PCCP

Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection

Retrieved on: 
Tuesday, April 23, 2024
FDA, Health, Medical Devices, Cloud, OSF, Brain, Patient, PCCP, Seizure, Food, Software, MD, Doctor of Philosophy, Neurology, Physician, REMI, Caregiver, Harvard Medical School, Diagnosis, EEG, CHV, Food and Drug Administration, Medical device

REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” said Mark Lehmkuhle, PhD, Chief Executive Officer and Co-Founder of Epitel.

Key Points: 
  • REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” said Mark Lehmkuhle, PhD, Chief Executive Officer and Co-Founder of Epitel.
  • REMI Vigilenz AI for Event Detection leverages state-of-the-art proprietary machine learning to identify and annotate potential seizure events in REMI EEG records.
  • REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings.
  • REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.

BEACON BIOSIGNALS EXPANDS SLEEP ANALYSIS CAPABILITIES WITH FDA CLEARANCE OF SLEEPSTAGEML

Retrieved on: 
Wednesday, March 27, 2024
Diagnosis, Neurology, EEG, Guilloché, Sleep, Harvard Medical School, DSM-IV codes, Machine learning, Psychiatry, Algorithm, Interest, Patient, PSG, Research, Beacon, Neuroscience, Doctor of Philosophy, Biosignal, Clinical trial, PCCP, Literature, FDA, Neurodegenerative disease, Pharmaceutical industry

BOSTON, March 27, 2024 /PRNewswire/ -- Beacon Biosignals announced today that it has received FDA 510(k) clearance for SleepStageML™️, an advanced machine learning software that automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings to aid in the diagnosis and evaluation of sleep and sleep-related disorders. Beacon Biosignals is a health technology company focused on accelerating the development of therapies for neurological, psychiatric, and sleep disorders, and SleepStageML opens the door for more consistent, efficient, and precise sleep staging for these therapeutic areas. This latest clearance complements Beacon's previous FDA clearance of the Dreem 3S wearable headband and integrated algorithms, providing a comprehensive solution for precisely measuring sleep architecture across home and clinical settings.

Key Points: 
  • Beacon Biosignals is a health technology company focused on accelerating the development of therapies for neurological, psychiatric, and sleep disorders, and SleepStageML opens the door for more consistent, efficient, and precise sleep staging for these therapeutic areas.
  • This latest clearance complements Beacon's previous FDA clearance of the Dreem 3S wearable headband and integrated algorithms, providing a comprehensive solution for precisely measuring sleep architecture across home and clinical settings.
  • "With FDA clearances for both SleepStageML and Dreem 3S™ headband, Beacon now provides an unparalleled capability to measure sleep physiology whether studies are conducted in-home or in-clinic," said Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals.
  • This FDA clearance represents a major milestone that bolsters Beacon Biosignals' powerful machine learning platform for rapidly analyzing large neurophysiology datasets.

360 Communities Unveils A Premier Build-to-Rent Townhome Community, Crossroads at Town Center, in Jacksonville, FL

Retrieved on: 
Friday, March 22, 2024
Principal, St. Johns Town Center, BTR, Social, 360 Communities, Partnership, Heart, PCCP, FCM

Crossroads is a joint venture between PCCP, LLC and 360 Communities.

Key Points: 
  • Crossroads is a joint venture between PCCP, LLC and 360 Communities.
  • "We think Crossroads marks a pivotal moment for 360 Communities as we continue to redefine residential living nationwide.
  • Crossroads is the latest addition to 360 Communities' portfolio of build-to-rent communities, including neighborhoods currently leasing in the Jacksonville and Nashville MSAs."
  • 360 Communities emphasizes the advantages of leasing new homes within environments reminiscent of master-planned communities that prioritize healthy living.

