Tenex (guanfacine immediate release tablet) / Dr. Reddy’s - LARVOL DELTA

A Stratified Precision Medicine Trial Targeting Selective Mechanisms of Alpha 2A Agonism as a Treatment for the Cognitive Biotype of Depression: The BIomarker Guided (BIG) Study for Depression. (PubMed, Res Sq) - "We evaluated guanfacine immediate release (GIR), an alpha 2A receptor agonist, as a novel treatment for selectively improving cognitive control circuit function and behavioral performance in a subtype of depression, the cognitive biotype...GIR significantly improved cognitive control performance, quality of life, and global life satisfaction. This study is the first to demonstrate both efficacy and target engagement of GIR as a mechanistically selective treatment specifically for the cognitive biotype of depression."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=150 | Not yet recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Feb 2025 ➔ Mar 2027 | Trial primary completion date: Feb 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Virtua Health, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Orthopedics

The Efficacy of Different Tenotomies in the Treatment of Lateral Epicondylitis: A Systematic Review. (PubMed, J Clin Med) - "Tenotomy is the gold standard for repair, but the research comparing the benefits of specific types of tenotomies (open, arthroscopic, percutaneous, ultrasonically assisted, and Tenex forms) is lacking...The secondary outcomes included patient-reported satisfaction, return-to-work timeframes, and procedural complications. The tenotomy outcomes were similar, regardless of the method, indicating that discussions with patients about their specific outcome preferences may help guide tenotomy method selection."

Journal • Review • Musculoskeletal Pain • Orthopedics • Pain

Ultrasound-Guided Percutaneous Ultrasonic Tenotomy for Refractory Patellar Tendinopathy in High-Level Athletes: A Case Series. (PubMed, Clin J Sport Med) - "PUT for refractory patellar tendinopathy in high-level athletes generally results in favorable treatment outcomes and successful return to sports. This study provides novel insights into the effectiveness of PUT for patellar tendinopathy in athletes, highlighting the need for future studies with larger sample sizes to validate these findings and explore factors associated with poor outcomes."

Journal • Infectious Disease • Orthopedics • Pain

Effectiveness of Percutaneous Needle Tenotomy for Tendinopathies: A Systematic Review. (PubMed, Sports Health) - "Mean risk of bias assessment scores were 8.35 out of 10 assessing internal and external validity for included studies. PNT and TENEX are safe, beneficial, and minimally invasive treatment option for patients, especially for conditions refractory to more conservative treatments options."

Journal • Review • Novel Coronavirus Disease • Pain

Percutaneous Coracohumeral Release for Patients with Adhesive Capsulitis: Two-Year Results from a Randomized Control Crossover Study. (PubMed, Pain Physician) - "While the algorithm for AC care has seen little change for several decades, the authors suggest that PCHLR is a safe, durable, and effective option for cases of AC that are refractory to traditional management."

Clinical • Journal • Anesthesia • Immunology • Osteoarthritis • Pain • Rheumatology

The Effects of Ultrasound-Guided Percutaneous Tenotomy on Patients' Pain and Satisfaction Levels. (PubMed, Cureus) - "Ultrasonic tenotomy provides significant relief for tendinopathy in the shoulder, elbow, and hip for the majority of patients. The knee pain scores were not significantly reduced, likely due to the small sample size of four patients. Some patients did not experience complete relief and benefited from a PRP injection after tenotomy. Some patients did not benefit, likely due to additional pathology, arthritis, and referred pain. Some limitations to our study include the lack of a control group and each procedure was performed by the same physician, which limits its generalizability. The survey responses were subjective, and the sample size was variable between each body region. More high-quality research is needed to establish the efficacy of tenotomy between different tendons and compare it to other treatment methods."

Journal • Fibrosis • Immunology • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology

A True Pain In The Heel (ACSM 2024) - "XR Ankle revealed enthesophyte at the insertion of the achilles tendon and calcific tendinopathy measuring 1.9 cm in length.MSK US confirmed calcific tendinopathy, insertional enthesophyte and additional achilles tendon tendinosis with intrasubstance partial tearing.FINAL WORKING DIAGNOSIS: Calcific Tendinopathy, Achilles Enthesopathy, Achilles Tendinosis with intra-substance partial tearingTREATMENT AND OUTCOMES: Patient did not want to pursue open surgery. She elected to proceed with ultrasound-guided percutaneous tenotomy utilizing the TENEX-Bone needle on 01/19/2022 followed by 4 wks of CAM boot. She noticed 30% improvement and due to the persistence of calcification and symptoms, she had a second procedure on 06/03/2022."

Chronic Kidney Disease • Genetic Disorders • Musculoskeletal Diseases • Obesity • Orthopedics • Pain

Targeting the Cognitive Biotype of Depression With a Selective Alpha 2A Receptor Agonist Using a Stratified Precision Medicine Design (SOBP 2024) - "Background: For the first time in depression, we present a novel stratified medicine trial in which we enriched for objective cognitive deficits and examined the effect of 8 weeks of open-label guanfacine immediate release (GIR), a selective alpha 2A receptor agonist shown to modulate the cognitive control circuit... This innovative stratified medicine trial provides evidence that objective cognitive testing successfully identifies depressed individuals with prefrontal dysfunction. Targeting this dysfunction with GIR is effective in treating depression, cognitive impairment, and poor function in the cognitive biotype of depression."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Virtua Health, Inc. | Trial completion date: Feb 2024 ➔ Jun 2025 | Trial primary completion date: Feb 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Orthopedics

