Peripheral artery disease

Calling Faith Leaders, Church and Community Members, and Health Professionals!

Retrieved on: 
Tuesday, June 13, 2023
Seele, United States Department of Health and Human Services, Education, Health, Human services, Multiple myeloma, Crystal Aikin, Bristol Myers Squibb, Multimedia, Strategic planning, African Americans, Janssen Pharmaceuticals, Nursing, Peripheral artery disease, Vertex Pharmaceuticals, City, Johnson & Johnson, Roadmap, Tourism, Pharmaceutical industry, Balm

RICHMOND, Va., June 13, 2023 /PRNewswire/ -- The Healthy Churches 2030 Roadmap Tour : "Forwarding the Black Health Agenda," provides faith, health and community leaders with training and resources to help reduce racial health disparities. The full-day, in-person conference, taking place in five cities, offers workshops for new and established health ministries plus education sessions about diseases that have disproportionate impact on Black Americans.

Key Points: 
  • The Healthy Churches 2030 Roadmap Tour: Making a Difference in Black Health
    RICHMOND, Va., June 13, 2023 /PRNewswire/ -- The Healthy Churches 2030 Roadmap Tour : "Forwarding the Black Health Agenda," provides faith, health and community leaders with training and resources to help reduce racial health disparities.
  • "Black faith institutions are primary influencers when it comes to health awareness and behaviors," said Dr. Pernessa C. Seele, Founder & CEO, The Balm In Gilead, Inc .
  • "The Roadmap Tour reflects Black faith traditions as it prepares churches, public health organizations, and individuals to help reverse systemic health disparities that result in worse health outcomes in our communities."
  • The Balm In Gilead, Inc., is a 35-year-old nonprofit organization that mobilizes Black faith communities to respond to racial health disparities.

Humacyte Announces Publication in Lancet Regional Health - Europe Presenting Use of Human Acellular Vessel™ (HAV™) to Treat Vascular Injuries in Ukraine

Retrieved on: 
Tuesday, May 9, 2023
Infection, Injury, US Foods, Surgeon, International, Amputation, AC 25.1309-1, Trauma, Trauma center, Sale, Military personnel, Regenerative medicine, Biological engineering, Hospital, Patent, Patient, Level, HUMA, Peripheral artery disease, FDA, HAV, Letter, Buddha's hand, BLA, Food, Pharmaceutical industry, Medical device, Health

DURHAM, N.C., May 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the publication in The Lancet Regional Health - Europe detailing the encouraging experience of Humacyte’s investigational Human Acellular Vessel (HAV) in treating battlefield and other vascular trauma injuries suffered in Ukraine-Russia conflict.

Key Points: 
  • Humacyte’s initial shipment of HAVs arrived in Ukraine in May 2022, in response to requests from surgeons on the frontlines in that country.
  • Additionally, Ukrainian surgeons were virtually trained by video conference to learn the procedures for HAV implantation into patients.
  • Since June 2022, 18 patients (13 at time of publication submission) in Ukraine have been treated with the HAV to repair vascular trauma and thereby prevent amputation.
  • Three patients received the HAV to treat arterial wounds after failure of their initial vascular repairs using vein or synthetic grafts.

Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma

Retrieved on: 
Tuesday, April 18, 2023
Infection, Biologics license application, Failure, Amputation, AC 25.1309-1, Aneurysm, Iliac artery, Reperfusion injury, Sale, Military personnel, Incidence, Polytetrafluoroethylene, Ischemia, Journal, Animal, Patient, HUMA, Host, Peripheral artery disease, FDA, HAV, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Medical imaging, Trauma

DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery comparing the use of its Human Acellular Vessel (HAV) to expanded polytetrafluorethylene (ePTFE) grafts for vascular repair following arterial trauma. In the preclinical study the HAV performed better than ePTFE on multiple indices.

Key Points: 
  • In the preclinical study the HAV performed better than ePTFE on multiple indices.
  • In this comparative preclinical study, 36 pigs were randomly assigned to treatment groups receiving either the HAV or an ePTFE graft to reconstruct a severed iliac artery after vascular trauma.
  • At the conclusion of the study, the HAV and ePTFE implants were removed and histologically evaluated for host cellular response.
  • The publication of this preclinical study comes as Humacyte nears the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of vascular trauma.

