Benign prostatic hyperplasia

Real-World, Long-Term Data Demonstrate Sustained Benefits of Aquablation Therapy for Men with Benign Prostatic Hyperplasia

Retrieved on: 
måndag, maj 6, 2024
FDA, Bleeding, Safety, Risk, American Urological Association, Abstract, LUTS, ASC, Surgeon, TURP, International Prostate Symptom Score, Patient, SDD, AUA, Health, Patient satisfaction, Clinical trial, SAN, BPH, IPSS, Benign prostatic hyperplasia

The results were presented this past weekend at the American Urological Association (AUA) Annual Meeting in San Antonio, Texas.

Key Points: 
  • The results were presented this past weekend at the American Urological Association (AUA) Annual Meeting in San Antonio, Texas.
  • “The data presented at AUA confirm the safety and long-term durability of Aquablation therapy in treating men with symptomatic benign prostatic hyperplasia, regardless of prostate size or shape," said Reza Zadno, CEO of PROCEPT BioRobotics.
  • Three surgeons at Potomac Urology collected data on 812 consecutive men treated with Aquablation therapy.
  • We have treated more than 800 men with Aquablation therapy and feel that the results truly speak for themselves,” said Shawn Marhamati, MD, MS, at Potomac Urology.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Nymox Reports Victory in Bahamas Litigation Against Terminated Ex-Employees – Court Awards Costs and Damages

Retrieved on: 
onsdag, mars 27, 2024
Order, Prostate cancer, General counsel, Benign prostatic hyperplasia, Counsel, Plaintiff, Court, Person

Dr. Averback continued: "The Company has 2 submissions under review for its Nymozarfex (TM) drug treatment for prostate enlargement. The Company also has the drug in development for prostate cancer. We are very happy to report that the work of the Company has proceeded methodically. We cannot guarantee things that we do not control. One thing we do control, and we can guarantee, is that our extended team gives 110% and does the maximum, -- we are working for our shareholders, and in their best interests."  

Key Points: 
  • IRVINE, Calif., March 27, 2024 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets - NYMXF) is pleased to report that the Bahamas Supreme Court has issued a formal Order officially putting an end to the Bahamas litigation brought by terminated ex-employees.
  • The Order also awards to Nymox its costs incurred in defending the ill-conceived lawsuit, as well as damages Nymox has suffered as a result of the litigation.
  • The Court order states the following:
    The Interim Injunction Order is set aside;
    The Claimants shall pay the Company’s net costs for the entire Action.
  • The amounts of expenses plus damages is in process, and we will report further when we have that exact information.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
onsdag, mars 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

scPharmaceuticals Announces Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue

Retrieved on: 
torsdag, januari 4, 2024
Coma, Urine, Hepatic encephalopathy, Ascites, Kidney, Oliguria, Physician, Benign prostatic hyperplasia, Blood volume, Uric acid, Organic acid, Anuria, Urinary retention, NYHA, Furosemide, Cerebral edema, Hypersensitivity, Diuresis, Thrombosis, Deafness, Glucose, Azotemia, Ototoxicity, Creatinine, Tinnitus, Traction, BUN, Hypoproteinemia, Edema, Growth, Investment, Congestion, Huber loss, Patient, Bruise, Dehydration, CO2, Heart failure, Cirrhosis, Embolism, History, Erythema, Pharmaceutical industry

BURLINGTON, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced preliminary unaudited fourth quarter 2023 net FUROSCIX revenue in a range of $5.9 million to $6.1 million, representing sequential growth of 55% to 61% over $3.8 million net FUROSCIX revenue reported for the third quarter of 2023.

Key Points: 
  • For the full year 2023, the Company anticipates net revenue to be in a range of $13.4 million to $13.6 million.
  • The gross-to-net discount decreased to approximately 18% from launch through the end of Q4 versus 21% from launch through the end of Q3.
  • Inventory levels at the end of Q4 2023 were consistent with levels at the end of Q3 2023.
  • scPharmaceuticals will report its final and complete fourth quarter and full-year 2023 financial results in March.

Nymox December 27 Message to Shareholders

Retrieved on: 
onsdag, december 27, 2023
Marketing, Prostate cancer, Disease, Annual general meeting, News, Benign prostatic hyperplasia, Knowledge, BPH, Dark Ages, Hearing

IRVINE, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) is pleased to provide this end-of-the year message to shareholders.