Guanfacine to Improve Substance Use Outcomes in Women (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed

Trial completion

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Pain

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=117 | Not yet recruiting | Sponsor: Montefiore Medical Center | Initiation date: Dec 2023 ➔ Feb 2025

Trial initiation date • Musculoskeletal Pain • Pain

Integrating Neural Circuit and Behavioral Measures to Define and Personalize Treatments for a Cognitive Biotype of Depression (ACNP 2023) - "To selectively treat cognitive control, we pursued a stratified medicine trial in 26 new patients with MDD enriched for C+ biotype status and treated for 8 weeks with guanfacine immediate release (GIR), selective for alpha 2a receptor agonism in the dLPFC...Prefrontal-amygdala connectivity improved with mood, but not cognition. Following treatment with GIR, 90% of patients achieved symptom response and the remission rate exceeded that for standard antidepressants."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Lack of Systemic Effects from Intra-articular XT-150 for the Treatment of Moderate to Severe Pain Due to OA of the Knee: Safety Results from a Phase 2 Trial (ACR Convergence 2023) - P2 | "Background/Purpose: This study (NCT04124042) was designed to assess the safety, tolerability, and efficacy of XT-150, a non-viral gene therapy, in adult participants with moderate to severe pain due to osteoarthritis (OA) of the knee. Safety data from this study support continued investigation of XT-150 for the management of pain and improvement of physical function in patients with knee OA. The local nature of treatment-related AEs and the absence of treatment-related SAEs support a two-dose regimen of 0.45 mg XT-150 (total dose of 0.9 mg) as safe and well-tolerated for future studies. 1."

Clinical • P2 data • Cardiovascular • Gene Therapies • Immunology • Musculoskeletal Pain • Myocardial Infarction • Osteoarthritis • Pain • Rheumatology • IL10

Efficacy of XT-150, a Novel Non-Viral Gene Therapy Delivering IL-10v, on Moderate to Severe Pain Due to Osteoarthritis of the Knee: Results of a Phase 2 Trial (ACR Convergence 2023) - P2 | "Background/Purpose: Interleukin (IL)-10 is a regulator of cytokine activity and has the potential to restore homeostasis in osteoarthritis (OA) of the knee. These data suggest improvement in pain and function with two doses vs one dose of XT-150 and support the future development of repeat doses of XT-150 for the potential treatment of pain from moderate-to-severe knee OA. 1. Kwilasz AJ, et al."

Clinical • Gene therapy • P2 data • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology • IL10

Prospective, Multicenter, RCT of the Tenex Ultrasound System (clinicaltrials.gov) - P=N/A | N=148 | Not yet recruiting | Sponsor: Tenex Health Inc.

New trial

Percutaneous ultrasonic debridement of equine tendinopathy and desmopathy: A report of 10 cases. (PubMed, Open Vet J) - "All horses underwent PUD using the Tenex Health TX System...The procedure was well-tolerated and safe. Removal of tendinopathic scar tissue with PUD resulted in a return to function and without recurrence of the original lesion in all horses."

Journal • Fibrosis

Percutaneous Ultrasound-Guided Coracohumeral Ligament Release for Refractory Adhesive Capsulitis: A Prospective, Randomized, Controlled, Crossover Trial Demonstrating One-Year Efficacy. (PubMed, Pain Physician) - "We demonstrate that our technique for PCHLR is a safe, effective, and durable procedure that improved ROM, pain, and shoulder function in our patient population when compared to the control."

Journal • Anesthesia • Cardiovascular • Diabetes • Dyslipidemia • Endocrine Disorders • Immunology • Metabolic Disorders • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

RCT GTPS: Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS) (clinicaltrials.gov) - P=N/A | N=117 | Not yet recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Aug 2024 ➔ Dec 2024 | Initiation date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Musculoskeletal Pain • Pain

Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. (PubMed, Pain Physician) - "PUT of the ITB using the TENEX® tissue remodeling device could be a safe and effective treatment for ITB tendinopathy-associated GTPS."

Journal • Observational data • Musculoskeletal Pain • Pain

TENEX Needle Tenotomy Delivers High Patient Satisfaction At 2 Years For Multiple Body Parts (ACSM 2023) - "PNT-US utilizing the TENEX needle provides high level of patient satisfaction over a follow-up of more than 2 years for multiple body parts and has higher sucess rate in individuals without prior surgical interventions."

Clinical • Musculoskeletal Diseases • Pain

Lateral epicondylitis: comparing ultrasound-guided tenotomy with or without amniotic membrane allograft injection. (PubMed, Regen Med) - "There was no significant difference in pain levels at 26- or 52-week follow-up or patient satisfaction between the two groups. USGT with or without AM allograft injections results in a significant reduction in pain with high patient satisfaction."

Journal • Musculoskeletal Pain • Pain

Percutaneous ultrasound-guided needle tenotomy for treatment of chronic tendinopathy and fasciopathy: a meta-analysis. (PubMed, Eur Radiol) - "• The best improvement in pain and function was achieved after the first 3 months following PUNT and was continued to the intermediate- and long-term follow-ups. • No significant difference was found between different tenotomy methods in terms of pain and function improvement. • PUNT is a minimally invasive procedure with promising results and low complication rates for treatments of chronic tendinopathy."

Journal • Retrospective data • Musculoskeletal Diseases • Pain