Fighting the Silent Killer: Innovative Therapies for Pancreatic Cancer on the Rise

Retrieved on: 
Monday, October 23, 2023
Colon, Oncolytics Biotech, Genetics, News, Lung, Disease, Risk, Messenger, Lijun International Pharmaceutical (Holding) Co. Ltd., BNTX, Glycine, BioNTech, G12, Hope, RET, Prostate cancer, BRCA2, Cancer, Immune system, Pancreatic cancer, ORR, Hand, University, Roche, Therapy, Patient, Natural history of disease, DNA, CR, Eli Lilly and Company, CAD, 23andMe, JD, OTC, Eli Lilly, FOLFIRINOX, BRCA, Research, Clinical trial, BBB National Programs, Survival rate, Aspartic acid, Valine, Woman, ONC, MD Anderson Cancer Center, TSX, PCCP, Survival, FDA, Lilly, Attention, AACR, Incidence, BRCA1, New View (Eleanor Friedberger album), MBA, KRAS, Entrepreneurship, Breast, Diagnosis, Prostate, FTD, Pharmaceutical industry, Medical imaging, Vaccine, Nature

VANCOUVER, BC, Oct. 23, 2023 /PRNewswire/ -- USA News Group - Despite being a relatively rare form of cancer, pancreatic cancer remains one of the deadliest in the oncology field, the third leading cause of cancer death in the USA. Still not fully understood, pancreatic cancer's 5-year survival rate is currently only 12%. New analysis of data from the National Program of Cancer Registries database, covering around 65% of the US population, suggests that the incidence of pancreatic cancer among individuals younger than 55 years is increasing more rapidly than in those 55 years or older, and also more quickly in women than in men. As more and more cases of young people are showing up, calls from the leading pancreatic cancer organization PanCAN to increase funding for research are getting louder. Thankfully, within the biotech sector, there have been plenty of developments giving hope in the fight against pancreatic cancer, including those from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Eli Lilly and Company, Roche Holding AG (OTC:RHHBY), BioNTech SE (NASDAQ:BNTX), and even 23andMe Holding Co (NASDAQ:ME).

Key Points: 
  • As more and more cases of young people are showing up, calls from the leading pancreatic cancer organization PanCAN to increase funding for research are getting louder .
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • The BRCA1 and BRCA2 variants may also be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.
  • "It's an important milestone that shows we're headed in the right direction – and this means so much to all those affected by pancreatic cancer."

Fighting the Silent Killer: Innovative Therapies for Pancreatic Cancer on the Rise

Retrieved on: 
Monday, October 23, 2023
Colon, Oncolytics Biotech, Genetics, News, Lung, Disease, Risk, Messenger, Lijun International Pharmaceutical (Holding) Co. Ltd., BNTX, Glycine, BioNTech, G12, Hope, RET, Prostate cancer, BRCA2, Cancer, Immune system, Pancreatic cancer, ORR, Hand, University, Roche, Therapy, Patient, Natural history of disease, DNA, CR, Eli Lilly and Company, CAD, 23andMe, JD, OTC, Eli Lilly, FOLFIRINOX, BRCA, Research, Clinical trial, BBB National Programs, Survival rate, Aspartic acid, Valine, Woman, ONC, MD Anderson Cancer Center, TSX, PCCP, Survival, FDA, Lilly, Attention, AACR, Incidence, BRCA1, New View (Eleanor Friedberger album), MBA, KRAS, Entrepreneurship, Breast, Diagnosis, Prostate, FTD, Pharmaceutical industry, Medical imaging, Vaccine, Nature

VANCOUVER, BC, Oct. 23, 2023 /PRNewswire/ -- USA News Group - Despite being a relatively rare form of cancer, pancreatic cancer remains one of the deadliest in the oncology field, the third leading cause of cancer death in the USA. Still not fully understood, pancreatic cancer's 5-year survival rate is currently only 12%. New analysis of data from the National Program of Cancer Registries database, covering around 65% of the US population, suggests that the incidence of pancreatic cancer among individuals younger than 55 years is increasing more rapidly than in those 55 years or older, and also more quickly in women than in men. As more and more cases of young people are showing up, calls from the leading pancreatic cancer organization PanCAN to increase funding for research are getting louder. Thankfully, within the biotech sector, there have been plenty of developments giving hope in the fight against pancreatic cancer, including those from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Eli Lilly and Company, Roche Holding AG (OTC:RHHBY), BioNTech SE (NASDAQ:BNTX), and even 23andMe Holding Co (NASDAQ:ME).