JanOne to Present Data On Its Two Non-Opioid Drug Candidates at The Appalachian Region Spine and Pain Meeting on Drug Development Programs to Treat Pain on April 15, 2023

Retrieved on: 
Thursday, April 13, 2023
Spine, Diabetic neuropathy, JAN, Risk, PAD, CRPS, Pain, Patient, Physician, Complex regional pain syndrome, Peripheral artery disease, Pain management, Security (finance), FDA, Chronic pain, Appalachia, Pharmaceutical industry, Janon

The Appalachian Spine and Pain Meeting is a forum attended mostly by pain management physicians to learn and discuss new and innovative treatments.

Key Points: 
  • The Appalachian Spine and Pain Meeting is a forum attended mostly by pain management physicians to learn and discuss new and innovative treatments.
  • JanOne is working to develop multiple medications to help treat pain without addiction.
  • "The opioid crisis really impacted this country and we realized what is needed are new options to treat pain without opioids.
  • We look forward to developing these products so doctors have the tools they need to treat pain without addiction", noted Tony Isaac CEO of JanOne.

Semler Scientific Comments on CMS Risk Adjustment Changes in the 2024 Medicare Advantage and Part D Final Rate Announcement

Retrieved on: 
Monday, April 3, 2023
HD, Medicare Advantage, CMS, Risk adjusted mortality rate, Centers for Medicare & Medicaid Services, Semler, PAD, Risk, MACE, Medicare, Journal, Patient, Collection, Physician, Peripheral artery disease, Diagnosis, Mortality, American Heart, Pharmaceutical industry

SANTA CLARA, Calif., April 3, 2023 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, commented on the recent Centers for Medicare and Medicaid Services (CMS) 2024 Medicare Advantage and Part D Final Rate Announcement.

Key Points: 
  • SANTA CLARA, Calif., April 3, 2023 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, commented on the recent Centers for Medicare and Medicaid Services (CMS) 2024 Medicare Advantage and Part D Final Rate Announcement.
  • "Semler Scientific remains confident that screening for peripheral artery disease (PAD) using our QuantaFlo® product is in the best interest of at-risk Medicare beneficiaries, despite CMS' decision to finalize removal of PAD without complications from its Medicare Advantage risk adjustment model," said Wayne T. Pan, Ph.D., M.D., chief executive officer of Semler Scientific.
  • " The removal of PAD without complications from the Medicare Advantage risk adjustment model was originally proposed by CMS in its 2024 Medicare Advantage and Part D Advance Notice, which CMS released in February 2023.
  • Semler Scientific believes that the paradigm of earlier diagnosis and intervention will become the standard of care in managing patients with PAD and/or HD.

Landmark New England Journal of Medicine Publication Reports Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

Retrieved on: 
Thursday, March 30, 2023
Health, FDA, Medical Devices, Surgery, General Health, Clinical Trials, Cardiology, Chin Na, Chronic limb threatening ischemia, The New England Journal of Medicine, Chronic kidney disease, Diabetes, Amputation, Rutherford, PAD, University Hospitals Cleveland Medical Center, Quality of life, Multimedia, Research, Doctor of Philosophy, Female, NEJM, Dialysis, DO, Professor, MD, Patient, Transcatheter arterial chemoembolization, Peripheral artery disease, Mortality, MPH, CLTI, Wound healing, Pharmaceutical industry, Medicine

The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months.

Key Points: 
  • The results demonstrated that the LimFlow System achieved 66% amputation-free survival (patients were alive and amputation-free) at six months.
  • The therapy is designed to prevent amputation, which is associated with significant complications, mortality, and deterioration of quality of life.
  • PROMISE II was designed to be representative of a broad patient population, with 43% of subjects being Black, Hispanic, or Latino, and 31% female.
  • The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat their CLTI.

PCORI approves $123 million for research on postpartum care, hypertension management, antibiotic prescribing and a range of conditions

Retrieved on: 
Tuesday, March 28, 2023
Asthma, Hearing loss, CER, Patient-Centered Outcomes Research Institute, Health equity, Neurofibromatosis, Research, Rehabilitation, Hypertension, Work, Patient, PCORI, Colorectal cancer, Machine learning, National Priorities List, Peripheral artery disease, MPH, Birth control, Pharmaceutical industry, Nursing, Medical device, Health

WASHINGTON, March 28, 2023 /PRNewswire/ -- The Patient-Centered Outcomes Research Institute (PCORI) today announced funding awards totaling $123 million to support 15 new research studies. These studies aim to fill evidence gaps, enhance research methods, or improve health care decision making for a range of high-burden concerns among adults and children, including postpartum complications occurring in populations experiencing the greatest disparities in health outcomes.