Key Points: 
  • IRVINE, Calif., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) is pleased to provide this end-of-the year message to shareholders.
  • The Company has overall had a good year and we expect 2024 to be an even better year for our Shareholders.
  • While the outcomes from these 2 applications cannot be guaranteed, these are very solid advances for which we are justifiably extremely proud.
  • There is litigation involved and when there is material news as always, we will provide it in a timely manner.

scPharmaceuticals Inc. Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
onsdag, november 8, 2023
NYHA, Cirrhosis, FDA, Research, Uric acid, Trial of the century, Deafness, Furosemide, Thrombosis, Erythema, Benign prostatic hyperplasia, Embolism, Internationalized domain name, Government, Hypoproteinemia, History, Kidney, Physician, Cerebral edema, Anuria, Bruise, Edema, Hepatic encephalopathy, Huber loss, Ototoxicity, Chronic kidney disease, Urinary retention, Congestion, Blood volume, Growth, Urine, Dehydration, Shanda, Diuresis, Pharmacy, Tinnitus, Medicaid, Azotemia, BUN, CO2, Oliguria, Organic acid, CKD, Investment, Patient, Creatinine, Heart failure, Hypersensitivity, Glucose, Coma, New York Heart Association Functional Classification, Ascites, Security (finance), Cryptocurrency, Pharmaceutical industry, Rare-earth element, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the third quarter ended September 30, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $3.8 million, and cost of product revenues were $1.1 million for the third quarter of 2023.
  • Research and development expenses were $3.4 million for the third quarter of 2023, compared to $3.7 million for the third quarter of 2022.
  • Selling, general and administrative expenses were $14.1 million for the third quarter of 2023, compared to $6.3 million for the third quarter of 2022.
  • As of September 30, 2023, scPharmaceuticals’ total shares outstanding was 35,859,045.
    scPharmaceuticals’ management will host a conference call and webcast to review the Company’s third quarter 2023 results today, Wednesday, November 8, at 4:30 p.m.

scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives

Retrieved on: 
tisdag, september 19, 2023
Overload, Furosemide, PK, Hypersensitivity, NYHA, Congestion, Embolism, Hypoproteinemia, Organic acid, Heart failure, Hospital, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Type, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Shanda, Investigational New Drug, HIV disease progression rates, Patent, Patient, Physician, Ototoxicity, Urinary retention, Erythema, Azotemia, Ascites, Coma, Type D, Growth, Diagnosis, Blood volume, FDA, Benign prostatic hyperplasia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Cerebral edema, CO2, Thrombosis, BUN, Food, Kidney disease, Anuria, Pharmaceutical industry

BURLINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.

Key Points: 
  • The Company also announced today feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD.
  • In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL.
  • CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.
  • “We are very pleased to have reached alignment with the FDA on the advancement of these two very important long-term growth initiatives for our company,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.

AUA Releases Amendment to the Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia Guideline

Retrieved on: 
torsdag, september 14, 2023
PAE, Male, Prostatic artery embolization, Prevalence, Guideline, E pluribus unum, Epithelium, AUA, BPH, LUTS, Urethra, Ageing, American Urological Association, Prostate, Literature, MD, Patient, Finasteride, Water, Memorial Sloan Kettering Cancer Center, Diagnosis, Benign prostatic hyperplasia, System, ULR, Update, Medical imaging, Dietary supplement

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the management of lower urinary tract symptoms attributed to benign prostatic hyperplasia.

Key Points: 
  • BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the management of lower urinary tract symptoms attributed to benign prostatic hyperplasia.
  • Benign prostatic hyperplasia (BPH) is a histologic diagnosis that refers to the production of smooth muscle and epithelial cells within the prostatic transition zone.
  • The prevalence and the severity of lower urinary tract symptoms (LUTS) in the aging male can be progressive and is an important diagnosis in the healthcare of patients and the welfare of society.
  • Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023.

Seoul St. Mary's Hospital Found Red Ginseng Oil is Excellent for Improving Prostatic Hyperplasia

Retrieved on: 
torsdag, september 14, 2023
Korea Ginseng Corporation, Retention rate, Urine, BPH, KGC, International Prostate Symptom Score, Nocturia, Research, Multimedia, JUNG, Malignancy, Capsule, Professor, Patient, Hospital, Department of Urology, University of Virginia, Ageing, Benign prostatic hyperplasia, Dietary supplement, IPSS

SEOUL, South Korea, Sept. 14, 2023 /PRNewswire/ -- Red ginseng oil has been found to be a safe and effective solution for improving prostatic hyperplasia for the first time.

Key Points: 
  • SEOUL, South Korea, Sept. 14, 2023 /PRNewswire/ -- Red ginseng oil has been found to be a safe and effective solution for improving prostatic hyperplasia for the first time.
  • Led by Professor Kim Sae Woong from the Department of Urology at Seoul St. Mary's Hospital, in collaboration with the Korea Ginseng Corporation (KGC), this research's results indicate that the intake of red ginseng oil extracted from JUNG KWAN JANG's RXGIN can safely and effectively improve prostatic hyperplasia.
  • It turns out that, compared to a mere 3.7% improvement in the control group, the red ginseng oil group experienced a significant 50.5% improvement in the red ginseng oil group in IPSS.
  • Professor Kim explained, "We found that red ginseng oil not only significantly improves the symptoms of BPH but also enhances dysfunction, which are the side effects of existing BPH(Benign prostatic hyperplasia) treatments."