Key Points: 
  • As more and more cases of young people are showing up, calls from the leading pancreatic cancer organization PanCAN to increase funding for research are getting louder .
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • The BRCA1 and BRCA2 variants may also be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.
  • "It's an important milestone that shows we're headed in the right direction – and this means so much to all those affected by pancreatic cancer."

UDOT Selects Granite for SR-108 Widening and Improvements

Retrieved on: 
Thursday, October 5, 2023
Public Policy, Government, State, Local, Other Construction & Property, Transport, Construction & Property, Urban Planning, Other Transport, Federal, PCCP, N, GVA, Sand, NYSE, UDOT, Acquisition, Safety, Utah Department of Transportation, Plumbing, Granite

Granite (NYSE:GVA) has been awarded an approximately $45 million contract by the Utah Department of Transportation (UDOT) to widen and improve State Route 108 (SR-108) in Davis County, Utah.

Key Points: 
  • Granite (NYSE:GVA) has been awarded an approximately $45 million contract by the Utah Department of Transportation (UDOT) to widen and improve State Route 108 (SR-108) in Davis County, Utah.
  • Funded by State and Federal sources, the project will be included in Granite's third-quarter CAP.
  • This represents a comprehensive reconstruction and expansion effort, encompassing the replacement and enhancement of all utilities and infrastructure components.
  • “By widening and enhancing the SR-108 corridor in this area, we are taking substantial steps to alleviate traffic congestion problems,” said Granite Vice President of Regional Operations, Jason Klaumann.

BBX Logistics Properties Announces Venture with PCCP, LLC to Develop Over 600,000 Square Foot Logistics Park over 40 Acres in Delray Beach, Florida

Retrieved on: 
Wednesday, September 13, 2023
Professional Services, Other Construction & Property, Commercial Building & Real Estate, Finance, Construction & Property, Building Systems, Urban Planning, Heart, PCCP, Partnership, Employment, BBX, Atlantic Avenue, U.S. 441, BBX Capital Corporation, Multimedia, Acquisition, OTCQX, PINK, Tourism, Warehouse

The joint venture intends to develop the site, which is entitled with rights to build up to 672,533 square feet (sf) of logistics space, into BBX Park at Delray, a logistics facility expected to be comprised of three buildings.

Key Points: 
  • The joint venture intends to develop the site, which is entitled with rights to build up to 672,533 square feet (sf) of logistics space, into BBX Park at Delray, a logistics facility expected to be comprised of three buildings.
  • View the full release here: https://www.businesswire.com/news/home/20230913802001/en/
    “Our plans at BBX Park at Delray reflect our goal of delivering high-quality logistics space in the heart of the rapidly growing population center of Western Palm Beach County.
  • We want to thank the Palm Beach County Commissioners and County staff who worked so tirelessly with us.”
    “We are pleased to partner with BBX Logistics Properties on this venture.
  • Our partnership underpins PCCP’s strategy to invest in Class-A logistics facilities in strategic locations," said Kevin Chin, Managing Director with PCCP.

23andMe Granted New FDA Clearance to Report Additional BRCA Variants

Retrieved on: 
Thursday, August 31, 2023
Lijun International Pharmaceutical (Holding) Co. Ltd., Pancreatic cancer, 23andMe, PCCP, DNA, Disease, Sanger, Ashkenazi Jews, Genetics, BRCA1, Food and Drug Administration, Cancer, Breast, Prostate, PGS, Marketing, Risk, Artificiality, Genetic testing, Entrepreneurship, BRCA2, BRCA, Health, FDA, Ovarian cancer, Gene, African Americans, Food, Saliva, Breast cancer, Prostate cancer, Birth control, Medical device, Pharmaceutical industry, Dietary supplement

SOUTH SAN FRANCISCO, Calif., Aug. 31, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, today announced the Company has received a U.S. Food and Drug Administration (FDA) 510(k) clearance to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report*. The clearance allows 23andMe to report an additional 41 variants in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. 23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk in 2018 to report 3 variants in the BRCA1 and BRCA2 genes, primarily found in people of Ashkenazi Jewish descent. Many of the 41 BRCA variants added through this clearance are known to have a higher rate of occurrence in populations traditionally underserved by genetic testing, including the African American and Hispanic/Latino communities. This marks the Company’s fourth FDA clearance for genetic cancer risk.