Key Points: 
  • WASHINGTON, March 28, 2023 /PRNewswire/ -- The Patient-Centered Outcomes Research Institute (PCORI) today announced funding awards totaling $123 million to support 15 new research studies.
  • This research also will contribute data and strategies to help achieve health equity, one of PCORI's National Priorities for Health."
  • All funding awards were approved pending a business and programmatic review by PCORI staff and the issuance of formal award contracts.
  • With these latest awards, PCORI has invested approximately $4 billion to fund patient-centered CER and other research-related projects.

Humacyte Announces Fourth Quarter and Year End 2022 Financial Results and Business Update

Retrieved on: 
Friday, March 24, 2023
Infection, Tissue, CABG, Heart, Insurance, Biologics license application, KOL, Amputation, American Heart Association, Kidney, Conference call, PAD, DRS, Research, Sale, AHA, Facial muscles, Net, Congress, MAC, Patient, Investment, HUMA, Rejection, Peripheral artery disease, AV, FACS, FDA, HAV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Trauma, BLA, Conference, Food, Pharmaceutical industry, Video game, Cryptocurrency

DURHAM, N.C., March 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2022, and highlighted recent corporate accomplishments.

Key Points: 
  • There was no revenue for the fourth quarter of 2022 compared to $177.0 thousand for the fourth quarter of 2021, and revenue was $1.6 million for the year ended December 31, 2022, compared to $1.3 million for the year ended December 31, 2021.
  • Research and development expenses were $15.0 million for the fourth quarter of 2022, compared to $16.3 million for the fourth quarter of 2021, and were $63.3 million for the year ended December 31, 2022, compared to $61.3 million for the year ended December 31, 2021.
  • The decrease for the quarter ended December 31, 2022 compared to the prior-year quarter resulted primarily from a decrease in non-cash stock-based compensation expense.
  • Other net income was $17.1 million for the fourth quarter of 2022, compared to $64.2 million for the fourth quarter of 2021, and was $72.6 million for the year ended December 31, 2022, compared to $54.7 million for the year ended December 31, 2021.

JanOne Welcomes John Bonfiglio -- Veteran Biotech Executive, Deal Maker and Strategist -- to Top Management Team

Retrieved on: 
Thursday, March 23, 2023
Diabetic neuropathy, US, HIV, Triclonella sequella, JAN, Risk, PAD, International, CRPS, Doctor of Philosophy, The Immune Response Corporation, LAS, Pain, Peripheral artery disease, Running, Pain management, Security (finance), Neuro, FDA, Chronic pain, Consultant, Pharmaceutical industry, Management, Bonfiglio, Janon

LAS VEGAS, March 23, 2023 /PRNewswire/ -- JanOne (Nasdaq: JAN), a biopharmaceutical company specializing in developing non-addicting pain killers and treatments for underlying causes of pain, announced the hiring of John N. Bonfiglio, PhD, as interim president of its JanOne Biotech subsidiary. JanOne Biotech focuses on pain management for diabetic neuropathy, Peripheral Artery Disease (PAD), and other chronic pain conditions using innovative treatments developed by JanOne Inc.

Key Points: 
  • Dr. Bonfiglio is a veteran leader in the biotech industry with a track record of raising capital, building start-ups and excelling in C-suite roles.
  • After spending his early career at Allergan Pharmaceuticals and Baxter HealthCare, he turned to discovering, promoting and leading smaller biotech ventures.
  • Currently he is a board member for Avipero and executive board member for Sequella, a US- based biotech company.
  • Dr. Bonfiglio expressed his "goals for collaborating with the well-respected scientific team at JanOne."

Semler Scientific Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, March 21, 2023
Medicare Advantage, Insulin, CMS, Heart failure, Centers for Medicare & Medicaid Services, Moyamoya disease, Medicare, Publication, Investment, Patient, Echo, Vascular disease, Peripheral artery disease, Diagnosis, Cryptocurrency, Video game, Nursing, Pharmaceutical industry, Management, Reinsurance

SANTA CLARA, Calif., March 21, 2023 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, today reported financial results for the three months and year ended December 31, 2022.

Key Points: 
  • For the year ended December 31, 2022, compared to the corresponding period of 2021, Semler Scientific reported:
    Revenue of $56.7 million, an increase of $3.7 million, or 7%, compared to $53.0 million.
  • Semler Scientific's two largest customers (including their affiliates) comprised 43.3% and 25.8% of fourth  quarter revenues in 2022.
  • For the quarter ended March 31, 2023, Semler Scientific expects continued profitability and generation of cash from operating activities.
  • The call will address results of the fourth quarter and year ended December 31, 2022, as well as provide a business update on Semler Scientific's market outlook and strategies for the near-term future.