniors #seniormedicine #seniorcare #seniorhealth www.sofpulse.com

✅ 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

🔍 New Study Links Semaglutide (Ozempic, Wegovy) to Eye Condition NAION A recent Harvard University study suggests a potential link between Novo Nordisk’s semaglutide (marketed as Ozempic and Wegovy) and nonarteritic anterior ischemic optic neuropathy (NAION). This condition can lead to serious vision loss due to decreased blood supply to the optic nerve. 📊 Key Findings: ▪ Semaglutide users are 4 to nearly 8 times more likely to develop NAION compared to users of other non-GLP-1 medications. ▪ 36-month cumulative incidence of NAION: 8.9% in Type 2 diabetes patients using semaglutide vs. 1.8% in non-GLP-1 users. ⚠️ Industry Response: Analysts urge caution, noting the study shows association, not causation, and recommend further research. 🔬 Study Context: The study evaluated nearly 17,000 patients at Massachusetts Eye and Ear, revealing significant findings that warrant deeper investigation. 📌 Why This Matters: NAION predominantly affects individuals over 50 and can lead to significant vision impairment, underscoring the need for thorough research and awareness. 🔗 Learn More: Dive into the detailed analysis on Blue Sky Legal’s website to understand the implications of these findings and the call for additional studies to confirm the potential risks of semaglutide. 💼 Legal Support: At Blue Sky Legal, we specialize in connecting affected individuals with experienced legal representation. Through strategic marketing campaigns and thorough intake processes, we aim to ensure justice and compensation for those affected by potentially harmful medications. 👉 Stay Informed: https://lnkd.in/gbS2MdMH #LegalUpdate #MedicalResearch #Ozempic #Wegovy #NAION #HealthAndSafety #LegalSupport #PatientCare #DiabetesTreatment #VisionHealth #BlueSkyLegal

2024 JCEM Case Reports Clinical Pearls Session Watch our Clinical Pearls from JCEM Case Reports session with presentations from authors and expert commentary that occurred at ENDO 2024: https://bit.ly/3WTjfz1    JCEM Case Reports is a peer-reviewed, open-access journal that publishes original clinical cases covering the entire spectrum of endocrinology, worldwide. Our editors welcome educational cases of special interest to early career endocrinologists and endocrinology care teams, and are particularly interested in cases where learning relating to limited resources for investigation or management choices may have important implications for a wider audience. We welcome the submission of case reports describing rare or unusual endocrine conditions or an unusual presentation or treatment of common endocrine disorders.    #JCEMCaseReports  #ENDO2024 

Sports injuries are common, and the subsequent pain is a normal physiological accompaniment to such an injury. The experience of pain is shaped by neurophysiological, cognitive, affective, social, and environmental influences. Given these complexities and, often, the absence of clear clinical guidelines, pain management strategies for both the professional athlete and the “weekend warriors” vary and often do not reflect an understanding of the cause and type of pain experienced by athletes. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most frequently used pain medication. NSAID use rates are concerning for several reasons, including concurrent use of multiple NSAIDs, multiple routes of administration, higher than the manufacturer's recommended dosing, use for prevention of pain, limited evidence-based clinical guidance, adverse effects, and limited evidence regarding effects on injury healing. Existing empirical research does not provide a sufficient body of evidence to guide athletes and healthcare professionals in making analgesic medication treatment decisions. SofPulse will provide pain relief without narcotics or any drugs. Additionally, using SofPulse will address the underlying cause of sports-related injuries - inflammation and edema. SofPulse is the only FDA-approved, technology-based, and patented pain relief product with a demonstrable ability to get you back to your life 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 #sportsinjuries #athletes #effectivepainrelief #painmanagement #edema #reducepain #veterans #veteranshealth #militarymedicine www.sofpulse.com