Key Points: 
  • The clearance allows 23andMe to report an additional 41 variants in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer.
  • In addition to the 510(k) clearance, the FDA also granted 23andMe the first-ever Predetermined Change Control Plan (PCCP), which allows the Company to add additional validated BRCA1 and BRCA2 variants and associated cancer risk information to its BRCA1/BRCA2 (Selected Variants) report without additional premarket review.
  • 23andMe also underwent robust analytical validation in order to meet FDA requirements to add variants to the BRCA1/BRCA2 (Selected Variants) report.
  • This clearance is the eighth pre-market authorization granted by the FDA to 23andMe covering its multiplexed Personal Genome Service.

Lovett Industrial and PCCP, LLC Acquire Two Industrial Business Parks in Houston, Texas

Retrieved on: 
Thursday, August 24, 2023
Commercial Building & Real Estate, Construction & Property, Building Systems, REIT, Heart, PCCP, Partnership, Texas State Highway Beltway 8, Voya Financial, JLL, Interstate 10, Multimedia, Tenant, Acquisition, Growth, Interstate Highway System, Industrial, Ring road, Warehouse

Ashley Bird, Asset Manager at Lovett Industrial commented, “Lovett Industrial is excited for the opportunity to acquire two business parks in the heart of Houston’s Northwest market.

Key Points: 
  • Ashley Bird, Asset Manager at Lovett Industrial commented, “Lovett Industrial is excited for the opportunity to acquire two business parks in the heart of Houston’s Northwest market.
  • The Claymoore Portfolio is Lovett Industrial’s second stabilized property acquisition and will be managed by Lovett Industrial Management.
  • In 2022, Lovett Industrial acquired Middlebrook Crossroads, an 18-building industrial business park, in Bridgewater, New Jersey.
  • Additionally in the Houston area, Lovett Industrial has 3.2 million square feet under construction and 3.3 million square feet of completed developments between seven projects.

JUNIPER SQUARE AND PEREVIEW TEAM UP TO DELIVER ASSET AND PORTFOLIO INSIGHTS FOR PRIVATE REAL ESTATE PARTNERS

Retrieved on: 
Wednesday, July 19, 2023
PCCP, Partnership, CMO, LP record, Organization, Acquisition, Investment, SAN, Microsoft Excel, Growth, CRE, GP, Security (finance), Financial services, Charles Dalfen

SAN FRANCISCO, July 19, 2023 /PRNewswire/ -- Juniper Square, the leading provider of partnership enablement for the private funds industry, today announced an exclusive partnership with Pereview, the only Life of The Asset® software platform supporting both equity and debt for real estate investments. By connecting Pereview's in-depth asset data to Juniper Square, joint clients can seamlessly share both asset-level and portfolio insights to improve fundraising efficiency and provide LPs with greater transparency.

Key Points: 
  • By connecting Pereview's in-depth asset data to Juniper Square, joint clients can seamlessly share both asset-level and portfolio insights to improve fundraising efficiency and provide LPs with greater transparency.
  • "Juniper Square and Pereview's combined offering provides a best-of-breed solution for fundraising and investor relations teams within leading GP organizations," says Matt Lawson, CMO at Juniper Square.
  • "The combination of Pereview and Juniper Square provides complete coverage for all of our needs," said Dalfen Chief Investment Officer Max Gagliardi.
  • In addition to Dalfen, existing mutual customers between Juniper Square and Pereview include PCCP, Ryan Companies, Rockwood Capital, Singerman Real Estate, and many more.